Annual Report 2011-2012 - Indian Drug Manufacturers' Association

Glimpses of IDMA Golden Jubilee Celebrations, various other Events, Seminars and Interactive Meetings held during the year 2012
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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
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.
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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
IDMA EXECUTIVE COMMITTEE – 2012
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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.
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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.
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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
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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
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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
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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.
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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.
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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.
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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
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
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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”
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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.
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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,
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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
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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
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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.
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Sr. No. Sub-Committees Chairmen 1 Bulk Drugs Mahesh H. Doshi
Dy-Mach Pharma
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.
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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]
Email : [email protected]
Email : [email protected]
New Delhi - 110 029 Tel.: 011-26171367 / 41650726 Fax: 011-26171369
Email : [email protected], [email protected]
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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 & Members 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
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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.
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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.
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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.
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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 Pharma Ltd., 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
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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.
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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.
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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
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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
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• 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
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
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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
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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.
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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
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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
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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
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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
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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
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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
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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).
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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
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.
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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.
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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.
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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.
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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
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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