LICENSED TO POST WITHOUT PREPAYMENT LICENCE NO. MR/Tech/WPP-337/West/2021-23 RNI REGN. NO. 18921/1970 RegnEGN NoO. MCW/95/2021-23
vol. NO. 52 Issue NO. 28 (Pages: 40) 22 to 30 July 2021 ISSN 0970-6054 weekly publication
Indian APIs & Formulations for Global Healthcare
.VIDMA (Page No. thanks 4) Dr. Rajeev Singh Raghuvanshi, .GSecretary-cum-Scientific (Page No. 8) Director, IPC for Three .RMonths (Page No. 24)Extension for Implementation of IP Addendum 2021 (Page No. 7) .A (Page No. 26) .CDoP (Page extends No. 27) the timeline for Submission of .Happlications (Page No. 29) under PLI till 31.08.2021 (Page No. 31) Indian pharma industry to touch USD 130 bn by 2030: Reddy (Page No. 32) IDMA Bulletin LII (28) 22 to 30 July 2021 1 Post Covid: Pharmaceutical Industry has become an alluring career option (Page No. 33)
IDMA Bulletin LII (28) 22 to 30 July 2021 2
Founder Editor: Vol. No. 52 Issue No. 28 22 to 30 July 2021 Dr A Patani Editor: IDMA ACTIVITIES: Dr Gopakumar G Nair Virus Attenuation Device (Shycocan Brand) Sponsored by JBCPL ....6 Associate Editors: J L Sipahimalani IDMA GSB team welcoming Shri Manoj Aggarwal, Additional Dr Nagaraj Rao Dr George Patani Chief Secretary, H & FW Dept on July 08, 2021 at Gandhinagar...... 7 National President INDIAN PHARMACOPOEIA: Mahesh H Doshi Immediate Past National President IDMA thanks Dr. Rajeev Singh Raghuvanshi, Secretary-cum- Deepnath Roy Chowdhury Scientific Director, IPC for Three Months Extension for Senior Vice-President Dr Viranchi Shah Implementation of IP Addendum 2021 - reg...... 7 Vice-Presidents: Bharat N. Shah PARLIAMENT NEWS: (Western Region) In Lok Sabha & In Rajya Sabha...... 8 Asheesh Roy (Eastern Region) GOVERNMENT press release: B K Gupta (Northern Region) NPPA has fixed ceiling prices of 355 medicines and 882 formulations T Ravichandiran for including Paracetamol, Dexamethasone, Methyl Prednisolone, (Southern Region) Hon General Secretary IVIGs, Enoxaparin, Budesonide, Heparin and Amphotericin...... 28 Dr George Patani Interview: Hon Joint Secretaries J Jayaseelan India must use, share Covid data transparently: Atul J Shah Hon Treasurer Kiran Mazumdar-Shaw...... 29 Vasudev Kataria DGFT matters: For information contact IDMA Secretariat: (H.O.) Daara B Patel Foreign Trade Policy 2015-20 - Introduction of online Secretary-General Deemed Exports Application Module - reg...... 30 Melvin Rodrigues Sr Manager (Commercial & Administration) Dop matters: Delhi Office: Ashok Kumar Madan DoP extends the timeline for Submission of applications Executive Director S Ranganathan under PLI till 31.08.2021 -reg...... 31 Asst Manager (Administration) NPPA matters: IDMA STATE BOARDs CHAIRMAN Gujarat State Board : Milan Patel List of Overcharging Cases (OC) including cases under Haryana State Board : P K Gupta litigation relating to DPCO 1979, 1987, 1995 and 2013-reg...... 31 Himachal Pradesh & Uttarakhand State Board : R C Juneja National News: Karnataka State Board : S M Mudda Madhya Pradesh State Board : Paresh Chawla Tamil Nadu, Puducherry Ensure no vaccine dose goes waste...... 32 & Kerala State Board : J Jayaseelan Telangana State Board : Shaik Janimiya Indian pharma industry to touch USD 130 bn by 2030: Reddy...... 32 West Bengal State Board : Shiv Sagar Tewari A Publication of Covid vaccines for children by September: AIIMS chief Indian Drug Manufacturers' Association 102-B, 'A-Wing', Poonam Chambers, Dr Randeep Guleria Hans ...... 33 Dr. A.B. Road, Worli, Mumbai - 400 018 Tel : 022-2494 4624 / 2497 4308 Fax: 022-2495 0723 Post Covid: Pharmaceutical Industry has become e-mail: [email protected]/ [email protected]/ website: www.idma-assn.org an alluring career option...... 33 Published on 7th, 14th, 21st and 30th of every month Annual Subscription Lower Barriers: India’s tariffs record sharp drop from ` 1000/- (for IDMA members) 17.6% in 2019 to 15% in 2020...... 35 ` 2000/- (for Government Research/Educational Institutions) ` 4000/- (for non-members) US$ 400 (Overseas) Please send your payment in favour of USP Education - Webinar ...... 4 Indian Drug Manufacturers' Association MAHE releases book on COVID-19...... 27 IDMAOpinions Bulletin Expressed LIIXLIV By Th(28)e (38)Au t22ho 08rs to Of to30 Individu 14 July Octobera l2021 Articl e s2013 3 Do Not Necessarily Represent The Official View Of Idma. Advertisements...... 2, 5, 38, 39 & 40
USPUSP EducationEducation USP Education
Dear Valuable Customer, Dear Valuable Customer, DearUSP IndiaValuable Education Customer, team is pleased to announce our upcoming live webinar courses for the month of July 2021. Please find the details as below. Kindly register yourself and nominate your team for this Dear Valuable Customer, USP course. India Education team is pleased to announce our upcoming live webinar courses for the month of July 2021. Please find the details as below. Kindly register yourself and nominate your team for this course.USP India Education team is pleased to announce our upcoming live webinar courses for the month of July 2021. Please find the details as below. Kindly register yourself and nominate your team for this course.USP India Education team is pleased to announce our upcoming live webinar courses for the month of July 2021. Please find the details as below. Kindly register yourself and nominate your team for this course. Course 1 Course 2 Course 1 Course 2 Course 1 Course 2 Course Title: Customer Complaint HandlingCourse 1 Course Topic: Audit fundamentals Course 2 CourseDate: Title: CustomerThursday, Complaint29 July 2021 Handling CourseDate: Topic: Audit Saturday, fundamentals 31 July 2021 Course Title: Customer Complaint Handling Course Topic: Audit fundamentals Date:Duration: Thursday,3 hrs 29 July 2021 Date:Duration: Saturday, 3 hrs 31 July 2021 Date:Course Title: CustomerThursday, 29Complaint July 2021 Handling Date:Course Topic: AuditSaturday, fundamentals 31 July 2021 Duration:Time: 310:00AM hrs - 01:00PM (IST) Duration:Time: 310:00 hrs am - 01:00 pm (IST) Duration:Date: 3Thursday, hrs 29 July 2021 Duration:Date: 3Saturday, hrs 31 July 2021 Time:Fee: 10:00AMINR 3,000.00+GST - 01:00PM = (IST) Rs.3,540.00 per person Time:Fee: 10:00 INR 3000.00+GST am - 01:00 pm = Rs(IST) 3540.00 per person Fee:Time:Duration: INR10:00AM3 hrs 3,000.00+GST - 01:00PM = (IST)Rs.3,540.00 per person Fee:Time:Duration: 10:00INR3 hrs 3000.00+GST am - 01:00 pm = Rs (IST) 3540.00 per person Fee:Time: INR10:00AM 3,000.00+GST - 01:00PM = (IST)Rs.3,540.00 per person Fee:Time: 10:00INR 3000.00+GST am - 01:00 pm = Rs (IST) 3540.00 per person Fee:USP Approved INR Speakers: 3,000.00+GST = Rs.3,540.00 per person Fee:USP Approved INRSpeakers: 3000.00+GST = Rs 3540.00 per person USPRaghunandan Approved HV,Speakers: Ph.D. USPRaghunandan Approved HV,Speakers: Ph.D. USP Approved Speakers: USP Approved Speakers: RaghunandanMr. T Lakshmana HV, Murthy Ph.D. RaghunandanMr. T Lakshmana HV, Murthy Ph.D. RaghunandanUSP Approved HV, Speakers: Ph.D. RaghunandanUSP Approved HV, Speakers: Ph.D. Mr. T Lakshmana Murthy Mr.Jaya T LakshmanaPrakash Didugu, Murthy Ph.D. Mr.Raghunandan T Lakshmana HV, Murthy Ph.D. Mr.Raghunandan T Lakshmana HV, Murthy Ph.D. Description : Jaya Prakash Didugu, Ph.D. Mr. T Lakshmana Murthy JayaMr. T Prakash Lakshmana Didugu, Murthy Ph.D. DescriptionThis three-hour : course explains customer complaint handling related to regulatory guidelines, Description: Description : Jaya Prakash Didugu, Ph.D. Thisclassification three-hour of course complaints. explains An customer overview ofcomplaint root cause handling analysis related (RCA) to and regulatory CAPA will guidelines, provide Description:This three hour course introduces the audit process, planning, data review, reporting and CAPA. ThisDescription three-hour : course explains customer complaint handling related to regulatory guidelines, Description: classificationinsights into the of complaints.complaint handling An overview process, of responsibilities, root cause analysis and investigations. (RCA) and CAPA will provide ThisParticipants three hour will course experience introduces applicable the audit template process, based planning, discussions data review,on theoretical reporting aspects and CAPA. of audit classificationThis three-hour of course complaints. explains An overviewcustomer of complaint root cause handling analysis related (RCA) to and regulatory CAPA will guidelines, provide ThisDescription: three hour course introduces the audit process, planning, data review, reporting and CAPA. insights into the complaint handling process, responsibilities, and investigations. Participantsfundamentals. will experience applicable template based discussions on theoretical aspects of audit insightsclassification into the of complaint complaints. handling An overview process, of responsibilities, root cause analysis and investigations. (RCA) and CAPA will provide ParticipantsThis three hour will course experience introduces applicable the audit template process, based planning, discussions data onreview, theoretical reporting aspects and CAPA. of audit Upon completion of the webinar, you will be able to understand: fundamentals. insights into the complaint handling process, responsibilities, and investigations. fundamentals.Participants will experience applicable template based discussions on theoretical aspects of audit Upon• Explain completion market complaintsof the webinar, including you will various be able triggers, to understand: categories and importance Upon completion of webinar, you will be able to understand: Upon completion of the webinar, you will be able to understand: fundamentals. •• Explain Describe market regulatory complaints guidelines including for handling various oftriggers, market categories complaints and importance Upon• Explain completion requirements of webinar, of self you -inspections will be able and to processunderstand: audits •Upon Explain completion market complaints of the webinar, including you will various be able triggers, to understand: categories and importance Upon completion of webinar, you will be able to understand: •• Describe Demonstrate regulatory knowledge guidelines of root for cause handling analysis of market tools and complaints their application for handling of •• Explain Describe requirements requirements of ofself the -inspections audit process and process audits • DescribeExplain market regulatory complaints guidelines including for handling various of triggers, market categoriescomplaints and importance •Upon Explain completion requirements of webinar, of self you-inspections will be able and to process understand: audits • Demonstrate market complaints knowledge through of root case cause studies analysis tools and their application for handling of •• Describe Summarize requirements how audits of are the conducted audit process and how audit reports are prepared. • DemonstrateDescribe regulatory knowledge guidelines of root for cause handling analysis of market tools and complaints their application for handling of • DescribeExplain requirements requirements of of self the -inspections audit process and process audits • marketExplain complaintsregulatory observationsthrough case pertaining studies to market complaints • Summarize how audits are conducted and how audit reports are prepared. • ExplainDemonstratemarket regulatorycomplaints knowledge observations through of rootcase pertainingcause studies analysis to market tools andcomplaints their application for handling of • SummarizeDescribe requirements how audits areof the conducted audit process and how audit reports are prepared. • Explainmarket regulatorycomplaints observations through case pertaining studies to market complaints • Summarize how audits are conducted and how audit reports are prepared. • Target Explain audience: regulatory observations pertaining to market complaints TargetQuality audience: Assurance, Quality Control, Analytical, Regulatory Affairs, Engineering, Manufacturing, personnel working in Pharma and allied industries. Target audience: Quality Assurance, Quality Control, Analytical, Regulatory Affairs, Engineering, Manufacturing, personnel working in Pharma and allied industries. QualityTarget audience: Assurance, Quality Control, Analytical, Regulatory Affairs, Engineering, Manufacturing, personnel working in Pharma and allied industries. After completion of the course participants will get USP certificate (soft copy) on their e-mail id provided. After Quality completion Assurance, of Quality the course Control, participants Analytical, will Regulatory get USP certificate Affairs, Engineering, (soft copy) on Manufacturing, their e-mail id personnel provided. working in Pharma and allied industries. After Speaker completion biographies: of the course participants will get USP certificate (soft copy) on their e-mail id provided. AfterSpeaker completion biographies: of the course participants will get USP certificate (soft copy) on their e-mail id provided. Speaker biographies: Speaker biographies:
Raghunandan HV, Ph.D. (Kuvempu University) RaghunandanExternal faculty HV, Ph.D. (Kuvempu University) Raghunandan HV, Ph.D. (Kuvempu University) ExternalUSP consultant faculty faculty since 2018 USPExternalRaghunandan consultant faculty HV, faculty Ph.D. since (Kuvempu 2018 University) External faculty Dr. RaghunandanUSP is consultanta Pharmacist faculty with sinceover 25+ 2018 years of progressive experience in Pharmaceutical Quality Assurance, Quality Control, Regulatory affairs, Manufacturing of formulations/API’s/Biological, USP consultant faculty since 2018 Dr.Contract Raghunandan Manufacturing is a Pharmacist and Pharmaceutical with over 25+ Technical years of Consultation,(Reg. progressive experience affairs, in Product Pharmaceutical Development Quality and Assurance, Quality), Research Quality Control, and Pharmaceutical Regulatory affairs, Education. Manufacturing of formulations/API’s/Biological, ContractDr. Raghunandan Manufacturing is a Pharmacist and Pharmaceutical with over 25+ Technical years of Consultation,(Reg. progressive experience affairs, in Product Pharmaceutical Development Quality and Assurance, Quality), Research Quality Control,and Pharmaceutical Regulatory affairs,Education. Manufacturing of formulations/API’s/Biological, ContractDr. Raghunandan Manufacturing is a Pharmacist and Pharmaceutical with over 25+ Technical years of Consultation,(Reg. progressive experience affairs, in Product Pharmaceutical Development Quality and Assurance, Quality), Research Quality Control,and Pharmaceutical Regulatory affairs,Education. Manufacturing of formulations/API’s/Biological, ContractHe is an experiencedManufacturing Quality and Pharmaceutical Auditor and has Technical good Knowledge Consultation,(Reg. and know howaffairs, of ProductQuality audits Development at site functional and Quality), level Research and corporate and Pharmaceutical Quality Management Education. level. Has also experienced in academics in the Heleadership is an experienced role as Deputy Quality Director Auditor and and Professor has good at Knowledge JSS Academy and ofknow Higher how Education of Quality and audits Research. at site functional Connected level Pharmaceutical and corporate Industries Quality Management with Institute level. for student Has also exchange experienced and infaculty academics Interactions. in the He is an experienced Quality Auditor and has good Knowledge and know how of Quality audits at site functional level and corporate Quality Management level. Has also experienced in academics in the leadershipHaving around role as17 yearsDeputy of DirectorPharmaceutical/Consumer and Professor at JSS Health Academy Care Industryof Higher work Education experience and Research.both at site Connected Leadership Pharmaceutical and corporate. HeIndustries has worked with withInstitute Cipla for Limited, student GSK exchange Pharmaceuticals and faculty India, Interactions. GSK Con- leadershipHe is an experienced role as Deputy Quality Director Auditor and and Professor has good at Knowledge JSS Academy and of know Higher how Education of Quality and audits Research. at site functionalConnected level Pharmaceutical and corporate Industries Quality Management with Institute level. for student Has also exchange experienced and faculty in academics Interactions. in the Havingsumer Healtharound Care 17 years India, of GSKPharmaceutical/Consumer Philippines and Biocon Health India in Care the Industrypast. work experience both at site Leadership and corporate. He has worked with Cipla Limited, GSK Pharmaceuticals India, GSK Con- sumerHavingleadership Health around role Care 17as years Deputy India, of GSK Pharmaceutical/ConsumerDirector Philippines and Professor and Biocon at JSS HealthIndia Academy in Care the past. Industry of Higher work Education experience and bothResearch. at site Connected Leadership Pharmaceuticaland corporate. He Industries has worked with with Institute Cipla forLimited, student GSK exchange Pharmaceuticals and faculty India, Interactions. GSK Con- sumerHaving Health around Care 17 years India, of GSK Pharmaceutical/Consumer Philippines and Biocon HealthIndia in Care the past. Industry work experience both at site Leadership and corporate. He has worked with Cipla Limited, GSK Pharmaceuticals India, GSK Con- sumerHe is an Health expert Care on theIndia, stability GSK Philippines studies for andAPI’s, Biocon Formulations, India in the and past. Biotechnology Products. Working as an independent Pharmaceutical Consultant / Auditor from Nov 2011 till date Supported few Pharma- Heceutical is an expert Companies on the for stability Regulatory studies Filings for API’s, (ANDA) Formulations, & IND, Due andDiligence, Biotechnology Training Products.and Formulation Working Development. as an independent Pharmaceutical Consultant / Auditor from Nov 2011 till date Supported few Pharma- ceuticalHe is an expertCompanies on the for stability Regulatory studies Filings for API’s, (ANDA) Formulations, & IND, Due Diligence,and Biotechnology Training andProducts. Formulation Working Development. as an independent Pharmaceutical Consultant / Auditor from Nov 2011 till date Supported few Pharma- ceuticalHe is an expertCompanies on the for stability Regulatory studies Filings for API’s, (ANDA) Formulations, & IND, Due Diligence,and Biotechnology Training andProducts. Formulation Working Development. as an independent Pharmaceutical Consultant / Auditor from Nov 2011 till date Supported few Pharma- ceutical Companies for Regulatory Filings (ANDA) & IND, Due Diligence, Training and Formulation Development. Lakshmana Murthy T, PG degree in Synthetic Organic Chemistry, Diploma in Integrated Chemistry & Chemical Engineering, Certified Pharmaceutical GMP LakshmanaProfessional Murthy (CPGP), T, PGCertified degree Quality in Synthetic Auditor Organic (CQA) byChemistry, ASQ & ICH Diploma Q7 Auditor in Integrated by API Compliance Chemistry &Institute Chemical in Europe Engineering, Certified Pharmaceutical GMP Lakshmana Murthy T, PG degree in Synthetic Organic Chemistry, Diploma in Integrated Chemistry & Chemical Engineering, Certified Pharmaceutical GMP ProfessionalDirector, Quality (CPGP), Assurance, Certified Quality Auditor (CQA) by ASQ & ICH Q7 Auditor by API Compliance Institute in Europe ProfessionalLakshmana Murthy (CPGP), T, Certified PG degree Quality in Synthetic Auditor Organic (CQA) by Chemistry, ASQ & ICH Diploma Q7 Auditor in Integrated by API Compliance Chemistry Institute& Chemical in Europe Engineering, Certified Pharmaceutical GMP Director,United States Quality Pharmacopeia Assurance, Director,Professional Quality (CPGP), Assurance, Certified Quality Auditor (CQA) by ASQ & ICH Q7 Auditor by API Compliance Institute in Europe UnitedUSP employee States Pharmacopeia since 2010 UnitedUSPDirector, employee States Quality Pharmacopeia since Assurance, 2010 USPUnited employee States Pharmacopeia since 2010 Lakshmana MurthyUSP serves employee as Director since 2010 Quality Assurance at USP-India. Lakshmana has been associated with USP for nearly ten years and is currently responsible for overall quality operations at USP-India. LakshmanaLakshmana Murthy also oversees serves asa group Director of GMPQuality auditors Assurance from at Verification USP-India. Program Lakshmana and has USP’s been flagship associated PQM withprogram. USP for nearly ten years and is currently responsible for overall quality operations at USP-India. Lakshmana Murthyalso oversees serves aas group Director of GMP Quality auditors Assurance from Verificationat USP-India. Program Lakshmana and hasUSP’s been flagship associated PQM program.with USP for nearly ten years and is currently responsible for overall quality operations at USP-India. Lakshmana Murthyalso oversees serves aas group Director of GMP Quality auditors Assurance from Verificationat USP-India. Program Lakshmana and hasUSP’s been flagship associated PQM program.with USP for nearly ten years and is currently responsible for overall quality operations at USP-India. LakshmanaLakshmana also is also oversees the subject a group matter of GMP expert auditors and chief from designer Verification of USP Program education and USP’s courses flagship on Pharmaceutical PQM program. Quality Assurance Practices and Data Assurance. He had approximately 20 years of experi- Lakshmanaence in development is also the qualitysubject assurance, matter expert GMP and auditing, chief designer quality assurance of USP education and regulatory courses compliance on Pharmaceutical functions. Quality He previously Assurance held Practices key positions and Data in Actavis Assurance. Pharma He Research had approximately and Development 20 years Centre of experi and- Lakshmana is also the subject matter expert and chief designer of USP education courses on Pharmaceutical Quality Assurance Practices and Data Assurance. He had approximately 20 years of experi- enceDr. Reddy’s in development before joining quality USP assurance, in September GMP auditing,2010. quality assurance and regulatory compliance functions. He previously held key positions in Actavis Pharma Research and Development Centre and enceDr.Lakshmana Reddy’s in development beforeis also thejoining quality subject USP assurance, matterin September expert GMP and 2010.auditing, chief designerquality assurance of USP education and regulatory courses compliance on Pharmaceutical functions. Quality He previously Assurance held Practices key positions and Data in Actavis Assurance. Pharma He Research had approximately and Development 20 years Centre of experi and- Dr.ence Reddy’s in development before joining quality USP assurance, in September GMP 2010.auditing, quality assurance and regulatory compliance functions. He previously held key positions in Actavis Pharma Research and Development Centre and Dr. Reddy’s before joining USP in September 2010.
Jayaprakash Didugu, Ph.D Computational Chemistry, MBA in Total Quality Management JayaprakashGMP Auditor, Didugu, Verification Ph.D Programs Computational Chemistry, MBA in Total Quality Management Jayaprakash Didugu, Ph.D Computational Chemistry, MBA in Total Quality Management GMPUnited Auditor, States Verification Pharmacopeia Programs GMPJayaprakash Auditor, Didugu,Verification Ph.D Programs Computational Chemistry, MBA in Total Quality Management UnitedUSP Employee States Pharmacopeia since 2015 UnitedGMPUSP Employee Auditor, States VerificationPharmacopeia since 2015 Programs United States Pharmacopeia Jaya Prakash hasUSP been Employee associated since with 2015 USP for more than five (5) years and is currently responsible for conducting GMP verification audits across Asia-Pacific region and occasionally in USA. Prakash con- USP Employee since 2015 Jayaducted Prakash several has audits been ofassociated pharmaceutical, with USP nutraceutical for more than and five excipient (5) years manufacturersand is currently in responsible US, Australia, for China,conducting Taiwan, GMP Thailand verification and India. audits Prakash across Asia-Pacificis also the subject region matter and occasionally expert and in supported USA. Prakash to design con- Jaya Prakash has been associated with USP for more than five (5) years and is currently responsible for conducting GMP verification audits across Asia-Pacific region and occasionally in USA. Prakash con- ductedthe USP several education audits courses of pharmaceutical, on Pharmaceutical nutraceutical Quality andAssurance excipient Practices manufacturers and Data in Assurance. US, Australia, Prior China, to joining Taiwan, USP, Thailand Prakash and worked India. Prakashin the pharmaceutical is also the subject industry matter for expert more thanand supported thirteen (13) to yearsdesign in Jayaducted Prakash several has audits been of associated pharmaceutical, with USP nutraceutical for more than and five excipient (5) years manufacturers and is currently in responsible US, Australia, for China, conducting Taiwan, GMP Thailand verification and India. audits Prakash across is Asia-Pacific also the subject region matter and occasionally expert and insupported USA. Prakash to design con- theQA, USP Regulatory education Compliance, courses on and Pharmaceutical GMP Auditing Quality with Pharma Assurance majors Practices such as and Granules Data Assurance. India, Aurobindo Prior to Pharma, joining Dr.USP, Reddy’s Prakash and worked Adcock in Ingram.the pharmaceutical industry for more than thirteen (13) years in ductedthe USP several education audits courses of pharmaceutical, on Pharmaceutical nutraceutical Quality Assuranceand excipient Practices manufacturers and Data in Assurance. US, Australia, Prior China, to joining Taiwan, USP, Thailand Prakash and worked India. in Prakash the pharmaceutical is also the subject industry matter for expertmore than and supportedthirteen (13) to years design in QA,{ Regulatory Compliance, and GMP Auditing with Pharma majors such as Granules India, Aurobindo Pharma, Dr. Reddy’s and Adcock Ingram. theQA, USPRegulatory education Compliance, courses on and Pharmaceutical GMP Auditing Quality with Pharma Assurance majors Practices such as andGranules Data Assurance.India, Aurobindo Prior toPharma, joining Dr. USP, Reddy’s Prakash and worked Adcock in Ingram. the pharmaceutical industry for more than thirteen (13) years in {Prakash holds a Ph. D in Computational Chemistry, and MBA in Total Quality Management. He is also a Certified Pharmaceutical GMP Professional (CPGP) and Certified Quality Auditor (CQA) by American QA,{ Regulatory Compliance, and GMP Auditing with Pharma majors such as Granules India, Aurobindo Pharma, Dr. Reddy’s and Adcock Ingram. PrakashSociety holdsfor Quality a Ph. D(ASQ) in Computational and Preventive Chemistry, Controls andQualified MBA inIndividual Total Quality (PCQI) Management. by FSPCA. He is also a Certified Pharmaceutical GMP Professional (CPGP) and Certified Quality Auditor (CQA) by American {PrakashSociety forholds Quality a Ph. (ASQ)D in Computational and Preventive Chemistry, Controls Qualified and MBA Individualin Total Quality (PCQI) Management. by FSPCA. He is also a Certified Pharmaceutical GMP Professional (CPGP) and Certified Quality Auditor (CQA) by American Prakash holds a Ph. D in Computational Chemistry, and MBA in Total Quality Management. He is also a Certified Pharmaceutical GMP Professional (CPGP) and Certified Quality Auditor (CQA) by American SocietyPayment for details: Quality (ASQ) and Preventive Controls Qualified Individual (PCQI) by FSPCA. Society for Quality (ASQ) and Preventive Controls Qualified Individual (PCQI) by FSPCA. PaymentFee payment details: can be done online through UPI payment, paytm, Gpay etc. we will share the link to join the webinar after the payment for the course. Payment details: FeeUSP payment India Service can be Tax done No: onlineAAACU7542CST001 through UPI payment, USP India paytm, Bank RTGSGpay /etc. NEFT we / will IFSCCode: share the ICIC0000008 link to join the Payment webinar of after Service the payment Tax comes for underthe course. services of "Commercial Training & Coaching Centre" FeePayment payment details: can be done online through UPI payment, paytm, Gpay etc. we will share the link to join the webinar after the payment for the course. USPUSP India India Service Bank account Tax No: No AAACU7542CST001 000805005833, I.C.I.C.I. USP India Bank, Bank 6-2-1012 RTGS /TGV NEFT Mansion, / IFSCCode: Khairatabad ICIC0000008 branch, Payment Hyderabad of Service - 500 004 Tax Telangana. comes under services of "Commercial Training & Coaching Centre" USPFee payment India Service can beTax done No: AAACU7542CST001online through UPI payment, USP India paytm, Bank RTGS Gpay / etc. NEFT we / willIFSCCode: share the ICIC0000008 link to join the Payment webinar of after Service the paymentTax comes for under the course. services of "Commercial Training & Coaching Centre" USPUSP India India Bank MICR account Number No / Bank 000805005833, Key /Bank code I.C.I.C.I. : 500229002. Bank, 6-2-1012 TGV Mansion, Khairatabad branch, Hyderabad - 500 004 Telangana. USP India BankService account Tax No: No AAACU7542CST001 000805005833, I.C.I.C.I. USP India Bank, Bank 6-2-1012 RTGS TGV/ NEFT Mansion, / IFSCCode: Khairatabad ICIC0000008 branch, PaymentHyderabad of -Service 500 004 Tax Telangana. comes under services of "Commercial Training & Coaching Centre" USPUSP India India MICR Bank NumberAccount /Type: Bank CurrentKey /Bank Account. code : 500229002. USP India BankMICR AccountaccountNumber NoType:/ Bank 000805005833, Current Key /Bank Account. code I.C.I.C.I. : 500229002. Bank, 6-2-1012 TGV Mansion, Khairatabad branch, Hyderabad - 500 004 Telangana. USP India BankMICR AccountNumber Type:/ Bank Current Key /Bank Account. code : 500229002. IDMAPleaseUSP Bulletin India share Bank below Account LII details (28) Type: for Current22 registration: to Account. 30 July 2021 4 Please share below details for registration: Please share below details for registration: Please share below details for registration: Invoice Address / Name Designation Department Email ID Contact Number Invoice Address / Name Designation Department Email ID Contact Number GST No. if applicable GSTInvoice No. if Address applicable / Name Designation Department Email ID Contact Number Invoice Address / Name Designation Department Email ID Contact Number GST No. if applicable GST No. if applicable
Kindly reach out to us on [email protected]/ [email protected] or call on 7893733699 / 9154030360 for any difficulty in registration or to get more information about the course, we Kindlywill be reach glad toout assist to us you. on [email protected]/ [email protected] or call on 7893733699 / 9154030360 for any difficulty in registration or to get more information about the course, we Kindlywill be reachglad to out assist to us you. on [email protected]/ [email protected] or call on 7893733699 / 9154030360 for any difficulty in registration or to get more information about the course, we Kindlywill be reachglad to out assist to us you. on [email protected]/ [email protected] or call on 7893733699 / 9154030360 for any difficulty in registration or to get more information about the course, we will be glad to assist you. USP Education
Dear Valuable Customer,
USP India Education team is pleased to announce our upcoming live webinar courses for the month of July 2021. Please find the details as below. Kindly register yourself and nominate your team for this course.
Course 1 Course 2
Course Title: Customer Complaint Handling Course Topic: Audit fundamentals Date: Thursday, 29 July 2021 Date: Saturday, 31 July 2021 Duration: 3 hrs Duration: 3 hrs Time: 10:00AM - 01:00PM (IST) Time: 10:00 am - 01:00 pm (IST) Fee: INR 3,000.00+GST = Rs.3,540.00 per person Fee: INR 3000.00+GST = Rs 3540.00 per person
USP Approved Speakers: USP Approved Speakers: Raghunandan HV, Ph.D. Raghunandan HV, Ph.D. Mr. T Lakshmana Murthy Mr. T Lakshmana Murthy Jaya Prakash Didugu, Ph.D. Description : This three-hour course explains customer complaint handling related to regulatory guidelines, Description: classification of complaints. An overview of root cause analysis (RCA) and CAPA will provide This three hour course introduces the audit process, planning, data review, reporting and CAPA. insights into the complaint handling process, responsibilities, and investigations. Participants will experience applicable template based discussions on theoretical aspects of audit fundamentals. Upon completion of the webinar, you will be able to understand: • Explain market complaints including various triggers, categories and importance Upon completion of webinar, you will be able to understand: • Describe regulatory guidelines for handling of market complaints • Explain requirements of self -inspections and process audits • Demonstrate knowledge of root cause analysis tools and their application for handling of • Describe requirements of the audit process market complaints through case studies • Summarize how audits are conducted and how audit reports are prepared. • Explain regulatory observations pertaining to market complaints Target audience: Quality Assurance, Quality Control, Analytical, Regulatory Affairs, Engineering, Manufacturing, personnel working in Pharma and allied industries.
After completion of the course participants will get USP certificate (soft copy) on their e-mail id provided.
Speaker biographies:
Raghunandan HV, Ph.D. (Kuvempu University) IDMA ACTIVITIES CDSCO MATTERSExternal faculty USP consultant faculty since 2018
Dr. Raghunandan is a Pharmacist with over 25+ years of progressive experience in Pharmaceutical Quality Assurance, Quality Control, Regulatory affairs, Manufacturing of formulations/API’s/Biological, Contract Manufacturing and Pharmaceutical Technical Consultation,(Reg. affairs, Product Development and Quality), Research and Pharmaceutical Education. CSR Initiatives CDSCOby IDMA provides with the guidancesupport of on Heits is an experiencedRegulatory Members Quality Auditor and has good Knowledge Pathway and know how of Quality audits at– site functional reg. level and corporate Quality Management level. Has also experienced in academics in the leadership role as Deputy Director and Professor at JSS Academy of Higher Education and Research. Connected Pharmaceutical Industries with Institute for student exchange and faculty Interactions. Having around 17 years of Pharmaceutical/Consumer Health Care Industry work experience both at site Leadership and corporate. He has worked with Cipla Limited, GSK Pharmaceuticals India, GSK Con- DCG(I) Circular Ref.X-11026107/2020-PRO,sumer Health Care India, GSK dated Philippines and 20 Bioconth IndiaMarch in the past. 2020 He is an expert on the stability studies for API’s, Formulations, and Biotechnology Products. Working as an independent Pharmaceutical Consultant / Auditor from Nov 2011 till date Supported few Pharma- ceutical Companies for Regulatory Filings (ANDA) & IND, Due Diligence, Training and Formulation Development.
Lakshmana Murthy T, PG degree in Synthetic Organic Chemistry, Diploma in Integrated Chemistry & Chemical Engineering, Certified Pharmaceutical GMP To, forProfessional sale (CPGP), and Certified distribution Quality Auditor (CQA) by would ASQ & ICH Q7 beAuditor processed by API Compliance Institute on in Europe Director, Quality Assurance, All Stakeholders through CDSCO web site Copy for priorityUnited States Pharmacopeia though expedited review/accelerated USP employee since 2010 Information, approval. PS to JS(R), Ministry of Health and Family Welfare, Nirman Lakshmana Murthy serves as Director Quality Assurance at USP-India. Lakshmana has been associated with USP for nearly ten years IDMAand is currently ACTIV responsibleITIES for overall quality operations at USP-India. IDMALakshmana ACT alsoIV IoverseesTIES a group of GMP auditors from Verification Program and USP’s flagship PQM program. Bhawan, New Delhi. 4. Any firm having DrugNaccine already approved for CDSCLakshmanaO MATTE is also the subjectRS matter expert and chief designer of USP education courses on Pharmaceutical Quality Assurance Practices and Data Assurance. He had approximately 20 years of experi- IDMA ACTIVITIES ence in development quality assurance, GMP auditing, qualityC assuranceSR andInitiatives regulatory compliance functions. by He I previouslyDM heldA keywith positions in Actavisthe Pharma support Research and Development of Centreits and M embers Dr. Reddy’s beforeCOVID-19 joining USP in September in any 2010. other country can directly approach Novel Corona-virus DiseaseCSR I (COVID-19)nitiatives hasby spreadIDMA with the support of its Members IDMA ACTIVITIES CDSCO MATTERSDCG(I) through Public Relations Office regarding over 118 countries with now more than 191,127 cases and Jayaprakash Didugu, Ph.D Computational Chemistry, MBA in Total Quality Management CSR Initiatives CDSCOby IDMA provides with the guidancesupport of on itsexpeditedGMP Regulatory Auditor, M Verificationembers review/accelerated Programs Pathway approval for marketing – reg. 7807 people have lost their lives as on 18.03.2020. World United States Pharmacopeia inUSP India. Employee since 2015 CSR InitiativesHealth CDSCOby Organization IDMA provides with(WHO) has the declared guidancesupport it as pandemic. of on its Regulatory Members Pathwayth – reg. DCG(I) Circular Ref.X-11026107/2020-PRO,Jaya Prakash has been associated with USPdated for more than 20 five (5) yearsMarch and is currently 2020responsible for conducting GMP verification audits across Asia-Pacific region and occasionally in USA. Prakash con- At present there is no current evidence from randomized ducted5. severalData audits of pharmaceutical, requirement nutraceutical andfor excipient animal manufacturers toxicity in US, Australia, study, China, Taiwan, clinical Thailand and India. Prakash is also the subject matter expert and supported to design the USP education courses on Pharmaceutical Qualityth Assurance Practices and Data Assurance. Prior to joining USP, Prakash worked in the pharmaceutical industry for more than thirteen (13) years in DCG(I) Circular Ref.X-11026107/2020-PRO,QA, Regulatory Compliance, dated and GMP Auditing 20 with PharmaMarch majors such 2020 as Granules India, Aurobindo Pharma, Dr. Reddy’s and Adcock Ingram. clinical trials to recommend any specific treatment for { study, stability study etc. may be abbreviated, To, Prakash holds a Ph. D in Computationalfor sale Chemistry, and and MBA distribution in Total Quality Management. would He is also a Certified be processedPharmaceutical GMP Professional on (CPGP) and Certified Quality Auditor (CQA) by American suspected or confirmed patients with COVID-19. Society for Qualitydeferred, (ASQ) and Preventive or Controlswaived Qualified on Individual case (PCQI) to by FSPCA.case basis depending To, All StakeholdersIDMA through ACTIVIT IES CDSCO web site Copy for Payment details:forupon sale prioritythe and type distribution of though vaccine, expedited wouldnature beof drug, review/acceleratedprocessed plant from on Information,NOT FOR PROlTWhat are the SUPPLY next steps OR EQUITY BASED in the trial? tiered pricing based as willvaccinesCIIFee people paymentfurther by can who beensuring suggesteddone are online deemed throughrobust theUPI payment,safetyat adoption high paytm, and risk Gpay efficacy fromof etc. wewide willCovid-19 reviews share scale the link to joinclea the webinar“Forrances after example, the forpayment API forcartons the parks, course. protect boosting the product drug formulations from light All StakeholdersIn order to encourage through research CDSCO & development web site Copy of drug forSri URGENTLYLankaUSP India Servicepriority pharma Tax No: AAACU7542CST001approval. though firms REQUIRED USP sayIndia expedited Bank noRTGS / NEFTshortage / IFSCCode: review/accelerated ICIC0000008 Payment of Service Tax comes under services of "Commercial Training & Coaching Centre" on countries’ needs and capabilities.” dueE-ICU/tele-consultationand toUSP their India removing Bank agewhich account or unwarrantedNomedical 000805005833,the todrug conditions. tackle I.C.I.C.I. is political extractedBank, the 6-2-1012 spread considerations TGV Mansion, & of its COVID- Khairatabad experience branch,whichfrom Hyderabad indigenous in can - 500case USED otherwise004 Telangana. 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CLEARHave youH renewedave you renewedyour Membership your Membership for the for the 1. Alkem9. NewLaboratories Zealand Ltd.46.95 44.75 4. andCoronaand Customs, support.Remedies Ministry Pvt. L oftd. Finance, Department of Revenue, Guidance on product needs in lower resource Source: settings IANS, IndiaTVNews, 02.05.2020 IIf Dnot,MA please BUdo so;LLE kindly contactTIN non-symptomatic,Dollar and 500 will be those who are out of New Delhi. Year 2019-2020Year 2019-2020 & 2020-2021 & 2020-2021 Sai Seva Mandal: IDMA is thankful to the above membersYear for 2019-2020Ytheirear help 2019-2020 & 2020-2021 & 2020-2021 KIIDMAND ATTENTIO NB OFU ALLLLETIN SUBSCRIBERS OF hospital,” Vishwakarma said. as early as possible as our understanding of COVID-19 If not, pleaseIf donot, so;I pleaseDMA kindly do contact so; Secretariat kindly IDMA contact Secretariat I DMAat: at: Secretariat at: 1. Alkem Laboratories Ltd. and support. and the tools to combat it evolve. If not, pleaseIf not, do please so; kindly do so; contact kindly IDMA contact Secretariat IDMA Secretariat at: at: Email: [email protected] Tel.:Email: [email protected] - 2494 / [email protected] 4624 / /[email protected] 2497 4308 / Email: [email protected]: [email protected] / [email protected] / [email protected] Tel.:Email: 022 [email protected] - 2494 4624 / 2497 4308 / / For AdvertisingFor Advertising in the Classified in the Classified Columns Columns and alsoTel.: andfor 022 series also - 2494Tel.: for 4624I 022 NDIANseriesFax: /- 24942497 022 46244308 / D/- 2497Fax:2495RUGS 4308022 - 0723/ 2495/ Fax: 0723 022 - 2495 0723 s !DVANCEHave youFIT FOR PURPOSE renewed your MREGULATORYembership ANDfor the LIABILITYTel.: 022 Tel.:- 2494 022 4624 - 2494 / 2497 4624 4308 / 2497 / Fax: 4308 022 / - Fax:2495 022 0723 - 2495 0723 [email protected]: 022 - 2495 0723/ Have you renewed your for the advertisementsadvertisements please contact: please contact:We are pleased to state that INDIAN DRUGS – our monthly magazine - is For AdvertisingprocessesHave forin youthe all stakeholdersClassified renewed Columns Myour involved,embership M embershipand which also prioritize for series for the advertisements E-mail: [email protected], Have you renewed your Membership for the Mr ChettiarMr Chettiar (+9820629907) (+9820629907) Publications Publications Department DepartmentE-mail:available [email protected],ONLINE. In order to enable you to have access of please contact:Mr Chettiar (+9820629907) Publications Department IDMA BulletinIDMA LI Bulletin (11) 15 LIto (11)21 March 15 to 202021Tel.: March Website 022 2020 - 2494: www.idma-assn.org, 4624 / 2497 4308 / 5 5 safetyYear while 2019-2020 not slowingIDMA Bulletin IDMAdown & Bulletin LIaccess2020-2021 (11) 15LI to (11)to critical21 15 March to 21 new 2020 March 2020 5 Indian5 DrugsWebsite online, kindly: www.idma-assn.org, arrange to E-mail us your updated email ID on Year 2019-2020 & 2020-2021 [email protected]: 022 / [email protected] 2495 0723 IYftools. not,ear Ypleaseear 2019-2020 do 2019-2020so; kindly contact & IDMA2020-2021 & Secretariat2020-2021 at: www.indiandrugsonline.org If not, please do so; kindlyIDMA contact IDMA BULLETIN Secretariat at: IDMAIDMA BULLETIN BULLETIN For morewww.indiandrugsonline.org details, please contact: Publications Department : Ifs not,Email:Email: "UILD please [email protected] [email protected] AND do MAINTAIN so; kindly PUBLIC / [email protected] contact CONlDENCE/ [email protected] IDMA IN Secretariat THE APPROVAL at: Tel:022-24944624/ 24974308 / Fax: 022-24950723 / E-mail: mail_idma@ Tel.: 022 - 2494IfTel.: not, 0224624 -please 2494 / 2497 4624 do/ 43082497 so; 4308 / kindlyFax: / Fax: 022 022 contact - 2495 0723 0723/ IDMA E-mail: Secretariat [email protected], at: Tel.: 022 - 2494 4624 / 2497 4308 / Fax: 022 - 2495 0723 Tel.: 022Tel.: - 2494 022 4624- 2494 / 2497 4624 4308 / 2497 / Fax: 4308 022 / Fax: - 2495 022 0723/ -idmaindia.com 2495 E-mail: 0723/ / web: E-mail:www.idma-assn.or g / www.indiandrugsonline.org Email:Email: [email protected] Website:[email protected] www.idma-assn.org, for diagnostics, / [email protected] www.indiandrugsonline.org /therapeutics, [email protected] and [email protected],[email protected], Tel.: Tel.:022 - 0222494 - 24944624 /4624 2497 / 43082497 4308/ Fax: / 022 Fax: - 2495022 -0723 2495 0723 IDMA Bulletin LI (11) 15 to 21 March 2020 5 Website:Website: www.idma-assn.org, www.idma-assn.org, www.indiandrugsonline.org www.indiandrugsonline.org IDMA IDMABulletin Bulletin LI (11) LI (15) 15 15to 21to 21 IDMAMarch April Bulletin 20202020 LI (37) 01 to 07 October 2020 IDMAIDMA IDMA BulletinBulletin Bulletin XLVIII11 LIXLVII (12) (04)(44) 22 5 to22 30 to March30 NovemberJanuary 2020 2017 2016 39 403829 IDMA BulletinIDMAIDMA LIBulletin Bulletin (18) 08 LI LI to(21) (22) 14IDMA 01 May08 to to 202007 Bulletin14 June June 2020 LI2020 (28) 22 to 30 July 2020 IDMAIDMA BulletinBulletin LI24LIILI (11) (16)(28) 15 222285 to toto 21 3030 March AprilJuly 20202021 2020 36 34315 IDMAIDMA Bulletin Bulletin LI (11) LI (11) 15 to 15 21 to IDMAMarch 21 IDMAMarch Bulletin 2020 Bulletin 2020 LI (12) LI (12)22 to 22 30 to March 30 March 2020 2020 5 5 16 16 INDIAN DRUGS ONLINE For AdvertisingPU inBLISHED the ON 28th OF EVERY MONTH ClassifiedADVERTISEMENT Columns and BANNER also RATES FOR INDIAN DRUGS WEBSITE for Series Advertisement(Rates in Rupees per insertion) 331,Kalyandas Udyog Bhavan,Century Bazar Lane, Position Size RATES VALIDITY Worli, Mumbai-25 For AdvertisingDRightiscount Side Banner in the Classified180 X 150 Pixel Columns25,000 and3 MONTHSalso for series advertisementsPleaseLeft Side contact Banner Please : 180Contact: X 150 Pixel Geeta25,000 Suvarna3 MONTHS (+9820161419) NEED MANPOWER FOR Terms and Conditions Publications Department All paymentsAdvertising by DD in advance Dept. only to be made in favour of Indian Drug Manufacturers’ Association, payable at YOUR COMPANY? 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IDMAIDMA Bulletin Bulletin LIIXLVII (24) (48) 22 to22 30 to June30 December 2021 2016 4836 IDMA Bulletin LII (22) 08 to 14 June 2021 42 IDMA Bulletin XLIV (14) 08 to 14 April 2013 43
IDMA ACTIVITIES Virus Attenuation Device (Shycocan Brand) Sponsored by JBCPL
Mr. Bharat Shah, Chairman, IDMA 60th Year Celebrations Committee along with his team Mr. Mehul Shah, Mr. Mahesh H Doshi, Mr. Daara B Patel, Dr. Viranchi Shah and Mr. B G Barve standing below the Viral Attenuation Device (Shycocan brand) gifted by M/s. J B Chemicals and Pharmaceuticals Ltd. courtesy their CEO Mr. Nikhil Chopra.
l l l
IDMA Bulletin LII (28) 22 to 30 July 2021 6
IDMA GSB team welcoming Shri Manoj Aggarwal, Additional Chief Secretary, H & FW Dept on July 08, 2021 at Gandhinagar
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INDIAN PHARMACOPOEIA IDMA thanks Dr. Rajeev Singh Raghuvanshi, Secretary- cum-Scientific Director, IPC for Three Months Extension for Implementation of IP Addendum 2021 - reg.
F. No. T.11014/01/2019-AR&D, dated 26th July 2021 To 1. The Drugs Controller General (India) 2. All Zonal Offices/Port Offices of CDSCO 3. All State Drug (Controllers) 4. Directors of Central Drugs Laboratories 5. Directors of State Drugs Laboratories 6. Members of the Scientific Body of IPC 7. Government Analysts 8. IDMA/BDMA/OPPI/FSSAI/Small Scale Industry Associations Considering the impact of the current COVID-19 pandemic, one time extension of three months in the effective date of Addendum 2021 to the Indian Pharmacopoeia (IP) 2018 is being provided to the stakeholders for implementation of the standards included therein. IP Addendum 2021 shall be effective from 31st December 2021.
All concerned are requested to bring it to the notice of all authorities under their control for the compliance. Dr. Rajeev Singh Raghuvanshi, Secretary-cum-Scientific Director, Sector 23, Raj Nagar, Ghaziabad 201 002 (U.P.), India l l l
IDMA Bulletin LII (28) 22 to 30 July 2021 7
PARLIAMENT NEWS In Lok Sabha & In Rajya Sabha
In Lok Sabha Financial Financial Financial CSR Funds of Corporate Year Year Year 2017-18 2018-19 2019-20 Houses Question No. of Companies 21,455 24,965 21,349 Lok Sabha Unstarred Question No. 83 CSR expenditure 13,909 18,728 21,231 (in Rs. Crore) Shri Asaduddin Owaisi: (Data upto 31.03.2021) [Source: National CSR Data Portal] Q. Will the Minister of CORPORATE AFFAIRS be pleased Ministry vide General Circular no.10/2020 dated to state: 23.03.2020 clarified that CSR funds may be spent by (a) whether it is a fact that corporate houses spend a the companies for various activities related to COVID- huge sum on Corporate Social Responsibility(CSR) 19 under item nos. (i) and (xii) of Schedule VII of the for the welfare of workers and local people in the Companies Act, 2013 (‘Act’) which relates to promotion country and if so, the details thereof; of health care, including preventive health care and sanitation, and disaster management. Further, Ministry (b) whether due to corona virus corporate houses vide General Circular no.05/2021 dated 22.04.2021 changed their strategy by setting up hospitals, and General Circular no.09/2021 dated 05.05.2021 oxygen plants in the area of their operation and if clarified that spending of CSR funds by the companies so, the details thereof; for setting up makeshift hospitals and temporary (c) whether the Government has asked the corporate COVID care facilities and ‘creating health infrastructure houses to establish hospitals, testing facilities and other for COVID care’, ‘establishment of medical oxygen health facilities for their workers and local people; generation and storage plants’ ‘manufacturing and supply of Oxygen concentrators, ventilators, cylinders (d) if so, the instructions issued by the Government to and other medical equipment for countering COVID-19 corporate houses to take up health infrastructure respectively, are eligible CSR activities. under CSR; and (e) As per the Act, financial statements and board (e) the number of corporate houses that have helped report containing disclosure about CSR, for the the local people in fighting the disease? ongoing financial year 2021-22, are required to be Answered on 19th July 2021 filed only after the end of financial year. A. (a) to (d): Section 135 of the Companies Act, 2013 Minister of State (Independent Charge) of the Ministry (‘Act’) mandates every company having net worth of of Statistics and Programme Implementation; Rs. 500 crore or more, or turnover of Rs. 1000 crore Minister of State (Independent Charge) of the or more, or net profit of Rs. 5 crore or more during Ministry of Planning and Minister of State in the the immediately preceding financial year to undertake Ministry of Corporate Affairs [Rao Inderjit Singh] Corporate Social Responsibility (CSR) activities. Separation of Chairman and Managing CSR is a Board driven process and the Board of the company is empowered to plan, decide, execute and Director Posts Question monitor the CSR activities of the company based on Lok Sabha Un-Starred Question No. 210 the recommendation of its CSR Committee. All data Shri Balashowry Vallabhaneni: related to CSR filed by companies in the MCA21 registry is available in public domain at www.csr.gov. Q. Will the Minister of CORPORATE AFFAIRS be pleased in. On the basis of filings made by the companies to state: in MCA21 registry, CSR amount spent by various (a) whether it is true that SEBI rules mandates separation companies in the financial years 2017-18, 2018-19 of Chairman and Managing Director posts before the and 2019-20 respectively are given below: end of this fiscal;
IDMA Bulletin LII (28) 22 to 30 July 2021 8
(b) if so, the details of companies that have implemented Shri Nayab Singh: this rule so far and the status of remaining companies; Q. Will the Minister of CORPORATE AFFAIRS be pleased to state: (c) the status of separation in Central Public Sector Enterprises (CPSEs); and (a) whether the Government has made any changes in the laws governing Corporate Social Responsibility (d) the measures likely to be taken by the Government (CSR); to address the apprehension in some quarters of corporate world that this arrangement would weaken (b) if so, the details of the changes made therein and the position of promoters? the reasons therefor; Answered on 19th July 2021 (c) whether the Government proposes to carry out radical changes in the laws governing CSR; A. (a) : Yes Sir, in terms of Regulation 17(1B) of SEBI (Listing Obligations and Disclosure Requirements), (d) if so, the details thereof; and Regulations, 2015 (“LODR”), the top 500 listed (e) the details of the total CSR spending by the Public entities by market capitalization are mandated to Sector Undertakings during the period from March, comply with the requirement of separation of the 2020 till date State/UT-wise? roles of Chairperson of the Board and MD/ CEO with th effect from April 01, 2022. Answered on 19 July 2021 (b) and (c): SEBI has informed the status of applicability A. (a) to (d): Yes sir. In pursuance of the Amendments of Regulation 17(1B) and the status of implementation to Section 135 of the Companies Act, 2013 (‘Act’) by of Regulation 17(1B)(a) and 17(1B)(b) for top 500 Companies (Amendment) Act, 2019 and Companies companies, including CPSEs as under:- (Amendment) Act, 2020, the Companies (CSR Policy) BSE NSE Rules, 2014 have been amended on 22nd January No. of entities to which Regulation 486 487 2021. These amendments aim at strengthening the 17(1B) of LODR is applicable Corporate Social Responsibility (CSR) ecosystem No. of entities that have non- CPSE OTHER CPSE OTHER by improving the disclosures, simplifying the executive director in terms of 6 274 6 273 compliances, bringing in more objectivity and Regulation 17(1B)(a) of LODR transparency, and entrusting more responsibility on No. of entities where Chair- 12 275 12 278 the Board of the company. These amendments, inter- person is not related to MD/CEO have implemented Regulation alia, include mandatory registration of implementing 17(1B)(b) of LODR agencies with the Ministry, flexibility to board for spending as per project requirements, treatment of (d): The separation of post of Chairperson from MD/CEO is considered to enhance corporate unspent amount as well as set-off of excess amount governance, therefore, apprehension that it would spent under CSR, impact assessment of CSR weaken the position of promoters is misplaced. projects, modalities for creation and acquisition of capital assets through CSR etc. Minister of State (Independent Charge) of the Ministry of Statistics And Programme Implementation; (e): As per the Companies Act, 2013 companies are Minister of State (Independent Charge) of The required to hold Annual General Meeting (AGM) within Ministry of Planning; and Minister of State for six months from the end of financial year. Thereafter, Corporate Affairs [Rao Inderjit Singh] financial statements and board report containing disclosure about CSR, are to be filed in MCA21 within AMENDMENT TO CSR RULES 30 days of the AGM. Thus, the CSR data for the Financial Year 2020-21 is not available. QUESTION Minister of State (Independent Charge) of the Ministry Lok Sabha Unstarred Question No. 212 of Statistics and Programme Implementation; Shri Sanjay Bhatia: Minister of State (Independent Charge) of the Ministry of Planning and Minister of State in the Shri Brijendra Singh: Ministry of Corporate Affairs [Rao Inderjit Singh] IDMA Bulletin LII (28) 22 to 30 July 2021 9
GST ON COVID RELIEF GOODS B.Oxygen, Oxygen generation equipment and related medical devices Lok Sabha Unstarred Question No.216 1. Medical Grade Oxygen 12% 5% Shri Anurag Sharma: 2. Oxygen Concentrator/Generator, 12% 5% including personal imports thereof Will the Minister of be pleased to state: Q. FINANCE 3. Ventilators 12% 5% (a) whether it is a fact that the Government has brought 4. Ventilator masks/canula/helmet 12% 5% down the Goods and Services Tax (GST) on 14 Covid 5. Bi PAP Machine 12% 5% relief goods; 6. High flow nasal canula (HFNC) 12% 5% (b) if so, the details thereof; device (c) whether it is also true that the relaxation given will C.Testing Kits and Machines remain till September, 2021 and if so, the details 1. Covid Testing Kits 12% 5% thereof; and 2. Specified Inflammatory Diagnostic 12% 5% (d) whether it is also true that this met with the demands Kits, namely D- Dimer, IL-6, Ferritin of the many States in this regard and if so, the details and LDH thereof? D. Other Covid-19 related relief material 1. Pulse Oximeters, including personal 12% 5% th Answered on 19 July 2021 imports thereof A. (a) : In order to ensure the availability and affordability 2. Hand Sanitizer 18% 5% of the items necessary for treatment and management 3. Temperature check equipment 18% 5% of COVID-19 situation, Government has reduced the 4. Gas/Electric/other furnaces for 18% 5% GST rates on such items. crematorium, including their (b) : The details of goods for Covid relief on which installation, etc. GST rate has been reduced is enclosed. 5. Ambulances 28% 12% (c) : The above stated concessions are effective upto th Minister of State in the Ministry of Finance and inclusive of 30 September, 2021. Sh. Pankaj Choudhary (d) : GST rates are prescribed on the basis of recommendations of the GST Council as made CSR Funds Question from time to time. GST Council is a constitutional body having Ministers of all the states and Union Lok Sabha Unstarred Question No. 230 Territory having legislature as its member. The Shri Annasaheb Shankar Jolle: recommendations, in this regard, were based on suggestions received from many State Q. Will the Minister of CORPORATE AFFAIRS be pleased Governments. to state:
ANNEXURE (a) the yearly expenditure of CSR funds under legally mandated law; Covid Relief Goods on which GST rate has been (b) whether the changes in its administration and reduced utilisation is evaluated against the funds spent; S. Description From To (c) if so, the details thereof and if not, the reasons No. therefor; A. Medicines (d) whether the data is available on the same is district 1. Tocilizumab 5% Nil and State-wise expenditure for proper planning and 2. Amphotericin B 5% Nil analyzing; and 3. Anti-Coagulants like Heparin 12% 5% (e) if so, the details thereof and time by which the same 4. Remdesivir 12% 5% will be available in near future?
IDMA Bulletin LII (28) 22 to 30 July 2021 10
Answered on 19th July 2021 sufficient safeguards. Whenever any violation of CSR provisions is reported, action against such non- A. (a) to (e): Section 135 of the Companies Act, 2013 compliant Companies are initiated as per provisions (‘Act’) mandates every company having net worth of the Act after due examination of records and of Rs. 500 crore or more, or turnover of Rs. 1000 crore or more, or net profit of Rs. 5 crore or more following due process of law. during the immediately preceding financial year to All data related to CSR filed by companies in the undertake Corporate Social Responsibility (CSR) MCA21 registry including district- wise and State- activities. CSR is a Board driven process and wise is available in public domain at www.csr.gov. the Board of the company is empowered to plan, in. The State-wise CSR spent by all the companies decide, execute and monitor the CSR activities of for the financial years 2014-15, 2015-16, 2016-17, the company based on the recommendation of its 2017-18, 2018-19 and 2019-20 respectively is at CSR Committee. The entire CSR architecture is Annexure. disclosure based and CSR mandated companies are required to file details of CSR activities annually in Minister of State (Independent Charge) of the Ministry MCA21 registry. The existing legal provisions such of Statistics and Programme Implementation; as mandatory disclosures, accountability of the CSR Minister of State (Independent Charge) of Committee and the Board, provisions for statutory the Ministry of Planning and Minister of State in the audit of accounts of the company etc. provide Ministry of Corporate Affairs [Rao Inderjit Singh]
Annexure Annexure Referred to In Reply to Lok Sabha Unstarred Question No. 230 For 19.07.2021
STATE/UT-WISE CSR EXPENDITURE DETAILS (IN RS. CRORE) States/UT Amount Amount Amount Amount Amount Amount Total Spent FY Spent FY Spent FY Spent FY Spent FY Spent FY 2014-15 2015-16 2016-17 2017-18 2018-19 2019-20 Andaman And 0.29 0.55 0.83 0.75 0.43 0.68 3.53 Nicobar Andhra 414.27 1,294.28 753.52 275.27 644.83 679.19 4061.36 Pradesh Arunachal 11.04 1.48 24.04 12.13 24.50 16.83 90.03 Pradesh Assam 134.78 164.60 269.91 86.23 206.01 753.73 1614.26 Bihar 36.68 124.61 100.77 47.49 136.47 138.15 584.17 Chandigarh 1.77 5.34 21.98 20.51 11.72 14.24 75.57 Chhattisgarh 161.30 241.16 84.94 71.79 146.66 156.64 862.48 Dadra And 4.41 12.02 7.58 6.93 13.48 18.92 63.33 Nagar Haveli Daman And 20.05 2.42 2.63 20.09 6.23 8.60 60.02 Diu Delhi 237.43 493.34 521.16 558.33 674.17 643.99 3128.41 Goa 27.11 30.15 37.89 53.34 46.74 43.71 23.93 Gujarat 313.44 551.42 870.84 775.90 1,065.90 910.13 4487.63 Haryana 187.40 375.61 390.07 266.09 334.53 474.43 2029.14 Himachal 10.94 52.28 24.03 60.60 79.97 76.09 303.92 Pradesh
IDMA Bulletin LII (28) 22 to 30 July 2021 11
Jammu And 43.70 107.80 42.84 46.44 35.34 24.93 301.06 Kashmir Jharkhand 79.56 117.03 95.69 45.92 70.30 139.04 547.54 Karnataka 403.46 784.66 887.68 1,034.33 1,224.92 1383.65 5718.69 Kerala 68.23 148.13 135.47 167.24 387.17 250.02 1156.25 Lakshadweep 0 0.30 0 2.07 0.39 1.00 3.76 Madhya 141.88 185.50 290.60 147.25 247.15 165.47 1177.84 Pradesh Maharashtra 1,445.91 2052.23 2492.11 2,565.59 2,864.04 2,751.21 14171.09 Manipur 2.44 6.27 12.35 4.03 7.64 10.87 43.61 Meghalaya 3.53 5.58 10.97 5.49 17.99 17.29 60.85 Mizoram 1.03 1.07 0.08 0.23 0.11 0.25 2.77 Nagaland 1.11 0.95 0.92 0.36 2.11 1.64 7.09 Odisha 252.18 624.04 316.72 472.58 682.87 679.43 3027.83 Puducherry 2.02 6.46 7.42 6.53 8.30 8.63 39.37 Punjab 55.60 69.92 75.83 89.32 164.58 176.06 631.31 Rajasthan 299.75 502.95 325.15 263.83 549.02 696.77 2637.47 Sikkim 1.19 1.98 6.83 6.84 4.58 3.94. 25.37 Tamil Nadu 539.63 633.23 550.94 627.75 829.27 919.05 4099.88 Telangana 101.96 265.40 259.88 293.53 422.39 404.97 1748.13 Tripura 1.33 1.47 1.25 1.83 23.06 4.34 33.29 Uttar Pradesh 148.90 423.79 328.31 302.91 479.88 496.13 2179.93 Uttarakhand 74.79 73.16 102.52 86.65 173.32 105.34 615.78 West Bengal 194.85 415.41 290.35 299.77 369.50 390.51 1960.39 NEC/ Not 26.94 0 7.63 132.04 3.68 3.42 173.72 mentioned PAN India* 4,615.03 4,740.61 4,990.68 5,050.79 6,767.74 8,662.86 34827.72 Grand Total 10,065.93 14,517.20 14,342.45 13,908.79 18,728.01 21,231.15 92793.54 (in Cr.) (Data upto 31.03.2021) [Source: National CSR Data Portal] *Companies either did not specify the names of States or indicated more than one State where projects were undertaken.
TAX Exemption on Import of Medical (c) whether the GST council has constituted a Group Items of Ministers to examine the requirement for GST concessions/exemption for items used as Covid-19 Lok Sabha Unstarred Question No.104 relief material; and Shri Kuruva Gorantla Madhav: (d) if so, the details of the report or the recommendations of the committee in this regard? Q. Will the Minister of FINANCE be pleased to state: th (a) whether the Government has granted tax exemptions Answered on 19 July 2021 on the import of essential medical items to combat A. (a) and (b): In order to ensure the availability and Covid-19; affordability of goods being used for Covid-19 relief (b) if so, the details thereof; and management, the Government has for specified
IDMA Bulletin LII (28) 22 to 30 July 2021 12 period provided the following indirect exemptions/ Answered on 19th July 2021 concessions on imports of such items:- A. (a) : In order to ensure the availability and affordability (i) Customs Duties including cesses, wherever of goods being used for Covid-19 relief and applicable, has been exempted on (a) medicines management, the Government has for specified such as Remdesivir injection, Remdesivir API, period provided the following indirect exemptions/ Amphotericin B and specified inputs for their concessions on such items:- manufacturing (b) oxygen and oxygen related equipment (c) Covid-19 Vaccines (d) specified (i) Customs Duties has been exempted on (a) inflammatory diagnostic kits, etc. medicines such as Remdesivir injection, Remdesivir API, Amphotericin B and specified (ii) Specified Covid relief items have also been inputs for their manufacturing (b) oxygen and exempted from payment of IGST when imported oxygen related equipment (c) Covid-19 Vaccines for donation to Central Government, State (d) specified inflammatory diagnostic kits, etc. Government or any relief agency, entity or statutory body for free distribution. (ii) Specified Covid relief items have also been exempted from payment of IGST when imported (iii) GST rate has been reduced on imports of for donation to Central Government, State specified goods like Covid-19 related medicines, Government or any relief agency, entity or oxygen, oxygen related equipment, specified statutory body for free distribution. Covid-19 testing kits, Pulse oximeters, hand sanitizers, temperature check equipment, (iii) GST rate has been reduced on specified Gas/electric furnace for crematorium and goods like Covid-19 related medicines, oxygen, ambulances. oxygen related equipment, specified Covid-19 testing kits, Pulse oximeters, hand sanitizers, rd (c) and (d): GST Council in its 43 meeting decided temperature check equipment, Gas/electric to constitute a Group of Ministers (GoM) to examine furnace for crematorium and ambulances. the issue of GST exemption/concession on Covid relief material. The GoM made recommendations (b) : The list of Covid-19 relief goods on which GST/ for reducing GST rates on specified Covid relief Customs duty has been reduced is enclosed. items. These recommendations were discussed Minister of State in the Ministry of Finance in 44th meeting of GST Council. Council made Sh. Pankaj Choudhary recommendation for reduction of GST rates, on Covid ANNEXURE relief items taking into account the recommendations of GoM. On the recommendation of Council, the A. Exemption/ Reduction in GST and IGST (on concessional GST rates on items mentioned at imports) on COVID-19 relief goods item no. (iii) in reply part (a) and (b) above were notified. S. Description From To No. Minister of State in the Ministry of A. Medicines Finance Sh. Pankaj Choudhary 1. Tocilizumab 5% Nil 2. Amphotericin B 5% Nil TAXES On Medical Equipments 3. Anti-Coagulants like Heparin 12% 5% Lok Sabha Unstarred Question No.18 4. Remdesivir 12% 5% Shri Nitesh Ganga Deb: B. Oxygen, Oxygen generation equipment and related medical devices Q. Will the Minister of FINANCE be pleased to state: 1. Medica lGrade Oxygen 12% 5% (a) whether the Government has waived taxes from 2. Oxygen Concentrator/Generator, 12% 5% articles and medical equipments used for corona including personalimports thereof treatments in the country; and 3. Ventilators 12% 5% (b) if so, the details thereof? 4. Ventilator masks/canula/helmet 12% 5%
IDMA Bulletin LII (28) 22 to 30 July 2021 13
5. BiPAP Machine 12% 5% 14. Oxygen cylinders including cryogenic cylinders 6. High flow nasal canula (HFNC)device 12% 5% and tanks C. Testing Kits and Machines 15. Parts of goods at S.No.6 to 14 above, used 1. Covid Testing Kits 12% 5% in the manufacture of equipment related to 2. Specified Inflammatory Diagnostic 12% 5% the production, transportation, distribution or Kits, namely D-Dimer, IL-6, Ferritin storage of Oxygen, subject to the condition that and LDH the importer follows the procedure set out in the Customs (Import of Goods at Concessional Rate D. Other Covid-19 related relief material of Duty) Rules, 2017. 1. Pulse Oximeters, including personal 12% 5% imports thereof 16. Any other device from which oxygen can be 2. Hand Sanitizer 18% 5% generated 3. Temperature check equipment 18% 5% 17. Ventilators, including ventilator with compressors; 4. Gas/Electric/ other furnaces for cre- 18% 5% all accessories and tubings; humidifiers; viral matorium, including the irinstallation, filters (should be able to function as high flow etc. device and come with nasal canula). 5. Ambulances 28% 12% 18. High flow nasal canula device with all attachments; nasal canula for use with the device. B. Full Exemption from Customs Duty on import of 19. Helmets for use with non-invasive ventilation. COVID-19 relief goods 20. Non-invasive ventilation oronasal masks for ICU S. No. Description of goods ventilators. 1. Remdesivir Active Pharmaceutical Ingredients 21. Non-invasive ventilation nasal masks for ICU (API) ventilators. 2. Beta Cyclodextrin (SBEBCD) used in manufacture 22. COVID-19 vaccine of Remdesivir, subject to the condition that the importer follows the procedure set out in the 23. Amphotericin B Customs (Import of Goods at Concessional Rate 24. 6 specified API/ excipients for manufacturing of Duty) Rules, 2017. Amphotericin B 3. Injection Remdesivir. 25. Raw materials for manufacturing COVID test 4. Inflammatory Diagnostic (marker) kits, namely- kits IL6, D-Dimer, CRP(C-Reactive Protein), LDH (Lactate De-Hydrogenase), Ferritin, Pro Calcitonin (PCT) and blood gas reagents Bulk Drug Park 5. Medical Oxygen Lok Sabha Starred Question No. 114 6. Oxygen concentrator including flow meter, Shri Anurag Sharma: regulator, connectors and tubings. 7. Vacuum Pressure Swing Absorption (VPSA) and Q. Will the Minister of CHEMICALS AND FERTILIZERS Pressure Swing Absorption (PSA) oxygen plants, be pleased to state: Cryogenic oxygen Air Separation Units (ASUs) (a) whether the Government has received any proposal producing liquid/gaseous oxygen. for construction of Bulk Drug Park (Pharmaceutical 8. Oxygen canister. Park) in Lalitpur, Uttar Pradesh; 9. Oxygen filling systems. (b) if so, the details thereof; 10. Oxygen storage tanks (c) the funds released for construction of the said park; 11. Oxygen generator and 12. ISO containers for Shipping Oxygen (d) the time by which the construction of the said park 13. Cryogenic road transport tanks for Oxygen is likely to be completed?
IDMA Bulletin LII (28) 22 to 30 July 2021 14
Answered on 27th July 2021 the list in accordance with their local needs and requirements for treatment/management of COVID- A. (a) to (d): A statement is laid on the Table of the 19 and its sequelae such as COVID-19 Associated House. Mucormycosis (CAM) and Multisystem Inflammatory Syndrome in Children (MIS-C). Statement Reffered to in Reply to Parts (A) to (D) of Starred Question No. 114 For Reply On 27.07.2021 (b) Government has taken various steps to enhance production and maintain sufficient supply of critical (a) to (b): Department of Pharmaceuticals has received drugs. The measures included expeditious approvals a proposal from the Government of Uttar Pradesh for to increase the number of manufacturing sites of establishment of a Bulk Drug Park under the scheme for Remdesivir and Amphotericin-B. There was regular “Promotion of Bulk Drug Parks”. The proposed site for engagement with the manufacturers of COVID-19 the bulk drug park is located in Saidpur Village (Mehrauni drugs to monitor their production. The export of Tehsil) of Lalitpur District. The appraisal of all the proposals Remdesivir and Amphotericin-B was also prohibited received under the scheme has been initiated. to maintain adequate domestic supply. The Ministry (c): No, Sir. of External Affairs also assisted the manufacturers (d): No such time has been decided. for import of raw materials and COVID-19 drugs. To ensure equitable distribution of drugs across the Minister in the Ministry of Chemicals & Fertilizers country, allocation of Remdesivir, Tocilizumab and (Shri Mansukh Mandaviya) Amphotericin-B was done to States/UTs based on rational and transparent allocation criteria. Daily Covid-19 Pandemic monitoring of supply of allocated drugs by National Lok Sabha Unstarred Question No. 1184 Pharmaceutical Pricing Authority (NPPA) was done for ensuring timely supply of drugs through Shri Parvesh Sahib Singh Verma: coordination with nodal officers of States and liaison Q. Will the Minister of CHEMICALS AND FERTILIZERS officers of manufacturers. Monitoring of availability be pleased to state: of the drugs was also done regularly by the Central Drugs Standard Control Organisation (CDSCO) and (a) whether the Government is preparing in advance for the NPPA. future wave of Covid-19 pandemic; (c) Amidst reports of black-marketing / hoarding (b) the steps taken by the Government to enhance / overcharging of COVID-19 management drugs, production and maintain sufficient supply of critical CDSCO has requested Licensing authorities of all drugs and medicines with regard to treatment of States/UTs through several advisories to instruct COVID19; and their enforcement staff to keep strict vigil especially (c) whether the Government has taken any steps to at sensitive places and to take stringent action check and prevent black-marketing and duplication against the offenders by conducting special drive of life saving drugs and if so, the details thereof? of monitoring and investigation. As per information available from various State Licensing Authorities, in th Answered on 27 July 2021 cases of black-marketing / hoarding/overcharging of A. (a): Yes, Sir. Ministry of Health and Family Welfare COVID-19 management drugs, various enforcement has prepared the guidelines for Buffer Stock actions like drug seizure, arrests of accused persons Management of COVID-19 on importance of / registration of FIRs etc. have been carried out by maintenance of sufficient buffer stocks of essential the State Licensing Authorities. drugs used in management of COVID-19 cases The NPPA vide letter dated 08.04.2021 addressed and their sequelae. Ministry of Health and Family to all State Drug Controllers, had directed to closely Welfare has identified a suggestive list of drugs to monitor the production and availability of COVID-19 be a part of the buffer stock to be maintained by drugs to prevent black marketing and hoarding. the State/UT Governments as well as the Central Government. Further, inter-alia, the Guidelines also Minister in the Ministry of Chemicals & Fertilizers provide that the States/UTs may suitably customize (Shri Mansukh Mandaviya)
IDMA Bulletin LII (28) 22 to 30 July 2021 15
Eluting Stents, Condoms and Intra Uterine Devices Affordable Medical Devices (Cu-T). Lok Sabha Unstarred Question No.1194 Recently, NPPA invoked Paragraph 19 of the DPCO, Shri Kanumuru Raghu Rama Krishna Raju: 2013 to regulate the price of Oxygen Concentrators vide Notification dated 03.06.2021, and prices of Shri Manoj Kotak: (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and Q. Will the Minister of CHEMICALS AND FERTILIZERS (v) Glucometer under ‘Trade Margin Rationalisation’ be pleased to state: Approach vide Notification dated 13.07.2021, in (a) whether the Government has any proposal to provide view of the extraordinary circumstances arising due affordable medical devices/equipments and surgical to COVID pandemic and with the aim of making items in the country, if so, the details thereof; these medical devices affordable during the evolving pandemic. (b) the details of the steps taken by the Government to make surgical items affordable in the country; NPPA also monitors prices of 28 notified medical devices under compulsory licensing framework under (c) whether the Department of Pharmaceuticals has Para 20 of the DPCO, 2013 to ensure their MRP is launched any Umbrella Scheme in this regard; and not increased more than 10% in preceding twelve (d) if so, the details thereof and the progress regarding months. the implementation of the said Scheme? (c) & (d): As part of the Umbrella Scheme on Answered on 27th July 2021 ‘Development of Pharmaceutical Industry’, there is a sub-scheme, viz., ‘Production Linked Incentive A. (a) and (b) :The Government has taken various Scheme for Promoting Domestic Manufacturing of measures to provide affordable medical devices/ Medical Devices’ with an outlay of Rs. 3,420 cr. equipments and surgical items to the citizens in the to boost domestic manufacturing and attract large country. investments in the Medical Devices Sector. Under With an objective of making quality generic the Scheme, financial incentive is given to the medicines, surgicals & consumables available at selected companies at the rate of 5% on incremental affordable prices to all the citizens, especially to the sales of medical devices manufactured. Under the poor and the deprived ones, Pradhan Mantri Bhartiya Scheme, 13 applications have been approved with Janaushadhi Pariyojana (PMBJP) was launched a total Committed Investment of Rs.798.93 crore. by the Department of Pharmaceuticals. Under the Another sub-scheme under the Umbrella Scheme for scheme, more than 7,900 dedicated outlets known ‘Promotion of Medical Device Parks’ with an outlay of Rs. 400 cr. provides support for creation of common as Pradhan Mantri Bhartiya Janaushadhi Kendras infrastructure facilities to provide easy access to (PMBJK) have been opened in all the districts of standard testing and infrastructure facilities through the country. The product basket of PMBJP presently creation of world class common infrastructure comprises of 1,451 medicines and 204 surgicals & facilities for medical devices. consumables. Minister in the Ministry of Chemicals & Fertilizers Further, the National Pharmaceutical Pricing Authority (Shri Mansukh Mandaviya) (NPPA) under the Department of Pharmaceuticals has fixed the ceiling prices of the Coronary Stents and Knee Implants under Para 19 of the DPCO, Shortage of Antiviral Drugs 2013 vide Notifications dated 13th Feb 2017 and Lok Sabha Unstarred Question No. 1223 16th August 2017 respectively in the larger public interest. Further, NPPA has extended ceiling price Shri Kumbakudi Sudhakaran: of four medical devices, which have been included Shri Mohammed Faizal P.P.: in the National List of Essential Medicines (NLEM) and in Schedule-I of the Drugs (Prices Control) Shri D.K.Suresh: Order, 2013(DPCO, 2013), viz., Cardiac Stents, Drug Shri Gaurav Gogoi:
IDMA Bulletin LII (28) 22 to 30 July 2021 16
Dr. A. Challakumar: sites of Remdesivir in India increased from 22 in mid- April, 2021 to 62 at present. The domestic production Shri Pradyut Bordoloi: capacity of Remdesivir increased from 38 lakh vials Dr. Amar Singh: per month in mid-April, 2021 to 122 lakh vials per month now. Similarly, in case of Tocilizumab, the Shri M. Selvaraj: imported quantity was maximised due to persistent Shri Sisir Kumar Adhikari: efforts of the Government with the sole manufacturer of Tocilizumab. Shri Saptagiri Sankar Ulaka: Further, in order to secure domestic supply of Q. Will the Minister of CHEMICALS AND FERTILIZERS Remdesivir, the export of Remdesivir Injection and be pleased to state: Remdesivir API (Active Pharmaceutical Ingredient) was prohibited from 11th April, 2021. In addition, Department (a) whether the Government has taken cognisance of of Pharmaceuticals (DoP) and Ministry of Health and shortage of antiviral drugs such as Remedesivir and Family Welfare (MoH&FW) jointly undertook an exercise Tocilizumab; for allocation of available stocks of Remdesivir and (b) if so, the details thereof and action taken to address Tocilizumab to all the States/UTs of the country in a move this shortage; to mitigate shortage and to ensure fair and equitable distribution across the country. The total allocation and (c) whether the Government, exercising its powers supply of these two drugs is given as under: under the Patents Act intends to issue compulsory licenses to generic pharmaceutical companies for Sr. Name of Allocation to States/ Supply till manufacturing of low cost versions of Remdesivir No. the drug UTs and Central 18.07.2021 and Tocilizumab; Institutions (in vials) (in vials) (d) if so, the details thereof and if not, the reasons 1. Remdesivir 98,87,000 97,03,393 therefor; Injection 2. Tocilizumab 9,900 9,578 (e) the number of Remdesivir manufacturers in the (400 mg) country and their production capacity, since 2019 Injection till date; and 3. Tocilizumab 65,000 53,284 (f) the number of Remedesivir and Tocilizumab (80 mg) manufacturing units set up between March 2020 and Injection May 2021? In addition to the above allocation of commercial supplies to States/UTs, the MoHFW has also Answered on 27th July 2021 distributed the following, free of cost, to the States/ A. (a) to (b): Yes, Sir. Shortages were noticed in the UTs: months of April and May, 2021 in case of Remdesivir • 21,86,936 vials of Remdesivir purchased from and Tocilizumab due to the sudden surge in demand the domestic manufacturers. of these drugs for managing COVID-19 patients. It may be noted that both these drugs are patented • 8,23,862 vials of Remdesivir sourced from drugs. Remdesivir is manufactured in India whereas outside India through donation and commercial Tocilizumab is available in India through imports only. purchases. To address the shortages, government immediately • 1,001 vials of Tocilizumab (400 mg) received in started working on augmenting supply of these donation from Oman have been distributed to drugs by augmenting domestic production in case States/UTs. of Remdesivir and by making efforts for increased • 27,381 vials of Tocilizumab (80 mg) received in quantity of imports in case of Tocilizumab. Due to donation from Roche have been distributed to collective efforts made in this direction by seven States/UTs. domestic manufacturers of Remdesivir and with the grant of expeditious approvals by Drug Controller As on date, the demand of Remdesivir has come General of India, the number of licensed manufacturing down considerably and the demand supply gap
IDMA Bulletin LII (28) 22 to 30 July 2021 17
has reversed in the sense that supply is much (b) whether these manufacturers are associated with more than the demand. Accordingly, Remdesivir Food and Drug Administration (FDA); and has been moved from Prohibited to Restricted (c) if so, the detailed list of the drugs manufactured by th Category of Exports on 14 June, 2021. Similarly, the aforesaid companies? the demand-supply position for Tocilizumab has stabilized considerably and some States are not Answered on 27th July 2021 placing purchase orders with the company marketing Tocilizumab as per quantities allocated by Central A. (a) to (c): As per Central Drugs Standard Control Government to them. The States and UTs have been Organisation (CDSCO), the details of number of advised to procure buffer stocks to deal with any pharmaceutical drug manufacturers, State/UT-wise, future requirements. in the country as on 29-05-2020 are attached as per Annexure. The manufacture for sale of any drug in (c) to (d): No sir. There is no application filed for the country is regulated under the provisions of Drugs invoking compulsory licensing under Section 84 of the & Cosmetics Act, 1940 and Rules, 1945 thereunder. Patents Act with central Government by manufacturer Licenses for manufacture of sale are granted by the or party intending to manufacture Remdesivir or State Licensing Authorities (SLAs) appointed by Toculizumab. Further, the manufacturing capacity respective State Governments. of Remdesivir, a patented drug has been ramped up from 38 lakh vials per month to 1.22 crore vials per Annexure month now, by the seven domestic manufacturers Number of Pharmaceutical Units present in States that have been licensed in 2020 by Gilead Sciences and UTs as on 29-05-2020 Inc, a USA based multinational company, holding the patent for Remdesivir. Tocilizumab is also a patented S. No. Name of the No. of Pharma drug of Hoffman La Roche, a Switzerland based State/UTs Units multinational company and is not manufactured in 1. Andhra Pradesh 261 India. It is pertinent to note that the Central Drugs 2. Arunachal Pradesh NIL Standard Control Organisation (CDSCO) under 3. Assam 25 MoHFW, has on 12th May, 2021 given permission to 4. Bihar 89 one Indian pharmaceutical company for conducting 5. Chhattisgarh 31 phase three clinical trials for a bio-similar drug. 6. Goa 51 (e) to (f): As per CDSCO, Remdesivir injection was 7. Gujarat 3332 approved on 20.06.2020 in the country. Presently, 62 8. Haryana 31 manufacturing sites of 7 manufacturers are approved 9. Himachal Pradesh 555 for manufacturing Remdesivir injection with total 10. Jammu & Kashmir 55 monthly installed capacity of 122 lakh vials/month. 11. Jharkhand 44 Presently Tocilizumab is not manufactured in India 12. Karnataka 376 but marketed in India only by way of imports. 13. Kerala 100 Minister in the Ministry of Chemicals & Fertilizers 14. Madhya Pradesh 267 (Shri Mansukh Mandaviya) 15. Maharashtra 929 16. Manipur NIL 17. Meghalaya NIL Registered Drug Manufacturer 18. Mizoram NIL Lok Sabha Unstarred Question No: 1255 19. Nagaland NIL 20. Odisha 18 Shrimati Sarmistha Sethi: 21. Punjab 156 Q. Will the Minister of CHEMICALS AND FERTILIZERS 22. Rajasthan 128 be pleased to state: 23. Sikkim 45 24. Tamil Nadu 514 (a) the details of the manufacturers of generic drugs and 25. Telangana 523 the companies registered for their manufacture in the 26. Tripura 6 country;
IDMA Bulletin LII (28) 22 to 30 July 2021 18
27. Uttarakhand 220 (Schedule-I of DPCO, 2013). Most of the drugs that 28. Uttar Pradesh 408 are part of COVID management protocol have ceiling 29. West Bengal 180 prices, viz., Paracetamol, Dexamethasone, Methyl 30. Pondicherry 86 Prednisolone, IVIGs, Enoxaparin, Budesonide, 31. Andaman & Nicobar Island NIL Heparin and Amphotericin etc. In the case of few non-scheduled medicines like Remdesivir, which are 32. Chandigarh 5 part of COVID protocol and are non-scheduled, on 33. Delhi 63 Government intervention, MRPs of various brands 34. Dadra & Nagar Haveli and 34 of Remdesivir have been reduced voluntarily by the Daman & Diu major manufacturers/marketers of the Remdesivir 35. Lakshadweep NIL Injection (lyophilized). Inter-brand MRPs that varied Total 8532 up to Rs 5400/ per vial were brought down to less Minister in the Ministry of Chemicals & Fertilizers than Rs 3500/-. (Shri Mansukh Mandaviya) Furthermore, to facilitate availability and ensure affordability, NPPA has capped the trade margin for Medicine Price Monitoring Oxygen Concentrators at 70% on Price to Distributor (PTD) level vide notification dated 3rd June, 2021 Lok Sabha Unstarred Question No. 1256 and on Pulse Oximeter, Glucometer, BP Monitor, Shri Manoj Kotak: Nebulizer and Digital Thermometer vide notification dated 13th July, 2021. Q. Will the Minister of CHEMICALS AND FERTILIZERS In addition, Retail prices for 1,640 formulations have be pleased to state: been fixed under DPCO, 2013 till date and in recent (a) whether the Department of Pharmaceuticals has any years exercising extraordinary powers under DPCO, scheme to monitor the prices of medicines especially 2013 in public interest, NPPA has fixed the prices of after the Coronavirus outbreak; following drugs and medical devices: (b) if so, the details thereof; (i) Ceiling price of Stents in February, 2017 (c) the steps taken by the Government for price control (ii) Ceiling price of Knee Implants in August, 2017 of medicines in the country during recent years and at (iii) Capped trade margin on selected 42 anti-cancer the peak of Coronavirus pandemic this year; and drugs in February, 2019. (d) if so, the details thereof? Minister in the Ministry of Chemicals & Fertilizers Answered on 27th July 2021 (Shri Mansukh Mandaviya) A. (a) & (b): Yes, Sir. The National Pharmaceutical Availability of Medicines Pricing Authority (NPPA) under the Department of Pharmaceuticals, as an on-going process, with the Lok Sabha Unstarred Question No. 1263 help of Price Monitoring & Resource Units (PMRUs) Shri Parbhubhai Nagarbhai Vasava: and State Drug Controllers (SDCs) undertake activities related to market-based data collection, Q. Will the Minister of CHEMICALS AND FERTILIZERS monitoring of the notified prices of medicines and be pleased to state: detection of violation of the provisions of Drug (Price (a) the details about the scheme being prepared by the Control) Order, 2013 (DPCO, 2013). Government to ensure that there will be no shortage (c) & (d): NPPA fixes the ceiling prices of scheduled of medicines during the third probable wave of the formulations as per provisions of DPCO, 2013 and coronavirus in the near future; monitors the prices of non-scheduled drugs so as to (b) the number of vaccine doses being produced in the ensure that their prices do not increase beyond 10 country per day for the prevention of coronavirus; and percent in a year. NPPA has fixed ceiling prices of 355 medicines and 882 formulations for medicines (c) the detailed regarding both of the above important under National List of Essential Medicines, 2015 information for public concerns?
IDMA Bulletin LII (28) 22 to 30 July 2021 19
Answered on 27th July 2021 (a) whether National Pharamaceutical Pricing Authority (NPPA) makes any efforts to stabilize the A. (a) Ministry of Health and Family Welfare vide pharmaceutical prices in the country; its D.O.No.X.11035/178/2021-DRS on dated 13.07.2021 issued “Guidelines for Buffer Stock (b) if so, the details thereof; Management of COVID 19” to State Governments/ (c) whether the NPPA has asked Pharma manufactures UT administrations requesting them to initiate the to reduce the prices on medicines in lieu of reduction necessary procurement process on priority, with a in GST by the Government; and view to ensure continuous availability of drugs for any possible future surge in cases. (d) if so, the details regarding the same and the list of medicines for which prices have been (b) & (c) The National Covid-19 Vaccination reduced? Programme is built on scientific & epidemiological evidence, WHO Guidelines and Global Best Answered on 27th July 2021 Practices. It is expected that beneficiaries aged 18 and above will be vaccinated by December 2021. A. (a) & (b): Yes, National Pharmaceutical Pricing Authority (NPPA) under the Department of The National Covid-19 Vaccination Programme Pharmaceuticals fixes / revises the ceiling prices commenced with vaccination of Health Care Workers, free of cost. The Programme was expanded with time of the scheduled formulations as per the provisions to include vaccination of Front Line Workers, citizens of the Drugs (Prices Control) Order, 2013 (DPCO, more than 60 years of age, citizens more than 45 years 2013). Further, NPPA also monitors the Maximum of age and eventually, citizens more than 18 years Retail Price (MRP) of scheduled formulations so as to of age. Government of India procures and provides ensure that the MRP of such formulations are within vaccine free of cost to the States/UTs. In addition, 25% the range of ceiling price and that of non-scheduled of the monthly production of vaccine manufactured is formulations to ensure that MRP does not increase by available for procurement by private hospitals. more than 10% of MRP during the preceding twelve Government of India has made pro-active months. The details of ceiling / retail prices fixed/ arrangements to augment the production capacities revised by NPPA are available on NPPA’s website, of domestic vaccine manufacturers by facilitating www.nppaindia.nic.in. technology transfer, providing financial assistance, (c) & (d): NPPA has issued detailed guidelines on providing advance payment against supply orders 13th April, 2016 for compliance of revised prices by and by streamlining the Regulatory pathway for approval of vaccines. Government of India has the manufacturers / marketing companies due to further placed procurement orders to ensure change in the Tax/ GST rates. Recently, the GST adequate supply of vaccines to facilitate vaccination Council in its 44th meeting held on 12th June, 2021 of eligible adult citizens. has reduced GST on goods being used in COVID- States/UTs are provided advance visibility of vaccine 19 management. A copy of the press release issued doses that would be supplied to them 15 days by the Ministry of Finance indicating the details of in advance to enable them to plan vaccination in medicines and medical devices used for COVID accordance with availability of doses and to maximize management, on which GST rates were revised, is the convenience of the beneficiaries. enclosed. Minister in the Ministry of Chemicals & Fertilizers In order to pass the benefit of reduction in GST rates (Shri Mansukh Mandaviya) to the consumers, NPPA has issued instructions on 15th June, 2021 to all the manufacturers and Price Reduction of Drugs marketing companies of drugs/formulations and medical devices to revise the MRP of drugs/ Lok Sabha Unstarred Question No. 1317 formulations on which Tax/GST rates have been Shri M.K. Raghavan reduced. A copy of OM dated 15th June, 2021 of NPPA is enclosed. Q. Will the Minister of CHEMICALS AND FERTILIZERS Minister in the Ministry of Chemicals & Fertilizers be pleased to state: (Shri Mansukh Mandaviya)
IDMA Bulletin LII (28) 22 to 30 July 2021 20
IDMA Bulletin LII (28) 22 to 30 July 2021 21
th 44th Meeting of the GST Council th 44 Meeting12th ofJune, the 2021GST Council th 12 June, 2021 44 Meetingth of the GST Council 12 June,*** 2021 12th June, 2021 PRESS ***RELEASE PRESS ***RELEASE (Change in GST Rates on GSTPRESS on goods RELEASE being used in Covid-19 management) (Change in GST Rates on GST on goods being used in Covid-19 management) th th (ChangeThe in GST GST Council Rates inon itsGST 44 thon meeting goods ,being held used on 12 inth June,Covid 2021-19 management) through Video Conference,The GST decided Council to reduce in its 44 theth meeting GST rates, held on the on 12specifiedth June, items2021 through being used Video in th th th CovidConference,-The19 relief GST decided and Council management to reduce in its 44 the till meeting GST30th September rates, held on the on, 2021, 12specified asJune, detailed items2021 below, through being - used Video in CovidConference,-19 relief decided and management to reduce the till GST30th September rates on the, 2021, specified as detailed items below, being - used in CovidS. -Description19 relief and management till 30th September, 2021,Present as detailed GST below, Rate - No.S. Description GSTPresent Rate recommendedGST Rate by No.S. Description GSTPresent Rate GSTrecommended RateCouncil by No. GST Rate recommended by A. Medicines GST Council A. Medicines GST Council 1.A. MedicinesTocilizumab 5% Nil A.1. MedicinesTocilizumab 5% Nil 1. Tocilizumab 5% Nil 2. Amphotericin B 5% Nil 1. Tocilizumab 5% Nil 2. Amphotericin B 5% Nil 3. Anti-Coagulants like Heparin 12% 5% 2. Amphotericin B 5% Nil 3. Anti-Coagulants like Heparin 12% 5% 4. Remdesivir 12% 5% 3. Anti-Coagulants like Heparin 12% 5% 4. Remdesivir 12% 5% 5. Any other drug recommended by Ministry of Applicable 5% 4. Remdesivir 12% 5% 5. HealthAny other and drug Family recommended Welfare (MoHFW) by Ministry and Dept.of RateApplicable 5% 5. ofHealthAny Pharma other and drug(DoP) Family recommended for Welfare Covid treatment(MoHFW) by Ministry and Dept.of RateApplicable 5%
ofHealth Pharma and (DoP) Family for Welfare Covid treatment(MoHFW) and Dept. Rate
B. Oxygen,of Pharma Oxygen (DoP) generation for Covid equipment treatment and related medical devices
B. Oxygen, Oxygen generation equipment and related medical devices 1. Medical Grade Oxygen 12% 5% B. Oxygen, Oxygen generation equipment and related medical devices 1. Medical Grade Oxygen 12% 5% 2. Oxygen Concentrator/ Generator, including 12% 5% 1. Medical Grade Oxygen 12% 5% 2. personalOxygen Concentrator/ imports thereof Generator, including 12% 5% 2. personalOxygen Concentrator/ imports thereof Generator, including 12% 5% 3. Ventilators 12% 5% personal imports thereof 3. Ventilators 12% 5% 4. Ventilator masks / canula / helmet 12% 5% 3. Ventilators 12% 5% 4. Ventilator masks / canula / helmet 12% 5% 5. BiPAP Machine 12% 5% 4. Ventilator masks / canula / helmet 12% 5% 5. BiPAP Machine 12% 5% 6. High flow nasal canula (HFNC) device 12% 5% 5. BiPAP Machine 12% 5% 6. High flow nasal canula (HFNC) device 12% 5% C. Testing Kits and Machines 6. TestingHigh flowKits andnasal Machines canula (HFNC) device 12% 5% C. Testing Kits and Machines 1. Covid Testing Kits 12% 5% C. Testing Kits and Machines 1. Covid Testing Kits 12% 5% 2. Specified Inflammatory Diagnostic Kits, namely 12% 5% 1. Covid Testing Kits 12% 5% 2. DSpecified-Dimer, InflammatoryIL-6, Ferritin and Diagnostic LDH Kits, namely 12% 5% 2. DSpecified-Dimer, InflammatoryIL-6, Ferritin and Diagnostic LDH Kits, namely 12% 5% D. Other Covid-19 related relief material OtherD-Dimer, Covid IL-19-6, related Ferritin relief and LDHmaterial D. Other Covid-19 related relief material 1. Pulse Oximeters, incl personal imports thereof 12% 5% D. Other Covid-19 related relief material 1. Pulse Oximeters, incl personal imports thereof 12% 5% 1. Pulse Oximeters, incl personal imports thereof 12% 5% IDMA Bulletin LII (28) 22 to 30 July 2021 22
S. Description Present GST Rate S. Description Present GST Rate No. GST Rate recommended by No. GST Rate recommended by GST Council GST Council 2. Hand Sanitizer 18% 5% 2. Hand Sanitizer 18% 5% 3. Temperature check equipment 18% 5% 3. Temperature check equipment 18% 5% 4. Gas/Electric/other furnaces for crematorium, 18% 5% 4. Gas/Electric/other furnaces for crematorium, 18% 5% including their installation, etc. including their installation, etc. 5. Ambulances 28% 12% 5. Ambulances 28% 12%
These rate reductions/exemptions shall remain in force up to 30th September 2021. These rate reductions/exemptions shall remain in force up to 30th September 2021. ***** PLI Scheme in Pharmaceuticals Sector*****(f) whether at present, low value generic drugs account for the major component of Indian exports, while a Lok Sabha Unstarred Question No. 1364 large proportion of the domestic demand for patented Shri Bidyut Baran Mahato: drugs is met through imports; and (g) if so, the manner in which the existing trend is likely Shri Ravi Kishan: to be change from the scheme? Shri Sanjay Sadashivrao Mandlik: Answered on 27th July 2021 Shri Ravindra Kushwaha: A. (a) to (b): Yes, Sir. The Government has approved Shri Subrat Pathak: the Production Linked Incentive Scheme for Shri Shrirang Appa Barne: Pharmaceuticals on 24.02.2021 which was notified in the Gazette on 03.03.2021. The Operational Shri Chandra Sekhar Sahu: Guidelines containing the details of the scheme Shri Sudheer Gupta: on each aspect and the process of making applications were issued on 01.06.2021. These Shri Prataprao Jadhav operational Guidelines can be found on the website of the Department and can be accessed at https:// Will the Minister of Q. CHEMICALS AND FERTILIZERS pharmaceuticals.gov.in/schemes. be pleased to state: (c) to (d): The scheme estimated the export generation (a) whether the Government has approved Production potential of Rs 1,96,000 crore over a period of 6 Linked Incentive Scheme (PLI) for Pharmaceuticals years in all the three categories of products under sector in the country; the scheme which includes high value products as (b) if so, the details and the salient features of PLI well. scheme; (e) The PLI scheme estimated the investment (c) whether the Government has made any assessment potential of around Rs 15,000 crore and the generation of employment potential of 20,000 direct to find out the expected promotion of the production and 80,000 indirect jobs as a result of the growth in of high value products, which are likely to be added the sector over the period of the scheme. in exports of the country in the coming years; (f) to (g): Yes Sir, at present low value generic (d) if so, the details thereof; drugs account for the major component of Indian (e) the details of the investments, employment exports. As far as patented drugs are concerned, the opportunities which are likely to be increased in the same are imported as well as manufactured in the country after the implementation of PLI Scheme in country. The scheme incentivizes the manufacturing Pharmaceuticals sector; of patented drugs and other high value drugs at an
IDMA Bulletin LII (28) 22 to 30 July 2021 23
incentive rate of 10% of incremental sales which is of pharmaceutical education and research and highest amongst the product categories under the maintenance of standards thereof. scheme. (b): NIPERs are autonomous institutions having their Minister in the Ministry of Chemicals & Fertilizers own Board of Governors, which are responsible for (Shri Mansukh Mandaviya) the general superintendence, direction and control of the affairs of the Institute. As the institutes are mainly NIPER Council funded by the Government, it periodically reviews their functioning. The annual accounts of the Institute Lok Sabha Unstarred Question No.1373 are also audited by the office of CAG. A third-party evaluation of NIPERs through a private party has also Dr. Sukanta Majumdar: been conducted. Further, the Expenditure Finance Shri Rajveer Singh (Raju Bhaiya): Committee (EFC) under the Ministry of Finance also appraise the functioning of NIPERs for their Shri Raja Amareshwara Naik: continuation/ expansion. Shrimati Sangeeta Kumari Singh Deo: Ministry of Education publishes annual National Shri Vinod Kumar Sonkar: Institutional Ranking Framework (NIRF) ranking public and private Higher Education Institutes (HEIs) Dr. Jayanta Kumar Roy: in the country under various categories. The ranking Shri Bhola Singh: of NIPERs under the “Pharmacy” category during last four years is as under: Will the Minister of Q. CHEMICALS AND FERTILIZAERS NIPERs 2017 2018 2019 2020 be pleased to state: Mohali 2nd 1st 3rd 3rd (a) whether the Government is planning to bring a Hyderabad 5th 6th 6th 5th legislation the NIPER (Amendment) Bill 2021 to Ahmedabad - 14th 9th 8th establish the NIPER Council and if so, the details Guwahati - - - 11th thereof; Raebareli - - - 18th th (b) whether the Government has reviewed the functioning Kolkata - - - 27 of the NIPER and if so, the details of achievements The institute-wise details of students passed out, made and funds spend so far, Institutewise; research papers published, patents filed and MOUs signed (c) whether the Government propose to set up four new are as under: NIPER and if so, the details thereof; NIPER Students Research Patents MoU (d) the details of vacancies of posts in NIPER, Institute- passed Papers filed signed wise; out published (e) whether same NIPER do not have its own campuses Mohali 3,735 2,777 198 23 and are running in temporary buildings and if so, the Ahmedabad 619 594 21 23 details thereof; and Hyderabad 1113 786 32 52 Guwahati 400 301 20 24 (f) the other steps being taken by the Government to Kolkata 479 204 02 23 strengthen the NIPER? Raebareli 385 238 20 15 Answered on 27th July 2021 Hajipur 333 134 03 10 Total 7,064 5,034 296 178 A. (a): Yes Sir. Government has introduced NIPER (Amendment) Bill 2021 in the Lok Sabha on 15th The institute-wise details of funds released to each March, 2021. The provisions of the Bill include NIPERs since their inception (upto June, 2021) are as setting up a NIPER Council under the chairmanship under: of Hon’ble Minister (Chemicals & Fertilizers) to NIPER Funds released (Rs. in crore) coordinate the activities of various NIPERs and Mohali 406.54 ensure planned and coordinated development
IDMA Bulletin LII (28) 22 to 30 July 2021 24
Ahmedabad 195.77 (d) : While, NIPER-Mohali already has sanctioned Hyderabad 310.45 posts and regular faculty/ non-faculty posts, the Guwahati 298.59 Ministry of Finance approved 156 faculty and 190 non-faculty posts in the year 2019 for other six Kolkata 117.37 NIPERs, viz., Ahmedabad, Guwahati, Hajipur, Raebareli 113.29 Hyderabad, Kolkata and Raebareli. After framing Hajipur 80.55 recruitment rules for various posts, the process Total 1522.56 for filling up the faculty/ non- faculty posts in these (c) : EFC proposal has been sent to the Ministry Institutes has been initiated and the same would of Finance for setting up five new NIPERs in the be completed soon. The institute-wise status of states of Tamil Nadu, Maharashtra, Chhattisgarh, sanctioned/ filled up posts are as under: Rajasthan and Karnataka.
Faculty Non-Faculty Sanctio Filled Under Vacant Sanctioned Filled Under Vaca nt ned process process Mohali 62 26 - 36 224 120 - 104 Ahmedabad 33 23 - 10 37 17 - 20 Hyderabad 33 23 - 10 37 16 - 21 Guwahati 33 20 - 13 37 17 18 02 Kolkata 19 12 04 03 27 13 05 09 Hajipur 19 04 08 07 26 05 10 11 Raebareli 19 16 - 03 27 06 15 06 Total 218 124 12 82 415 194 48 173
(e) and (f): While NIPER Mohali and NIPER Guwahati Q. Will the Minister of ENVIRONMENT, FOREST AND have own permanent campus, the construction of CLIMATE CHANGE be pleased to state: NIPER Ahmedabad has started in full swing. At (a) the details of bio-medical waste generation pertaining present, NIPERs at Ahmedabad, Hajipur, Hyderabad, to the treatment of COVID-19 patients since 2020 till Kolkata and Raebareli are functioning from rented date, State-wise; and premises. A consolidated EFC proposal with an (b) the details of management and handling of such outlay of Rs. 4,300 crore for the period 2020-21 to bio-medical waste, State-wise? 2024- 25 has been sent to the Ministry of Finance for strengthening and equipping of the existing seven Answered on 19th July 2021 NIPERs and setting up of five new NIPERs. The A. (a)&(b) The Central Pollution Control Board has proposal also includes construction of the campuses, developed guidelines for handling, treatment and up-gradation of laboratories, setting up Centres of disposal of COVID-19 Bio-medical Waste (BMW) Excellences, etc. generated during treatment/ diagnosis/ quarantine Minister in the Ministry of Chemicals & Fertilizers of COVID-19 patients under the provisions of (Shri Mansukh Mandaviya) Biomedical Waste Management Rules, 2016 (BMWM Rules, 2016). As per the guidelines, Healthcare In Rajya Sabha Facilities are required to segregate the BMW at source and hand over such segregated waste to Bio-medical waste generation the Common Bio-medical Waste Treatment Facility pertaining to COVID-19 treatment operators for treatment and disposal. Similarly, the Rajya Sabha Unstarred Question No. 40 waste generated from Quarantine camps/ Home Quarantine/ Home Isolation, is treated as ‘domestic Shri Bikash Ranjan Bhattacharyya: hazardous waste’ as defined under Solid Waste
IDMA Bulletin LII (28) 22 to 30 July 2021 25
Management Rules, 2016 for collection by Urban Uttar Pradesh 3881.7 Local Bodies, and thereafter, disposed as per the West Bengal 3128.9 provisions of BMWM Rules, 2016. Total 56898.4 Further, to track the generation and disposal of COVID-19 Bio-medical Waste (BMW), CPCB has The above generated wastes are to be treated as per developed an app namely COVID19 BWM. The guidelines issued by CPCB in respective States. State-wise waste generation details from June-2020 to June-2021 are mentioned below: Minister of State in the Ministry of Environment, Forest and Climate Change States/Union Territories COVID-19 BMW (Shri Ashwini Kumar Choubey) generated (in Tonnes) Andaman & Nicobar 4.0 Inclusion of retail/wholesale business in Andhra Pradesh 2877.5 MSMEs Arunachal Pradesh 34.8 Rajya Sabha Unstarred Question No.112 Assam 337.4 Bihar 336.0 Shri Mahesh Poddar: Chandigarh 671.4 Q. Will the Minister of Micro, Small and Medium Chhattisgarh 381.4 Enterprises be pleased to state: Daman & Diu 14.1 (a) whether Government has included retail and Delhi 3995.3 wholesale business also in the category of Micro, Goa 124.2 Small and Medium Enterprises (MSMEs) and if so, whether this move is intended to provide priority Gujarat 5004.9 loans to them only under priority sector lending or Haryana 3025.3 they will be provided with the priority in Government Himachal Pradesh 414.3 procurement like other MSMEs and arbitration facility Jammu and Kashmir 543.0 in recovery of dues; Jharkhand 136.6 (b) whether under the MSMEs Act, 2006, it is mandatory Karnataka 3133.6 to respect the provision of protection of payment Kerala 6442.2 for Small Scale Industry (SSI) under IBS laws also; Lakshadweep 3.6 and Madhya Pradesh 2462.8 (c) whether this protection of payments will be made Maharashtra 8317.0 available to medium scale industries also? Manipur 56.5 Answered on 19th July 2021 Meghalaya 92.2 A. (a) : Yes Sir. From 2nd July, 2021, the government Mizoram 29.2 has included Retail and Wholesale Trades as Nagaland 34.1 MSMEs. They are allowed to be registered on Odisha 1642.9 Udyam Registration Portal and benefits to Retail and Puducherry 428.4 Wholesale trade MSMEs are restricted to Priority Punjab 1289.1 Sector Lending only. Rajasthan 1382.8 (b) & (c): Chapter V of the Micro, Small and Medium Sikkim 36.6 Enterprises Development (MSMED) Act, 2006 provides that a buyer is liable to make payment to any Tamil Nadu 4835.9 Micro and Small Enterprise (MSE) supplier provided Telangana 1109.7 that the MSE qualifies as supplier under the Act. Tripura 7.6 Minister of Micro, Small and Medium Uttarakhand 683.4 Enterprises (Shri Narayan Rane)
IDMA Bulletin LII (28) 22 to 30 July 2021 26
MAHE releases book on COVID-19
on various aspects of human existences and how most of them have been addressed in the 30 chapters contained in this more than 500-page book. He said, the multidisciplinary approach of the book which includes geopolitical and anthropological perspectives as well, speak volumes about the expertise present within the MAHE system that stand to support the epidemiologists, virologists, microbiologists and others. He suggested that earnest efforts be made to continue research and publish a second volume to follow as the research advances in different fields to combat COVID-19. COVID-19: A Multidimensional Response - Book release event (Clockwise) Dr Shashikiran Umakant, Dr Raviraj N Seetaram, Dr H Vinod Bhat, Lt Gen (Dr) M D Venkatesh, Dr Chiranjay Mukhopadhyay, Dr Shashikiran Umakant, Professor in Medicine Dr Neeta Inamdar Department of Udupi TMA Pai Hospital, who led the Manipal Academy of Higher Education (MAHE) battle against COVID-19 at the district level and is released a book titled Covid-19 A Multidimensional widely recognized for his contribution, summed up Response, 210th publication by Manipal Universal Press MAHE’s response to the pandemic as CARE response (MUP) on 30 June 2021 in Manipal. – clinical, administrative, research and educational. He said, MAHE was the only university in the country Releasing the book, Lt Gen (Dr) M D Venkatesh, which dedicated an entire hospital for treating the Vice Chancellor, MAHE, spoke about the role played COVID-19 patients. by MAHE and Manipal group of hospitals in healthcare management during the COVID-19 outbreak. Being One of the editors, Dr Raviraj N Seetaram spoke one of the largest healthcare providers, MAHE built about the evolution of the book in very short and stringent a creative alliance between higher education and the timelines to ensure the research as-it-happened reach wider community to control and mitigate the pandemic its audiences. He hoped the book would connect in constant engagement with the civil society, he said. This was done through mass testing, innovative COVID- researchers within the field with more vigour in combating 19 treatment protocols, mass health literacy programs, the pandemic and would reach lay readers with more vaccination drive and technical innovations like vaccine information that they have been seeking. carriers, he added. In her welcome note, Dr Neeta Inamdar, Chief Editor, Releasing the book on COVID-19 was a continuation Manipal Universal Press said, MUP would strive hard of these efforts by MAHE where 305 papers on to keep pace with the research being carried out in the COVID-19 have been already published by faculty members, he said, highlighting the academic and field and be with the authors willing to publish their work research contribution of the University in tackling the and share it with fellow colleagues. challenges posed by the pandemic. Other editors of the book, Dr Chiranjay Mukhopadhyay Chief guest Dr Vinod H Bhat, Executive Vice and Dr N Udupa were present on the occasion, where President, MAHE, highlighted the impact of the pandemic Dr Chiranjay delivered a vote of thanks.
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IDMA Bulletin LII (28) 22 to 30 July 2021 27
GOVERNMENT press release NPPA has fixed ceiling prices of 355 medicines and 882 formulations for including Paracetamol, Dexamethasone, Methyl Prednisolone, IVIGs, Enoxaparin, Budesonide, Heparin and Amphotericin - reg.
NPPA has capped the trade margin for Oxygen Concentrators at 70% on Price to Distributor (PTD) level
Attention Members We give below the PIB released on 27th July 2021 by the Ministry of Chemicals and Fertilizers in regards to NPPA fixing ceiling prices of 355 medicines and 882 formulations for including Paracetamol, Dexamethasone, Methyl Prednisolone, IVIGs, Enoxaparin, Budesonide, Heparin and Amphotericin. Also, kindly note that NPPA has capped the trade margin for Oxygen Concentrators at 70% on Price to Distributor (PTD) level.
The National Pharmaceutical Pricing Authority Furthermore, to facilitate availability and ensure (NPPA) under the Department of Pharmaceuticals, as affordability, NPPA has capped the trade margin for an on-going process, with the help of Price Monitoring Oxygen Concentrators at 70% on Price to Distributor & Resource Units (PMRUs) and State Drug Controllers (PTD) level vide notification dated 3rd June, 2021 and (SDCs) undertake activities related to market-based data on Pulse Oximeter, Glucometer, BP Monitor, Nebulizer collection, monitoring of the notified prices of medicines and Digital Thermometer vide notification dated 13th and detection of violation of the provisions of Drug (Price July, 2021. Control) Order, 2013 (DPCO, 2013). In addition, Retail prices for 1,640 formulations have NPPA fixes the ceiling prices of scheduled formulations been fixed under DPCO, 2013 till date and in recent years as per provisions of DPCO, 2013 and monitors the prices exercising extraordinary powers under DPCO, 2013 in of non-scheduled drugs so as to ensure that their prices do public interest, NPPA has fixed the prices of following not increase beyond 10 percent in a year. NPPA has fixed drugs and medical devices: ceiling prices of 355 medicines and 882 formulations for (i) Ceiling price of Stents in February, 2017 medicines under National List of Essential Medicines, 2015 (Schedule-I of DPCO, 2013). Most of the drugs that are (ii) Ceiling price of Knee Implants in August, 2017 part of COVID management protocol have ceiling prices, (iii) Capped trade margin on selected 42 anti-cancer viz., Paracetamol, Dexamethasone, Methyl Prednisolone, drugs in February, 2019. IVIGs, Enoxaparin, Budesonide, Heparin and Amphotericin etc. In the case of few non-scheduled medicines like The information was given by the Union Minister of Remdesivir, which are part of COVID protocol and are non- Chemicals and Fertilizers, Shri Mansukh Mandaviya in a scheduled, on Government intervention, MRPs of various written reply in the Lok Sabha today. brands of Remdesivir have been reduced voluntarily by the Source: PIB Delhi, 27.07.2021 major manufacturers/marketers of the Remdesivir Injection (lyophilized). Inter-brand MRPs that varied up to Rs 5400/ per vial were brought down to less than Rs 3500/-.
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IDMA Bulletin LII (28) 22 to 30 July 2021 28
Interview India must use, share Covid data transparently: Kiran Mazumdar-Shaw
Decrying the country’s “lack of scientific temperament,” Kiran Mazumdar-Shaw urged greater transparency in sharing data on the pandemic, and said India has great potential to plan and respond to the virus based on such inputs.
A lack of sufficient Can vaccine imports supplement domestic vaccines has hampered production? India’s drive to inoculate a majority of its population Vaccine imports will be limited. The government by year-end, according to cannot rely heavily on imported vaccines. Only a few Biocon chairperson Kiran in the private sector will get vaccines from outside and Mazumdar-Shaw , w h o (that too,) to inoculate a small number of people. We emphasised the need to speedily should ramp up domestic production to cater to a large ramp up domestic production of part of the population. Let us not get carried away with
In an interview with Akshatha M & vaccines. Decrying the country’s talks of importing Moderna and Pfizer because they In anRaghu interview Krishnan, with Akshatha Shaw M calls & Raghu for a Krishnan,“lack Shaw of callsscientific for a smarter, temperament,” more data-led initiative to deliveraccount vaccines for a very small part. We have to depend on andsmarter, inoculate more the most data-led vulnerable. initiative to Covishield, Covaxin, Novavax, Biological E’s domestic A deliverlack vaccinesof sufficient and inoculate vaccines the she has urged hampered greater transparency India’s drive to inoculate most vulnerable. in sharing data on the pandemic, production. a majority of its population by year-end, according to and said India has great potential to plan and respond Bioconto the virus chairperson based on KiranMazumdar such inputs. In -anShaw interview, who emphasiswith edW thehat are your views on how the country has needAkshatha to speedily M & Raghu ramp Krishnan,up domestic she production calls for a smarter,of vaccines. managed the pandemic so far? Decryingmore data-led the country’s initiative “lackto deliver of scientific vaccines temperament,” and inoculate she urged India is missing out on a huge opportunity by not the most vulnerable. Edited excerpts: greater transparency in sharing data on the pandemic, andfocusing said on data gathering and analysis. We have a great IndiaW hashat great can bepotential done to planhasten and the respond pace ofto Ithendia’s virus bapotentialsed on to plan and respond to Covid based on data suchCovid inputs. vaccination In an interview drive? with Akshatha M & Raghu Krishnan,inputs. We have a very high prevalence of Delta variants, which provides us a chance to collect data on infection she calls for a smarter, more data-led initiative to deliver vaccines The issue is lack of availability of vaccines. Six rates, peaking and vaccines that work against variants. and inoculate the most vulnerable. Edited excerpts: months after we started the vaccination drive, we are We should be doing a lot of vaccination and reinfection at about 135 million doses a month — with 100 million surveillance and focus on analysing the cycle threshold Whatdoses can coming be done from tothe hasten Serum theInstitute. pace Bharatof India’s Biotech Covid value of infected persons. vaccinatioaccounts forn drive?35 million doses a month and a really small But, what also worries me is that as a country, we Thevolume issue comes is lack from of availability both ZydusCadila of vaccines. and SixSputnik. months By after we August, it is likely we will get 200 million doses if Sputnik lack scientific temper. We don’t ask pertinent questions. started the vaccination drive, we are at about 135 million doses a starts manufacturing (locally) at a certain scale and Bharat Why don’t we have data on (whether) Remdesivir is really monthBiotech — scaleswith 100 up millioncapacity. doses The coming government from thehas Serum now Institute.effective to treat Covid? Why don’t we ask if Itolizumab is Bharatscaled Biotech down its accounts projection for of35 vaccination million doses coverage a month to and as a reallyeffective as Tocilizumab in Covid treatment? small1.3 billion volume doses. comes from both ZydusCadila and Sputnik. By Is Covid fatigue the reason why we don’t see August, it is likely we will get 200 million doses if Sputnik starts This is from the earlier projection of 2.5 billion doses enough data coming through? manufacturingby the end of this(locally) year. at With a certain such limitedscale and availability Bharat Biotechof scales They may be gathering and analysing the data but upvaccines, capacity. the The strategy government should hasbe targetednow scaled vaccination down itss. projection of not sharing it with the public. I think there is opacity in vaccinationWe should coveragego by data to and 1.3 startbillion vaccinating doses. vulnerable terms of research done on Covid. We need to have more populations, people that are most at risk and populations transparency on research and their outcomes. It should that are not exposed to the virus yet. I wonder why that be out in the public domain. All state and city Covid is not happening. dashboards should be transparent. They should put out
IDMA Bulletin LII (28) 22 to 30 July 2021 29
more data on daily hospitalisation, ICU admissions to help companies are getting enough investments and the public get a realistic view of the situation. support?
I am also surprised at the claim that no one died due This world is besotted with quick returns on to medical oxygen shortage. We had a severe scarcity and investment, precisely why people prefer investing in IT had to import oxygen and concentrators as aid. To be in and digital startups.Let us not forgot that life sciences and denial of the oxygen situation is worrying. We need to be healthcare is more important for humanity to survive. If we transparent as a country. don’t invest in new medicines, vaccines and drugs, we will be demolished. We can have the smartest technologies, You have recently pledged financial support to but now do we live without progress in medicine and Mynvax, an Indian Institute of Science –Incubated healthcare? startup that is working on a home grown Covid vaccine. Do you think domestic vaccine and biotech Source : Economic Times, 26.07.2021 l l l
DGFT matters Foreign Trade Policy 2015-20 - Introduction of online Deemed Exports Application Module - reg.
Notice No.12 /2021 - 2022, dated 28th July 2021
To, submission of such applications for processing of the 1. All Exporters/Members of Trade applications at RAs. 2. All RA's of DGFT. 4. Please note that this new application Module will 1. The members of trade are hereby informed that this cater to new applications filed in this regard by the Directorate is introducing an online Deemed Exports applicants and old/legacy physical applications Module on the DGFT website as a part of IT Revamp submitted earlier manually will continue to be for receiving applications under the Chapter 7 of FTP processed manually by concerned RAs. 2015-20. 5. The members of trade can file application in e-TED/ 2. Henceforth, the following applications are required to DBK module through following navigation: be submitted online through the importer/exporter's dashboard on the DGFT Website : https//dgft.gov.in>Deemed Exports to access the new e-module. i. Refund of Terminal Excise Duty (TED) For guidance on these new processes, the Help manual ii. Grant of Duty Drawback as per AIR and 6. & FAQs may be accessed at https://dgft.gov.in> Learn iii. Fixation of Brand Rate for Duty Drawback > 'Application Help & FAQs'. For any further assistance 3. The members of trade can login to the portal, fill in you may utilize any of the following channels — the requisite details in the form, upload the necessary documents and submit the application after paying i. Raise a service request ticket through the DGFT requisite fee. The system will generate a file number Helpdesk service under Services a 'Trade which can be used for tracking purposes through Helpdesk Service' the portal. The RAs would issue online deficiency ii. Call the toll-free DGFT Helpdesk number letters calling for any additional information/document 1800111550 required and the exporter would be able to reply iii. Send an email to the Helpdesk on [email protected]. to the deficiency letters online only. However, the F. No. 01/92/180/12/AM21/Policy 6 applicants will have to submit the corresponding Pradyumna Sahu, Deputy Director General of Foreign Trade, supporting physical documents as prescribed under Directorate General of Foreign Trade, Department of Commerce, ANF -7A to concerned RAs within 7 days of online New Delhi. l l l IDMA Bulletin LII (28) 22 to 30 July 2021 30
Dop matters DoP extends the timeline for Submission of applications under PLI till 31.08.2021 -reg.
F.No. 31026/16/2020-Policy/Scheme, dated 27th July, 2021
1. Reference is invited to this Department’s Notice of even number dated 30.04.2021, 14.06.2021 & 02.07.2021 on the above-mentioned subject. It has been decided to extend the timeline for submission of applications under the “Production Linked Incentive Scheme for Promotion of Domestic Manufacturing of Critical Key Starting Materials (KSMs)/ Drug Intermediates and Active Pharmaceutical Ingredients (APIs) in India” and “Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices” till 31.08.2021.
2. The eligible applicants may apply through online only. The link is https://plibulkdrugs.ifciltd.com. Detailed guidelines of the Scheme are available at https://pharmaceuticals.gov.in/schemes.
N. K. Joshi, Under Secretary, Ministry of Chemicals & Fertilizers, Department of Pharmaceuticals, New Delhi.
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NPPA matters List of Overcharging Cases (OC) including cases under litigation relating to DPCO 1979, 1987, 1995 and 2013-reg.
Office Memorandum dated 16th July 2021
To, under litigation relating to DPCO, 1979, 1987, All Drug Manufactures/Marketers 1995 and 2013 has been updated and is enclosed 1. The undersigned is directed to refer to the subject herewith. cited above and to enclose the Status of Overcharging 3. This issues with the approval of competent amount under DPCO 1979, 1987, 1995 and 2013 authority. as on 31.03.2021 (Annexure-A) and the Detailed End: As Above Statement of Overcharging cases up to 31" March, 2021 (Annexure-B). F. No. 28(1)/20/Div.IV/NPPA 2. In respect of the OM dated 11th January 2021 issued Manjesh Porwal, Deputy Director, Overcharging Division, and hosted by this office on NPPA website, enclosing National Pharmaceutical Pricing Authority, Department the Provisional list of 324 cases, NPPA received of Pharmaceuticals, Ministry of Chemicals & Fertilizers, New Delhi. the feedback/representation from companies in this reference. These representations were examined Note : For enclosure details, you may please contact IDMA and accordingly, the Provisional List of OC cases Secretariat.
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IDMA Bulletin LII (28) 22 to 30 July 2021 31
National News
Ensure no vaccine dose goes waste Indian pharma industry to touch States,Ensure including no Kerala vaccine and Tamil dose Nadu, goes complain USD 130 bn by 2030: Reddy of shortages. At the same time, there are also The Indian pharmaceutical sector can contribute to reports of millions ofwaste vaccine doses lying unused. Synopsis the country through the development of drugs for States, includingThere Kerala is and a Tamilneed Nadu, tocomplain keep of shortages. increasing At the same time, the there floware also reports of of millions of vaccine doses lying unused. There is a need to keep increasing the flow of vaccines into the India-specific ailments which, unfortunately, do not system. vaccines into the system. get much global attention, Reddy rued. India’s vaccination levels have improved. But the luxury of taking the foot off the pedal does not exist. The government has set a goal of fully inoculating 950 Reuters Reutersmillion adults by the end of India’sthe year. vaccination Meeting levels that have goal improved. will require But the ensuringluxury of taking a daily thevaccination foot off the tallypedal ofdoes 7 million.not exist. TheHowever, government the currenthas set a rate goal of ofdaily fully inoculationinoculating 950 hovers million aroundadults by thethe end5 million of the year. mark. Meeting that goal will require ensuring a daily vaccination tally of 7 million. However,States, the current including rate of Kerala daily inoculation and Tamil hovers Nadu, around complain the 5 millionof shortages. mark. At the same time, there are also reports of millions of vaccine doses lying unused. There is a need
States,to keep including increasing Kerala theand Tamilflow Nadu, of vaccines complain intoof shortages. the system. At the same time, there are also reports of millions of vaccine doses The Indian pharmaceutical industry worked continuously during the At the same time, given the size of the requirement — Thetesting Indian times pharmaceutical of COVID-19 pandemicindustry workedsecond wave continuously to ensure duringthe the testing times of COVID-19 lying unused. There is a need to keep increasing the flow of domestic, contractual exports and supply to the Covax pandemic secondavailability wave to of ensure life saving the medicines. availability of life saving medicines. vaccines into the system. At the same time, given the size of the facility — reaching a place where supply outstrips demand The Indian pharmaceutical industry is expected to requirement — domestic, contractual exports and supply to will take time. Thegrow Indian almost pharmaceuticalby three times to aboutindustry 130 is billion expected US dollars to grow almost by three times to the Covax facility — reaching a place where supply outstrips by 2030, Chairman of Dr Reddy’s Laboratories, K Satish demandThe will corrective take time. The measures corrective measures to increase to increase production about 130 billion US dollars by 2030, Chairman of Dr Reddy’s Laboratories, K Satish Reddy said on Saturday. productioncapacity capacityfor vaccines for vaccines will takewill take some some time time toto kickkick in. in. The The Union government has now placed orders well in advance to ensure Reddy said on Saturday. Union government has now placed orders well in advance “If you see, currently it’s (pharmaceutical industry) that there is a steady flow of vaccines. Last week, the government to ensure that there is a steady flow of vaccines. Last week, “Ifabout you 42 see, billion currently dollars, it’ halfs (pharmaceutical between the domestic industry) sales, about 42 billion dollars, half the government placed an order for 660 million doses with betweenhalf between the the domestic exports. sales,We expect half that between it will grow the almostexports. We expect that it will grow the Serum Institute. And, supply constraints are expected by three times in the coming decade, reaching almost 120 to ease in August, with new vaccines, including the DNA- almostto 130 bybillion three dollars times by in 2030. the coming Truly, we decade, believe reachingthat we almost 120 to 130 billion based vaccine from Zydus entering the supply chain. dollarsare poised by for2030. a tremendous Truly, we growth believe in thethat coming we are decade,” poised for a tremendous growth in the he predicted. Careful planning and allocation of vaccines particularly coming decade,” he predicted. at the state level is required. The Union government Reddy, Chairman of Board of Governors of NIPER- provides vaccine availability projections 15 days in Hyderabad, was virtually addressing the 9th Convocation advance. States should use this information along with Reddy,of the institute. Chairman of Board of Governors of NIPER-Hyderabad, was virtually granular data from districts to plan out its vaccination roll- addressing the 9th Convocation of the institute. out. States must allocate vaccine keeping in mind factors The government’s encouragement (‘AtmaNirbhar such as the percentage of the inoculated population, first TheBharat’ government’s policy), a lot encouragementof reforms in the policy (‘AtmaNirbhar to incentivize Bharat’ policy), a lot of reforms in the industry and thrust being given to innovation, among and second dose ratio, and positivity rate. Private hospitals the policy to incentivize the industry and thrust being given to innovation, among with vaccines on hand must tie up with companies and others, augur well for the industry, he said. others, augur well for the industry, he said. other hospitals to ensure no dose goes waste. The Indian pharmaceutical industry worked continuously Source: ET Editorial, 20.07.2021 Theduring Indian the testingpharmaceutical times of COVID-19 industry workedpandemic continuously second during the testing times of wave to ensure the availability of life saving medicines. l l l COVID-19 pandemic second wave to ensure the availability of life saving medicines. During the period, the companies involved in making During the period, the companies involved in making critical COVID-19 medicines
IDMA Bulletin LII (28) 22 to 30 July 2021 responded very quickly ramping up production, he32 added. He lauded the efforts of Union Chemicals and Fertilizers Minister MansukhMandaviya and the officials for providing a lot of interventions which helped the industry ramp up capacities. Noting that the future of the Indian pharmaceutical industry is dependent on its ability to develop stronger capabilities in innovation and
critical COVID-19 medicines responded very quickly India has given over 42 crore doses of vaccines so far ramping up production, he added. and inoculated nearly 6 per cent of its population while the government aims to vaccinate all adults by the end of He lauded the efforts of Union Chemicals and this year. However, the country is yet to clear a vaccine for Fertilizers Minister Mansukh Mandaviya and the officials children amid concern over a third wave. for providing a lot of interventions which helped the industry ramp up capacities. Noting that the future of the On Friday, the European medicines watchdog approved Indian pharmaceutical industry is dependent on its ability the use of Moderna’s coronavirus vaccine for children to develop stronger capabilities in innovation and R&D, aged 12-17. In May, the United States had authorised Reddy said such capabilities which already exist, need to the Pfizer-BioNTech Covid-19 vaccine for children aged be strengthened further. 12-15 years old. The Indian pharmaceutical sector can contribute to “We need to get our own vaccines too - that’s why the country through the development of drugs for India- both Bharat Biotech and Zydus are important. Getting specific ailments which, unfortunately, do not get much the Pfizer vaccine will also be helpful, as there is enough global attention, he rued. data to suggest it’s safe... but we can’t be sure if we will get required numbers. We will hopefully have more than He also said digital technologies were heralding a big one vaccine for children by September,” the AIIMS chief change in the whole spectrum of healthcare – the way said. patients are treated, the way medicines are supplied to patients and automation in manufacturing. A whole host A study published earlier this week by The Lancet, of opportunities got accelerated during the pandemic, he one of the world’s oldest medical journals, underlined that added. “living with 11-17-year-olds increases the risk of infection by 18-30 per cent.” Talking about it, Dr Guleria said: “It’s Secretary of the Department of Pharmaceuticals, an important issue. Vulnerable people - the elderly or those Ministry of Chemicals and Fertilizers, S Aparna spoke on having illnesses - are at an increased risk of getting the efforts to attain self-sufficiency in APIs and others. infection (in such cases). That’s one of the reasons why Source : Financial express, 25.07.2021 people are worried about children going to schools... they may get a mild infection, but they may pass it to their l l l grandparents. We need more data, but this is something Covid vaccines for children by September: that has been shown even with influenza.” AIIMS chief Dr Randeep Guleria Hans Source : The Hans India , 25.07.2021 HIGHLIGHTS India is likely to start vaccinating children l l l by September, AIIMS chief Dr Randeep Guleria said on Saturday as he underlined that it will be an important move Post Covid: Pharmaceutical Industry to break the chain of transmission. has become an alluring career option New Delhi: India is likely to start vaccinating children As the healthcare sector across the globe is growing, it has opened great by September, AIIMS chief Dr RandeepGuleria said on career opportunities to thousands of students of pharmaceutical science Saturday as he underlined that it will be an important move because the rate of growth of the pharmaceutical sector is interlinked and to break the chain of transmission. is directly proportional to the growth of the healthcare sector. “I think Zydus has already done the trials and they’re The current pandemic has brought the entire world to waiting for the emergency authorisation. The Bharat its knees and the whole world has observed the adverse Biotech’s Covaxin trials should be over by August or catastrophe of this Global Pandemic. As the healthcare September, and by that time we should get an approval. sector across the globe is growing, it has opened great career Pfizer vaccine has been already approved by the FDA opportunities to thousands of students of pharmaceutical (US regulator). Hopefully, by September, we should start science because the rate of growth of the pharmaceutical vaccinating children, and that will be a big boost as far sector is interlinked and is directly proportional to the as breaking the chain of transmission is concerned,” Dr growth of the healthcare sector. Guleria said.
IDMA Bulletin LII (28) 22 to 30 July 2021 33
According to IBEF, Indian pharmaceutical sector Paucity of proficiency in the Innovation Space: supplies over 50% of global demand for various vaccines Due to limited government Supported research and also states that India is the largest provider of generic ecosystem the Indian pharmaceutical companies have drugs globally. In the current Scenario the demand for been slow to grow in the innovation space. To overcome medicines is increasing day by day, so the employment this hurdle government needs to invest in research & in the pharma sector is also rising. According to sources Development initiatives and talent in order to expand of government statistics, over 300 institutions impart India’s innovation. A talent pool with advanced skills is diplomas or degrees to nearly 20,000 students in India limited in India as compared to other countries. There every year. Indian Pharmaceutical Industry is one of the is also a huge gap between the college curriculum and largest pharma industries in the world and this widens the industry’s requirements. Clinical trials should also be scope of Pharma studies in India and abroad. supported and subjectivity in certain regulatory decision- As per the report of IES (Indian Economic Survey making removed. )2021, in the next decade the domestic market is expected to grow 3x. The pharmaceutical industry is currently valued Generic Market exporting: at $41.7 bn. India’s domestic pharmaceutical market is Just like any other industry, the pharmaceutical estimated at US$ 41 billion in 2021 and likely to reach industry is also a sales-driven Industry. With the help of AI US$ 65 billion by 2024 and further expand to reach US$ technology, companies can gather information regarding 120-130 billion by 2030. targeting audiences and create unique marketing strategies In India, Pharmacy Council of India (PCI) is the for them. This way they can understand the needs of the regulatory body which has been designing the Education market and can convert most leads into revenues. AI Regulations pertaining to Pharmacy which outlines the can help in protecting the success or failure rate of the conditions to be followed by pharmacy colleges, Institutions marketing strategy. and Universities. PCI grants approval to the universities Effect of External Market: and colleges in India to run the various programmes in the domain of Pharmacy. The PCI has well-defined standards, More than 50% of Pharmaceutical Ingredients are norms, and guidelines to be followed by the entities seeking dependent on other countries such as China. Slight changes approval from the regulatory Council. in policies can bring a big difference in the production of medicines and equipment (e.g., to fulfil domestic The India Pharma industry is worth about $37 billion, consumption, America delays the export of raw material with exports accounting for about $18 billion. As compared for manufacturing Covid-19 vaccines which creates an to other countries, the prices of medicines in India are extra burden on manufacturers in India). For a developing amongst the lowest in the world. Although having some of country, our government needs to create an environment the medicine’s lowest prices in the world, leading firms of for the healthcare startup, so that companies and patients India also have the capacity to not only serve the Indian can co-exist without burdening each other. market for essential drugs but also supply their drugs to the world. Conclusion: Challenges in Pharma Industry Due to growth in the Pharma industry in India, both Price Fluctuation and Policy Environment: directly and indirectly about 2.7 million jobs have been created for the citizens. Government needs to make India Price fluctuation and policy environment are the a life sciences innovation hub to promote innovation by challenges created by unexpected and frequent domestic creating a research ecosystem and expanding and upskill pricing policy changes in India. One of the biggest the talent pool to handle complex technologies with challenges in the pharmaceutical industry in India is advanced resources. analysing the shifting customer behaviour and fluctuating prices, due to this vague environment of innovations (Author:Prof. (Dr.) Rana Singh is the Vice-Chancellor and investments has created in Industry. According to of Sanskriti University) The Indian Pharmaceuticals Alliances (IPA) to produce Source: ETHealthWorld, 08.07.2021 affordable Indian patients’ drugs, the government and stakeholders work together. l l l
IDMA Bulletin LII (28) 22 to 30 July 2021 34
Lower Barriers: India’s tariffs record India was branded “tariff king” by former US President sharp drop from 17.6% in 2019 to 15% Donald Trump, who had demanded that New Delhi slash in 2020 duties on a broad range of products, even though the world’s largest economy turned more protectionist under him. Economists, however, have been critical of New Delhi’s move to undermine liberalisation, achieved In response, Indian officials have pointed out that New assiduously over the years since the 1990s. Delhi’s applied tariffs are way below the permissible limit A sustained drop in imports will also help the country under the WTO framework, or the so-called bound rate lower its trade imbalance, which, some officials reckon, (which was 50.8% in 2020). The trade-weighted average will not just ease pressure on its current account but boost tariff is even lower than the simple average one (Washington its GDP growth as well. highlights only the latter). Moreover, unlike other large economies, India hardly uses non-tariff barriers to crack In a break from the recent past, India’s average applied down on imports it deems non-essential or sub-standard. import tariff dropped to 15% in 2020 from as high as 17.6% in the previous year, recording the sharpest annual Following a surge in its crude oil import bill in 2018, fall in about a decade and a half. New Delhi had targeted “non-essential imports” to curb pressure on its current account. It again resorted to This reflects a partial reversal of duty hikes that had increases in customs duties on scores of products in 2019 marked India’s sustained push for import substitution to prepare the way for its Aatmanirbhar initiative amid an through self-reliance and its response to a spurt in trade escalating trade war between the US and China. These protectionism in key economies – especially the US and moves pushed up the applied tariff (simple average) sharply China — in recent years. The tariff is still higher than the from 13.8% in 2017 to 17.1% in 2018 and 17.6% in 2014 level of 13.5%. 2019. Trade-weighted average tariff — total customs revenue The proposed re-examination of the customs duty as percentage of overall import value — also eased for a exemption is part of the broader effort to promote domestic second straight year to 7% in 2019, the lowest since 2014 manufacturing, which, in turn, is expected to curb imports and compared with 10.3% in 2018, show the latest World and boost exports. A sustained drop in imports will also Trade Organization (WTO) data. help the country lower its trade imbalance, which, some However, as the government undertakes a comprehensive officials reckon, will not just ease pressure on its current review of various customs duty exemptions this fiscal, in account but boost its GDP growth as well. sync with a Budget announcement, this tariff fall may prove Economists, however, have been critical of New Delhi’s to be short-lived unless imposts on scores of products are move to undermine liberalisation, achieved assiduously trimmed as well. over the years since the 1990s. While the applied tariff (simple average) on farm Former vice-chairman of Niti Aayog Arvind Panagariya products eased to 34% in 2020 from 38.8% in the has cautioned that the duty hikes can be counter- previous year, industrial tariff declined to 11.9% from productive. No major economy has grown 8-10% without 14.1%. Similarly, based on trade-weighted average, tariff on farm items dropped to 32.5% in 2019 from as high as opening up its market and India needs to bring down its 60.7% in the previous year, while industrial tariff dipped industrial tariff to at most 10%, he has argued. to 5.8% from 8%. These tariffs are meant for imports from In a paper with Shoumitro Chatterjee last year, former countries to which India has accorded the most-favoured chief economic advisor Arvind Subramanian said India nation (MFN) status. was turning inward. “Domestic demand is assuming Last year, the government reduced customs duties on primacy over export-orientation and trade restrictions are various products, including crude palm oil, precious metals increasing, reversing a 3-decade trend,” the paper said. like platinum and palladium, certain fuels, chemicals and India still enjoys large export opportunities, especially in plastics, select machinery and electronics items, sports labour-intensive sectors such as clothing and footwear. “But goods and newsprint. Of course, the duties on certain exploiting these opportunities requires more openness and products were raised as well. more global integration,” the paper argued. Analysts have
IDMA Bulletin LII (28) 22 to 30 July 2021 35
also pointed out duty hikes have been mostly unsuccessful to re-organise and monetise the asset. GLS considered a in containing imports, especially from China. minority stake sale earlier, but the surge in API industry prominence and stepped up financial performance of API Domestic industry, meanwhile, clamours for more operations have allowed for better monetisation opportunity protection, arguing that in the absence of credible now. GLS has shown revenue and EBITDA growth of around structural reforms to bring down its costs (including costs 16 per cent in 2019-21 with industry leading EBITDA of logistics, wage, electricity and credit) and provide it a margins of 30 per cent. The IPO values the API business, level-playing field, allowing increased foreign competition at relatively comparable P/E of 22.1 times. Long term is patently unfair. investors can subscribe to the IPO and participate in the Reforms to boost competitiveness of the economy largely anticipated domestic API growth. haven’t been undertaken since liberalisation as they should have, it stresses. Bolstering competitiveness not just enables a country to improve its exports but also reduce costly imports. As pointed out in a 2016 report by HSBC, India’s domestic bottlenecks explain 50% of the slowdown in overall exports (remaining the biggest threat to its outbound shipments), followed by world growth (33%) and the exchange rate (just 17%).
Source: Banikinkar Pattanayak, Financial Express, Glenmark Life Sciences26.07.2021 – Growth at reasonablel l l price Sai PrabhakarGlenmark Yadavalli BL Life Research Sciences Bureau | Updated on– JulyGrowth 24, 2021 Offers industryat-leading reasonable margins inprice highly competitive activeOffers pharma industry-leading ingredient making margins space in highly competitive active pharma ingredient making space
DomesticPortfolio API Industry and margins
The Indian API industry with 6.1 per cent global marketGLS share,derives has to90 be persupplemented cent of by revenues Chinese from API which are described Glenmark Life Sciences (GLS), the API spin off from Glenmark Life Sciences (GLS), the API spin off from Glenmark imports which accounts for 68 per cent of API imports. Glenmark Pharma has announced its IPO. The IPO will raise Pharma has announced its IPO. The IPO will raise a total of ₹1,513 Theby overGLS reliance as nonon Chinese-commoditised, supplies was not without high value, and mature, products, a total of `1,513 crore (at the upper price band) consisting crore (at the upper price band) consisting of fresh issue of ₹1,060 its moments of volatility, as in the recent disruptions of fresh issue of `1,060 crore. Post IPO, Glenmark Pharma crore. Post IPO, Glenmark Pharma shareholding will come off from fromgenerating China environmental high margins.clean-up (2018) The and endCovid--products GLS is active in, have shareholding will come off from 100 per cent to around 100 per cent to around 83 per cent. The IPO proceeds will primarily 19 period. 83 per cent. The IPO proceeds will primarily be used lost patent exclusivities in the last 6-8 years and hence have passed be used for repaying the remaining interest-bearing purchase As the industry, with impetus from the government considerationfor repaying of the₹800 remainingcrore that GLS interest-bearing owes to Glenmark purchasePharma for through its PLI scheme, gears up to focus on the backend theconsideration API carve out. of Glenmark `800 crore started that its APIGLS operations owes to in Glenmark 2001-02 through the initial years of sharp price erosion and now face of formulations, API and speciality chemicals industries periodPharma and for spun the it offAPI in earlycarve 2019 out. to Glenmarkre-organise andstarted monetise its APIthe are now witnessing a palpable surge in demand. GLS asset.operations GLS considered in 2001-02 a minority period stake and salespun earlier, it off but in earlythe surge 2019 in manageable mid-single digit erosions. GLS also improves cost management has reported a strong traction in demand, efficiencies through the product life-cycle, which might impact the IDMA Bulletin LII (28) 22 to 30 July 2021 36 top line realisations, but sustain margins or contract life. New products were introduced, based on customer timelines, at the rate of 6 per year in the last three years which replenish the constantly eroding top line and margins. GLS is planning to enter complex APIs of oncology, peptides and iron compounds and has commercialised an iron compound with two more in the pipeline. The other segment started 3 years back - CDMO (Contract Development and Manufacturing operations) contributes 8-10 per cent of revenues and bears significant potential with longer customer cycles and better margins. GLS has more than 30 per cent market share in 4 products which contributed 43 per cent to sales in FY21 and top 10 products contributed to 66 per cent of sales. The portfolio is geared towards chronic therapies and regulated markets (66 per cent), with leading products like Telmisartan, Atovaquone, Perindopril, Teneligliptin, Zonisamide and Adapalene. at the rate of 6 per year in the last three years which replenish the constantly eroding top line and margins. GLS is planning to enter complex APIs of oncology, peptides and iron compounds and has commercialised an iron compound with two more in the pipeline. The other segment started 3 years back - CDMO (Contract Development and Manufacturing operations) contributes 8-10 per cent of revenues and bears significant potential with longer customer cycles and better margins. GLS has more than 30 per cent market share in 4 products which contributed 43 per cent to sales in FY21 and top 10 products contributed to 66 per cent of sales. The portfolio is geared towards chronic therapies and regulated markets (66 per cent), with leading products like Telmisartan, Atovaquone, Perindopril, Teneligliptin, Zonisamide and Adapalene.
Financials and valuation GLS reported a revenue growth of 16 per cent CAGR in FY19-21 with EBITDA margins of 30 per cent, compared to the peer set margin range of 15-20 per cent. The selectively curated chronic portfolio supported by strong execution capabilities has supported the margins. GLS has a capacity of 786 KL across its 4 manufacturing facilities operating at high 85 per cent capacity utilisation. In the medium term, 200 KL addition in existing facilities is planned, with a mix of internal accruals and debt, and in the longer term a 800 KL greenfield facility is planned, covering APIs and CDMO operations.
GLS’s PLI participation is at the early stages with further clarity awaited. GLS’s will deleverage by clearing the only debt in the form of outstanding purchase consideration aFinancials part of which it ascribes and to valuationvendors adding a local owed to the parent company. Similarly the parent company source. GLS reported a revenue growth of 16deleveraging per cent with CAGR expected in inflows FY19 of around-21 `1200 Portfolio and margins crore from IPO (repayment + offer for sale) and further reorganisation of verticals, can focus on generics based withGLS EBITDAderives 90 per centmargins of revenues of from 30 API per which cent, compared to the peer set growth aiding GLS’s largest business. are described by GLS as non-commoditised, high value, and mature, products, generating high margins. The end- At 22 times FY21 earnings, GLS is priced reasonably, products GLS is active in, have lost patent exclusivities in compared to its peers which have witnessed re-rating in the last 6-8 years and hence have passed through the initial the last year on account improved prospects for domestic years of sharp price erosion and now face manageable mid- APIs. single digit erosions. GLS also improves cost efficiencies Source: Sai Prabhakar Yadavalli, BL Research Bureau, through the product life-cycle, which might impact the top 25.07.2021 line realisations, but sustain margins or contract life. New l l l products were introduced, based on customer timelines,
IDMA Bulletin LII (28) 22 to 30 July 2021 37
IDMA Bulletin LII (28) 22 to 30 July 2021 38
IDMA Bulletin LII (28) 22 to 30 July 2021 39
LICENSEDLICENSED TOTO POSTPOST WITHOUTWITHOUT PREPAYMENTPREPAYMENT LICENCELICENCE NO.NO. MR/Tech/WPP-337/West/2021-23MR/Tech/WPP-337/West/2021-23 RNIRNI REGN.REGN. NO.NO. 18921/1970,18921/1970, REGN.NO.MCW/95/2021-23REGN.NO.MCW/95/2021-23 PublishedPublished andand PostedPosted onon 77thth,, 1414thth,, 2121stst andand 3030thth ofof everyevery monthmonth ThisThis issueissue postedposted atat MumbaiMumbai PatrikaPatrika ChannelChannel SortingSorting OfficeOffice onon 14.06.202130.07.2021
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Aptar Pharma Taking on injectable complexities
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