PRICE Hon’ble LICENSED TO POST WITHOUT PREPAYMENT PER COPY Supreme CourtLI CENCE NO. MR/Tech/WPP-337/West/2018-20 Judgement - 25/- RNI REGN.RN INO. REG 78921/1970N. NO. 18921/1970 Gleevec Regn No.R EMCW/95/2015-2017GN NO. MCW/95/2018-20 Supreme Court

VOL. NO. 51 ISSUE NO. 36 (PAGES: 44) 22 TO 30 SEPTEMBER 2020 ISSN 0970-6054 WEEKLY PUBLICATION

Indian APIs & Formulations for Global Healthcare

 DGFT extends implementation date of Track and Trace for Pharma Export Packs to 1st April 2021 (Page No. 12)  Indian Pharma sector set to emerge stronger due to higher Exports (Page No. 28)  India’s World Bank Executive Director S Aparna, IAS named New Pharma Secretary (Page No. 30)  DCGI’s new Guidelines for Covid-19 vaccine: At least

IDMA Bulletin50 LI percent(36) 22 to 30 efficacy September 2020 in Phase 3 Trials (Page No. 31) 1  Union Minister Gowda lauds contribution of Indian Pharma Industry amid COVID-19 crisis (Page No. 36)

IDMA Bulletin LI (36) 22 to 30 September 2020 2

Founder Editor: Vol. No. 51 Issue No. 36 22 to 30 September 2020 Dr A Patani IDMA ACTIVITIES: Editor: Dr Gopakumar G Nair IDMA Representation to DCG(I) re. Inclusion of ‘Marketer’ in D&C Rules – reg...... 4 Associate Editors: IDMA Representation to DCGI for extension of validity of Form 10 Licence J L Sipahimalani along with Form 41 Registration Certificate – reg...... 6 Dr Nagaraj Rao Dr George Patani IDMA Representation to FSSAI for Clarification of status of Methylcobalamin National President as Ingredient under FSS Regulations 2016 – reg...... 7 Mahesh H Doshi NPPA MATTERS: Immediate Past National President Deepnath Roy Chowdhury NPPA order for submission of data by manufacturers and re-fillers of medical oxygen - reg...... 9 Senior Vice-President Dr Viranchi Shah CBIC MATTERS: Vice-Presidents: CBIC notifies Administrative Instructions for recovery of Interest Bharat N. Shah on Net Cash Tax Liability w.e.f. 01.07.2017 - reg...... 10 (Western Region) th Asheesh Roy CBIC notifies New Exchange Rates w.e.f. 18 September 2020 - reg...... 10 (Eastern Region) DGFT MATTERS: B K Gupta (Northern Region) DGFT extends implementation date of Track and Trace for Pharma Export st T Ravichandiran Packs to 1 April 2021 – reg...... 12 (Southern Region) Publication of Revised ANF-7A – reg...... 12 Hon General Secretary PARLIAMENT NEWS: Dr George Patani Hon Joint Secretaries In Lok Sabha & In Rajya Sabha...... 20 J Jayaseelan Atul J Shah new Developments: Hon Treasurer T cells take the lead in controlling SARS-CoV-2 and reducing Vasudev Kataria COVID-19 disease severity...... 27 For information contact IDMA Secretariat: (H.O.) Kochi-based Company to start Phase 2b trials of COVID Daara B Patel Secretary-General drug next week...... 28 T R Gopalakrishnan National News: Deputy Secretary-General Indian Pharma sector set to emerge stronger due to higher Exports...... 28 Melvin Rodrigues Sr Manager (Commercial & Administration) Incentives not enough, Bulk Drug industry seeks level playing C K S Chettiar field to make India ‘Atma Nirbhar’...... 29 Asst. Manager (Publications & Administration) India’s World Bank Executive Director named New Pharma Secretary...... 30 Delhi Office: DCGI’s new Guidelines for Covid-19 vaccine: At least Ashok Kumar Madan 50 percent efficacy in Phase 3 Trials ...... 31 Executive Director S Ranganathan Indian Pharma needs regulatory surveillance system for disposal Asst Manager (Administration) of unused & date expired drugs: Dr Jagashetty...... 31 IDMA STATE BOARDs CHAIRMAN Ayurveda offers myriad approaches to pandemics and „ Gujarat State Board : Milan Patel all infectious diseases: Dr Ram Manohar...... 32 „ Haryana State Board : P K Gupta Haryana showcases readiness to bid for Bulk Drugs and „ Himachal Pradesh & Uttarakhand State Board : R C Juneja Medical Device Parks at PHDCCI webinar ...... 33 „ Karnataka State Board : S M Mudda Hyderabad soon to emerge as leading API Hub of India as more firms „ Madhya Pradesh State Board : Paresh Chawla seek land to set up their API units in Pharma City...... 34 „ Tamil Nadu, Puducherry & Kerala State Board : J Jayaseelan SCTIMST signs MoU with Tynor Orthotics for joint R&D in orthotics „ Telangana State Board : Shaik Janimiya and rehabilitation devices...... 34 „ West Bengal State Board : Utpal Moitra Punjab Government receives encouraging response from A Publication of Pharma industry for Bathinda Bulk Drug Park ...... 35 Indian Drug Manufacturers' Association 102-B, 'A-Wing', Poonam Chambers, Industry approaches Centre to urgently notify methylcobalamin Dr. A.B. Road, Worli, Mumbai - 400 018 for neurological disorders...... 36 Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 e-mail: mail_ [email protected]/ Union Minister Gowda lauds contribution of Indian Pharma [email protected]/ Website: www.idma-assn.org Industry amid COVID-19 crisis ...... 36 th th st th Published on 7 , 14 , 21 and 30 of every month Can’t directly deal with complaints of Unethical Practices: Department Annual Subscription of Pharmaceuticals...... 37 ` 1000/- (for IDMA members) ` 2000/- (for Government Research/Educational Institutions) International news: ` 4000/- (for non-members) US$ 400 (Overseas) Please send your payment in favour of Russia to supply Avifavir drug to 17 nations for Coronavirus Treatment ...... 38 Indian Drug Manufacturers' Association FEATURE: IDMAOpinions Bulletin Expressed LIXLIV By (36)The Au(38) 22tho rs08to Of 30to Individu 14September Octoberal Article s20132020 3 Do Not Necessarily Represent The Official View Of Idma. Why Vaccines are a better bet against Coronavirus than Drugs: Michelle Cortez ...... 39 Advertisements...... 2, 41, 42, 43 & 44

IDMA ACTIVITIES IDMA Representation to DCG(I) re. Inclusion of ‘Marketer’ in D&C Rules – reg.

The Association has submitted the following by another manufacturer under an agreement for representation on 23rd September 2020 to Dr V G marketing of such drug by labeling or affixing his name Somani, Drugs Controller General of India, Central on the label of the drug with a view for its sale and Drugs Standard Control Organisation, New Delhi distribution;’ (in response to Gazette Notification No.GSR 101(E) dated 11th February 2020) on the above subject: The term ‘Agent or in any other capacity’ in the definition of 'Marketer' have wider meaning and are not “Greetings from Indian Drug manufacturers’ specific. Be sides, as explained below, Marketer not being Association. a manufacturer or an agent gets an exemption under We refer to the Gazetted Notification as above for Section 19(3). The definition thus needs to be revised defining “Marketer’ under Drugs and Cosmetics Rules that accordingly. places certain responsibilities for quality and regulatory compliance on the marketer for the products marketed by In fact, provisions under Section 19(3) of the Act him. The Rule comes into force on the 1st day of March, provide safeguard to the person not being either a 2021. manufacturer or agent of the drug. Since the Section is not being amended, it would have conflicting implications We had made a detailed submission on 24th July for making marketers responsible for quality as well as 2019 (copy enclosed for immediate reference)* on other regulatory compliances. Any Rule contrary to the the draft Notification amendment [GSR 447(E) dated provisions under the Act or having overriding effect will 24th June 2019]. While IDMA had welcomed in principle not withstand judicial scrutiny. the sharing of responsibilities for quality by the marketer, we had brought out the issues of: 84E. Responsibility of marketer of the drugs - Any marketer who sells or distributes any drug shall be a) lack of clarity related to responsibilities for quality responsible for quality of that drug as well as other and compliance with regulations; and regulatory compliances along with the manufacturer under b) requirements being inconsistent with the law as a these rules.” challenge for implementation of the Notification in it's draft form. As stated in our representation, the responsibility and had requested to keep the Notification in abeyance for quality and regulatory compliance cannot be placed until the suggested changes were made. However, the on the marketer grossly and has to be specified clearly, draft Notification was finalized without considering our particularly in view of the fact that the outsourcing of suggestions. products is done in two different manners - Loan License arrangement and P2P arrangement that has different set Some of our members have expressed a great concern of responsibilities on the marketing company. about these issues and have shared their suggestions. We are reiterating these in a summary with a request to In the Loan License arrangement, where the provide suitable explanation and necessary amendment technology/product know-how is provided by marketer, to the Notification: the Drugs and Cosmetics Rules, 1945 provide the responsibilities in the form of conditions for grant of a Rule 2 loan license. ‘(ea) “Marketer” means a person who as an agent In P-to-P arrangement, two P-to-P parties, one having or in any other capacity adopts any drug manufactured manufacturing skills and capabilities and the other having

IDMA Bulletin LI (36) 22 to 30 September 2020 4

marketing skills and capabilities work synergistically b) The definition of the term Marketer has to be modified using their respective skills and resources. Under this to remove the words 'agent' or 'person in any other arrangement the marketer accepts the product developed capacity’ since these words have wider meaning and and manufactured by the manufacturer under a drug are not specific. Marketer cannot be considered as license. an agent of the manufacturer since he works on a P-to-P Contract basis. Under the marketing arrangement, it is practically c) For the reasons explained in our response, the not possible for a marketer to exercise a control on the responsibility for quality and regulatory compliance manufacturing and testing of the drugs that is governed by cannot be placed on the marketer grossly and has the conditions of the license issued to the manufacturing to be specified clearly. company. d) For this purpose, the concept of Contract Giver (one Further, the words “responsible for other regulatory who outsources the GMP service) and Contract compliance”, are vague, non-specific and wide in Acceptor (one who manufactures products in meaning. The expected regulatory compliances to be accordance with applicable GMP requirements) complied by the marketer needs to be provided in clear provided in EU GMP, PIC/s Guideline will be terms. beneficial. The requirements clearly divide the responsibilities between the Contract Giver and the In fact, since the marketer is neither a manufacturer, Contract Acceptor. nor a Loan Licensee, the provisions of Chapter VII e) In fact, an attempt has already been made on these governing conditions of manufacturing license would not lines in introducing this concept in the proposed draft apply to him. The applicable requirements for storage amendment vide GSR 999(E) dated 05.10.2018 to and distribution of drugs are specified in Part VI. Thus, Schedule M under Para 9, Production under loan providing for the responsibility of a marketer under Part licence or contract and contract analysis and other VII would be out of place, context and scope of the part activities. IDMA has submitted a detailed response VII. to this part that requires amendment to the Rules rather than Schedule M alone. Further, Rule 84D requires that before marketing of the product the marketer should have an agreement This Notification, if implemented without with the manufacturer. However, here again the key amendments suggested by us, may interrupt supply contents of the agreement are not specified. The shared of medicines that would be against the interest of the responsibilities for quality and regulatory compliance patients, particularly in the current pandemic period. between the manufacturer and marketer have to be The disruption caused by the pandemic is predicted consistent with the legal requirements and hence have to last for at least 2 years and any interruption to the to be specified. supply has to be prevented.

IDMA Suggestions: In conclusion, this amendment, in its current form, may not provide any additional benefit in terms of Notwithstanding the above submission, the intent ensuring product quality but may act as an impediment in of making a marketing company responsible for quality, Government's thrust on 'Ease of doing business'. Until the requires consideration of the following points: suggested amendments are notified, the implementation a) Introduction of separate Part in the Drugs and of the Rules may be deferred. Thanking You”. Cosmetic Rules, since Part VII applies to license (*Not reproduced here. The said Representation was holders for manufacturing - Own License/Loan published in IDMA Bulletin Issue dated 7th August 2019 License and not to Marketers. Page No. 5)

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IDMA Bulletin LI (36) 22 to 30 September 2020 5

IDMA Representation to DCGI for extension of validity of Form 10 Licence along with Form 41 Registration Certificate – reg.

The Association has made the following existing Registration Certificate shall be valid until orders representation on 28th September 2020 to Dr V G are passed on the application and shall be deemed to be Somani, Drugs Controller General of India, Ministry of valid for all purposes”. We are grateful to the Government Health and Family Welfare, New Delhi for clarification for this gesture. in Gazette Notification No. S.O.2450(E), dated 27th July 2020: We request you to clarify whether Form 10 licence issued against Form 41 is also similarly valid. It will be a “Greetings from Indian Drug Manufacturers’ great favour if immediate clarification is issued by CDSCO Association. or by Ministry of Health so that importers will not have to apply for fresh application to get Form 10 to avoid We acknowledge with thanks receipt of Gazette duplication of work. Notification No. S.O.2450(E) dated 27 July 2020 by Government of India by which validity of Registration We would appreciate an urgent clarification on this Certificate issued under Form 41 has been extended for matter from your esteemed office. Thanking you”. 6 months. It is a timely decision particularly in view of the COVID-19 pandemic. The Notification also states that if S.O.2450(E), dated 27th July 2020 Gazette Notification an application has been made for a fresh Registration extending the validity of Registration Certificate Certificate before the expiry of the existing certificate, “the (Form 41) is reproduced below:

S.O.2450(E), dated 27th July, 2020

1. Whereas, an outbreak of COVID-19 pandemic is that notwithstanding anything contained in rule 28A of prevailing throughout India and worldwide; the Drugs and Cosmetics Rules, 1945, for import of drugs for sale or distribution, if an existing Registration And whereas, several Registration Certificates in Certificate holder under the said rules, makes an Form-41 are in existence and their validity periods of three application for a fresh Registration Certificate before the years are likely to expire shortly; expiry of the existing certificate, the existing Registration Certificate shall be valid until orders are passed on And whereas, pharmaceutical companies and their the application and shall be deemed to be valid for all associations have requested for extension of the validity purposes. of Registration Certificate (Form-41) for six months in the wake of COVID-19 pandemic; 2. This order shall come into force on the date of its publication in the Official Gazette and shall remain valid And whereas, the Central Government is of the for a period of six months. considered view that supply of drugs may not get affected and the drugs must remain available to the public; F.No.X.11014/01/2020-DR

Now, therefore, in exercise of the powers conferred Dr Mandeep K Bhandari, Joint Secretary, Department of Health by section 26B of the Drugs and Cosmetics Act, 1940 and Family Welfare, Ministry of Health and Family Welfare, (23 of 1940), the Central Government, hereby directs New Delhi.

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IDMA Bulletin LI (36) 22 to 30 September 2020 6

IDMA Representation to FSSAI for Clarification of status of Methylcobalamin as Ingredient under FSS Regulations 2016 – reg.

The Association has submitted the following initiatives and consequently on release of the circular representation on 28th September 2020 to Mr Arun dated 29th December 2017 [F.No.Std/Nutra-(DCGI)/ Singhal, IAS, Chief Executive Officer, Food Safety FSSAI/2017.(Pt.1)], derivatives such as methylcobalamin, and Standards Authority of India (FSSAI), with copy have been incorporated in marketed formulations by to Ms Rita Teaotia, IAS, Chairperson, FSSAI, New FBOs. In fact, methylcobalamin forms the backbone for Delhi for Clarification of status of Methylcobalamin consumer wellness as far as providing the benefits of as Ingredient under FSS Regulations 2016: vitamin B12. “Greetings from Indian Drug Manufacturers’ Cyanocobalamin has questionable efficacy following Association. oral intake since it requires the Intrinsic Factor (IF) to facilitate absorption. The IF is saturated when up to 2 mcg We refer to the above mentioned subject and of vitamin B is taken as cyanocobalamin. Thus, there is request your kind intervention to help dispel all prevailing 12 very limited scope to ensure adequate amounts of available confusions regarding Methylcobalamin usage as a vitamin B in blood with forms such as cyanocobalamin. standardized ingredient under the Schedule-I of the FSS 12 “All of the B forms are reduced to the core cobalamin Regulations, 2016 for Health Supplements, Nutraceuticals, 12 molecule inside the cytosol and then converted to the Food for Special Dietary Use, Food for Special Medical 2 active forms of B —MeCbl and AdCbl—irrespective of Purpose, Functional Food and Novel Food products. 12 the form of B12 ingested.” Schedule-I of the FSS Regulations as above lists the Animals store bioavailable vitamin B compounds in vitamins and minerals and their components. Table A is 12 their milk, eggs, muscles and organs, and especially in for vitamins and Table B for minerals. After the Table B the liver. Adenosylcobalamin (AdCbl) is the predominant is a footnote. B12 form found in meats, at 68%, with the rest occurring as “Note - Suitable esters and salts of vitamins and salts hydroxycobalamin (OHCbl) and methylcobalamin (MeCbl). and chelates of minerals may be used” MeCbl is the predominant form in milk and eggs. This matter was represented by us and there were [Ref: Paul C & Brady DM. Comparative Bioavailability deliberations and discussions held which resulted in and Utilization of Particular Forms of B12 Supplements With the need for suitably changing the footnote under the Potential to Mitigate B12-related Genetic Polymorphisms. Table B. Accordingly the FSSAI also issued a Circular Integr Med (Encinitas) 2017; 16(1): 42-49 – copy th dated: 29 December 2017 [F.No.Std/Nutra(DCGI)/ enclosed]* FSSAI/2017 (Pt.1)] which mentioned under Annexure I: Thus, methylcobalamin is a safe and naturally “(ii) after serial number B(15), in the note, for the occurring form of vitamin B12 and a derivative of words “Suitable esters and salts of vitamins and salts cyanocobalamin. and chelates of mineral may be used”, the following shall be substituted, namely;- Scientific Opinion of European Food Safety Authority: Suitable esters, derivatives and salts of vitamins The European Food Safety Authority (EFSA) and salts and chelates of minerals may be used.” has published a ‘Scientific Opinion of the Panel on The word ‘derivative’ especially is very necessary Food Additives and Nutrient Sources added to food’ since it implies that all vitamin-derived ingredients can be titled “Scientific Opinion on 5’-deoxyadenosylcobalamin included under the Health Supplements, Nutraceuticals, and methylcobalamin as sources for Vitamin B12 added Food for Special Dietary Use, Food for Special Medical as a nutritional substance in food supplements” which was Purpose, Functional Food and Novel Food products adopted on 25 September 2008 (copy enclosed)*. After a categories. The industry has believed in FSSAI’s detailed study, the Panel has concluded that:

IDMA Bulletin LI (36) 22 to 30 September 2020 7

“ … the use of 5’-deoxyadenosylcobalamin and Bearing in mind the above explanation, and the methylcobalamin as a source of vitamin B12 in crucial need for methylcobalamin for consumer benefits food supplements for the general population at the with respect to vitamin B12 supplementation, we would proposed uses and use levels [below the Guidance request you to issue Gazette Notification stating: value of 2000 μg/day defined by EVM (Expert Group on Vitamins & Minerals)] is not of safety concern.” 1. Methylcobalamin and adenosylcobalamin are included under Schedule I (for Vitamins, Minerals FDCA Gujarat has issued a circular [Ref No.Food and their components) of FSS Regulations, 2016 for safety/Methylcobalamin/President/2019/I-56147-C-2 Health Supplements, Nutraceuticals, Food for Special dated 11 June 2019] against use of methylcobalamin Dietary Use, Food for Special Medical Purpose, in food products. FSSAI has also issued another recent Functional Food and Novel Food products. circular to Commissioners of Food Safety cautioning 2. ‘Suitable esters, derivatives, active moieties and them about methylcobalamin being used in food products salts of vitamins and salts and chelates of minerals [File No.4(12)2016/Gujarat/Enf/FSSAI dated 31st October may be used’ as the modified statement below the 2019]. In this context it is requested to expressly issue above mentioned same Schedule I. clarification that methylcobalamin is safe and can be used as a food product especially because: The word ‘active moieties’ was discussed during our meeting prior to accepting the change in footnote • Cyanocobalamin is converted (90%) and utilized as (Circular dated: 29th December 2017) but was by a methylcobalamin. typographic error omitted. Hence, including the same in • Cyanocobalamin is synthetic whilst methylcobalamin the sentence mentioned above is imperative and would is natural form of vitamin B12. be requested. • Cyanocobalamin cannot be absorbed in amounts more than 2 mcg since the IF is saturated thereafter; therefore 47% of Indians need supplementation with vitamin it has necessarily to be administered as an injection if B12 and hence it is essential stating that derivatives it is to be an effectively supplement to meet vitamin of vitamins are also to be considered as standardized under Schedule-I, AND all methylcobalamin-containing B12 requirements. Methylcobalamin in recommended, and already commonly incorporated in innumerable formulations need to be announced as IMMEDIATELY permissible under the various categories of FSSAI as products, has proven efficacy as vitamin B12 supplement in amounts currently present in products. may be applicable. Moreover, the Scientific Panel has already “approved methylcobalamin (vitamin B12) as a • Methylcobalamin is safe and amounts upto nutraceutical ingredient after risk assessment based on 2,000 mcg per day as required, has been defined as secondary data” as per communication by the erstwhile Guidance value by EVM (Expert Group on Vitamins CEO Mr Pawan Agarwal to an FBO. (as below): & Minerals).

Also being forwarded two more press reports of the pertaining to declaring ‘methylcobalamin as a Nutraceutical’ same as above. We urge you to review the Minutes of THE and immediately Gazette the said conclusion pertaining to

Meeting (held in first half of 2019) of the Scientific Panel this natural form of vitamin B12.

IDMA Bulletin LI (36) 22 to 30 September 2020 8

Considering the contrary directives being sent by Include: Methylcobalamin under Schedule VI (List of FSSAI that methylcobalamin is not to be considered as an ingredients as nutraceuticals) of FSS Regulations, approved ingredient in Schedule-I of the FSS Regulations, 2016 for Health Supplements, Nutraceuticals, Food for 2016 for Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food products. Functional Food and Novel Food products there is urgent ‘Suitable esters, derivatives, active moieties and salts of vitamins and salts and chelates of minerals may be necessity for your clarification. Only your quick resolve can used’ as the modified statement below the Table B of prevent numerous consumers being denied the benefits Schedule I. of vitamin B12 being accrued through its natural, safe and effective form viz methylcobalamin. In the FAQs released in May 2020 pertaining to Question No.34, it has been explicitly mentioned We are confident of an early resolve of this uncertainty and implied that derivatives are NOT allowed for since there are a wide array of Health Supplements nutrients in spite of your circular of 29th December 2017 and Nutraceutical products that presently contain [F.No.Std/Nutra(DCGI)/FSSAI/2017-(Pt .1)]. The various methylcobalamin and other derivatives and active moieties Press reports of the Scientific Panel have also accepted of vitamins listed in Schedule I. methylcobalamin as an approved ingredient under the category nutraceuticals. We request you to kindly please Kindly issue Gazette of the following already decided clarify this issue”. and concluded findings of the Scientific Panel: (*Enclosures not reproduced here) l l l NPPA MATTERS NPPA order for submission of data by manufacturers and re-fillers of medical oxygen - reg.

NPPA Notification dated 24th September 2020

To, The information complete in all respect for the day 1. All manufacturers and re-fillers of medical oxygen for may be given by the manufacturers/re-fillers to the Control compliance of direction given above. Room on e-mail: [email protected] by the end of the 2. All India Industrial Gases Manufacturers Association next day, without fail. (AIIGMA) to circulate this order and ensure the compliance by their member companies. The DCGI, CDSCO will monitor that the information sought is provided by manufacturers and re-fillers, The Central Government has established a Central timely. Control Room for monitoring the situation of Availability, Distribution and Demand of the medical oxygen. For this This issue with the approval of the Competent purpose availability of the precise information on situation Authority. of capacity, stocks, production and sales of the oxygen by F.No.12(41)/2020/Div.II/NPPA all manufacturers and re-fillers is very important. S S Ojha, Joint Director, National Pharmaceutical Pricing In exercise of powers conferred under para 29 Authority, Department of Pharmaceuticals, Ministry of Chemicals (Maintenance of records and production thereof for & Fertilizers, New Delhi. inspection) of Drug Price Control Order (DPCO), 2013, (Annexures not reproduced here. The same can be the manufacturers and re-fillers of medical oxygen are downloaded from NPPA website: www.nppaindia.nic.in OR hereby directed to submit the information to Control Room contact IDMA Secretariat for having a soft copy of the same on e-mail: [email protected] as per the attached format through email) on daily basis till further order.

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IDMA Bulletin LI (36) 22 to 30 September 2020 9

CBIC MATTERS CBIC notifies Administrative Instructions for recovery of Interest on Net Cash Tax Liability w.e.f. 01.07.2017 - reg.

CBIC Communication dated 18th September, 2020

To, recommendation to charge interest on net cash The Principal Chief Commissioners / Chief Commissioners / liability w.e.f. 01.07.2017. Consequently, a press Principal Commissioners / Commissioners of Central Tax (All), release, dated 26.08.2020 was issued to clarify the The Principal Director Generals / Director Generals (All). position. Further, in order to implement the decision 1. Based on the recommendations of the 35th meeting of the Council in its true spirit, and at the same of the GST Council held on 21st June, 2019, the time working within the present legal framework, provision of section 50 was amended vide section it has been decided to address the issue through 100 of the Finance (No. 2) Act, 2019 to provide for administrative arrangements, as under: charging interest on the net cash tax liability. The said a. For the period 01.07.2017 to 31.08.2020, field amendment was to be made effective from a date formations in your jurisdiction may be instructed to be notified by the Government. Accordingly, the to recover interest only on the net cash tax liability said provision was made effective vide notification (i.e. that portion of the tax that has been paid by No. 63/2020-Central Tax dated the 25th August, 2020, debiting the electronic cash ledger or is payable w.e.f. 01.09.2020. through cash ledger); and The GST Council, in its 39th meeting, held on 2. b. wherever SCNs have been issued on gross tax 14th March, 2020 recommended interest to be payable, the same may be kept in Call Book till charged on the net cash tax liability w.e.f. 01.07.2017 the retrospective amendment in section 50 of the and accordingly, recommended the amendment CGST Act is carried out. of section 50 of the CGST Act retrospectively w.e.f. 01.07.2017. The retrospective amendment in 4. Difficulty, if any, in the implementation of these the GST laws would be carried out in due course instructions may please be brought to the notice of through suitable legislation. the Board. 3. Post issuance of notification 63/2020 - Central F. No. CBEC-20/01/08/2019-GST th Tax dated the 25 August, 2020, there were Yogendra Garg, Pr Commissioner, Central Board of Indirect apprehensions raised by taxpayers that the said Taxes and Customs, GST Policy Wing, Department of Revenue notification is issued contrary to the Council's Ministry of Finance, New Delhi.

l l l CBIC notifies New Exchange Rates w.e.f. 18th September 2020 - reg.

Notification No.88/2020-Customs (N.T.),dated 17th September, 2020

In exercise of the powers conferred by section 14 of each of the foreign currencies specified in column (2) of the Customs Act, 1962 (52 of 1962), and in supersession each of Schedule I and Schedule II annexed hereto, into of the Notification No.84/2020-Customs(N.T.), dated Indian currency or vice versa, shall, with effect from 3rd September, 2020 except as respects things done 18th September, 2020, be the rate mentioned against or omitted to be done before such supersession, the it in the corresponding entry in column (3) thereof, for Central Board of Indirect Taxes and Customs hereby the purpose of the said section, relating to imported and determines that the rate of exchange of conversion of export goods.

IDMA Bulletin LI (36) 22 to 30 September 2020 10

IDMA ACTIVITIES CDSCO MATTERS IDMA ACTIVITIES CDSCO MATTERS CSR Initiatives CDSCOby IDMA provides with the guidancesupport of on its Regulatory Members Pathway – reg.

DCG(I)C SRCircular I Ref.X-11026107/2020-PRO,nitiatives CDSCOby dated IDM 20th MarchA provides with 2020 the guidancesupport of on its Regulatory Members Pathway – reg.

To, for sale and distributionDCG(I) would be Circular processed onRef.X-11026107/2020-PRO, dated 20th March 2020 All Stakeholders through CDSCO web site Copy for priority though expedited review/accelerated Information, approval. SCHEDULE-I IDMA ACTIVITIES PS to JS(R), Ministry of Health and Family Welfare, Nirman IDMA ACTIVITIES 13. 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JS(R), Ministry of Health and FamilyRand Welfare, Nirman IDMA ACTIVITIES Health Organization (WHO)(1) hasC declaredSR (2) Iit nitiativesas pandemic. by (3)IDMA with the support of its Members IDMA congratulates Dr Kiran Mazumdar-Shaw on beingBhawan, New Delhi. 4. Any firm having DrugNaccine already approved for At present there is no current evidence from randomized 5. Data requirement for animal toxicity16. study,Swedish clinical Kroner 8.45 8.20 named EY World Entrepreneur Of The Year 2020(a) (b) CSR Initiatives by IDMA with the support of its Members clinical trials to recommend any specific treatment for study, stability study etc. may17. be abbreviated,Swiss Franc COVID-19 in any other country can directly approach (For Imported (For Exported CSR Initiatives by I82.40DMA with 79.15the support of its Members suspected or confirmed patients with COVID-19. deferred,Novel orCorona-virus waived on case to Disease case basis depending(COVID-19) has spread Dr Kiran Mazumdar-Shaw, My business focus is global health care Goods)and the provision Goods) 18. 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InstituteKroner of Medical Sciences (AIIMS), New Delhi, AIIMSWeDrugs are thankful Controller to the following GeneralDollar members (India), who donated 3. CentaurTNPKSB-Chairman- Pharmaceuticals Ltd. free medicinesOn to being them. anointed as the EY World EntrepreneurWe areand thankful passion and to forthe philanthropy following members that annexedhas who delivered donated hereto,huge globaland into territories Indian vying currency for the world 2. I CachetSchedule Pharmaceuticals II Pvt.3. Ltd.Centaur PCentralharmaceuticals Drugsmedicines L Standardtd. for thisvaccine nobleRadhakrishnan Control cause: role which Organization, in couldeconomic Ananth, be used development, Deputy to both Secretary, cure and and for protecttoo Central long theirBoard of impact. She has built India’s largest biopharmaceutical th 15. South African 4.254. CoronaMr Remedies Jayaseelan,3.95 Pvt. Ltd. Trial Vice- may be processed within 7 days. of the Year, Dr Mazumdar-Shaw3. 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Ltd.Centaur Pharmaceuticalsmedicines Ltd. for this noble cause: IDMA Bulletin LI (21) 01 to 07 June 2020 whohave livea vaccinefrom pilgrimagein and the against mostaround from respectedthe Mumbai diseaseUdvada to Chairman Shirdias8 andearly every also asof theone year supplies Hospital month for Padma 1. Aimpact.lkem SheLaboratories has(For built Imported India’s Ltd. largest (For biopharmaceutical Export Central Drugs Standard Control Organization, 4. Corona Remedies Pvt. Ltd. TECHNICALof MONOGRAPH the Year, Dr Mazumdar-Shaw NO. 5 said, “At 5.its medicinescore,Ind TECHNICALSwift L foraboratories this noble MONOGRAPH Limited cause: NO. 6 freefrom3. medicines now,Canadian approximatelyat least Dollarto for them. emergency500 pilgrims 3.55.30 use. weApplications volunteered53.45 to contribute for addingClinical the that it willTrial be applicablepermissionGoods) for all age and groups.Goods) Directorate4. Corona General Remedies of Health Pvt. Ltd. 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F.No QUALIT . 468   / 01 Y / 20204.0 D-Cusigital.V Technology of the F uture  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 Copies are8. availableKuwaitiWe are at thankful IDMADinar Office, to the following Mumbai.254.65 members We do who not238.80 donated mail any 3. publications disease.PramodCentaurIDMA PKumar,againstharmaceuticals is Director,thankfulVPP payment. L td.Central to the All Boardabove payments of members Indirect to be made Taxes for in their advance help as Have you renewed your Membership for the 1. Alkem600 L medicinesaboratorieswillc beheque/DD/RTGS/NEFT forthose this noble who L td.cause: have testedin favour positive of “INDIAN but DRUG MANUFACTURERS’and support. ASSOCIATION”Have atyou Mumbai. 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, New Delhi. Source: IANS, IndiaTVNews, 02.05.2020 non-symptomatic,For more detailsDollar please and 500 contact: will be those who are out of Tel.: 022 - 2494 4624 / 2497 4308 Fax: 022 - 2495 0723 Year 2019-2020 & 2020-2021 Sai Seva Mandal: PUBLICATIONS DepartmentIDMA 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. AlkemE-mail: Laboratories [email protected] Ltd. , Website:and www.idma-assn.org/www.indiandrugsonline.org 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: Have you renewed your Membership for the please contact:Mr Chettiar (+9820629907) Publications Department Mr Chettiar (+9820629907)IDMA Bulletin Publications LI (11) 15 Departmentto 21 March 2020 5 Year 2019-2020IDMA & Bulletin 2020-2021 LI (11) 15 to 21 March 2020 5 YYearear 2019-2020 2019-2020 & 2020-2021 & 2020-2021 If Inot,f not, please do do so; kindlyso;IDMA kindly contact contactIDMA BULLETIN Secretariat IDMA at: Secretariat at: IDMA BULLETIN 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, www.indiandrugsonline.org / [email protected] [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 BulletinIDMA Bulletin LIIDMAIDMA (36) LIBulletin Bulletin 22(18) to 08 LILI30 to(21) (22) September14 01 May08 to to 202007 14 June June 2020 2020 2020 24 85 11 IDMA Bulletin LI (11) 15 to 21 IDMAMarch Bulletin 2020 LI (12) 22 to 30 March 2020 5 16

DGFT MATTERS DGFT extends implementation date of Track and Trace for Pharma Export Packs to 1st April 2021 – reg.

DGFT Public Notice No.16/2015-2020, dated 22nd September, 2020

1. In exercise of the powers conferred under Paragraph 66/2015-2020 dated 30.03.2020), "01.10.2020" may 2.04 of the Foreign Trade Policy, 2015-20, as be substituted by "01.04.2021". amended from time to time, the Director General 3. Effect of this Public Notice: of Foreign Trade hereby amends Para 2.90A of Handbook of Procedure- 2015-20, as notified vide The date for implementation of Track and Trace Public Notice No. 43/2015-20 dated 05.12.2017 system for export of drug formulations with respect read with Public Notice No. 52 / 2015-20 dated to maintaining the Parent-Child relationship in 05.01.2016, Public Notice No. 05/2015-20 dated packaging levels and its uploading on Central Portal 09.05.2018, Public Notice No. 43/2015 2020 dated has been extended upto 01.04.2021 for both SSI and [भाग01.11.2018,I—ख � ड 1 ]Public Notice No. 16/2015-2020भारत datedका राजप� : असाधारणnon SSI manufactured drugs. 9 04.07.2019 and Public Notice No. 66/2015-2020 F.No. 01/91/180/648/AM 09/EC/E-21052 dated 30.03.2020 on layingMINISTRY down the procedure OF COMMERCE for AND INDUSTRY Amit Yadv, implementation of the Track and Trace system for (Department of Commerce) Director General of Foreign Trade & export consignments of drug formulations. (DIRECTORATE GENERAL OF FOREIGN) Ex-officio Additional Secretary, 2. In Para 2.90 A (vi) and (vii) of Handbook of Procedure Department of Commerce, Ministry of Commerce and Industry, New Delhi. - 2015-20 (as amended vide Public NoticePUBLIC No. NOTICE New Delhi, thel 23 rd l Septe lmber, 2020 No. 18 /2015.2020 Subject : PublicationPublication of Revised ANF of-7A Revised–regd. ANF-7A – reg. F. No. DGFT 01/92/180/19/AM Public Notice-21/PC No.18/2015-2020,-VI, E-file Computer dated 23 rd No September,. 21700.—In 2020 exercise of powers conferred under Paragraph 1.03 of the Foreign Trade Policy 2015-2020, as amended from time to time, the In exercise of powers conferred under Paragraph 1.03 of the Foreign Trade Policy 2015-2020, as amended Director General of Foreign Trade hereby notify the revised ANF-7A of Appendices & ANFs of Handbook from time to time, the Director General of Foreign Trade hereby notify the revised ANF-7A of Appendices & ANFs of Handbookof Procedure of Procedure 2015-20 2015-20 with immediate with immediate effect: effect: Effect of this Public Notice: NF-7A of Appendices & ANFs has been revised. Effect of this Public Notice: NF-7A of Appendices & ANFs has been revised. F. No. 01/92/180/19/AM-21/PC-VI AMIT YADAV, Director General of Foreign Trade Amit Yadv, Director General of Foreign Trade & Ex-officio Additional Secretary, Department of Commerce,& Ex-Officio Ministry Addl of Commerce. Secy. and Industry, New Delhi.

ANF-7A APPLICATION FOR CLAIM OF TED REFUND / DUTY DRAWBACK / BRAND RATE FIXATION (Please tick whichever is applicable) (Application shall be filed online once the software is ready) 1. IEC No. Branch Code: 2. Applicant details: i. Name of the firm/company ii. Full address iii. Contact Number iv. E-mail address 3. Bank’s details: IDMA Bulletin LI i.(36) 22Name to 30 of September the Bank 2020 12 ii. Address of the Bank iii. IFSC code iv. Nature of account(SA/CA) v. A/c Number vi. Telephone / Fax No. 4. (a) Excise Authority details: i. Excise Registration No. ii. Address of the jurisdictional Central Excise Authority iii. Contact details of Excise Authority iv. Amount of excise duty paid during last year v. Product registered for manufacturing activities (b) Jurisdictional Customs Authority details: i. Address of the jurisdictional Customs Authority ii. Contact details of Jurisdictional Customs Authority iii. Amount duty paid during last year iv. Product registered for manufacturing activities [भाग I—ख � ड 1] भारत का राजप� : असाधारण 9

MINISTRY OF COMMERCE AND INDUSTRY (Department of Commerce) (DIRECTORATE GENERAL OF FOREIGN) PUBLIC NOTICE New Delhi, the 23rd September, 2020 No. 18 /2015.2020 Subject : Publication of Revised ANF-7A –regd. F. No. 01/92/180/19/AM-21/PC-VI, E-file Computer No. 21700.—In exercise of powers conferred under Paragraph 1.03 of the Foreign Trade Policy 2015-2020, as amended from time to time, the Director General of Foreign Trade hereby notify the revised ANF-7A of Appendices & ANFs of Handbook of Procedure 2015-20 with immediate effect: Effect of this Public Notice: NF-7A of Appendices & ANFs has been revised. AMIT YADAV, Director General of Foreign Trade & Ex-Officio Addl. Secy.

ANF-7A APPLICATION FOR CLAIM OF TED REFUND / DUTY DRAWBACK / BRAND RATE FIXATION (Please tick whichever is applicable) (Application shall be filed online once the software is ready) 1. IEC No. Branch Code: 2. Applicant details:

i. Name of the firm/company ii. Full address iii. Contact Number iv. E-mail address 3. Bank’s details: i. Name of the Bank ii. Address of the Bank iii. IFSC code iv. Nature of account(SA/CA) v. A/c Number vi. Telephone / Fax No. 4. (a) Excise Authority details: i. Excise Registration No. ii. Address of the jurisdictional Central Excise Authority iii. Contact details of Excise Authority iv. Amount of excise duty paid during last year v. Product registered for manufacturing activities (b) Jurisdictional Customs Authority details: i. Address of the jurisdictional Customs Authority ii. Contact details of Jurisdictional Customs Authority iii. Amount duty paid during last year 10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1] iv. Product registered for manufacturing activities 5. Application for: i. Refund of Terminal Excise duty ii. Refund of Duty Drawback as per AIR iii. Fixation of brand rate for duty draw back 6. Application is made by: (i) Supplier of goods (ii) Recipient of goods 7. Supply details: i. Description of goods ii. Category of supplies under Para 7.02 of FTP

8. If application is for refund on TED Sl. Inv. No. Date of Description of Quantity Quantum Late Net No. item(s) of supply of TED cut, if claim Supply Payment any

(Provision to be made to add multiple invoices) 9. If the application is for drawback as per AIR under drawback schedule: Sl. Invoice Date of Description of Tariff No. FOR Net Draw back No. No. item(s)of value quantity of Rate supply supplies IDMA Bulletin LI (36) 22 to 30 September 2020 13 Supply Payment

Value Cap (if any) Amount of Late cut, if any Net payable amount DBK

(Provision to add multiple supply Invoices)

10. If supply towards discharge of export obligation to Advance Yes/No Authorisation Holder against Invalidation letter and drawback is claimed on inputs either imported or procured locally on payment of basic custom duty: Whether, in the application for Advance Authorisation for intermediate supply, it was declared that such inputs to be procured locally /imported on payment of basic custom duty? 11. If answer to Col. No 10 is yes, Advance Authorization no. & date and File. no. under which it was issued. 12. Whether claim is made within the prescribed time

10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1] 10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1] 10 5. Application for: THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1] 5. Applicationi. Refund for: of Terminal Excise duty 5. Applicationii.i. Refund for: of TerminalDuty Drawback Excise asduty per AIR iii.ii.i. RefundFixation of of TerminalDuty brand Dr rateawback Excise for duty asduty per draw AIR back ii. Refund of Duty Drawback as per AIR 6. Applicationiii. Fixation is made of brand by: rate for duty draw back iii. Fixation of brand rate for duty draw back 6. Application(i) is made Supplier by: of goods 6. Application(i)(ii) is made SupplierRecipient by: of of goods goods (i) Supplier of goods 7. Supply details:(ii) Recipient of goods (ii) Recipient of goods 7. Supplyi. Descriptiondetails: of goods 7. Supplyii.i. DescriptionCategorydetails: of ofsupplies goods under Para 7.02 of FTP i. Description of goods ii. Category of supplies under Para 7.02 of FTP ii. Category of supplies under Para 7.02 of FTP 8. If application is for refund on TED

8.Sl. If applicationInv. No. is for refundDate on TEDof Description of Quantity Quantum Late Net 8. If application is for refund on TED No. item(s) of supply of TED cut, if claim Sl. Inv. No. SupplyDate ofPayment Description of Quantity Quantum Late Net No.Sl. Inv. No. Date of item(s)Description of supply of Quantity Quantumof TED cut,Lateany if claimNet No. Supply Payment item(s) of supply of TED cut,any if claim Supply Payment any (Provision to be made to add multiple invoices)

9. (Provision If the application to be made is forto add drawback multip leas invoices) per AIR under drawback schedule: (Provision to be made to add multiple invoices) 9. Sl. If theInvoice application is forDate drawback of as perDescription AIR under of drawbackTariff No.schedule: FOR Net Draw back 9. If the application is for drawback as per AIR under drawback schedule: No.Sl. InvoiceNo. Date of Descriptionitem(s)of of Tariff No. valueFOR quantityNet of DrawRate back No.Sl. No.Invoice Date of item(s)ofDescriptionsupply of Tariff No. valueFOR quantitysuppliesNet of DrawRate back No. No. supplyitem(s)of value quantitysupplies of Rate Supply Payment supply supplies Supply Payment Supply Payment

Value Cap (if any) Amount of Late cut, if any Net payable amount

Value Cap (if any) AmountDBK of Late cut, if any Net payable amount Value Cap (if any) Amount of Late cut, if any Net payable amount DBK DBK

(Provision to add multiple supply Invoices)

(Provision to add multiple supply Invoices) (Provision to add multiple supply Invoices) 10. If supply towards discharge of export obligation to Advance Yes/No

10. IfAuthorisation supply towards Holder discharge against Invalidation of export letterobligation and drawbackto Advance is Yes/No 10. AuthorisationIfclaimed supply on towards inputs Holder either discharge against imported Invalidation of or export procured letterobligation locally and drawbackto on Advance payment is Yes/No claimedAuthorisationof basic custom on inputs Holder duty: either against imported Invalidation or procured letter locally and drawback on payment is Whether,ofclaimed basic custom onin the inputs duty:application either importedfor Advance or procuredAuthorisation locally for intermediate on payment of basic custom duty: Whether,supply, it in wasthe application declared thatfor Advance such inputs Authorisation to be procured for intermediate locally supply,Whether,/imported it in on wasthe payment application declared of basic thatfor custom Advance such duty? inputs Authorisation to be procured for intermediate locally supply, it was declared that such inputs to be procured locally 11. If/imported answer onto Col.payment No 10 of isbasic yes, custom Advance duty? Authorization no. & date and /imported on payment of basic custom duty? 11. IfFile. answer no. under to Col. which No 10it was is yes, issued. Advance Authorization no. & date and 11. If answer to Col. No 10 is yes, Advance Authorization no. & date and [12.भाग I—खWhetherFile. �ड 1 ]no. underclaim whichis made it withinwas issued. theभारत prescribed का राजप� time : असाधारण 11 File. no. under which it was issued. 12. Whether claim is made within the prescribed time 12.13. WhetherIf not, rate claim of late is madecut as within per Para the 9.02 prescribed of HBP time

14. If claim for refund of TED is made by supplier: Whether CENVAT credit has been availed by recipient? 15. If claim for refund of TED is made by recipient: Whether CENVAT credit has been availed by him? 16. If claim for duty drawback is made by supplier: Whether CENVAT credit has been availed by him on excisable inputs 17. If claim for duty drawback is made by recipient of goods: Whether CENVAT credit has been availed by supplier of goods on excisable inputs? 18. In case of claim made against supply under Para-7.02(a) & (c) whether authorization number and date figure in the supply invoices/ARE. 19. If the application is for fixation of brand rate: IDMA BulletinDrawback LI (36) 22 rate to under30 September AIR not 2020 available 14 AIR is less than 4/5 of actual duty paid. (i) Claim is made for basic customs duty. 20. If answer to Col. 19 is yes, Whether: 1. Inputs/components were imported directly : 2. Imported inputs/component used from stock/ out sourced locally:

21. DBK-I Statement Sl. Name of the Quality/ Whether Unit Gross Wastage Quantity No. materials/ Technical imported/ Quantity Components Characteristics indigenous required Irrecoverable Recoverable 1 2 3 4 5 6 7 8

Sale Price of waste By Product/ co-product Net wt. of the Remarks per unit of Qty material Qty. Sale value per unit 9 10 11 12 13

[भाग I—ख �ड 1] भारत का राजप� : असाधारण 11 [भाग I—ख �ड 1] भारत का राजप� : असाधारण 11 13. If not, rate of late cut as per Para 9.02 of HBP 13. If not, rate of late cut as per Para 9.02 of HBP 14. If claim for refund of TED is made by supplier: 14. If claim for refund of TED is made by supplier: Whether CENVAT credit has been availed by recipient? Whether CENVAT credit has been availed by recipient? 15. If claim for refund of TED is made by recipient: 15. If claim for refund of TED is made by recipient: Whether CENVAT credit has been availed by him? Whether CENVAT credit has been availed by him? 16. If claim for duty drawback is made by supplier: 16. If claim for duty drawback is made by supplier: Whether CENVAT credit has been availed by him on excisable inputs Whether CENVAT credit has been availed by him on excisable inputs 17. If claim for duty drawback is made by recipient of 17. goods:If claim for duty drawback is made by recipient of goods: Whether CENVAT credit has been availed by supplier of goods on excisableWhether CENVATinputs? credit has been availed by supplier of goods on excisable inputs? 18. In case of claim made against supply under Para-7.02(a) & (c) whether 18. In case of claim made against supply under Para-7.02(a) & (c) whether authorization number and date figure in the supply invoices/ARE. authorization number and date figure in the supply invoices/ARE. 19. If the application is for fixation of brand rate: 19. If the application is for fixation of brand rate: Drawback rate under AIR not available Drawback rate under AIR not available AIR is less than 4/5 of actual duty paid. AIR is less than 4/5 of actual duty paid. (i) Claim is made for basic customs duty. (i) Claim is made for basic customs duty. 20. If answer to Col. 19 is yes, 20. If answer to Col. 19 is yes, Whether: Whether: 1. Inputs/components were imported directly : 1. Inputs/components were imported directly : 2. Imported inputs/component used from stock/ out sourced 2. locally:Imported inputs/component used from stock/ out sourced locally:

21. DBK-I Statement 21. DBK-I Statement Sl. Name of the Quality/ Whether Unit Gross Wastage Quantity NoSl. . materials/Name of the TechnicalQuality/ imported/Whether Unit QuantityGross Wastage Quantity No. Componentsmaterials/ CharacteristicsTechnical indigenousimported/ requiredQuantity Irrecoverable Recoverable Components Characteristics indigenous required Irrecoverable Recoverable 1 2 3 4 5 6 7 8 1 2 3 4 5 6 7 8

Sale Price of waste By Product/ co-product Net wt. of the Remarks perSale unit Price of ofQty waste By Product/ co-product materialNet wt. of the Remarks per unit of Qty material Qty. Sale value per Qty. unitSale value per unit 9 10 11 12 13 9 10 11 12 13

12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1]

22. Statement of inputs/components used, either imported or imported materials procured locally ** S. Description Technical S.No. in B/E /Invoice No Name of the Unit Qty. imported/ Assessable No. characteristics DBK-I & date under Customs procured locally value statement which imported/ House/Excise

procured Authority 1 2 3 4 5 6 7 8 9

Heading No. Country from Name and full Rate of Duty Is assessment Total amount of Remarks in Customs which address of the final duty paid

Tariff Act, imported / supplier in case (basic custom IDMA1975 Bulletin LI (36)name 22 of to 30 Septemberthe foreign 2020 15 duty) supplier material/ Components

obtained locally

10 11 12 13 14 15 16

** Only inputs which were imported/ procured and consumed during the period commencing 90 days prior to the date of supply(s) shall only be taken into account for such claim. A separate work sheet as per DBK form II, and II(A) and certificates attached thereto duly certified by Chief Executive/production in-charge shall be submitted, as given in the APPENDIX-7E 23. Check List of documents to be attached duly scanned or submitted in the physical form at counter: (1) (a) Copy of Invoices or a statement of invoices duly signed by the units receiving the excisable goods and attested by Central Excise Authorities, as per the procedure prescribed by CBEC in their circular 15/2008-Cus. dated 26.9.2008. To facilitate attestation by Central Excise Authorities, intimation regarding receipt of goods should be given to the said authorities within 48 hours of receipt of goods. Corresponding ER-1/ER-3 or a monthly statement confirming duty payment attested by excise Authorities or Invoices/statement of Invoices certified by Jurisdictional Central Excise Authority of recipient. (b) In case of supply of non-excisable goods, copy of Tax invoices as prescribed under GST Rules or a statement of invoices duly signed by the units receiving the goods and attested by Jurisdictional Customs Authorities, as per the procedure prescribed by CBEC in their circular 15/2008-Cus. dated 26.9.2008. To facilitate attestation by Jurisdictional Customs Authorities, intimation regarding receipt of goods should be given to the said authorities within 48 hours of receipt of goods. (2) In case supply of goods to EOU/EHTPI STPI BTP, procedure prescribed in Circular No-14/14/2017- GST dated 6th November, 2017 issued by GST Policy Wing, Central Board of Excise and Customs, Department of Revenue shall be followed, Accordingly, copy of Form A along with copy of Tax Invoice duly endorsed by recipient shall be considered as proof of deemed export supplies, (3) Self certified copy of B/Es (4) Proof of payment through e-BRC/Bank Certificate of Exports and Realisation as per APPENDIX-2U or Payment Certificate issued by Project Authority in APPENDIX-7D in original, as the case may be. (5) PAC issued by the Project Authority in original as per APPENDIX-7C or File No. where the original has been submitted. (6) Copy of contract if supplies were to Project Authority or supplier’s copy of original ARO or recipient’s copy of original Invalidation Letter (if supply against ARO/Invalidation Letter issued against AA/ DFIA/EPCG, as the case may be). 12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1] 12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1] 22. Statement of inputs/components used, either imported or imported materials procured locally ** 22.S. StatementDescription of inputs/componentsTechnical S.No. used, in eitherB/E /Invoice imported No orName imported of the materials Unit Qty. procured imported/ locally Assessable ** No. characteristics DBK-I & date under Customs procured locally value S. Description Technical S.No. in B/E /Invoice No Name of the Unit Qty. imported/ Assessable statement which imported/ House/Excise No. characteristics DBK-I & date under Customs procured locally value procured Authority statement which imported/ House/Excise

1 2 3 4 procured5 Authority6 7 8 9 1 2 3 4 5 6 7 8 9

Heading No. Country from Name and full Rate of Duty Is assessment Total amount of Remarks in Customs which address of the final duty paid Heading No. Country from Name and full Rate of Duty Is assessment Total amount of Remarks Tariff Act, imported / supplier in case in Customs which address of the final duty(basic paid custom 1975 name of the foreign Tariff Act, imported / supplier in case duty) supplier material/ (basic custom 1975 name of the foreign Components duty) supplier material/ obtained locally Components

obtained locally 10 11 12 13 14 15 16 10 11 12 13 14 15 16 ** Only inputs which were imported/ procured and consumed during the period commencing 90 days prior** Only to the inputs date ofwhich supply(s) were imported/shall only procuredbe taken intoand consumedaccount for during such claim. the period commencing 90 days priorA separate to the datework of sheet supply(s) as per shall DBK only form be II, taken and II(A)into accoun and certificatest for such attachedclaim. thereto duly certified by ChiefA separate Executive/production work sheet as per in DBK-charge form shall II, beand submitted, II(A) and as certificates given in the attached APPENDIX thereto- duly7E certified by 23.Chief Check Executive/production List of documents in-charge to be shall attached be submitted, duly scanned as given orin the submitted APPENDIX in the-7E physical form at 23.counter: Check List of documents to be attached duly scanned or submitted in the physical form at counter:(1) (a) Copy of Invoices or a statement of invoices duly signed by the units receiving the excisable goods and(1) (a) attested Copy byof Invoices Central Exciseor a statement Authorities, of invoices as per duly the proceduresigned by the prescribed units receiving by CBEC the inexcisable their ci goodsrcular and15/2008 attested-Cus. bydated Central 26.9.2008. Excise To Authorities, facilitate attestation as per the by procedure Central Excise prescribed Authorities, by CBEC intimation in their regarding circular 15/2008receipt of-Cus. goods dated should 26.9.2008. be given To to facilitate the said authoritiesattestation bywithin Central 48 hours Excise of Authorities, receipt of goods. intimation Corresponding regarding receiptER-1/ER of- 3goods or ashould monthly be given statement to the saidconfirming authorities duty within payment 48 hours attested of receipt by of excise goods. AuthoritiesCorresponding or Invoices/statementER-1/ER-3 or a of monthly Invoices statement certified byconfirming Jurisdictional duty Central payment Excise attested Authority by of excise recipient. Authorities or Invoices/statement(b) In case of supply of Invoicesof non-excisable certified bygoods, Jurisdictional copy of Tax Central invoices Excise as Authority prescribed of underrecipient. GST Rules or a statement(b) In case of of invoices supply dulyof non signed-excisable by the goods, units receivingcopy of Tax the invoicesgoods and as attestedprescribed by Jurisdictionalunder GST Rules Customs or a statementAuthorities, of asinvoices per the duly procedure signed prescribedby the units by receiving CBEC in the their goods circular and 15/2008attested -byCus. Jurisdictional dated 26.9.2008. Customs To Authorities,facilitate attestation as per the by procedureJurisdictional prescribed Customs by Authorities, CBEC in their intimation circular regarding 15/2008 receipt-Cus. dated of goods 26.9.2008. should Tobe facilitategiven to theattestation said authorities by Jurisdictional within 48 Cushourstoms of receiptAuthorities, of goods. intimation regarding receipt of goods should be given(2) In to case the supplysaid authorities of goods within to EOU/EHTPI 48 hours of STPI receipt BTP, of goods.procedure prescribed in Circular No-14/14/2017- GST(2) In dated case supply 6th November, of goods 2017to EOU/EHTPI issued by STPI GST BTP, Policy procedure Wing, Central prescribed Board in Circular of Excise No and-14/14/2017 Customs,- GSTDepartment dated 6thof Revenue November, shall 2017 be followed, issued by Accordingly, GST Policy copy Wing, of Form Central A along Board with of Excise copy of and Tax Customs, Invoice Departmentduly endorsed of byRevenue recipient shall shall be be followed, considered Accordingly, as proof of copydeemed of Formexport A supplies, along with copy of Tax Invoice duly(3) Self endorsed certified by copyrecipient of B/Es shall be considered as proof of deemed export supplies, (4)(3) Self Proof certified of copy payment of B/Es through e-BRC/Bank Certificate of Exports and Realisation as per APPENDIX(4) Proof - of2U or payment Payment through Certificate e- BRC/Bankissued by Project Certificate Authority of in Exports APPENDIX and -7D Realisation in original, as as perthe caseAPPENDIX may be. -2U or Payment Certificate issued by Project Authority in APPENDIX-7D in original, as the case(5) PAC may be.issued by the Project Authority in original as per APPENDIX-7C or File No. where the original has (5) beenPAC submitted.issued by the Project Authority in original as per APPENDIX-7C or File No. where the original has (6) beenCopy submitted. of contract if supplies were to Project Authority or supplier’s copy of original ARO or recipient’s [ copyभाग(6) Copy I— ofख � originalof ड 1contract] Invalidation if supplies Letterwere to (ifभारतProject supply का Authorityराजप� aga :inst असाधारण or ARO/Invalidation supplier’s copy of Letteroriginal issued ARO or against recipient’s AA/13 DFIA/EPCG,copy of original as the Invalidation case may be). Letter (if supply against ARO/Invalidation Letter issued against AA/ DFIA/EPCG,(7) Non-availment as the of case CENVAT may be). credit certificate as per ANNEXURE-I, by the recipient of finished goods (in case claim for TED). (8) A certificate regarding non-availment of CENVAT credit on inputs used in the resultant product by the supplier of goods as per ANNEXURE-II (in case claim for drawback). (9) Declaration/disclaimer certificate from supplier, in case claim is filed by recipient of goods and from IDMArecipient Bulletin of goods, LI (36) if 22 claim to 30 is September filed by supplier 2020 of goods, as per ANNEXURE-III 16 (10) Statement of supplies for Fixation of Drawback Rate as per APPENDIX-7E.

DECLARATION / UNDERTAKING 1. I/We hereby declare that the particulars and the statements made in this application are true and correct to the best of my/our knowledge and belief and nothing has been concealed or held there from. If found incorrect or false, it will render me / us liable for any penal action or other consequences as may be prescribed in law or otherwise warranted. 2. I/We undertake to abide by the provisions of F.T. (D&R) Act, the Rules and Orders framed there under, the FTP, HBP, SION and the ITC(HS) Classification of Export & Import Items. 3. I/we further declare that the claim made by me/us is not a matter of right and I/we shall immediately refund the amount of TED/drawback obtained by us in excess of any amount/rate which may be re-determined by concerned RA/DGFT/Government as a result of post verification/ Audit objection or otherwise. 4. None of the Proprietor/Partners(s)/Director(s)/Karta/Trustee of the firm/company has come under the adverse notice of DGFT or is in the caution list of RBI. 5. None of the Proprietor/Partners(s)/Director(s)/Karta/Trustee of the firm/company, as the case may be, is/are a Proprietor/Partner(s)/Director(s)/Karta/Trustee in any other firm/Company which has come under the adverse notice of DGFT or is in the caution list of RBI, to the bestof my knowledge. 6. I / We hereby declare that no export proceeds are outstanding beyond the prescribed period as laid down by RBI or such extended period for which AD/RBI permission has been obtained. 7. I/we further declare that the goods supplied are excisable goods but no CENVAT credit is availed/ available to the recipient of goods. (In case of items covered under schedule 4 of the central excise Act 1944). 8. I/we further declare that no CENVAT credit facility has been availed on inputs for which drawback claim is made. 9. I hereby certify that I am authorised to verify and sign this declaration as per Paragraph 9.06 of the FTP.

Signature of the Applicant Name Designation Official Address Telephone/Mobile No. Residential Address Email Address Place Date [भाग I—ख � ड 1] भारत का राजप� : असाधारण 13

(7) Non-availment of CENVAT credit certificate as per ANNEXURE-I, by the recipient of finished goods (in[भाग caseI— खclaim � ड 1 ]for TED). भारत का राजप� : असाधारण 13 (8) A certificate regarding non-availment of CENVAT credit on inputs used in the resultant product by the [(7)भाग NonI—ख-availment � ड 1] of CENVAT credit certificateभारत का राजप� as per : असाधारणANNEXURE -I, by the recipient of finished goods13 supplier of goods as per ANNEXURE-II (in case claim for drawback). (in case claim for TED). (9)(7) NonDeclaration/disclaimer-availment of CENVAT certificate credit from certificate supplier, as perin caseANNEXURE claim is filed-I, by by the recipient recipient of of goods finished and goods from (8) A certificate regarding non-availment of CENVAT credit on inputs used in the resultant product by the (inrecipient case claim of goods, for TED). if claim is filed by supplier of goods, as per ANNEXURE-III supplier of goods as per ANNEXURE-II (in case claim for drawback). (10)(8) A Statement certificate of regarding supplies fornon Fixation-availment of ofDrawback CENVAT Rate credit as per on APPENDIXinputs used in-7E the. resultant product by the supplier (9) Declaration/disclaimer of goods as per ANNEXURE certificate -fromII (in supplier,case claim in for case drawback). claim is filed by recipient of goods and from recipient of goods, if claim is filed by supplier of goods, as per ANNEXURE-III (9) Declaration/disclaimer certificate from supplier, in case claim is filed by recipient of goods and from recipient(10) Statement of goods, of suppliesif claim foris filed Fixation by supplier of Drawback of goods, Rate as as per per ANNEXURE APPENDIX-III-7E . DECLARATION / UNDERTAKING (10) Statement of supplies for Fixation of Drawback Rate as per APPENDIX-7E. 1. I/We hereby declare that the particulars and the statements made in this application are true and correct to the best of my/our knowledge and belief and nothing has been concealed or held there DECLARATION / UNDERTAKING from. If found incorrect or false, it will render me / us liable for any penal action or other 1. consequencesI/We hereby declare as may thatbe prescribed DECLARATIONthe particulars in law and or / otherwise theUNDERTAKING statements warranted. made in this application are true and correct to the best of my/our knowledge and belief and nothing has been concealed or held there 2. I/We undertake to abide by the provisions of F.T. (D&R) Act, the Rules and Orders framed there 1. from.I/We hereby If found declare incorrect that the or false,particulars it will and render the statements me / us liablemade in for this any application penal action are ortru e other and under, the FTP, HBP, SION and the ITC(HS) Classification of Export & Import Items. consequencescorrect to the asbest may of bemy prescribed/our knowledge in law and or otherwise belief and warr nothinganted. has been concealed or held there 3. I/wefrom. further If found declare incorrect that or the false, claim it made will render by me/us me / is us not liable a matter for any of penal right action and I/we or other shall 2. I/We undertake to abide by the provisions of F.T. (D&R) Act, the Rules and Orders framed there immediatelyconsequences refund as may the be prescribed amount of in TED/drawback law or otherwise obtained warranted. by us in excess of any amount/rate under, the FTP, HBP, SION and the ITC(HS) Classification of Export & Import Items. 2. whichI/We undertake may be re to-determined abide by the by provisionsconcerned ofRA F.T./DGFT/Government (D&R) Act, the Rulesas a result and Ordersof post framedverification/ there 3. AuditI/weunder, furtherobjection the FTP, declare HBP,or otherwise. SION that the and claim the ITC(HS) made byClassification me/us is notof Export a matter & Import of right Items. and I/we shall immediately refund the amount of TED/drawback obtained by us in excess of any amount/rate 4. None of the Proprietor/Partners(s)/Director(s)/Karta/Trustee of the firm/company has come under 3. whichI/we further may be declare re-determined that the by claim concerned made RA by/ DGFT/Government me/us is not a matter as a result of ri ofght post and verification/ I/we shall the adverse notice of DGFT or is in the caution list of RBI. Auditimmediately objection refund or otherwise. the amount of TED/drawback obtained by us in excess of any amount/rate 5. Nonewhich ofmay the be Proprietor/Partners(s)/Director(s)/Karta/Trustee re-determined by concerned RA/DGFT/Government of the firm/company,as a result of post as the verification/ case may 4. None of the Proprietor/Partners(s)/Director(s)/Karta/Trustee of the firm/company has come under be,Audit is/are objection a Proprietor/ or otherwise.Partner(s)/Director(s)/Karta/Trustee in any other firm/Company which has the adverse notice of DGFT or is in the caution list of RBI. 4. comeNone of under the Proprietor/ the adversePartners(s)/Director(s)/Karta/Trustee notice of DGFT or is in the caution of the listfirm/company of RBI, to has the come bestof under my 5. knowledge.Nonethe adverse of the notice Proprietor/Partners(s)/Director(s)/Karta/Trustee of DGFT or is in the caution list of RBI. of the firm/company, as the case may be, is/are a Proprietor/Partner(s)/Director(s)/Karta/Trustee in any other firm/Company which has 6. I / We hereby declare that no export proceeds are outstanding beyond the prescribed period as laid 5. comeNone of under the Proprietor/Partners(s)/Director(s)/Karta/Trustee the adverse notice of DGFT or is in the caution of the listfirm/company, of RBI, to as the the bestof case may my down by RBI or such extended period for which AD/RBI permission has been obtained. knowledge.be, is/are a Proprietor/Partner(s)/Director(s)/Karta/Trustee in any other firm/Company which has 7. I/wecome further under declare the adverse that the notice goods of supplied DGFT are or excisable is in the goods caution but list no ofCENVAT RBI, to credit the bestofis availed/ my 6. I / We hereby declare that no export proceeds are outstanding beyond the prescribed period as laid availableknowledge. to the recipient of goods. (In case of items covered under schedule 4 of the central excise down by RBI or such extended period for which AD/RBI permission has been obtained. 6. ActI / We 1944). hereby declare that no export proceeds are outstanding beyond the prescribed period as laid 7. I/we further declare that the goods supplied are excisable goods but no CENVAT credit is availed/ 8. I/wedown further by RBI declare or such that extended no CENVAT period forcredit which facility AD/RBI has been permission availed hason inputsbeen obtained. for which drawback available to the recipient of goods. (In case of items covered under schedule 4 of the central excise claim is made. 7. ActI/we 1944). further declare that the goods supplied are excisable goods but no CENVAT credit is availed/ 9. Iavailable hereby certify to the recipientthat I am ofauthorised goods. (In to caseverify of and items sign cove thisred declaration under schedule as per 4Paragrap of the centralh 9.06 exciseof the 8. I/we further declare that no CENVAT credit facility has been availed on inputs for which drawback FTP.Act 1944). claim is made. 8. I/we further declare that no CENVAT credit facility has been availed on inputs for which drawback 9. Iclaim hereby is made.certify that I am authorised to verify and sign this declaration as per Paragraph 9.06 of the FTP. 9. I hereby certify that I am authorised to verify and sign this declaration as per Paragraph 9.06 of the FTP. Signature of the Applicant Name Signature of theDesignation Applicant Signature Officialof the Applicant AddressName Telephone/MobileDesignationName No. ResidentialOfficialDesignation Address Telephone/MobileOfficialEmail Address No. Telephone/MobileResidential AddressPlace No. ResidentialEmail AddressDate Email AddressPlace PlaceDate IDMA Bulletin LI (36) 22 to 30 September 2020 17 Date

14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1]

ANNEXURE-I DECLARATION FOR CLAIMING BENEFIT OF TERMINAL EXCISE DUTY (TED) It is certified that no CENVAT credit under the Central Excise Rules has been availed by us, nor will be availed in future, on supply of these items as per the application.

Signature (Authorized Signatory): Full Name: Designation: Name of the company: Telephone Number: E-mail Address: Fax No.: Note: To be given on the letter head of the recipient of goods. ANNEXURE-II DECLARATION FOR CLAIMING DEEMED EXPORT DRAWBACK 1. I, (Name & Designation) …..on behalf of M/s. ….. (Name and address of the supplier) hereby certify that we have supplied the following goods to M/s….. (Name and address of the recipient): Description of S.No. Inv. No. & date Unit Qty. Value goods

2. We are the manufacturer exporters/suppliers and are registered/not registered with Central Excise Authority and have not availed and will not avail CENVAT credit facility in respect of duty paid on inputs/components and/or tax paid on input services, in aforesaid supplies. We have also not availed and will not avail rebate on the duty paid on inputs/components used in aforesaid supplies and/or tax paid on input services. 3. We also certify that we have not been issued any Advance Authorization/Duty Free Import Authorization in respect of the aforesaid supply of goods and have not availed any benefit thereon. 4. The complete address of the Jurisdictional Assistant/Deputy Commissioner of the Central Excise Division is given as follows:

Yours faithfully, Signature (Authorized Signatory) Full Name Designation Name of the Company Telephone Number Address Fax No. E-mail address IDMANote Bulletin : Declaration LI (36) 22 is to to 30 be September given on letter 2020 head of the supplier. The Declaration furnished by the supplier18 to Office of the Development Commissioner or RA of DGFT should be in duplicate with complete address of the Jurisdictional Assistant/Deputy Commissioner of the Central Excise Division. The Development Commissioner/RA of DGFT would forward the second copy of this Declaration, duly stamped, to the addressed Assistant /Deputy Commissioner of the Central Excise Division for cross verification. 14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART I—SEC. 1]

ANNEXURE-I DECLARATION FOR CLAIMING BENEFIT OF TERMINAL EXCISE DUTY (TED) It is certified that no CENVAT credit under the Central Excise Rules has been availed by us, nor will be availed in future, on supply of these items as per the application.

Signature (Authorized Signatory): Full Name: Designation: Name of the company: Telephone Number: E-mail Address: Fax No.: Note: To be given on the letter head of the recipient of goods. ANNEXURE-II DECLARATION FOR CLAIMING DEEMED EXPORT DRAWBACK 1. I, (Name & Designation) …..on behalf of M/s. ….. (Name and address of the supplier) hereby certify that we have supplied the following goods to M/s….. (Name and address of the recipient): Description of S.No. Inv. No. & date Unit Qty. Value goods

2. We are the manufacturer exporters/suppliers and are registered/not registered with Central Excise Authority and have not availed and will not avail CENVAT credit facility in respect of duty paid on inputs/components and/or tax paid on input services, in aforesaid supplies. We have also not availed and will not avail rebate on the duty paid on inputs/components used in aforesaid supplies and/or tax paid on input services. 3. We also certify that we have not been issued any Advance Authorization/Duty Free Import Authorization in respect of the aforesaid supply of goods and have not availed any benefit thereon. 4. The complete address of the Jurisdictional Assistant/Deputy Commissioner of the Central Excise Division is given as follows:

Yours faithfully, Signature (Authorized Signatory) Full Name Designation Name of the Company Telephone Number

Address Fax No. [भाग I—ख � ड 1] भारत का राजप� : असाधारण 15 [भाग I—ख � ड 1] भारत का राजप� : असाधारण E-mail addr15ess [भाग I—ख � ड 1] भारत का राजप� : असाधारण 15 ANNEXURE-III [भागNoteI— : ख Declaration � ड 1] is to be given on letterभारत head का राजप� of the :supplier. असाधारण The Declaration furnished by the supplier15

to OfficeANNEXUREDISCLAIMER of the - DevelopmentIII CERTIFICATE Commissioner FOR NOT or RACLAIMING of DGFT DEEMED should be EXPORT in duplicate BENEFITSANNEXURE with complete -III [भाग I—ख � ड 1] भारत का राजप� : असाधारण 15 address of the Jurisdictional Assistant/Deputy Commissioner of the Central Excise ANNEXURE Division. The-III DISCLAIMER CERTIFICATE FOR NOT CLAIMING DEEMED EXPORTWe BENEFITSherebyDISCLAIMER declare that CERTIFICATE we have neither FOR drawn NOT nor CLAIMINGwill draw any DEEMED benefit of EXPORT deemed export BENEFITS on supply of [भागDevelopmentI—ख � ड 1] Commissioner/RA of DGFTभारत का would राजप� forward : असाधारण the second copy of this Declaration, duly15 Wegoods herebyDISCLAIMER as declared/to declare that be CERTIFICATE wedeclared have neitherin the FOR applicationdrawn NOT nor CLAIMINGwillfor claimdraw anyof DEEMEDdee benefitmed exportof EXPORTdeemed benefits export BENEFITS ANNEXURE and on we supply have - IIIofno We hereby declare that we have neither drawn nor will draw any benefit of deemedstamped, export on to supply the addressed of Assistant /Deputy Commissioner of the Central Excise Division ANNEXURE for cross-III [objectionभाग I—ख �if ड M/s……1] (Name and addressभारत of theका राजप�recipient/supplier, : असाधारण as the case may be) draws the deemed15 Wegoods hereby DISCLAIMERas declared/to declare that be CERTIFICATE wedeclared have neitherin the FOR applicationdrawn NOT nor CLAIMINGwillfor claimdraw ofany deeDEEMED benefitmed exportof EXPORTdeemed benefits export BENEFITS and on we supply have noof goods as declared/to be declared in the application for claim of deemed export benefitsexportverification. DISCLAIMERand benefits we have on such no CERTIFICATE supply of goods asFOR mentioned NOT CLAIMING in the application. DEEMED EXPORT BENEFITS ANNEXURE -III goodsobjection as declared/toif M/s…… be(Name declared and addressin the application of the recipient/supplier, for claim of dee asmed the caseexport may benefits be) draws and wethe havedeemed no objection if M/s…… (Name and address of the recipient/supplier, as the case may Webe) drawshereby the declare deemed that we have neither drawn nor will draw any benefit of deemed export ANNEXURE on supply- IIIof exportWe(Either herebyDISCLAIMER benefits party declare on will such that have CERTIFICATE supplywe to have give of goodsneither disclaimer asFOR drawn mentioned NOT in nor favour CLAIMINGwill in the draw of application. other any DEEMED benefit for not of claiming EXPORTdeemed benefitsexport BENEFITS on of supply deemed of export benefits on such supply of goods as mentioned in the application. goodsobjection as declared/toif M/s…… be(Name declared and addressin the application of the recipient/supplier, for claim of dee asmed the caseexport may benefits be) draws and wethe havedeemed no Wegoodsexport hereby DISCLAIMERas against declared/to declare supply that be CERTIFICATE wedeclared of goodshave neitherin as the declared FOR applicationdrawn NOT nor in theCLAIMINGwillfor Applicationclaimdraw ofany deeDEEMED benefit med for claim. exportof EXPORTdeemed Thebenefits disclaimerexport BENEFITS and on we supply ishave to no beof objection(Eitherexport benefits party if M/s…… willon such have (Name supply to giveand of goods address disclaimer as ofmentioned the in recipient/supplier, favour in the of application. other foras the not case claiming may be) benefits draws the of deemeddeemed (Either party will have to give disclaimer in favour of other for not claiminggoodsobjectionsubmitted benefits as declared/toif ofonM/s…… deemedthe letter be(Name headdeclared and of theaddressin thefirm/company) application of the recipient/supplier, for claim of dee asmed the caseexport may benefits be) draws and wethe havedeemed no export against supply of goods as declared in the Application for claim. Theexport(EitherWe disclaimer hereby benefits against party declare is willon supply to such thatbe have supplywe of to goodshave give of goods neither disclaimer as declared as drawn mentioned in innor f avour thewill in Applicationthe draw of application. other any benefit for for not claim. of claiming deemed The disclaimerbenefitsexport on of supply is deemed to beof objection if M/s…… (Name and address of the recipient/supplier, as the case may be) draws the deemed submitted on the letter head of the firm/company) goodsexportsubmitted as against declared/to on the supply letter be head ofdeclared goods of the in as firm/company)the declared application in the for Applicationclaim of dee formed claim.export Thebenefits disclaimer and we ishave to beno (Eitherexport benefits party willon such have supply to give of goods disclaimer as mentioned in favour in the of application. other for not claiming benefits of deemed objection if M/s…… (Name and address of the recipient/supplier, as the case may be) draws the deemed export submitted against on the supply letter head of goods of the as firm/company) declared in the Application for claim. The disclaimerYours faithfully, is to be (Eitherexport benefits against party willon supply such have supply of to goods give of goods disclaimer as declared as mentioned in in f avour the in Applicationthe of application. other for for not claim. claiming The disclaimerbenefits of is deemed to be submitted on the letter head of the firm/company) Signature (AuthorizedYours Signatory)faithfully, (EitherexportYours against party faithfully, will supply have of to goods give disclaimer as declared in in f avour the Application of other for for not claim. claiming The disclaimerbenefits of is deemed to be Yours faithfully, Signature (Authorizedexport submitted against on Signatory) the supply letter head of goods of the as firm/company) declared in the Application for claim.Signature The (Authorized disclaimer Signatory)Full is toName be Signature (AuthorizedYours Signatory) faithfully, submitted onFull the Name letter head of the firm/company) YoursDesignationFull faithfully, Name Signature (Authorized FullSignatory) Name Designation Signature (AuthorizedNameYours of theDesignation Signatory) faithfully, company YoursDesignationFull faithfully, Name Name of the company Signature (AuthorizedName Telephone of the FullSignatory) company Number Name Signature (AuthorizedName of theDesignation Signatory) company Telephone Number Telephone Designation Full Number EName-mail Name Telephone of theFull company Number Name E-mail Name of the Designation company Address E-mail Telephone Designation Number E-mail Address Name Telephone of the company AddressNumberFax No. Name of the company Address E-mail Fax No. Telephone NumberFax E-mail No. Telephone AddressNumberFax No. ANNEXURE Address E-mail-IV AddressFax E-mail No . FORMATANNEXURE OF CERTIFICATE-IV TO BE ISSUED BY PUBLIC SECTOR OILANNEXURE COMPANIESFax No-IV. CERTIFYING AMOUNT OF TED PAID BY EOU / PROJECT ON PURCHASE ANNEXUREOF HSD AddressFaxFROM No-IV . FORMAT OF CERTIFICATE TO BE ISSUED BY PUBLIC SECTOR FORMAT OIL COMPANIES OF CERTIFICATE TO BE ISSUED BY PUBLIC SECTOR OIL COMPANIES CERTIFYINGTHEIR DEPOT AMOUNTS: OF TED PAID BY EOU / PROJECT ON PURCHASE OF HSD FROM CERTIFYING AMOUNT OF TED PAID BY EOU / PROJECT ON PURCHASE FORMAT OF HSD OF FROM CERTIFICATE TO BE ISSUED BY PUBLIC SECTOR OILANNEXURE COMPANIESFax No-IV .

THEIR DEPOTS: CERTIFYINGTHEIRI ______DEPOT (name AMOUNTS: of authorized OF TED signatory PAID ofBY PSU EOU Oil / PROJECTCompany) herebyON PURCHASE declare that OF we HSD (name FROM of the FORMAT OF CERTIFICATE TO BE ISSUED BY PUBLIC SECTOR OILANNEXURE COMPANIES-IV THEIRICompany) ______DEPOT have (name S: supplies of authorized HSD to signatory M/s. ______(Name of PSU Oil Company) of EOU/Project) hereby declare from that our we depot (name at ------of the I ______(name of authorized signatory of PSU Oil Company) hereby declareCERTIFYING that we (name ofAMOUNT the OF TED PAID BY EOU / PROJECT ON PURCHASE OF HSD FROM Company) ______asFORMAT have OF per supplies CERTIFICATE details given HSD below. to M/s. TO BE______(Name ISSUED BY ofPUBLIC EOU/Project) SECTOR from OIL ourANNEXURE depotCOMPANIES at------IV Company) have supplies HSD to M/s. ______(Name of EOU/Project) fromTHEIRI ______our depot DEPOT (name at------S: of authorized signatory of PSU Oil Company) hereby declare that we (name of the ______asCERTIFYINGFORMAT OF per AMOUNT CERTIFICATEdetails given OF below. TED TO PAID BE BY ISSUED EOU / BYPROJECT PUBLIC ON SECTORPURCHASE OIL OF COMPANIES HSD FROM ______as per details given below. ICompany) ______have (name supplies of authorized HSD to signatory M/s. ______(Name of PSU Oil Company) of EOU/Project) hereby declare from that our we depot (name at ------of the CERTIFYINGTHEIRI ______DEPOT (name AMOUNTS: of authorized OF TED signatory PAID ofBY PSU EOU Oil / PROJECTCompany) herebyON PURCHASE declare that OFwe HSD (name FROM of the Company)______as have per supplies details given HSD below. to M/s. ______(Name of EOU/Project) from our depot at------THEIRICompany) Description______DEPOT have (name S: suppliesInvoice of authorized No. HSD to signatory M/s.Invoice ______(Name Dateof PSU OilQuantity Company) of EOU/Project) herebyValue declare from that our weTotal depot (name Duty at ------of paid the ______asDescription per Invoicedetails given No. below.Invoice Date Quantity Value Total(with Duty breakup paid Description Invoice No. Invoice Date Quantity Value ICompany) ______Total haveDuty (name paid supplies of authorized HSD to signatory M/s. ______(Name of PSU Oil Company) of EOU/Project) hereby declare from that our we depot (name at ------of the (withof components) breakup Company)______asDescription (with have breakup per supplies Invoicedetails given No. HSD below. to Invoice M/s. ______(Name Date Quantity of EOU/Project)Value from ourTotal depot Duty at------paid of components) (withof components) breakup ______asDescription per Invoicedetails given No. below.Invoice Date Quantity Value Total Duty paid (with of components) breakup Description Invoice No. Invoice Date Quantity Value Total(with Duty breakup paid of components) Disclaimer Description Certificate:Invoice No. Invoice Date Quantity Value Total(with Duty breakup paid (with of components) breakup Disclaimer Certificate: DisclaimerWe hereby certifyCertificate: that we are not claiming any deemed export benefits on the above supplies and we do not have any objection if ______(Name of EOU/Project) claims deemed export benefits. of components) We hereby certify that we are not claiming any deemed export benefits on the above supplies WeDisclaimer hereby and certifyCertificate: we do that not we are not claiming any deemed export benefits on the above supplies and we do not have any objection if ______(Name of EOU/Project) claims deemed export benefits. have any objection if ______(Name of EOU/Project) claims deemed export benefits.Disclaimer We hereby certifyCertificate: that we are not claiming any deemed export benefits on the above suppliesAuthorized and weSignatory do not have any objection if ______(Name of EOU/Project) claims deemed export benefits.Authorized Signatory WeDisclaimer Authorized hereby certifyCertificate: Signatory that we are not claiming any deemed export benefits on (Withthe above full suppliesname and and Designation) we do not have any objection if ______(Name of EOU/Project)l l claims l deemed export benefits.Authorized Signatory (With full nameWeDisclaimerhave hereby anyand objectionDesignation) certifyCertificate: that if ______we are not (Name claiming of EOU/Project) any deemed claimsexport deemedbenefits export on (Withthe benefits.above full namesupplies and and Designation) we do not (With full nameAuthorized and Designation) Signatory IDMAWehave hereby anyBulletin objection certify LI (36) that if22 ______towe 30 are September not (Name claiming of 2020 EOU/Project) any deemed claimsexport deemedbenefits export on the benefits.above suppliesAuthorized and weSignatory do not19 (With full name and Designation) have any objection if ______(Name of EOU/Project) claims deemed export(With benefits. full nameAuthorized and Designation) Signatory

(With full nameAuthorized and Designation) Signatory

Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 (With full nameDigitally and signed by MANOJ Designation) MANOJ KUMAR KUMAR VERMA and Published by the Controller of Publications, Delhi-110054. Date: 2020.09.23 22:53:08 Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New VERMA Delhi-+05'30'110064 Digitally signed by MANOJ Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi -110064 MANOJ KUMAR KUMAR VERMA Digitally signed by MANOJ and Published by the Controller of Publications, Delhi-110054. Date: 2020.09.23 22:53:08 MANOJ KUMAR KUMAR VERMA VERMA +05'30' and Published by the Controller of Publications, Delhi-110054. Date: 2020.09.23 22:53:08 VERMA +05'30' Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 Digitally signed by MANOJ MANOJ KUMAR KUMAR VERMA and Published by the Controller of Publications, Delhi-110054. Date: 2020.09.23 22:53:08 VERMA +05'30' Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 Digitally signed by MANOJ Digitally signed by MANOJ MANOJ KUMAR KUMAR VERMA MANOJ KUMAR KUMAR VERMA Date: 2020.09.23 22:53:08 and Published by the Controller of Publications, Delhi-110054. Date: 2020.09.23 22:53:08 and Published by the Controller of Publications, Delhi-110054. VERMA +05'30' VERMA +05'30' Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 Digitally signed by MANOJ MANOJ KUMAR KUMAR VERMA and Published by the Controller of Publications, Delhi-110054. Date: 2020.09.23 22:53:08 VERMA +05'30' Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 Digitally signed by MANOJ MANOJ KUMAR KUMAR VERMA and Published by the Controller of Publications, Delhi-110054. Date: 2020.09.23 22:53:08 VERMA +05'30'

PARLIAMENT NEWS In Lok Sabha & In Rajya Sabha

In Lok Sabha stimulus package and if so, the details thereof along with the future strategy likely to be adopted for Impact of Covid-19 Pandemic and reviving the economy of the country; Lockdown of Economy (e): whether the Government proposes to extend the Lok Sabha Unstarred Question No.20 period of moratorium and also to write off the interest of loans during the moratorium period considering the Shri Balubhau Alias Suresh Narayan Covid-19 and there is any demand for restructuring Dhanorkar: of loans and if so, the details thereof along with the Shrimati Mala Roy: steps taken in this regard; and (f): whether it has come to the notice of the Government Shri Benny Behanan: that it is impossible to pay the interest even after the Shri Asaduddin Owaisi: lifting the moratorium and if so, the action taken for protection from the penal actions of the banks and Shri N K Premachandran: financial institutions? Shri Kunwar Pushpendra Singh Chandel: Answered on 14th September 2020 Shrimati Sangeeta Kumari Singh Deo: A. (a): As per the Estimates of Gross Domestic Product Adv Adoor Prakash: for the First Quarter (Q1) of 2020-21 released by the National Statistical Office on 31st August 2020, Dr Jayanta Kumar Roy: the real GDP in India contracted by 23.9 percent Shri Syed Imtiaz Jaleel: during the first quarter of 2020-21 (as against a 5.2 percent growth in Q1 of 2019-20). On the Shri K Navaskani: demand side, private consumption spending fell by 26.7 percent and Investment demand also declined Will the Minister of be pleased to state; Q. FINANCE by 47.1 percent. On the supply side, the decline (a): the details of financial crisis in the country due to in Gross Value Added (GVA) was broad-based lockdown and restrictions imposed due to Covid-19 with fall of 50.3 percent seen in construction indicating the fall in economy in last quarter along followed by services like trade, hotels, transport with the sectors affected due to lockdown and unlock and communication, 2 manufacturing and mining. process and the action taken in this regard; Agriculture emerged as the bright spot, growing at a healthy rate of 3.4 percent. (b): the details and status of stimulus package including Atma Nirbhar Bharat and Pradhan Mantri Garib (b) to (d): The Government has announced a special Kalyan Yojana as announced and implemented economic and comprehensive package of Rs.20 lakh by the Government for various sectors/individuals crores, equivalent to 10% of India’s GDP to combat to overcome the economic slowdown, Sector-wise the impact of the COVID-19 pandemic in India. The along with their utilization and the manner in which details of the major components of the package along the Government is planning to raise funds for with the status are attached at Annexure. Under stimulus package; the “Aatma Nirbhar Bharat Abhiyan”, an additional Rs.40,000 crore has been allocated for MGNREGS (c): the details of assistance given to those who have to help generate nearly 300 crore person days lost their livelihood due to lockdown and the steps to address the need of work of returning migrant recently taken by the Government for the welfare of workers. Under Prime Minister Garib Kalyan Package the workers of unorganized sector; (PMGKP), financial assistance has been extended (d): whether the Government has analyzed the progress to building & construction workers (BoCW). 31 State of programmes and schemes implemented as and UT Governments have announced cash benefits,

IDMA Bulletin LI (36) 22 to 30 September 2020 20

ranging from Rs.1000/- to Rs.6000/- to around beneficiaries. 1.82 crore workers and total amount disbursed Ø Rs.10,325 crore credited to 20.65 crore (100%) women th is Rs.4987.18 crore as on 7 September, 2020. Jan Dhan account holders as first installment. Government of India launched a massive rural public works scheme ‘Garib Kalyan Rojgar Abhiyaan’ on Ø Rs. 10,315 crore credited to 20.63 crore (100%) June 20, 2020 to empower and provide livelihood women Jan Dhan account holders with second opportunities to the returnee migrant workers and installment. rural citizens. 25 schemes of the Government have Ø Rs.10,312 crore credited to 20.62 crore (100%) women been brought together under this programme and Jan Dhan account holders with third instalment. villages across 116 districts in the six states viz Ø Total Rs.2,814.5 crore disbursed to about 2.81 crore Bihar, Uttar Pradesh, Madhya Pradesh, Rajasthan, old age persons, widows and disabled persons, in Jharkhand, and Odisha through the Common two installments. Benefits transferred to all 2.81 crore Service Centres and Krishi Vigyan Kendras. A total beneficiaries in two installments. of 26.34 crore person days have been generated and expenditure of an amount of Rs.22,761.15 Ø 1.82 crore Building & construction workers received crore has been incurred under the programme as on financial support amounting to Rs.4,987.18 crore. 8th September 2020. The implementation of the Ø Under Pradhan Mantri Garib Kalyan Ann Yojana, package is reviewed and monitored regularly. 37.52 LMT of food grains has been distributed, to (e) & (f): The Reserve Bank of India has announced 75.04 crore beneficiaries in April 2020, 37.46 LMT certain regulatory measures wherein, in respect of distributed to 74.92 crore beneficiaries in May 2020, all term loans (including agricultural term loans, retail and 36.62 LMT distributed to 73.24 crore beneficiaries and crop loans) outstanding as on March 1, 2020, all in June 2020. Scheme was further extended for 5 lending institutions regulated by the Reserve Bank months till November. Since then, 98.31 LMT food were permitted to grant a moratorium of six months grains has been lifted by States/UTs so far. In July on payment of all instalments falling due between 2020, 36.09 LMT food grains has been distributed March 1, 2020 and August 31, 2020. Subsequently, to 72.18 crore beneficiaries, in August 2020, 30.22 the Reserve Bank of India has provided a framework LMT distributed to 60.44 crore beneficiaries, and to enable the lenders to implement a resolution in September 2020, 1.92 LMT distributed to 3.84 plan in respect of eligible corporate exposures crore beneficiaries as on 7th September, 2020. A without change in ownership and personal loans. total of 5.43 LMT pulses has also been distributed Under the Plan, lending institutions may, inter alia, to 18.8 crore beneficiaries between April – June grant moratorium upto two years. The Government 2020. 4.6 LMT Chana has been dispatched so far. has constituted an Expert Committee for making In July 1.03 LMT Chana has been distributed to 10.3 an overall assessment of the impact of waiving crore beneficiary households, in August 23, 258 MT of interest and waiving of interest on interest on distributed to 2.3 crore beneficiary households. As on the COVID-19 related moratorium on the national 7th September, 2020, 1475 MT of Chana distributed to economy and financial stability. 0.15 crore beneficiary households in September, 86 MT distributed to 0.008 crore beneficiary households Minister of State in the Ministry of Finance for October, and 40 MT distributed so far to 0.004 (Shri Anurag Singh Thakur) crore beneficiary households for November. Ø During the distribution period up to August, total 2.67 Annexure LMT of food grains was distributed to 5.32 crore, Pradhan Mantri Garib Kalyan Package (As per Press migrants. This works out to an average of about 2.66 Release dated 7th September, 2020): crore beneficiaries per month, which is nearly 95% of the estimated number of migrants. Total quantity of Around 42 crore poor people have received financial Chana distributed is 16,417 MT to 1.64 crore migrant assistance of Rs.68,820 crore so far, the details of which households, which is 82 Lakh households on an are as under: average per month. Ø Rs.17,891 crore front loaded towards payment Ø Total 8.52 crore Pradhan Mantri Ujjwala Yojana of the first instalment of PM-KISAN to 8.94 crore (PMUY) cylinders have been booked and already,

IDMA Bulletin LI (36) 22 to 30 September 2020 21

delivered for April and May 2020 under this Scheme Ø Rs 30,000 crore Special Liquidity Scheme for so far. 3.27 crore PMUY free cylinders delivered NBFCs/HFCs/MFIs: to beneficiaries for June 2020, 1.05 crore for July As per press release dated 24th July 2020, five 2020, 0.89 crore for August 2020, and 0.15 crore for proposals involving an amount of Rs.3090 crore September 2020. have been sanctioned as on 23rd July. Further, Ø 36.05 Lakh members of EPFO has taken benefit of 35 more applications have been received seeking online withdrawal of non-refundable advance from, financing upto Rs.13776 crore, which are under EPFO account amounting to Rs.9,543 crore. 24% process. EPF contribution transferred to 0.43 crore employees Ø For local MSMEs, Department of Expenditure amounting to Rs.2476 crore. Benefits for March were amended present Rule 161 (iv) of General Financial given to 34.19 lakh employees amounting to Rs.514.6 Rules (GFR), 2017 and GFR Rules relating to crore, for April given to 32.87 lakh employees Global Tenders. Now, no Global Tender Enquiry amounting to Rs.500.8 crore, for May given to 32.68 (GTE) shall be invited for tenders upto Rs.200 lakh employees amounting to Rs.482.6 crore, for crore, unless prior approval is obtained from Cabinet June given to 32.21 lakh employees amounting Secretariat. to Rs.491.5 crore, for July given to 30.01 lakh employees amounting to Rs.461.9 crore, and for Relief to Contractors: August given to 1.77 lakh employees amounting to Rs.24.74 crore. All central agencies like Railways, Ministry of Road Transport and Highways and CPWD will give Ø MNREGA: Increased rate has been notified w.e.f extension of up to 6 months for completion of contractual 01.04.2020. In the current financial year, 195.21 obligations, including in respect of EPC and concession crore person’s man-days of work generated. Further, agreements. On the invocation of Force Majeure Rs.59,618 crore released to states to liquidate pending Clause (FMC), contract period may be extended for a dues of both wage and material. period not less than three months and not more than Ø Under District Mineral Fund (DMF), States have been six months without imposition of any cost or penalty on asked to spend 30% of the funds, which amounts to the contractor/concessionaire. Instructions were also Rs.3,787 crore and that Rs.343.66 crore has been issued to return the value of performance security to the spent so far. contractor/suppliers proportional to the supplies made/ contract work completed to the total contract value. The Progress of Aatma Nirbhar Bharat Package – Progress same is being implemented by various Departments/ so far pertaining to Ministry of Finance and Ministry Ministries. of Corporate Affairs: Rs.30,000 crore Additional Emergency Working Ø Rs.3 lakh crore Collateral-free Automatic Loans Capital Funding for farmers through NABARD: for Businesses, including MSMEs and Rs.45,000 crore Partial Credit Guarantee Scheme 2.0 for New front loaded special refinance facility of Rs.30,000 NBFCs; crore was sanctioned by NABARD during COVID-19 to Ø As per press release dated 3rd September 2020, an RRBs & Cooperative Banks to benefit 3 crore farmers, amount of Rs.1.58 lakh crore has been sanctioned consisting mostly small and marginal farmers in meeting as on 31.8.2020 under the 100% Emergency Credit their credit needs for post-harvest and kharif sowing Line Guarantee Scheme (ECLGS), out of which requirements. Rs.24,876.87 crore out of Rs.30,000 crore more than Rs.1.11 lakh crore has been disbursed has been disbursed as on 06.07.2020, out of this special in 24 lakh accounts. Under Partial Credit Guarantee facility. Support to State Governments Borrowing limits of Scheme 2.0, Bonds/CPs of Rs. 25,055.5 crore have States has been increased from 3% to 5%, for 2020-21 been approved for purchase by Public Sector Banks in view of the unprecedented situation, which will give so far, out of which Rs.13,318.5 crore amounting to States extra resources of Rs.4.28 lakh crore. Additional more than 53% of the portfolio pertains to Bonds/CPs borrowing of 2 percent of projected GSDP will be given to rated below AA-, a crucial intervention for lower rated the States in 2020-21 subject to implementation of specific Bonds/CPs. State Level Reforms.

IDMA Bulletin LI (36) 22 to 30 September 2020 22

Rs.50,000 crore liquidity through TDS/TCS rate Rs.1 crore as the minimum amount of default for the reduction: purposes of the said section” vide Notification dated 24.06.2020. TDS rates for specified payments to residents and Ø Ministry of Corporate Affairs is finalising a special specified TCS rates were reduced by 25% for transactions insolvency resolution under section 240A of the made from 14th May, 2020 to 31st March, 2021. Code, to provide relief to the MSMEs and the same would be notified soon. Other Direct Tax Measures: Ø Insolvency and Bankruptcy Code (Amendment) Ø The Central Board of Direct Taxes (CBDT) has Ordinance, 2020 has been promulgated on issued refunds worth Rs.71,229 crore in more 5th June, 2020 thereby provided for insertion of than 21.24 lakh cases upto 11th July, 2020, to help Section 10A in the Insolvency and Bankruptcy Code taxpayers with liquidity in Covid-19 pandemic days, 2016 to temporarily suspend initiation of Corporate since the Government’s decision of 8th April, 2020 to Insolvency Resolution Process (CIRP) under Section issue pending income tax refunds at the earliest, as 7, 9 & 10 of the Code for a period of six months or stated in press release dated July 17, 2020. Income such further period, not exceeding one year from tax refunds amounting to Rs.24,603 crore have such date. been issued in 19.79 lakh cases to taxpayers and corporate tax refunds amounting to Rs.46,626 crore in 1.45 lakh cases have been issued to taxpayers Ban on Freebies to Doctors by during Covid days. Pharmaceutical Companies Ø The Department also issued Notification dated Lok Sabha Unstarred Question No: 2134 24.06.2020, the due date for income-tax return for FY 2019-20 (Assessment Year 2020-21) has P Velusamy: st been extended from 31 July, 2020 (for individuals Q. Will the Minister of HEALTH AND FAMILY WELFARE st etc) and 31 October, 2020 (for companies etc) to be pleased to state; 30th November, 2020. Further, the due date for furnishing of tax audit report has also been extended from existing (a): whether the Government has banned doling 30th September, 2020 to 31st October, 2020. out freebies, cruise tickets, paid vacations and sponsorships for educational conferences and Ø The Department of Revenue has extended the time seminars to doctors by Pharmaceutical companies barring date for assessments getting barred by from January 1, 2014, if so, the details thereof; limitation on 30th September, 2020 to 31st March, 2021. Payment without additional amount under (b): whether the Government is aware that Mumbai the "Vivad se Vishwas" Scheme will be extended to branch of the Income Tax Appellate Tribunal has 31st December, 2020 and the legislative amendments disallowed an allowance of Rs.76.55 lakhs paid by a for the same in the Vivad Se Vishwas Act, 2020 leading Pharma company, if so, the details thereof; (VsV Act) shall be moved in due course to time. (c): the steps taken by the Government to prevent such Further, through the Notifications, compliance dates kind of unethical practices followed by the Pharma mentioned under the VsV Act falling during period companies hitherto; and 20th March, 2020 to 30th December, 2020 have been (d): whether the Government is having any proposal to extended to 31st December, 2020. bring out specific comprehensive law in this regard, Enhancement of Ease of Doing business through IBC if so, the details thereof? related measures: Answered on 14th September 2020 Ø Ministry of Corporate Affairs has raised the threshold A. (a) The Department of Pharmaceuticals has informed of default under Section 4 of the IBC, 2016 to that the Government had prepared and announced Rs.1 crore (from the existing threshold of Rs.1 lakh) in year 2014 a Uniform Code for Pharmaceutical i.e. “in exercise of powers conferred under Section Marketing Practices (UCPMP) for stopping unethical 4 of Insolvency & Bankruptcy Code, 2016 (31 of practices employed by Pharma Companies for 2016), the Central Government hereby specified promoting sales of their medical products, on

IDMA Bulletin LI (36) 22 to 30 September 2020 23

12th December, 2014. It was sent to all the Pharma (c) & (d): The Uniform Code for Pharmaceutical associations for voluntary implementation with effect Marketing Practices (UCPMP) is voluntary in from 01.01.2015. nature and under UCPMP, there is no provision for Further, as per clause 6.8.1 of the Indian Medical Department of Pharmaceuticals to directly deal with Council (Professional Conduct, Etiquette and Ethics) complaints received regarding unethical practices. Regulations, 2002, a Registered Medical Practitioner As per UCPMP, any complaint received against a is not allowed to receive gifts, travel facilities, Pharmaceutical company is to be handled by an hospitality and cash/monetary grants. Ethical Committee for Pharma Marketing Practices (ECPMP) that is to be constituted in each of the (b): No. Pharmaceutical associations. Department has (c): The Department of Pharmaceuticals has been following up with the Pharma associations to informed that the Uniform Code for Pharmaceutical implement the code effectively. In this regard, this Marketing Practices (UCPMP) is voluntary in department has also taken multiple meetings with nature and under UCPMP, there is no provision for the Pharmaceuticals associations and most of the Department of Pharmaceuticals to directly deal with associations have put UCPMP on their websites and complaints received regarding unethical practices. constituted the Committees for handling complaints As per UCPMP, any complaint received against regarding breach of UCPMP. a Pharmaceutical company is dealt by an Ethical Minister in the Ministry of Chemicals & Fertilizers Committee for Pharma Marketing Practices (ECPMP) (Shri D V Sadananda Gowda) constituted in the Pharmaceutical associations. (d) No. Draft Environmental Impact The Minister of State in the Ministry of Health and Assessment (EIA) Notification, 2020 Family Welfare (Shri Ashwini Kumar Choubey) Rajya Sabha Unstarred Question No.76 In Rajya Sabha Smt Shanta Chhetri: Uniform Code for Pharmaceutical Q. Will the Minister of ENVIRONMENT, FOREST AND CLIMATE CHANGE be pleased to state; Marketing Practices (UCPMP) (a): Whether the Draft Environmental Impact Assessment Rajya Sabha Unstarred Question No. 702 (EIA) Notification, 2020 legitimises ex-post facto Shri Jyotiraditya M Scindia: environmental clearances and encourages industries with no prior clearance to commence operations Q. Will the Minister of Chemicals and Fertilizers and eventually get regularized by paying a penalty be pleased to state; amount (Clause 22); (a): whether Government had decided to make a Uniform (b): Whether draft EIA Notification allows only project Code for Pharmaceutical Marketing Practices proponents and Government authorities to officially (UCPMP) mandatory; report cognisance of violations (Clause 22 (1)) and (b): if so, the present status of the UCPMP; non compliance of conditions (Clause 23 (1)), curbing the rights of any other concerned or affected person; (c): whether the implementation of voluntary code has and not shown any results and unethical practices have increased and; (c): If so, the details thereof; if not, the reasons (d): if so, the corrective steps that Government proposes therefor? to take in this regard? Answered on 14th September 2020 th Answered on 18 September 2020 A. (a) to (c): No Sir. The draft EIA Notification 2020 A. (a): No Sir. does not provide for ex-post facto clearance to (b): In view of reply to (a) above, the question does cases that have commenced operations without prior not arise. environmental clearance. Clause 22 (14) of the draft EIA Notification 2020 clearly specifies that the project

IDMA Bulletin LI (36) 22 to 30 September 2020 24

proponent is liable for action under Section 19 of the Shri Kanakamedala Ravindra Kumar: Environment Protection Act 1986 for the violations committed by it. In addition, the draft Notification Q. Will the Minister of Micro, Small and Medium also lays down additional liability on the project Enterprises be pleased to state; proponent for causing damage to the environment (a): whether Government is aware of the fact that due through assessment of environment damage caused, to announcement of nation-wide lockdown in the remedial plans and community augmentation plan country w.e.f. 25th March, 2020 the Micro, Small and (reference clause 22(5) of the draft Notification). Medium Enterprises (MSME) sector was severely The Environment Clearance shall be granted only affected across the country particularly in the State prospectively as also held by the Hon’ble Supreme of Andhra Pradesh; Court in the case of Common Cause V/s Union of India. The draft EIA Notification 2020 is based on the (b): if so, the details thereof; following guiding principles: (c): whether Government has initiated any steps to (1): Various court decisions have directed the help/revive the MSME sectors which were severely Government to consider violation cases on affected due to nation-wide lockdown; merit and it has held that closure is not an (d): if so, the details thereof; and option. (e): if not, the reason therefor?

(2): All entities, not complying with environmental th regulations, be brought under regulatory ambit Answered on 14 September 2020 in an expedient manner; A. (a) & (b): Yes Sir. Various sectors including MSME Sector has been affected temporarily by nation-wide (3): Establish a process for appraisal of violation lockdown in the country including Andhra Pradesh. cases so as to prescribe requisite environmental safeguards; (c) to (e): The Ministry of MSME implements various schemes and programmes for growth and development (4): Process should deter future violations. of MSME Sector in the country. These schemes and (5): ‘Principles of Proportionality’ and ‘Polluters programmes include Prime Minister’s Employment Pays’ principles as enunciated by Hon’ble Generation programme (PMEGP), Scheme of Fund Courts has been followed. for Regeneration of Traditional Industries (SFURTI), A Scheme for Promoting Innovation, Rural Industry The draft EIA Notification 2020 does not curb the right of & Entrepreneurship (ASPIRE), Interest Subvention any concern or affected person to report cases of violation. Scheme for Incremental Credit to MSMEs, Credit Clauses 22 (1) and 23 (1) of the Draft EIA Notification, 2020 Guarantee Scheme for Micro and Small Enterprises, mention that the cognizance of violation or non-compliance Micro and Small Enterprises Cluster Development shall be made on the basis of (a) Suo-moto application of Programme (MSE-CDP), Credit Linked Capital project proponent, (b) Report by any Government authority, Subsidy and Technology Upgradation Scheme (c) Violation/Non-compliance found during the appraisal (CLCS-TUS). Recently, Post Covid-19, Government by appraisal committee or while during processing of has taken a number of initiatives under Aatma Nirbhar applications by any Regulatory Authority. The public, Bharat Abhiyan to support the MSME Sector in the NGOs and other affected persons can approach any of the country especially in Covid-19 pandemic. Some of Government authorities, who after preliminary verifications, them are: can refer the matter to the Ministry or respective States for taking action in the matter. (i): Rs 20,000 crore Subordinate Debt for MSMEs. Minister of State in the Ministry of Environment, (ii): Rs.3 lakh crores Collateral free Automatic Loans Forest and Climate Change (Shri Babul Supriyo) for business, including MSMEs. Steps for revival of MSME sector (iii): Rs.50,000 crore equity infusion through MSME Fund of Funds. due to COVID-19 Pandemic (iv): New revised criteria for classification of Rajya Sabha Unstarred Question No.121 MSMEs.

IDMA Bulletin LI (36) 22 to 30 September 2020 25

(v): New Registration of MSMEs through ‘Udyam on the total number of jobs lost in the MSME sector. Registration’ for Ease of Doing Business. However, the Ministry held a number of consultations (vi): No global tenders for procurement up to Rs.200 with various MSME/Industry Associations of the crores, this will help MSME. country. During the deliberations, certain problems were highlighted by stakeholders. This included need An online Portal “Champions” has been launched on for easy finance, more liquidity, moratorium on loans, 01.06.2020 by Hon’ble Prime Minister. This covers many etc. aspects of e-governance including grievance redressal (c): As per RBI’s Covid-19 Regulatory Package dated and handholding of MSMEs. Through the portal, total March 27, 2020, RBI had permitted moratorium 18,723 grievances have been redressed upto 09.09.2020. of three months on payment of all installments/ RBI has also announced several measures to Reduce interest falling due between March 1, 2020 and Financial Stress of MSMEs. May 31, 2020. RBI, again, on May 22, 2020 had Minister of Micro, Small and Medium Enterprises extended moratorium on repayment of loans/ (Shri Nitin Gadkari) interest for another 3 months till August 31, 2020 along with Asset Classification standstill during this Support to MSMEs in light of COVID-19 period. (Total 6 months moratorium starting from March 1, 2020). In addition, RBI vide its Notification Pandemic dated August 6, 2020 on restructuring of advances Rajya Sabha Unstarred Question No.130 related to MSME sector, has extended the one-time restructuring window upto March 31, 2021 for the Shri Binoy Viswam: existing loans to MSMEs upto Rs.25 crore, classified Q. Will the Minister of Micro, Small and Medium as ‘standard’ as on 01.03.2020 without a downgrade Enterprises be pleased to state: in the asset classification. (a): whether Government has conducted a research on Further, as per RBI’s Notification dated August 6, the impact of COVID-19 on the Micro, Small and 2020 on Resolution Framework for COVID-19-related Medium Enterprises (MSMEs) sector the country, if stress, in respect of eligible corporate exposures so, the details thereof; exceeding Rs.25 crore, the Resolution framework permits lenders to allow moratorium up to two years, (b): the total number of jobs lost in the MSME sector due as per their Board approved policy, depending on the to the COVID-19 Pandemic; merits of the case. (c): whether Government plans to extends the moratorium (d): As per data reported by Member Lending given by RBI to enterprises in MSME sector on Institutions (MLIs), an amount of Rs.1,63,103 repayment of loans; and crore has been sanctioned to 42,01,060 borrowers (d): the number of MSMEs which have availed loans and an amount of Rs.1,17,885 crore disbursed to under the emergency provisions announced by 25,01,216 borrowers under the Emergency Credit Government as part of the ‘Atmanirbhar’package? Line Guarantee Scheme (ECLGS) as on September Answered on 14th September 2020 9, 2020. A. (a) & (b): No formal research has been conducted Minister of Micro, Small and Medium Enterprises on the impact of COVID-19 on the MSME sector and (Shri Nitin Gadkari) l l l

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IDMA Bulletin LI (36) 22 to 30 September 2020 26

new Developments

T cells take the lead in controlling protective antibodies; and killer T cells (CTL), which seek SARS-CoV-2 and reducing COVID-19 out virus-infected cells and eliminate them. disease severity For their latest study, the researchers collected blood samples from 50 COVID-19 patients and analyzed all three Ever since SARS-CoV-2 first appeared, researchers branches of the adaptive immune system - SARS-CoV-2 have been trying to understand whether sometimes the specific antibodies, helper and killer T cells - in great detail. immune system does more harm than good during the “It was particularly important to us to capture the whole acute phase of COVID-19. The latest study by researchers range of disease manifestation from mild to critically ill so at La Jolla Institute for Immunology clearly argues in we could identify differentiating immunological factors,” favor of the immune system. Their work, published in the says co-first author and infectious disease specialist September 16, 2020, online issue of Cell, confirms that a multi-layered, virus-specific immune response is important Sydney Ramirez, M.D., Ph.D., who spearheaded the sample for controlling the virus during the acute phase of the collection. infection and reducing COVID-19 disease severity, with What the team found was that similar to their previous the bulk of the evidence pointing to a much bigger role for study all fully recovered individuals had measurable antibody, T cells than antibodies. A weak or uncoordinated immune helper and killer T cell responses, while the adaptive immune response, on the other hand, predicts a poor disease response in acute COVID-19 patients varied more widely outcome. The findings suggest that vaccine candidates with some lacking neutralizing antibodies, others helper or should aim to elicit a broad immune response that include killer T cells or any combination thereof. antibodies, helper and killer T cells to ensure protective immunity. “When we looked at a combination of all of our data across all 111 measured parameters we found “Our observations could also explain why older that in general, people who mounted a broader and COVID-19 patients are much more vulnerable to the disease,” says senior author Shane Crotty, Ph.D., who well-coordinated adaptive response tended to do better. A co-led the study with Alessandro Sette, Dr Biol.Sci., strong SARS-CoV-2 specific T cell response, in particular, both Professors in LJI’s Center for Infectious Disease and was predictive of milder disease,” says co-first author Vaccine Research. “With increasing age, the reservoir of and postdoctoral research Carolyn Moderbacher, Ph.D. T cells that can be activated against a specific virus “Individuals whose immune response was less coordinated declines and the body’s immune response becomes less tended to have poorer outcomes.” coordinated, which looks to be one factor making older The effect was magnified when the researchers broke people drastically more susceptible to severe or fatal down the dataset by age. “People over the age of 65 were COVID-19.” much more likely to have poor T cell responses, and a poorly Adds Sette, “What we didn’t see was any evidence coordinated immune response, and thus have much more that T cells contribute to a cytokine storm, which is more severe or fatal COVID-19,” says Crotty. “Thus, part of the likely mediated by the innate immune system.” When massive susceptibility of the elderly to COVID-19 appears SARS-CoV-2 (or any other virus) infiltrates the body, the to be a weak adaptive immune response, which may be innate immune system is first on the scene and launches a because of fewer naïve T cells in the elderly.” broad and unspecific attack against the intruder. It releases waves of signaling molecules that incite inflammation and Naïve T cells are inexperienced T cells that have not alert the immune system’s precision forces to the presence met their viral match yet and are waiting to be called up. of a pathogen. As we age, the immune system’s supply of deployable naïve T cells dwindles and fewer cells are available to be Within days, the so-called adaptive immune system activated to respond to a new virus. “This could either lead tools up and moves with pinpoint precision against the to a delayed adaptive immune response that is unable to virus, intercepting viral particles and killing infected cells. control a virus until it is too late to limit disease severity The adaptive immune system consists of three branches: or the magnitude of the response is insufficient,” says antibodies; helper T cells (Th), which assist B cell to make Moderbacher.

IDMA Bulletin LI (36) 22 to 30 September 2020 27 In line with what other research teams had found Kochi-based Pharma Company is set to begin Clinical Trials before, antibodies don’t seem to play an important role in on patients suffering from the disease next-week. controlling acute COVID-19. Instead, T cells and helper T Balaram said the company received approval from cells in particular are associated with protective immune the Drug Controller General of India (DCGI) on Friday, responses. “This was perplexing to many people,” says 18.09.2020 to conduct phase 2b Clinical Trial of their Crotty, “but controlling a primary infection is not the same proprietary drug PNB-001 (GPP-Baladol). He said the as vaccine-induced immunity, where the adaptive immune molecule is capable of treating fever, body pain and lung system is ready to pounce at time zero.” infection - conditions normally associated with Covid-19. If a vaccination is successful, vaccine-induced According to Balaram, the company had proposed antibodies are ready to intercept the virus when it shows up testing the drug on two sets of people - one group that at the doorstep. In contrast, in a normal infection the virus would consume only PNB’s proprietary drug and another gets a head start because the immune system has never that would consume it along with other drugs to treat seen anything like it. By the time the adaptive immune these other conditions. However, the Government declined system is ready to go during a primary infection, the virus permission for it and, hence, the Clinical Trials will be has already replicated inside cells and antibodies can’t get done on patients who will also be consuming other drugs to it. “Thus, these findings indicate it is plausible T cells for their other conditions and symptoms. are more important in natural SARS-CoV-2 infection, and antibodies more important in a COVID-19 vaccine,” says “This is the first chemical entity in the phase Crotty, “although it is also plausible that T cell responses 2 chemical trial in the world,” he said. “If it works, it will against this virus are important in both cases.” be a miracle molecule. We think it will give a much better effect than dexamethasone or any other steroids. This is Source: La Jolla Institute for Immunology, Science Daily, also a very safe molecule because just a 100mg capsule is 16.09.2020 (Excerpts) required to get the effect on patients. We are planning to l l l complete the whole phase-II Clinical Trial within 60 days as the Government is speeding up the approval process Kochi-based Company to start Phase and recruiting patients may not be a big problem,” he said. 2b trials of COVID drug next week The study will be conducted on 40 Covid-19 patients at Pune’s BMJ Medical College who are moderate patients PNB Vesper Life’s Chief Executive P N Balaram on oxygen support. is upbeat the company’s experimental drug PNB-001 will be effective in treating symptoms of Covid-19. The Source: The Economic Times, 20.09.2020 (Excerpts)

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National News

Indian Pharma sector set to emerge 11-12 percent when compared to 10 percent during the last stronger due to higher Exports fiscal. The report observes that the operating profitability for around 350 Pharmaceutical companies rated by CRISIL The Growth in exports will be around 11-12 percent, representing 70 percent of the sector revenue, would says a CRISIL Report soften by 100-150 bps but remain healthy at 19 percent Higher exports are likely to help the Indian Pharma despite higher input prices for drug manufacturing. Credit sector to garner upto eight to nine percent growth this profiles of Pharma companies will continue to be supported fiscal. It is expected that the Rs. 2.8 lakh crore Indian by healthy balance sheets. Interestingly the export pie is Pharmaceutical Sector is set to emerge stronger due to divided into regulated markets such as the US and Europe higher exports despite the COVID-19 pandemic this fiscal. (45 percent), Rest of World (ROW) markets (35 percent) A report by CRISIL says that the Indian Pharma Sector is and bulk drugs (20 percent). It is expected that exports well-diversified with exports and domestic formulations accounting for almost equal share. The report points growth will remain strong at 10 and above in each of the out that this fiscal, the growth in exports will be around segments in the current fiscal.

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The growth in the regulated markets will be supported It is expected that despite the slight moderation by steady increase in new product launches from compliant in business performance, credit profiles of domestic plants that will lower pricing pressure on existing generics, companies would remain largely steady, benefiting from and a visible easing in scrutiny by the United States Food healthy balance sheets and liquidity. Equity infusions and Drug Administration (US FDA) in recent months. from private equity funds have also helped improve “India accounted for almost half the Abbreviated New credit metrics in recent times. Experts at CRISIL expect Drug Application Approvals provided by the US FDA since an increase in Capital and Research and Development fiscal 2019. This strong pipeline, coupled with lower import spending, as well as efficient working capital management alerts and warning letters in recent months, should ensure will enable Indian Pharma companies to manage transition a steady pace of new launches, which will help sustain through the current challenging times. However there are export momentum to regulated markets,” remarked Isha challenges as a few large Indian pharmaceutical companies Chaudhary, Director, CRISIL Research. are facing antitrust suits in the US and any unanticipated litigation costs or adverse developments such as increased At the same time exports to ROW markets, too, US FDA scrutiny impacting new product launches will be are expected to rebound to 10 percent compared with monitorables. 7 percent this fiscal that will be driven by opportunities in under penetrated generic markets such as Africa and Source: Abhinav Singh, The Week, 24.09.2020 Latin America. Also, bulk drug exports are expected to l l l benefit from moves worldwide to reduce dependence on China. Experts at CRISIL on a query from THE WEEK Incentives not enough, Bulk Drug on the increase in raw material prices by China and that impacting Indian Pharma players said that although industry seeks level playing field there has been an increase in raw material prices from to make India ‘Atma Nirbhar’ China, Pharma players are able to pass on the rise in The PLI package announced in July for 53 bulk drugs prices. offers financial incentives to domestic manufacturers Also diversification of supply chain from China and Even as the Narendra Modi Government hopes to see a dual sourcing strategy (China plus India) has opened new tremendous response for its Production Linked Incentive (PLI) scheme for Greenfield bulk drug manufacturing opportunities for players, supporting revenue and margin projects, the domestic Pharmaceutical industry fears that growth. Some bulk drug players have also allocated their the incentives alone may not be enough to ward off Chinese capacities and resources to more profitable products. Export imports that turned manufacturing of several key bulk drugs demand for both formulation and bulk drugs is strong owing unviable in the first place. to COVID-19. The PLI (Performance-Linked Incentive) scheme, announced recently by the Government to boost “The scheme seems to be encouraging and there is a domestic bulk drug manufacturing, aims at reducing import possibility that people will come forward with a positive dependence. However, it will come to fruition only in the state of mind. But, apprehensions remain. First of all, there medium to long term. is a very strong chance that China may dump these products at a much lesser price once India starts production. Unless “Higher exports should offset some of the reduction countered with very quick anti-dumping measures, it may in domestic formulation sales because of pandemic led turn the production of such items unsustainable for Indian disruptions, especially in the acute therapies segment. At industry. There is a need for a written assurance from the the same time, lower footfalls in hospitals and fewer field Government that quick action by way of anti-dumping visits by medical representatives have affected prescription investigations and anti-dumping duty will be taken in such based sales in acute therapies, as evident from the steep cases” says B R Sikri, Chairman of Federation of Pharma moderation in the first quarter sales of anti-infectives and Entrepreneurs (FoPE). gastro-intestinal drugs. On the other hand, a steady demand He said concerns have been flagged and the Government for chronic therapies pertaining to lifestyle diseases should is seriously considering the industry proposal to provide help keep domestic formulation sales growth at around additional protection. The PLI package announced in July 5 to 6 percent,” said Tanvi Shah, Associate Director, for 53 bulk drugs (raw materials for medicine production) CRISIL Ratings.

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offers financial incentives to domestic manufacturers these products on the list immediately. “All that the based on sales for 41 specific products (which cover all 53 Government needs to do is put a condition that whatever bulk drugs that are heavily import-dependent) in a graded such companies are manufacturing today, that should manner for six years. not be discontinued. A declaration that the company is producing so and so products...so and so capacity...and it The Government will select two to four companies for each product, depending on the bids manufacturers will continue. Any additional capacity within the existing offer. The deadline to apply is November end. Sikri also infrastructure, used for the production of the items in the said the industry is doubtful if the entire quantum of PLI list, should be incentivised. incentive announced by the Government will be available Among the chemical synthesis products, 60 to to the manufacturer due to conditionalities attached to 70 percent products can be manufactured from tomorrow the scheme. “Though the Government is saying there is a if that happens,” he said. Sikri points out the members 10 percent incentive for chemical synthesis products and of apex industry associations like IDMA (Indian Drug 20 percent incentive for fermentation-based products, Manufacturers’ Association) and BDMA (Bulk Drug the actual incentive for at least some products may be Manufacturers’ Association) have informed that they are 4 percent or less,” Sikri said. willing to start production. “For instance, the current market rate of Meropenem, one of the products in the list, is Rs.68,000 per kg. The However, it is not viable today because they can’t scheme stipulates that the industry sets up a unit of match the costing of Chinese imports. “The PLI scheme, 10-tonne annual capacity to avail concessions under the no doubt, is a timely decision and Atma Nirbhar Bharat scheme. Theoretically, if I produce and sell 10 tonnes scheme will give a chance to our industry to shine. The of Meropenem, my turnover is going to be Rs.68 crore overall industry seems to be happy, it’s just that if the annually. Hence, according to the scheme, I am eligible Government can give incentives for existing manufacturers, for 10 percent of the turnover or Rs.6.8 crores as an India’s self-reliance in bulk drugs will improve tomorrow incentive,” Sikri said. itself,” he adds. He added that it’s where it hurts. “The fine print of Source: Business Today, 26.09.2020 the PLI scheme puts a limit for incentive, which is either l l l Rs.2.5 crore or 10 percent of the turnover, whichever is less. There are many products where the issue is similar. It erodes the attractiveness of the scheme,” he adds. India’s World Bank Executive Director The industry is also worried that the sale price (based named New Pharma Secretary on which the cost calculation happens) remain frozen IAS Officer S Aparna, upwards once you quote a price at the time of applying who was serving as the for the scheme. “Tomorrow, if the price goes down, the World Bank’s Executive Government will give less incentive, but if it goes up, Director from India, the incentive will continue to be decided based on the has been appointed declared price,” he said. a s n e x t S e c r e t a r y, Pharmaceuticals, under This is also a problem as the cost of inputs remains the Ministry of Chemicals dynamic, he added. “How can I factor in the changes in and Fertilisers, and will take over after the retirement of chemical prices, other inputs, power tariffs, manpower cost, incumbent Dr P D Vaghela, an official statement said on and economic circumstances of the future while quoting Friday, 18.09.2020. Dr Vaghela’s superannuation date is the price? In short, there are impractical and unrealistic September 30. demands too. The overall enthusiasm will receive a big A 1988-batch IAS officer of the Gujarat cadre, Aparna boost if the Government looks at such operational issues,” was appointed an Executive Director to the World Bank, Sikri said. representing the constituency of India, Bangladesh, According to FOPE Chairman, the existing manufacturers Bhutan, and Sri Lanka in August 2017, and her three-year have the capacity and technology to produce some of stint ended this year.

IDMA Bulletin LI (36) 22 to 30 September 2020 30 Aparna, 56, has held several top positions in Gujarat, Dr Bhargava answered in view of the draft Guidelines including Principal Secretary, Economic Affairs, and Surat published by the Central Drugs Standard Control Municipal Commissioner, while she has also served as Joint Organisation (CDSCO) for the development of a vaccine Secretary, Urban Development at the Centre. with special consideration for the COVID-19 vaccine. The draft Guidelines further say that the Pharma companies Source: IANS.Ommcom News, 19.09.2020 for a statistical final analysis plan finalised before closing l l l the trial database and unblinking treatment assignments (if these were blinded). “This should include any planned DCGI’s new Guidelines for Covid-19 interim analyses, which should be adequately addressed in vaccine: At least 50 percent efficacy terms of purpose, timing, and any statistical adjustments required.” in Phase 3 Trials If a trial fails to meet the predefined criteria for On the lines of the World Health Organization (WHO) and superiority and/or non-inferiority with respect to any of the US Food and Drug Administration (US FDA), the Drugs the antigenic components, the possible reasons for the Controller General of India (DCGI) has issued a new set of result and the clinical implications it should be carefully Guidelines for Covid-19 vaccine candidates, focussing on considered before proceeding with clinical development safety, immunogenicity and efficacy parameters. or licensure, noted the Guidance. Safety assessments The Drugs Controller General of India (DCGI) has throughout clinical development and all pregnancies in issued a new set of Guidelines, focusing on safety, study participants for which the date of conception is prior immunogenicity and efficacy parameters for Pharma giants to vaccination or within 30 days after vaccination should who are developing COVID-19 vaccines. The DCGI has said be followed for pregnancy outcomes, including pregnancy that a COVID-19 vaccine candidate should have at least loss, stillbirth, and congenital anomalies, it said. 50 percent of efficacy in the Phase-III Clinical Trial for it COVID-19 vaccine trials should periodically monitor to be widely deployed and adequate data informing the for unfavorable imbalances between vaccine and control potential risk of vaccine-associated Enhanced Respiratory groups in COVID-19 disease outcomes, in particular for Disease (ERD) needs to be generated. cases of moderate to severe COVID-19 that may be a The comprehensive draft regulator Guideline for the signal for vaccine-associated ERD. Studies should include development of a vaccine with special consideration for pre-specified criteria for halting based on signals of the COVID-19 vaccine provides Guidance to the vaccine potential vaccine-associated ERD. It has also recommended developers to ensure that — vaccines are well characterised the Pharmaceutical companies to use an independent Data and manufactured consistently. The Guidance reads that Safety Monitoring Board (DSMB) for vaccine-associated considering the urgent need for a safe and effective vaccine ERD and other safety signal monitoring, especially during for prevention of COVID-19, clinical development programs later-stage development. of the COVID-19 vaccine may proceed through an adaptive Source: ANI, newsx.com, 23.09.2020 and seamless approach including data to inform the potential risk of vaccine-associated ERD will be needed. l l l The document has highlighted that the use of COVID-19 preventive vaccines in pregnancy and in women Indian Pharma needs regulatory of childbearing potential is an important consideration surveillance system for disposal for vaccination programs. “There are three things for a of unused & date expired drugs: vaccine – (i) the safety, (ii) immunogenicity, and (iii) the Dr Jagashetty efficacy. Even, WHO says that if we can get more than 50 percent efficacy that is an accepted vaccine. For Indian Pharma needs a regulatory surveillance in respiratory viruses, we never get 100 percent efficacy. We are place to monitor the disposal of unused and date expired aiming for 100 percent efficacy but may get 50-100 percent,” drugs. Currently, in the absence of any rules under the Dr Balram Bhargava, ICMR, Director-General said on Drugs & Cosmetics Rules, disposal is guided by the Tuesday, 22.09.2020 while responding to a query on the Biomedical Waste Management Rules under State Pollution efficacy of COVID-19 vaccine. Control Board (SPCB) norms, said Dr B R Jagashetty,

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former National Adviser (Drugs Control) to Union Health Ayurveda offers myriad approaches to Ministry. pandemics and all infectious diseases: It is high time the D&C Act includes a schedule or Dr Ram Manohar a dedicated guidance for proper disposal of unused and date expired drugs. Rule 65(17) of D&C Rules only states While modern medicine is struggling to come up about not to sell such drugs and to keep aside with proper with a solution for epidemics like COVID-19, Ayurveda labeling till its disposal, but does not provide any procedure offers myriad approaches to pandemics and all infectious for disposal of such drugs. However, it follows the norms diseases. The classical clinical narrations specified in prescribed under Biological Waste Management Rules, Ayurveda need to be repurposed with the Guidance of he added. learned Ayurveda Practitioners for the medical management of COVID-19. The D&C Act Schedule P provides the life period of certain drugs and Rule 96 calls to mention the date of There is no particular drug for curing COVID in expiry on its label as per said schedule. If it is not found Ayurveda, but there are preventive and curative measures under Schedule P, then the date of expiry on the label for any kind of such pandemic and it has to be applied of drug shall not exceed 60 months from the date of accordingly, said Dr Ram Manohar, Director of Research, manufacture, provided this period may be extended by School of Ayurveda at the Amrita University in Kerala. the Central Licensing Authority if satisfactory evidence is “There is no simple solution prescribed in Ayurveda produced by the manufacturer, said Dr Jagashetty. to cure COVID-19 or any viral disease, but there is a This procedure for disposal of date expired drugs needs comprehensive approach to treat infectious diseases to be issued by the CDSCO either as a separate schedule and they have to be applied after repurposing them with to D&C Rules or in the form of Guidelines. Going by the the Guidance of modern Ayurveda Practitioners,” he profusion of formulations marketed in India, there is a commented. need for a separate schedule to be included in the D&C Participating in an online international seminar Act or dedicated Guidelines. To this end, it is learnt that on Ayurveda organized by a German team of Ayurveda various sub-committees were formed under DCC which have Practitioners from Frankfurt, Dr Ram Manohar said the submitted their recommendations however, the decision is traditional system of Ayurveda is well-equipped with its pending, Dr Jagashetty told. classical formulations by which even 98% of all infectious The current practice by Pharma companies to dispose diseases are getting cured. If the good clinical care date expired and unused medicines include returning protocols specified in Ayurveda are applied in conditions of to manufacturer, landfill, and waste immobilization: diseases, even the present pandemic can be cured without encapsulation/inertization, flushing it down the sewer and waiting for research for medicines for Coronavirus disease. incineration. Despite precautions associated with these Ayurveda has no magical vaccine to stop viral infection at methods, these methods are not that effective, he noted. once, but the formulations specified there can cure even What we need is a surveillance system to monitor the any deadly viral disease, he claimed. disposal of such drugs. This is when the Government brought Apart from medicines, the traditional system in the Track and Trace system to ensure transparency of encourages sleep and exercise as other tools to fight drug dispatch from manufacturers to chemists and its against diseases and to develop immunity in humans. disposal of such unused and date expired drugs. It will also For this, each person of the modern day has to correct prevent entry of spurious drugs into the market as the entire his lifestyle and physical activities. Ayurveda cannot inventory will be monitored. The manufacturers should keep recommend one medicine for COVID-19, but a clinical track of the drugs including those of disposal across the understanding based on traditional knowledge in the supply chain from the distributor to the pharmacy retail. Indian system is necessary to find new medicines for In the absence of guidance, disposal of expiry dated drugs viral diseases like COVID and to contain the spread of is a problem, he said. the pandemic. It is the collective responsibility of all Source: Nandita Vijay, Pharmabiz, 21.09.2020 concerned to address infectious diseases. He said even the developed countries which have accessed good l l l healthcare have now been affected by the epidemic.

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According to Dr Manohar, the future healthcare system It has excellent road and air connectivity because 15 will be a healthcare of self-responsibility rather than a national highways are present in Haryana with four of them system that envisages health for all. He said ‘Rasayanas’ passing through the Delhi-NCR region and has international prescribed in Ayurveda helps to boost immunity in airports in its vicinity, at Delhi and Chandigarh. However, people of all ages. In the international webinar, quoting he also raised concerns that the evaluation criteria of the Charakasamhita, the Ayurveda Research Director said bulk drug parks seem to be favouring the coastline states. pandemic like COVID-19 is the effect of affliction of vayu He said that the state has slipped from its ranking of ease (air), jala (water), desa (land) and kaala (time). With the of doing business and will be losing the three points for influence of these factors one disease can affect a large coastal preference in the selection criteria. number of people simultaneously. As per Charakasamhita He stated, “We do not understand why the coast has there is a reason to consider modern day epidemics been given the advantage in the detailed Guidelines of like SARS, MERS, Swine Flu, Ebola and COVID-19 as Bulk Drug Parks when only 11 states in the country have a ‘Janapadodhvamsaka’ disease. Janapadodhva? saka refers coastline.” He said that during the Britishers’ time the ports to epidemic among large number of people happening used to play an important role in the movement of goods but simultaneously. now the situation is not the same. And it is something that cannot even be created. He said that the state is looking “Charaka says that available medicines will not work forward to a fair evaluation in the selection criteria. on the epidemic. Medicines have to be specially prepared with high potency by anticipating epidemics. Cleansing N K Ahuja, Haryana State Drug Controller highlighted therapies and immune stimulating medicines should also the Pharma Policy of Haryana, which has been drafted be administered in addition to the available medicines,” in consultation with all stakeholders. He added that said Dr Manohar who is part of the German Ayurveda the regulatory policy of Haryana acts as a friend, academy for the last 20 years. philosopher and guide and its focus is to handhold and encourage entrepreneurs in the State. Presenting the Source: Peethaambaran Kunnathoor, Pharmabiz, 21.09.2020 industry’s expectations, B R Sikri, Vice President, Bulk Drugs Manufacturers Association of India stressed that l l l transparency, ease of doing business, location of all concerned offices in the park, single window system and Haryana showcases readiness to bid for deemed approval, competitive land cost etc., will go a long Bulk Drugs and Medical Device Parks way in the success of proposed parks in Haryana. at PHDCCI webinar Mohit Jain, Chairman, Haryana State Chapter PHDCCI, The Haryana State Industrial and Infrastructure appreciated the Haryana Government’s move to boost Development Corporation (HSIIDC) is ready to bid for the the Pharmaceutical sector in the State by launching a central Government announced bulk drug and medical dedicated Haryana Pharmaceutical Policy 2019. A K Singh, device parks. It has acquired 1000-acre land in Panipat for Principal Secretary, Industries and Commerce, Government a proposed bulk drug park and is in the process of acquiring of Haryana also informed that there is a big scope for the more land. The state Government is also proposing to set Pharma industry in Haryana as the State has an attractive up a medical devices park in Karnal. industrial policy, titled Enterprise Promotion Policy. In the recently held webinar organised by the PHD He said that the policy will now lay stress on employment too. He said that for designing the bulk drug park in Panipat Chamber of Commerce and Industry (PHDCCI) on “The it has entered into an MoU with NIPER Mohali for setting Future of Pharma Industry”, the authority informed up a research unit. It is also aiming to sign 10 more MoUs that the proposed bulk drug park will be designed and with the industry for research collaborations. Responding to equipped keeping all the industry requirements for ease the query on the coastline, Navdeep Rinwa, Joint Secretary, of doing business. Anurag Aggarwal, MD, HSIIDC said that Department of Pharmaceuticals, Government of India said Haryana is ideal for setting up the Pharma parks due to that the Bulk Drug Parks scheme is on a challenge mode its strategic advantage as Haryana surrounds Delhi from and the marks to the coastline states is not only considered three sides providing access to nearly 11 percent of the only from a dumping purpose but also from the fact that domestic market.

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huge capital is required for effluent treatment plants According to officials from the industries department and compete with China when it is playing the game of of Telangana, as many as 350 firms have approached the volume. Government seeking land in the Pharma City. Of them, the officials have decided to allot land to 150 firms in the first To make Indian industry competitive, the Government phase. “We are about to complete the first phase of Pharma of India is giving preference to high scale and high-quality City project in the next few days. Already a couple of API manufacturing. He also informed that Pharma is one of manufacturing, research and formulation based Pharma the ‘champion sectors’ identified by the Government of companies have been allotted lands and work for setting India to provide hand-holding to investors for improving up of their units is in the process. The TSIIC has also manufacturing capabilities in the country. He said that completed more than 95 percent of works under the first the Production Linked Incentive (PLI) schemes for phase and very soon by end of this year we are planning to promoting domestic manufacturing of KSMs, DIs, APIs and operationalise the first phase of the Pharma City,” informed Medical Devices will go a long way in boosting domestic Jayesh Ranjan, Principal Secretary, Industries. manufacturing. Recently, the Saptagir Labs, an API manufacturing Informing that for the PLI scheme, the Government is company based in Hyderabad, had also expressed its receiving a good response, he mentioned that it has received intention to set up its unit in the Pharma City project a suggestion from the industry to increase the investment and had even revealed that it had applied to the state criteria of one of the product categories for which the Government for the allotment of the land. As already minimum investment criteria was set at Rs.4000 crores. Saptagir Labs has invested Rs.75 crore in its WHO GMP The participants at the webinar also raised queries like; certified Pharmaceutical plant located at Chegunta in will anti-dumping duty be put on China on all government Medhcal. The firm is now planning to accomplish its dream announced PLI scheme products to safeguard the industry, of becoming a US FDA certified firm by setting up its most would the units in the bulk drugs parks be exempted from advanced API manufacturing unit at Pharma City. Environment Clearance etc. “We have already submitted an application to the Source: Usha Sharma, Express Pharma, 22.09.2020 industries department for allotment of land in Pharma l l l City. We are targeting to achieve a manufacturing capacity of 500 kiloliter in the coming 2-3 years and planning Hyderabad soon to emerge as leading API to set out a strong footage as a leading API exporter Hub of India as more firms seek land to from Hyderabad,” informed Shilpa Reddy, Promoter and Managing Director of Saptagir Labs. set up their API units in Pharma City Source: A Raju, Pharmabiz, 19.09.2020 With many Pharmaceutical companies in the field of Active Pharmaceutical Ingredient manufacturing seeking l l l land for setting their bases in the newly developing Pharma City region, very soon Hyderabad is going to become SCTIMST signs MoU with Tynor the leading API manufacturing Hub of India. With the Orthotics for joint R&D in orthotics central Government granting the national investment and rehabilitation devices manufacturing zone status to Hyderabad Pharma City, the Telangana Government is now going ahead with its plans The Sree Chitra Tirunal Institute for Medical Sciences to allot land to as many as 150 Pharmaceutical companies and Technology (SCTIMST) has signed a Memorandum of in the first phase. Understanding (MoU) with Tynor Orthotics Private Limited to set up an orthotics and rehabilitation research & Earlier, out of the total earmarked extent of over development (R&D) vertical to promote indigenous device 19,000 acres of Pharma City land, the Telangana State development in this sector. Industries and Infrastructure Corporation (TSIIC) has already taken over 8,500 acres and developed roads, The main objective of this Institute-Industry drains, common effluent plants, established power collaboration is to develop a cluster of orthoses for lines and other necessary infrastructure needed for the catering to clinical conditions such as osteoarthritis and Pharmaceutical companies. diabetic foot ulcer. The project is planned for 1 year with

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Tynor contributing Rs.27 lakhs to the programme, said Park in Bathinda in Punjab. The webinar saw participation the statement. from more than 50 eminent Pharma industries from across India (including Punjab) and USA. “R&D ties up with an Indian industry right from the start and after a detailed study of the Indian market is the These included Dr Reddy’s, Divis Labs, IOL Chemicals, way to go forward to ensure development of high-quality Sun Pharma, Nectar Lifesciences, Anupam Rasayan, affordable technologies for India and to strengthen our Sequent Scientific, Ami Lifesciences, Saurav Chemicals medical devices industry, reduce the country’s import etc. The session was also attended by other stakeholders dependence for such devices and ensure commercial such as UNIDO, NCL, CSIR, Pharma EXCIL amongst others. success of our products. Our research team is enthused The session started with an introduction of Government of to work with an industry leader in this segment and India’s “Promotion of Bulk Drug Parks” Scheme by Joint will do their best to get the desired results of this Secretary, Department of Pharmaceuticals, Government of partnership in a year or two,” said Dr Asha Kishore, India, Mr Navdeep Rinwa. Director, SCTIMST. The high-level interaction included engagement with Global diabetic foot ulcers and pressure ulcer market senior officers of Invest Punjab and Housing & Urban is expected to reach US$ 5,265 million by 2025 with a Development. Apart from sharing a brief overview of the CAGR of 6.6% from 2019-2025 which is quite alarming. advantages of Punjab as a preferred investment destination Similarly, the global knee braces market is growing due to especially for incoming Pharma units, the main emphasis the rising prevalence of osteoarthritis, increasing number was on apprising the participants on the upcoming Bulk of orthopedic knee surgeries, and growing number of sports Drugs Park at Bhatinda spread over an area of approx injuries in athletics. 1300 acres. The global knee braces market size was estimated at The webinar served as a platform for Punjab US$ 1.5 billion in 2018 and is expected to witness a CAGR of 4.3%. The growing burden of osteoarthritis, the increase Government to understand the requirements of the in target population, and the technology of cost effective Pharma units in India and to take industry feedback on and easy to wear braces are the major growth propellers the State Government’s bulk drugs park proposal. The for the market, said the release. progressive reforms and initiatives taken by the Punjab Government for creating an investor-friendly ecosystem in “SCTIMST has done considerable amount of R&D the State and for taking an innovative approach towards work in biomedical devices over the last 30 or more years the conceptualization of a Pharma Park was appreciated and has established itself as a pioneer in this field. This by the participants. collaboration with an Industry leader for co-development of ortho rehab devices in the country is a commendable Meanwhile, the State Chief Secretary Vini Mahajan step and is fully aligned with the Prime Minister’s Vision outlined the close relationship that industries within of Aatmanirbhar Bharat”, said Dr V K Saraswat, NITI Punjab share with the Government which in turn promotes Aayog Member, noted missile scientist and the President collaboration and excellence. The Finance Minister of SCTIMST. assured the participating leaders from industry and other Source: Pharmabiz, 21.09.2020 organizations of the serious intent of the State Government to encourage the growth of the emerging Pharma sector l l l in Punjab through offering plug and play infrastructure at competitive rates and facilitating collaborations for Punjab Government receives strengthening backward and forward integration for the encouraging response from Pharma industry. industry for Bathinda Bulk Drug Park This was a unique engagement between Punjab and leaders of Pharma industry to showcase Punjab’s position The Punjab Government led by Finance Minister as the preferred Pharma destination within India. Manpreet Singh Badal, held strategic discussions with industry captains and academic leaders during a virtual Source: Punjab New Express, 23.09.2020 stakeholder consultation session for upcoming Bulk Drug l l l

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Industry approaches Centre to urgently a year without a logical conclusion. On the contrary, FSSAI notify methylcobalamin for neurological has allowed usage of cyanocobalamin which has cyanide content within but banned methylcobalamin which is a disorders superior form of vitamin B12. The pharmaceutical industry has recently led a “Until and unless FSSAI does not inform the industry delegation to Union Minister of Chemicals and Fertilizers that methylcobalamin is approved, there is no value of D V Sadananda Gowda to urgently notify methylcobalamin prescribing RDA value for the same. Surprisingly the mails for neurological disorders as regulatory action cannot be which we have received from FSSAI methylcobalamin taken against those who are manufacturing methylcobalamin and cyanocobalamin both have the same RDA value to based formulations without scientifically defined efficacious manufacture. Please be advised we are talking about per Recommended Dietary Allowance (RDA) value due to delay serving usage value which the manufacturer can refer in notification. to and not the RDA value for a healthy person,” Pharma Once notified, approved RDA value can be defined in a consultant Dr Sanjay Agrawal argued. scientific way based on evidence. The issue, however, has Methylcobalamin is an essential nutrient and is been festering due to missing exact information on Tolerable required to treat vitamin B12 deficiency, in people with Upper Limit (TUL) of vitamin B12 or methylcobalamin for pernicious anemia, diabetes and other conditions as well. It neurological disorders and immunity booster from the is important for the brain, nerves and for the production of public domain. Red Blood Cells (RBCs). Methylcobalamin as a supplement The pending notification which is being sought for is is very essential specifically for Indians where the majority also based on former Food Safety and Standards Authority of the population is vegetarian as naturally it is present in of India (FSSAI) CEO Pawan Agrawal’s confirmation that non-vegetarian products. When a supplement is taken for methylcobalamin has been approved by its scientific prophylactic cause it must at least be of the therapeutic committee in December 2019. Mail correspondences dose. shared on the issue have been reviewed by Pharmabiz. Source: Shardul Nautiyal, Pharmabiz, 18.09.2020 Drug and nutraceutical industry players have voiced l l l concern that methylcobalamin RDA value has been approved by Central Drugs Standard Control Organisation (CDSCO) uptill 2000 mcg but FSSAI is approving only Union Minister Gowda lauds contribution 1 mcg which is of no use. Drugs Controller General of India of Indian Pharma Industry (DCGI) recommended 2,000 mcg of methylcobalamin even amid COVID-19 crisis in injectable form and brands are available as patients Union Minister for Chemical and Fertilizers take methylcobalamin based on the medical condition. D V Sadananda Gowda has lauded the contribution of However, on January 7, 2020, FSSAI issued a Notification the Indian Pharma industry during the testing time of regarding RDA of vitamin B12 which is specified as COVID expressing confidence that the Indian Pharma 1 mcg without mentioning type of vitamin B12 like industry will be among the first one to develop and supply methylcobalamin, adenosylcobalamin, hydroxycobalamin low-cost vaccines for this pandemic. Gowda was addressing and cyanocobalamin. a Webinar organized by Invest India Pharma Bureau and “No adverse effect has been associated with excess Department of Pharmaceuticals on #EIF2020 Medical methylcobalamin intake from food or supplements in Devices and Pharmaceutical Sector Edition - unraveling healthy individuals. Methylcobalamin has a history of the investment potential, Gol initiatives, infrastructure safe long term use as a therapeutic agent given in high & emerging opportunities in the sector through video dosage or via intramuscular injection for the treatment of conferencing recently. disorders associated with impaired vitamin B12 absorption Union Minister also stressed that the Indian Pharma but industry is yet to see the much awaited Notification on and medical devices industry was able to rise to the the same,” informed Anshu Yadav who led the delegation occasion. He added, “It is a matter of great pride for me to the Government further adding that we are pursuing the and millions of Indians that from being a net importer, issue of banning methylcobalamin by FSSAI for more than India has become the second-largest producer of PPE Kits

IDMA Bulletin LI (36) 22 to 30 September 2020 36

in the world with daily production capacity surpassing more Can’t directly deal with complaints than 5 lakh per day. Similarly in the case of ventilators, of Unethical Practices: Department within a very short span of time, indigenous production of Pharmaceuticals capacity has increased to 3 lakh per annum. In addition, India did not face any scarcity of medicines, prices of The Department of pharmaceuticals (DoP) has medicines remained stable throughout. This was achieved admitted in Parliament that under the Uniform Code of due to active cooperation among various Departments and ethical Marketing Promotion (UCPMP), there is no provision agencies of the Central Government, State Governments, for it to directly deal with complaints received regarding and private sector, Shri Gowda said. unethical practices by Pharma companies. Yet, a big exercise is underway to make Pharma associations submit Stressing on the need of development of indigenous quarterly reports to drug price regulator. capacity in Medical devices Gowda said, “it is very “As per UCPMP, any complaint received against a important as it has a crucial role to play in improving Pharmaceutical company is to be handled by an Ethical accessibility and affordability of healthcare especially with Committee for Pharma Marketing Practices, that is, to be respect to the availability of precision devices for screening constituted in each of the Pharmaceutical associations,” and diagnosis, advanced surgical equipment needed for it said in response to a question in the Parliament treatment, and devices for monitoring of health indicators, on September 18. “DoP has been following up with among others.” Pharma associations to implement the code effectively. He further said under the leadership of Prime Minister This department has also taken multiple meetings Shri Narendra Modi, the Department of Pharmaceuticals has with associations, most of whom have put UCPMP on taken several measures to create an enabling environment their websites and constituted committees for handling for the development of domestic capacity in the Pharma complaints regarding breach of UCPMP. The Government also held a meeting on September 4, asking Pharma and medical device sector and has decided to support the companies and associations to submit a quarterly report development of three bulk drug parks and four medical on implementation of Uniform Code of Ethical Marketing devices parks across the country in coordination with State Promotion. DoP also asked Pharma associations to submit Governments and private sector. The objective is to make compliance report and form committees to look into action India self-reliant in the production of 53 critical APIs or taken on the complaints. Key Starting Materials (KSMs), and in the production of medical devices, for which India is crucially dependent Pharma lobby groups and associations have been asked upon imports. to make sure companies adhere to marketing norms during their conferences, despite the clear failure to self-regulate Gowda said that he is very much sure that these parks by Pharma companies. Malini Aisola, co-convenor, All India will be able to attract significant investment as well as Drugs Action Network (AIDAN) said the meetings by the the latest technology. Within a period of 2-3 years, due Government are eyewash. “It is sheer absurdity that the to business-friendly policies of the Union Government Government is trying to monitor a self-regulatory mechanism under the leadership of Shri Narendra Modi, the Pharma of the industry that it has no tools to enforce. sector will become atmanirbhar, not only in sense of The DoP Secretary has admitted that under the code, meeting domestic requirements but also for fulfilling only associations can take action against companies. global demand of low cost - high-quality medicines and To make matters worse, NPPA, the agency that had medical devices. It is expected that these schemes of the been tasked by DoP to oversee UCPMP implementation, Union Government for the development of bulk drug & has conceded it is neither mandated nor authorised to medical device park will attract cumulative investment monitor Pharma Marketing Practices. This is just days of Rs.78000 crore and can generate about 2.5 lakh after it instructed associations and companies to submit employment. quarterly reports to its office.” Earlier DoP had even said it had received grievances that Pharma companies Source: Ruchika, Medical Dialogues, 20.09.2020 “arrange hotels, accommodations, local sight-seeing” in l l l conferences conducted by the doctors. UCPMP has been voluntarily adopted by Pharma companies since 2015.

IDMA Bulletin LI (36) 22 to 30 September 2020 37

However, concerns over the influence of offering gifts Manufacturers’ Association (IDMA), among others. “We to medical professionals by Pharmaceutical companies have been pressing for a legal instrument to replace have surged from time to time. The meeting was attended the voluntary code and submitted evidence of unethical by the Secretary DoP, other officials in DoP, NPPA practices. Yet, DoP has not held a single consultation with Chairperson along with members of the associations civil society in the last two years. The whole process is including Indian Pharmaceutical Assocaition (IPA)-that an eyewash,” Aisola added. represent the top Pharma companies, Organisation of Source: Teena Thacker, The Economic Times, 24.09.2020 Pharmaceutical Producers of India (OPPI), Indian Drug

l l l

International news

Russia to supply Avifavir drug to 17 The efficacy of Avifavir has been demonstrated in nations for Coronavirus Treatment Clinical Trials which significantly exceed in scale those conducted by other Russian manufacturers of Favipiravir. The Russian These trials have been conducted in full compliance with Direct Investment international standards and the requirements of regulatory Fund (RDIF), Russia’s authorities around the world. Since April, 408 patients with sovereign wealth confirmed Coronavirus have participated in the studies at fund, and ChemRar 35 medical centers across Russia. In October the number Group have agreed to of patients will increase to 460. supply Avifavir, the Since June 2020, more than 60,000 packages of world’s first registered Avifavir have been delivered to clinics in 74 Russian Favipiravir-based drug regions. Since the start of Avifavir supplies, clinical AP Avifavir and other favipiravir-based drugs against Coronavirus produced in Russia, as well as Remdesivir monitoring has been carried out based on data from the developed in the US are currently the leading and Russia’s first register of patients with Coronavirus of the Ministry of drugs against Covid. (Representational image) drug approved for Health of Russia. Data on the use of Avifavir has been the treatment of COVID-19, to 17 countries. Avifavir and collected, with further analysis as well as scientific and other Favipiravir-based drugs produced in Russia, as well as medical assessment conducted. Remdesivir developed in the US are currently the leading drugs against COVID-19 registered globally. According to the results of the observational post-registration Clinical Trial of 940 patients, those taking Avifavir will be delivered to Argentina, Bulgaria, Brazil, Avifavir demonstrated elimination of the virus at an earlier Chile, Colombia, Ecuador, El Salvador, Honduras, Kuwait, stage in 30% of the cases and the level of oxygen saturation Panama, Paraguay, Saudi Arabia, Serbia, Slovakia, South Africa, UAE and Uruguay. The drug has already been was restored to normal twice as quickly compared with delivered to Belarus, Bolivia, Kazakhstan, Kyrgyzstan, standard therapy (within two days versus four days). Turkmenistan and Uzbekistan. On May 29, 2020, Avifavir According to the results of the research, the drug is well received a registration certificate from Russia’s Ministry tolerated, with no new adverse events identified. of Health based on thorough and transparent clinical data Avifavir is now the leading Russian anti-COVID drug and became the first Favipiravir based drug in the world in terms of exports. In particular, the start of deliveries approved for the treatment of COVID-19. to Bolivia and other countries in Latin America was Approximately five months after the Clinical Trials of announced on September 21 as part of the agreement to Avifavir in Russia, the efficacy of Favipiravir against the deliver 150,000 packs. Avifavir has also been approved by novel Coronavirus infection was confirmed by Japan’s regulators in Europe, Middle East and Asia. Kirill Dmitriev, Fujifilm. On September 23, 2020, the company announced CEO of the Russian Direct Investment Fund, said, “When that according to the results of its Phase III Clinical Trial, we registered the first anti-Coronavirus drug in the world the administration of its Favipiravir-based drug Avigan to based on Favipiravir there was a lot of skepticism as people 156 patients demonstrated shorter time to resolution as were wondering how we could register it when Japan had compared with the placebo group. not registered it yet.

IDMA Bulletin LI (36) 22 to 30 September 2020 38 Now five months after our Clinical Trials we see that alongside reputable international financial and strategic Japan has confirmed the clinical efficacy of Favipiravir. investors. RDIF acts as a catalyst for direct investment Avifavir has been tested in more than 1,300 patients in the Russian economy. RDIF’s management company is including 408 patients in Clinical Trials and 940 patients based in Moscow. Currently, RDIF has experience of the during the observational post registration Clinical Trial.” successful joint implementation of more than 80 projects with foreign partners totalling more than RUB1.9 tn and “We have now conducted the largest Clinical Trial of covering 95% of the regions of the Russian Federation. a favipiravir-based drug against Coronavirus in the world and can confirm its high efficacy. Since June, more than RDIF portfolio companies employ more than 60,000 packages of Avifavir have been delivered to clinics 800,000 people and generate revenues which equate in 74 Russian regions and more than 15 countries have to more than 6% of Russia’s GDP. RDIF has established confirmed their interest in the drug. Based on our extensive joint strategic partnerships with leading international Clinical Trials and the research in Japan confirming co-investors from more than 18 countries that total more than Favipiravir’s efficacy against Coronavirus we believe that $40 bn. ChemRar Group unites R&D service and investment Avifavir and other favipiravir-based products will be the companies in the field of innovative Pharmaceuticals for leading antiviral medicines against COVID-19 in the world. the development and commercialization of innovative In addition to proven efficacy and safety Avifavir is also medicines, diagnostics, preventive care and new treatments three to four times cheaper than Remdesivir.” of life-threatening diseases in Russia and abroad. RDIF is Russia’s sovereign wealth fund established in Source: Dipanjan Roy Chaudhury, The Economic Times, 2011 to make equity co-investments, primarily in Russia, 24.09.2020

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FEATURE Why Vaccines are a better bet against Coronavirus than Drugs

In humanity’s millennia-long struggle against viruses, prevention with vaccines has been far more successful than treatment with drugs Michelle Cortez In humanity’s millennia-long struggle against viruses, prevention with vaccines has been far more successful than treatment with drugs. In fact, modern medicine has come up with a true cure for only one viral infection. For many serious infections, the best approaches are a cocktail of drugs that throw speed bumps in front of the infection. It’s a lackluster medical armory, belied by the seeming simplicity of our viral foes. “They can’t live by themselves, they aren’t independent, they can’t process food, take in oxygen, reproduce themselves without the master support system of being the parasite inside a living cell,” said Paula Ampoules containing components of the Covid vaccine ‘Gam-COVID- Cannon, a Professor at the University of Southern California’s Vac’, also known as Sputnik V, developed by the Gamaleya National Research Center for Epidemiology and Microbiology and theRussian Keck School of Medicine. So why do viruses give humans so Direct Investment Fund (RDIF) | Andrey Rudakov | Bloomberg much trouble? Outside of the body, a vigorous hand-washing is enough to kill many. Inside, the immune system’s long A Global push is on to develop a vaccine to slow the memory is enough to make short work of most. spread of Covid-19, and experts hope several will be ready It’s when we run into a new virus that the problems in 2021. Yet even with one, the Coronavirus is likely to start. The Coronavirus, SARS-CoV-2, is the latest in a remain with us for years, demanding long efforts to find a procession of new infectious diseases that have surprised cure for those who still fall sick. the world in recent years. The best hope against it is a

IDMA Bulletin LI (36) 22 to 30 September 2020 39

vaccine, which can stop infections before they take hold. most people, any viral treatment will have to outperform A vaccine is, essentially, a shortcut to immunity. But if an already formidable and existing approach: the human we don’t have immunity and get sick, things get more immune system. complicated. Because viruses can’t survive on their own, they hijack our cells to multiply. That parasitic dependence The best defence: makes them hard to treat with most traditional drugs. A It’s not a coincidence that many infections last for virus is so interwoven with its host that it’s difficult to hurt about two weeks, Cannon said. That’s how long it takes for one without hurting the other. the immune system to kick into gear. “Our immune system SARS-CoV-2 infects the airways and lungs — the very is the world’s best drug maker,” she said. “Whether you things we need to breathe. That leaves an unappealing had measles as a 5-year-old or Covid as a 50-year-old, our choice, according to Cannon. “I can kill the virus, but I immune system comprises this vast library of potential would have to kill you to do it.” Some vaccines, such as antiviral approaches that offer protection.” Antibodies, for measles, have created enough herd immunity that the the infection-fighting proteins produced to ward off foreign virus can no longer take hold and spread in the population. invaders, are biological drugs we make ourselves, Cannon In the best case, as with small pox, the shots have driven said. The body has the ability to make millions and millions the disease out of the human host population and into of them, activating just the right one when it binds to a extinction. Treating an active infection is another matter. virus – then mass producing it over a period of about 14 There’s a Pharmaceutical cure for only one virus: Hepatitis C. days. “This is when the immune system gets the upper Because of the “kill the virus, kill the host” problem, the best hand,” Cannon said. “There are so many antibodies in the bet is often to slow the virus down enough that the body’s blood, coating the virus. They do a good job of neutralizing own defenses can do their job. “When we can’t kill a virus, the virus. Eventually, the antibodies win the day.” Those the best thing we can do is stop them from replicating,” antibodies never fully recede to their initial low levels. said Raed Dweik, Chair of the Cleveland Clinic’s Respiratory Instead, they remain in reserve and on patrol for years, Institute in Ohio. “All we can do is shorten the period of in case the threat returns. If that happens, the response infection, not cure. Even when the infection is over, the doesn’t take 14 days. patient is more recovered than cured.” “If you get that same virus, the infection doesn’t take Remdesivir, the only drug in wide use that targets off because the antibodies kick in,”Canon said. “You SARS-CoV-2 itself, works by messing with the virus’s don’t even get sick. That’s why, with the vast majority of ability to replicate. It causes errors when the virus tries viruses, you get them once and you are immune in the to copy itself. It was also a product of luck: the drug was future.” It’s this process that vaccines mimic. The man- originally developed as a treatment for Ebola, but it wasn’t made immunizations offer up a piece of the virus to the terribly effective and the waning outbreak in Africa made immune system, providing just enough for the body to activate against a potential threat without actually making it difficult for its manufacturer, Gilead Sciences Inc., to the person sick. The immune system is thus alerted and study. Clinical trials have shown that Remdesivir can help able to prevent infection, rather than having to fight one off. hospitalized Covid-19 patients recover more quickly. But It’s also the approach behind another wave of therapies in it’s not a cure, and it’s unlikely there will be one any time development for more severe Covid-19 patients. Drug makers soon. “It will take years to have potent and specific drugs have figured out how to grow antibodies that mimic the that can stop Coronavirus in it stracks,” Cannon said. “The natural ones the body produces, and experimental medicines vast majority of drug candidates fail.” based on them are coming from Regeneron Pharmaceuticals In the future, patients will likely get a cocktail of Inc., Roche Holding AG and Eli Lilly & Co. therapies that attack the virus and others that help keep But those therapies are likely to be reserved for them stable. Currently, Remdesivir is part of a cocoon the sickest, hospitalized patients. And those types of of care that includes the only other cleared therapy, the therapies tend to be expensive — thousands of dollars for steroid dexamethasone, as well as standard fare like fluids, a single course. Gilead’s hepatitis C drug, for example, plus aggressive approaches when needed including putting cost $84,000 after it was approved for US sale in 2013. patients on ventilators. Other medicines are layered on Biotechnology drugs like the ones under development top: blood thinners and experimental approaches to calm for Covid-19 likewise tend to cost tens of thousands of a potentially overactive immune system. As new approaches dollars per course. Vaccines, on the other hand, tend to reach the market, they’ll be added to the mix. But for be cheap— and keep people out of more expensive care.

IDMA Bulletin LI (36) 22 to 30 September 2020 40

“Because we can’t treat them very well, the critical thing “Think about it from the perspective of a Pharmaceutical is always prevention,” the Cleveland Clinic’s Dweik said. company,” said James Cutrell, Director of the infectious “Once you get infected, there is very little we can do other diseases fellowship program at the University of Texas than support you through it or perhaps shorten it a bit. Southwestern Medical Center in Dallas. “Infection typically That’s why finding a vaccine is so important.” is an acute illness that you are going to treat for a short period of time. If it’s a rare infection, there may not be Drugmaker incentives: that many people who take it. When these other viruses There are hundreds of viruses that cause respiratory initially came out there was a lot of interest in developing infections and are generally lumped together under the treatments, but once they died off there wasn’t enough “common cold” banner. Several are Coronaviruses. The for clinical trials.” The economic incentives for drug reasons we don’t have treatments for them is because each makers changed with the Covid-19 pandemic, which is so is so individualized and drug development is so expensive, widespread and so disruptive that a vaccine is seen as a often topping $1 billion per therapeutic. Each treatment societal necessity. The US Government, under its Operation would have to be crafted for a specific pathogen, following Warp Speed program, has struck deals worth about $10 a tailor-made path so narrow that it would be almost billion with drugmakers to develop and manufacture impossible. Already, thousands have failed. And a cold? It multiple vaccines. The shots they come up with, and their typically goes away on its own. The broader economics have successors, could end up being used for years around the historically worked against medicines for viral infections, globe. It’s also certainly not the last new virus the world leaving a gap in the type of innovation that has happened will encounter. “The science tells us that this virus isn’t with other, more profitable conditions like cancer and unique, it’s one of many that are circulating in animals heart disease. The most recent viral outbreaks, including that may spread to us,” Dweik said. “There is no reason SARS and MERS, both novel Coronaviruses, as well as to think this won’t happen again.”. Zika, all ebbed before new treatments gained a foothold. Source: Bloomberg/theprint.in,14.09.2020 (Excerpts) l l l

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IDMAIDMA BulletinBulletin LILI (11)(36)(21) 152201 toto 213007 MarchSeptemberJune 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 7th, 14th, 21st and 30th of every month This issue posted at Mumbai Patrika Channel Sorting Office on 30.09.2020

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IDMA Bulletin LI (36) 22 to 30 September 2020 44