PRICE LICENSED TO POST WITHOUT PREPAYMENT PER COPY LICENCE NO. MR/Tech/WPP-337/West/2018-20 ` RNI REGN. NO. 18921/1970 25/- REGN NO. MCW/95/2018-20 PRICE LICENSED TO POST WITHOUT PREPAYMENT PER COPY LICENCE NO. MR/Tech/WPP-337/West/2018-20 `25/- RNI REGN.RNI NO. REGN. 78921/1970 NO. 18921/1970 Regn No.R egnMCW/95/2015-2017 No. MCW/95/2018-20

VOL. NO. 51 ISSUE NO. 40 (PAGES: 44) 22 TO 30 OCTOBER 2020 ISSN 0970-6054 WEEKLY PUBLICATION

vol. NO. 51 Issue NO. 41 (Pages: 44) 01 to 07 november 2020 ISSN 0970-6054 weekly publication 46

IndianIndian API APIss && Formulations forfor Global Global Healthcare

ADVANCED PROGRAM IN PHARMACEUTICAL QUALITY MANAGEMENT (APPQM) A VIRTUAL TRAINING PROGRAM - SERIES 2 Commences 1st February 2021 (Details on Page Nos. 4 & 5)

 IDMAIDMSpecifiedA RepresentationSubmission medicines on suppliedto Draft DCG Guidelines(I) free on Pathwayof cost for under dealingfor Regularization Patient cases Assistance of Kokate ofCommitteeProgrammes discontinuation approved run by of PharmaceuticalFDCs Scheduled including Formulations companies471 FDCs of exempted (PageVitamins, No. 4) from Minerals and Micro-nutrientsImport Duty (Page (Page No. 9) No. 6)  ‘Why Phytopharmaceutical Drug Discovery?’ by Dr S S Handa  (PageIDMContainer ANo. welcomes 6) shortage Patent affects (Amendment) Pharma exports, Rules 2020 industry (Page No. 8) Financeseeks solution Ministry (Page issues No. 28) Guidelines for implementation of interest waiver  Advisory: COVID-19 – Amendments/Relaxations/Compliances  (PageonBoosting loan No. 8) (Page domestic No. 30) APIs crucial for India to sustain its Global stronghold IDMA Bulletin Tasrade LI Generic(40) hit 22 toby 30 Supplier:record October 202060 Experts% surge (Page in freight No. 29) (Page No. 31) 1  Export restrictions on Hydroxychloroquine lifted (Page No. 19)  APharmaIOCD urges exports PM soarto utilize 15% itsin firstestablished half of FY21supply (Page chain No. 31) for COVID-19 IDMA Bulletin DoPvaccine LI (41) comes 01 distribution to 07 out November with (Page 2020 draft No. 32)Guidelines for Rs.6,940 crore PLI scheme1  COVID-19 vaccine delivery: Prepping for challenge extraordinaire (Page No. 33) to promote domestic production of Bulk Drugs (Page No. 32)  Reducing API dependence: Have we got the strategy right? (Page No. 39)

IDMA Bulletin LI (41) 01 to 07 November 2020 2

Founder Editor: Vol. No. 51 Issue No. 41 01 to 07 November 2020 Dr A Patani IDMA ACTIVITIES: Editor: Dr Gopakumar G Nair IDMA Representation to DoP on Revised Guidelines for the Production Linked Incentive Scheme (PLI) dated 29th October, 2020 – reg...... 6 Associate Editors: J L Sipahimalani GOVErNMENT NOTIFICATIONS: Dr Nagaraj Rao Scheme for grant of ex-gratia payment of difference between compound Dr George Patani interest and simple interest for six months to borrowers in specified loan National President accounts (01.03.2020 to 31.08.2020) – reg...... 7 Mahesh H Doshi DGFT matters: Immediate Past National President Discontinuation of Extension Counter RA Goa - reg...... 8 Deepnath Roy Chowdhury CUSTOMS MATTErs: Senior Vice-President Dr Viranchi Shah CBIC further amends Notification No.16/2017 to provide exemption to Vice-Presidents: Specified Medicines under certain Patient Assistance Programmes Bharat N. Shah (PAPs) run by Pharmaceutical Companies - reg...... 9 (Western Region) Manufacturing and other operations undertaken in bonded warehouses Asheesh Roy under Section 65 of the Customs Act, 1962 - reg...... 10 (Eastern Region) CBIC notifies New Exchange Rates w.e.f. 16th October 2020 - reg...... 12 B K Gupta GST MATTErS: (Northern Region) T Ravichandiran CBIC extends due date of return under Section 44 till 31.12.2020 - reg...... 13 (Southern Region) PArLIAMENT NEWS: Hon General Secretary In Lok Sabha & In Rajya Sabha...... 14 Dr George Patani New Developments: Hon Joint Secretaries Inhaled antibody drug for COVID-19 clears Coronavirus in animals...... 17 J Jayaseelan Atul J Shah Johns Hopkins researchers publish COVID-19 ‘prediction model’...... 18 Hon Treasurer Strong activation of anti-bacterial T cells linked to severe COVID-19...... 19 Vasudev Kataria Researchers uncover clues for COVID-19 treatment...... 20 For information contact IDMA Secretariat: (H.O.) New drug candidate for the treatment of COVID-19...... 21 Daara B Patel SCTIMST develops OralScan hand held device for detecting oral cancer...... 21 Secretary-General T R Gopalakrishnan National News: Deputy Secretary-General Health Ministry to review 4-point PSAIIF recommendations Melvin Rodrigues to improve Healthcare Services in the Country...... 22 Sr Manager (Commercial & Administration) DoP introduces revised PLI scheme for Bulk Drugs & Medical C K S Chettiar Devices Removing Minimum Investment limit...... 22 Asst. Manager (Publications & Administration) Health Ministry amends D&C Rules to bring Tapentadol under Delhi Office: Schedule H1 to curb its abuse...... 24 Ashok Kumar Madan Medical Device Companies ask DoP to reduce threshold investment Executive Director limit to Rs.75 to 90 crore from Rs.180 crore under PLI Scheme...... 25 S Ranganathan Asst Manager (Administration) CBIC assures of no delay in Customs Clearance of imported consignments at ports due to implementation of Faceless Assessment...... 26 IDMA STATE BOARDs CHAIRMAN Serbia throws up opportunities for Indian drug exporters...... 26 „ Gujarat State Board : Milan Patel „ Haryana State Board : P K Gupta Indian Pharma industry calls on US FDA to conduct virtual inspections „ Himachal Pradesh & in the wake of COVID-19 pandemic: Dr Sandhu...... 27 Uttarakhand State Board : R C Juneja Container shortage affects Pharma exports, industry seeks solution...... 28 „ Karnataka State Board : S M Mudda Boosting domestic APIs crucial for India to sustain its Global „ Madhya Pradesh State Board : Paresh Chawla stronghold as Generic Supplier: Experts...... 29 „ Tamil Nadu, Puducherry & Kerala State Board : J Jayaseelan Government expands PLI scheme: India seeks to cull China reliance „ Telangana State Board : Shaik Janimiya with latest move to boost bulk drug manufacturing...... 30 „ West Bengal State Board : Utpal Moitra Pharma exports soar 15% in first half of FY21...... 31 A Publication of Indian Drug Manufacturers' Association International News: 102-B, 'A-Wing', Poonam Chambers, Virus-hunting trio win Nobel for medicine on Hepatitis C discovery...... 31 Dr. A.B. Road, Worli, Mumbai - 400 018 When we can get a Covid Vaccine? Crucial results coming over next few weeks...... 32 Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 e-mail: mail_ [email protected]/ FEATUrE: [email protected]/ Website: www.idma-assn.org COVID-19 vaccine delivery: Prepping for challenge extraordinaire: Published on 7th, 14th, 21st and 30th of every month Lakshmipriya Nair ...... 33 Annual Subscription Indian Pharma is being squeezed – and it’s bad news for drug access ` 1000/- (for IDMA members) ` 2000/- (for Government Research/Educational Institutions) in developing countries: Thankom Arun & Reji K Joseph...... 37 ` 4000/- (for non-members) US$ 400 (Overseas) Reducing API dependence: Have we got the strategy right?: Reji K Joseph...... 39 Please send your payment in favour of Indian Drug Manufacturers' Association Announcement on "Advanced Program in Pharmaceutical Quality Management IDMAOpinions Bulletin Expressed LIXLIV By (41)The Au(38) 01tho rs08to Of 07to Individu 14November Octoberal Articl e2020 s2013 (A ppqm ) A Virtual Training Program - Series 2" Commences 1st February 2021...... 43 Do Not Necessarily Represent The Official View Of Idma. Advertisements...... 2, 41, 42, 43 & 44

MBA-STYLE INTERNATIONAL EDUCATIONAL PROGRAM FOR POTENTIAL LEADERS MBA-STYLE INTERNATIONAL EDUCATIONAL PROGRAM FOR POTENTIAL LEADERS

ADVANCED PROGRAM IN PHARMACEUTICAL QUALITY MANAGEMENT ADVANCAE VDIR TPURAOL TGRRAIANMIN G I NPR OPGHRAARM M- SAECREIESU T2 I CStAarLts 3QrdUWAeeLkIT oYf J aMnuAarNy A20G21EMENT A VIRTUAL TRAINING PROGRAM - SERIES 2 Starts 3rd Week ostf January 2021 A VIRTUAL TRAINING PROGRAM - SERIES 2 Commences 1 February 2021 Commences 1st February 2021 For further information / queries, please open the below links on our website www.idma-assn.org: For further information / queries, please open the below links on our website www.idma-assn.org:

APPQM FOR DEVELOPING CHANGE AGENTS FOR QUALITY EXCELLENCE APPQM FOR DEVELOPING CHANGE AGENTS FOR QUALITY EXCELLENCE APPQM - Program Modules Advantages of NSF’s Virtual Training APPQM - Program Modules Advantages of NSF’s Virtual Training 1. Pharmaceutical Quality Management Systems –  NSF’sNSF virtual’s vi trainingrtual combinestraining live instructor-ledcombines virtual liv e APPBestQM Industry - Prog Practicesram Mo dules Adclassroomsvantages and of N self-pacedSF’s V i learningrtual T onlinerain in(easyg to 1. (How Pha tor mensureace yourutic QMSal drives businessQ uality navigateiNnSstFru’s c e-learning)tovir-lredtua vl irtotuat r provideali nclinga s participantssrcooommbsi neand withs s anlivel fe- 1. M improvements) Pahnaargmeacemenutt icalS ystems – QuBaliestyt interactiveipansctreudc t landoer-ar lengagingedning v iortuan learninglinel cl (ae sexperience.assryo otom nas andvigat see elf- 2. 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Why sAPPQMet & k ineep INDIA?* your people) with electronic course material When 4. launchingTransfo therm firsting series of theDa APPQM,ta we i atn t IDMAo along TG iuem withes t NSF,f orS spe UKelaf -kreflectedsetudrs y ( eai onncl c thehu d d perceivedingay. MHR trustA , deficit US with4. internationalI n Tfroarnmsafot iregulatorsromn ing – despite t hDbeingea ta regarded Prac tiasicn tao l‘Pharmacy GFD ueofA thes et xWorld’S-rpeegu aandklaet rofferedosr s)( inenh acl globaluadningc educatione tMheHR m programAodu, UleSs APPQM,AInpf opinrl icamcollaborationation witho–f NSFt SHealthheta ti sSciences,tPricsac tic UK,taol as a collectiveFandDA m eproactiveoxt-irveguate response lathtoer des) lenhfromega attheensc industry. e the mWeodu boldlyles stated APPQM would be Unique, World-Class and transform the operation efficiency of companies attending. Well, did series one liveTArp auppn ltosica fexpectations?otrimon y ouro Bf usinSetassti stics to and motivate the delegates Over T(40Tr headelegatesn spforarcm tattendedi cyaol uappr seriesBulicsa ione.ntioness of statistics Add itional Benefits: to(T hetran psrfaocrtmic aylou appr bulicsiantieonss )of statistics A dd Sitaiofentya l oBf eIndnefiviits:dua ls during this COVID- to transform your business) S19a fpanety deof mIndic. ividuals during this COVID- 5. Reduction in Course Fees IDMAIDMA BulletinBulletinQua l XLVIILIiLIt y (41)(40) (15) 0122by to15to 07 30to D November21Octobere sAprilign 2016,2020 2020Pr ocess 19 pandemic. (from £80004944 5. V Qaluidaalittiyon abnyd TecDhnesioglno,g y TPrraoncesssfer tRoedu £33ct0ion0) in Course Fees (from £8000 (VBauliilddaintigon a a nfdo unTecdahntionol ogfoyr TrParnodusferct tSoa vi£3ng30 0o)f time especially travel time to (QBuuaillidtiyn gand a Knfoounwleddagetion M anagefor Pmroduentc) t Svenaviunge ino fB tanimgea leosrepe acinadll y ttrraavveel l &ti mhotee tol Quality and Knowledge Management) vsentayu ex penin Bsanesg alore and travel & hotel stay expenses

This is what they thought: "Transformative", "world-class", "best business investment we've ever made", "life changing", "worth every penny and more", "my company will be sending more delegates to series two", "has helped transform our quality culture" are just some examples of the feedback we've received from APPQM delegates. Nearly 30 'work placement projects' have been completed by APPQM delegates.These have generated $ millions in savings for their parent companies, improved their operational efficiency (profit), regulatory compliance and reduced risk. *Please visit IDMA website for details of benefits

Current Challenges & APPQM In this challenging times, the pharmaceutical industry will become competitive only if the 3 factors - Legacy & Reputation (License to Operate), Profit & Efficiency (Cost Control) and Customer service are balanced and managed well. The COVID-19 pandemic has created unique challenges as well as opportunities for the industry. In the absence of any regulatory inspections happening until quarter III of 2021 and reduced physical oversight by the corporate QA functions, the external interventions on the site will be reduced. There is an urgent need to use this time for building a strong leadership at the site for quality and compliance. We recommend the virtual APPQM for the site teams for keeping themselves updated with the changing regulatory expectations in the post COVID-19 phase, once the physical inspections start.

The need of the hour is to focus on long term preventive measures aimed at achieving continual improvements rather than short term Compliance-Oriented approach. Please don't get left behind and register for the second series of APPQM to have a competitive edge in the global market and to be future ready.

REGISTRATION FEE FOR SERIES TWO The Registration Fee for APPQM SERIES 2 is restructured at

Rs.3,15,000/- (Rupees Three Lakh Fifteen Thousand Only) Plus 18% GST Per Participant. You can initially block the seats by paying an advance amount of Rs.1,00,000/- (Rupees One Lakh Only) and balance 15 days before commencement of the program.

Registration Procedure : Please fill the Registration Form and send it to

Melvin Rodrigues Batul [email protected] [email protected] 9821868758 9920045226

For further information / queries : You may also contact Mr. S. M. Mudda, @ [email protected] / 9972029070 We sincerely hope that you see the benefit of attending this World-Class, MBA style, education program in order that you may reap the same benefits. Sincerely Yours,

S M MUDDA MAHESH H DOSHI DR. GEORGE A PATANI DAARA B PATEL Chairman, Regulatory National President, Hon. General Secretary & Secretary – General, Affairs Committee, IDMA & IDMA Vice Chairman, Industry IDMA Program Director, APPQM Institution Interaction Committee, IDMA

IDMAIDMA BulletinBulletin XLVIILILI (41)(40) (15) 0122 toto15 0730 to NovemberOctober21 April 20162020 2020 505 IDMA ACTIVITIES IDMA Representation to DoP on Revised Guidelines for the Production Linked Incentive Scheme (PLI) dated 29th October, 2020 – reg.

The Association has submitted the following 3. Point at 12.5 (iii): mentions “Base Line (if applicable)”. rd representation on 3 November 2020 to Ms S Aparna, Base Line is not defined in the revised PLI. We IAS, Secretary, Department of Pharmaceuticals, New request for clarification of this term. Delhi with copies to Dr V K Saraswat, Member, NITI Aayog and Ms Shubhrata Prakash, Director, NITI 4. Change of location may be permitted as long as the Aayog on the above subject: committed investment is achieved. 5. Clause 4.2.6 – Suggest rethinking. Carry forward of “At the outset we wish to thank you for the revised PLI st Guidelines incorporating industry suggestions. Removal unused incentive amount be allowed as in the 1 year of the minimum investment criteria and the condition of it may not be possible to achieve 100% production domestic sales should encourage a greater number of due to teething problems. applicants to take advantage of the Scheme. As regards 6. Finally, since the criteria of “minimum investment” ‘Brownfield units’ we are sending a separate note for is now removed in the revised Guidelines, some flexibility in present environmental regulations for better of the wordings (in Bold) as shown below are no utilisation of surplus capacity. At the same time we still feel longer relevant or need minor alterations, which if they can be covered under the PLI Scheme, the country can see expeditious production of eligible products. you may wish to look into as there is no longer an investment criteria. Further, we wish to bring to your kind notice our following suggestions: 2.18. However, the investment already made in the ancillary facilities shall not qualify for the purpose 1. Reasonable time limits for grant of various of the committed investment to be made under the permissions for additional production from Pollution Control authorities needed for timely implementation scheme. of the project, and ultimate success of the PLI 2.21.3 Expenditure on land shall not be considered. Scheme. Similarly Guest House, Recreation building, office 2. Many of the eligible products are “Intermediates” or building residential accommodation etc shall not be require intermediates to be developed to achieve considered as threshold investment. value addition. Although, Para 5(f) of EIA 2006 Notification mentions “API & Intermediates” but the 6.11 Investment as defined in the Guidelines shall recent relaxation in EC rules by MoEF&CC wide Notification No.S.O.3636(E) dated 15.10.2020 for be considered for determining the eligibility. treating all Bulk Drug Projects as B2 category has 6.1.6 omitted word “Intermediates”. Even the draft 2020 The applicant shall submit a certificate EIA Notification (yet to be notified) also mentions by Chartered Engineer to be appointed by PMA for under para 5(f) “APIs & Intermediates”. Unless committed investment by the applicant and shall be included intermediates’ production under PLI relied upon by PMA. Looking forward to your favourable Scheme will get delayed, as EC will be insisted consideration”. upon. l l l

IDMA Bulletin LI (41) 01 to 07 November 2020 6

GOVErNMENT NOTIFICATIONS Scheme for grant of ex-gratia payment of difference between compound interest and simple interest for six months to borrowers in specified loan accounts (01.03.2020 to 31.08.2020) – reg.

DFS Notification Ref.F.No.2/12/2020-BOA.I, dated 23rd October 2020

1. State Bank of India (SBI), (v): Credit card dues; 2. All India Financial Institutions (AIFIS), (vi): Automobile loans; 3. All Nationalised Banks, (vii): Personal loans to professionals; 4. All Banking Companies, Urban Co-operative Banks, and Non-Banking Financial Companies (NBFCs) registered (viii): Consumption loans. with RBI [through RBI}), Any borrower whose aggregate of all facilities 5. All NBFC–Micro Finance Institutions (NBFC-MFIS) that with lending institutions is more than Rs.2 crore are members of an RBI-recognised Self-Regulatory Organisation [through Micro Finance Institutions Network (sanctioned limits or outstanding amount) will (MFIN) and Sa-Dhan], not be eligible for ex-gratia payment under this 6. All State Co-operative Banks, District Central Co-operative scheme. Banks and Regional Rural Banks (RRBs) [through the rural (b):: The aforesaid eligibility shall be subject to the banking system supervisor {National Bank for Agriculture and Rural Development (NABARD)}, following further conditions and stipulations: 7. All Housing Finance Companies (HFCs) registered with (i): Account should be standard as on the National Housing Bank (NHB) [through the supervisor 29.02.2020, i.e., loan should not be a Non- of HFCs (National Housing Bank)], Performing Asset (NPA) as on 29.02.2020. The undersigned is directed to convey that in view of 1. (ii): Lending institution must be either a banking the unprecedented and extreme COVID-19 situation, company, or a Public Sector Bank, or a the Central Government has approved “Scheme for Co-operative Bank [j.e., an Urban Co- grant of ex-gratia payment of difference between operative Bank or a State Co-operative compound interest and simple interest for six months Bank or a District Central Co-operative to borrowers in specified loan accounts (01.03.2020 Bank], or a Regional Rural Bank, or an All to 31.08.2020)”. Benefits under the scheme would India Financial Institution, or a Non-Banking be routed through lending institutions. Operational Financial Company or a Housing Finance Guidelines for the scheme are attached . * Company registered with RBI or National 2. Eligibility criteria for ex-gratia payment under the Housing Bank as the case may be. A scheme are as follows: Non-Banking Financial Company, Micro (a):: Borrowers in the following segments/classes of Finance Institution should be a member loans, who have loan accounts having sanctioned of a Self-Regulatory Organisation (SRO) limits and outstanding amount of not exceeding recognised by RBI. Rs.2 crore [aggregate of all facilities with lending (iii): The ex-gratia payment under this scheme institutions] as on 29.02.2020, shall be eligible shall be admissible irrespective of whether under the Scheme: the borrower in sub-clause (1) had (i): MSME loans; fully availed or partially availed or not availed of the Moratorium on repayment (ii): Education loans; announced by RBI vide its circular DOR. (iii): Housing loans; No.BP.BC.47/21.04.048/2019-20, dated (iv): Consumer durable loans; 27.03.2020 and extended on 23.05.2020.

IDMA Bulletin LI (41) 01 to 07 November 2020 7

3. The period to be reckoned for crediting of difference to appropriately equip its designated officer(s)/cell between compound interest and simple interest by for processing such claims in a timely manner, and the lending institutions mentioned in paragraph 2(b) to notify details of the same on its website. (ii) above to eligible borrowers as per paragraph 2 7. Issues and concerns relating to claims submitted above would be from 01.03.2020 to 31.08.2020 (six by the lending institutions shall be handled through months/184 days). For accounts closed during the the designated cell at SBI in consultation with said period, the period for crediting would be from Government of India. Each lending institution shall 01.03.2020 and restricted to the date of closure of put in place a grievance redressal mechanism for the such account. eligible borrowers for redressal of their grievances 4. The benchmarks and modalities for ex-gratia payment arising out of the present scheme within one of difference between compound interest and simple week from the date of issuance of these Scheme interest under the scheme would be as detailed in the Guidelines, at appropriate level(s). While putting in attached operational Guidelines. The rate of interest place such grievance redressal mechanism, lending would be as prevailing on 29.02.2020, i.e.,incasethe institutions can keep in mind the communication rate of interest has changed thereafter, it shall not be dated 01.10.2020 issued by the Indian Banks’ reckoned for the purposes of this computation. The Association in respect of resolution framework for payable ex-gratia amount shall have to be credited COVID-19 related stress for Guidance. Grievances, to the account of the borrower by the respective if any, of the lending institutions shall be resolved lending institutions as ex-gratia payment under the through the designated cell at SBI in consultation scheme. with the Ministry of Finance, Government of India. 5. The aforesaid exercise of crediting the amount as 8. In case of any issues/queries relating to interpretation stated above in the respective accounts of the eligible of this scheme, the decision of Government of India borrowers described in paragraph 2 above by the shall be final. respective lending institution shall be completed on A K Ghosh, or before 05.11.2020. Under Secretary, 6. After the exercise mentioned in paragraph 5 above Department of Financial Services, has been completed, lending institutions can lodge Ministry of Finance, New Delhi. their claim for reimbursement latest by 15.12.2020. (*Operational Guidelines not reproduced here. Members- Claims shall be submitted to designated officer(s)/ interested to have the same may kindly write to IDMA cell at the State Bank of India (SBI). SBI is advised Secretariat at email: [email protected] for getting a soft copy of the same through email).

l l l DGFT matters Discontinuation of Extension Counter RA Goa - reg.

Joint DGFT Trade Notice No.01, dated 29th october 2020

To All Concerned; All the Trade & Industry in Goa are hereby requested to file all the applications and correspondence henceforth Attention of the Trade is invited to the discontinuation in RA Mumbai by using the Office Code 03 instead of Extension Counter RA Goa with immediate effect as per of Office Code 17 which was used for erstwhile Goa the instructions received from Director General of Foreign Trade (Hqrs.) vide letter no.01/69/12/33/2018-O&M (Pt.) Office. th dated 6 October, 2020 and in continuation of O&M A K Choudhary, Additional Director General of Foreign Trade, th Instruction No.05/2018 dated 6 September, 2018 and Office of The Additional Director General of Foreign Trade, earlier Trade Notice No.03 dated 10th September, 2018. Mumbai.

l l l

IDMA Bulletin LI (41) 01 to 07 November 2020 8

CUSTOMS MATTErs CBIC further amends Notification No.16/2017 to provide exemption to Specified Medicines under certain Patient Assistance Programmes (PAPs) run by Pharmaceutical Companies - reg.

Notification No.41/2020-Customs, dated 29th October, 2020 In exercise of the powers conferred by sub-section (1) of section 25 of the Customs Act, 1962 (52 of 1962), the Central Government, on being satisfied that it is necessary in the public interest so to do, hereby makes the following further amendments in the notification of the Government of India, in the Ministry of Finance (Department of Revenue), No.16/2017-Customs, dated the 20th April, 2017, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R.394(E), dated the 20th April, 2017, namely:

In the said notification, in the Table, for the entries in column (3) and column (4) at the serial numbers given in column (1) of the Table below, the corresponding entries at column (2) and column (3) of the Table below shall be substituted, namely: Table

(1) (2) (3) 17. “Win for Patients - Cancer Care/Umaang Novartis Healthcare Private Limited 18. Win for Patients - Cancer Care/Umaang Novartis Healthcare Private Limited 19. Win for Patients - Cancer Care/Umaang Novartis Healthcare Private Limited 20. Win for Patients - Cancer Care/Umaang Sandoz India Private Limited 21. Win for Patients - Cancer Care/Umaang Novartis Healthcare Private Limited 22. Win for Patients - Cancer Care/Umaang Novartis Healthcare Private Limited 43. Sutent Patient Assistance Programme - STAR Pfizer Products India Private Limited 44. Crizalk Patient Assistance Programme - STAR Pfizer Products India Private Limited 45. Inlyta Patient Assistance Programme - STAR Pfizer Products India Private Limited 46. Palbace Patient Assistance Programme - PRERNA Pfizer Products India Private Limited 47. Enbrel Patient Assistance Programme Pfizer Limited 48. Xeljanz Patient Assistance Programme Pfizer Limited 49. Genotropin Patient Assistance Programme Pfizer Products India Private Limited 50. Atgam Patient Assistance Programme Pfizer Products India Private Limited 51. Aromasin Patient Assistance Programme Pfizer Products India Private Limited 52. Campto Patient Assistance Programme Pfizer Products India Private Limited”.

F.No.332/24/2010-TRU (Pt.III)

Gaurav Singh, Deputy Secretary, Department of Revenue, Ministry of Finance, New Delhi.

Note: The Principal Notification No.16/2017-Customs, dated the 20th April,2017 was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide number G.S.R.394(E), dated the 20th April, 2017, and was last amended by Notification No.83/2017-Customs, dated the 31st October, 2017 published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide number G.S.R.1356(E), dated the 31st October, 2017. l l l

IDMA Bulletin LI (41) 01 to 07 November 2020 9

Manufacturing and other operations undertaken in bonded warehouses under Section 65 of the Customs Act, 1962 - reg.

Circular No.48/2020-Customs, dated 27th October, 2020

To, for job work and the procedure to be followed for All Principal Chief Commissioners/Chief Commissioners of removal of goods for job work by a Section 65 Customs/Customs (Preventive), unit. All Principal Chief Commissioners/Chief Commissioners of Clarification: Circular No.34/2019-Customs Customs & Central tax, dated 1st October 2019 had provided, in All Principal Commissioners/Commissioners of Customs/ Annexure B (Form to be maintained by a unit Customs (Preventive), operating under section 65 of the Customs Act, All Principal Commissioners/Commissioners of Customs 1962 for the receipt, processing and removal of & Central tax, goods) for removal of goods from a Section 65 All Principal Director Generals/Director Generals under CBIC. unit for job work and receipt after job work, as part 1. Section 65 of the Customs Act, 1962 provides that of the manufacture or other operations. Thus, only the owner of any warehoused goods may carry on inputs are allowed to be sent out from a Section any manufacturing process or other operations in 65 unit for job work. The capital goods can be the warehouse in relation to such goods, with the sent outside the Section 65 unit for repair, with permission of the Principal Commissioner of Customs the permission of the bond officer. or Commissioner of Customs and subject to such The job work shall be subject to the following conditions as may be prescribed. Manufacture and conditions: Other Operations in Warehouse (No.2) Regulations 2019, were issued vide Notification No.69/2019- (i) The goods upon import should be first deposited Customs (N.T.) dated 01.10.2019, hereinafter in the Section 65 premises and duly accounted for referred to as, “MOOWR, 2019” prescribing the before the same is sent for job work. procedure, documentation and compliances to be (ii) It should be possible to establish the identity/correlate followed under Section 65 of the Customs Act, the goods after job work with those sent for job 1962. work. Board has from time to time received suggestions and 2. (iii) On completion of the job work, the goods can be requests from members of the trade and industry on brought back to the Section 65 unit or exported/ the scheme of Manufacturing and other Operations in a Warehouse under Section 65 of the Customs cleared to DTA from the job worker’s premises. Act, 1962. The requests revolve around making the In case the goods are exported/cleared to DTA scheme more investor friendly and seeking more from the job worker’s premises, the procedure as clarity with regard to certain aspects. A Committee per Regulations 14 and 15 of MOOWR 2019, as was therefore constituted by the Board to study the applicable shall be followed and the date of removal provisions of Section 65 of the Customs Act, 1962 from job workers premise shall be deemed to be the and the regulations issued there under and make date of removal from the warehouse. recommendations for consideration of the Board. The committee has since submitted its report. (iv) Scrap, waste or remnants generated during the job work shall be either returned to the Section 65 unit The issues raised by the trade and the 3. or cleared from job-worker’s premises on payment recommendations of the Committee have been examined. To bring in greater regulatory clarity and of applicable duties. certainty for investors, Board has decided to clarify (v) The procedure and timeline for the return of goods the following issues: sent for job work under Section 65 unit will be in line (i) Job work for a Section 65 unit: Trade has with GST provisions, as the Section 65 Unit is also sought clarity on the goods eligible to be sent a GST registrant.

IDMA Bulletin LI (41) 01 to 07 November 2020 10

(vi) The account to be maintained under Circular (i.e. the warehoused goods) by filing Ex-Bond No.34/2019-Customs dated 1st October 2019 Bill of Entry, when such job worked goods are will be kept updated as regards job work at all returned to the principal/owner. In case the goods times. after job work are exported from the premises of the Section 65 unit, the import duty on the Trade has also requested that moulds, jigs, tools, warehoused goods used for the job work need fixtures, tackles, instruments, hangers, patterns and not be paid as per section 69 of the Customs Act, drawings be allowed to be sent to the job workers premises 1962. for use in the job work. Considering the nature of goods sought to be removed from a Section 65 unit for the (iii) Whether a Section 65 unit can procure goods purposes of job work, Board has decided to allow the said from FTWZ: Circular 34/2019-Customs dated goods viz moulds, jigs, tools, fixtures, tackles, instruments, 1st October 2020, does not explicitly mention hangers, patterns and drawings to be sent to the premises sourcing of goods from FTWZ. Hence there of a job worker, subject to due accounting of the goods by is apprehension on whether such sourcing is the Section 65 unit in the account specified. Such goods allowed. will be used by the job worker exclusively for the concerned Clarification: Vide para 14 of Circular No. Section 65 unit. The procedure and timeline will be in line 34/2019-Customs dated 1st October 2020, with the GST provisions. Board has clarified that the objective of Section 65 is to enable manufacture and other It may also be noted that the bond to be executed by operations in customs bonded warehouses. a Section 65 unit, prescribed through the aforementioned For this purpose, the units should be able to circular, stays in full force notwithstanding the removal of procure required raw materials, consumables, goods for job work from a Section 65 unit. capital goods etc., imported or procured from In case of violation of any of the above provisions, domestic market. the goods shall be deemed to be cleared for home There are no restrictions imposed on sourcing consumption on the date of clearance of the goods for job of goods by units operating under Section 65. work. The applicable duties, interest and penalties shall Moreover,the units are GST registrants, which be reckoned accordingly. are also allowed to procure goods from SEZ/ FTWZs. In view of the foregoing, it is clarified that (ii) Job work for others by a Section 65 unit: a Section 65 unit may source capital goods or Trade has sought clarity on whether the Section inputs from a SEZ/FTWZ, following the applicable 65 unit can itself carry out job work for other units procedures. and the procedure to be followed for the same. 4. The above provisions may be given wide publicity The issue has been examined Clarification: through issue of Public Notices. with a view to enhance capacity utilization and acknowledging the realities of manufacturing 5. Any difficulties faced in the implementation of this Circular may please be brought to the notice of environment where various units support each Board. other in producing the final product. It is clarified that a Section 65 unit being a GST registered F.No:473/03/2015-LC unit, can perform job work operations and shall maintain due accounting of such job work as per Temsunaro Jamir, Additional Commissioner(ICD), the provisions of GST law. Central Board of Indirect Taxes & Customs, In case any imported inputs which are warehoused Department of Revenue, Ministry of Finance, are consumed during the job work process, duty New Delhi. shall be paid on such goods

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IDMA Bulletin LI (41) 01 to 07 November 2020 11

CBIC notifies New Exchange Rates w.e.f. 16th October 2020 - reg.

Notification No.99/2020-Customs (N.T.), dated 15th October, 2020

In exercise of the powers conferred by section 14 of 8. Kuwaiti Dinar 247.80 232.35 the Customs Act, 1962 (52 of 1962), and in supersession New Zealand 9. 50.10 47.85 of the Notification No.95/2020-Customs(N.T.), dated Dollar 1st October, 2020 except as respects things done or omitted Norwegian to be done before such supersession, the Central Board 10. 8.05 7.80 Kroner of Indirect Taxes and Customs hereby determines that the rate of exchange of conversion of each of the foreign 11. Pound Sterling 97.15 93.85 currencies specified in column (2) of each of Schedule I 12. Qatari Riyal 20.80 19.55 and Schedule II annexed hereto, into Indian currency or Saudi Arabian 13. 20.20 18.95 vice versa, shall, with effect from 16th October, 2020, be Riyal the rate mentioned against it in the corresponding entry Singapore 14. 55.00 53.10 in column (3) thereof, for the purpose of the said section, Dollar relating to imported and export goods South African 15. 4.55 4.30 SCHEDULE-I Rand 16. Swedish Kroner 8.45 8.15 Rate of exchange of one Sr. Foreign 17. Swiss Franc 82.00 78.75 unit of foreign currency No. Currency equivalent to Indian Rupees 18. Turkish Lira 9.55 9.00 (1) (2) (3) 19. UAE Dirham 20.65 19.35 (a) (b) 20. US Dollar 74.25 72.55 (For Imported (For Exported

Goods) Goods) SCHEDULE-II Australian Rate of exchange of 100 units 1. 53.55 51.25 Sr. Foreign Dollar of foreign currency equivalent No. Currency 2. Bahraini Dinar 200.95 188.60 to Indian Rupees 3. Canadian Dollar 56.85 54.85 1. Japanese Yen 71.05 68.40 4. Chinese Yuan 11.10 10.75 2. Korean Won 6.60 6.20 5. Danish Kroner 11.80 11.35 F.No.468/01/2020-Cus.V 6. EURO 87.80 84.70 Bullo Mamu, Under Secretary , Central Board of Indirect Taxes Hong Kong 7. 9.65 9.30 and Customs, Department of Revenue, Ministry of Finance, Dollar New Delhi.

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IDMA Bulletin LI (41) 01 to 07 November 2020 12

IDMA ACTIVITIES CDSCO MATTERS CSR Initiatives CDSCOby IDMA provides with the guidancesupport of on its Regulatory Members Pathway – reg. DCG(I) Circular Ref.X-11026107/2020-PRO, dated 20th March 2020

To, for sale and distribution would be processed on All StakeholdersIDMA through ACTIVIT IES CDSCO web site Copy for priority though expedited review/accelerated Information, approval. IDMA ACTIVITIES PS to JS(R), Ministry of Health and Family Welfare, Nirman IDMA ACTIVITIES CSR Initiatives by IDMA with the support of its Members Bhawan, New Delhi. 4. Any firm having DrugNaccine already approved for COVID-19 in any otherCSR country Initiatives can directly by approach IDMA with the support of its Members Novel Corona-virus DiseaseCSR I (COVID-19)nitiatives hasby spreadIDMA with the support of its Members DCG(I) through Public Relations Office regarding over 118 countriesCBIC with MATTE nowRS more than 191,127 cases and treatment, which boosts “innate immunity”, was initiallyNATIO IDMANHowAL NEWS doesACTIVITIES Sepsivac(SPECIAL) work? expedited review/accelerated approval for marketing approved by the Drug Controller7807 General people of India have (DCGI) lost their lives as on 18.03.2020. World It contains heat-killed mycobacterium w (Mw), in India. for gram negative sepsis whichHealth is a Organization disease caused by (WHO) has declared it as pandemic. IDMA congratulatesCBICIDMA-TNPKSB notifies Dr New Kiranan immunomodulator, Exchange CSR Mazumdar-Shaw Activities which is a non-pathogenic on being bacteria. At present there is noth current evidence from randomized 5. Data requirement for animal toxicity study, clinical namedRates EY w.e.f. World 17 Entrepreneur Aprilmycobacterium. 2020 “Normally -O reg.f The when youYear developAssociation-Tamil 2020 a vaccine, Nadu, But the scientists found thatclinical the pathological trials symptoms to recommend you grow the any organism specific and kill treatment it. It is calledPuducherry for heat killed. & Kerala study, State stability study etc. may be abbreviated, th of this disease and Covid-19Notification were quite No.39/2020-Customs similar. And given Here (N.T.), we heat dated killed 16 the April, bacteria. 2020 It is a Boardstandard (IDMA-TNPKSB) vaccine suspected or confirmedIDMA ACTIVITIES patients with COVID-19. deferred, or waived on case to case basis depending the urgency of finding a solution toDr the Kiran rapidly Mazumdar-Shaw, rising concept,” My Vishwakarma business focus said, is addingglobal healththatis the gladcare bacterium toand inform the is provision that on In exercise of the powers conferred by section 14 of 10. Norwegian 7.40 7.15 Covid-19 cases across the world, Executivethe scientists Chairperson thought of of India-producedof by universal fermentation. access to life savingth medicine; however,upon my the type of vaccine, nature of drug, plant from the Customs Act, 1962 (52 of 1962), and in supersession Kroner 8 June 2020, we donated testing theC treatmentSR Initiatives against the current basedInby order I pandemicDM Biocon toA encouragewith caused Limited, the was support research responsibility &of development its as M an embers entrepreneur of drug is greater than simply of the Notification No.37/2020-Customs(N.T.), dated 11.“ThePound treatment Sterling we are 97.40 testing againstRs.18.0094.05 Covid-19 Lakhs whichworth the drug is extracted & its experience in case st named ‘EY World Entrepreneur delivering value to shareholders. by1 April,the SARS-CoV-2 2020 except virus. as respectsor vaccine things done for or prevention omitted or treatment of COVID-19,of any these 3 medicines, of The Year 2020’ at a ground-is12. designedQatari to Riyal enhance innate21.75 immunity which20.45 is very of Phyto-pharmaceuticals. to be done before such supersession, the Central Board She added, “Wealth creationin thecan presencebe a catalyst of ourfor CSIR got the approval application to testbreaking, “Sepsivac” virtual submitted award against ceremony. tocritical. CDSCO13. Saudi People will Arabian who be are processed weak 21.10in innate on immunity high19.80 will get of Indirect Taxes and Customs hereby determines that change, and all entrepreneurs Deputyhave a Drugresponsibility Controller- to Covid-19 in a Phase 2 clinical trialKiran about was picked10 days from ago. among theGST 46 infection MATTErS Riyal faster,” he said. 6. Applications to manufacture or import DrugNaccine the rate of exchange of conversionpriority. of eachCDSCO of the foreign will also providethe world guidance around them on regulatoryand the communities in which The trial is being conducted on 50award patients winners at the from All India 41 countries 14. Singapore 54.60 Dr Manivanan,52.80 IDMA- currencies specified in columnpathway (2) of each on of such Schedule matter. Vishwakarmathey operate. explained Women that also it is play a non-specific a hugely important for test, analysis and further use BA/BE or Clinical Institute of Medical Sciences (AIIMS),and territories New Delhi, vying AIIMS for the world Dollar TNPKSB-Chairman- I and Schedule II CBICannexed hereto, extends into Indian due currency date vaccine of role whichreturn in couldeconomic beunder used development, to bothSection cure and and for protect44too long their Bhopal, and Post Graduate Institutetitle. of Medical Inth the Education award’s 20-year15. South African 4.25 Mr Jayaseelan,3.95 Trial Vice- may be processed within 7 days. or vice versa, shall, with effect from 17 April, 2020, be people. He explained that there are generally three types IDMA donated medicines to the following contribution2.Rand Bliss has GVS been ignored.PharmaChairman-Mr It’s L importanttd. Sathish that we & andthe rateResearch history,mentioned (PGIMER), Kiran against becomes Chandigarh. Theit in thethe details thirdcorresponding EY are Worldtill as entryEntrepreneur under31.12.2020 - - reg. of vaccines.use the platform of EY World Entrepreneur of7. The YearIn case to of emergency, Import license (Form 10) would Institutions:in columnof (3)The thereof, Year Award for the winner purpose from of India.the said She section, follows former16. Swedish Kroner 7.75 Members7.50 Mr Pandian “We expect the results from this Phase 2 trial within encourage3. C achetmore women thPharmaceuticals to participate in entrepreneurial Pvt. Ltd. IDMA donated medicines to the following 2. Bliss GVS Pharma Ltd. relating toIndian imported world and title export winnersGST-Central1. goods. UdayAny Kotak firm Tax of havingNotification Kotak Mahindra a Drug17. “ThereNo.80/2020, VaccineSwiss are therapeuticFranc dated under 28vaccines, development 80.85October, where& 2020 you Mr77.80 give Rajesh. them We 30-45 days from now. And if the results are encouraging, IDMA donated medicines to the following 2.be Bgrantedliss GVS Pwithoutharma LInstitutions:td. Registration Certificate (Form 41) Bank (2014) and– Narayana which Murthy organises of Infosys Technologies walking(Centralas18. a drugpursuits.Turkish Tax) for curing. Lira I’m trulyThere honoured 11.45are prophylactic towere receive 10.75fortunate vaccines, this prestigious to have 3. Cachet Pharmaceuticals Pvt. Ltd. 1. Sai Sevawe will seek Mandal approval from the Drugfor Controller COVID-19 because ofcan I nstitutions:directly4. approach Fourrts DCG(I) (India) through Laboratories 3. P vt.Cachet Ltd. Pharmaceuticals Pvt. Ltd. IDMA donatedLimited medicinesThe (2005). AdyarSC Cancer H toSheEDU the also LInstitute followingE -becomesI (WIA), the as second you are woman aware,which19.2. to is youUAEBaward.” lissgive Dirham GVSto people Pharma to protect21.60 Ltd. them. And20.25 there are subject to approval1. ofSai Central Seva Mandal Government. – which organises walking pilgrimageemergency from and keep Mumbai on continuing to the Shirdi Phase 3 every trial. That’s year for 4. Fourrts (India) Laboratories Pvt. Ltd. Institutions: holdIn the exercise title, following of the powersOliviaPublic Lum conferred of RelationsHyflux by Limited sub-section 1. from Office Sai Seva forIn the seekingMandal said notification,– which guidance organises for the for figures, walking letters 4. andFourrts (India) Laboratoriespilgrimage Pvt. Ltd. from Mumbai to Shirdi every year for Sr. a Foreignpublic charitable Ratevoluntary of exchange institute dedicated of one to thesome 20.care3. whichC5.USachet Manny haveDollarI nd P both harmaceuticalsStul, Swift the Chairman properties,77.65 Laboratories and P which vt.Co-CEO L 75.95td. are of calledL imitedMoose Toys approximatelyhow it happens,” 500 Ram pilgrims Vishwakarma, Director, Integrative pilgrimageword “31 fromst October, Mumbai 2020”, to Shirdi the everyfigures, year letters for and word approximately 500 pilgrims 5. Ind Swift Laboratories Limited No. (1)SingaporeofCurrency cancerof section forin 2011.the44 oflast unitthe 60 Central ofyears. foreignregulatory DuringGoods currency these and pathway. Services Covid Times,immunomodulators. Tax and Chair of the EY World Entrepreneur of The YearFor 5.judging Ianynd Swift additional Laboratories informati Limited on kindly contact Public 1. SaiMedicine Seva (Council Mandal of Scientific– which & organises Industrial Research), walking approximatelyst 500 pilgrims - Act,the institute2017 (12 is of badly 2017), in need read ofwith funds/materials rule 80 of the (as Central Covid4. Fourrts“31 December, (India)SC H2020”LEDUaboratoriesL shallE II be substituted. Pvt. Ltd. 2. M. C. Damanwalla Charitable Dispensary, 6. Sai Mirra Innopharm Pvt. Ltd. Dr Mazumdar-Shaw,equivalent 67, to founded Indian rupees Bangalore-based“Sepsivac panel,6. will says:Sai be an“Kiran Mirra immunomodulator, is Iannnopharm inspirational which entrepreneur Pwillvt.Relations have L td.6. whoSai Office Mirra Innopharm through P tollvt. L td.free number 1800 11 1454 & 2. M. C.pilgrimageJammu, Damanwalla told. from Mumbai Charitable to Shirdi every Dispensary, year for 2. M. C. Damanwalla Charitable Dispensary, Udvada - This institution aims at helping and treating (1) GoodsBioconmaterials(2) and Limited to Services each in health 2. 1978Tax Rules,warrior withAny(3) 2017, just in firm the two the hospital or employeesCommissioner, research is an extraSr.and5. instituteIdemonstratesndForeign Swift havingLaboratories thatRate determination, protocol of exchange Limited for perseverance of 100 and a Udvadaapproximately - This institution 500 pilgrims aims at helping and treatingprotectiveU dvadaF.No.CBEC-20/06/09/2019-GST effect - This and institution therapeutic aims effect at helping both,” and he treating said.write to startupinnovPcdsco.nicinthe poor and needy patients, villagers and Adivasis M. C. Damanwalla Charitable Dispensary, Udvada: Vishwakarmacurrentlyburden to saidleads such that thecharitable oncecompany(a) it hospital,applies, that is butthe now (b) stillapproval worth many close patientsNo. to willingnessCurrency to innovateunits canof foreign create currencylong-term value.M. CThe. Damanwalla Charitable Dispensary, Udvada: on the recommendations ofrepurposing the Council, hereby of existing makesthe drugs/vaccines poorM. andC. needyDamanwalla patients, for villagerstreatment Charitable and Adivasis Dispensary, Udvada: who live in and around Udvada and also supplies 1. Alkem Laboratories Ltd. the2. poorM.from C. theand Damanwalla areDrug needy dependent Controller patients, on(For is Charitable expectedthem), Imported villagersas toall come patients (For Dispensary, fast Exportedand are as treateditAdivasis is there6.Vishwakarma SaiPramod Mirra Kumar, is hopefulInnopharm Director,equivalent that the Central P Phasevt. to BoardLIndiantd. 2 clinical of rupees Indirect trials Taxes and IDMtheRsA donated 50,000following medicines crore further by to amendmentmarket-cap the followingof COVID-19 andin the employs notification will more2. also of Bthan lissthe who beGVSjudging givenlive Pharma in andpanel priorityLtd. around were for impressedUdvada review and by alsoandher abilitysupplies to build1. andAlkem Laboratories Ltd.free medicines to them. who Uanlivedvada emergency in either -and This situation. free aroundinstitution or at Soa very ifUdvadaaimsGoods) the minimal Phaseat helping cost.and2 trial Goods) Onand alsoshows the treating mass thatsupplies request of(1) thefree treatment Customs,medicines(2) will Department to provide them. ofpositive Revenue, results. (3)Ministry And of Finance,because New Delhi. Dr V G Somani, 2. Cachet Pharmaceuticals Pvt. Ltd. Institutions:Government11,000 people. of India in the Ministry of Finance (Department3. Cachet Psustainharmaceuticals1. growthAlkem Povervt. LL thetd.aboratories past 30 years and Ltd. by her integrity2. Cachet Pharmaceuticals Pvt. Ltd. 1. Australian Dollar 49.30 47.10 theM. drug C. Damanwallais already in use Charitable for sepsis Dispensary,or septic shock U dvada: WeDrugs are thankful Controller to the following General members (India), who donated the“Sepsivac” poor byand theis effectiveneedy Hospital patients, againstfor donors Covid-19, villagers &approval. on a specific the and world Adivasisrequest may for th drugs and passion for philanthropy(a) that has delivered(b) huge global 3. Centaur Pharmaceuticals Ltd. free medicines1. ofSai Revenue),On Sevato being them. Mandal No.41/2020-Central anointed – which as organisesthe EY Tax, World walking dated Entrepreneur the4. 5 May,FourrtsWe are (INote:ndia) thankful L Theaboratories to Principal the following Pvt. Notification Ltd. members No.41/2020-Central who donated Tax, 2. Bahraini Dinar 206.20 200.90 treatment,2. “human Cthachet safety isP alreadyharmaceuticals assured,” he said, Pvt. 3. Ltd.Centaur Pharmaceuticalsmedicines Ltd. for this noble cause: whohave livea vaccinefrom pilgrimagein and the against mostaround from respectedthe Mumbai diseaseUdvada to Chairman Shirdias andearly every also asof theone year supplies Hospital month for Padma 1. Aimpact.datedlkem the SheL 5aboratories May, has(For 2020,built Imported wasIndia’s L td.published largest (For in biopharmaceutical theExport Gazette of India, Central Drugs Standard Control Organization, 4. Corona Remedies Pvt. Ltd. 2020of the published Year, Dr inMazumdar-Shaw the Gazette of India,said, Extraordinary,“At 5.its medicinescore,Ind Swift L foraboratories this noble Limited cause: th freefrom3. medicines now,Canadian approximatelyat least Dollarto for them. emergency500 pilgrims 3.55.30 use. weApplications volunteered53.45 to contribute for adding Clinical the thatExtraordinary, it willTrial be videapplicable permission numberGoods) G.S.R.275(E),for all age and groups.Goods) dated theDirectorate 5 May,20204. Corona General Remedies of Health Pvt. Ltd. Services, Public Relation Office, We are thankfulentrepreneurshipVibhushan to the Drfollowing V Shanta,is about members solving problems. who The donated greatest2. CcompanyDrachet Shanta onP inharmaceuticals a Person foundation at the of timecompassionate P ofvt. donating Ltd. capitalism the medicines. and Sai Seva Mandal: 4. 2. ChinesePartM. C.II, SectionDamanwallaYuan 3, Sub-section 11.00 Charitable (i), Dispensary, vide10.70 number 6. G.S.R.Sai Mirra and I3.nnopharm was Clastentaur P vt.amended Ltd. P videharmaceuticals Notification No.69/2020–Central Ltd. IDMA is thankful to the above members for their help opportunitieslist of 3 medicines often requestedarise at applicationsthe by toughest them. Namely times, to and Neukineimport Saithat’s1. Seva“We , orJapanese puttingare manufactureMandal: keeping patient Yen our needsfingersth Drug72.40 before crossed Vaccine profits.” and hoping69.80 for the IDMA is thankful to the above members for their help New Delhi. medicinesWe for 5.areMeanwhile, this thankfulDanish275(E),U dvadanoble Kroner todated Vishwakarma - theThis cause: institutionfollowingthe 5th 11.40May, aims informed members at2020, helping namely:- that and who 11.00 CSIRtreating donated has TaxShe datedwas very the 30thankfulSeptember, to IDMA 2020, & all publishedits members. vide May number our 1. Alkem Laboratories Ltd. and support. & . Indian Drug Manufacturers’M. C. Damanwalla2.3. KoreanCentaur Charitable Won Pharmaceuticals Dispensary,6.45th Udvada: Ltd. 6.05 also6. got beenapprovalPegastatheEURO poor my experienceandfor needyconductingPeg-Grafeel patients, throughout85.00 Phase villagers my 3 clinicalentrepreneurialand 81.95Adivasis trial of journey.1.best,” A lkemVishwakarmaG.S.R.595(E),service4. L aboratories Cto oronaHumanity said.Source: dated AsLtd. the Moneycontrol,developingRemedies Continue 30 September, asa PRNewswire,vaccine ever... P 2020.vt. against L td. 04.06.2020 and support. medicines for thiswho livenoble in and cause: around Udvada and also supplies 1. Alkem Laboratories Ltd. “Sepsivac”7. Hong against Kong Covid-19. 10.10 9.75 a new4. diseaseCorona takes Remedies time, researchers Pvt. L td.the world over are     free medicines to them. F.l No . 468  l  / 01 / l 2020-Cus.V    Sai Seva Mandal:Dollar 2. rushingCachet Ptoharmaceuticals repurposeIDMA existing Pisvt. thankful Ltd. drugs, vaccines to the against above the members for their help Sai Seva“The Mandal: Phase 3 trials will be done on 1,100 people 8. KuwaitiWe are thankful Dinar to the following254.65 members who238.80 donated 3. disease.PramodCentaurIDMA PKumar,harmaceuticals is Director,thankful L td.Central to the Boardabove of members Indirect Taxes for their help Have you renewed your Membership for the 1. Alkem600 L medicinesaboratorieswill be forthose this noble who L td.cause: have tested positive but and support. Have you renewed your Membership for the 1. Alkem9. NewLaboratories Zealand Ltd.46.95 44.75 4. andCoronaand Customs, support.Remedies Ministry Pvt. L oftd. Finance, Department of Revenue, Source: IANS, IndiaTVNews, 02.05.2020 non-symptomatic,Dollar and 500 will be those who are out of New Delhi. Year 2019-2020 & 2020-2021 Sai Seva Mandal: IDMA is thankful to the above members for Ytheirear help 2019-2020 & 2020-2021 hospital,” Vishwakarma said. If not, please do so; kindly contact IDMA Secretariat at: 1. Alkem Laboratories Ltd. and support.         If not, please do so; kindly contact IDMA Secretariat at: Email: [email protected] / [email protected] Email: [email protected] / [email protected]    For Advertising in the Classified Columns and alsoTel.: for 022 series - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723 Have you renewed your Membership for the Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723 For AdvertisingHave in youthe Classified renewed Columns your M embershipand also for series for the advertisements advertisements please contact: NOW AVAILABLEHave you renewed your M embership! 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IDMA Bulletin LI (41) 01 to 07 November 2020 13

PArLIAMENT NEWS In Lok Sabha & In Rajya Sabha

In Lok Sabha Export of Medical Items Ban on Chinese Products Lok Sabha Unstarred Question No.503 Lok Sabha Unstarred Question No.482 Shri Kuruva Gorantla Madhav: Prof Saugata Ray: Shri Gopal Chinnaya Shetty: Shri Lavu Sri Krishna Devarayalu:

Q. Will the Minister of COMMERCE & INDUSTRY be Shri Pocha Brahmananda Reddy: pleased to state; Q. Will the Minister of COMMERCE & INDUSTRY be (a): whether Union Government has achieved success in pleased to state; banning the import of Chinese products on the basis (a): whether the Government has removed the ban of rules; on exports for diagnostic kits, PPEs, sanitizers, (b): if so, the details thereof; Hydroxychloroquine and other medical items; (c): whether the Industrial Sector of the country has been (b): if so, the details thereof; benefitted with this decision; and (c): whether after the ban on exports of said items, (d): if so, the details thereof; and the indigenous production of the above items has increased drastically; and (e): whether banning the import of China products helps Atmanirbhar Bharat Abhiyan and if so, the details (d): if so, the details thereof? thereof? Answered on 16th September 2020 Answered on 16th September 2020 A. (a) and (b): The prohibition on export of various medical items such as PPE Coveralls, 2/3 Ply A. (a) to (e): The Government regularly reviews the masks, Face Shields, Sanitizers (except when country’s import policy, based on emerging trade exported in containers with dispenser pumps), and economic factors. Decisions to regulate imports Hydroxychloroquine API and its formulations, 13 are taken based on the assessment in national and other Pharmaceutical APIs and its formulations public interest. At present, approximately 550 tariff and Ventilators has been removed. While export lines are under the ‘Restricted’/‘Prohibited’ category of Diagnostic Kits, N-95/FFP2 masks is currently for imports under the Foreign Trade Policy, imports restricted, their export is allowed subject to a monthly of which are restricted from all countries including quota. China. To support and expand domestic capacities, (c) & (d): The prohibition on export of medical items Government has also implemented policies to was imposed to ensure domestic availability of these promote the domestic manufacturing through ease items to fight COVID-19. These have been relaxed of doing business and Production Linked Incentives based on an assessment, from time to time, of the (PLSs), including in the field of mobile phones and domestic requirement, production capacity and surplus available for export. Prior to 20th March, 2020, electronics components and bulk drugs and medical the requirement for PPE Coveralls was largely met devices, in line with the vision of Atmanirbhar Bharat. through imports as there was very limited domestic The full impact of the promotional measures on the production suitable for COVID-19 requirements.The industry will be discernible as the global economy export ban on PPE Coveralls was removed when the recovers. domestic production of PPE Coveralls subsequently The Minister in the Ministry of Commerce & reached 1.5 crore units per month. The availability of Industry (Shri Piyush Goyal) Alcohol based Hand Sanitizers was 10 lakh litres per

IDMA Bulletin LI (41) 01 to 07 November 2020 14

annum. This manufacturing capacity subsequently with by the Customs Authorities under the relevant increasedannum. This to 38manufacturing Lakh litres percapacity day, subsequentlyenabling the provisionswith by the of Customs law. Authorities under the relevant prohibitionincreased toon 38 the Lakh export litres of perAlcohol day, basedenabling hand the provisions of law. prohibition on the export of Alcohol based hand The Minister in the Ministry of Commerce & sanitizers (except when exported in containers The Minister in the Ministry of Commerce & sanitizers (except when exported in containers Industry (Shri Piyush Goyal) with dispenser pumps) to be removed. Ventilators Industry (Shri Piyush Goyal) productionwith dispenser in country, pumps) which to be was removed. negligible Ventilators prior to Januaryproduction 2020, in country, was ramped which up was to negligibleenable export prior ofto In Rajya Sabha In Rajya Sabha domesticallyJanuary 2020, manufactured was ramped ventilators up to enable today. export of Raw materials for making drugs domestically manufactured ventilators today. Raw materials for making drugs The Minister in the Ministry of Commerce & Rajya Sabha Unstarred Question No.691 The MinisterIndustry in the (Shri Ministry Piyush of Goyal) Commerce & Rajya Sabha Unstarred Question No.691 Industry (Shri Piyush Goyal) Smt Phulo Devi Netam: Smt Phulo Devi Netam: Misclassification of Export Items Q. Will the Minister of CHEMICALS AND FERTILIZERS Misclassification of Export Items Lok Sabha Unstarred Question No.516 beQ. pleasedWill the Ministerto state; of CHEMICALS AND FERTILIZERS Lok Sabha Unstarred Question No.516 be pleased to state; Shri Ravneet Singh Bittu: (a): whether it is a fact that our dependency on China in Shri Ravneet Singh Bittu: (a): thewhether matters it is of a medicine fact that isour increasing, dependency if so, on the China details in Q. Will the Minister of COMMERCE & INDUSTRY be ofthe import matters of ofmedicines medicine during is increasing, the last if six so, months; the details pleasedQ. Will theto state; Minister of COMMERCE & INDUSTRY be of import of medicines during the last six months; (b): whether it is also a fact that the supply of raw pleased to state; (a): whether it is a fact that there are increasing cases (b): materialswhether forit is drugs also froma fact China that has the declined supply ofduring raw (a): ofwhether misclassification it is a fact thatof items there byare the increasing importers cases as thematerials spread for of drugsCoronavirus from China infection; has declined during the spread of Coronavirus infection; ‘Others’;of misclassification of items by the importers as (c): whether it is also a fact that China has overcharged (b): if‘Others’; so, the details thereof, sector-wise and the action (c): forwhether raw material it is also used a fact for that making China drugs, has overcharged the details (b): takenif so, theagainst details the thereof, defaulting sector-wise importers; and the action thereof;for raw materialand used for making drugs, the details thereof; and (c): whethertaken against the Government the defaulting is planning importers; to curb import (d): the efforts being made by Government to make (c): ofwhether uncategorised the Government items and is planning impose to requirement curb import (d): Indiathe efforts self-reliant being in madethe field by of Government medicine, the to details make ofof specialuncategorised licences itemsfor them and and impose take otherrequirement related thereof?India self-reliant in the field of medicine, the details measures; thereof? of special licences for them and take other related Answered on 18th September 2020 (d): ifmeasures; so, the details thereof; and Answered on 18th September 2020 A. (a): Many APIs are imported from China, for (e):(d): ifif not,so, thethe detailsreasons thereof; therefor? and A. manufacturing(a): Many APIs of medicine. are imported As per from available China, data for

(e): if not, the reasons therefor?th frommanufacturing the various of Portmedicine. Offices As of per CDSCO, available the data details from Answered on 16 September 2020 ofthe import various of Portsuch Offices APIs duringof CDSCO, the last the sixdetails months of import are th A. (a)A nsweredto (e): About on one 16 fourth September of India’s total2020 imports under:of such APIs during the last six months are under: A. are(a) tounder (e): Aboutthe ‘Others’ one fourth category of India’s of Indian total importsTrade Classificationare under the (Harmonized‘Others’ category System) of Indian [ITC (HS)],Trade 2017,Classification Schedule–I (Harmonized (Import Policy). System) Accordingly, [ITC (HS)], Government2017, Schedule–I has initiated (Import a reviewPolicy). of Accordingly, the imports underGovernment ‘Others’ has category initiated and a review advised of theTrade imports and Industryunder ‘Others’ to accurately category mention and theadvised specific Trade ITC (HS) and codeIndustry of the to accurately item sought mention to be theimported specific while ITC filing(HS) thecode Bill of of the Entry. item Insought addition to be to importedefforts being while made filing (b):(b): TheThe supplysupply ofof rawraw materialmaterial fromfrom ChinaChina gotgot bythe the Bill Government,of Entry. In addition trade advisories to efforts werebeing issued made impactedimpacted forfor shortshort time.time. However,However, thethe majormajor IndianIndian requestingby the Government, importers to trade propose advisories separate were new issued ITC pharmaceuticalpharmaceutical companiescompanies hadhad adequateadequate stocksstocks (HS) codes where no such codes exists for a specific requesting importers to propose separate new ITC whichwhich werewere monitoredmonitored byby thethe Department.Department. TheThe supplysupply item. As part of this initiative, the Finance (No.2) Act, (HS) codes where no such codes exists for a specific waswas restoredrestored onceonce thethe factoriesfactories openedopened afterafter thethe 2019 dated 1st August, 2019 created new specific item. As part of this initiative, the Finance (No.2) Act, lockdownlockdown periodperiod inin China.China. ITC2019 (HS) dated codes 1st August,for a number 2019 ofcreated items, newwhich specific were (c): No complaints/references regarding overcharging earlierITC (HS) in thecodes ‘Others’ for a number category. of Mattersitems, which related were to (c): No complaints/references regarding over for raw material used for making drugs has been misclassificationearlier in the ‘Others’ of export-import category. Matters items are related dealt to charging for raw material used for making drugs has received. misclassification of export-import items are dealt been received. IDMA Bulletin LI (41) 01 to 07 November 2020 24 IDMA Bulletin LI (41) 01 to 07 November 2020 15

IDMA ACTIVITIES CDSCO MATTERS CSR Initiatives CDSCOby IDMA provides with the guidancesupport of on its Regulatory Members Pathway – reg. IDMA ACTIVITIES CDSCO MATTEDCG(I)RS Circular Ref.X-11026107/2020-PRO, dated 20th March 2020

CSR Initiatives CDSCOby IDMA provides with the guidancesupportTo, of on its Regulatory Members Pathway –for reg. sale and distribution would be processed on All StakeholdersIDMA through ACTIVIT IES CDSCO web site Copy for th priority though expedited review/accelerated DCG(I) Circular Ref.X-11026107/2020-PRO,Information, dated 20 March 2020 approval. IDMA ACTIVITIES PS to JS(R), Ministry of Health and Family Welfare, Nirman IDMA ACTIVITIES CSR Initiatives by IDMA with the support of its Members Bhawan, New Delhi. 4. Any firm having DrugNaccine already approved for To, for sale and distribution would be processed on COVID-19 in any otherCSR country Initiatives can directly by approach IDMA with the support of its Members All StakeholdersIDMA through ACTIVIT IES CDSCO web siteNovel Copy Corona-virus for DiseaseCprioritySR I (COVID-19)nitiatives though expedited hasby spreadIDM A review/accelerated with the support of its Members Information, DCG(I) through Public Relations Office regarding over 118 countriesCBIC with MATTE nowRapproval.S more than 191,127 cases and PS to JS(R), Ministrytreatment, of Health which and boosts Family “innate Welfare, immunity”, Nirman was initially IDMAHow doesACTIVITIES Sepsivac work? expedited review/acceleratedIDMA ACTIVITIES approval for marketing CSR Initiatives by IDMA with (d):the With asupport view to attain7807 self-reliance ofpeople its and havereduce Members importlostIDMANATIO their ACTNAL I VNEWSI TlivesIESHowever, (SPECIAL) as on Russia 18.03.2020. is an important World destination for approveddependence by the Drug in Controller APIs/Bulk General drugs, theof IndiaDepartment (DCGI) of Indian pharmaceutical exports and it is the fourth Bhawan, New Delhi. 4. ItAny contains firm havingheat-killed DrugNaccine mycobacterium already w (Mw), approvedin India. for for gramPharmaceuticals negative sepsis has whichHealth rolled is a Organizationtwo disease schemes caused viz by (WHO) (i) haslargest declared importer of it pharmaceuticalas pandemic. products from CBICIDMA-TNPKSB notifies Newan immunomodulator,COVID-19 Exchange CSR Activities in any which otherC isSR country a non-pathogenic Initiatives can directly by approach IDMA with the support of its Members bacteria. “ProductionCSR IDMA Initiatives Linked congratulates Incentive by (PLI) IDM SchemeA Drwith thfor Kiran theIndia, supportMazumdar-Shaw worth USD 552.41of its million, M emberswhich on grew being at 14% Novel Corona-virus Disease (COVID-19)At present has spreadthere is no currentmycobacterium. evidence “Normally from when randomized you develop a vaccine,5. Data requirement for animal toxicity study, clinical promotion of domesticRates manufacturing w.e.f. of critical 17 Key April DCG(I)and 2020 contributed through - reg. 2% of Public the total RelationsPharmaAssociation-Tamil exports Office from Nadu, regarding But the scientistsnamed found that the EY pathological World symptoms Entrepreneur you grow the organism O andf The kill it. ItYear is called 2020 heat killed. over 118 countriesCBIC with MATTE nowStartingRS more Materials than (KSMs)/Drug191,127clinical cases trialsIntermediates and to recommend (DIs) India. any Other specific than Russia, treatment countriesPuducherry such for as Poland,& Keralastudy, State stability study etc. may be abbreviated, treatment, which boosts “innate immunity”, was initiallyNATIO IDMANHowAL NEWS doesACTIVITIES Sepsivac(SPECIAL)Notification work? No.39/2020-Customs (N.T.),expedited dated 16 review/acceleratedth April, 2020 approval for marketing 7807 people have lostof this their diseaseand lives Active and as Covid-19Pharmaceutical on 18.03.2020.suspected were quite Ingredients similar. or World confirmedAnd (APIs) given In Here patients weGreece, heat withkilled Ukraine, theCOVID-19. bacteria. Romania, It is Slovenia, a Boardstandard (IDMA-TNPKSB)Uzbekistan vaccine approved by the Drug Controller General of India (DCGI) Dr Kiran Mazumdar-Shaw,IDMA ACTIVITIES My business focus is global health care and the provisiondeferred, or waived on case to case basis depending the In urgency exerciseIndia”It contains ofand of finding the(ii) “Promotionpowersheat-killed a solution conferred of mycobacterium toBulk the by Drug rapidlysection Parks”. rising14 w ofThe(Mw), concept,” in India.and Vishwakarma Hungary are said, the addingother markets thatis the glad bacteriumin theto informEastern is that on for gram negative sepsis whichHealthCBIC is a Organization disease notifies caused by (WHO) New Exchangehas declared it Executive as pandemic. Chairperson of India-10. ofNorwegian universal access to7.40 life saving medicine;7.15 however, my IDMA-TNPKSBCovid-19the CustomsanGuidelines immunomodulator,cases Act,CSR across 1962 of both the (52Activities world, theof 1962), schemeswhich the scientistsand is inwerea supersession non-pathogenic thoughtreleased of on produced Europe by fermentation. which have business potential8th June for 2020,India, wefrom donatedupon the type of vaccine, nature of drug, plant from bacteria. IDMA congratulates Drth Kiran Mazumdar-Shaw on being Kroner At present there is notesting currentmycobacterium. the27Cth treatmentSR July, evidence I2020.nitiatives against “Normally thefrom current basedwhenInby randomized order Iyou pandemicDM Biocon develop toA encouragewith caused Limited, a vaccine, the5. was support researchData theresponsibility perspectiverequirement &of development its as of Mangenerics embers entrepreneurfor animalmarket. of drug is greatertoxicity than study, simply clinical Rates w.e.f. 17of theApril Notification 2020 No.37/2020-Customs(N.T.), - reg. Association-Tamil dated 11. “The Nadu,Pound treatment Sterling we are 97.40 testing againstRs.18.0094.05 Covid-19 Lakhs whichworth the drug is extracted & its experience in case named EY World Entrepreneurbyst the SARS-CoV-2 virus. Of Thenamed Year ‘EY World 2020 Entrepreneur delivering value to shareholders. 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Applications to manufacture or import DrugNaccine Covid-19 cases across the world, Executivethe scientists Chairperson thought theof of rate India-produced of exchangeof by universal fermentation. of conversion access to oflife each saving of theth medicine; foreign however,upon myGroups,the theworld typeregularly around of themvaccine,engages and thewith natureDr communities the Manivanan, respective of drug, in IDMA- which plant from the Customs Act, 1962 (52 of 1962), and in supersessionThe trial is beingExport Kronerconducted opportunities on 50award patients winners at for the8 from June All India 41 2020, countries we14. donated Singapore 54.60 52.80 testing theC treatmentSR Initiatives against the current basedInby order I pandemicDM Biocon toA encouragewith caused Limited,currencies the was support research specifiedresponsibility in&of columndevelopment its pathway as M an(2) embers entrepreneur of each on of of such drug Schedule is greater matter. than simplyVishwakarmacountry’sthey operate. 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(Shri of Finance, D V Sadananda DepartmentHave you Gowda) ofrenewed Revenue, your MembershipNew Delhi. for the 5.Meanwhile,DanishopportunitiesUdvada Kroner Vishwakarma - This ofteninstitution arise11.40 aims informed at atthe helping toughest that and 11.00 CSIRtreating1. times, hasA andlkem9. that’s opportunityNewL“Weaboratories Zealand areShe keeping wasfor Indian very L ourtd. thankful 46.95fingerspharmaceutical crossedto IDMA and & exports.44.75 all hoping its members. for4. theC oronaand MayIDMA support.ourRemedies is thankful Pvt. L td.to the1. above Alkem members Laboratories for their help Ltd. and support. medicinesWe for are this thankful noble to the cause: following members who donated 3. Centaur Pharmaceuticals Ltd. New Delhi. Source: IANS, IndiaTVNews, 02.05.2020 beenPegastathe poor my experienceand & needyPeg-Grafeel patients, throughout villagers. Indian my entrepreneurialand Drug Adivasis Manufacturers’ non-symptomatic,M. journey. C1.best,”. Damanwalla 2. A DollarlkemVishwakarmaKorean L aboratoriesandCharitable Won 500 said. will Dispensary, AsL td.be developing 6.45those U dvada:who a vaccineare out6.05 againstof and support. Year 2019-2020 & 2020-2021 also6. got approvalEURO for conducting85.00 Phase 3 clinical81.95 trial of Sai Seva Mandal:service4. Cto oronaHumanitySource: Moneycontrol,Remedies Continue as PRNewswire, ever... Pvt. Ltd. 04.06.2020IDMA is thankful to the above members for Ytheirear help 2019-2020 & 2020-2021 medicines for thiswho livenoble in and cause: around Udvada and also supplies hospital,”1. Alkem Vishwakarma Laboratories said.Ltd. If not, please do so; kindly contact IDMA Secretariat at: 7. Hong Kong 10.10 9.75 a new4. diseaseCorona takes Remedies time, researchers Pvt. L td.the world overl and are support.  l  l        “Sepsivac”free against medicines Covid-19. to them. 1.F .No A.lkem 468  /L01aboratories / 2020-Cus Ltd..V    If not, please do so; kindly contact IDMA Secretariat at: Sai Seva Mandal: 2. Cachet P harmaceuticals  Pvt. Ltd.    Email: [email protected] / [email protected] Dollar rushing to repurposeIDMA existing is thankful drugs, vaccines to the against above the members for their helpEmail: [email protected] / [email protected] Sai Seva“The Mandal: Phase 3 trials will be done on 1,100 people    For Advertising in the Classified Columns and alsoTel.: for 022 series - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723 8. KuwaitiWe are thankful Dinar to the following254.65 members who238.80 donated 3. disease.PramodCentaurIDMA PKumar,harmaceuticals is Director,thankful L td.Central to the Boardabove of members Indirect Taxes for their help Tel.: 022 - 2494 4624 / 2497 4308 / Fax:Have 022 you - 2495 renewed 0723 your Membership for the 1. Alkem600 L medicinesaboratorieswill be forthose this noble who L td.cause: have tested positive but and support. HaveH youave you renewed renewed your your MMembership for for the the advertisements please contact: 1. Alkem9. NewLaboratories Zealand Ltd.46.95 44.75 4. andCoronaand Customs, support.Remedies Ministry Pvt. ForL oftd. Finance, Advertising H Departmentave in youthe ofClassified renewed Revenue, Columns your M embershipand also for series for the advertisements Source: IANS, HIndiaTVNews,ave you renewed 02.05.2020 your Membership for the Mr Chettiar (+9820629907) Publications Department non-symptomatic,Dollar and 500 will be those who are out of New Delhi. please contact:Mr Chettiar (+9820629907) Publications Department Year 2019-2020IDMA & Bulletin2020-2021 LI (11) 15 to 21 March 2020 5 Sai Seva Mandal: IDMA is thankful to the above members for Ytheirear help 2019-2020 IDMA & Bulletin 2020-2021 LI (11) 15 to 21 March 2020 5 hospital,” Vishwakarma said.  Y ear  2019-2020 & 2020-2021 If not, please do so; kindly contact IDMA Secretariat at: 1. Alkem Laboratories Ltd.  and support.    Year 2019-2020 & 2020-2021 If not,If Yplease not,ear please do do2019-2020so; so; kindly kindly contact contact IIDMADMA & Secretariat Secretariat2020-2021 at: at: Email: [email protected] / [email protected] If not,Email: please [email protected] do so; kindlyIDMA contact IDMA /BULLETIN [email protected] Secretariat at: IDMA BULLETIN    Email: [email protected] / [email protected] Advertising in the Classified Columns and alsoTel.: for 022 series - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723 Email:If not, [email protected].: please 022 - 2494 do 4624 so; / 2497kindly 4308 / [email protected] /contact Fax: 022 -I 2495DMA 0723 Secretariat at: Have you renewed your MembershipTel.: for the022 - 2494Tel.: 0224624 - 2494 / 2497 4624 / 43082497 4308 / Fax: / Fax: 022 022 - 2495 0723 0723/ E-mail: [email protected], For AdvertisingHave in youthe Classified renewed Columns your and also for Tel.:series for 022the advertisements - 2494 4624 / 2497 4308 / Fax: 022 - advertisements2495 0723 please contact: Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723/ E-mail: MembershipEmail: Website:[email protected] www.idma-assn.org, www.indiandrugsonline.org / [email protected] Have you renewed your Membership for the Mr Chettiar (+9820629907) Publications Department [email protected], please contact:Mr Chettiar (+9820629907) PublicationsTel.: Departmen 022 - 2494t 4624 / 2497 4308 / Fax: 022 -IDMA 2495 Bulletin 0723 LI (11) 15 to 21 March 2020 5 YYear 2019-2020 2019-2020 & IDMA2020-2021IDMA & BulletinBulletin 2020-2021 LI LI (11) (11) 15 15to 21to March21 March 2020 2020 5 5 Website: www.idma-assn.org, www.indiandrugsonline.org Year IDMA2019-2020 IDMABulletin Bulletin LI (11) LI & (15) 15 2020-2021 15to 21to 21 March April 20202020 11 5 If Inot,f not, please do do so; kindlyso;IDMA kindly contactIDMAIDMA contactI DMABulletin IDMABulletinIDMABULLETIN Secretariat IDMA LIBulletin Bulletin LI(18) at:(41) Secretariat 08 LI LI01 to(21) (22) to14 07 01 May08 at: Novemberto to 202007 14 June June 20202020 2020 IDMA BULLETIN2416 85 Email:Email:If not, [email protected] [email protected] please do so; / [email protected] / [email protected] contact IDMA Secretariat at: Tel.: 022 - Tel.:2494Tel.: 0220224624 - -2494 2494 / 2497 4624 4624 / 43082497 / 43082497 / Fax: / 4308Fax: 022 022 / - 2495Fax: 0723 022 0723/ - 2495 E-mail: 0723 [email protected], Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723/ E-mail: Email: Website:[email protected] www.idma-assn.org, Bulletin LI (11) www.indiandrugsonline.org / 15 [email protected] to 21 IDMAMarch Bulletin 2020 LI (12) 22 to 30 March 2020 5 16 [email protected], Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723 IDMA Bulletin LI (11) 15 to 21 March 2020 5 Website: www.idma-assn.org, www.indiandrugsonline.org IDMA IDMABulletin Bulletin LI (11) LI (15) 15 15to 21to 21 March April 20202020 11 5 IDMA BulletinIDMAIDMA LIBulletin Bulletin (18) 08 LI LI to(21) (22) 14 01 May08 to to 202007 14 June June 2020 2020 24 85 IDMA Bulletin LI (11) 15 to 21 IDMAMarch Bulletin 2020 LI (12) 22 to 30 March 2020 5 16

10/21/2020 Inhaled antibody drug for COVID-19 clears coronavirus in animals | FierceBiotech

Inhaled antibody drug for COVID-19 clears coronavirus in animals NewNEW DevelopmeDEVELOPMENTSnts

fiercebiotech.com/research/inhaled-antibody-drug-for-covid-19-clears-coronavirus-animals IInhalednhaled antibody drug for COCOVID-19VID-19 ability to forecast unit delivery resulting in the optics you Research clears CCoronavirusoronavirus in animals need to ensure a successful trial, and hear experts share industryindustry trendstrends ofof whatwhat isis affectingaffecting thethe ClinicalClinical ResearchResearch Organization industry today. “Over 90% COVID-19 symptomatic patients are home-bound, under quarantine, and often not treated. While these patients wait, their health can deteriorate, and they could infect those around them,” Aridis CEO Vu Truong, Ph.D., said in a statement. “Having a convenient way to self-medicate with the simplicity of an asthma inhalerinhaler wherewhere thethe drugdrug isis delivereddelivered directlydirectly toto thethe infectioninfection site can have a transformative impact on patients’ lives, expand treatment coverage, and ultimately reduce global transmissibility.”transmissibility.” Most antibodies and vaccines that are being developed by drug companies target the Receptor-Binding Domain Aridis PharmaceuticalAridis has developed Pharmaceutical an inhalable has developed COVID-19 an inhalable antibody that successfully COVID-19 antibody that successfully eradicated signs of the (RBD)(RBD) ofof thethe novelnovel Coronavirus’sCoronavirus’s spikespike protein.protein. ThisThis smallsmall eradicated signs of thenovel novel Coronavirus coronavirus in ininfected infected hamsters. hamsters. (pixabay) (pixabay) part plays an important role in viral infection, as it docks Monoclonal antibodiesMonoclonal for COVID-19 antibodies recently for took COVID-19 center stage recently as Regeneron’s took toto thethe ACE2ACE2 receptorsreceptors onon humanhuman cellscells toto gaingain entry.entry. experimental cocktailMonoclonal was used antibodiesto treat President for COVID-19Donald Trump, recently who went took on to rave center stage as Regeneron’s ex-perimental cocktail was about it. Butcenter that therapy, stage as as is Regeneron’stypical for antibody ex-perimental drugs, needs cocktail to be injected was into theA team of scientists from the University of Alabama at used to treat President Donald Trump, who went on to rave body. used to treat President Donald Trump, who went on to rave Birmingham and the Texas Biomedical Research Institute about it. But that therapy, as is typical for antibody drugs, isolatedisolated RBD-specificRBD-specific B cellsB cells from from recovered recovered patients patients to Aridis Pharmaceuticals is working on an inhaled neutralizing antibody for COVID-19 needs to be injected into the body. toproduce produce monoclonal monoclonal antibodies antibodies that canthat neutralize can neutralize SARS- dubbed AR-711, which was discovered using samples from patients who had recovered SARS-CoV-2,CoV-2, the virus the that virus causes that COVID-19. causes COVID-19. One candidate, One from COVID-19.Aridis The drug Pharmaceuticals successfully cleared issigns working of SARS-CoV-2 on an virusinhaled from infected candidate,1212C2, emerged 1212C2, with emerged potent inhibition with potent of RBD inhibition binding of hamsters at neutralizinga far lower dose antibody compared for withCOVID-19 other experimental dubbed AR-711, monoclonal which antibodies, RBDtoACE2. binding to ACE2. according towas results discovered published onusing preprint samples site bioRxiv from. patients who had recovered from COVID-19. The drug successfully cleared Encouragedrecovered by the preclinical from COVID-19.results, Aridis The plans drug to start successfully testing AR-711 cleared in non- Recent research has shown hamsters to be a good signs of SARS-CoV-2 virus from infected hamsters at a far hospitalizedsigns mild-to-moderate of SARS-CoV-2 COVID-19 virus patientsfrom infected in the first hamsters half of next at a year. far If themodel drug for COVID-19-related research. So the researchers eventually succeedslowerlower dosedose in human comparedcompared trials, withthewith company otherother experimentalexperimental could offer a self-administered monoclonalmonoclonal optioninjectedinjected the the antibody antibody into into hamsters’ hamsters’ abdomens abdomens before before for COVID-19,antibodies, saving patients according the need to toresults travel publishedto healthcare on facilities preprint for site infusions challenging that the animals with SARS-CoV-2. could take hoursbioRxiv. to complete. bioRxiv. While control hamsters developed live virus in their Encouraged by the preclinical results, Aridis plans to Featured WebinarEncouraged by the preclinical results, Aridis plans to nasal cavities and lungs, animals that got 1212C2 before start testing AR-711 in non-hospitalized mild-to-moderate thethe challengechallenge showedshowed aa meaningfulmeaningful viralviral loadload reductionreduction COVID-19 patients in the firstfirst halfhalf ofof nextnext year.year. IfIf thethe drugdrug after two days, and three of four animals eradicated the eventually succeeds in human trials, the company could virus after four days. The treated hamsters also experienced offer a self-administered option for COVID-19, saving https://www.fiercebiotech.com/research/inhaled-antibody-drug-for-covid-19-offer a self-administered optionclears-coronavirus-animals for COVID-19, saving significantlysignificantly1/4 lessless lunglung diseasedisease comparedcompared withwith controlcontrol patients the need to travel to healthcare facilities for rodents.rodents. infusions that could take hours to complete. infusions that could take hours to complete. The The scientists scientists further further modifiedmodified 1212C21212C2 toto increaseincrease itsits half-life and used a proprietary technology to stabilize it to How to streamline your Clinical Research Organization’s half-life and used a proprietary technology to stabilize it to Processes end to end: allow for delivery with a nebulizer. In hamsters, the inhaled version cleared COVID-19 in the lungs of all animals Learn how implementing one platform leads to data Learn how implementing one platform leads to data after four days, while all control hamsters had detectable consistency and ultimately facilitate faster Clinical Trials consistency and ultimately facilitate faster Clinical Trials virus in their lungs at that time point. Lung lesions were while reducing overall trial costs, leave behind spreadsheets while reducing overall trial costs, leave behind spread also significantlysignificantly decreaseddecreased inin 1212C2-treated1212C2-treated hamstershamsters and home-grown tools for a predictable trial and the sheets and home-grown tools for a predictable trial and the compared with those in the control group.

IDMAIDMA BulletinBulletin LILI (41)(41) 0101 toto 0707 November 2020 1726

Injection is the typical approach for administering Johns Hopkins researchers publish monoclonal antibodies, but usually less than 0.1% of COVID-19 ‘prediction model’ the injected dose makes it into the fluid lining the lung. That makes it an inefficient delivery vehicle Using a combination of demographic and clinical for respiratory infections such as COVID-19, the data gathered from seven weeks of COVID-19 patient researchers argue. care early in the Coronavirus pandemic, Johns Hopkins researchers today published a “prediction model” they say Several other teams are exploring inhaled drugs to treat can help other hospitals care for COVID-19 patients - and COVID-19. A team led by scientists at the University of make important decisions about planning and resource Pittsburgh School of Medicine recently developed a drug allocations. Brian Garibaldi, MD, Associate Professor that’s based on an antibody component 10 times smaller of Medicine at the Johns Hopkins University School of than a full-sized antibody. The drug blocked SARS-CoV-2 Medicine, led a team that published in the Annals of in hamsters, and a startup called Abound Bio is looking Internal Medicine the article that shares important lessons to move the candidate into clinical trials as an inhaled learned in the care of COVID-19 patients between March therapy. 4 and April 24, 2020, at five Johns Hopkins hospitals in UK biotech Synairgen, meanwhile, recently said its Maryland and Washington, DC. inhaled formulation of inter feronbeta, called SNG001, cut During those 52 days, The Johns Hopkins Hospital, the risk of developing severe COVID-19 by 79% compared Johns Hopkins Bayview Medical Center, Howard County to placebo among patients in a double-blind trial. Patients General Hospital, Suburban Hospital and Sibley Memorial who got the drug were also more than twice as likely to Hospital admitted a combined 827 people age 18 or older recover from COVID-19. - 336 Black, 264 white, 135 Hispanic, 48 Asian, 2 Native Gilead Sciences is also testing an inhalable form of American and 42 multiracial - who tested positive for the its COVID-19 drug remdesivir after the infused version Coronavirus and had symptoms of COVID-19. From the showed it could cut recovery time for hospitalized patients. data those patients generated, the researchers developed The hope is that the inhaled formulation could reach less a prediction model using a set of risk factors known to be severely ill patients outside the hospital setting. associated with COVID-19 to forecast how likely a patient’s One potential advantage of Aridis’ drug is its dosing. disease is to worsen while being treated in a hospital and at The lowest dose that cleared the virus in hamsters what point in their care that might happen. Among the risk corresponded to an estimated human equivalent strength factors researchers considered as part of the model were of 2mg to 6mg. “This compares very favorably to other a patient’s age, Body Mass Index (BMI), lung health and clinical stage COVID-19 mAbs, where up to 8,000 mg chronic disease, as well as vital signs and the severity of a are being studied to achieve clinical benefit,” Hasan patient’s COVID-19 symptoms at the time of admission. Jafri, M.D., Chief Medical Officer of Aridis, noted in a The model, called the “COVID Inpatient Risk Calculator statement. (CIRC),” is available online. Garibaldi says the calculator “The exceedingly low drug dose that achieved is meant to help hospital physicians and other health care therapeutic efficacy is particularly exciting, as it provides providers assess the risk of a patient’s condition worsening. a unique opportunity to meaningfully reduce treatment “This is some of what we’ve learned in the months since we costs and hospitalization burden at a potential magnitude started seeing patients with COVID-19 at our hospitals,” not previously achievable with mAbtherapies,” Truong says Garibaldi. “As we continue to grapple with high said. numbers of COVID-19 infections across the United States, it’s important to share knowledge with our colleagues at The company is also pairing AR-711 with another other hospitals.” antibody in a cocktail dubbed AR-701, which is being developed as an intravenous treatment for moderate-to- Among the highlights of the study was the rapidity severe hospitalized COVID-19 patients. with which the disease can progress from mild or moderate to severe, particularly if a patient had all or some of the Source: fiercebiotech.com, 22.10.2020 (Excerpts) risk factors associated with the disease. Forty-five of the l l l patients in the study had severe COVID-19 when they

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were admitted to the hospital. But 120 patients developed than 3,000 COVID-19 patients admitted to Johns Hopkins severe disease or died within 12 hours of being admitted. hospitals since the start of the pandemic,” Garibaldi says. Of the 302 patients in the study who developed severe “We hope it can teach us more about the nature of COVID- disease or died, the median time of disease progression 19 and improve both patient care and research as we was 1.1 days. prepare for a second wave of infections in the fall.” “Rapid progression of disease following admission Source: World Pharma News, 23.09.2020 (Excerpts) [to the hospital] provides a narrow window to intervene,” l l l Garibaldi writes in the article. “Different combinations of risk factors appear to predict severe disease or death, with probabilities ranging from over 90% to as little as 5%.” Strong activation of anti-bacterial For example, using the CIRC, Garibaldi and his colleagues T cells linked to severe COVID-19 estimate that a 60-year-old white woman with a BMI of A type of anti-bacterial T cells, so-called MAIT cells, 28, no chronic disease and no fever who is hospitalized are strongly activated in people with moderate to severe for COVID-19 has a 10% chance of her disease worsening COVID-19 disease, according to a study by researchers at by day two of her hospital stay. The longer she’s in the Karolinska Institutet in Sweden that is published in the hospital, the greater that chance becomes, at 15% after journal Science Immunology. The findings contribute to four days and 16% after a week. increased understanding about how our immune system Conversely, the researchers considered an responds against COVID-19 infection. “To find potential 81-year-old Black woman admitted to the hospital with treatments against COVID-19, it is important to understand COVID-19. The hypothetical patient has a BMI of 35, in detail how our immune system reacts and, in some diabetes, hypertension and a fever. CIRC forecasts her cases, perhaps contribute to worsening the disease,” probability of progressing to severe disease or even death says Johan Sandberg, Professor at the Department of by just the second day of her hospital stay is 89%. That Medicine, Huddinge, at Karolinska Institutet and the percentage increases to higher than 95% by days four and study’s corresponding author. seven. By June 24, 694 of the patients in the study had T cells are a type of white blood cells that are specialized been discharged from the hospital, 131 had died and seven in recognizing infected cells, and are an essential part of were still hospitalized with severe COVID-19. the immune system. About 1 to 5 percent of T cells in the “We identified a few readily measurable demographic blood of healthy people consist of so-called MAIT cells and clinical factors that, when assessed on admission (mucosa-associated invariant T cells), which are primarily to the hospital, can predict if someone has a 5% or a important for controlling bacteria but can also be recruited 90% risk of developing severe disease or dying from by the immune system to fight some viral infections. In COVID-19,” says Amita Gupta, MD, Professor of Medicine this study, the researchers wanted to find out which role at the Johns Hopkins University School of Medicine, who MAIT cells play in COVID-19 disease pathogenesis. They directs the Center for Clinical Global Health Education examined the presence and character of MAIT cells in and is a co-author of the study. “This is incredibly useful blood samples from 24 patients admitted to Karolinska information to have when communicating with patients and their families, as well as for informing resource allocation University Hospital with moderate to severe COVID-19 in the hospital.” disease and compared these with blood samples from 14 healthy controls and 45 individuals who had recovered from The study’s data comes from a registry of all patients COVID-19. Four of the patients died in the hospital. treated for the novel Coronavirus infection at hospitals in the Johns Hopkins system. Known as “JH-CROWN,” the The results show that the number of MAIT cells in the registry - which is funded by InHealth, the institution’s blood decline sharply in patients with moderate or severe precision medicine initiative - offers demographics, COVID-19 and that the remaining cells in circulation are diagnoses, procedures, social histories and other data highly activated, which suggests they are engaged in the points relevant to caring for COVID-19 patients. immune response against SARS-CoV-2. This pattern of “The JH-CROWN data registry embodies the same reduced number and activation in the blood is stronger teamwork and dedication that went into the care of more for MAIT cells than for other T cells. The researchers also

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noted that pro-inflammatory MAIT cells accumulated in epithelial cells,” says corresponding author Erich Gulbins, the airways of COVID-19 patients to a larger degree than MD, a visiting Professor in UC’s Department of Surgery. in healthy people. He is also Chair of the Department of Molecular Biology at the University of Duisburg-Essen, Germany. “Sphingosine “Taken together, these analyses indicate that the has been shown in past studies to prevent and eliminate reduced number of MAIT cells in the blood of COVID-19 patients is at least partly due increased accumulation bacterial infections of the respiratory tract, but it is in the airways,” Johan Sandberg says. In convalescent unknown if it can be used to prevent viral infections. The patients, the number of MAIT cells in the blood recovered Coronavirus needs to bind to specific molecules on the at least partially in the weeks after disease, which can be surface of human cells as a prerequisite to infect them,” important for managing bacterial infections in individuals Gulbins says. who have had COVID-19, according to the researchers. In “This is similar to the key and lock principle of a door: the patients who died, the researchers noted that the MAIT To open the door you must insert the key into the lock. cells tended to be extremely activated with lower expression We show that the lipid sphingosine binds into the cellular of the receptor CXCR3 than in those who survived. ‘lock,’ the receptor ACE2, for SARS-CoV-2 and thereby “The findings of our study show that the MAIT cells prevents binding of the virus to and infection of human are highly engaged in the immunological response against cells.” COVID-19,” Johan Sandberg says. “A likely interpretation is that the characteristics of MAIT cells make them engaged Researchers in this study analyzed the use of this early on in both the systemic immune response and in the lipid in regulating infection in cultured human cells local immune response in the airways to which they are with SARS-CoV-2 particles added. “We showed that recruited from the blood by inflammatory signals. There, sphingosine prevented cellular infection in these cultures, they are likely to contribute to the fast, innate immune and pretreatment of cultured cells or freshly obtained response against the virus. In some people with COVID-19, human nasal epithelial cells with low concentrations the activation of MAIT cells becomes excessive and this of sphingosine prevented adhesion of and infection correlates with severe disease.” with the virus,” says Gulbins. “These findings indicate

Source: Karolinska Institutet, Science Daily, 28.09.2020 that sphingosine prevents at least some viral infection by interfering with the interaction of the virus with its l l l receptor; it could be used as a nasal spray to prevent or treat infections with SARS-CoV-2,” he adds. “The nasal Researchers uncover clues spray must be developed, but sphingosine is a natural for COVID-19 treatment product. More research is needed to see if this could be By examining preexisting research for other conditions, a treatment for COVID-19.” researchers at the University of Cincinnati have found a Co-author Syed Ahmad, MD, Co-Director of the UC potential treatment that could be applied to COVID-19. Cancer Center, Professor and chief of the division of The findings, published in the Journal of Biological surgical oncology at UC and a UC Health surgeon, says this Chemistry, established that a lipid found in the human collaboration is particularly fascinating because it takes body could be used to prevent or treat infections with medical research from other areas of study and applies SARS-CoV-2, the virus that causes COVID-19. That lipid, it to a timely public health issue. “The ACE2 receptor called sphingosine, is a natural element taken from the has been studied and identified as a treatment target body and is important in the lipid metabolism of all cells in pancreatic cancer,” says Ahmad, the Hayden Family and the local immune defense in epithelial cells, a type Endowed Chair for Cancer Research. “This is an example of cell that lines the surfaces of the body including skin, of taking existing research and applying it to COVID-19 blood vessels, urinary tract and organs. They serve as a barrier between the inside and outside of your body and science in order to make progress in the field. This is how protect it from viruses. translational science works.” “We investigated whether a specific lipid is able Source: World Pharma News, 29.09.2020 (Excerpts) to interfere with the binding of SARS-CoV-2 to human l l l

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New drug candidate for the Science and Technology (DST). Oral scan was designed treatment of COVID-19 and developed entirely in India and supported by the biotechnology ignition grant of Biotechnology Industry Researchers from the University of Kent, the Goethe- Research Assistance Council (BIRAC), INVENT (DST), University in Frankfurt am Main (Germany), and the and Kerala Start-Up Mission. The company recently Hannover Medical School (Germany) have identified received investment from Unicorn India Ventures, said a drug with the potential to provide a treatment for the release. COVID-19. “Kerala Government plans to compile a registry of The international team led by Professor Martin cancer patients in the state as part of efforts to codify its Michaelis, Dr Mark Wass (both School of Biosciences, various initiatives against the deadly disease. These kind University of Kent), and Professor Jindrich Cinatl (Institute of innovations have come forward to brace this change of Medical Virology, Goethe-University) found that the and also appreciating the efforts of Business incubator approved protease inhibitor aprotinin displayed activity TIMED-SCTIMST at this time,” Kerala State Health against SARS-CoV-2, the Coronavirus that causes COVID- Minister K K Shailaja said. 19, in concentrations that are achieved in patients. Aprotinin inhibits the entry of SARS-CoV-2 into host cells According to Dr Subhash Narayanan, CEO of and may compensate for the loss of host cell protease Sascan, oral cancer is a growing concern in India with inhibitors that are down regulated upon SARS-CoV-2 more than 80,000 fresh cases reported each year. The infection. disease has a high mortality rate because of the delay in Aprotinin aerosols are approved in Russia for the detection. Current practice relies on oral examinations treatment of influenza and could be readily tested for the using a torch light to detect early stage cancers of the treatment of COVID-19. oral cavity. Varies studies have demonstrated that this screening technique is not very reliable and often Oral Professor Martin Michaelis said: “The aprotinin Potentially Malignant Lesions (OPMLs) go undetected aerosol has been reported to be tolerated extremely well in in the early stages. influenza patients. Hence, it may have a particular potential to prevent severe COVID-19 disease when applied early “This device is expected to have good demand after diagnosis. in general dentistry, oral medicine, oral/maxillofacial

Source: World Pharma News, 30.10.2020 (Excerpts) pathology and surgery,” said Balram, Engineer, CEO of the incubator Sree Chitra. Varies studies have demonstrated l l l that this screening technique is not very reliable and often Oral Potentially Malignant Lesions (OPMLs) go undetected SCTIMST develops OralScan handheld in the early stages. Even experienced clinicians find it device for detecting oral cancer difficult to locate the optimal site for a biopsy based on The Sascan Meditech, a startup incubated at TiMED, conventional oral examination. This leads to multiple a technology business incubator of the Sree Chitra Tirunal biopsies, increased expenditure and false negative reports Institute for Medical Science and Technology (SCTIMST), which can delay diagnosis and outcome. The device will Thiruvananthapuram has developed OralScan, a hand be marketed at a price of Rs.5.9 lakhs. This will be a held imaging device for screening, detection and biopsy onetime investment for hospitals and laboratories without guidance of oral cancer. any additional costs of consumables, said the statement OralScan is a Make-in-India initiative with seed issued by the SCTIMST. funding from the scheme National Initiative for Developing Source: Pharmabiz, 31.10.2020 and Harnessing Innovations (NIDHI) of Department of l l l

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National News

Health Ministry to review 4-point Pharmacovigilance Programme of India, Haemovigilance PSAIIF recommendations to improve Programme of India, Materiovigilance Programme of India, Consumer Awareness & Publicity and Price Monitoring Healthcare Services in the Country and others. The Union Health Ministry will now closely review the Thirdly, for Universal Health Coverage to take, we see recommendations of the Patient Safety and Access Initiative digital technology as a key enabler. The Government must of India Foundation (PSAIIF) to improve healthcare services consider increasing healthcare spends from 1 to 5% and in the country. The Government sees the need to improve increase subsequently to 7% of GDP, investing at least the healthcare delivery as COVID-19 pandemic has brought 5% of the GDP in healthcare. There should be focus on out the disparities in the system. innovation, R&D and use of modern technology. People The Foundation, which completes ten years of its must be able to access healthcare without facing financial existence, has put forth a four-point recommendation hardships, said Bejon Misra, founder, PSAIIF. to the Government where it insists people should have In the National Digital Health Mission, e-pharmacy cost-effective choices at the Health and Wellness Centres would be a vital tool and therefore Government should (H&WC), CGHS and ESIC approved medical centres, notify the same at the earliest, said Dr B R Jagashetty, besides hospitals managed by the state and Central former National Adviser (Drugs Control) to MoHFW & Governments without any discrimination and bias. CDSCO, even the prescriptions should have the brief In a virtual dialogue with PSAIIF members, Rajesh diagnosis based on which medicines are prescribed to have Bhushan, Secretary, Ministry of Health & Family Welfare proper prescription audit. said that every effort will be made to look into the The OTC drugs must be defined and listed with the suggestions to handle the issues confronting medical care Guidelines. The order of direction U/s 33P issued to all for quality and affordable access. State Licensing Authorities not to grant licenses to brands “We are looking to develop a multi-stakeholder but only generic names needs to be withdrawn or modified consultation module in order to effectively facilitate suitably to have proper index of all medicines produced/ implementation of the various schemes across 11 imported, he added. Ministries: Health, Commerce, Chemicals & Fertilizers The fourth agenda is to build a common platform to among others in the interest of the patients. The initiative promote quality healthcare bringing in all stakeholders with emerges from the lessons learnt from ongoing COVID-19 various Ministries working in the interest of the patients, pandemic, Bhushan said. said Misra.

In its proposals, PSAIF first sees the need to engage Source: Nandita Vijay, Pharmabiz, 02.11.2020 with patient groups and expand Ayushman Bharat to cover all vulnerable and senior citizens irrespective of their l l l economic profile and digitize patient records with total data privacy. DoP introduces revised PLI scheme Secondly, it mandates a multimedia campaign and a for Bulk Drugs & Medical Devices citizen portal similar to Jago Grahak Jago to build a robust Removing Minimum Investment limit awareness and education initiative for patients and care In a bid to ensure effective participation of the industry, givers to access safe, credible and quality information to the Department of Pharmaceuticals has introduced revised make an informed choice in medical consultation. It sees Production Linked Incentive (PLI) scheme guidelines for the need to control misleading, deceptive claims promised promoting domestic manufacturing of key starting materials by the manufacturers and healthcare service providers (KSMs), Drug Intermediates (DIs), Active Pharmaceutical to curb the menace of spurious and not-of-standard Ingredients (APIs) and medical devices, removing minimum medicines and devices. There is a need to discourage investment criteria and incorporating export and sale-based self-medication, irrational use of antibiotics, medicines, production criteria following an appeal by drug and medical diagnostics by linking with several schemes managed by the device industries.

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As per the revised Guidelines of PLI scheme for based products and Rs.50 crore for ten fermentation based boosting indigenous production of 41 products which products. Similarly, threshold investment was Rs.50 crore cover all the identified 53 APIs for which India is critically for four chemically synthesised products, and Rs.20 crore dependent on China, the criteria of ‘minimum threshold’ for 23 chemically synthesised products. investment have been replaced by ‘committed investment’ Majmudar also hailed inclusion of export criteria in by the selected applicant. The change has been made to the revised PLI scheme, saying that this will increase the encourage efficient use of productive capital as the amount number of the applicants in the scheme. of investment required to achieve a particular level of production depends upon choice of technology and it also If there are more than four applicants for 27 chemical varies from product to product. synthesised products and more than two applicants for 14 fermentation based products, selection of applicants for The provision for verification of the actual investment the incentive will be done on the basis of marks obtained made by the selected applicant for the purpose of giving by them in the evaluation criteria which include committed incentives under the scheme continues. The provision which annual production capacity and quoted sale price etc. restricts the sales of eligible products to domestic sales only for the purpose of eligibility of receiving incentives has It is learned that so far DoP has received around been deleted, bringing the scheme in line with other PLI 125 applications for manufacturing of bulk drugs under schemes and encouraging market diversification. the PLI scheme. The Pharmaceutical Industry is still in the wait-and-watch mode on making investment in A change has been made in the minimum annual manufacturing identified bulk drugs as there are chances production capacity for 10 products viz tetracycline, of a steep decline in prices of Chinese APIs, once Indian neomycin, para amino phenol (PAP), meropenem, manufacturers commence production of these bulk drugs, artesunate, losartan, telmisartan, acyclovir, ciprofloxacin said an industry expert. and aspirin. Minimum annual production capacity is a part of eligibility criteria under the scheme. The last date for It will take around two years to commence operation receiving applications under the scheme is now extended of Greenfield projects of identified KSMs, DIs, APIs. China by a week to November 30, 2020. could reduce prices of these products to discourage their local production by then, he said. The Guidelines of the scheme were originally issued on July 27, 2020 which has now been superseded by In the past, there were instances of Chinese API revised Guidelines issued by the department on October makers reducing prices of raw materials to sabotage the 29, 2020. local manufacturing of bulk drugs. The Government had also not come forward to support the manufacturers of The revised Guidelines were approved by NITI Aayog fermentation based products grappling with dumping of Chairman led empowered committee of the scheme low priced Chinese products, he added. following recommendation of technical committee set up under the scheme which received suggestions from the With the minimum investment criteria has been DoP. Industry associations such as IDMA, BDMA, SMPMA done away with, the provision of committed investment etc have made representations to the department seeking mentioning that using ancillary facilities of existing plants removal of threshold investment criteria and inclusion of will not qualify for committed investment to be made under export and sale based production criteria in the PLI scheme the scheme is a little bit confusing to manufacturers. The to encourage participation of more manufacturers. provision should have been removed, said another industry expert. Welcoming the revised Guidelines of the PLI scheme, Yogin Majmudar, Chairman of Bulk Drug Committee, IDMA said, Hailing the revised PLI scheme Guidelines, Nipun Jain, “The removal of minimum investment criteria is a welcome Chairman of Small and Medium Pharma Manufacturers step. The threshold investment requirement was a constraint Association said replacement of the criteria of threshold for the manufacturers who can make minimum investment to investment with committed investment is a great relief. It produce identified products considering they already have will encourage MSME manufacturers to participate in the common surplus utilities available to them.” PLI scheme in large numbers. This will make the country self-reliant in the production of APIs in the long run. As per PLI scheme Guidelines dated July 27, 2020, Currently, India is known as the Pharmacy of the World. threshold investment was Rs.400 crore for four fermentation

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Besides this, it supplies APIs across the world whenever schedule H, H1 or X drug and is thus available more or less needed. The revised Guidelines will make it a worldwide over the counter. Taking serious note of widespread abuse leader in APIs.” of Tapentadol, psychiatrists have appealed to drug control authorities to consider regulation of the drug. Similarly, there is replacement of the criteria of ‘minimum threshold’ investment with ‘committed According to a study carried out by Centre for Addiction investment’ by the selected applicant in the revised PLI Medicine, Department of Psychiatry, National Institute of scheme Guidelines of medical devices. Mental Health and Neurosciences, Bangalore last year to assess Tapentadol abuse and dependence in India, Besides this, the eligibility criteria of minimum sales injection drug abuse of Tapentadol is emerging rapidly threshold has been amended in line with projected demand, and is associated with high rates of Hepatitis C infection technology trend and market development, for the purpose in southern India. A possible reason is easy and cheap of availing incentive under the scheme. availability of tablets that can be easily repurposed for The tenure of the scheme has been extended by one injection, stated the study. year considering the capital expense expected to be borne Analysis of internet search data also shows that by the selected applicants in FY 2021-22. Accordingly, Tapentadol is receiving attention from internet users in the sales for the purpose of availing incentives will be India and this interest is maximum in northern states like accounted for 5 years starting from FY 2022-2023 instead Punjab, Jammu & Kashmir, Himachal Pradesh with a high of FY 2021-2022. The last date for receiving applications prevalence of current opioid use. under the scheme has also been extended by a week to November 30, 2020. Said Diptadhi Mukherjee, MD, Senior Resident, Centre for Addiction Medicine, Department of Psychiatry, National Source: Laxmi Yadav, Pharmabiz, 02.11.2020 Institute of Mental Health and Neurosciences, Bangalore, l l l who is among eight authors of the study, “Urgent regulatory measures were required to curb Tapentadol abuse. The Health Ministry amends D&C Rules to increase in the number of cases at our centre last year bring Tapentadol under Schedule H1 shows that Tapentadol is attaining notoriety as an easily to curb its abuse and cheaply available drug of abuse. In India, prescription opioids have contributed more to opioid abuse than illicit The Union Ministry of Health and Family Welfare has opioids in the past as well as present.” notified a draft amendment to the Drugs and Cosmetics It has been eight and a half years since Tapentadol Rules, 1945 that would bring Tapentadol, a synthetic entered the Indian market. There are no drug safety alerts opioid analgesic under Schedule H1 to regulate its sale, or advisories from the Pharmacovigilance Programme of distribution and prevent its abuse. Schedule H1 stipulates India (Indian Pharmacopoeia Commission, 2019), and the that the drug can be sold only on prescription. According current drug label does not indicate that Tapentadol is a to the draft amendment issued by the Ministry on October Schedule H or H1 drug, Dr Mukherjee pointed out. 20, 2020, in the Drugs and Cosmetics Rules, 1945, in Schedule H1, after serial number 47 and entry relating Abusers mostly take Tapentadol through an intravenous thereto, the following serial number and entry shall be route which is very dangerous. Unlike Tramadol, parenteral inserted, namely — 48. Tapentadol. preparations of Tapentadol are not available, and there is minimal safety data for intravenous use. This is important The Central Drug Standard Control Organisation as the bioavailability of oral Tapentadol is only 32%, (CDSCO) approved Tapentadol Immediate-Release (IR) due to extensive first-pass metabolism, added the senior preparations (50, 75 and 100 mg) for moderate to severe resident doctor. acute pain and Extended-Release (ER) preparations (50,100,150 and 200 mg) for severe acute pain in April Regulatory systems take a long time to respond to the 2011 and December 2013 respectively. abuse of new drugs. For example, doctors reported that widespread tampering and injecting of dextropropoxyphene Tapentadol which has been available in India since in northeastern states was causing high morbidity and 2011 is widely abused due to its easy and cheap availability. mortality as early as 2005. It was banned much later The packaging of the drug does not indicate that it is a in 2013, only to be reintroduced in 2017 with strict

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regulations. Similarly, Tramadol received approval in ceilings as decided by the Empowered Committee (EC). 1993 and was brought under Schedule H1 in 2013 This has been done to address disability in manufacturing followed by being classified as a psychotropic drug under of medical devices in India vis-à-vis other major Narcotic Drugs and Psychotropic Substances (NDPS) Act manufacturing economies. in 2018. AiMeD has worked with Quality Council of India (QCI) “We aver that initially allowing unregulated sale of a to expedite finalization of Indian Certification for Medical new opioid medication and responding later with excessive Devices (ICMED) Scheme Plus Certification as well as regulations constitutes double jeopardy. During the initial with consultants consortium to provide online training on period several users get addicted and when there is Quality Management System (QMS) certification to new decreased availability due to regulation, they switch to entrepreneurs who had ventured into medical devices other opioids,” Dr Mukherjee stated. manufacturing towards capacity building to meet QCIs Source: Laxmi Yadav, Phamabiz, 31.10.2020 ICMED certification and regulatory compliance so that they could develop confidence to seek global certification l l l of CE and US FDA compliance for enabling global competitiveness. Medical Device Companies ask DoP Under the PLI scheme, financial incentives shall be to reduce threshold investment limit given to selected companies based on threshold investment to Rs.75 to 90 crore from Rs.180 crore and incremental sales (over Base Year) of medical devices under PLI Scheme covered under target segments. Under the Scheme, financial incentive shall be given to selected companies Medical device manufacturers have urged the at the rate of 5% of incremental sales (over Base Year) of Department of Pharmaceuticals (DoP) to consider goods manufactured in India and covered under Target reducing threshold investment limit in range of Rs.75 to segments, for a period of five years i.e. from FY 2021-22 Rs.90 crore from Rs.180 crore for domestic manufacturers to FY 2025-26. The PLI scheme, however, is applicable in the Production Linked Incentive (PLI) Scheme for only for Greenfield projects. Financial incentive under the promoting domestic manufacturing of medical devices. scheme shall be provided only to companies engaged in This, according to the Association of Indian Medical Device manufacturing of goods covered under target segments Industry (AiMeD), will also widen the scope of eligibility to in India. cover COVID-19 utility medical devices. Eligibility shall be subject to thresholds of investment The Government of India through its flagship “Make in and incremental sales of manufactured goods (covered India” initiative relied heavily on the Indian manufacturers under Target Segments) over Base Year. An applicant to meet the rising demand of essential healthcare equipment must meet all the threshold conditions to be eligible for for the country pushing the Indian medical devices disbursement of incentive. Eligibility under Production sector to become self-reliant especially for essential 39 Linked Incentive scheme shall not affect eligibility under COVID-19 medical devices. DoP had notified PLI Scheme any other Scheme and VICE-VERsa. The tenure of the for promoting domestic manufacturing of medical devices scheme is from FY 2020-21 to FY 2026-27. through a Gazette Notification dated July 21, 2020. Total financial outlay of the Scheme is Rs.3,420 crore. The application window for receiving the applications shall be 120 days. Financial Year 2019-20 shall be treated According to Rajiv Nath, Forum Coordinator, AiMeD, as the base year for computation of incremental sales of “The threshold investment limit of Rs.180 crore over manufactured goods. Assessment of threshold investment 3 years is palatable for those manufacturers with turnovers and incremental sales of manufactured goods shall be of over Rs.800 to Rs.1,000 crore which hardly anyone can based on details furnished to the departments/ministries/ bear. That is why, we have sought DoP to consider reducing agencies and statutory auditor certificates. Application this in the range of Rs.75 crore to Rs.90 crore for domestic under the Scheme can be made by any company registered manufacturers. in India As per the PLI Scheme for medical devices, the Source: Shardul Nautiyal, Pharmabiz, 30.10.2020 incentive per company will be applicable on incremental sales of manufactured goods over base year subject to l l l

IDMA Bulletin LI (41) 01 to 07 November 2020 25

CBIC assures of no delay in Customs “The concept of introduction of faceless assessment Clearance of imported consignments at was to bring an end to cut down the physical appearance and illegal gratification whereas the results are quite ports due to implementation of Faceless different. The officers even do not know how to assess the Assessment Bill of Entry (knowingly/unknowingly) and have started The Central Board of Indirect Taxes and Customs (CBIC) giving multiple means of queries, giving unnecessary has assured the Federation of Custom Brokers’ Association examination orders, etc. The Bill of entry is idle for several in India that there will be no delay in inbound shipment days unattended by the assessing officer at different clearance at ports in the country after the next couple of faceless assessment locations. weeks due to the implementation of faceless assessment The status of the Bill of Entry is untraceable at the for customs clearance. faceless assessment point. The customs brokers are forced The faceless assessment for customs clearance to appoint middle-men to look after their assessment work introduced by CBIC across the country in the first week at other ports resulting in additional costs on the customs of September 2020 in a phased manner, has led to broker, which is indirectly passed on to the importer. It 15-20 days delay in shipment clearance at ports as may kindly be noted that the illegal gratification has not against 2-3 days before the implementation of faceless been stopped, whereas, it has grown enormously. Hence, assessment. The first phase of the faceless assessment the importers are left with no choice but to surrender the has started in Chennai and Bengaluru ports with an aim to assessing officers just to save their business. bring transparency and remove red tape. It has now been The goods are required at the factory for the production introduced at other ports in the country as well. purpose of the importer. The traders who have sold their The CBIC has decided to roll out nationwide faceless goods in advance are also suffering in this situation. It assessment for imports at all ports by October 31, 2020 appears that ease of doing business does not prevail,” whereby assessing officers physically located in a particular stated the letter. jurisdiction will assess bills of entry of imports of a different Hence, it has suggested to the authority that instead of customs station or port, which will be assigned to them implementing fully faceless assessment the focus should through an automatic system. The processing will be done be on a Risk Management System (RMS). In the last without any direct interaction between the importer and 10 years, the percentage of RMS clearance of Bill of Entry has customs authorities. gradually increased and that is the best option for ensuring Now the delay in customs clearance of imported uniformity in assessment across the country, said Dave. consignments has reduced to 4-5 days which will be ended Source: Laxmi Yadav, Pharmabiz, 29.10.2020 over next couple of weeks, stated Parthiv Dave, founder, Federation of Custom Brokers’ Association in India. The l l l CBIC has assured Dave led Federation of reducing delay in customs clearance of imported consignments in 15 Serbia throws up opportunities days. for Indian drug exporters Earlier the Federation had written to Prime Minister The southeast European country, Serbia which is Narendra Modi informing about the difficulties faced referred to as the crossroad of Europe due to its position in by customs brokers since implementation of faceless the central Balkan Peninsula, has thrown up opportunities assessment which led to rise in numerous hidden for Indian pharmaceutical companies. About 32 Serbian costs. drug firms are looking for business collaboration with Indian drug makers. These companies are Uni-Chem, Farmix “After the implementation of faceless assessment the d.o.o, SB Trade, Zdravlje Actavis (part of Teva Group - dwell time of assessment has increased due to which the Israel), Hemofarm (STADA Group - Germany), Galenika transaction cost has increased. This has caused a slowdown (NC Group - Brasil), Phoenix Pharma (German Company), in the manufacturing process and also the economy of Salveo, PharmaS, Interlab exim, AbelaPharm, ADOC, India. The shipping companies are charging EXIM rate Dimidijus Pharm, Dragis pharm, Esensa, EcotradeBG, in foreign currencies in a haphazard manner,” stated the Innventa pharm, Inpharm, Vemax Pharma, Vemax Pharma, trade association in the letter.

IDMA Bulletin LI (41) 01 to 07 November 2020 26

R&B Medical Company, Slaviamed, Sanomed, El Pharma, products in Serbia. The market offers tremendous UTI, Oktal Pharma, Unifarm Medicom, Eurofarm, Proton opportunities for Indian drug makers considering total System, Sibex Line, and Group International. imports and the share of Indian drug companies in the Serbian market.” Some of these companies also assist in product registrations as required in Serbia. Serbia could prove to He said “We have requested member companies to be a stepping stone for Indian drug companies to boost avail this opportunity and contact the Serbian companies their exports to EU, EFTA, CEFTA, EAEU regions, Turkey, directly for business collaborations. The member companies Australia, Japan and USA since the country has free trade can also send a proposal to the embassy of India, Belgrade agreements with them. which will further introduce them to the Serbian companies and concerned authorities for further correspondence on According to Rados Gazdic, Director at the Development the subject.” Agency of Serbia, a skilled workforce, prime geographic location, financial incentives and tremendous support The Pharmexcil proposed to mount a trade delegation from the Government are a few factors that make Serbia a to Belgrade, Serbia during the first quarter of 2020. The hotspot for foreign investments. A 10-year Corporate Profit delegation was however postponed due to time constraints Tax Holiday is available for investors who hire more than and comparatively less participation interest from the 100 employees and invest more than €8.5 million. The Tax member companies, added Bhaskar. holiday begins once the company starts making a profit. Source: Laxmi Yadav, Pharmabiz, 26.10.2020 Further more, investors can benefit from 14 free zones l l l in Serbia that provide exemption from the payment of VAT and custom duties, said Gazdic. Serbia has imported organic chemicals worth US$ 3,9954.9 and medicinal Indian Pharma industry calls on US FDA and pharmaceutical products worth US$ 6,487.7 from to conduct virtual inspections in the India in FY 2019. wake of COVID-19 pandemic: Dr Sandhu The medicinal and pharmaceutical products which are Indian pharmaceutical industry has called on the US imported from India include vitamins and their derivatives, FDA to consider conducting virtual inspections of their Intermixtures of provitamins and vitamins, streptomycins plants and facilities in the wake of COVID-19 pandemic. and their derivatives; salts thereof, chloramphenicol and its The shift from physical to virtual inspections would derivatives; salts thereof, erythromycin and its derivatives; certainly ease the challenges and smoothen the continued salts thereof, antibiotics, Ephedrines and their salts, availability of life-saving medicines, which would involve Theophylline and aminophylline and their derivatives; salts a significant transition which, when made possible, thereof, steroidal hormones, their derivatives and structural would be a giant step in embracing the post-COVID-19 analogues, glycosides and their derivatives, antisera and scenario, stated Dr Gurpreet Sandhu, President, Council other blood fractions and modified immunological products, for Healthcare and Pharma & Founder Reva Pharma. Sterile suture materials and sterile surgical catgut, adhesive The virtual inspection can be slightly more challenging dressings and other articles having an adhesive layer, dental for the highly toxic products manufactured in contained cements and other dental fillings etc. facilities due to limited visibility of internal infrastructure Serbia has offered immense opportunities for Indian used despite having windows in place. The additional Pharma industry considering total imports and Indian share physical inspection may be added for ensuring the safety in the Serbian market. Considering this, the embassy of of products, but this may delay the approval and launch of India, Belgrade has written to the Pharmaceutical Export life-saving drugs. With COVID-19-enforced imperative to Promotion Council of India (Pharmexcil) throwing light protect its personnel, the US FDA had suspended physical on business opportunities for India Pharma industry in inspections in March and indicated towards late July that Serbia. it was looking to restart domestic inspections. Said Uday Bhaskar, Director General, Pharmexcil, “We In view of the sheer severity of the ongoing pandemic, have received communication from the embassy of India, the US FDA has proposed a series of alternative tools Belgrade towards promotion of Indian pharmaceutical of inspection such as product sampling at borders,

IDMA Bulletin LI (41) 01 to 07 November 2020 27

summoning of records in advance, examination of a affecting business activities. To overcome these challenges, company’s compliance history and even making use of the Pharma industry is urging the Government to resolve information shared by other Governments as part of mutual the issue on a priority. recognition and confidentiality agreements. Reportedly, exporters are facing 50-60 percent Dr Sandhu added that unlike the physical surveillance hike in freight charges, which is affecting the business inspection in which trained drug inspectors make a significantly. Recently, the Pharmexcil communicated to physical visit to plants, virtual inspections would involve its members that they are in receipt of a communication deploying advanced IT, internet, and video technologies for from the Logistics Division of the Commerce Department an inspector to make an assessment. India has not only informing that the division has several representations traditionally been one of the largest suppliers to the US regarding the shortage of empty containers for exports. The meeting 40% of the latter’s generic demand, it has emerged Division has interacted with the Container Shipping Lines as a critical source for COVID-related medications. Association (CSLA) and the stakeholders on the subject matter. It is, therefore, requested that the industry should Even assuming that the US FDA would have the best give the projection of the requirements of containers for technology options available at its end, the Indian plants and the next two months. facilities – some of them located in the remote areas of the country – would need an upgrade so that the two systems are According to an industry source, the Ministry of Shipping able to communicate and engage with each other seamlessly has informed that there are huge chunks of unclaimed for an immaculate inspection, stated Dr Sandhu. containers lying at the docks unclaimed for months, which is also resulting in the shortage of containers. “Since COVID-19 came unexpectedly, there has been no prior technological arrangement between the US FDA To deal with the situation, Piyush Goyal, Commerce and and the designated manufacturing plants, putting in place Industry Minister, has requested Mansukh L Mandaviya, a remote inspection and assessment architecture. The Minister of State for Road Transport and Highways, alignment of technologies, platforms and standards along Shipping and Chemicals and Fertilizers to auction such with data protection and confidentiality measures must be cargo and also invite non-cartel shipping lines to give speeded up because of the efficiencies and rigour that this preferential berthing to cartelised lines who have berths arrangement can potentially achieve”, added Dr Sandhu. leading to 40-60 percent increase in freight, which will increase competition, lessen monopoly in the market and The appeal by the Indian Pharmaceutical industry ultimately benefit the exporters. may be worth exploring at this juncture because of the substantial improvement and upgradation of infrastructure Responding to this, Dr Dinesh Dua, Chairman, achieved by it in the last decade. Dr Sandhu added that Pharmexcil, said, “If the Ministry of Shipping can break the integrity of the whole process would in the end be the cartel of shipping lines who have increased freight contingent on the integrity and the intent of the Pharma charges by 49-60 percent by inviting other shipping lines manufacturers whose plants are under inspection. As who do not have berthing space to get preferential space a result, the credibility of a virtual inspection is likely and their rates are reasonable it’ll do a world of good to all to depend on the veracity of a few random physical exporters, including Pharma.” inspections so that the transition to the new process can Expressing concerns, Nipun Jain, Chairman, Small be embedded as a norm for posterity. and Medium Pharma Manufacturers Association (SMPMA) Source: Yash Ved, Pharmabiz, 26.10.2020 commented, “There is a need for the higher authorities to intervene in this matter, as the shortage of containers l l l and increase in freight charges are not only affecting the Container shortage affects Pharma Pharma industry in India but our Pharma products supply which goes to nearly 200 plus countries, is also likely to exports, industry seeks solution have a severe impact due to this hurdle. We are facing Due to the shortages of containers, exporters are back to back challenges, which is ultimately slowing down facing 50-60 percent hike in the freight charges the growth momentum of the Indian Pharma industry. Exporters across the country are facing a shortage of Therefore, we urge the authority to take up this matter on containers along with the rise in freight charges which is a priority.”

IDMA Bulletin LI (41) 01 to 07 November 2020 28

Mr S V Veerramani, Chairman and Managing Director, policy makers do not take urgent corrective steps to save Fourrts (India) Laboratories and Past National President, IDMA the industry, according to industry experts. expressed, “Off-late, there has been a shortage of containers According to Dr P V Appaji, former Director General for exports. Vessel availability and container availability of Pharmexcil, although India is known as the “Pharmacy have become serious concerns. With the result, exports are of the World”, as it contributes 20 percent of the world suffering heavily. We understand that this is because of a generics and 60 percent of the total vaccines in the reduction in imports, which has resulted in the availability of global market, it is a matter of great concern that even containers for exports.” today India is depending on a single country like China He elaborated, “Because of this, there are efforts to even for sourcing its APIs, Key Starting Materials (KSMs) and get paid empty containers into India, which will certainly other intermediates. add to the cost of freight in exports. Already the carriers “Even though Indian Pharma industry has made long have indicated that the freight will go up substantially in the strides and succeeded to rule the roosts of global markets in coming months. For example, a 20Ft container with a freight supplying high quality low cost generics, the recent COVID- cost of $628 to Tanzania is likely to be revised to $1200 19 pandemic and the border disputes with China have from December 1, 2020. Same way, the freight to Ghana for really opened up our eyes and made us understand that a 20Ft container costing $1987 is likely to be increased whatever we have achieved is not going to stay sustained to $3943 from December 1, 2020. Therefore, the increase for longer, unless and until we take concrete steps to boost in freight will certainly result in reducing the margins for our domestic API sector,” opined Dr Appaji. exporters.” Despite the fact that India is among the few countries Anwar Daud, MD, Zim Laboratories informed, “There in the world which has 665 US FDA approved plants is an acute shortage of containers. It is partly due to the outside US and has 44 percent global ANDAs, the country’s tendency of exporters including Pharma to ensure security dependence on China to source its Pharmaceutical raw and safe passage of their smaller (LCL) consignments also materials will make all these achievements demean if the by dispatching them in full, sealed containers. Receipt of Indian Pharma sector is not self reliant in producing its goods is damaged or partly missing condition has been own APIs. more frequently noticed due to mishandling in transit during COVID-19 and exporters have found that exports in If one looks at how the recent prevailing COVID-19 full containers reduce human handling and errors.” has impacted the policy decisions of central Government with regard to changes in import-export policies, the DGFT He added that Central India has huge seasonal exports (Directorate General of Foreign Trade) during the month of rice, oranges, etc and the post-harvest grain and fruit of March this year has made changes in their export export season has picked up, which is causing further policy and they banned several formulations. Later, on pressure on containers.” 25th March 2020 again, this export policy was changed Source: Usha Sharma, Express Pharma, 02.11.2020 and the “wonder drug” Hydroxychloroquine, considered for treatment of COVID-19, too was included in the list. l l l All this was done because the API which is used Boosting domestic APIs crucial for in the manufacturing of these formulations is imported India to sustain its Global stronghold from the global market especially from China and due to as Generic Supplier: Experts COVID-19 the import of these APIs was badly affected, as these APIs were in short supply. In view of this, it can With India receiving the double whammy of widely be clearly observed how COVID-19 pandemic has gravely spreading COVID-19 pandemic and the sudden cutting impacted India’s policy decision making machinery. Taking down of API imports from China due to the border disputes lessons from this, it is high time the Indian Government and other currently prevailing issues, it has been clearly and its policy makers take urgent initiatives to boost understood that the Indian Pharmaceutical Industry which India’s API capabilities, or else Indian Pharma sector will is boasting of its global stronghold as a lead generic become vulnerable not just due to global pandemics like supplier to the world is highly vulnerable and cannot sustain COVID-19, but also will be compelled to dance to the tunes for long, unless and until the Indian Government and its of countries like China and may even lose India’s stronghold

IDMA Bulletin LI (41) 01 to 07 November 2020 29

as a global generic supplier to the world market,” warned the 3rd largest in the world by volume, and the 14th largest S V Krishna Prasad, CEO and Managing Director of Cito in terms of value. Healthcare. Yet, although it contributes approximately 3.5 percent However, despite COVID-19 pandemic created havoc of total drugs and medicines exported across the world, in India, the one thing that is hailed all over is Indian its import dependency on China for APIs has been much bulk drug industry’s growth rate. While during the period cautioned against. Bulk drugs, or APIs, are the raw 2016-20 the industry has witnessed its growth between materials required to make formulations or medicines. 8-9 percent, even during the COVID-19 pandemic ruining China, reportedly, controls 55 percent of the global API all kinds of businesses and giving a shocker to the economy, space. Indian pharmaceutical companies rely on Chinese the Indian Pharmaceutical sector is still hovering around API imports for roughly 70 percent of their total bulk drugs 8-9 growth rate which is a positive sign even during the requirement. period of healthcare uncertainty in India, observed industry The Government’s approval of the PLI scheme in March experts. was aimed to address this over-dependency which has been Source: A Raju, Pharmabiz, 24.10.2020 brutally exposed by the COVID-19 pandemic. Under the scheme, which runs for 6 years starting with the base year l l l of FY 2019-20, financial incentives will be provided based on the sales of Pharma manufacturers for 41 products Government expands PLI scheme: India covering all of India’s required 53 APIs. Applicable only seeks to cull China reliance with latest for Greenfield projects, the total financial outlay for the move to boost bulk drug manufacturing scheme is Rs.6,940 crore. The latest amendments to the Centre’s PLI scheme According to reports, as of October 8, the come on the heels of several complaints received by Department of Pharmaceuticals (DoP) had received the DoP claiming that the scheme was too restrictive as many as 29 applications to the PLI scheme from • India’s pharma industry is, reportedly, the 3rd largest India’s Pharma companies. However, several bulk drug in the world by Volume, and the 14th largest in terms manufacturers had complained that the scheme was of Value. too restrictive. • Indian pharmaceutical companies rely on Chinese The DoP had received several recommendations API imports for roughly 70 percent of their total from Pharma manufacturers to amend the scheme bulk drugs requirement. by removing the minimum investment limit of • According to reports, as of October 8, the Rs.400 crore for the manufacturing of four fermentation- Department of Pharmaceuticals (DoP) had received based bulk drugs, and Rs.20-50 crore for the as many as 29 applications to the PLI scheme from manufacturing of 37 other bulk drugs. With the latest India’s pharma companies. relaxations on the minimum investment criterion, it appears that the DoP has paid heed to the concerns of The central Government, on Thursday, 29.10.2020 India’s Pharma manufacturers. decided to remove the criteria of ‘minimum investment’ and ‘barring exports’ in the Production-Linked Incentive While the PLI scheme is indeed a significant step scheme aimed to strengthen India’s indigenous production forward toward enabling the Pharma industry to become of pharmaceutical raw materials. The move is specifically ‘aatmanirbhar,’ several challenges do remain. Industry geared to further encourage increased production of experts have noted that the production of cost of APIs in China are a staggering 20 to 30 percent less than they Active Pharmaceutical Ingredients (APIs) required in the are in India. manufacture of medicines. As per some reports, a substantial chunk of India’s API In late July this year, the Government notified the PLI units run at just 30 percent capacity compared to China’s scheme as India’s Pharmaceutical industry reeled from capacity utilisation of 70 percent. It is widely acknowledged major supply-chain disruptions encountered due to the that the last three decades has seen India cede its COVID-19 outbreak in China, and the stringent lockdown production advantage in the Pharma manufacturing space measures imposed. India’s Pharma industry is, reportedly, to China. As such, further infrastructural incentives and tax

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benefits may be required if India is to truly transform its and lockdowns in various importing countries during Pharma industry into one characterised by self-reliance. Covid-19 pandemic in last quarter of fiscal ended March 2020,” Uday Bhaskar told. Source: etnownews.com, 31.10.2020 Besides formulations and biologicals, herbal products l l l also saw a record growth of 20.77% year-on-year in the Pharma exports soar 15% in first first half at $168.87 million. Herbal products account for less than 1.5% of Indian pharma exports. half of FY21 Exports of bulk drugs, drug intermediates, Ayush, Pharmaceuticals exports from the country is on course vaccines and surgicals declined marginally in the first to cross $23b for the first time this fiscal after growing half, owing to change in immediate healthcare focus 14.85% y-o-y at $11.78b in the first half, a Senior of nations across the globe towards handling Covid-19 Commerce Ministry official said. pandemic. Bulk drugs and drug intermediates reported a “Going by the indications of demand for our pharma fall of 4.5% at $1.87 billion during this first half, down products across the globe, India is likely to maintain similar from $1.96 billion last fiscal. “The fall in bulk drugs growth in pharmaceutical exports during the second half and drug intermediate exports can also be seen as a of the fiscal as well to close the fiscal with exports of at positive development since most Indian companies have least $23b and may even touch $24b,” said Ravi Uday used them for value addition to make high-margin and Bhaskar, DG, Pharmexcil. high-value formulations, adding to the overall growth of Indian pharmaceutical exports,” Uday Bhaskar said. The growth is driven by drug formulations and biologicals, shipment of which grew a record 21.85% year- Exports of vaccines dipped 7.27% in the first on-year at $8.99 billion in the April-September period as half at $359.05 million while exports of surgicals and countries across the globe turned to India to meet a spike Ayush products remained almost flat, slipping 0.11% at in demand amid the Covid-19 pandemic that caused $317.07 million and by 0.65% at $72.1 million, lockdowns and production disruptions in many parts of respectively. the world. “India exports vaccines mostly to meet the scheduled For the first time in the history of Indian pharmaceutical immunisation programmes to children by various countries exports, formulations and biologicals accounted for 76.3% and with the change in healthcare focus of these countries of the total pharma exports this first half, up from around towards addressing Covid-19 pandemic, India saw a fall in 72% a year ago. vaccine exports,” said Uday Bhaskar. India had exported pharmaceuticals worth $20.58 However, the country “may see a significant surge in billion last fiscal. export of vaccines this fiscal if it succeeds in introducing Covid-19 vaccine before the fiscal end”, he added. “We had projected India to report $22 billion of pharmaceutical exports last fiscal but we fell short and Source: C R Sukumar, ET Bureau, The Economic Times, ended up at $20.58 billion, owing to disruptions in logistics 03.11.2020

l l l

International News

Virus-hunting trio win Nobel for Briton Michael Houghton mean there is now a chance of medicine on Hepatitis C discovery eradicating the Hepatitis C virus – a goal the World Health Organization wants to achieve in the next decade. Two Americans and a Briton won the 2020 Nobel Prize “It’s so other-worldly – it’s something you don’t think for Medicine on Monday, 05.10.2020 for identifying the will ever happen,” Alter, 85, said after picking up the Hepatitis C virus, in work spanning decades that has helped phone only after a third pre-dawn call from Stockholm. The to limit the spread of the fatal disease and develop drugs to trio-share the 10 million Swedish crown ($1.1 million) cure it. The discoveries by Harvey Alter, Charles Rice and award for discovering and proving that a blood-borne virus

IDMA Bulletin LI (41) 01 to 07 November 2020 31

causes Hepatitis C, which afflicts 70 million people and his team’s work on a Hepatitis C vaccine, which is now in causes 400,000 deaths each year. Clinical Trials.

“(To) go from basically the beginning-part of this Costly Treatment: discovery to when it can be successfully treated – this is kind of a rare treat for a basic scientist,” Rice, 68, told While effective antiviral treatments are now available, reporters on a Zoom call. a course can cost $30,000 in the United States. “In well-resourced countries that have the political will to Nominations for this year’s award preceded the Global do it, we are seeing huge progress,” said Graham Cooke, spread of the new Coronavirus pandemic, but the choice of NIHR Professor of Infectious Diseases at Imperial College, winners recognises the importance of identifying a virus as London. the first step in winning the battle against a new disease. In poorer countries, he said, “there are lots of challenges Rice said advances in gene sequencing would make it possible today for researchers to achieve “spectacular” to overcome, but I think it is a realistic ambition”. Rice progress towards developing treatments and vaccines said manufacturers were now attempting to lower the price, for COVID-19. Nearly 3 million Hepatitis C sufferers are in part by granting production rights in poorer countries. co-infected with the Human Immune deficiency Virus (HIV) “I would have been much happier had it been more rapid,” that causes AIDS, according to the WHO. he said. Because of the Coronavirus pandemic, the Nobel Three Steps: Foundation has cancelled the banquet that traditionally The shared prize recognizes research dating back to the forms the centre piece of the award ceremonies in 1960s when Alter, at the US National Institutes of Health Stockholm in December, and will present medals and (NIH), found that a liver disease that was not Hepatitis A diplomas in a televised event instead. or B could be spread through blood transfusions. A team 9/30/2020 Source: ReutersWhen News we can get Service/Cyprus-mail.com, a covid vaccine? Crucial results coming over next few07.10.2020 weeks led by Houghton, then working for the pharmaceuticals firm Chiron, created a clone of a new virus in the l l l mid-1980s from fragments found in the blood of an When we can get a covid vaccine? Crucial results coming over next few weeks infected chimpanzee. WWhenhen we can get a CCovidovid Vaccine? CCrucialrucial 42 days but have not published any interim results. Their livemint.com/science/health/when-we-can-get-a-covid-vaccine-crucial-results-may-be-coming-next-few-weeks- 11601446279547.html early-stage trial results were peer-reviewed and published The disease it causes was named Hepatitis C. It’s results coming over next few weeks September 30, 2020 in 4HE,ANCET. Russia had approved a Covid vaccine in identification made it possible to develop tests to screen August even before the final-stage trials. blood bank supplies and greatly reduce the spread of the disease, which can cause cirrhosis and liver cancer. “We The head of the Food and Drug Administration office thought it would be solved quickly, but it actually took that oversees vaccines said drug makers developing seven years to find,” Houghton told a news conference on Covid-19 shots are aware of the data that will be required to Zoom. “I thought I was going mad.” gain an emergency-use authorization, regardless of whether the agency provides formal guidance. The final piece of the jigsaw puzzle came when Rice, now at Rockefeller University in New York, was able to “The companies know what we’re expecting,” said genetically engineer a version of the Hepatitis C virus Peter Marks, Director of the FDA’s biologics office, at an and demonstrate that it alone could cause symptoms in a event recently. The US agency has scheduled a meeting chimpanzee comparable to an infection in humans. of outside experts to discuss a vaccine. The Center for Biologics Evaluation and Research’s (CBER),Vaccines and But Rice told Reuters that the WHO was unlikely to Some developersSome developersof covid vaccines of may Covid release vaccines interim data may from theirrelease final stage interim trials over the next few weeks. There is no approved COVID-19 vaccine yet, but several are in Related Biological Products Advisory Committee (VRBPAC) be able to eradicate the virus by 2030, in part because advanceddata trials,from including their finalfinalfrom Pfizer stagestage Inc , trialsJohnsontrials over &over Johnson, thethe AstraZeneca-Oxford nextnext fewfew weeks.weeks. will meet in open session, to discuss, in general, the a broadly effective and widely available vaccine was still University,There Novavaxis no andapproved Moderna. COVID-19 vaccine yet, but several development, authorization and/or licensure of vaccines years away, and also because many countries have banned Pfizerare and in its advanced partner BioNTech trials, could including have late-stage from clinical PfizerPfizer data as Inc,soonInc, as Johnson Johnsonthe end of October, the vaccine makers had said earlier. "Based on current infection rates, the to prevent COVID-19. No specific application will be research on chimpanzees, which was more powerful than & Johnson, AstraZeneca-Oxford University, Novavax and companies continue to expect that a conclusive readout on efficacy is likely by the end of discussed at this meeting. studies on rodents. October,"Moderna. Pfizer said earlier this month while seeking US regulator's approval to expand its trial to 44,000 participants. 3OURCE,IVE-INT7ITH!GENCY)NPUTS  Houghton, 69, is a Professor of Virology at Canada’s PfizerPfizer andand itsits partnerpartner BioNTechBioNTech couldcould havehave late-stagelate-stage Data from Moderna is also expected soon after. Johnson & Johnson and Novavax have (Excerpts) University of Alberta. He told reporters the award validated alsoClinical recently begun data their as own soon late-stage as thetrials endand could of haveOctober, data over the next fewvaccine months.    Meanwhile,makers a hadtop Russian said scientistearlier. behind “Based its Sputnik on currentV covid vaccine infection told Reuters rates, that Moscowthe companies plans to publish continue interim results to basedexpect on the that first a42 conclusive days of monitoring readout IDMA Bulletin LI (41) 01 to 07 November 2020 volunteers. If Russia is able to publish interim data from final-stage trials it has a high32 chanceon ofefficacy becoming theis firstlikely worldwide by the to announce end of any October,” data from a final-stage Pfizer trial. said earlier this month while seeking US regulator’s approval The first of 5,000 volunteers in Russia was vaccinated on September 9, which means interimto expand results could its be trial issued to some 44,000 time after participants. October 21. Russia's sovereign wealth fund, which has invested in the vaccine's roll-out, has said it expects interim results to be publishedData in October from or Moderna November. is also expected soon after. Johnson & Johnson and Novavax have also recently begun their https://www.livemint.com/science/health/when-we-can-get-a-covid-vaccine-crown late-stage trials and coulducial-results-may-be-coming-next-few-weeks-1 have data over next1601446279547.html few 1/2 months. Meanwhile, a top Russian scientist behind its Sputnik V Covid vaccine told Reuters that Moscow plans to publish interim results based on the first 42 days of monitoring volunteers. If Russia is able to publish interim data from final-stage trials it has a high chance of becoming the first worldwide to announce any data from a final-stage trial. The first of 5,000 volunteers in Russia was vaccinated on September 9, which means interim results could be issued some time after October 21. Russia’s sovereign wealth fund, which has invested in the vaccine’s roll-out, has said it expects interim results to be published in October or November. Several Western developers are conducting final- stage trials that have already been going on for more than

IDMA Bulletin LI (41) 01 to 07 November 2020 42

makers had said earlier. “Based on current infection rates, going on for more than 42 days but have not published the companies continue to expect that a conclusive readout any interim results. Their early-stage trial results were on efficacy is likely by the end of October,” Pfizer said peer-reviewed and published in The Lancet. Russia had earlier this month while seeking US regulator’s approval approved a Covid vaccine in August even before the to expand its trial to 44,000 participants. final-stage trials. Data from Moderna is also expected soon after. Johnson The head of the Food and Drug Administration office & Johnson and Novavax have also recently begun their that oversees vaccines said drug makers developing own late-stage trials and could have data over next few Covid-19 shots are aware of the data that will be required to months. gain an emergency-use authorization, regardless of whether Meanwhile, a top Russian scientist behind its Sputnik V the agency provides formal guidance. Covid vaccine told Reuters that Moscow plans to publish “The companies know what we’re expecting,” said interim results based on the first 42 days of monitoring Peter Marks, Director of the FDA’s biologics office, at an volunteers. If Russia is able to publish interim data from event recently. The US agency has scheduled a meeting final-stage trials it has a high chance of becoming the first of outside experts to discuss a vaccine. The Center for worldwide to announce any data from a final-stage trial. Biologics Evaluation and Research’s (CBER), Vaccines and The first of 5,000 volunteers in Russia was vaccinated Related Biological Products Advisory Committee (VRBPAC) on September 9, which means interim results could be will meet in open session, to discuss, in general, the issued some time after October 21. Russia’s sovereign development, authorization and/or licensure of vaccines wealth fund, which has invested in the vaccine’s to prevent COVID-19. No specific application will be roll-out, has said it expects interim results to be published discussed at this meeting. in October or November. Several Western developers Source: Live Mint (With Agency Inputs), 30.09.2020 are conducting final-stage trials that have already been (Excerpts)

l l l

FEATUFEATUrERE COVID-19COVID-19 vaccinevaccine delivery:delivery: PreppingPrepping forfor challengechallenge extraordinaireextraordinaire Lakshmipriya Nair Lakshmipriya Nair IndiaIndia will will have have a a very very strategic strategic role role to to play play in in ensuring ensuring universal universal access access to to COVID-19 COVID-19 vaccines. vaccines. AllAll stakeholders stakeholders must must step step up up their their game game and and eliminate eliminate chinks chinks in in their their supply supply chain chain and andsuccessfully successfully execute execute this this critical critical task task

COVID-19 three biggest challenges that the logistics sector will be vaccinesC O V I D -are 1 9 facedbillions with of andCOVID-19 the preparations vaccine doses underway efficiently to tackle across them. the lvaccines i k e l y tare o bl eik Becauseglobally, afterwith utmostall, aren’t care we for only their as efficacy,strong as ourwhen weakest they are ae l reality y t o b very e a link?approved and available for distribution is going to be the soon,reality very and soon, the ultimate logistics challenge witnessed until now. and the world Ultra-low transport and storage temperatures: world lives in the A few weeks earlier, DHL along with McKinsey, published lives in the belief belief that it will Generally, vaccines are stored and transported between that it will help a white paper on ‘Delivering Pandemic Resilience’, which help vanquish the temperatures of 2°C to 8°C range. However, with vanquish the highlights, “To provide global coverage of COVID-19 the Coronavirus. over 250 vaccines are being developed and tested across Coronavirus. Yet, as experts rightly point out, ensuring vaccines, up to ~200,000 pallet shipments and ~15 Yet, as experts rightly point out, ensuring universal access the world, the temperature requirements for at least universal access to these vaccines will be a very crucial million deliveries in cooling boxes as well as ~15,000 to these vaccines will be a very crucial aspect in the battle some of them are likely to be considerably lower. And, aspect in the battle strategy against the wily virus which has flights will be required across the various supply chain strategy against the wily virus which has disrupted lives as the development of most of these vaccines has been disrupted lives and livelihoods worldwide. And, supplying set-ups.” The DHL-McKinsey whitepaper also identifies and livelihoods worldwide. And, supplying billions of fast-tracked looking at their urgent need to control and COVID-19 vaccine doses efficiently across the globally, end the pandemic, experts also feel that more rigorous withIDMA utmost Bulletin care LI for (41) their 01 efficacy, to 07 November when they 2020 are approved procedures will be imposed to maintain and protect33 and available for distribution is going to be the ultimate their efficacy during transportation and storage. This logistics challenge witnessed until now. may necessitate temperature-controlled transport and A few weeks earlier, DHL along with McKinsey, published warehouses at ultra-low temperatures (up to -80°C). a white paper on ‘Delivering Pandemic Resilience’, which While India does have considerable expertise in highlights, “To provide global coverage of COVID-19 vaccine production and distribution, the scale and scope of vaccines, up to ~200,000 pallet shipments and ~15 COVID-19 vaccines could pose a serious problem. So, million deliveries in cooling boxes as well as ~15,000 how are the Indian players in this sphere optimizing and flights will be required across the various supply chain ramping their capacities before the COVID-19 vaccines set-ups.” The DHL-McKinsey whitepaper also identifies become available? Vikash Khatri, Co-Founder, Aviral key hurdles in COVID-19 vaccine logistics. Take a look at Consulting informs, “Indian logistics players have already some of the pain points that the report highlights. started preparations to handle the volume surge. Since this demand is not permanent, companies are looking for coordinated efforts to ramp up short term competencies.” He adds, “For surface transportation and storage, we don’t foresee a major gap in the available infrastructure and the required infrastructure. A large quantum of infra will be used out of the existing setup, for which logistics companies are getting ready with necessary upgrades for the Pharma industry.” The flurry of measures on varied fronts by the different players corroborates Khatri’s views.

To cite a few examples; Hence, Express Pharma spoke to a few players in DHL opened its first temperature-controlled facility the Pharma logistics space to gain more insights into the

IDMA Bulletin LI (41) 01 to 07 November 2020 43

FEATURE COVID-19 vaccine delivery: Prepping for challenge extraordinaire Lakshmipriya Nair

India will have a very strategic role to play in ensuring universal access to COVID-19 vaccines. All stakeholders must step up their game and eliminate chinks in their supply chain and successfully execute this critical task

COVID-19 three biggest challenges that the logistics sector will be vaccines are faced with and the preparations underway to tackle them. l i k e l y t o b e Because after all, aren’t we only as strong as our weakest a reality very link? soon, and the world lives in the Ultra-low transport and storage temperatures: belief that it will Generally, vaccines are stored and transported between help vanquish the temperatures of 2°C to 8°C range. However, with the Coronavirus. over 250 vaccines are being developed and tested across Yet, as experts rightly point out, ensuring universal access the world, the temperature requirements for at least to these vaccines will be a very crucial aspect in the battle some of them are likely to be considerably lower. And, strategy against the wily virus which has disrupted lives as the development of most of these vaccines has been and livelihoods worldwide. And, supplying billions of fast-tracked looking at their urgent need to control and COVID-19 vaccine doses efficiently across the globally, end the pandemic, experts also feel that more rigorous with utmost care for their efficacy, when they are approved procedures will be imposed to maintain and protect and available for distribution is going to be the ultimate their efficacy during transportation and storage. This logistics challenge witnessed until now. may necessitate temperature-controlled transport and A few weeks earlier, DHL along with McKinsey, published warehouses at ultra-low temperatures (up to -80°C). a white paper on ‘Delivering Pandemic Resilience’, which While India does have considerable expertise in highlights, “To provide global coverage of COVID-19 vaccine production and distribution, the scale and scope of vaccines, up to ~200,000 pallet shipments and ~15 COVID-19 vaccines could pose a serious problem. So, million deliveries in cooling boxes as well as ~15,000 how are the Indian players in this sphere optimizing and flights will be required across the various supply chain ramping their capacities before the COVID-19 vaccines set-ups.” The DHL-McKinsey whitepaper also identifies become available? Vikash Khatri, Co-Founder, Aviral keykey hurdleshurdles inin COVID-19COVID-19 vaccinevaccine logistics.logistics. TakeTake aa looklook atat Consultingindustry.” informs,The flurry “Indian of measures logistics on players varied have fronts already by the somesome ofof thethe painpain pointspoints thatthat thethe reportreport highlights.highlights. starteddifferent preparations players corroborates to handle Khatri’s the volume views. surge. Since this demand is not permanent, companies are looking for

coordinatedTo cite a few efforts examples; to ramp up short term competencies.” He adds,DHL “For opened surface its transportation first temperature-controlled and storage, we facilitydon’t foreseein India a major in July gap near in the the available Hyderabad infrastructure airport for and Pharma the requiredshipments. infrastructure. The company A largeinformed quantum that theof infra new willfacility be usedoffers out “conditioning of the existing ofsetup, packaging for which materials logistics incompanies different arechambers getting readyfor varying with necessary temperatures upgrades up tofor -20°C.”the Pharma The industry.”facility offers The online flurry temperature of measures monitoring on varied and fronts SMS by alerts the differentwith all dataplayers available corroborates for download Khatri’s from views. a cloud-hosted service as well. To cite a few examples; Similarly, Kool-ex, a Pharma cold chain logistics service Hence,Hence, ExpressExpress PharmaPharma spokespoke toto aa fewfew playersplayers inin providerDHL openedhas partnered its first with temperature-controlled IndoSpace, a Developer facility and thethe PharmaPharma logisticslogistics spacespace toto gaingain moremore insightsinsights intointo thethe Manager of industrial real estate and warehousing in India, three biggest challenges that the logistics sector will be to build GDP/GWP compliant, temperature-controlled, IDMAfaced Bulletinwith and LI the (41) preparations 01 to 07 November underway 2020to tackle them. 43 Pharma distribution centres across the country. They plan Because after all, aren’t we only as strong as our weakest to jointly design and set up three warehouses with 42,000 link? pallet positions in each warehouse, in the first phase by Ultra-low transport and storage temperatures: 2021 near Mumbai, Delhi and Bengaluru. Koolex also intends to set-up 10-11 warehouses by 2023. These Generally, vaccines are stored and transported between also include cold room facilities which will offer -20°C, the temperatures of 2°C to 8°C range. However, with if required for COVID-19 vaccines. over 250 vaccines are being developed and tested across the world, the temperature requirements for at least Blue Dart, an express logistics provider and part of the some of them are likely to be considerably lower. And, Deutsche Post DHL Group (DPDHL) is also ramping up its as the development of most of these vaccines has been infrastructure with its pre-existing specialized Temperature- fast-tracked looking at their urgent need to control and Controlled Logistics (TCL) to transport critical shipments end the pandemic, experts also feel that more rigorous such as vaccines, medical samples and more. The company procedures will be imposed to maintain and protect informed through a statement that it can handle various their efficacy during transportation and storage. This temperature requirements be it frozen: (-80°C to -20°C), may necessitate temperature-controlled transport and deep chilled (2°C to (8°C) or ambient (15°C to 25°C) warehouses at ultra-low temperatures (up to -80°C). “With an agile response team overseeing the up While India does have considerable expertise in scaling of our current capabilities, a strong fleet of vaccine production and distribution, the scale and scope of dedicated Boeing 757 aircraft and robust infrastructure COVID-19 vaccines could pose a serious problem. So, for our temperature-controlled logistics solutions, we are how are the Indian players in this sphere optimizing and capable and prepared to meet any immediate large-scale ramping their capacities before the COVID-19 vaccines demand,” informs Ketan Kulkarni, CMO & Head – Business become available? Vikash Khatri, Co-Founder, Aviral Development, Blue Dart through a statement. Consulting informs, “Indian logistics players have already A few players also suggest that the cold chain facilities started preparations to handle the volume surge. Since which are used to transport cell and gene therapies, as well this demand is not permanent, companies are looking for as the capabilities in the food and agro-based industries, coordinated efforts to ramp up short term competencies.” can also be redeployed with suitable upgrades to undertake He adds, “For surface transportation and storage, we don’t and successfully execute this huge task. This could be a foresee a major gap in the available infrastructure and the good idea but given how vital is the endeavour and the required infrastructure. A large quantum of infra will be implications it will have on the wellbeing of populations used out of the existing setup, for which logistics companies across the country, putting strict protocols in place and are getting ready with necessary upgrades for the Pharma ensuring that they are adhered to will be paramount.

IDMA Bulletin LI (41) 01 to 07 November 2020 34

Airfreight capabilities: Thakkar updates, “Currently, AAI and private airport operators are building capacity and implementing solutions The air cargo industry will obviously have a very pivotal which should be ready by the time vaccines are approved. role to play in the whole vaccine delivery chain given It is also pertinent to point out that a lot of passenger the nature of the cargo, need for speedy delivery with aircraft have been drafted into carrying cargo, which will temperature compliance for safety and efficacy, handling increase carrying capacity and therefore reduce delays in capability of the stakeholders and operational specialization shipping.” He says that our airports already have a certain etc. But, this would translate into mammoth capabilities. amount of infrastructure which can be upgraded to create Recently, IATA, an airline industry body had said that short-term competencies. To explain his point, he informs transporting the COVID-19 vaccines will be the “largest that per month 20000 tonnes of cargo is flown from only transport challenge ever” and the equivalent of 8,000 Mumbai, and since the time a new facility was launched in Boeing 747s will be needed to execute this mammoth January 2020, the capacities have doubled. The Mumbai task assuming that each person will require only one dose airport can keep almost 100 pallets at any given time on of the vaccine. any given day. Giving more understanding about the scenario, Khatri Likewise, all major cities have air cargo terminals with points out, “COVID-19 vaccine will be required for each cold storage facilities, be it Mumbai’s Cargo Service Centre human being leading to the overall requirement of 7.8 and Air India’s APEDA; Delhi Cargo Service Centre and billion units of doses, while the overall estimated market of Celebi Delhi Cargo Terminal Management in Delhi; AISATS vaccines was 3.5 billion doses, in 2018. Once we include and Menzies Aviation Bobba (Bangalore) in Bengaluru or booster doses for COVID-19 vaccines, this requirement GMR Hyderabad Air Cargo in Hyderabad. These terminals will be double than this. Air cargo plays a key role in the can customise to meet ultra-low storage requirements. supply chain of vaccines in normal times and it has a well- Moreover, he promises, “Indian cargo agents will be established global time-and-temperature- sensitive network ready to meet the increased demand for vis-à-vis transport to cater to routine requirement. But such a high volume from factories and onwards. Cargo agents, such as requires extraordinary capabilities.” ourselves, have had experience in moving mission-critical “Even if we consider that 25 percent of volume can be cargos across the world for aid in times of natural disasters, connected by surface mode in and around manufacturing famines and even in times of war. He discloses that he is also working to optimize the processes to make them more countries, the demand of air cargo capacity will be efficient and cost-effective with the existing resources. approximately 12000 large freighters for primary and Hariramani also assures, “Most important aspect is the air booster dose of vaccines,” he adds. Bharat Thakkar, capacity. We are working to create enough air cargo capacity Co-Founder & Joint MD, Zeus Air Services admits, “Air to handle large volumes of vaccine with the type of service cargo will be the primary initial solution that Governments that would be required – active/ passive along with the and Pharma companies will engage to deliver the vaccines. provision for end-to-end tracking of the shipment.” Therefore, yes, the demand for vaccine deliveries will overtake the demand for regular cargo by quite a He explains, “Warehouses being a dominant aspect, we margin.” have partnered with reputed organisations having exclusive facilities pan India for various temperature ranges, besides Giving some more clarity into the whole issue, Rajiv our warehouse close to the cargo terminal in Delhi which Hariramani, VP–Air Freight, Skyways Air Services informs serves packing stations, temperature zones, dangerous that in the months since the onset of COVID-19, air cargo goods handling arena, general and courier screening from India has touched about 65000 tonnes per month as well as storage zones.” He updates that Skyways’ of which 70 percent is Pharma exports. This is only likely warehouse in Delhi has a cold room of 20 cubic metres to increase once the vaccines become available. However, and they are currently constructing a cold room in their both, Thakkar and Hariramani are upbeat about India’s warehouse in Bangalore of the same capacity. In Mumbai air cargo sector’s abilities to handle exports of COVID-19 and Hyderabad too, the company is working to expanding vaccine delivery because they believe that there is ample its GDP-compliant warehousing capabilities. untapped capacity that could be galvanized to deal with “Understanding the need for reefer transportation, we a spurt in demand. have joined hands with a few reputed GDP/ISO certified

IDMA Bulletin LI (41) 01 to 07 November 2020 35

vendors who can cater to Pan India transportation with from other pre-existing setups for short term and second their dedicated fleets. Besides, our subsidiary Phantom is about improving operating efficiency, so that same infra Express owns a fleet of 35 trucks in Delhi NCR and we can handle more volumes with faster turnaround.” are further mapping across South and West of India,” adds So, all stakeholders of the supply chain are stepping Hariramani. “Considering the various aspects involved in up their game and getting ready to collaborate on a level vaccine handling, we have appointed a dedicated team unseen before. For instance, Rahul Agarwal, Director, that has been trained by GDP certified authorities and will Kool-ex Warehousing, enlightens that the private sector is act as a central control tower,” he apprises. The industry not sure to what extent the Government will control the stakeholders also share the belief that vaccine delivery will supply and distribution of the vaccines and price-control be carried out in phases and not as a one-time activity since of these vaccines are also likely. So, they are slightly wary the vaccines need to be produced in massive quantities. of making huge investments at their end which might not Another report from PwC Health Research Institute, get utilised and are looking for partners in this exercise. titled, ‘Developing a COVID-19 vaccine may not be enough,’ He says that several Pharma companies are talking also states that “vaccination is likely to occur in waves as to Kool-ex to create end-to-end supply capabilities. After the federal and state governments make decisions about discussions with these players, the company has worked out which groups should be the highest priority and how the a per vial costing, which ranges between Rs.10 to Rs.25 criteria for vaccine recipients are broadened as more for end-to-end distribution based on different scenarios doses become available.” While the report refers to the US and conditions. This includes two legs of warehousing scenario, it stands true for India as well. The stakeholders and three legs of transportation. “We are not giving them hope that this, in turn, will help them to plan out a more (Pharma companies) a Capex model, but a pay-per-use co-ordinated approach, thereby avoiding sudden spikes rental model. It will be viable for them because it will and unanticipated glitches. help them benchmark an end-to-end cost, right from the Last-mile delivery: beginning,” explains Agarwal. Ensuring that the COVID-19 vaccines reach every nook So the company is building portable storages which can and corner of India, no matter how far-flung and remote be rented. Once the need is over, these storage facilities they are, will require a robust infrastructure for a green can be put to other uses. Khatri also states, “Industry is corridor to transport COVID-19 vaccines, along with a large working with Government agencies, freight forwarders, number of trained personnel and monitoring capabilities. port operators for quick turnaround of aircraft and speedy Combining all this to create a blueprint that is fail-safe border clearances.” At the same time, industry players will require all our famed ingenuity and expertise gained like Hariramani emphasise on the huge role that the as one of the major global exporters of Pharma products. Government will have to play in this whole exercise. He A Herculean task indeed! Thakkar points out, “The points out that as the private players plan and prepare for challenges will be in proper planning of the movement of this massive endeavour, the Government will have to be in the vaccines, which will need to be synchronised between the forefront of facilitating a smooth path for the supply Pharma companies, logistics solutions provider, airlines and distribution of these vaccines to all nook and corners and distribution channels.” of the country as well as worldwide. “It will be prudent for Pharma companies to work with “Governments of vaccine producing nations have been their cargo handlers to define daily production capabilities. requested by world bodies to take the lead in facilitating The cargo handlers, in turn, can build capacity (if need be) seamless logistics across borders whilst providing security and also advise their respective clients as to cold chain since this will be a highly valuable commodity,” reminds solutions required to move the cargo from their factories Thakkar as well. to the airport and onwards to their eventual distribution To explain his point, he calls attention to a snag in the channels,” advises Thakkar. Khatri outlines, “Creation current scenario that needs to be smoothened and states, of capability for short term demand is one of the key “Another challenge that has come to the fore recently is challenges, where logistics players can’t justify huge the fact that Ministry of Civil Aviation has announced a CAPEX. To mitigate this risk, the industry is adopting a change in the rule of open sky policy of 1990. The new two-way strategy. First is around mobilization of resources rules have restricted non-schedule freighter operators to

IDMA Bulletin LI (41) 01 to 07 November 2020 36

unseen before. For instance, Rahul Agarwal, Director, on to a cargo plane of non-scheduled operators in metros. Kool-ex Warehousing, enlightens that the private sector is This will have to be reviewed for vaccines movement and not sure to what extent the Government will control the other exports to cut down on lead times.” supply and distribution of the vaccines and price-control The DHL-McKinsey whitepaper also outlines the most of these vaccines are also likely. So, they are slightly wary of making huge investments at their end which might not important measures that the Government should take to get utilised and are looking for partners in this exercise. ensure adequate supplies. The paper highlights that these aspects will form the “pillars of successful crisis response He says that several Pharma companies are talking management” and “will be key to meeting the supply chain to Kool-ex to create end-to-end supply capabilities. After challenges of future global health emergencies”. They are discussions with these players, the company has worked as follows: out a per vial costing, which ranges between Rs.10 to (1): Developing and disseminating a clear and pre-defined Rs.25 for end-to-end distribution based on different emergency response plan. scenarios and conditions. This includes two legs of warehousing and three legs of transportation. “We are not (2): Building a partnership network of both public-private giving them (Pharma companies) a Capex model, but a and public-public partnerships. pay-per-use rental model. It will be viable for them because (3): Identifying and ensuring access to required physical it will help them benchmark an end-to-end cost, right from logistics infrastructure. the beginning,” explains Agarwal.operate from six metro airports rather than operating pan On a hopeful note, Dr Harsh Vardhan, Union Minister India. This will lead to delays in(4): the transportationEstablishing IT-enabled of the ofsupply Health chain and transparency.Family Welfare, recently informed that the So the company is buildingvaccines. portable Duestorages to this which policy, can we will need to move cargo on Centre is also working on plans for building capacities (5): Creating organisational structures and allocating be rented. Once the need is scheduledover, these operators storage facilities from non-metro locations and load it in HR, training, supervision etc., on a massive scale and resources to institutionalize and coordinate the entire can be put to other uses. Khatrion to also a cargo states, plane “Industry of non-scheduled is operators in metros. roughly estimates to receive and utilise 400-500 million response management including plan, partners, working with Government agencies,This will have freight to forwarders,be reviewed for vaccines movement and doses covering approximately 20-25 crore people by July infrastructure and IT. port operators for quick turnaroundother exports of aircraft to cut and down speedy on lead times.” 2021. border clearances.” At the same time, industry players The stakes are very high and the margin for error The DHL-McKinsey whitepaper also outlines the most He said that there is a high-level committee headed like Hariramani emphasise on the huge role that the important measures that the Governmentis very low. should The take Indian to Governmentby Dr V K Paul, must Member consider (Health), Niti Aayog is drawing Government will have to play in this whole exercise. He ensure adequate supplies. The paperthe recommendations highlights that these by industryup the entire stakeholders process. Vaccine while procurement is being done points out that as the private aspectsplayers planwill form and theprepare “pillars for of successfulformulating crisis its blueprint. response centrally and each consignment will be tracked real-time this massive endeavour, the Government will have to be in management” and “will be key until delivery to ensure it the forefront of facilitating a tosmooth meeting path the for supply the supply chain reaches those who need it and distribution of these vaccineschallenges to all nook of futureand corners global most. He added that these of the country as well as worldwide.health emergencies”. They are Committees are working on “Governments of vaccine asproducing follows: nations have been understanding the timelines of availability of various requested by world bodies to(1): take Dthe e vlead e lo in p facilitating i n g a n d vaccines in the country, seamless logistics across borders whilstdisseminating providing a security clear and obtaining commitments since this will be a highly valuablepre-defined commodity,” emergency reminds from vaccine manufacturers Thakkar as well. response plan. to make available maximum To explain his point, he calls(2): attentionBuilding to a snagpartnership in the number of doses for India network of both public- current scenario that needs to be smoothened and states, 3OURCE$(, -C+INSEYREPORT inventory and supply chain private and public-public “Another challenge that has come to the fore recently is management and also on partnerships. On a hopeful note, Dr Harsh Vardhan, Union Minister the fact that Ministry of Civil Aviation has announced a prioritisation of high-risk groups. States are being closely of Health and Family Welfare, recently informed that the change in the rule of open sky(3): policy Identifying of 1990. and The ensuring new access to required physical guided to submit details about cold chain facilities and Centre is also working on plans for building capacities rules have restricted non-schedulelogistics freighter infrastructure. operators to other related infrastructure which will be required down in HR, training, supervision etc.,to the on block a massive level. scale and operate from six metro airports(4): rather Establishing than operating IT-enabled pan supply chain transparency. roughly estimates to receive and utilise 400-500 million India. This will lead to delays in the transportation of the (5): Creating organisational structuresdoses covering and approximately allocating Impact 20-25 and crore implications: people by July vaccines. Due to this policy, we willresources need to move to institutionalize cargo on and coordinate the entire 2021. Thus, preparations are on in full swing but their result scheduled operators from non-metroresponse locations management and load it including plan, partners, will be seen only in the days to come. However, it is to be infrastructure and IT. IDMA Bulletin LI (41) 01 to 07 November 2020 hoped that this entire venture46 will not only be successful in The stakes are very high and the margin for error ending this pandemic but also be instrumental in creating a is very low. The Indian Government must consider structure which will bring in better efficiencies in the supply the recommendations by industry stakeholders while chain and fasten access to medicines and vaccines. formulating its blueprint. Source: Express Pharma, 22.10.2020 (Excerpts) l l l Indian Pharma is being squeezed – and it’s bad news for drug access in developing countries

Thankom Arun, Professor of Global Development and Accountability, University of Essex and Reji K Joseph, Associate Professor of Economics, Institute for Studies in Industrial Development

India’s Pharmaceutical industry is renowned for its fight against HIV/Aids, for instance. Such endeavours selling medicines to the world at reasonable prices, have earned India a reputation as the “Pharmacy of the especially developing countries. This has helped Africa in World”.

IDMA Bulletin LI (41) 01 to 07 November 2020 37

Now, the advantages that have enabled India to play may drive up its production costs for formulations – thus this role are in danger of being eroded. Not only would potentially benefiting India. this be bad news for India’s economy, it could make it Another challenge to India is wealthy countries harder for developing countries to access the medicines protecting their Pharma industries to ensure drug security. they need – threatening the UN Sustainable Development In August, President Trump issued an executive order that Goals in the process. called for the elimination of drug imports, both as Active India’s challenges: Ingredients and Formulations. France and Germany look to be heading in a similar direction. India is the World Leader in generic medicines, which contain the same ingredients as the originator version, If the US order is strictly adhered to, it will heavily and go on the market after the original Patent has expired. affect Indian Pharma. More than half of India’s Pharma India’s top Pharma firms include Cipla, Aurobindo Pharma, sales are from exports, and by our calculations, the US has Lupin, Dr Reddy’s Laboratories and Sun Pharmaceutical bought 37% of them over the past three years. Industries Ltd. Access to the US market is also critical for leading firms One challenge is coming from China, which has to maintain profit margins. For example, when Dr Reddy’s increasingly been exporting Active Pharmaceutical secured 180-day exclusivity in the US for selling the Ingredients in recent years. Indian companies have antidepressant fluoxetine 40mg in 2001-02, it increased managed to turn this into an opportunity by using these the company’s annual sales of generic drugs by 81% and ingredients to supply medicines at reasonable prices while operating profits by 50%. reducing their production costs and R&D spend. The COVID dimension: But China is also expanding into drug formulations. COVID-19 underlines India’s importance to developing By our calculations, China’s global share of formulations countries when it comes to drug access. The Serum Institute exports trebled from 0.4% in 2009 to 1.2% in 2018, of India (SII), the world’s largest vaccines producer, while India’s doubled over the same period from 1.5% to 3.6%. Remarkably, 36% of China’s exports are to the is collaborating with the World Health Organization, EU and North America, where regulations are the most the COVAX facility of Global Alliance for Vaccines and stringent, compared to 19% in 2009. Beijing’s “Made in Immunisation (GAVI), and the Coalition for Epidemic China 2025” policy has identified Pharmaceuticals as one Preparedness Innovations (CEPI) to produce and supply of its strategic industries. 100 million doses of a COVID-19 vaccine at a maximum cost of US$ 3 per dose. China’s rising share of formulations has been aided by improved standards that appear to be making the world This is the lowest quoted price in the world for a COVID less apprehensive about Chinese medicine quality. Notably, vaccine, and will see them distributed in low-and-middle- the China Food and Drug Administration issued Guidelines income countries. By comparison, German biotech firm in 2013 to make generic medicines bioequivalent to BioNTech’s deal with US involves a price of US$ 19.50 the originals, and in 2016, the Government made them per dose, while the Moderna/US deal is set at between mandatory. US$ 32 and US$ 37 per dose. Chinese Pharma has also placed much emphasis on SII separately has a manufacturing agreement with using AI and genetics for developing new drugs. This AstraZeneca to produce one billion doses of the Covishield enables firms like XtaIPi to identify thousands of molecules vaccine, which the UK company is developing with the which could be used to treat a disease with fewer resources University of Oxford. The drug is in phase III trials in India and time. at the moment. One silver lining is that China is proposing a new regulation that would give its firms exclusive control over SII is also partnering with US firm Novavax to develop their clinical test data. This sort of rule is favoured by the and distribute the NVX-CoV2373 vaccine in collaboration “innovator” Pharma industries that we see in the west, with CEPI and COVAX. Again, this involves a minimum of and is opposed by generic Pharma industries like India’s. one billion doses for India and other low to middle income It indicates where Chinese Pharma might be headed, and countries.

IDMA Bulletin LI (41) 01 to 07 November 2020 38

Several other COVID vaccine candidates are being as an instrument of foreign policy. All decisions on developed by Indian Pharma firms: Covaxin, being export destinations and pricing have been made by developed jointly by Bharat Biotech and the Indian Council the firms. of Medical Research, has just entered phase III; and Contrast this with China, which is reportedly using ZyCoV-D, by Zudus Cadila, is in phase II. These too are its own vaccine projects as a commercial negotiating tool likely to be much cheaper than western equivalents. with countries who stand to benefit. This threatens to put Besides vaccines, Indian firms are developing drugs pressure on countries whose leverage was limited already. for treating COVID conditions. Baladol, developed by PNB It is another reason why India’s position as Pharmacy of Vesper Life Sciences, has become the first new drug for the World has a value far beyond its borders. treating COVID to enter phase II Clinical Trials around (Disclosure statement: The authors do not work for, consult, the world. Studies so far have shown that it reduces own shares in or receive funding from any company or death rates by 80% – whereas WHO-approved medication organisation that would benefit from this article, and have dexamethasone reduces them by 20%. disclosed no relevant affiliations beyond their academic appointment). Despite India’s contribution to global access to Source: The Conversation, 31.10.2020 (Excerpts) medicines, the Government has never tried to use this

l l l Reducing API dependence: Have we got the strategy right?

Reji K Joseph, Associate Professor, Institute for Studies in Industrial Development, New Delhi explains that the PLI scheme has some gaps that need to be plugged for it to be truly successful

The Government of India launched two schemes in July formulations. It was coercion in the form of marketing this year for the promotion of indigenous manufacturing approval of formulations tied to the indigenous production of Active Pharmaceutical Ingredients (APIs), Drug of APIs that made the Indian private sector invest in the Intermediaries (DIs) and Key Starting Materials (KSMs). production of APIs. Withdrawal of this coercion and removal The Production Linked Incentive (PLI) scheme exclusively of restrictions on imports through economic reforms in the focuses on those APIs, which the Drug Security Committee 1990s again made the private sector to shun indigenous constituted by the Department of Pharmaceuticals (DoP) production of APIs. has identified as heavily import-dependent on China. The Another interesting aspect of the dynamics of the Indian API Parks scheme, on the other hand, has the objective of pharma industry is that the small and Medium Enterprises enhancing the competitiveness of Indian API industry by (SME) have an important role, especially in the production providing easy access to common utilities such as steam, of APIs. It is reported that they account for 70-80 per cent waste management, etc in three selected API Parks. The of the APIs produced in India in terms of quantity. This industry response to these schemes, however, has been may sound defying logic, small fellows producing more lukewarm especially the PLI scheme. A closer examination capital-intensive segment of the pharma industry. But, as shows that the design of these two schemes has some major APIs are sold in their chemical name, without branding, flaws which may result in much less than the expected large firms have no interest in the production of APIs and outcome in terms of elimination of import-dependence their focus is on branded formulations. Their production on China. of APIs, if at all, is largely for captive consumption. The The history of Indian pharma industry shows that SMEs, which are not in a position to establish brands, the focus of the private sector has always been on the focus on APIs. formulations and not APIs. The Hathi Committee (1975), Interestingly, the focus of the PLI scheme is on large the recommendations of which laid the foundation of firms which are not interested in the manufacture of APIs. a vibrant generic pharma industry in India, had looked In the antibiotics area, where more than half of the budget into this issue and found that the capital invested to for the scheme is allocated, each of the beneficiaries is turnover ratio was much higher in APIs as compared to required to incur a minimum investment of Rs. 400 crores.

IDMA Bulletin LI (41) 01 to 07 November 2020 39

This huge amount of investment is required in each of the DoP has given the go-ahead to governments of Andhra four antibiotics APIs/DIs/KSMs. Only large companies can Pradesh, Himachal Pradesh and Telangana in establishing afford investments at this scale. the API parks. The API parks scheme may not be of much Secondly, the PLI scheme doesn’t consider the option use in reducing the import-dependence and ensuring drug of utilising those API manufacturing facilities which are security. lying idle. It requires all likely beneficiaries to make fresh What should be done, then? It seems this is the high investments in the manufacturing facility, irrespective time for leaving the private sector to focus on their area of of whether or not they have the idle capacity to produce interest – formulations. Unless the formulations segment the same product. There are many firms which used to is well taken care of, it may also face the fate of the API produce APIs but closed down operations due to cheaper industry and the ‘Pharmacy of the World’ tag may become imports from China. It doesn’t make any business sense a thing of the past. for a firm which has unused API manufacturing capacity The Indian pharma industry has undergone a major to invest afresh for creation of new additional capacity. transformation since the 1990s and now more than The report of the Drug Security Committee provides a list half of the turnover is coming from exports. China of more than 30 firms including Biocon, Torrent, Alembic, is considerably enhancing its presence in the global Hindustan Antibiotics Ltd (HAL) and Indian Drugs and Pharmaceuticals Ltd (IDPL) that have wound up production generic drug market, a challenge to the Indian pharma of fermentation-based APIs. industry. During the last ten years, from 2009 to 2018, the share of China in the global export of formulations Thirdly, and most importantly, the PLI scheme doesn’t (as captured by ITC HS codes 3003, 3004 and 300220), have a technology component. Without appropriate has grown at a Compound Annual Growth Rate of 15 per technology, API manufacturers in India would not be in a cent as compared to 11 per cent of India. While the share position to beat their Chinese counterparts in pricing. There of India in global exports of formulations doubled during are four key areas where Chinese firms have an edge over this period to reach 3.6 per cent, the share of China Indian firms – the cost of raw materials, cost of electricity, increased three times and reached 1.2 per cent. What is cost of steam and effluent treatment and size of operations. more significant is that China has managed to export more The only advantage that Indian API manufacturers enjoy than one-third of its exports to the regulated markets of vis-a-vis their Chinese counterparts is in the cost of labour. EU and North America, where the regulations are most As a result, the import of APIs is 35-40 per cent cheaper stringent. The share of these destinations in China’s as compared to the cost of indigenously produced APIs. exports increased from 19 per cent to 36 per cent during It is not possible to overcome some of the disadvantages the same period. India is having like the size of operations. Therefore, only technology can compensate for the disadvantages and make This shows that after placing its foot firmly in APIs, the production of APIs a profitable business. China is focusing on formulations. The API Parks scheme may help in reducing the Who then should produce the APIs? The task of cost of inputs like electricity and steam and the cost of manufacturing of those APIs in which the private sector effluent treatment. As this scheme is open to all APIs, it has no interest should be entrusted with the Public Sector is likely that producers of those APIs in which India has Enterprises (PSEs). There are five central PSEs in the a comparative advantage will shift their operations to the pharma sector, which had played an important role in Parks. It is not that India is only importing APIs, it is, in establishing the API manufacturing capability in India fact, a major exporter in the case of certain APIs. Many during the 1970s and 80s. PSEs such as HAL and IDPL APIs are categorised under Indian Trade Classification (Harmonised System) chapter 29.42 (other organic have huge capacities for the production of APIs which are kept idle. Instead of treating PSEs as a liability, they compounds), which includes APIs of Cefadroxil, Ibuprofen, need to be strategically utilised. It comes out that API Cimetidine, Famotidine, etc. dependence can only be eliminated with the involvement Export from India of this category in 2019 accounted of PSEs unless the Government is willing to whip the for 71 per cent of global exports. It is reported that the private sector.

IDMA Bulletin LI (41) 01 to 07 November 2020 40

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2495 0723 0723/YOUR E-mail: [email protected], COMPANY?5 Tel.:Website: 022 Website:- 2494www.idma-assn.org, 4624 www.idma-assn.org, / 2497Mumbai 4308 www.indiandrugsonline.org / Fax: www.indiandrugsonline.org 022 - 2495 0723/ E-mail:EPIP-II, Thana,TehsilWebsite: Baddi,www.idma-assn.org, Distt.Solan H.P. www.indiandrugsonline.orgTel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723/ E-mail: Email: Tel.:[email protected] 022 - 2494 4624 / 2497 4308 / [email protected] / Fax: 022 - 2495 0723 IDMA Bulletin LI (37)Tel.: 01 022 to 07- 2494 October 4624 2020 / 2497 4308 / Fax:Email:  022IDMA IDMAWebsite:[email protected] -Widmaindia.com 2495ebsite: Bulletin Bulletin 0723/www.idma-assn.org, www.idma-assn.org, / web:XLVIII XLVII E-mail:www.idma-assn.or (04)(44) 22 tog www.indiandrugsonline.org www.indiandrugsonline.org / /30www.indiandrugsonline.org [email protected] NovemberJanuary 2017 2016 39   4038 IDMA Bulletin LI (15) 15 to 21Email: April 2020 Website:[email protected] www.idma-assn.org,IDMA IDMAwww.indiandrugsonline.orgBulletin / [email protected] Bulletin LI (11) LI (18)(15) 15 0815 to 21to  1421 IDMAIDMAMarch IDMA MayApril  Bulletin 2020 2020 Bulletin2020 XLVIII11LI XLVII (40) (04)(44)22 to 22 30 to October30 NovemberJanuary 2020 2017 2016 IDMAIDMA BulletinBulletin LI2411LI (11)(12) 1522 to5to 2130 MarchMarch 20202020 403840 [email protected],3429 IDMA IDMABulletin BulletinIDMA LI (11) LI Bulletin (18) 15 08to LI 21to (22) 14 MarchIDMA May08 to 2020 Bulletin142020 June LI2020 (28) 22 to 30 July 2020 IDMAIDMA Bulletin Bulletin LI LI (21) (22)IDMAIDMAIDMA 01 08 to to Bulletin Bulletin07 Bulletin14 June June LI24 2020 LILI2020 (11) (12)(28) 15 22225 to5 toto [email protected], 3030 March [email protected], 2020 20202020 Bulletin LI (21)36 01 Tel.:to 07IDMA June022 Bulletin -2020 2494 4624LI (16) / 22 249785 to 30 4308 April / 2020 Fax: 022 - 2495342936 0723 8 31 IDMA Bulletin LI (21)Tel.: 01 Tel.:022to 07 - June 0222494 -2020 24944624 /4624 2497 / 43082497 4308/ Fax: “We/ 022 Fax: are- 2495022 a leading -0723 2495 0723IDMA job placement Bulletin LI (16) 228 to 30 April 25%2020 discount applicable only for IDMA members 31 Website: www.idma-assn.org, www.indiandrugsonline.org IDMA Bulletin LI (11) 15 to 21 March 2020 5 Website:Website: www.idma-assn.org, www.idma-assn.org, www.indiandrugsonline.org www.indiandrugsonline.org IDMA Bulletin LI (11) 15 to 21 IDMA March  Bulletin 2020  LI (12) 22 to 30 March 2020    5 16 IDMAIDMA BulletinIDMA Bulletin IDMABulletinLI (11) LI Bulletin (11) LI15 (11) LIto 15 (15) 2115 to 15IDMAtoMarch 21 21to 21 MarchMarch BulletinApril 2020 20202020 2020 LI (12) 22IDMA to 30 BulletinMarchconsultant 2020 LI (11) working 15 to for21 theIDMAMarchIDMAIDMAIDMAIDMA Pharma Bulletin Bulletin Bulletin Bulletin 2020 IDMAIndustry LI XLVIII11LI LI XLVII (41) (40)LI(12) (12) (04)01(44)Bulletin 2222 to 5to to 22 22 07 3030 to Novemberto October March30 LI 30 November5IDMAJanuary(11)15% March 2020 2020 discountBulletin 1520205 2017 2016 to2020 LIis 21 applicable (21) IDMA March 01 to on07Bulletin 2020 AnnualJune 2020 Contract16 LI (12) for Non22 toIDMA 30 Members March 20205 4038414029 168 5 16 IDMA BulletinIDMAIDMA LIBulletin Bulletin (18) 08 LI LI to(21) (22) 14IDMAIDMA 01 May08 to to 202007 BulletinBulletin14 June June 2020 LI2020 LI(28) (12) 22 to 22 30 to July 30 2020 March 2020 IDMAIDMA BulletinBulletin LI24LI (11)(16) 152285 toto 2130 MarchIDMAApril 2020 2020 BULLETIN36 16 3431 with excellent candidate profiles  Please provide Banner Artwork as per the size for advertisementsINDIAN before the deadline DRUGS ONLINE IDMA Bulletin LI (11) 15 to 21 IDMAMarch Bulletin 2020 LI (12) 22 to 30 March 2020 IDMA BulletinINDIAN LI 5(11) 15 to DR 21 IDMAMarchUGS Bulletin 2020 ONLINE 16 LI (12) 22 to 30 March 2020 5 16 IDMA Bulletin LI (11) 15 to 21 IDMAMarch Bulletin 2020 LI (12) 22 to 30 Marchto suit 2020 all your requirements.”  5 For Advertising16 in the th For Advertising Tel.:PAdvertisementU inBLISHED 022the -ON material 2494 28th mustOF 4624 EVERY reach / us MONTH 249710 days before the date PofU releaseBLISHED ON 28 OF EVERY MONTH Contact: INDIAN DRUGSFor moreClassified ONLINE details pleaseADVERTISEMENT contact Columns Publications and DepartmentBANNER also RATES FOR INDIAN DRUGS WEBSITE ClassifiedADVERTISEMENT Columns and BANNER4308 also RATES/ Ext.:th FOR 103 INDIAN DRUGS WEBSITE Gargi Mukherjee: 9987799131/02232261414For Advertising PU inBLISHED the ON 28 OF EVERY MONTH (Rates in Rupees perIndian insertion) Drug Manufacturers’ Association(Rates in Rupees per insertion) email: [email protected] Series AdvertisementFax: 022102-B, - 2495 Poonam Chambers,0723 Dr/for A E-mail:B Road Series Worli, Mumbai Advertisement 400 018. Tel: 24944624/24974308 Fax: 24950723 Candidates can also registerClassified their resume at ADVERTISEMENT ColumnsEmail: and [email protected]/ANNER also RATES [email protected] INDIAN DRUGS /PositionWE Website:BSITE www.idma-assn.or Sizeg / www.indiandrugsonline.orgRATES VALIDITY 331,Kalyandas Udyog Bhavan,Century Bazar Lane, 331,Kalyandas UdyogPosition Bhavan,Century BazarSize Lane, RATES VALIDITY email: (Rates in Rupees per insertion) DRightiscount Side Banner 180 X 150 Pixel 25,000 3 MONTHS Worli, Mumbai-25 [email protected] SeriesDRightWorli, iscount Advertisement Side Mumbai-25 Banner [email protected] X 150 Pixel 25,000 3 MONTHS 331,Kalyandas Udyog Bhavan,Century Bazar Lane, Left SidePosition Banner 180 X Size150 Pixel 25,000RATES PleaseLeft3VALIDIT MONTHS Side contact BannerY : 180 X 150 Pixel 25,000 3 MONTHS Worli, Mumbai-25 PleaseDRightiscount SidecontactIDMA Banner Bulletin : XLVII180 X (48) 150 22Pixel to 30 December25,000 2016 3 MONTHS 48 NEED MANPOWER FOR Terms andNEED Conditions MANPOWER FOR Terms and Conditions IDMA Bulletin XLIV (14) 08 to 14 April 2013 Left Side Banner 180 X 150 Pixel  All25,000 paymentsAdvertising 43by DD3 MONTHS in advance Dept. only to be made in favour of , payable at  All paymentsAdvertisingPlease by DD in contact advance Dept. only :to be made in favour of Indian Drug Manufacturers’ Association, payable at Indian Drug Manufacturers’ Association YOUR COMPANY? 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Mumbai NEED MANPOWER FOR TermsMumbai and Conditions Advertising Dept.  25% discount applicable only for IDMA members “WeYOUR are a leading COMPANY? job placement  25%All payments discount“We are applicableby aDD leading in advance only jobfor IDMAonlyplacement to members be made in favour of Indian Drug Manufacturers’ Association, payable at consultantMumbai working for the Pharma Industry  15% discount is applicable on Annual Contract for Non IDMA Members consultant working for the Pharma Industry IDMA 15% discount is applicableBULLETIN on Annual Contract for Non IDMA MembersIDMA BULLETIN “We are a leading job placement  25% discountwith excellent applicable candidate only for IDMA profiles members with excellent candidate profiles  Please provide Banner Artwork as per the size for advertisements beforePlease the provide deadline Banner Artwork as per the size for advertisements before the deadline to suit all your requirements.” consultantto suit working all your for requirements.” the Pharma Industry IDMA 15% discount is applicableBULLETIN on Annual Contract for Non IDMA Members  Tel.:Advertisement 022 - material 2494 must 4624 reach / us 249710 days before the date Tel.: ofAdvertisement release 022 - material 2494 must 4624 reach / us 249710 days before the date of release with excellent candidate profiles  Please provide Banner Artwork as per the size for advertisements before the deadline For more details please contact to suit all yourContact: requirements.” Contact:For more details please contact Publications Department4308 / Ext.: 103 Publications Department  Tel.:AdvertisementGargi 0224308 Mukherjee: - material 2494/ 9987799131/02232261414Ext.: must 4624 103reach / us 249710 days before the date of release Gargi Mukherjee: 9987799131/02232261414 Indian Drug Manufacturers’ Association Indian Drug Manufacturers’ Association email: 102-B, Poonam Chambers, Dr A B Road Worli, Mumbai 400 018. Tel: 24944624/24974308 Fax: 24950723 email: [email protected]: 102-B,[email protected] Poonam Chambers,For more Dr A details B Road please Worli, Mumbaicontact 400Publications 018.Fax: Tel: 24944624/24974308022 Department - 2495 Fax: 0723 24950723 / E-mail: Fax: Candidates0224308 - 2495 can / also Ext.: 0723 register 103 their/ E-mail: resume at Email: [email protected]/ [email protected]. / Website: www.idma-assn.org / www.indiandrugsonline.org CandidatesGargi Mukherjee: can also 9987799131/02232261414 register their resume at Email: [email protected]/Indian [email protected]. Drug Manufacturers’ / Website: www.idma-assn.or Associationg / www.indiandrugsonline.org email: [email protected] [email protected] email:email: [email protected] [email protected] Fax: [email protected], - 2495 Poonam Chambers,0723 Dr/ A E-mail:B Road Worli, Mumbai 400 018. 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IDMA Bulletin LI (41) 01 to 07 November 2020 42

IDMAIDMA BulletinBulletin LILI (11)(41)(21) 1501 toto 2107 MarchNovemberJune 2020 2020 2020 384339

LICENSED TO POST WITHOUT PREPAYMENT LICENCE NO. MR/Tech/WPP-337/West/2018-20 RNI REGN. NO. 18921/1970, REGN.NO.MCW/95/2018-20 Published and Posted on 7thth, 14thth, 21st and 30thth of every month This issue posted at Mumbai Patrika Channel Sorting Office on 21.09.202007.11.2020

True experts love a challenge

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