Glimpses of IDMA Golden Jubilee Celebrations, various other Events, Seminars and Interactive Meetings held during the year 2012
N O T I C E
The 51st Annual General Meeting of the Indian Drug Manufacturers’ Association will be held on Saturday, 5th January 2013 at 4:30 p.m., at Hotel The Lalit, Sahar Airport Road, Andheri (E), Mumbai to transact the following business:-
AGENDA
1. To read the Notice convening the meeting 2. To adopt the Annual Report for the year 2011-12 3. To adopt the audited Statement of Accounts for the year ended 31st March 2012 4. To announce the names of the Office-bearers and Executive Committee Members for the year 2013 5. To appoint auditors for the year 2012-13. 6. Any other business with the permission of the Chair.
Daara B. Patel Secretary-General
Date: 21st December 2012
Note : Members who need clarifications or details with regard to the Agenda for the meeting are required to write to IDMA office specifying the clarification required by them on or before 4th January 2013.
1 2 IDMA EXECUTIVE COMMITTEE – 2012 PRESIDENT MANISH U DOSHI Managing Director Umedica Laboratories Ltd. 105, 1st Floor, Rewa Chambers, 31, New Marine Lines, Mumbai – 400 020.
IMMEDIATE PAST PRESIDENT N R MUNJAL Vice Chairman cum Managing Director Ind-Swift Laboratories Ltd. S. C. O. No. 850, Shivalik Enclave, NAC Manimajra (UT), Chandigarh – 160 101
VICE PRESIDENTS
Western Region KAMLESH C PATEL Managing Director West-Coast Pharmaceutical Works Ltd. Meldi Estate, Nr. Prasang Party Plot, Opp. Sola Bhagwat, Sayona City Road, Gota, Ahmedabad – 382 481. Gujarat.
Northern Region B R SIKRI Director Next Wave (India) Auronext Pharma Pvt. Ltd. C-980, Sushant Lok, Phase – I, Gurgaon – 122 002. Haryana.
Southern Region S V VEERRAMANI Chairman & Managing Director Fourrts (India) Laboratories Pvt. Ltd. Plot No. 1, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai – 600 097
Eastern Region SUBHARTHEE DEY Wholetime Director Dey’s Medical Stores (Mfg.) Ltd. 62, Bondel Road, Kolkata – 700 019
3 HON. GENERAL SECRETARY B K GUPTA Managing Director Medicamen Biotech Ltd. 10, Community Centre No. 2, Ashok Vihar, Phase – II, Delhi -110052
Hon. Joint Secretaries VINOD KALANI (Resigned on 28/09/2012) Director Cris Pharma (India) Ltd. Oasis Test House Ltd. SP-2, 22 Godam Industrial Estate, Jaipur 302006, Rajasthan
PRANAV CHOKSI Director Gufic Biosciences Limited Old Shankar Jyot School Bldg, 2nd Flr., Above Bank of Maharashtra S V Road, Andheri(W), Mumbai-400058
HON. TREASURER MAHESH H DOSHI Partner Dy-Mach Pharma B-12, Anand Sagar, Old Nagardas Road, Andheri (E), Mumbai – 400 069
Elected members ASHEESH ROY Director STADMED PVT. LTD. AA21, Sector I, Salt Lake City, Kolkata 700 064
ASHUTOSH GUPTA Executive Director MEDICAMEN ORGANICS LTD. 10, Community Centre No. 2, Ashok Vihar, Phase II, Delhi – 110 052.
B. G. BARVE Dy. Managing Director BLUE CROSS LABORATORIES LTD.
4 Peninsula Chambers, Gr. Floor, Lower Parel, Mumbai – 400 013.
BHAVIN MUKUND MEHTA Director KILITCH CO. (PHARMA) LTD. Unit No. 37, Ujagar Industrial Estate, W T Patil Marg, Deonar, Mumbai – 400 088
BHUPENDRA SANGANI Director GALENTIC PHARMA (INDIA) PVT. LTD. Samruddhi Venture Park, 4th Floor, MIDC Central Road, Andheri (East), Mumbai – 400 093
CHIRAG H. DOSHI Director Yash Medicare Pvt. Ltd. 401, Shaswat Complex, Opp. Gujarat College, Ellisbridge, Ahmedabad - 380 006.
DILIP SURANA Chairman & Managing Director MICRO LABS LTD. 27, Race Course Road, Bangalore – 560 001
DR DUSHYANT R. PATEL President & CEO ASTRAL STERITECH PVT LTD. 911, G.I.D.C., Makarpura, Vadodara – 390010. Gujarat
MOHAN JAIN Director NAPROD LIFE SCIENCES PVT. LTD. 304, Town Centre, Andheri Kurla Road, Andheri (East), Mumbai – 400 059.
5 NIRAV K. MEHTA Marketing Director CORONA REMEDIES PVT. LTD. “C” Mondeal Business Park, Nr. Gurudwara, S. G. Highway, Thaltej, Ahmedabad-380054, Gujarat
PARESH CHAWLA Chief Operating Officer ALPA LABS ( INDIA ) LTD. 33/2, A. B. Road, Pigdamber – 453 446. Madhya Pradesh
DR. SHRENIK K. SHAH Director MONTAGE LABORATORIES PVT. LTD. AT. Dhandha, Idar Road, Himatnagar – 383 001. Gujarat
T. RAVICHANDIRAN Managing Director PHARM PRODUCTS PVT. LTD. AH-64, (New No. 24), 5th Street, Shanthi Colony, Anna Nagar, Chennai – 600 040. Tamil Nadu.
VASUDEV KATARIA Director VINDAS CHEMICAL INDUSTRIES (P). LTD. 210 Adamji Building, 413, Narsi Natha Street, Masjid Bandar Road, Mumbai 400 009
VINAY PINTO Executive Director WALLACE PHARMACEUTICALS PVT. LTD. B – 307/312, Floral Deck Plaza, Off Central M.I.D.C. Road, Next to Rolta Bhavan, Andheri (East), Mumbai 400 093
6 Corporate Members Ajit Singh Chouhan Managing Director RPG Life Sciences Ltd., RPG House, 463, Dr. A.B. Road, Worli, Mumbai 400 030
Amit Parasmal Bohora Managing Director Biosensors Interventional Technologies (India) Pvt. Ltd. Plot # 14, Shed #A-2, Near Charak Pharma, GIDC Umbergaon, Dist-Valsad, South Gujarat-396171
Anil Mittal Director Punjab Formulations Ltd. 340, Laxmi Plaza, Laxmi Indl Estate, New Link Road, Andheri (W) Mumbai 400 053
Dr. Kiran Mazumdar Shaw Chairman & Managing Director Biocon Limited 20th K.M. Hosur Road Electronic City, P.O., Hebbagodi, Bangalore 560 100
N D Rajpal Resident Director Alembic Pharmaceuticals Ltd. Prithvi Mansion, 4/8 Asaf Ali Road, New Delhi – 110 002.
Mohan. P. Gandhi Executive Director (Technical) Torrent Pharmaceuticals Ltd. Ahmedabad-Mehsana Highway, Village : Indrad, Taluka :Kadi, Dist : Mehsana (NG) - 382721
7 Neeraj Agrawal CEO-Generics Jubilant Organosys Limited Plot 1A, Sector 16 A Institutional Area, Noida - 201301 Uttar Pradesh
S. Chatterji Technical Advisor Parenteral Drugs (India) Ltd 340, Laxmi Plaza Laxmi Indl Estate, New Link Road, Andheri (W) Mumbai 400 053
Sanjeev Jain Director Akums Drugs & Pharmaceuticals Ltd 304, Mohan Place, LSC, Block C, Saraswati Vihar, New Delhi-110034
Sanjeev Kumar Director, United Biotech (P) Ltd. FC/B-1 (Extn.), Mohan Co-op. Indl. Estate, Mathura Road, New Delhi – 110 044.
S Abhaya Kumar Managing Director Shasun Pharmaceuticals Ltd. “Batra Centre”, No. 28, Sardar Patel Road, Guindy, Chennai – 600 032. Tamil Nadu
CO-OPTED MEMBERS ( 8 Members ) K Nithyananda Reddy Managing Director, Aurobindo Pharma Ltd. Plot No. 2, Maitri Vihar, Ameerpet, Hyderabad – 500 038
8 K D Vora Partner, Pure (Drugs) India 203-205, T. V. Industrial Estate, S. K. Ahire Marg, Worli, Mumbai – 400 025.
Pankaj R Patel Chairman & Managing Director, Cadila Healthcare Ltd. Zydus Tower, Satellite Cross – Road, Ahmedabad – 380 015. Gujarat
Dr Prakash A Mody Chairman & Managing Director, Unichem Laboratories Ltd. Mahalaxmi Chambers, 2nd Floor, 22 Bhulabhai Desai Road, Mumbai – 400 026.
Prashant Tewari, Managing Director, USV Ltd. B.S.D. Marg, Govandi, Mumbai – 400 088.
Premchand Godha Chairman & Managing Director, IPCA Laboratories Ltd. 142-AB, Kandivali Industrial Estate, Kandivali (West), Mumbai – 400 067.
Dr. Rajesh Jain Joint Managing Director, Panacea Biotec Ltd. B-1, Extn. A-27, Mohan Co-op. Industrial Estate, Mathura Road, New Delhi – 110 044.
9 Y. C. Patel Chairman & Managing Director Elysium Pharmaceuticals Ltd. At & Post Dabhasa Tal - Padra Dist. Baroda, Gujarat 391 440
SPECIAL INVITEES ( 16 Members )
Ajit Kumar Jain Jt. Managing Director IPCA Laboratories Ltd. 142-AB, Kandivali Industrial Estate, Kandivali (West), Mumbai – 400 067.
Anil Gidwani Director (Indian Operations & Global Pharma Business) Member of Board of Directors Dana Pharmaceuticals Pvt Ltd 209 Bhaveshwar Complex, Vidyavihar (W), Mumbai 400 086
Bharat R Desai Managing Director Bharat Parenterals Ltd. Vill. Haripura, Tal. Savli, Dist. Vadodara – 391 520. Gujarat.
J Jayaseelan President Edict Pharmaceuticals Pvt. Ltd. New No. 25, 12th Cross Street, Shastri Nagar, Adyar, Chennai – 600 020.
J L Sipahimalani Managing Partner Chem Med Analytical Laboratories 5-6-7, Kakad Estate, R G Thadani Marg, Worli, Mumbai - 400 018.
10 Mehul Shah Managing Director Encube Ethicals Pvt. Ltd. Unit No. 24, Steel Made Industrial Estate, Marol Village, Andheri (East), Mumbai – 400 059.
Nandan Chandavarkar Jt. Managing Director FDC Limited 142/48, S V Road, Jogeshwari (West), Mumbai – 400 102.
Dr R K Sanghavi Consultant, Pharma Neuro Marketing Sunita Nivas, 78, SV Road, Opp. Sacred Heart Church, Santacruz (West), Mumbai - 400054
S M Mudda Executive Director – Technical & Operations Micro Labs Limited No. 27, Race Course Road, Bangalore – 560 001.
S R Vaidya Partner Sunayan Pharmaceuticals Flat No. 10, Dipty Building, Aarey Road, Goregaon (East), Mumbai – 400 063.
Shakti P Chakraborty Group President – India Region Formulations Lupin Ltd. Laxmi Towers, 4th Floor, C Wing, Bandra – Kurla Complex, Bandra (East), Mumbai – 400 051.
Smitesh C Shah Chairman & Managing Director Calyx Chemicals & Pharmaceuticals Ltd. A/37-38, MIDC Phase I, Golavli Naka, Kalyan-Shil Road, Dombivli (East), Dist. Thane – 421 203. 11 Sudhir V Valia Executive Director Sun Pharmaceutical Inds. Ltd. Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai – 400 059.
Sundeep Bambolkar Joint Managing Director Indoco Remedies Ltd. Indoco House, 166 CST Road, Santacruz (East), Mumbai – 400 098
Tushar A Korday Director Emil Pharmaceutical Inds. Pvt. Ltd. 101, Mangalam Kulupwadi, Near National Park, Borivali (East), Mumbai – 400 066.
V Chandrasekaran Managing Director Carewell Steuart Pharma Pvt. Ltd. No. 9, Nagi Reddy Gardens, Giundy, Chennai – 600 032.
EX-OFFICIO MEMBER
(PAST PRESIDENTS) Dr. Abraham Patani (Founder Secretary) C.M.D. Inga Laboratories Pvt. Ltd., Inga House, Mahakali Road, Andheri (E), Mumbai 400 093
Jyotindra B. Mody Chairman & Managing Director JB Chemicals & Pharmaceuticals Ltd. Neelam Centre, 4th Floor, B Wing, Hind Cycle Road, Worli, Mumbai 400 030
Chandrakant I. Gandhi Chairman Gentech Laboratories Ltd
12 105, A to Z Industrial Estate, G.K. Marg, Lower Parel (W), Mumbai - 13
Late Indravadan A. Modi Chairman Cadila Pharmaceuticals Ltd., Cadila Corporate Campus, Sarkhej Dholka Road, Bhat, Ahmedabad 382210, Gujarat
N. I. Gandhi Chairman & Managing Director Lyka Labs Ltd., 101 Shivshakti Industrial Estate, Andheri-Kurla Road, Andheri (E), Mumbai - 400 059
Anant. R. Thakore Managing Director Avik Pharmaceutical Ltd 194, Arvind Chambers, Gauri Studio Compound, Western Express Highway, Andheri (E), Mumbai - 400 069
Dinesh B. Mody Whole Time Director (Admn.) JB Chemicals & Pharmaceuticals Ltd Neelam Centre, B Wing, 4th Floor, Hind Cycle Road, Worli Mumbai - 400 030
Dr. Dinesh S. Patel Managing Director & CEO Themis Medicare Limited 11/12, Udyog Nagar, S.V. Road, Goregaon (West) Mumbai - 400 104
Dr. Gopakumar G. Nair CEO Gopakumar Nair Associates 3rd Floor, “Shivmangal”
13 Next to Big Bazaar, Akurli Road, Kandivali (E) Mumbai – 400 101
Nihchal H. Israni Chairman Blue Cross Laboratories Ltd Peninsula Chambers P.O. Box 16360, Lower Parel, Mumbai - 400 013
Yogin R MAJMUDAR Managing Director Bakul Aromatics and Chemicals Ltd. Sterling Centre, 4th Floor, Dr. A.B. Road, Worli, Mumbai - 400 018
Suresh G. Kare Chairman Indoco Remedies Ltd. Indoco House, 166, C.S.T. Road, Santacruz (East), Mumbai – 400 098.
B. N. Singh Managing Director Alkem Laboratories Ltd. Alkem House, Devashish, Next to Matulya Centre, S. B. Marg, Lower Parel, Mumbai – 400 013
EX – OFFICIO MEMBERS M J SHAH Director BIOCHEM PHARMACEUTICAL INDUSTRIES LTD. 'A' Aidun Bldg., John Crasto Lane, Near Metro Adlabs, Marine Lines, Mumbai – 400 002
DEEPNATH ROY CHOWDHURY Managing Director STRASSENBURG PHARMACEUTICALS LTD.
14 P-6, C. I. T. Road, 4th Floor, Kolkata – 700 014
BHARAT P MEHTA Director J B CHEMICALS & PHARMACEUTICALS LTD. Neelam Centre, 4th Floor, “B” Wing, Hind Cycle Road, Worli, Mumbai – 400 030
BHARAT N SHAH Director, S KANT HEALTHCARE LTD. (A Div. of Sevantilal Kantilal Pvt. Ltd.) 3-A, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai – 400 018
PATRON MEMBERS Jayashree Nair Chairperson & MD BDH Industries Ltd. Nair Baug, Akurli Road, Kandivali (E), Mumbai – 400 101.
Jayesh P. Choksi CMD / President Gufic Biosciences Limited Old Shankar Jyot School Bldg, 2nd & 3rd Flr, Above Bank of Maharashtra S V Road, Andheri(W), Mumbai-400 058
Kushal A Shah Marketing Executive Acichem Laboratories, Prem Parag Industrial Estate, Prabhat Nagar,Jogeshwari (W), Mumbai 400 102
Nirmal L. Jain Partner Nirlac Chemicals 14th Flr, Nirmal Bldg,
15 241/242, Nariman Point, Mumbai – 400 021
Sachin C. Gandhi Managing Director Magna Laboratories (Guj) Pvt. Ltd., 5/6, Shreyas, 2nd Hasnabad Lane, Santacruz (W), Mumbai - 400 054
Dr. Vivek V. Palkar Chairman & Managing Director Nivedita Chemicals Pvt. Ltd. Anek Prayog Pvt. Ltd. A – 14, M.I.D.C., Andheri (E), Mumbai – 400 093.
CHAIrMEN & SECRETARIES OF STATE BOARD
GUJARAT STATE BOARD
Chairman CHIRAG H. DOSHI Director Yash Medicare Pvt. Ltd. 401, Shaswat Complex, Opp. Gujarat College, Ellisbridge, Ahmedabad - 380 006.
Hon. Secretary Viranchi Shah Director / Partner Saga Laboratories Unit 1 : Plot No. 1409, Phase III, GIDC Vatwa, Ahmedabad. Gujarat
Executive Secretary Dr. R.S. Joshi IDMA, Gujrat State Board, 4,Park Avenue, (1st Floor) Parimal Garden Char Rasta Near Gujarat Gas Company Ahmedabad – 380 006. Guajrat
16 WEST BENGAL STATE BOARD
Chairman Manab Kumar Bakshi Managing Director Cradel Pharmaceuticals (P) Ltd. 17, Collin Lane, 1st Floor, Kolkata – 700 016.
Hon. Secretary Siddhartha Paul Executive Director Palsons Drugs Pvt. Ltd. 10/D/1, Ho-Chi-Minh, Sarani, Kolkata-700071
TAMILNADU STATE BOARD
Chairman M. Rajarathinam Director MMC Healthcare Ltd. No. 61, Fathima Nagar, Kurunji Street, Valasaravakkam Chennai – 600 087
Hon. Secretary R Murugan Managing Director Cassel Research Laboratories Pvt Ltd PK 19, Phase 5, Indl.Estate Ekkattuthangal, Chennai – 600 032
Executive Secretary S. Krishnan IDMA, Tamil Nadu State Board Block-D1, Baid Metha Complex, Old No. 183, New No.16, Anna Salai, Little Mount, Saidapet, Chennai - 600015
HARYANA STATE BOARD
Chairman P. K. Gupta President Belco Pharma
17 515, Modern Industrial Estate, Bahadurgarh – 124507 Dist. Jhajjar (Haryana).
Hon. Secretary T. C. Kansal Managing Director Crystal Pharmaceuticals 365 Model Town, Ambala City – 134 003. Hariyana
HIMACHAL PRADESH & Uttarakhand STATE BOARD
Chairman R. C. Juneja Managing Director Mankind Pharma Ltd. 236, Okhla Indl. Estate, Phase – 3, New Delhi – 110 020
Hon. Secretary B R SIKRI Director Next Wave (India) Auronext Pharma Pvt. Ltd. C-980, Sushant Lok, Phase – I, Gurgaon – 122 002. Haryana.
18 List of Sub-Committees
Sr. No. Sub-Committees Chairmen 1 Bulk Drugs Mahesh H. Doshi Dy-Mach Pharma 2 Employee Relations & Development Deepnath Roy Chowdhury Strassenburg Pharmaceuticals Ltd. 3 Excise & Taxation B. G. Barve Blue Cross Laboratories Ltd.
4 Finance & Administration Bharat N. Shah S. Kant Healthcare Ltd. 5 Industry Trade Matters S V Veerramani Fourrts (I) Laboratories Ltd. 6 International Trade (Incl. Customs) Dinesh B. Mody J B Chemicals & Pharmaceuticals Ltd. 7 I P R Dr. Gopakumar G Nair Gopakumar Nair Associates 8 Marketing Vinay Pinto Wallace Pharmaceuticals Ltd. 9 Medical Dr. R K Sanghavi Consultant, Pharma Neuro Marketing 10 Membership and Constitution Anant R. Thakore Avik Pharmaceuticals Ltd. 11 MSME Vinod Kalani Cris Pharma India Limited 12 Nutraceuticals Dr. R K Sanghavi Consultant, Pharma Neuro Marketing 13 Pricing/Consumer Affairs N. I. Gandhi Lyka Labs Ltd. 14 Publications Dr. Abraham A. Patani Inga Laboratories Pvt. Ltd. 15 Public Relations K. D. Vora Pure Drugs (India) 16 Quality Management & Technical J. L. Siphimalani Chem-Med Analytical Laboratories 17 Regulatory Affairs S M Mudda Micro Labs limited 18 Youth Wing M.J. Shah Biochem Pharmaceutical Inds.
19 SECRETARIAT
HEAD OFFICE (MUMBAI) 102, Poonam Chambers, A Wing, 1st Floor, Dr. Annie Besant Road, Worli, Mumbai - 400 018. Maharashtra, India Tel.: +91-22-24944624 / 24974308 Fax: 24950723
Daara B. Patel Secretary-General Email : [email protected]
T. R. Gopalakrishnan Advisor Email : [email protected]
Prachi Rane Sr. Manager (Publications & P. R.) Email : [email protected]
Melvin Rodrigues Manager (Accounts & Administration) Email : [email protected]
C. K. S. Chettiar Assistant Manager (Publications & Administration) Email : [email protected]
DELHI OFFICE 2nd Floor, B-4 / 115, Safdarjang Enclave, New Delhi - 110 029 Tel.: 011-26171367 / 41650726 Fax: 011-26171369 Email : [email protected], [email protected]
S. K. Arya Joint Director
20 51st ANNUAL REPORT 2011-12
Dear Member,
The successful completion of 51 years of service to the nation fills us with a sense of awe and satisfaction. Our founding Members, when they set up the Association, would not have visualized such impressive growth of the Association that led to the spectacular growth of the Indian Pharmaceutical Industry, from being basically importers to being the largest suppliers of safe and affordable quality generic medicines in the world, with the befitting recognition as the Pharmacy of the world!
This 51st Annual Report covers varied activities, initiatives and achievements of your Association during the past year. The year was unique and saw many firsts in your Association’s endeavours to discuss and work out solutions with the Government for the manufacturing and other related activities of Members, as also our active initiatives that brought your Association to national focus and goodwill. This has been possible due to the consistent efforts and support of our President, Past Presidents, Office-Bearers, and Chairmen &m embers of various Sub-committees. Due to their collective efforts in effective recommendations and representations to the government, we managed to get many issues resolved in your favour.
Grand Finale of Golden Jubilee Year Celebrations : The grand finale of the Golden Jubilee Year Celebrations was held over two days on 6th and 7th January 2012 in Mumbai. The efforts put in by the Chairman Mr N I Gandhi and his team in very efficiently organising the grand finale of the Golden Jubilee Year Celebrations was well appreciated.
The Chief Guests at the Golden Jubilee Celebrations were the late Shri Vilasrao Deshmukh, Hon'ble Minister of Science & Technology & Earth Sciences on Day 1 and on Day 2, Shri Praful Patel, Hon'ble Union Minister for Heavy Industries, and Public Enterprises. Other key personalities who graced the Golden Jubilee were Mr Shiv Khera, the world renowned motivational guru, Shri Satej Patil, Minister of State, Maharashtra Food & Drugs Administration, Home & Rural Development, Mr Martin Khor, Executive Director, South Centre, Geneva, Dr Rekha Shetty, Managing Director, Farstar Distribution Network, Shri Raja Shekhar Vundru, Jt. Secretary, Department of Pharmaceuticals, Mr T C A Ranganathan, CMD, EXIM Bank, Shri Rajeev Kher, Additional Secretary, Department of Commerce, Mr Ramu Deora, President, FIEO, Dr K Bangarurajan, Dy. DC(I) and a host of other heavyweights from the industry.
The unforgettable highlight of the Celebrations was the awarding of mementos to each Past President of IDMA by Shri Amitabh Bachchan, in recognition of their unstinted contribution in
21 serving IDMA and the Indian Pharma industry. Also, well-known playback singer Mr Sonu Nigam and the stand-up comedian Mr Kapil Sharma entertained the audience on day one and Mr Sivamani, the famous percussionist along with his band kept the audience engrossed on the second day at the conclusion of the Celebrations.
Golden Jubilee Corpus Fund : The activities during the Golden Jubilee Year had generated about ` 31 lakhs surplus from contributions, sponsorships, delegate fees, etc and it was placed in a Corpus Fund and invested in FDs, to be utilised towards providing for educational and training programmes for Members and the industry, setting up a Data Bank and also utilizing part of the corpus towards Industry-Academia co-ordination activities.
Mega Blood Donation Drive on 14th June 2012 : In continuation of the CSR activities of the Golden Jubilee Year, we successfully organized a Mega Blood Donation Drive on 14th June 2012 to mark ‘World Blood Donation Day’ in many parts of the country. A special camp was organized at IDMA Secretariat Office in Mumbai and 64 bottles of blood were collected. M/s Akums Drugs and Pharmaceuticals Ltd., Haridwar collected 573 bottles, which was the highest number of bottles collected at a Camp this year. Reports were also received from most of the participants and over 1300 bottles of blood were collected.
National Pharmaceutical Pricing Policy 2012 : The much awaited Pharmaceutical Policy was at last notified by the Government dated 7th December 2012. The National Pharmaceutical Pricing Policy 2012 (NPPP 2012) as recommended by the Department of Pharmaceuticals was Market Based Pricing with a simple average of prices of all products with at least 1% market share by volume in a therapeutic category based on IMS data. The span of control is restricted to dosages and strengths listed in NLEM 2011 and would also include products under DPCO 1995 for a year, with increases allowed up to WPI. Formulations are to be priced only by fixing a ceiling Price as per the dosage, which means manufacturers are free to fix any price up to or below the ceiling price. NDDS and indigenously patented products are allowed 5 year exemption from price control. The hearing in Supreme Court was scheduled on 12th December 2012, but was postponed to mid January 2013.
Some Important Meetings with Government Officials :
Dr G N Singh, DCG(I) We held interactive meetings with DCG(I) Dr G N Singh on 2-3 occasions. We discussed many issues pertaining to problems in export, import and regulatory activities. He was as always very patient and co-operative and made whole-hearted attempts at resolving the issues.
22 Dr Jagdish Prasad, DGHS We met Dr Jagdish Prasad, Director General of Health Services (DGHS) and discussed various issues such as providing industry representation in DTAB and setting up a Joint Task Force with the Director General in the Chair and 4-5 officials including the DCG(I), the Dy DC(I)s and industry representatives to meet every three months to discuss industry and policy issues, granting of ‘Division’ status to CDSCO West Zone to ease the overwhelming burden on the DCG(I)’s office etc.. We also invited him to a meeting with our Members at IDMA office.
Shri Chaitanya Prasad, Controller General of Patents, Designs and Trade marks : We organised an interactive meeting with Shri Chaitanya Prasad, Controller General of Patents, Designs & Trade marks to enable Members to be appraised of the current status of the Patent & Trademark Office. He was working on making their website up-to-date and more user-friendly with advanced search facilities etc. and appreciated various suggestions for streamlining and expediting the scrutiny of patent applications and the general working of the Patent Office.
Shri D S Kalha, Secretary, DoP on UCPMP : The President and senior Members met the Secretary of the Department of Pharmaceuticals to discuss the Uniform Code of Pharmaceutical Marketing Practices (UCPMP). He was of the view that industry should adhere to the same MCI guidelines as notified – i.e., strictly no free gifts, hospitality etc to medical professionals in any form. We objected that the Department had not even considered our detailed suggestions submitted and the MCI Guidelines were very rigid and not practically workable.
Tripartite Meeting on FMRAI issues : We met the Labour Minister of Maharashtra, Shri Hassan Miyanlal Mushrif, along with pharma industry representatives, FMRAI and Mumbai Labour Commissioner and discussed FMRAI’s troublesome stand on implementing ‘8 hours fixed working’ as ‘workmen’ under SPE Act. As also an issue about industry not issuing appointment letters as per Form ‘A’ under Section 5 of the Act. The industry met separately on 5th March and set up a core group for joint advocacy by IDMA and OPPI. We subsequently submitted representations to the Maharashtra Chief Minister and Labour Minister and also Mumbai Labour Commissioner. Details are published in the subcommittee’s reports.
Interactive Meeting with Expert Consultant on Indirect Taxes : We organised an interactive meeting with Mr Shailesh Sheth, an expert on indirect taxes, Mumbai for understanding the implications of the CENVAT Tax and Service Tax proposals in the Union Budget 2012-13. Mr Sheth explained the intricacies of many of the newly introduced Rules and amendments of old Rules and their potential impact on the industry.
23 Other Issues :
Competition Commission Cases : We received notices from Competition Commission of India (CCI) in January 2012 along with Investigation Report by the Director General (DG) and detailed Annexures pertaining to certain cases filed against AIOCD and its affiliates. We had signed agreements with the trade earlier to harmonise the industry activities so that SMEs were provided a level playing field in the market. We had terminated all agreements with AIOCD and informed them on 2nd December 2011 as it appeared that these agreements were being considered as restrictive practices. However the CCI thought otherwise and sent us notices, as they were proceeding further in the case after considering the DG’s report. We submitted detailed replies to them and provided all documents of accounts, minutes etc to their satisfaction. CCI also issued notices to our Office-Bearers in connection with a case as above and directed them to submit their audited Profit & Loss Accounts and Balance Sheets for the last three years. After consulting legal experts and as per their advise, we informed the office-bearers to send their replies along with their accounts statements as requested by CCI, as these were public documents. We also received notice regarding another case directing us to appear before the Commission for oral hearing on 4th October 2012, which was attended by the undersigned. At the hearing, we informed them that we had already made detailed submission earlier the Association had nothing to do with any activity between individual manufacturers and trade. We further reiterated that we do not compel any member or interfere in their appointment of stockist, distributor etc and it was purely the individual company’s business decision.
CBDT circular disallowing Gifts to Doctors as Expenses : A major setback for the Pharma industry was the circular from CBDT that gifts and other services provided to Doctors would not be tax deductible. We represented to the Hon’ble Minister of Finance Shri P Chidambaram that expenses up to a certain amount must be allowed as business expenses as also gifts, hospitality, travel facility etc. We also met the Revenue Secretary Shri Sumit Bose and discussed the Circular. The Secretary has agreed to consider our request for prospective implementation of the Circular. We are also working on meeting with the officials of Medical Council of India to discuss amendments in the MCI Act. As a last resort, we might take the legal route to resolve this matter.
Barcoding for Exports and Domestic packs : Our efforts seeking an amicable solution to this issue of barcoding for exports seems to be reaching a stalemate. Madras High Court granted a Stay against the DGFT Public Notices in December 2011 after hearing our plea about the almost impossible nature of the requirements of barcoding and serialisation to be implemented on tertiary, secondary and primary packs. In good faith, the industry agreed to incorporate barcodes on tertiary packs. However, the Department of Commerce appears to be vehemently insisting on implementing barcoding on secondary packs too. Unfortunately our Writ Petition has been dismissed by the Madras High Court on 21 December 2012.
24 In response to the Allahabad High Court directive to conduct a ‘Feasibility Study for Track and Trace of Drugs in India’, the Health Ministry formed a Special Task Force with an objective to analyze different ways to combat spurious drugs in India and study different means for drug authentication within the country. Wipro was selected to conduct this study and recommend a drug authentication mechanism by a common man using simpler means. But we objected to this as it would be a huge burden to SMEs as even a small manufacturer with exports of around ` 15-20 Crore would need to invest ` 2 Crore on barcode machines (one for each blister machine and one each for syrups and injections) with other miscellaneous costs. Wipro released the report in December 2012 and it was being studied by our experts.
India’s landmark Compulsory License : We were very pleased that our stand all along has been justified with the Indian Patent Office granting the country’s first Compulsory License to our Member, M/s Natco Pharmal td., for Sorafenib Tosylate used in treatment for liver and kidney cancer. The Controller General reasoned that the patent holder had not met the reasonable requirement of the public, i.e., it was not affordable and had not ‘worked the patent’ (manufactured) to a reasonable extent in India.
3rd Meeting of Health Ministry Task Force : As informed in the last year’s Annual Report, the Health Ministry’s Task Force for formulating a long term policy and strategy met twice last year to review the activities and reports of the six sub-groups. The 3rd meeting was held on 17th January 2012 in Delhi and discussed recommendations of all the six Sub-Groups in detail. Many of our recommendations were accepted and a draft summary of the sub-groups’ recommendations was provided to us for our suggestions.
Sub-Group on ‘Spurious and Adulterated Drugs’ under the Task Force : We raised the issue of bail provisions under Section 36AC with the Sub-Group on ‘Spurious and Adulterated Drugs’ under the Task Force. Section 36AC was amended to penalize unscrupulous spurious drug manufacturers, but needed redrafting in the Drugs and Cosmetics Rules to protect genuine manufacturers from being harassed by field officers, who were given unlimited powers. We made a representation to Dr V M Katoch, Chairman of the Task Force about our apprehensions on the bail provisions and suggested solutions for amending the same. Dr Katoch took up the matter with DCG(I) and requested him to consider our plea.
Rajya Sabha Committee on Petitions : Following a petition filed by a concerned citizen praying to put a check on manufacture of spurious drugs in our country and other related issues, the Rajya Sabha Committee on Petitions of the Rajya Sabha Secretariat issued a Public Notice calling for comments / suggestions from all stakeholders. We submitted our suggestions on all the issues mentioned in the Public Notice. We brought to their
25 notice about the planned propaganda of vested interests in brandishing a high percentage of Indian Pharmaceutical products as spurious and which had been proved to be totally false by the all India survey undertaken by the DCG(I). We also informed them about the need to include necessary amendments in the spurious drugs provisions for providing bail to protect genuine manufacturers.
33-P direction to States to provide licenses in Proper/Generic names : The Central Government issued Directions vide letter dated 1-10-2012 to all State Governments invoking section 33-P of Drugs and Cosmetics Act, 1940 to instruct their SLAs to grant / renew licenses of all single ingredient formulations for manufacture for sale or distribution only in proper (generic) names. We informed them that the directions were not in accordance with the objective of the Drugs and Cosmetics Act, 1940 which was to ensure availability of safe, standard and efficacious medicines and the Act had nothing to do with brand names. Also the directions were contrary to the provisions of Trade Mark Act and therefore such directions could not be issued taking recourse to the provisions of Section 33-P. They subsequently issued a clarification under Section 33P under the Drugs and Cosmetics Act, 1940 that the directive was applicable only for manufacturing license issued by the Drugs Licensing Authorities under the provisions of the Drugs and Cosmetics Act, 1940 and did not extend to export activities and export related documents such as COPP. The clarification was silent on allowing manufacturers to sell their products under brand names registered under Trade Marks Act. An additional representation seeking further clarifications was sent.
Meanwhile, the Drugs Controller of Uttarakhand issued covering letters to manufacturers directing them to sell drugs only under generic name and not to use any brand name on the label of such product. We took up the matter with the Drugs Controller of Uttarakhand to stop issuing such letters as it was beyond his scope to bar manufacturers from using registered brand names. We also took up the matter with Department of Health to immediately direct the SLAs not to issue such directions to sell drugs only under generic name. (Details are published under the relevant Sub-committee section).
Application in Proper name only for Single Ingredient Formulation : The Central Government also issued a notification to amend the Drugs and Cosmetics Rules to allow renewal and grant of licenses for all single ingredient formulations for manufacture for sale only in proper (generic) names. We informed the Health Ministry that medicines were manufactured by various manufacturers and differed both in their therapeutic equivalence and also in the standard of production. A brand name enabled a doctor to make the choice of the precise drugs to be prescribed to the patient. However, this amendment would take away this right to advise from the doctor and transfer the choice to the chemist, whose decision would be more influenced by the business considerations such as discounts and schemes offered by a particular manufacturer. Hence we requested that the proposed draft notification must not be finalised and the Drugs & Cosmetics Rules must not be amended as proposed.
26 Submission on various Issues to Commissioner, FDA Maharashtra – and FDA Maharashtra notifications on appointment of Stockists :
Mr Mahesh Zagade, Commissioner, FDA, Maharashtra called us for a meeting on 27th June 2012 to discuss the problems and prospects of pharma industry in Maharashtra. We informed the Commissioner about the need to proactively support the industry, especially the API industry. He was very supportive and as requested by him, we submitted a list of such issues hindering the dynamic growth of the industry in the State on 29th June 2012. He also raised the issue of the MoU between IDMA, OPPI and AIOCD and the issue of appointment of additional stockists. We informed him that we had already terminated all MoUs with AIOCD on 2nd December 2011 and informed Members about the same and submitted copies of the letters and circular.
Pilferage and Adulteration of Raw Materials from warehouses, in transit etc. Meeting with Commissioner of Police, Thane :
We were informed about the increasing pilferage of raw material from warehouses and in transit etc., especially at Bhiwandi, near Mumbai and Gujarat border. The modus operandi of these unscrupulous perpetrators was to remove the raw materials from the storage containers and replace the quantity of drug stolen with some other fake & cheap raw material to maintain the weight and expertly reseal the container again. The crime was invariably noticed only when the buyer used the raw material. We represented to various senior Police & FDA officials in Maharashtra and also to officials in Gujarat. We met Mr K P Raghuvanshi, Commissioner of Police, Thane in his office and discussed the matter with him. The Commissioner understood the gravity of the situation and suggested various measures that needed to be taken up by affected parties such as installing CCTV in warehouses, installing GPS by the transporters, informing the Police immediately on noticing the pilferage. He also advised against allowing the main transporter to sublet/outsource the transport activities to other small time transporters. He issued instructions to his officers to file FIRs immediately on receipt of complaints in this matter. The details were published in IDMA Bulletin to bring to the notice of all our Members about this serious issue and to take necessary steps to safeguard themselves from theft and possible penal action under the Drugs and Cosmetics Act & Rules.
MoU signed with ABLE :
We entered into a MoU with ABLE (Association of Biotechnology Led Enterprises) to co-operate on issues of mutual interest to support the development of Pharmaceutical and Biotechnology sectors in the country. One of the key points in the MoU was that Presidents of both Associations would be inducted as Honorary Members of each other’s Executive Committee to synergise and to strive to improve Indian Industry’s competency, competitiveness and market share within the international pharmaceutical industry.
27 MoU signed with Dubiotech : We signed a MoU with Dubiotech (Dubai Biotechnology Park) on 21st September 2012 at the 15th IDMA-APA PAC 2012 held in Mumbai. This would enable our Member companies to set up their operations in Dubiotech and access the fast growing, emerging current opportunities in the Middle East and North Africa. It would also enable Members, especially our SMEs to establish partnerships and joint alliances with Life Sciences/Pharmaceutical companies. Dubiotech offered Free Trade Zone Benefits with 100% foreign ownership, 100% tax exemption, 100% repatriation of profits and capital, Tax free salaries for all employees, 50 year exemption from personal income taxes, 50 year exemption from corporate taxes, exemption from customs duty for goods and services etc.
Conference on Pharma Marketing : We organised a Conference cum Training Program on ‘Pharma Marketing – The Fast & Promising Ways’ on 5th April 2012 in Mumbai. It was a grand success with participation from over 120 delegates. On public demand, we organised the Conference again successfully on 19th May in Chennai.
IDMA-FICCI Pharmaceutical Delegation to Japan : FICCI invited us to jointly take a large delegation of senior Members to Japan for interacting with their government officials in Tokyo and participating in the Pharmaceutical Conference in Osaka under the aegis of the Osaka Pharmaceutical Manufacturers’ Association. On 19th March, the OPMA organized a Seminar with active participation by our delegation, led by our President.
International Pharmaceutical Ingredients Expo & Conference : The International Pharmaceutical Ingredients Expo & Conference was held in Japan from 27 to 29 June 2012. We made a very successful presentation on ‘India – Global Pharma Capital of the World’.
Third Sino-India Forum : The 3rd Sino-India Forum organised by China Pharmaceutical Industry Association and Reed Sinopharm Exhibitions Co Ltd. and was held on 7th - 9th November 2012 at Xiamen, China. The theme this year was ‘Turn a pharmaceutical power from major to strong’. We made presentations ‘India - The Generics Pharma Capital of the World’ and ‘Quality Systems Approach for cGMP Implementation - From Philosophy to Practice’. The presentations were well appreciated by all.
Two new Sub-committees formed : Two new Subcommittees were formed this year for Regulatory Affairs and Nutraceuticals, as the issues relating to both fields required focussed attention. Mr S M Mudda, Executive Director – Technical & Operations, Micro Labs Limited was nominated Chairman of the Regulatory Affairs
28 Sub-committee and Dr R K Sanghavi who is already handling the Medical Sub-committee was nominated to Chair the Nutraceuticals Sub-committee.
Mr G. Wakankar, Executive Director, IDMA retires : Mr G Wakankar, our Executive Director heading the Delhi office retired on 30th September 2012. He was actively involved in promoting our interests and issues with the Government and other organisations. During his 14 years of service with the Association, his knowledge and wide grasp on IPR issues ensured that the interest of the National Sector in pharma industry was protected.
IDMA Trade mark : The registration of the acronym ‘IDMA’ and ‘IDMA’ logo as Trade marks was taken up, as it was being misused by others. The process has been initiated with the help of Dr G G Nair, Chairman of IPR subcommittee and soon it would be completed.
Service Tax paid ‘Under Protest’ : We received a summons from the Office of Additional Commissioner, (Anti-Evasion), Service Tax Mumbai dated 11 May 2012 initiating an inquiry against the Association seeking information and documents about our stand and status on complying with service tax provisions. We made a submission at the inquiry held on 21 May 2012, providing details of total income over the last four years as requested and informing them that we are an Association set up by Members working on the principle of ‘Mutuality of Interest”. However, as decided by the Executive Committee, we paid the Service Tax this year ‘under protest’, as our experts and consultants considered that a non-profit Association such as ours which is set up by Members should not have to pay service tax for services rendered for the growth and welfare of Members.
All important representations made by your Association and the details of important meetings were published in the IDMA Bulletin for information of the Members. A detailed report on your Association’s activities during the last year is presented in the following pages of this Annual Report.
I wish you all Godspeed in all your endeavours.
Fondly remembered for their Contribution towards the National Sector Pharma Industry : • V D Deshmukh, former Jt. Commissioner, FDA Maha and Advisor to IDMA on DPCO and regulatory matters passed away on 8 January 2012 • N C Punwani, Advisor to IDMA on Trade related matters passed away on 14 January 2012 • S K Rangnekar, Founder Director, Centaur Pharmaceuticals Ltd., passed away on 10 May 2012
29 • I A Modi, Founder and Chairman, Cadila Pharmaceticals Ltd and Past President, IDMA passed away on 26 November 2012 • G Swaminathan, founder, Pharm Products Pvt Ltd. and former Rajya Sabha MP passed away on 9 December 2012
Thanking you for your continued support & involvement.
Daara B Patel Secretary-General
30 51st ANNUAL REPORT 2011-12
EMPLOYEE RELATIONS & DEVELOPMENT
Tripartite Meeting on FMRAI issues : The Mumbai Labour Commissioner organised a tripartite meeting of Labour Minister of Maharashtra, Shri Hassan Miyanlal Mushrif, pharma industry representatives and FMRAI on 21st February 2012. The meeting was called to discuss FMRAI’s stand on implementing fixed ‘8 hours fixed working’ as ‘workmen’ under SPE Act. They had also raised an issue that industry was not issuing appointment letters as per Form ‘A’ under Section 5 of the Act. As the industry representatives were informed of the meeting at the last minute we requested for time to prepare our response which was granted. Industry representatives met on 5th March and set up a core group for joint advocacy by IDMA and OPPI.
Maharashtra CM’s intervention sought : A representation dated 16 April 2012 was submitted to Shri Prithviraj Chavan, Hon’ble Chief Minister of Maharashtra requesting for intervention in the proposed move by FMRAI to regularize fixed working hours as it would drastically impact the Pharma industry in Maharashtra and also to advise his Minister of Labour against the same. We sought an audience with him to explain our problems in detail. Meanwhile, we received a draft notification from the State Government about the proposal to fix the number of working hours from 10.00 am. to 2.00 p.m. & 4.00 p.m. to 8.00 p.m. We made detailed representations to Hon’ble Labour Minster and Labour Secretary of Maharashtra on 3rd May 2012 as also to the Labour Commissioner, Mumbai in response to the Maharashtra Government’s draft Notification dated 9th April 2012. In our representations, we objected to the proposal of fixing working hours for Medical Representatives as their main job involved meeting Doctors to educate them on their Company’s latest medicines and the Doctors invariably managed to provide them time only after they had met their patients first. Hence no fixed working hours was possible for MSRs and their job required flexible hours of working.
A representation was also made to the Maharashtra Labour Minister on 3rd May 2012 regarding the appointment letter in Form 'A' of SPE Act. We explained to the Hon’ble Minister that the appointment letter as set out in Form 'A' was directory and not mandatory and all factors and details were already incorporated in the appointment letters issued individually by the Pharma companies.
EXCISE & TAXATION
Refund of VAT to Exporters in Maharashtra : Members exporting from Maharashtra were deeply affected as their claims for refund of VAT by the State Government of Maharashtra were getting unduly delayed. Some of the claims
31 were reportedly pending since 2006. We submitted representation to Shri Ratnakar Gaikwad, Chief Secretary and Shri Swadheen Kshatriya, Principal Secretary in Government of Maharashtra on 30th January 2012 requesting their immediate intervention and support in this matter. We pointed out that the main reason usually cited by them for not refunding the pending claims was that one or two of the suppliers from whom materials were purchased had not deposited the VAT amount and thus claims were kept pending till all the suppliers deposited the VAT amount. Other reasons also cited were inordinate delay in audit by the VAT officers on the pretext of non-availability of staff, heavy workload etc., files/claims rejected citing minor technical objections etc. We requested the Secretaries that claims for VAT Refund of all exporters must be cleared within 60 days from the date of filing of claim, without keeping them pending for want of depositing of VAT amount by all the suppliers from whom the exporters purchase the materials, and action as required could be taken on the defaulters separately, without linking it to the clearance of VAT claims of exporters. We also informed the Secretaries that this matter was discussed with Shri Satej Patil, Minister of State, Maharashtra Food & Drugs Administration, Home & Rural Development at our 50th Annual Celebrations on 7th January 2012 in Mumbai and the Hon’ble Minister had agreed to look into this vexing issue to suitably resolve it at the earliest. The representation was published in IDMA Bulletin dated 7th February 2012.
Urgent Request to keep SMEs, Excise Free Zones out of purview of Alternate Minimum Tax (AMT) : The Government had made a proposal to impose 18.5% Alternate Minimum Tax (AMT), on all types of identities / persons other than companies such as sole proprietorships and partnership firms etc in the Union Budget 2012. The levy in shape of AMT was a proposal to tax the small companies equivalent to the level of big corporates @ 18.5% except for an exemption of initial income/gains of ` 20.00 Lacs. In our representation to the Finance Secretary Shri R S Gujral on 17th May 2012, we requested the Government to rollback this proposal, as it would severely impact the manufacturers in Tax Exempted Zones, especially the MSMEs, as they will have to pay minimum 18.5% tax on their book profits against NIL tax currently. These units were till now exempted from payment of Income Tax on their Profits / Gains, under Section 80IC, operating in Himachal Pradesh, Jammu & Kashmir etc.
Accumulated CENVAT Credit : There was ongoing debate about the mismatch in the rate structure of Excise Duty - with Excise Duty on inputs i.e., APIs at 12% and on output i.e., the finished formulations at 6% and the consequent accumulation of CENVAT credit with the formulators. Manufacturers involved in exports were provided a reprieve under the CENVAT Credit Rules to claim refund under the revised Rule 5 when exported under Bond or LUT. For manufacturers for domestic market, there was no provision made other than to take third party route of exports. Members suggested various solutions such as increasing the abatement on MRP to 50% from the present 35%, to introduce a separate chapter listing APIs to levy Duty on par with finished formulations etc. Reducing Excise Duty on APIs was also not considered advisable as API manufacturers would then have accumulation of CENVAT
32 credit on their inputs. At our request, the Department of Pharmaceuticals agreed to take up the matter with the Ministry of Finance. We issued a circular to Members on 2nd May 2012 requesting them to inform the Association about details of their accumulated CENVAT credit lying unclaimed with them, as of 1st April this year. Even after reminders, only 11 Members responded and their data was forwarded to the Department on 6th August 2012.
Interactive Meeting with Expert Consultant on Indirect Taxes An interactive meeting was organised with Mr Shailesh Sheth, an expert on indirect taxes, on 4th June, 2012 at IDMA Office, Mumbai for understanding the implications of the CENVAT Tax and Service Tax proposals in the Union Budget 2012-13. Only a few Members attended and benefitted from the session. Mr Sheth explained the intricacies of many of the newly introduced Rules and amendments of old Rules and their potential impact on the industry. Some of the provisions were very severe even for minor offences and Rules even if violated unknowingly attracted penalty of jail terms. In certain cases, the Rules had been revised under Excise Act but not revised in Customs.
CBDT circular disallowing Gifts to Doctors as Expenses : The CBDT issued an IT Circular No. 5 dated 1st August 2012 notifying about the “inadmissibility of expenses incurred in providing freebies to medical practitioner by pharmaceutical and allied health sector industry”. Considering the serious implications on Members, we invited Mr Mrudul D. Inamdar, Partner, Bansi S Mehta & Co. and an expert on IT laws to inform Members on 16th August 2012 at IDMA office. The Circular referred to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009 notified on 10th December 2009 that barred the Medical practitioners from accepting any gifts, travel facilities, hospitality, cash or monetary grants etc from pharmaceutical and allied health sector industry. The CBDT circular aimed to disallow these from being claimed as expenses by the Pharma industry. Three main issues needed to be considered in the Circular - whether it had force of law, whether it amounted to double taxation as it prohibited any claims of expense in this regard rendering the amount taxable and at the same time taxed the medical practitioner for receiving the freebies. The effective date of applicability of the circular was also not mentioned and CBDT could raise issues on previous assessment years. Another point discussed was how CBDT considered it an ‘offence’ or ‘prohibit’ Pharma industry citing a notification that was applicable only to Medical Practitioners. Further, the Circular was discriminatory and therefore violated the Constitution of India, as similar gifts given by other industries were being allowed as valid business expenditure.
A representation was made to the Hon’ble Minister of Finance Shri P Chidambaram on 10th September 2012 requesting that expenses up to a certain amount be allowed as business expenses as also gifts, hospitality, travel facility etc. Also physicians’ samples, provided free to them, should be allowed as legitimate expenses and also the circular, if implemented, should only be prospective after 31st August 2012. A meeting with Medical Council of India was also being organised to discuss amendments in the MCI Act.
33 We met the Revenue Secretary Shri Sumit Bose on 10th October 2012 to discuss the Circular. The Secretary agreed to consider our request for prospective implementation of the Circular from 1st September 2012. However, amendments would be required to be made in the MCI Act notified in 2009 to be effective from September 2012.
The Association was considering the possibility of having to take the legal route as there was no response from the Finance Ministry.
Union Budget Proposals 2013-14 Inputs / Suggestions sought : As requested by the Department of Pharmaceuticals and the Department of Revenue, the proposals for the Union Budget 2013-14 were prepared and submitted on 23rd November 2012. An addendum to our proposals was submitted subsequently on 4th December 2012
In the Union Budget 2012-13 announced on 16 March 2012, Excise Duty on bulk drugs was revised from 10 to 12%, formulations from 5 to 6%, and Service Tax from 10 to 12%; 200% weighted deduction for R&D expenditure was extended for another 5 years and a weighted deduction of 150% on expenditure incurred on skill development was introduced. The concessional basic customs duty of 5% with full exemption from excise duty/CVD was extended to 6 specified life saving drugs/vaccines [Raltegravir potassium, Rotavirus vaccine (Live Oral Pentavalent), Pneumococcal Polysaccharide Vaccine, Posaconazole Oral suspension, Temsirolimus Concentrate for infusion for injection and Natalizumab] and basic customs duty and excise duty was reduced on Iodine.
INDUSTRY TRADE MATTERS
Competition Commission Cases : We received notices from Competition Commission of India (CCI) in January 2012 along with Investigation Reports by the Director General (DG) and detailed Annexures pertaining to cases as below:
1. Case no. 20/2011 – filed by M/s Santuka Associates Pvt. Ltd., Cuttack against AIOCD, Mumbai & others. 2. Case No. 41/2011 - filed by M/s Sandhya Drug Agency against Assam Drug Dealers Assn. and others 3. Case No. 30/2011 – Filed by Peeveear Medical Agencies, Palakkad against AIOCD, Mumbai and others
The Commission was proceeding further in the case after considering the DG’s report. In our reply dated 2nd February 2012 made collectively on all the above cases, we provided all documents including our Annual reports to CCI as directed by the Executive Committee and as advised by Mr Kasim Master. We informed them that the matter was reported in detail in our Annual Report 2010-11 for information of Members. We also sent detailed emails to all Members about the
34 termination and the background for terminating the agreements and also published the same prominently in IDMA Bulletin issue of 7th February 2012. Members were also informed that all their dealings with the trade will be on their own and IDMA would not be a party or guide them in this matter. On CCI’s demand, we sent reply to each case separately on 23rd February 2012, along with copies of Annual Reports for the last three years and all other documents as submitted earlier.
We received another Notice from CCI dated 30 March 2012 that AIOCD and its affiliates were allegedly indulging in anti-competitive practices and since IDMA had agreements with them, we were being called upon to submit all relevant documents such as Annual Reports, correspondences MOUs etc. EC Minutes etc. We replied on 9 April 2012 under advice of Mr Master that all these documents were already with the CCI and we had terminated all agreements and had no say in the day to day business activities of any of our Members. We also provided copies of all our correspondences with CCI till date.
CCI Notices to Members : Some members received notices from the CCI informing them that they were arrayed as opposition party in cases involving AIOCD & its affiliates and directed them to furnish information and documents on details of their appointing distributors, wholesalers etc., regarding paying PIS / Advertisement charges in launching new products, deciding trade margins etc.
We sought Mr Kasim Master’s inputs on this matter and he drafted a detailed reply for framing their response suitably as per their business practices, that the Association had already furnished all documents pertaining to the points raised, and had also terminated all agreements with AIOCD subsequently. Also as manufacturers, they needed to inform trade about the newly launched drugs to ensure its wide availability when doctors prescribed the same.
CCI Notices to Office-Bearers : The CCI issued notices to our Office-Bearers in connection with the case No. 20/2011 filed by M/s. Santuka Associates Pvt. Ltd., Cuttack against AIOCD referred above. The Office-Bearers were directed to submit their audited Profit & Loss Accounts and Balance Sheets for the last three years. IDMA Secretariat had not received any communication in this regard. On being informed of the receipt of the notice as above by the Office-bearers, our expert Mr Kasim Master was requested for his advice as he had been advising us on all matters pertaining to CCI. He drafted a brief covering letter, which was forwarded by email to the concerned Office-Bearers on 18th July 2012, that these were public documents and as CCI had asked for the same, they could be submitted as requested. Legal opinion from other experts was also sought in this matter. The Association had, as mentioned earlier submitted all relevant documents including Annual Reports of the Association, correspondences with IDMA Members on this matter etc. as demanded by CCI and as advised by him.
We also sought advice from Mr Sanjay Jhanwar, Advocate Supreme Court (based in Jaipur). and after revising the draft letter suitably, President informed all concerned Office-Bearers by email
35 on 26th July 2012 to forward their reply based on the draft letter to the CCI requesting CCI to inform on what basis were honorary Office-bearers being directed to submit their independent company’s audited accounts as the Association had already submitted all documents as directed.
Subsequently the CCI sent another notice to the Office-bearers dated 23rd August 2012 again directing them to submit their Profit & Loss Statements, Balance Sheets etc for the last three years. We consulted various legal firms such as Wadia Ghandy & Co., Economic Law Practice etc and they all opined that the Balance Sheets etc would need to be submitted, as requested by CCI. Mr Master drafted a reply for the Office–Bearers for submitting these documents again with a request to inform in what context was the information of the companies of Office-Bearers required by the CCI. This was forwarded to all Office-Bearers by email on 11 September 2012 for necessary immediate action.
CCI notice to IDMA re Sandhya case : We received notice regarding another case (No. 41/2011 - filed by M/s Sandhya Drug Agency against Assam Drug Dealers Assn. and others) directing the Association to appear before the Commission for oral hearing on 4th October 2012. As advised by Mr Master, we informed CCI that all documents as requested by them earlier in this case had already been submitted. As directed by the Executive Committee, the Secretary-General attended the oral hearing as above and informed them that we had already made detailed submission earlier on 28th February 2012 as directed by CCI and that the MoUs with AIOCD were terminated on 25th November 2011 by a Resolution passed by our Executive Committee and the Association had nothing to do with any activity between individual manufacturers and trade. Our Members and CCI had also been informed about the same. Also, IDMA does not advice any member or interfere in their appointment of stockist, distributor etc and it was purely the individual company’s business decision. Hence, we requested CCI that we should not be drawn into this controversy for which, as an Association, we were not responsible. The Chairman in charge of the case agreed that the Association would not be required to attend the next hearing in this matter on 30-10-2012.
Submission on various Issues to Commissioner, FDA Maharashtra – and FDA Maharashtra notifications on appointment of Stockists : Mr Mahesh Zagade, Commissioner, FDA, Maharashtra called us for a meeting on 27th June 2012 to discuss the problems and prospects of pharma industry in Maharashtra. We informed the Commissioner about the need to proactively support the industry, especially the API industry. He was very supportive and as requested by him, we submitted a list of such issues on 29th June 2012, hindering the dynamic growth of the industry in the State.
He also raised the issue of the MoU between IDMA, OPPI and AIOCD and the issue of appointment of additional stockists. We informed him that we had already terminated all MoUs with
36 AIOCD on 2nd December 2011 and informed Members about the same and provided him copies of the letters and circular issued to Members. Our submission to the Commissioner and his notices & Note about the trade matters were published in IDMA Bulletin dated 7th July 2012.
INTERNATIONAL TRADE (including CUSTOMS)
Barcoding for Exports – Chennai High Court Stay Order : The Madras High Court had granted a Stay Order [to our WP 29214 of 2011] on 19th December 2011 against the Public Notices issued by DGFT for implementing barcodes on Secondary and Primary Pharma packs. The DGFT meanwhile issued a Public Notice : 87(RE-2010)/ 2009-2014) dated 22-12-2011 postponing the implementation of barcoding on secondary packs to 1st July 2012 and 1st January 2013 for tertiary packs. The Public Notice was published in IDMA Bulletin of 30 December 2012. Our lawyers sent a letter to the DGFT on 26th June 2012 informing them that, as the DGFT Public Notices had been quashed and stayed by the Hon’ble High Court, the Public Notice could not be invoked for implementing or extending the date of barcoding and requested them vide the letter, not to issue any further orders on the same. The High Court Stay Order and our lawyer’s letter to DGFT were emailed to our Members on 12th July 2012. Even though the matter was considered sub judice, the DGFT issued a Public Notice No. 10 dated 11th July 2012 extending implementation dates of secondary and primary packs to 1st January 2013 and 1st July 2013 respectively. A copy of the Public Notice was also emailed to all Members on 13th July 2012 and also published in IDMA Bulletin of 21 July 2012.
The Government submitted a counter-affidavit in Chennai High Court seeking to dismiss the Stay Order. We were informed that Pharmexcil had represented to the Government that 2D barcoding on secondary packs could be considered. However it was decided that since the setting up of machinery and equipments for implementing barcodes were very expensive, unnecessary and practically out of reach of our SME Members, the Association should stick to its stand and not agree to barcoding on primary as well as secondary packs. The hearing on our writ petition for barcoding for exports was expected to come up in November/December 2012.
Our detailed reply to the counter–affidavit submitted by DGFT was prepared and was to be submitted. Unfortunately our Writ Petition has been dismissed by the Madras High Court on 21 December 2012.
Problems in Clearance at Customs/ADC at Mumbai Airport and Nhava Sheva Port : There were complaints about the constant delay in clearances of imports and exports of pharmaceutical APIs, intermediates and formulations especially at the Mumbai airport and at Jawaharlal Nehru Port Trust (Nhava Sheva Port) by customs, allegedly for not receiving clearance from the ADC and it was very troublesome in getting the consignments cleared. We submitted a representation to DCG(I) Dr G N Singh dated 17th April 2012 suggesting that clearance rules must
37 be simplified and follow global standards in customs clearance of the consignments both for imports and for exports, considering the credentials and history of the company. We also recommended that, while industry is accountable for quality of products for exports and proper documentation, the concerned ADCs at the ports should also be held answerable and accountable for any unnecessary delays in clearances of consignments. Subsequently, DCG(I) Dr G N Singh took immediate action and the concerned official at JNPT was transferred.
Farewell meeting with Dr Ramakrishna, Deputy DC(I), West Zone : Dr R Ramakrishna, Deputy Drugs Controller (I), West Zone retired on 31 May 2012. We organized a special farewell meeting for him in IDMA office on 1st June 2012. Smt Shanthy Gunasekaran took charge as Deputy DC(I), West Zone from 1st June 2012. We sent her a congratulatory letter and made a courtesy call on her on 21st June 2012. As it was a courtesy visit, we managed to discuss only a few important issues such as increasing validity of COPP from 2 to 3 years, regularly imported intermediates and APIs from reputed manufacturers not to be sent for testing, to push for EDI connectivity mooted by the previous Dy DC(I), as it would benefit importers and exporters in speeding up the processing at Customs and Ports, speeding up the processing of Form 29 etc.
Madras High Court dismissal of Stay Orders on COPP cases : The Madras High Court dismissed all the three cases on COPP filed before the Hon’ble Court in July 2012. The Court had earlier granted Stay Orders to the petitioners against the Government move to centralise all COPP grants and approvals with DCG(I). However, the Karnataka High Court had also granted a Stay on this issue which continued to be valid.
Follow up on Representation for full refund in cash against export under rebate : We had submitted a follow up reminder on 29 February 2012 to Joint Secretary, CBEC (to the submission made in detail on 22nd October 2010 to Chairman, CBEC and a reminder on 20 December 2011) requesting that the industry was being made to clear export consignments on payment of excise duty @10%, while rebate was provided for only 4% in cash and balance 6% provided in the form of Cenvat credit, instead of full rebate of 10% in cash.
Exemption from Service Tax on Commission paid to Agent outside India : The exemption upto 1% of FOB value allowed under service tax (@ 10%) to commission paid to agents outside India was based on 10% Service Tax. As it was raised to 12%, the 1% had increased to 1.2%, representation was suitably made to DGFT requesting him to issue notification extending exemption to 1.2%, effective this year.
Representation to extend COPP validity to at least 3 years : We requested DCG(I) Dr G N Singh vide our representation dated 12 October 2012 to extend the validity of Certificate of Pharmaceutical Product (COPP) from 2 years to at least 3 years. We
38 informed him that regulatory authorities in most countries did not acknowledge or accept COPP with remaining validity of only six months, effectively reducing the validity period of COPP to 6 months, adversely impacting exports of our products and in some instances, cancellation of orders, which manufacturers could ill-afford. The representation was published in the IDMA Bulletin issue of 21st October 2012.
Interactive meetings with DCG(I) Dr G N Singh : We held interactive meetings with DCG(I) Dr G N Singh on 24th April 2012 in Mumbai, on 31st August 2012 in Delhi and 27th September 2012 at CDSCO, West Zone, Mumbai. At the meeting on 27th September, we also met Dr Jagdish Prasad, Director General of Health Services (DGHS) and Deputy DC(I) Dr Venugopal Somani, West Zone, Mumbai. The meetings with the DCG(I) and DGHS are covered in detail under the Regulatory Affairs section. Many issues pertaining to problems in export, import and regulatory activities were discussed with the DCG(I) and his officials. Detailed presentations were made and the DCG(I) agreed to look into the issues. The Agenda Points and presentations made to the DCG(I) were published in IDMA Bulletin issues dated 21 May and 7 September 2012.
European Union Directives on APIs imports : The Department of Pharmaceuticals forwarded us a communication from Shri Rajgopal Sharma, Adviser – Embassy of India, Brussels on the Directive No. 2011/62/EU issued by European Union (EU) of the European Parliament and Council amending an earlier Directive. The main requirement was a written confirmation from exporting country’s regulatory authorities that the API manufacturing unit of the exporter was subjected to regular, strict and transparent controls. The law comes into force on 2nd July 2013. We immediately emailed the DOP letter and the communication from Embassy of India Brussels along with the EU Directive and the European Commission Concept Paper to all our Members on 12th March 2012 requesting for urgent inputs/suggestions.
It was understood that the DCG(I) was empowered to approve units exporting APIs to EU and the ADC offices were authorised to issue the approvals on behalf of the DCG(I).
IPR
Interactive Meeting with Controller of Patents, Designs and Trade marks : We organised an interactive meeting with Shri Chaitanya Prasad, Controller General of Patents, Designs & Trade marks on 2nd May 2012 at IDMA office, Mumbai to enable Members to be appraised of the current status of the Patent & Trademark Office, the future plans of the new Controller General and exchange of mutual expectations. The Controller General was also keen to meet the Heads of our Member-companies as well as IPR experts. Shri Prasad, an MSc IIT graduate had held various important positions as Director, Finance in the Department of Economic Affairs
39 in Finance Ministry, as Jt. Secretary in DIPP, Ministry of Commerce before taking charge as the Controller General of Patents, D&TM in March 2012. He was very frank and forthcoming with his views and was working on making their website up-to-date and more user-friendly with advanced search facilities etc. and also in the process of clearing backlogs. He agreed to our views that there should be flexibility to ensure lifesaving drugs were affordable and available at reasonable prices. He appreciated various suggestions from Members in streamlining the scrutiny of patent applications and the general working of the Patent Office.
Indian Patent office grants landmark first Compulsory License : The Indian Patent Office granted the country’s first Compulsory License to our Member, M/s Natco Pharma ltd under the provisions of Section 84 of the Indian Patents Act, 1970 for Sorafenib Tosylate (brand name: Nexavar the first-line treatment for liver and kidney cancer, owned by Bayer Corporation). The judgement reasoned that the patent holder had not met the reasonable requirement of the public, i.e., it was not affordable and had not ‘worked the patent’ (manufactured) to a reasonable extent in India.
The Compulsory License was granted to sell the drug at a price not exceeding ` 8880/- for a pack of 120 tablets (one month’s therapy) against ` 284,428/- being the cost of Naxavar sold by Bayer and subject to certain conditions such as maintaining account of sales, and payment of royalty at 6% of the net sales on a quarterly basis etc and also made it obligatory for the company supply the drug free of cost to at least 600 needy and deserving patients per year.
Scheme to support SMEs for filing patents internationally : The Department of Information Technology in the Ministry of Communications and Information Technology (MCIT) launched a scheme this year to provide financial support to SMEs and Technology start-ups for international patent filing to encourage indigenous innovation and capture growth opportunities. Entities eligible to apply include registered Indian all MSMEs engaged in the production of goods with investment less than ` 10 crore and technology incubation enterprises registered as companies. The Scheme envisaged covering 50% of the total patent cost or ` 15 lakhs whichever is lesser.
Representations and Responses were made during the year on following Patent, WTO, TRIPs and R&D matters:
1. Draft suggestions on improvements in Patent Offices and Opinion on Search submitted to DIPP & IPO. 2. Participated in Task Force - Sub Group on “Drug Discovery, Research & Development”. 3. Extensive representations were made on alleged “Counterfeit Medicines” definition to WHO and through DIPP to EU. 4. Assisted DIPP in finalizing definition of “generic medicines” Indo-Japan CIPA (Bilateral Agreement).
40 MEDICAL
Notifying ‘Approved as Not Irrational’ FDCs : The DCG(I) had convened a meeting of the Expert Group on 25th and 26th April 2012 at Delhi to take up 86 FDCs that were pending for discussion. The status of the 294 FDCs under discussion after the meeting is as below:
Not Irrational = 140 Not approved = 61 Irrational = 57 Yet to be discussed = 36
A meeting was organised with the DCG(I) Dr G N Singh to discuss this and other issues. In our meeting, we requested the DCG(I) that the ‘approved’ 140 FDCs may be notified by DCG(I) at the earliest
Meeting on UCPMP with Dept. of Pharma : Shri D S Kalha, Secretary, Department of Pharmaceuticals (DoP) organised meetings on 18th July 2012 and 24th July 2012 in Delhi to discuss the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) with all stakeholders. The Department had earlier released a revised draft of the UCPMP and had requested for our suggestions, which was submitted to them on November 2009. The Secretary was disappointed that even after all these years, no concerted efforts were made to implement UCPMP. The negative media publicity and Parliamentary queries etc on alleged Doctor-Industry nexus etc. was putting the Government under pressure to act decisively. He suggested that the Medical Council of India had their guidelines notified in 2009 and were following it and the industry should also adhere to the same MCI guidelines as notified – i.e., strictly no free gifts, hospitality etc to medical professionals in individual capacity in any form. We objected that the Department had not even considered our detailed suggestions submitted on 16th May 2012 and the MCI Guidelines were very rigid and not practically workable; implementing the same would deprive the medical profession to exposure of recent advances and trends discussed at scientific discussions and deliberations on varied platforms which in turn could impact patient care adversely. The Secretary agreed to the latter and promised to set up meeting with MCI to incorporate suitable amendments in their act.
The Secretary also suggested that an ombudsman be appointed to sit in judgment on alleged violations of the UCPMP by the industry. The Industry Associations were to jointly appoint a very senior official such as a retired judge as the ombudsman who would be conversant with the functioning of the industry. Efforts were under way to organise a meeting with MCI to discuss and propose suitable amendments to the MCI Guidelines on: Professional Conduct, Etiquette & Ethics Regulation.
41 New Drug Applications: Approval of Protocols, Completed Studies : Twelve New Drug Advisory Committees (NDACs) were set up in CDSCO to provide medical / technical expertise in applications for approvals of new chemical entities (including novel FDCs) other than Investigational New Drugs (INDs). CDSCO had earlier also issued a ‘Draft Guidance on Approval of Clinical Trials & New Drugs’ in July 2011. As per the Guidelines, the experts in the relevant NDAC were to be consulted only if necessary with respect to permission for applications for trials of already approved drugs (or their combinations). We requested DCG(I) in our representation dated 7th Feb. 2012, to ensure that all permissions for studies for such applications were scrutinized by the office of DCG(I) itself, as there was inordinate delay in getting permissions for protocol approvals, and also subsequently for granting final permission based on studies conducted as per already approved protocol/s. We also pointed out that the Guidelines also stated that the applications for grant of approval for conduct of clinical / bioequivalance or bioavailability studies with new dosage form, new indication, new route of administration, etc of approved drugs (including FDC of already approved and marketed drugs) needed to be examined by CDSCO (and not necessarily referred to NDAC). The representation was published in IDMA Bulletin dated 14th February 2012.
Permission for New Drugs and subsequent New Drugs : The DCG(I) had stopped issuing approvals for New Drugs and subsequent New Drugs, following an internal communication that directed him not to approve the same. We made a submission to Dr A K Panda, Joint Secretary, Health on 2nd Feb. 2012 and requested him to withdraw this directive immediately, as this had dampened the growth of the industry and would be a deterrent to further R&D in India involving Clinical Trials, Bioequivalence / Bioavailability studies etc. It would also deprive the patients of new and more therapeutic drugs and if these drugs were required urgently, it would need to be imported at exorbitant prices, thereby burdening our poor patients heavily. The representation was published in IDMA Bulletin dated 14th February 2012.
Registration of Ethics Committee : The CDSCO proposed amendments to streamline and regularise the conduct of Clinical Trials in the country and its related issues and issued a draft notification dated 17th July 2012 to introduce Rule 122 DD in the Drugs & Cosmetics Rules. A schedule Y1 was also being introduced for ‘Requirements and Guidelines for Registration of Ethics Committee’ attached with the Contract Research Organisations (CROs) for conducting clinical trials. Earlier, only the registration of clinical trials with the DCG(I) was mandatory. We submitted our detailed representation proposing changes/alternations and the reasons for the same on 20th August 2012. The salient feature of the suggestion made was that the Ethics Committee differentiates between adverse event occurring during the study which could be not drug-related and direct test-drug related adverse reaction.
42 Guidelines for Determining Quantum of Financial Compensation to be paid in case of Clinical Trial Related Injury or Death : CDSCO also separately put up a draft ‘Guidelines for Determining Quantum of Financial Compensation to be paid in case of Clinical Trial related Injury or Death’. Our suggestions on the proposed changes along with reasons were also submitted on 20th August 2012.
In this proposal too, we suggested that it was very important to differentiate death related to drugs used in clinical trial responsible for injury /death from those due to any other reason whilst the subject was enrolled and undergoing the treatment during study period. Also for determining the compensation quantum, the advice and guidance of the investigator concerned or an expert /specialist dealing with the specific injury needed to be logical. Hence this needed to be decided by the ethics committee in consultation with investigator and / or expert in accordance with the Guidelines.
‘Early Stage Studies Conference – Translational Research: Lab to Clinic’ : We organised an ‘Early Stage Studies Conference - Translational Research: Lab to Clinic’ on 24th and 25th February 2012 in Mumbai. The Conference familiarized the participants with early stage studies so that these could be knowledgeably designed for smoother transition to next level of drug development. Also the media was involved in panel discussion with respect to their regularly voicing resent on clinical research being rampantly done in India and with respect to the functioning of the clinical research industry as a whole. The media agreed in an open forum that they felt 90% of research being carried out in India is genuine and well done and they have played a role to shout loud on the balance 10% which has inherent faults in its conduct.
Panel Discussion on Clinical Research in India – Where Are We Heading? Clinical Trials were really mushrooming with multi-centre, multi-national activities in India. However, there was a lot of hue and cry attracting negative publicity about the ethical issues. Hence a Panel Discussion ‘Clinical Research in India – Where are we heading?‘ was organised jointly with the Association of Contract Research Organizations (ACRO-India) and Indian Society of Clinical Research (ISCR) on 12th September 2012 in Mumbai to clear the misunderstandings. A white paper of the outcome of deliberations of the proceedings was compiled and jointly signed by chiefs of IDMA’s Medical Subcommittee, ACRO-India and ISCR and forwarded to CDSCO and Health Ministry by the IDMA Secretariat.
MSME
Limitation criteria while applying for Government Tenders : Government Organisations and Departments were imposing limitations, while applying for tenders, with turnover criteria and not allowing SSI manufacturers with lesser turnover to apply. We had made submissions and also met Ministers, other officials in the Ministries and respective Boards to attempt to rectify the same.
43 The Directorate General of Health Services published ‘Procurement and Operational Manual for Medical Store Organisation and Government Medical Store Depots’ that set a limitation of eligibility for participation in tenders at a minimum annual turnover of ` 50 crores. We submitted a strong representation to DGHS dated 24 July 2012 that such conditions were denying a level playing field to our Small and Medium manufacturers, who manufacture and sell quality medicines in India with valid regulatory approvals and licenses and denied them an equal opportunity to apply for these contracts, only because their annual turnover was less than ` 50 crores. The manual also specified that “All medicines supplied should incorporate GS1 barcodes at various packaging levels (primary, secondary and tertiary level packaging) and should encode the information within the barcodes”. We pointed out that it was almost impossible to implement barcoding on primary Pharma packs as it was not financially viable and also for lack of requisite manpower and equipments. We requested them to remove these clauses from the Manual and appealed to them not to stipulate such extraordinary conditions for supply of medicines under tender. The representation was published in IDMA Bulletin dated 7 August 2012.
Proposed revision in MSME definition, limits : Following news reports that Government was considering revising the limits and definition of MSMEs, the issue was discussed by the sub-committee and some senior Members, as there were differing views on the investment limits that needed to be set to compensate for the increase in costs of plant and machineries. A representation was made to the Ministry of MSME on 1st August 2012 requesting for a revision of the investment limits for SSI enterprises from ` 5 crores to ` 10 crores, for Medium enterprises, from ` 10 crores to ` 20 crores and for Micro enterprises from ` 25 lakhs to ` 50 lakhs to enable the vital MSME sectors to continue functioning.
MEMBERSHIP & CONSTITUTION During the year, 53 new members were inducted viz., 2 Corporate Members, 36 Ordinary and 15 Associate Company members. The total number of members stood at 595.
Associate Membership Fees revised : The costs of various inputs were rising and the Associate Membership fees had been retained at very low prices for almost 20 years. A study of the increase in costs borne by the Association in the previous 5 years was conducted to consider an increase in Membership fees of Associate Membership. The Study revealed that the hike in costs under various heads was on an average over 65%. A Special General Body Meeting of Members was convened on 26th April 2012 which passed the Resolution for revising the fees as approved by the Executive Committee, with Minimum Annual Gross Turnover set at ` 5 crore and a new category of ` 50 crore and above introduced.
44 NUTRACEUTICALS
Nutraceuticals Sub-Committee formed : The Food Safety Standards Authority of India (FSSAI) notified stringent Food Safety and Standards Rules and Regulations in 2011 under the Food Safety and Standards Act (FSSA) 2006, and made granting of licenses, renewals etc very stringent. We published an Advisory to Members in the IDMA Bulletin dated 14th May 2012 cautioning them about the revised regulations for registration of all nutraceutical manufacturers under the FSSA 2006. Though Government granted six months’ extension for the same upto August 4, 2012, detailed follow up with concerned authorities were required to ensure that the Rules were industry-friendly. Hence, to ensure that the issues of Members were properly taken care of, a Nutraceuticals Sub-Committee was formed and Dr R K Sanghavi was nominated Chairman to work closely with the Regulatory and Medical Sub-Committees.
FSSAI Rules 2011 : As vitamins, dietary supplements, etc were under the purview of FSSAI Rules 2011, many of our Members were adversely impacted and the Rules were strict and each product had to be licensed separately, and different dosages of the same product were treated as separate products. A detailed submission was made to the FSSAI on 28th August 2012 explaining our concerns on the various provisions of the FSSAI Act, Rules and Regulations 2011 and providing suggestions for resolving the same. The State Boards were requested to contribute funds if the Association decided to approach the High Court for a Stay. Meanwhile, the FSSAI released a Statutory Advisory on 25th July 2012 extending the time period for seeking conversion/renewal of licenses by another six months from 5th August 2012.
PRICING/CONSUMER AFFAIRS Pharma Policy
Joint letter to Minister re Pharma Policy 2011 : The Department of Pharmaceuticals had prepared a draft National Pharmaceutical Pricing Policy 2011, following a directive by the Supreme Court that all essential medicines be brought under price control. We submitted our views and suggestions on 30th November 2011.
Meetings with Prime Minister’s Economic Advisory Council : We were invited by the Prime Minister’s Economic Advisory Council to discuss the draft National Pharmaceutical Pricing Policy 2011 with them. We met Dr. K. P. Krishnan, Secretary, Economic Advisory Council to PMO on 30th January 2012. The Secretary had good understanding of the issues related to the proposed Pharma Policy. We informed him that the span of control under the proposed Policy was over 60% and with combinations it increased to over 80% of the domestic market, which was not desirable. Also Government needed to freeze prices of drugs under DPCO only for one
45 year instead of the proposed two years and an exemption in price control needed to be made on all drugs under ` 5/- per tablet etc., instead of ` 3/-, as proposed by the Policy. The Secretary enquired whether price controls were required on pharmaceuticals. We informed him that the Indian Pharma Industry had matured and almost every medicine had a number of manufacturers, which led to intense competition in the market, ensuring continued availability of medicines and keeping prices in check. Hence drug prices must be decontrolled and prices be monitored for non-patented drugs. Patented drugs being monopoly products needed some ceiling/control on prices. The Secretary understood our stand and promised support in this matter.
Meeting with Mr Arun Maira, Member, Planning Commission : We also met with Mr Arun Maira, Member, Planning Commission on the same day (30th January) to discuss the growth hurdles of Indian Pharma industry. We informed him that the Indian Pharma Industry was showing a healthy trend in growth through Production, Consumption, Market Competition, availability of Finished Products etc. However, our main concern was the reverse trend in growth in manufacturing activities in APIs. China, with whom India was generally compared vis-a-vis APIs, had overtaken India as the main source of APIs due to planned and sustained support from their Government in terms of infrastructure, subsidies, cheap power, transportation, dedicated capacities with voluminous manufacturing, effluent treatment facilities, industry-friendly labour laws etc. Such sustained mega growth could be replicated in India with whole-hearted support from our Government on all these fronts. We suggested that our Government must have a dialogue with their Chinese counterparts to streamline their regulatory procedures to welcome Indian companies and products, as provided in India. We also discussed about the need for Government’s sustained support in R&D funds, due to the heavy investments required and the uncertain and high risk nature of committing such investments and other issues.
Rejoinder to article ‘Pharma Pricing Policy: A Critique’ : As requested by Shri Arun Maira, Member, Planning Commission, we sent our rejoinder to the article ‘Pharma Policy: a Critique’ published in Economic & Political weekly dated January 28, 2012) to him. In our rejoinder, we pointed out that the proposed Pharma Policy was based on recommendations of Dr Pronab Sen Committee Report published in September 2005 and the proposed Pharma Policy was a very rational attempt at achieving a fine balance between reasonable prices, uninterrupted availability, administrative feasibility, rational use of drugs and future growth and investment. Our rejoinder was published in IDMA Bulletin dated 14 March 2012.
Meeting with Minister of Chemicals & Fertilizers Shri M K Alagiri : We met the Hon’ble Minister of Chemicals & Fertilizers Shri M K Alagiri on 28th March 2012 at his request along with other major Associations. After the discussions the industry Associations submitted a joint representation to the Hon’ble Minister highlighting our common stand that the
46 span of control should not go beyond specified formulations in the NLEM 2011 and Department of Pharmaceuticals should not deviate from its proposal in the Draft Policy on the method of price fixation. The Joint representation was published in IDMA Bulletin dated 7 April 2012.
Meeting with GoM and Presentation : The Group of Ministers led by Shri Sharad Pawar held a meeting on 25th April 2012 and decided to call the Stakeholders to the next meeting to hear our views. We were invited to make a presentation to the Group of Ministers on the proposed Pharma Policy 2011 on 14th May 2012. In our submission, we suggested that a paradigm shift from cost based price control to market based pricing was long overdue to ensure continuity in production and availability of controlled products. In the proposed Policy, the Span of Control should be limited only to NLEM 2011 Packs and Market Based Pricing based on Weighted Average Price of largest selling three brands. Alternately, we recommended Weighted Average Price of products in descending order of market share up to 50% market share. Also as recommended by Dr Pronab Sen Committee, all drugs under ` 3/- per tablet, capsule, syrups, ointments and Injectables etc on pro-rata basis should be exempted. We also insisted that the prices of drugs that were scheduled under current DPCO but not under NLEM should be deregulated. The presentation was published in IDMA Bulletin dated 21 May 2012.
Meeting with Shri D S Kalha, Secretary, DoP : Shri D S Kalha took charge as the Secretary, Department of Pharmaceuticals in January 2012. We made a courtesy call on him 30th January 2012. He was keen to understand the industry’s issues on various matters. At his request, we met him along with OPPI and IPA together on 12th June 2012 at Mumbai to discuss the proposed Pharma Policy. The Secretary was looking for a consensus from the industry on the formula to determine price fixations and suggested a price cut, but the Associations did not commit to this as the impact would not be uniform on all manufacturers, as the highest priced brands would need to drastically cut their prices whereas it may not be so severe on others. On the proposed Pharma Policy, the Associations agreed on market based pricing, but suggested different methodologies to fix prices under the proposed Pharma Policy to the GoM. We also discussed other issues such as: regular interactions and linkages between NIPER and Industry, how to maximize the use of vacant land lying unutilized with PSUs, Government/Industry partnership in tackling epidemics like TB, Kala azar, CSR initiatives, Industry/Association views on PICS membership, etc.
Supreme Court directive to DoP : The Supreme Court in its hearing on the case on 11th September 2012 was firm on concluding the hearings on the case. The Court stated that in case the Government was unable to take a decision before the next hearing on 27th September 2012, then the Court would direct that the NLEM drugs be included in the DPCO (DPCO 1995).
47 Representation to DoP on three main issues : In light of the Court’s ultimatum, we submitted a representation dated 17th September 2012 to the Secretary, Department of Pharmaceuticals listing our three main requests that needed to be considered while submitting suggestions to the Supreme Court: (1) no cost based pricing, (2) restricting the inclusion of NLEM drugs to the 348 items only as listed in the NLEM, and (3) repealing DPCO 1995 while announcing the new Drug Policy.
DoP Affidavit in Supreme Court : The Group of Ministers cleared the Pharma Policy on 27th September 2012 recommending to the Cabinet that only drugs listed in NLEM should be considered, and Market Based Pricing with weighted average prices of products with at least 1% market share by volume should be adopted. The hearing was again taken up on 3rd October by the Supreme Court. The Government informed the Supreme Court that the Empowered Group of Ministers had already taken a decision and the recommendations would be considered by the Cabinet. Subsequently, the hearing was held again on 11th October. The Supreme Court emphasized that the structure of the Pharma policy be reviewed once again. The Department of Pharma informed the Supreme Court in their affidavit that they had circulated a Cabinet Note on NPPA 2012 for Inter-Ministerial consultation on 9th October and after receiving the comments from the various concerned Ministries the Note would be submitted to Cabinet Secretariat by 15th October. From the wording of the Affidavit submitted by Dept of Pharma, it appeared that the Government had also recommended Market Based Pricing mechanism. The petitioners All India Drug Action Network (AIDAN) filed their affidavit arguing for comprehensive Cost Based Pricing.
Cabinet approval on National Pharmaceutical Pricing Policy 2012 : Following the hearing in the Supreme Court on 11th October 2012, the next hearing was fixed for 27th November. 2012. The Group of Ministers met on 21st November and submitted their final report on the proposed Pharma Policy with market based pricing with modifications that were influenced by the last minute concerns raised by the Finance Minister, who was also invited as a special invitee in the GoM deliberations.
Dept of Pharma finalises National Pharmaceutical Pricing Policy 2012 : The Government finalized the National Pharmaceutical Pricing Policy 2012 and it was put it up on the website of Department of Pharmaceuticals. The NPPP 2012 has recommended that Market Based Pricing with a simple average of prices of all products with at least 1% market share by volume in a therapeutic category be considered based on IMS data. The span of control is restricted to dosages and strengths listed in NLEM 2011 and would also include products under DPCO 1995 for a year, with increases allowed up to WPI. Formulations are to be priced only by fixing a ceiling Price as per the dosage, which means manufacturers are free to fix any price up to or below the ceiling price. NDDS and indigenously patented products are allowed 5 year holiday from price control.
48 The hearing in the Supreme Court was to take place on 12th December 2012. However, it was postponed to 15 January 2013.
Abatement of 50% at MRP : We received a letter dated 20th April 2012 from Shri B K Singh, Director, Department of Pharmaceuticals seeking our comments for increasing abatement on pharmaceuticals to 40%. We sent him a justification on 15 May 2012 for abatement at 50% under MRP based Excise Duty. The justification was published in IDMA Bulletin dated 21 May 2012.
CC, PC, PL and PM Norms – Urgent Appeal : As requested by NPPA, we appealed through IDMA Bulletin dated 30 May 2012, 21 July 2012 and 14 August 2012 as also by emails on 9th August 2012, requesting Members to submit CC, PC, PL data for the year 2010-11 & 2011-12 and PM norms for the year 2012 to NPPA, as it was very much essential for NPPA to have sufficient and varied data from small, medium and large manufacturers in order to finalize norms that were favourable to the industry, especially our SMEs. NPPA vide letter dated 17-09-2012 informed us that response was very poor and that they received data from only three companies. Subsequently we again appealed to Members to submit data vide emails on 25th September 2012, 30th October 2012 and 7 November 2012 and also through IDMA Bulletin dated 30th October 2012 and also 7 November 2012.
NPPA Internal Guidelines : NPPA published two Internal Guidelines, No.1 dated 4-10-2012 & No. 2 dated 9-10-2012, that sought to penalise manufacturers for allegedly ‘Overcharging’ and selling ‘Without Price Approvals’. The Guidelines were published in the IDMA Bulletin issue of 21st October 2012 for information of Members. The Pricing Sub-committee met on 2nd November 2012 and a letter was sent on the same day to the Secretary, Dept of Pharma requesting to withhold the NPPA Internal Guidelines from implementation, as it appeared that neither the Dept of Pharma or the Ministry of Chemicals & Fertilisers were consulted before publishing the Guidelines on the NPPA website. Subsequently, a detailed representation dated 2nd November 2012 was submitted with the guidance of Mr Kirit Mehta, Cost Accountant and Mr K C Kohli, Consultant highlighting the serious irregularities in the Guidelines as NPPA exceeded its powers and the ramifications it would have on the industry. Our representation was published in the 7 December 2012 issue of IDMA Bulletin.
Writ Petition No. 2368 of 1996 - Bills for DPEA : Our Writ Petition (No. 2368 of 1996) filed in Bombay High Court pertained to about 600 notices that were yet to be issued which could run into crores and lawyers had appeared 27 times on our behalf. Our Advocate M/s M&M Legal Ventures had hired very senior lawyers and represented us in good faith, even though we had informed him of our inability to pay and to collect the same from
49 the affected Members. As decided by the Executive Committee, we paid M/s M&M Legal Ventures, ` 26,93,525/- in three instalments, which constituted our share of the balance amount and informed him that no bills raised/received after 23rd December 2011 would be recognised.
PUBLICATIONS
Dr G G Nair takes charge as Editor of Indian Drugs and IDMA Bulletin : After 50 years of serving as Editor of IDMA Bulletin and Indian Drugs, Dr A Patani handed over the charge to Dr Gopakumar G Nair. Dr Nair has been associated with the publications for almost four decades as Assistant Editor.
IDMA Bulletin : IDMA Bulletin was published every week on time. Through this publication up-to-date information and data was disseminated on developments in the drug industry, Government regulations on pricing, customs duty, excise, import, export, Direct and Indirect Taxation, Sales Tax Matters, important RBI circulars etc., and all other aspects concerned with the drug industry including Parliament question and answers to all our members & subscribers. Also the activities of the Association, representations made, new members inducted and all other developments were regularly reported.
Indian Drugs : The technical and scientific journal of the Association; ‘Indian Drugs’, a monthly publication, covering original research articles and review articles of current scientific interest to the drug industry was also published regularly on time.
Indian Drugs Online : The Indian Drugs was already available on the internet, with access to the contents page. The Association was in the process of revamping and updating the website to make it fully online in a phased manner so that subscribers and others could access the abstracts, full paper etc online, which would increase the citations of the journal internationally and thus improve its Impact Factor.
50th Annual Publication : The 50th Annual Publication 2012 was a very special edition with the theme “Indian Pharma Inc. – Creating a Global Impact”. This compendium containing data on exports, imports, new drugs approved for marketing, alphabetical list of bulk drugs & formulations registered with DCG(I) for import into India, and various other useful data and information such as the total comparative value of production of bulk drugs and formulations, imports and exports, was released on the occasion of the 50th Annual Celebrations of the Association held on 6th and 7th January 2012 in Mumbai and was well received by all as a useful reference book. This Special edition also provided messages
50 from the President of India, Vice-President, Prime Minister, Minister of Chemicals & Fertilisers, Secretary, Ministry of Health & Family Welfare. A special feature was the glimpse of the origins of the Association in the 1960s by the Founder-Secretary Dr A Patani with pictorial coverage and listing of all the Past-Presidents who contributed their time and whole-hearted efforts in the growth of the Association.
REGULATORY AFFAIRS
Suggestions submitted to Task Force : Our suggestions on the draft reports of the six sub-groups [National Drugs Security (Promoting indigenous production of bulk drugs), Drug Discovery and Research & Development, Intellectual Property Rights, National Drugs Security (Takeover of Indian Pharma Companies), Spurious and Adulterated Drugs and National Drugs Security (Pricing of Drugs & Generic Drugs)] under the ‘Task Force set up by the Ministry of Health and Family Welfare for formulating a Long Term Policy and Strategy for Strengthening of Drug Sector in the Country’ was submitted on 25th January 2012.
Amendments for bail provisions required under Drugs and Cosmetics Act & Rules : The Association had worked hard in the last few years to get the CDSCO to notify the Guidelines on action to be taken by field officers in respect of drugs reported to be not of standard quality, adulterated or spurious. Though it was put up on the website of CDSCO as Guidelines, it was not notified officially. The Association also diligently followed up with the Hon’ble Health Minister and succeeded in getting a directive issued under section 33-P of Drugs and Cosmetics Act directing the State Health Departments and their Legislative Authorities to take utmost care while taking action in spurious drugs issues, in December 2010. The bail provisions as amended by the Drugs and Cosmetics (Amendment) Act 2008 were made very stringent under Section 36AC to penalize unscrupulous spurious drug manufacturers. However, Section 36AC itself needed redrafting in the Drugs and Cosmetics Rules to protect genuine manufacturers from being harassed by field officers, who were given unlimited powers. We raised this issue with the Sub-Group on ‘Spurious and Adulterated Drugs’ under the ‘Task Force set up by the Ministry of Health and Family Welfare for formulating a Long Term Policy and Strategy for Strengthening of Drug Sector in the Country’. We also made a representation to Dr V M Katoch, Chairman of the Task Force and the DCG(I) Dr G N Singh on 22nd March 2012 informing them about our apprehensions on the bail provisions and suggesting solutions for amending the same. Dr Katoch took up the matter with DCG(I) and requested him to consider our plea. The representation was published in IDMA Bulletin dated 30 March 2012.
Three-Member Committee formed : To ensure that the issue of amendments to spurious drugs provisions is further pursued vigorously, a three Member core committee comprising of Mr S M Mudda, Mr S W Deshpande and Mr Vinod Kalani was formed to prepare our submissions and follow-up with DCG(I). The Committee
51 was authorized to work out solutions for further amendments required on the issue of bail provisions under Spurious drugs section in D&C Act & Rules. It has been brought to the notice of the DCG(I) that the directions issued under section 33P are not being followed uniformly by the state authorities and he was requested to advise the concerned authorities to implement the directions of the directive to ensure that the genuine manufacturers are not subjected to undue hardship.
Rajya Sabha Committee on Petitions : Following a petition filed by a concerned citizen praying to put a check on manufacture of spurious drugs in our country and other related issues, the Rajya Sabha Committee on Petitions of the Rajya Sabha Secretariat issued a Public Notice in Hindustan Times dated 26.05.2012 on the Petition calling for comments / suggestions from all stakeholders. We submitted our written comments and suggestions on all the issues mentioned in the Public Notice as above. We brought to their notice about the planned propaganda of vested interests in brandishing a high percentage of Indian Pharmaceutical products as spurious and which had been proved to be totally false by the all India survey undertaken by the DCG(I). We also informed them about the need to include necessary amendments in the spurious drugs provisions for providing bail to protect genuine manufacturers.
Non-Clearance of pending files by the Office of the DCG(I) : The office of the DCG(I), was, for some reason, not taking any decisions on various requests/ applications pending with them for various permissions and licenses. Members were confused and this was affecting their production and also impacting their export activities as various NOCs and licenses were not being issued in time. We submitted an urgent representation to Jt. Secretary, Health on 17th February 2012 requesting him to instruct the office of the DCG(I) to immediately act on the various pending applications.
Meeting with Ministry of Health & FW on WHO CEWG report : We were invited to a meeting with Health Ministry officials on 1st August 2012 in Mumbai along with other Associations to discuss Indian Pharma Industry’s views on the Report by WHO’s Consultative Expert Working Group (CEWG) on Research and Development: Financing and Coordination. The CEWG recommended a new agreement for financing and coordination mechanisms to meet the health needs of developing countries with a focus on the development of health technologies for diseases in the developing countries. The key recommendations of the Group were that affordable products could best be achieved through free open market competition and required delinking of R&D costs and prices of products. At present the budgeted expenditure on Health in India was only 1% of GDP, which needed to be increased significantly. R&D labs needed to be funded to take up R&D on diseases such as malaria, dengue etc that largely affect the Indian population. The CEWG also recommended that open knowledge innovation which was free to use without legal or contractual restrictions needed to be encouraged.
52 Interactive Meetings with DCG(I) : We held interactive meetings with DCG(I) Dr G N Singh on 24th April 2012 in Mumbai at IDMA Office, on 31st August 2012 in Delhi and 27th September 2012 at CDSCO, West Zone, Mumbai. Many issues pertaining to problems in export, import and regulatory activities were discussed with the DCG(I) and his officials. Detailed presentations were made and the DCG(I) agreed to look into the issues and try to resolve them. The Agenda Points and presentations made to the DCG(I) were published in IDMA Bulletin issues dated 21 May and 7 September 2012.
Meeting with Dr Jagdish Prasad, DGHS : Following our successful meeting with DCG(I) Dr G N Singh on 31st August 2012, he invited us for further discussions on 27th Sept at CDSCO West Zone Mumbai along with Deputy DC(I) Dr Venugopal Somani. At the meeting on 27th September 2012, we met Dr Jagdish Prasad, Director General of Health Services (DGHS). We discussed various issues. He agreed to provide industry representation in DTAB and in setting up a Joint Task Force with the Director General in the Chair and 4-5 officials including the DCG(I), the Dy DC(I)s and industry representatives to meet every three months to discuss industry and policy issues so that the entire industry and the patients benefit. CDSCO West Zone office in Mumbai would be granted ‘Division’ status, with authority to grant licenses, approvals etc almost on par with the DCG(I)’s office in Delhi, so that the overwhelming burden on the DCG(I)’s office could be reduced. The State Health Departments would be given independence in procurement of medicines with the Central Procurement Cell only providing guidance and monitoring the system of distribution of medicines (generic drugs) by the States. However, we suggested that L1 would not be the best method for selection of tender applications for providing quality drugs that were also efficacious, as the applicant would cut corners to get the tender and sacrifice efficacy in the bargain. He requested for our views on the number of laboratories to be increased and whether our quality was enough or we need to guarantee efficacy of generics. A report of the meeting was published in IDMA Bulletin issue dated 21 October 2012.
33-P direction to States to provide licenses in Proper/Generic names : The Central Government issued Directions vide letter dated 1-10-2012 to all State Governments invoking section 33-P of Drugs and Cosmetics Act, 1940 to instruct their SLAs to grant / renew licenses of all single ingredient formulations for manufacture for sale or distribution only in proper (generic) names. After detailed discussions, a representation was prepared under the guidance of Mr S W Deshpande, our expert consultant on Regulatory matters, that the directions were not in accordance with the objective of the Drugs and Cosmetics Act, 1940 which was to ensure availability of safe, standard and efficacious medicines and the Act had nothing to do with brand names. Also the directions were contrary to the provisions of Trade Mark Act and therefore such directions could not be issued taking recourse to the provisions of Section 33-P. The representation submitted on 22 October 2012 to Secretary, Ministry of Health and Family Welfare was published in IDMA Bulletin dated 30 October 2012. We also met Jt. Secretary and Addl. Secretary and
53 the DCG(I) to understand their interpretation and sought clarification on the Guidelines and its consequences, its impact on domestic sales and also whether COPP would be exempted as it will impact exports.
Clarification on 33-P Directive for granting/ renewing licenses in generic names by Health Ministry : The Health Ministry issued a clarification subsequently dated 9th November 2012, that the directive did not extend to export activities and export related documents such as COPP would be issued with brand names as required internationally. The clarification specified that the directions under Section 33P have been issued under the Drugs and Cosmetics Act, 1940 and that the directions are applicable only for manufacturing license issued by the Drugs Licensing Authorities under the provisions of the Drugs and Cosmetics Act, 1940. The clarification was however incomplete in regard to the domestic sales, as it did not state that manufacturers are allowed by law to sell their products under brand names registered under Trade Marks Act. The clarification was sent to our experts for further advice. An additional representation seeking further clarifications has been sent. It was learnt that the Federation of South Indian Pharmaceutical Manufacturers’ Associations approached the Madras High Court for relief and IDMA was gearing itself up to join the Federation’s case, for the benefit of our Members. The Clarification as above was emailed urgently to all Members on 12 November 2012. It was also published in IDMA Bulletin of 21st November 2012.
Application in Proper name only for Single Ingredient Formulation : The Central Government had earlier issued Directions vide letter dated 1-10-2012 to all State Governments invoking section 33-P of Drugs and Cosmetics Act, 1940 to instruct their SLAs to grant / renew licenses of all single ingredient formulations for manufacture for sale or distribution only in proper (generic) names. In our representation dated 12 November 2012, we submitted that medicines were manufactured by various manufacturers and differed both in their therapeutic equivalence and also in the standard of production. A brand name enabled a doctor to make the choice of the precise drugs to be prescribed to the patient. However, this amendment would take away this right to advise from the doctor and transfer the choice to the chemist, whose decision would be more influenced by the business considerations such as discounts and schemes offered by a particular manufacturer. Hence we requested that the proposed draft notification must not be finalised and the Drugs & Cosmetics Rules must not be amended as proposed. This representation was published in our 21st November 2012 issue of IDMA Bulletin.
Uttarakhand directive to manufacturers denying brand names : As reported earlier, we had requested the Health Ministry to issue clear clarification that manufacturers after obtaining license from SLAs under generic names would be allowed to market their products under brand names as per Trade Marks Act. However, the Health Ministry issued a
54 clarification that was silent on this aspect and our worst fears that SLAs will misread the clarification and insist on sale only under generic name came true. The Drugs Controller of Uttarakhand issued covering letters to manufacturers at the time of their renewal of licenses directing them to sell drugs only under generic name and not to use any brand name on the label of such product. We took up the matter with the Drugs Controller of Uttarakhand and submitted a representation dated 5 December 2012 and requested him not to insist for sale of drug only under generic name.
We also made a submission to the Secretary, Department of Health, with copies to Additional Secretary Shri R K Jain and DCG(I) Dr G N Singh, to direct the Drugs Controller, Uttarakhand to withdraw his directions and stop the practice of issuing such covering letters. We also requested the Secretary to direct all the State Drugs Controllers immediately not to issue such directions to sell drugs only under generic name and allow the manufacturers to use brand name after grant of product permission under generic name. The representations are being published in IDMA Bulletin dated 21 December 2012.
33-P direction to cancel licenses of ‘New Drugs’ including FDCs issued by SLAs : The Government invoked Section 33-P to issue another Directive to not allow licenses issued by SLAs to manufacture ‘New Drugs’ including FDCs as defined under Rule 122 (E), as the Parliamentary Standing Committee, in its 59th Report had taken strong objections to this practice. The SLAs would now need to take prior approval from DCG(I) before granting the same, as the power to grant a ‘New Drug’ license was only with the Central Licensing Authority. The DCC (in its meeting held on 20th July 2012) discussed this issue and decided to form a Committee of Drug Controllers from Gujarat, Odisha, Himachal Pradesh, Tamil Nadu, Pondicherry, Maharashtra and Rajasthan with Shri A K Pradhan, Dy DC(I), CDSCO as Convenor. The Committee was entrusted with preparing guidelines for States to grant licenses for FDCs and would be preparing a list of FDCs approved by DCG(I) as ‘New Drug’. It would also recommend a cut-off date for conventional FDCs, which were there before the introduction of the definition of the term ‘New Drug’.
New Schedule H1 : A draft notification GSR 228(E) dated 20-3-2012 about omitting 40 drugs from the scope of Schedule H under D&C Rules and proposing a new Schedule H1 with 91 antibiotics was issued by the Department of Health. A special labelling requirement “it is dangerous to take preparations except in accordance with the medical advice” in addition to the warning “not to be sold by retail without prescription of the Registered Medical Practitioner” were specified and would require drastic changes in the packing material such as cartons, labels, aluminium foils, new cylinders for foil printing etc.. We requested for three months’ time to make necessary changes and to enable members to exhaust the inventory of existing packaging material. The representation was published in IDMA Bulletin of 14 May 2012.
55 Representations on NDPS to Ministry of Finance and to Standing Committee of Finance, Lok Sabha : The Department of Revenue in the Ministry of Finance proposed enacting the Narcotic Drugs & Psychotropic Substances (Regulation of Controlled Substances) Order, 2011. The Order set 4 lists A, B, C, D under which controlled substances were to be included for manufacture, sale, import, export, distribution, consumption etc and stipulated their regulation and severe punishment for non-compliance. The representation along with our detailed suggestions was published in IDMA Bulletin dated 29 February 2012. Further suggestions were submitted on 20 March 2012.
The Standing Committee on Finance, Lok Sabha proposed to introduce ‘The Narcotic Drugs & Psychotropic Substances (Amendment) Bill, 2011’ to regulate or prohibit the production, manufacture, supply and distribution of narcotic drugs and psychotropic substances. It also set stringent penalties even for non-compliance of the conditions of license, procedural requirements etc. The representation along with our detailed suggestions was published in IDMA Bulletin dated 7 March 2012. The Standing Committee published its report and recommended that “The Committee also find it pertinent to point out that the issues raised by the stakeholders viz., OPPI, IDMA, ICC and BDMAI, in their representations pertaining to amendments to Section 21, 22, 25-A, 26 of the NDPS Act, 1985 to enable compounding of unintended or inadvertent non-compliances or procedural lapses, and amending of sub-sections (1) & (2) of Section 42 to address undue harassment faced by legally authorized manufacturers, dealers traders etc. of Narcotic, Psychotropic and controlled substances during investigations and enforcement of laws/rules pertaining to the substances are genuine. The Ministry of Finance (Department of Revenue) assertion that “slight amendments in NDPS Rules” would suffice to address the issues raised by stakeholders does not satisfy the Committee. The Committee is of the opinion that the issues raised as such by the stakeholders merit serious consideration from the Ministry/Government though they are not covered in the provisions of the Bill currently under examination. The Committee, therefore, expect the Government to incorporate these provisions by way of amendments in the present Bill itself.” We submitted our suggestions to ensure that legitimate manufacturers and users of NDPS substances were protected and not harmed or harassed unnecessarily by enforcement authorities. We made a submission on 10 September 2012 requesting the Finance Minister and the Revenue Secretary for personal hearings to discuss the matter. The representation was published in IDMA Bulletin of 21 September 2012.
Barcoding for Domestic Retail Packs : The hearing at Allahabad High Court (Criminal Writ Petition No.16212 of 2008) came up on 6th January regarding barcoding for domestic sales.. It was learnt that Ministry of Health & Family Welfare had not submitted their reply to the Hon’ble High Court and therefore, the Court had made very serious observations and directed the Ministry that in case the reply was not submitted immediately, DCGI or any senior representative from the Ministry of Health & Family Welfare would need to appear before the Court on 13-2-2012. A Special Task Force was formed and their final findings were submitted to the Ministry of Health and Family Welfare on 5th March
56 2012. The Objective of the Special Task Force was to analyze different ways to combat spurious drugs in India and study different means for drug authentication. The High Court directed the Ministry to conduct a ‘Feasibility Study for Track and Trace of Drugs in India’ and Wipro was selected to conduct this study and recommend a drug authentication mechanism by a common man using simpler means. But we objected to this as it would be a huge burden to SMEs as even a small manufacturer with exports of around ` 15-20 Crore would need to invest ` 2 Crore on barcode machines (one for each blister machine and one each for syrups and injections) with other miscellaneous costs. Wipro released the report in December 2012 and it was being studied by our experts.
Guidelines on Product Recall : The CDSCO issued draft ‘Guidelines on Recall and Rapid Alert System for Drugs (including Biologicals and Vaccines) and put it up on their website on 22nd October 2012 inviting objections and suggestions. Our experts prepared our constructive suggestions for amending the Guidelines and it was submitted to DCG(I) Dr G N Singh on 5th November. We also requested the DCG(I) to organise a joint meeting of CDSCO officers, representatives of IDMA and other stakeholders such as AIOCD, as the successful implementation of the recall from the market would depend on active participation of distributors, wholesalers and retailers.
Shelf life of APIs vs. Drug Products : In our meeting with DCG(I) on various matters as reported earlier, we raised the pending issue of linking shelf life of formulation with that of API. We also had raised this issue earlier in our submissions dated 29 September 2009 and 28 July 2010. As per para 10.9 under Part I of Schedule M, the requirement of ensuring that shelf life of the Drug Product was within the shelf life of the API used was not in line with any International Regulation or Guideline and was causing difficulties to our members. A review of the provisions of the various Guidelines such as ICH Q7, ICH Guideline Q1A(R2), WHO Working document QAS/06.179/Rev.3, Medicines Control Council, etc reaffirmed our stand that there was no correlation between the shelf life of a Drug Product and that of the API. In fact the Guidelines clearly stated that the API could be used in the formulation of the product until its re-test date or extended re-test date based on the stability of the API. Hence we requested that the shelf life of formulation be decided on the basis of stability studies and not linked to the shelf life of the API. In order to delink shelf life of formulation from shelf life of API, we suggested that the sentence “It shall be ensured that shelf life of formulation product shall not exceed that of active raw materials used” needed to be deleted from the existing Schedule M Part I Proviso 10.9. Such an amendment would then make the requirement under Drugs and Cosmetics Rules, 1945 consistent with the current global practices and regulations, as also with the requirements of conducting stability studies by the quality control department as contemplated under Para 16.10, Part I of Schedule M. The representation to DCG(I) dated 11th October 2012 was published in IDMA Bulletin dated 30 October 2012.
57 Limiting of Paracetamol in Prescription Combination Products : The DCG(I) had issued a Memorandum on 23rd September 2011 to all State Drug Controllers requesting them not to grant fresh licences or renewals of the combinations products of paracetamol containing more than 325 mg per tablet or capsule. All paracetamol combination products with more than 325 mg would need to be limited to 325 mg within three years or discontinued after three years. The memo was published in IDMA Bulletin dated 7th November 2011 and also reported in the Annual Report last year. Based on the recommendation by DTAB in its 59th meeting held on 24th June, 2011, manufacturers of paracetamol were also requested to provide a box warning on the label that taking more than daily dose may cause serious liver damage or allergic reactions (swelling on the face, mouth and throat, difficulty in breathing, itching or rash). DTAB in turn had taken note of USFDA news release dated 13-01-2011. Our representation to the DCG(I) Dr G N Singh on 21 November 2012 was published in IDMA Bulletin dated 30 November 2012. However, the clarification issued by the DCG(I) dated 4 April 2012 about limiting content of paracetamol to 325mg excluded the words “prescription combination pain medication”. We submitted that paracetamol may be limited to 325 mg only in combination pain medication products as there were several other indications where Paracetamol was prescribed in combination, where the role of Paracetamol was completely different from the other drug in the combination. We requested that another clarification be issued clearly stating that paracetamol is limited at 325mg only when in combination with other analgesic or anti-inflammatory drugs and excluded all other paracetamol combinations from the said directive.
TECHNICAL & QUALITY MANAGEMENT
Extending Date of Implementation of Addendum 2012 to 1st April 2012 : The Addendum 2012 to Indian Pharmacopoeia 2010 was released in end-December and made effective from 1st January 2012. Many Members were still awaiting copies of the Addendum, and at our request vide our letter dated 24th January 2012, Dr G N Singh, Secretary, Indian Pharmacopeia Commission extended the date of implementation to 1st April 2012.
IP Addendum 2014 : Various meetings were organised at IDMA office over the year to work on the IP Addendum 2014. The Association whole-heartedly supported the activities as usual.
15th IDMA-APA PAC 2012 : The 15th IDMA-APA Pharmaceutical Analysts’ Convention was organised on 21st and 22nd September 2012 in Mumbai, with the focus this year on “Conformance to Emerging Global Quality Standards”. Dr Nitya Anand, Chairman, Ranbaxy Science Foundation, First Chairman, S.B.IPC, Co-Chairman, IPC & Ex-Director CDRI was felicitated for his Life Time Achievements & contributions to Drug Discovery Research. Dr Kamal Sharma, managing Director, Lupin Ltd. was the Chief Guest
58 and keynote speaker. A special feature this year was the guided tour of Piramal’s Healthcare and Life Sciences Research Centres at Goregaon, Mumbai.
Seminar on HVAC Validation : A One-Day Seminar on ‘Why and How of HVAC Validation - Current Guidelines for Pharma Industry’ was organised on 11th May 2012 in Mumbai and on 8th September 2012 in Chennai. Both events were well attended and appreciated by the large number of participants.
APA Forum : The quarterly APA Forum Newsletters were published regularly containing very informative articles and presentations.
Quality Management Section :
Seminar on Pharma QbD - a 360° view on Quality by Design (QbD) : We organised a Seminar on ‘Pharma QbD - a 360° view on Quality by Design (QbD)’ in association with SSA Business Solutions on 31st October 2012 at Mumbai. The seminar was organised to explain QbD in the context of the ICH guidelines for pharmaceutical manufacturing industry in the 21st century and also to enable our manufacturer-exporters to implement Quality by Design (QbD) into their Abbreviated New Drug Applications (ANDA) while seeking approval of US FDA as it would be made mandatory from January 2013. Experienced personnel from the industry provided a good understanding of statistical, analytical and risk assessment methods required for new drug application and also described the way to implement this new approach.
Corrective and Prevention Action (CAPA) : A technical Monograph on Corrective and Prevention Action (CAPA), the sixth in the series of technical monographs, was published in September 2012, which was well received.
IDMA Quality Excellence Awards 2011 : IDMA Quality Excellence Awards were instituted in 1984, to assist, encourage, recognize, appreciate and nurture the quality excellence achievement among IDMA members. The awards were categorized as Gold and Silver. The units were also categorized as follows:-
(1) Companies with Total Annual Turnover upto ` 25 Crores (2) Companies with Total Annual Turnover between ` 25 Crores to ` 100 Crores (3) Companies with Total Annual Turnover above ` 100 crores.
Turnover was taken as the entire turnover of the company and not only of the unit visited.
59 For the year 2011, there were 3 Gold Award winners and 6 silver Award winners. A total of 26 units participated. The assessment for the Awards was made with consensus among the visiting experts, using the transparent point rating system, points being assigned for various aspects like product development, GMP, GLP, Personnel, Environment, Stores, Manufacture, Quality assurance, etc. The assessment for the Awards was made with consensus among the visiting experts, using the scale for 0 to 10, score being assigned for each of 70 points concerning product development, GMP, GLP, personnel, environment, stores, manufacture, quality assurance etc. Only 2 types of awards were considered, if appropriate, namely Gold and Silver Awards. The details of the Award winners are provided in the Awards section.
IDMA State Boards : As in previous years, all the State Boards of IDMA viz., Gujarat, Haryana, Tamil Nadu, West Bengal and Himachal Pradesh-Uttrakhand functioned efficiently and in co-ordination with the Head office.
Executive Committee Meetings : The Executive Committee met 13 times during the period 20th January 2012 to 21st December 2012 including a Special Executive Committee meeting on 13 December 2012.
Membership of Other Organisations : The Association is a member of following Organizations:
1. All India Organization of Employers 2. Employers’ Federation of India 3. Confederation of Indian Industry 4. Federation of Associations of Small Scale Industries of India 5. Federation of Indian Chambers of Commerce and Industry 6. Indian Merchants’ Chamber 7. Indian Pharmaceutical Association 8. Maharashtra Economic Development Council 9. Centre for Advancement of Philanthropy 10. Council of EU Chambers of Commerce in India
Representation on Government Committees : It was a privilege for the Association to have interaction with a number of Government Committees directly concerned with the Pharmaceutical Industry. Members of the Association served on several such Committees, the important amongst them were:-
60 • Prime Minister’s Task Force on Micro, Small and Medium Enterprises (MSMEs) • PMO’s Task Force on Pharmaceutical & Knowledge based Industries
Technical Committee for rendering advice for preparation of “Detailed Project Report For Developing India As A Drug Discovery And Pharma Innovation Hub 2020” by Department of Pharmaceuticals.
Committee set up by Planning Commission for issue of FDI in existing Indian Pharmaceutical Companies.
• DCG(I) Committee to work out procedure for permission for Dual Purpose Bulk Drugs • Working Group subgroups of Department of Pharmaceuticals for 12th Five Years Plan • Task Force formed by Ministry of Health & Family Welfare under leadership Dr V M Katoch, DG – ICMR and Secretary – Deptt of Health Research for formulating long term Policy and Strategy for strengthening Drug Sector in the country • Expert Committee for comprehensive examination of drug regulatory issues including problems of spurious Drugs (Dr. Mashelkar Committee) • I.P. Working Group • Sandhu Committee constituted by the Department of Chemicals & Petrochemicals • Pharmaceutical Advisory Forum constituted by the Department of C&PC, Ministry of C&F. • Department of Pharmaceuticals scheme for opening Retail Outlets for sale of unbranded Generic Drugs • DoP Working Group on Branded Generic Drugs • DCG(I)’s Screening Committee to examine the contentious Fixed Dose Combinations • International Medical Products Anti-Counterfeiting Task force (IMPACT) - a WHO-WHA initiative • Working Group on Drugs and Pharmaceuticals for Eleventh Five Year Plan • Joint Committee to suggest proposals for National Pharmaceutical Policy 2006 constituted by the Minister of C&F and Steel • National Manufacturing Competitiveness Council (NMCC) • Evaluation Committee formed by Dept. of Scientific and Industrial Research, Ministry of Science and Technology. • ECGC - Western Regional Advisory Committee, Mumbai. • Watchdog Committee of Customs, Mumbai • Open House Meet of Chief Commissioner of Customs, Mumbai • RAC meetings of the Chief Commissioner of Central Excise, Mumbai IV. • “Help Centre” Constituted by Central Excise Mumbai IV (For SSI members particularly for Excise related matters)
61 • Ministry of Health’s Committee to suggest remedial measures to combat menace of spurious drugs. • National Working Group of Patent Law (NWGPL)
We are also represented in other Committees such as:
• FICCI’s Foreign Trade Committee • FICCI’s Health Services Committee • FICCI’s Pharmaceutical Committee • Confederation of Indian Industry’s - Pharmaceutical Committee
IDMA AWARDS
IDMA Best Patent Awards :
The Association introduced this Award in 2001-02 to appreciate the talent of the large community of research scientists in the country and to take note of the need for greater emphasis on innovative research for developing new drugs in India. This year, the panel of experts for the assessment of the Awards recommended IDMA Patent Appreciation Awards 2010-11 to the following Patents:
IDMA Patent Appreciation Awards 2010-11 in the category of API to M/s HETERO DRUGS LTD., HYDERABAD for their ten US Patents, one Canadian Patent and one European Patent.
IDMA Patent Appreciation Award 2010-11 in the category of API to M/S LYKA LABS LTD., MUMBAI for their European Patent validated in 23 countries.
IDMA Quality Excellence Awards :
The Panel of experts were Mr. J. L. Sipahimalani, Mr. Gidy Asrani, Mr. Kapil Bhargava, Mr. R Raghunandanan, Dr. V. Chandrasekharan, Mr. Satish Rajkondawar, Dr. V K Joshi, Mr. Sharad S. Sardessai, Dr. Shailesh Nagarsenkar and Mr. Sridharan. During the visits, apart from the assessment for the Awards, the benefit of the joint expertise of the panel members was made available to the participating units during the discussions.
The assessment for the Awards was made with consensus among the visiting experts, using the scale for 0 to 10, score being assigned for each of 70 points concerning product development, GMP, GLP, personnel, environment, stores, manufacture, quality assurance etc. Only 2 types of awards were considered, if appropriate, namely Gold and Silver Awards.
62 The panel of experts for the assessment of the participating units recommended the following units as the recipients of the ‘Gold Awards’ and ‘Silver Awards’ in the said category, for the year 2011.
Gold Awards : • Micro Labs Ltd., Baddi, Category : Formulations Units - Companies with Total Annual turnover above ` 100 crores • Bafna Pharmaceuticals Ltd., Chennai, Category : Formulations Units - Companies with Total Annual turnover above ` 100 crores • Encube Ethicals Ltd., Goa, Category : Formulations Units Companies with Total Annual turnover between ` 25 crores to ` 100 crores
Silver Awards : • Indoco Remedies Ltd., Baddi, Category : Formulations Unit - Companies with Total Annual turnover above ` 100 crores • Indoco Remedies Ltd., Unit 2, Goa, Category : Formulations Unit - Companies with Total Annual turnover above ` 100 crores • Micro Labs Ltd., Goa, Category : Formulations Units - Companies with Total Annual turnover above ` 100 crores • Micro Labs Ltd., Bangalore (Ophthalmic Unit # 113/116), Category : Formulations Unit - Companies with Total Annual turnover above ` 100 crores • Troikaa Pharmaceuticals Ltd., Dehradun, Category : Formulations Units - Companies with Total Annual turnover Above ` 100 crores • IPCA Laboratories Ltd., Dehradun, Category : Formulations Units - Companies with Total Annual turnover Above ` 100 crores
IDMA Research Paper Awards : In order to encourage R & D in the country, IDMA instituted “Research Awards for the Best Original Research Articles” published in the “Indian Drugs” every year, from the year 1981-82. Awards in the form of a citation and a cash award of ` 2500/- in each discipline are considered and given away in the following disciplines at the Annual Celebrations in the disciplines of Pharmaceutical Chemistry, Natural Products, Pharmaceutics, Pharmaceutical Analysis and Pharmacology.
An Award for the Best Review Article was instituted in 2001. A citation and special cash Award of ` 5000/- was presented to the recipient of Best Review article published during January to December in the year 2011 as below:
REVIEW ARTICLE : Paper : Nanotechnology in Drug Delivery: A Review Authors : Gadad A., Soni A., Dandagi P. and Mastiholimath V.
63 Institute : Dept. of Pharmaceutics, K.L.E.U’s College of Pharmacy, JNMC, Nehru Nagar, Belgaum- 590 010, Karnataka. Volume : 48(11) Page no. : 5-16
PHARMACEUTICAL CHEMISTRY Paper : Synthesis, Characterisation and Computational ADME Studies of Some Novel Analogs of (±)-2-(4-Isobutylphenyl) Propionic Acid Authors : Velingkar V. S. and Desai D. M. Institute : Pri. K. M. Kundnani College of Pharmacy, Jote Joy Building, Rambhau Salgaonkar Marg, Cuffe Parade, Colaba, Mumbai-400 005. Volume : 48(05) Page no. : 23-30
NATURAL PRODUCTS Paper : In Vitro Antidotal Study of Aconite Authors : Sarkar P. K., Prajapati P. K., Shukla V. J. and Ravishankar B. Institute : Department of Rasashastra, J. B. Roy State Ayurvedic Medical College & Hospital, 170-172, Raja Dinendra Street, Kolkata- 700004, West Bengal. Volume : 48(05) Page no. : 41 – 44
PHARMACEUTICS Paper : Stabilization of Amorphous form of Poorly Water-soluble drug and hence Solubility Enhancement using Poloxamer-188 and Gelucire-50/13 Authors : Kulthe V. V. and Chaudhari P. D. Institute : Modern College of Pharmacy, Nigdi, Pune – 411 044, Maharashtra Volume : 48(02) Page no. : 25-37
PHARMACEUTICAL ANALYSIS Paper : Lower Level Determination of Epichlorohydrin Content in Drug Substance by using Dimethyl Sulfoxide as an Internal Standard with Gas Chromatography Authors : Dubey J. K., Kolhe P. Y., Srivastava B. K., Parmar M., Tandel H., Mehta D. and Prajapati H.
64 Institute : CTX Life Sciences Pvt. Ltd., 251-252, Sachin Magdalla Road, Sachin, Surat-394230, Gujarat. Volume : 48(02) Page no. : 38-42 PHARMACOLOGY: No award this year.
IDMA J B Mody Best Student Awards 2010 : Since the inception of IDMA in 1961, we were striving to promote the best pharmaceutical practices in India, which will provide the necessary quality and skill to develop and advance the growth of the National Sector of the Indian Pharmaceutical Industry. Our aim has been to reach out to every University in India to popularize this prestigious Award and also to acknowledge and reward the deserving First Ranking B. Pharm Students. IDMA instituted the IDMA G.P. NAIR Awards in 1970, in honour of the first President and Founder Member of IDMA, Shri G P Nair, and were being given away for the past 40 years. Deserving winners of these Awards are spread all over the world in enviable positions as leaders of the Industry, Research and Pharmaceutical Education. From the year 2010, the award is known as the IDMA J B Mody Best Student Awards, in honour of Past President Shri J B Mody and will continue to encourage and recognize excellence among the B Pharm students and will be very proudly remembered by them and their families. This Award of encouragement, appreciation and motivation to the Pharmacy graduates from Indian Universities, has resulted in spreading the Indian Pharma diaspora into the arena of global research, industry, academia and government organizations and have also helped to strengthen Indian Pharma industry, to a large extent.
17 candidates from 17 Universities received the Award for having stood first in their respective Universities in the final B.Pharm Examinations held in 2010. The Award winners are as follows:
1. Mr. Rachumallu Ramakrishna, B. Pharm, Acharya Nagarjuna University, Guntur 2. Ms. Ritika Nagar, B. Pharm, Banaras Hindu University, Varanasi 3. Miss Neha Hura, B. Pharm, Birla Institute of Technology (Deemed University), Mesra, Ranchi 4. Mr. Manas Mishra, B. Pharm, Devi Ahilya Vishwavidyalaya, Indore 5. Mr. Biplab Paul, B. Pharm, Dibrugarh University, Dept. of Pharmaceutical Sciences, Assam 6. Ms. Akanksha Saini, B. Pharm, Dr. Harisingh Gour Vishwavidyalaya, Formerly University of Sagar, Sagar 7. Mr. Borse Vivek Bhaskar, B. Pharm, North Maharashtra University, Jalgaon 8. Ms. Supreet Kaur, B. Pharm, Panjab University, University Institute of Pharmaceutical Sciences, Chandigarh 9. Mr. Abhishek Dilip Deshmukh, B. Pharm, Sant Gadge Baba Amravati University, Amravati
65 10. Shri Abhinandan Ravsaheb Patil, B. Pharm, Shivaji University, Kolhapur 11. Ms. Priti Girotra, B. Pharm, The Maharaja Sayajirao University of Baroda, Vadodara 12. Ms. Doppalapudi Sindhu, B. Pharm, The Tamil Nadu Dr. M.G.R. Medical University Chennai 13. Ms. Amala Abraham, B. Pharm, University of Kerala, Thiruvananthapuram 14. Ms. Jadhav Seema Mohan Rukmini, B. Pharm, University of Mumbai 15. Ms. Snehal Ravindra Patil, B. Pharm, University of Pune 16. Ms. Indira Maity, B. Pharm, Jadavpur University, Kolkata. 17. Ms. Barve Ulka Ravindra Shraddha, B. Pharm, S.N.D.T. Women’s University, Mumbai
IDMA Seminars/ Workshops / Interactive Meetings / CSR Initiatives :
Date Topic Place
15th Feb 2012 Seminar on Quality Assurance (IDMA-GSB & Ahmedabad MSME) 24th–25th Feb 2012 Early Stage Studies Conference (Clinical Trials) Mumbai
5th April 2012 Pharma Marketing Conference-Marketing Mumbai Innovation- The Fast and Promising Ways 11th May 2012 Why and how of HVAC-Current Guidelines for Mumbai Pharmaceutical Industry 19th May 2012 Pharma Marketing Conference-Marketing Chennai Innovation- The Fast and Promising Ways, by Tamil Nadu State Board 8th Sept 2012 Why and How of HVAC Validation –Current Chennai Guidelines for Pharma Industry 8th–10th Sept 2012 Pharma India 2012 Gujarat
21st–22nd Sept 2012 IDMA-APA-PAC 2012 Mumbai “15th Pharmaceutical Analysts’ Convention”
66 Meetings held during 2012 :
11.01.2012 Meeting with Shri B K Singh, Director DoP regarding DGFT’s requirement for bar-coding on export of Pharmaceuticals for Tracing and Tracking purpose. 17.01.2012 IDMA delegation led by President, Mr. Manish U Doshi had a meeting chaired by Dr V M. Katoch, with Task Force for formulating a long term policy and strategy for strengthening of Drug Sector in the country. 30.01.2012 IDMA delegation led by Shri Manish U Doshi, had an important discussion on draft National Pharmaceutical Policy 2011 with Dr. K P Krishnan, Secretary, Office of the Economic Advisory Council to the PMO. In the forenoon, met Shri Arun Maira, Member-Planning Commission and also in the afternoon they had a meeting with the Secretary, Office of the Economic Advisory Council to the PMO. 21.02.2012 Tripartite meeting of Labour Minister of Maharashtra, Shri Hassan Miyanlal Mushrif, pharma industry representatives and FMRAI organised by Mumbai Labour Commissioner 22.02.2012 Interactive meeting with the Belarus Deputy Foreign Minister Mr. Sergei F Aleinik at New Delhi. The meeting was chaired by Shri Rajan Kohli, Advisor - FICCI. 23.02.2012 One day seminar on theme “Innovation and Cluster” at New Delhi organized by FICCI and Ministry of Micro, Small and Medium Enterprises. Dr. Ashwani Kumar, Hon’ble Minister of State for Science & Technology, Earth Sciences & Ministry of Planning was the Chief Guest. 29.02.2012 IDMA, OPPI and CIPI jointly met Shri Rajesh Nandan Srivastava Director (Narcotics Control) Ministry of Finance and Shri R K Jain, Director Lok Sabha Secretariat in connection with Narcotic Drugs and Psychotropic Substances Amendment Bill 2011. 29.02.2012 Meeting organized by FICCI and WTO at New Delhi to apprise on the current status of Trade Facilitation and make analysis on the gaps.
05.03.2012 Delegation led by IDMA President had a meeting with Shri D S Kalha, Secretary, Deptt of Pharmaceuticals with a specific purpose to discuss the National Pharmaceutical Pricing Policy 2011 with an eye on the recommendations given by the Ministry of Health & Family Welfare which are in contrast to the draft policy announced by DoP. 06.03.2012 Consultative Meeting on Government Procurement organized by Consumer Unity and Trust Society (CUTS) in collaboration with British High Commission. 13.03.2012 Meeting with the Task Force constituted under the Chairmanship of Dr. V M Katoch, Secretary-Deptt of Health Research & DG-ICMR for formulating a long term policy and strategy for strengthening of Drug Sector in the Country.
67 18.03.2012 Meeting of the Expert Committee to examine comments on the draft rules published for making a provision for payment of financial compensation in the cases of trial related injury or death during the clinical trials. 11.04.2012 Second meeting of FICCI’s IPR committee in New Delhi. 12.04.2012 IDMA-GSB interactive meeting with Dr G N Singh, DCGI, during his visit to Ahmedabad 25/26.04.2012 Meeting on the Fixed Dose Combinations at New Delhi. 26.04.2012 Meeting with Department of Pharmaceuticals by Technical Committee on Drug Discovery 26.04.2012 Interactive Meeting with DCGI during his visit to IDMA Office, Mumbai. 26.04.2012 two programmes on Intellectual Property day (as this day known as IPR day all over the world) one in FICCI and another in CII.
29.04.2012 IDMA participated in the Meeting of the expert committee held in FDA Bhavan to examine comments on the draft rules published for making a provision for payment of financial compensation in the cases of trial related injury or death during the clinical trials. 30.04.2012 Attended the programme on UNAIDS – FICCI Roundtable on ‘India’s partnership with Africa in Pharmaceuticals’ organised by FICCI. 01.05.2012 Interactive meeting with the Members of European Parliament on India-EU Free Trade Agreement organized by FICCI. 02.05.2012 Interactive Meeting with Shri Chaitanya Prasad, Controller General of Patents, Designs & Trademarks, at IDMA Office, Mumbai.
14.05.2012 IDMA delegation led by President, Mr. Manish U Doshi, attended the first meeting of the Group of Ministers (GoM) in New Delhi under the chairmanship of Shri Sharad Pawar, Minister for Agriculture. Other members of the Group were Shri Ghulam Nabi Azad, Minister for Health & Family Welfare, Shri Anand Sharma, Minister for Commerce & Industry, and Dr. Montek Singh Ahluwalia, Deputy Chairman Planning Commission. In total, five associations, i.e. IDMA, IPA, OPPI, CIPI and AIOCD gave their PowerPoint presentation. NGOs Jan Swasthya Abyan (JSA), All India Drug Action Network (AIDAN) and Dr. (Mrs.) Jyoti Mirdha, Congress Member of Parliament (LS) and Member – Standing Committee on Health & Family Welfare. 14.05.2012 Meeting with NPPA on the revision of CC, PC and PM norms for the year 2012
28.05.2012 Participated at the Seminar organised by FICCI, Centre for WTO Studies of IIFT, RIS, UNESCAP and FFFAI on “Facilitating Trade in South Asia” at New Delhi.
68 01.06.2012 Felicitating Meeting at IDMA office Mumbai to Dr R Ramakrishna, who retired on 31.05.2012 as DDC (I) 04.06.2012 Interactive meeting of Members with Mr Shailesh Sheth, expert Consultant on indirect taxes at IDMA Office 15.06.2012 Meeting with Mr. Marwan Abdulaziz, ED, DuBiotech, in Mumbai. 18.06.2012 Attended the Meeting held under the Chairmanship of Dr. Rajasekhara Vundru, Joint Secretary on India-Tunisia Joint Working Group on Drugs & Pharmaceuticals which was organized by DoP. 24.06.2012 IDMA- GSB - 33rd AGM held at Ahmedabad. 27.06.2012 Meeting with Mr. Mahesh Zagade, Commissioner, FDA, Maharashtra, at his office. 29.06.2012 IDMA attended the Joint Meeting with Mr. Sandeep Arya, Deputy Chief of Mission designate to the Indian Embassy Russian Federation organized by FICCI. 03.07.2012 Attended the first meeting of the consultative group on exports of Pharma products constituted under the Chairmanship of Shri Anand Sharma, Minister of Commerce & Industry. 06.07.2012 FICCI organized the Second meeting of the Working group on Labour Laws for Service sectors at New Delhi. organized by FICCI. All India Organization of Employers is affiliated to FICCI. 16.07.2012 Participated at the Meeting organized by The Federation of Indian Micro, Small & Medium Enterprises (FISME) . 18.07.2012 Meeting with Shri D S Kalha, Secretary, Deptt. of Pharmaceuticals on Uniform Code of Pharmaceutical Marketing Practices (UCPMP). 23.07.2012 Participated in the meeting with Dr. Rajasekhar Vundru, Joint Secretary, DoP on New Requirements for Export of Active Pharmaceutical Ingredients to European Union. 24.07.2012 Meeting with Shri D S Kalha, Secretary, DoP to deliberate on the voluntary Uniform Code on Pharmaceutical Marketing Practices for the Indian Pharma industry. 01.08.2012 IDMA participated in the meeting organised by ASSOCHAM on Regulatory challenges of the Indian Pharma industries at ASSOCHAM House, New Delhi.
69 06.08.2012 Shri C B Mehta, GM (Environment & Health Services) of JB Chemicals represented IDMA in providing feedback to Secretary DoP. Parliamentary Standing Committee on Science & Technology, Environment and Forest called some of the ministries to depose before the standing committee on the issue” Review Steps taken to mitigate Pollution” in New Delhi. Shri D S Kalha, Secretary, DoP was the spokesperson for the Pharma industry. 07.08.2012 Attended the meeting regarding use of Cytotoxic drugs and its implications on the occupational staff organised by the Just Environment (Charitable) Trust – Toxics Link for a toxic-free world at New Delhi. 09.08.2012 Attended in the Roundtable on New Exit Mechanism under National Manufacturing Policy organized by FICCI and DIPP at New Delhi. The draft National Manufacturing Policy was brought out by Planning Commission in November 2011 in which the National Investment and Manufacturing Zone (NIMZ) is a concept propounded to the National Manufacturing Policy of DIPP. Some important options were proposed by Ms. Anjali Prasad, Joint Secretary DIPP on the Exit Mechanism for the consideration of the stakeholders. 16.08.2012 Mr Mrudul D. Inamdar, Partner, Bansi S Mehta & Co. and an expert on IT laws about the implications of this notification at the meeting of Excise and Taxation Sub-committee at IDMA office 31.08.2012 IDMA delegation led by Shri Manish U Doshi, President, met Shri S R Rao, Commerce Secretary, Dr. G N Singh, DCGI and Shri C P Singh Chairman NPPA. 07.09.2012 Participated at the 5th meeting of India-EU Joint Working Group on pharmaceuticals and biotechnology. The meeting was chaired by Shri D S Kalha, Secretary, DoP. 20.09.2012 GoM on Pharma policy meeting was held. 26.09.2012 Attended the meeting on Market Access of pharmaceutical products in Japan was taken up by Shri Asit Tripathy, Joint Secretary, Department of Commerce in New Delhi. 27.09.2012 Meeting with Dr Jagdish Prasad, Director-DGHS, Dr G N Singh, DGCI & Dr V G Somani, DDC, at CDSCO, West Zone office, Mumbai. 04.10.2012 Secretary-General, IDMA appeared before the Competition Commission of India in respect to Case No.41/2011 filed by Sandhya Drug Agency Vs Assam Drug Dealers Association & others. 10.10.2012 Attended the Meeting chaired by Shri Sumit Bose, Revenue Secretary on Narcotic Drugs & Psychotropic Substances (Amendment) Bill 2011. Also met the Revenue Secretary in regard to CBDT Circular No.5/2012 dt.1.8.2012.
70 16.11.2012 Attended the meeting chaired by Committee on Petition of Rajya Sabha to have the views of the stakeholders against the petition praying to put a check on manufacture of spurious drugs in our country and other related issues.
IDMA Representations & Submissions : During the year 2012 - IDMA made the following important representations to various Government Departments/ Ministries. Those representations were regularly published in IDMA Bulletin, on respective dates as mentioned under column (4) here below:
Subject Date of Representation made to Published in Repn/ IDMA Bulletin submission dated Vat Refund to 31.01.2012 Shri Ratnakar Gaikwad, Chief Secretary, 07.02.2012 the Exporters in Govt of Maharashtra, AND Maharashtra Shri Swadheen Kshatriya, Principal Secretry, Revenue & Forest Dept, Govt of Maharashtra cc to: Shri Satej Patil, Hon’ble Minister of State, Maharashtra FDA, Home and Rural Development Permission for New 02.02.2012 Joint Secretary, Ministry of Health & 14.02.2012 Drugs & Subsequent Family Welfare New Drugs from cc to: Secretary, Ministry of Health & DCG(I)’s office Family Welfare, Government of India New Drug 08.02.2012 Dr V G Somani, Drugs Controller 14.02.2012 Applications: General (India) Approval of Protocols cc to: Dr A K Panda, Joint Secretary, Ministry of Health & Family Welfare Congratulatory Note 06.02.2012 Shri Dilshar Singh Kalha 14.02.2012 on taking charge as Secretary, DoP Congratulatory Note 22.02.2012 Dr G N Singh 29.02.2012 on taking charge as DCGI
71 Proposed enactment 21.02.2012 Dr Amitabh Rajan, Additional Secretary 29.02.2012 of the Narcotic Drugs (Revenue) Ministry of Finance & Psychotropic cc to: Rajesh Nandan Srivastava, Substances Director (Narcotics Control), Dept of (Regulation Revenue of Controlled Substances) Order, cc to: Ms Jagjit Pavadia, Narcotics 2011 Commissioner, Central Bureau to Narcotics On Ferrous 15.02.2012 The Chairman, NPPA, 07.03.2012 Ascorbate cc to : Member Secretary, NPPA The Narcotic Drugs 22.02.2012 The Chairman, Standing Committee on 07.03.2012 & Psychotropic Finance, Lok Sabha Secretariat Substances (Amendment) Bill, 2011 Pilferage and 24.01.2012 Senior Police & FDA Officials in 07.03.2012 Adulteration of Maharashtra and Gujarat Raw Materials from Warehoues and In Transit IDMA Letter along 21.02.2012 Shri Arun Maira, Member Planning 14.03.2012 with Rejoinder on Commission Pharma Pricing Policy: A Critique Congratulatory Note 12.03.2012 Shri Chaitanya Prasad, I.A.S. 21.03.2012 on taking charge as “Controller General of Patents (Designs& Trademarks)” Proposed enactment 20.03.2012 Dr Amitabh Rajan, Additional Secretary 30.03.2012 of the Narcotic Drugs (Revenue) Ministry of Finance & Psychotropic cc to: Mr Rajesh Nandan Srivastava, Substances (RCS) Director (Narcotics Control), Dept of Order, 2011 Revenue, Ministry of Finance and cc to: Ms Jagjit Pavadia, Narcotics Commissioner , CBN
72 Amendments 22.03.2012 Dr G N Singh, DCGI and 30.03.2012 urgently required in Dr V N Katoch, Chairman-Task Force D&C Act to protect for formulating a Long Term Policy bonafide Licensed and Strategy for Strengthening of Drug Manufacturers Sector, Ministry of Health & Family and ensue their Welfare. continued interest in the Manufacturing Sector On National 29.03.2012 Shri M K Alagiri, Hon’ble Minister of 07.04.2012 Pharmaceutical Chemicals & Fertilizers Ministry of Pricing Policy Chemicals & Fertilizers (NPPP) 2011-IDMA, IPA & OPPI joint repn Request for further 30.03.2012 Dr G N Singh, Secretary-cum-Scientific 14.04.2012 extension of effective Director, Indian Pharmacopoeia date of the IP Commission Addendum 2012 by three months to 30.06.2012 Response to DoP’s 14.04.2012 Shri Raj Kumar, Under Secretary to 14.04.2012 request for Project Government of India, DoP. Report on Barcoding Delay at Customs/ 17.04.2012 Dr G N Singh, DCGI 30.04.2012 ADC-Import &Export of consignments Industry objects 03.05.2012 Hon’ble Labour Minister, Govt of 14.05.2012 to proposal to fix Maharashtra working hourse cc to: Labour Secretary and Labour for Medical Commissioner, Govt of Maharashtra Representatives Appointment Letter 03.05.2012 Labaour Minister, Govt of Maharashtra, 14.05.2012 in Form A of the cc to: Labour Secretary and Labour Sales Promotion Commissioner, Govt of Maharashtra Employees (SPE) Act Interactive Meeting 30.04.2012 Dr G N Singh, DCGI 14.05.2012 with DCGI
73 Drugs and Cosmetics 04.05.2012 Dr G N Singh, DCGI, CDSCO 14.05.2012 Act 1940 and Rules 1945/Comments on Draft Rules issued under GSR-228/E Requirement of Advisory to Member-Manufacturers of 14.05.2012 registration under the Nutraceuticals, Dietary Supplements Food Standard and Safety Act (FSSA) 2006 and Licensing Regulations there under Interactive Meeting 26.04.2012 Dr G N singh, DCGI 21.05.2012 Uniform Code of 16.05.2012 Shri Ram Chander, Under Secretary to 21.05.2012 Pharamceuticals Government of India, DoP Marketing Practices (UCPMP) On Urgent Request 17.05.2012 Shri R S Gujaral, Finance Secretary, 30.05.2012 to keep SMEs, Ministry of Finance Excise Free Zones out of purview of Alternate Minimum Tax (AMT) On various issues 27.06.2012 Shri Mahesh Zagade, Commissioner, 07.07.2012 to be resolved for FDA, Maharashtra reviving Pharma Industry in Maharashtra Permission for New 11.07.2012 Shri A K Panda, Joint Secretary, 30.07.2012 Drugs & Subsequent Government of India, Ministry of Health New Drugs from & Family Welfare and DCGI’s office cc to: Shri P K Pradhan, Secretary, MH&FW Dr G N Singh, DCGI Study/Revision of 09.08.2012 Shri A K Gautam, Advisor (Bulk & Drug), 14.08.2012 Norms for CC,PC,PL NPPA, DoP, Ministry of Chemical s & and PM for the year Fertilizers 2012
74 Problems faced by 03.08.2012 Dr G N Singh, DCGI and 21.08.2012 the Industry due to cc to: Dr Arun Kumar Panda, Joint delay in clearance Secretary, Govt of India, Ministry of from CDSCO, West Health & Family Welfare zone office On Drugs & 20.08.2012 Dr Arun Kumar Panda, Joint Secretary 30.08.2012 Cosmetics (4th to the Govt of India, Ministry of Health & amendment) Rules, Family Welfare 2012 (122 DD) – cc to: Drug Controller General (India) Registration of Ethics Committee Suggestions 20.08.2012 Dr G N Singh, DCGI 30.08.2012 on Guidelines for Determining Quantum of Financial Compensation to be Paid in case of Clinical Trial Related Injury or Death- August 2012 On revising MSME 01.08.2012 Shri R K Mathur, Secretary, Ministry of 30.08.2012 definition MSME Presentation on 31.08.2012 Dr G N Singh, DCGI – (during the 07.09.2012 various urgent and interactive meeting with IDMA delegates longstanding issues in New Delhi) of the Pharma industry On seeking 28.08.2012 To Food Safety and Standards Authority 14.09.2012 amendments to of India (FSSAI) Food Safety and Standards Act & Rules 2011 Requesting 10.09.2012 Shri P Chidambaram, Hon’ble Finance 21.09.2012 for reviewing Minister the proposed cc to: Mr Sumit Bose, Revenue Narcotic Drugs Secretary, Ministry of Finance & Psychotropic Substances (Amendment) Bill, 2011
75 Repn regarding 10.09.2012 To Hon’ble Finance Minister, Govt of 21.09.2012 CBDT Circular India No. 5/2012 dated cc to : Shri Sumit Bose, Revenue 01.08.2012 Secretary, Ministry of Finance disallowing Gifts to Doctors as expenses
IDMA letter 01.10.2012 Dr Jagdish Prasad, Director General, 21.10.2012 subsequent to the DGHS, at CDSCO Meeting with DGHS in Mumbai Repn seeking 11.10.2012 Shri Sumit Bose, Revenue Secretary, 21.10.2012 clarification and Department of Revenue, Ministry of support on IT Finance circular No. 5 dated 01.08.2012
Submission to 12.10.2012 Dr G N Singh, DCGI 21.10.2012 provide CoPP with 3 years validity Seeking clarifications 22.10.2012 Shri P K Pradhan, Secretary, Ministry of 30.10.2012 on Government Health & Family Welfare, Directions for cc to: Shri R K Jain, Additional applications only on Secretary, MH&FW, generic names cc to : Dr Arun Kumar Panda, Joint Secretary, MH&FW, cc to : Shri Sanjay Prasad, Director, MH&FW, cc to : Dr G N Singh, Drug Controller General (India) and Shri Sudhir Kumar, Under Secretary, MH&FW Repn on Shelf life 11.10.2012 Dr G N Singh, DCGI 30.10.2012 of APIs Vs Drug Products IDMA requests 09.10.2012 Shri Anand Sharma, 07.11.2012 to withdraw Bar- Hon’ble Minister of Commerce & coding on exports of Industry Pharma Packs
76 IDMA appeal to stay 02.11.2012 The Secretary, Department of 07.11.2012 NPPA Guidelines Pharmaceuticals, Ministry of Chemicals & Fertilizers Submission on 05.11.2012 Dr G N Singh, Drug Controller General 14.11.2012 Guidelines on of India (DCGI) Product Recall and Rapid Alert System for Drugs – including Biologicals and Vaccines Repn on proposed 12.11.2012 The Secretary, Ministry of Health & 21.11.2012 amendment to Drugs Family Welfare, Department of Health & Cosmetics Rules, 1945 for grant / renewal of applications in generic names for single ingredient formulations Submission 09.11.2012 Mr Rajesh Nandan Srivastava, Director 21.11.2012 on proposed (NC), Department of Revenue, Ministry amendment to the of Finance NDPS (RCS) Order 1993 with regard to controls over import and export of precursor chemicals Representation/ 08.12.2012 Secretary, Department of 07.12.2012 Observations on NPPA Pharmaceuticals, Ministry of Chemicals Internal Guidelines & fertilisers Representation on 01.12.2012 Chairman, NPPA, Department of 07.12.2012 Allowance of 100% Pharmaceuticals MAPE on revision of prices of scheduled formulation under DPCO 1995
77 IDMA Proposals for 22.11.2012 Shri Raj Kumar, Under Secretary to the 14.12.2012 the Union Budget Government of India, Department of 2013-14 Pharmaceuticals, Ministry of Chemicals & Fertilizer and Shri V. K. Garg, Joint Secretary (TRU-II), Central Board of Excise & Customs, Department of Revenue, Ministry of Finance Representation 07.12.2012 Dr. S. C. Sharma, Drug Licensing 21.12.2012 on Drugs and and Controlling Authority, Department Cosmetics Act, 1940 Directorate of Health Services, and Rules, 1945 / Uttarakhand Directions to sale drugs only under generic name. In the matter of 05.12.2012 Secretary, Ministry of Health and Family 21.12.2012 directions issued by Welfare, Shri R K Jain, Additional the Drugs Controller, Secretary, Department of Health and Dr Uttarakhand to sell G N Singh, DCG(I) drugs only under generic name
CONSULTANTS Shailesh Sheth Taxation Bakul Mody Taxation S W Deshpande Regulatory Kasim K Master DPCO & Industry Trade matters K C Kohli DPCO and related matters K Srivathsan Excise & Customs Chetan Doshi Accounts/Finance K T Rai Labour Prof S G Deshpande Indian Drugs
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