Introduction 1. 1 Mandate of Department of Pharmaceuticals The Department of Pharmaceuticals in the Ministry of Chemicals & Fertilizers was created on 01. 07. 2008 to provide greater focus for the growth of the Pharmaceuticals industry. Following work has been allocated to the Department of Pharmaceuticals: 1) Drugs and Pharmaceuticals, excluding those specifically allotted to other departments. 2) Promotion and co-ordination of basic, applied and other research in areas related to the Pharmaceuticals sector. 3) Development of infrastructure, manpower and skills for the Pharmaceuticals sector and management of related information.
4) Education and training including high end research and grant of fellowships in India and abroad, exchange of information and technical guidance on all matters relating to pharmaceutical sector. 12) Bengal Chemicals and Pharmaceuticals Limited. 13) Hindustan Antibiotics Limited & its subsidiaries as & JVs. 14) Indian Drugs and Pharmaceuticals Limited & its subsidiaries. 15) Karnataka Limited. Antibiotics and Pharmaceuticals 16) Rajasthan Drugs and Pharmaceuticals Limited. 17) Bengal Immunity Limited. 18) Smith Stanistreet Pharmaceuticals Limited. The work of the Department has been organized into three Divisions viz.
Pharmaceuticals Industry Division, Public Sector Undertakings Division and R&D Division comprising National Institute of Pharmaceutical Education & Research, (NIPER) and Research & Development. The National Pharmaceuticals Pricing Authority (NPPA), an attached office of this Department, is entrusted with fixation and revision of prices of Pharmaceuticals products under Drug Price Control Order, 1995 (DPCO, 1995). 10) All matters relating to National Institutes for Pharmaceuticals Education and Research (NIPERs). There are five Central Public Sector Undertakings (CPSUs) viz Indian Drugs and Pharmaceuticals.
Limited (IDPL), Hindustan Antibiotics Limited (HAL), Bengal Chemicals and Pharmaceuticals Limited (BCPL), Bengal Immunity Limited (BIL) and Smith Stanistreet Pharmaceuticals Limited(SSPL). Earlier Karnataka Antibiotics & Pharmaceuticals Limited. (KAPL) was a joint venture between Hindustan Antibiotics Limited (HAL) and State Government of Karnataka and Rajasthan Drugs and Pharmaceuticals Limited (RDPL) was a joint venture of Indian Drugs and Pharmaceuticals Limited (IDPL) and the State Government of Rajasthan. But in order to sustain the growth & development of KAPL & RDPL, Government has approved de-linking of both these companies from.
HAL & IDPL respectively. The shares of KAPL held by HAL has now been transferred to the President of India w. e. f 1st October, 2009 and similarly shares of RDPL held by IDPL has been transferred to the President of India w. e. f 17th August, 2010. The shareholding of respective States in these joint ventures would continue to remain unaffected. 11) Planning, development and control of; and assistance to, all industries dealt with by the Department. National Institutes of Pharmaceuticals Education & Research (NIPERs) are autonomous institutions under this Department.
5) Promotion of public – private – partnership in pharmaceutical related areas. 6) International cooperation in pharmaceutical research, including work related to international conferences in related areas in India and abroad. 7) Inter-sectoral coordination including coordination between organizations and institutes under the Central and State Governments in areas related to the subjects entrusted to the Department. 8) Technical support for dealing with national hazards in pharmaceutical sector. 9) All matters relating to National Pharmaceuticals Pricing Authority including related functions of price control/monitoring. 7 Annual Report | 2011-12 Shri M. K.
Alagiri is the Minister of Chemicals and Fertilizers and Shri Shrikant Kumar Jena is the Minister of State, Independent Charge in the Ministry of Statistics and Programme implementation and Minister of State in the Ministry of Chemicals and Fertilizers. Shri Dilsher Singh Kalha, is Secretary in the Department of Pharmaceuticals w. e. f 25. 01. 2012 Shri K. Jose Cyriac, Secretary (Chemicals & Petrochemicals) had been entrusted additional charge as Secretary (Pharmaceuticals) w. e. f 1st November, 2011 to 24Th January, 2012. 1. 2 VISION AND MISSION OF THE DEPARTMENT Vision:
Based on the mandate given to the Department of Pharmaceuticals through the allocated functions a 8 vision has been fixed in concurrence with the Cabinet Secretariat, which is as follows: “India : The largest global provider of quality medicines at reasonable prices. ” Mission: ? Ensure availability of drugs at reasonable prices as per provisions of the Drug Prices Control Order, 1995 ? Develop Human Resources for Pharmaceutical Industry and Drug Research and Development ? Formulate Scheme/ Project for promoting Public-Private Partnership for development of pharmaceuticals Industry ? Formulate Scheme/ Project for promoting Pharma Brand India through International Cooperation ?
Formulate Scheme/ Project for promoting environmentally sustainable development of Pharmaceutical Industry Chapter 2 An Overview of Pharmaceuticals Industry 2. 1 Financial Performance of the Drugs and Pharmaceuticals Industry 2. 2 Imports 2. 3 Export of Drugs and Pharmaceuticals Industry 2. 4 Share in National Trade 2. 5 Pharma Export Promotion Council (Pharmexcil) 2. 6 International Cooperation/Export Promotion of Pharmaceuticals 2. 7 Proposed Major areas of International Conference 2. 8 India Pharma Summit – 2011 2. 9 Growth in Indian Pharmaceutical Industry Annual Report | 2011-12 CHAPTER -2 An Overview of Pharmaceuticals Industry.
2. 1Financial performance of the Drugs and Pharmaceutical Industry The financial performance of the Drugs and Pharmaceutical industry for the year 2009-10, 2010-11 and the forecast for the year 2011-12 are given in Table below:- Drugs and Pharmaceuticals: Growth and Profitability in the year 2010-11 (%age Change over year ago) S. No. Particulars Quarterly Annual June’11 Sept. ’11 Dec. ’11 March’12 2009-10 2010-11 2011-12 Estimates Forcast Forcast 10. 9 10. 0 17. 9 17. 4 15. 0 10. 9 14. 1 1 Income 2 Net sales 9. 2 11. 0 17. 1 16. 3 11. 9 12. 4 13. 5 3 Total expenses 11. 6 -1. 8 18. 8 14. 8 3. 1 19. 2 10. 3 4 Raw materials 13. 6.
14. 0 19. 0 16. 8 8. 0 14. 8 15. 9 5 Salaries & wages 15. 5 13. 0 13. 3 13. 6 18. 2 21. 1 13. 8 6 Power & fuel 10. 2 24. 0 24. 0 10. 0 2. 5 20. 1 17. 1 7 Selling & marketing 9. 0 15. 1 10. 0 9. 0 0. 1 11. 9 10. 7 8 Other expenses 2. 8 28. 0 11. 1 12. 1 -19. 3 15. 9 13. 7 9 Depreciation 9. 1 13. 0 11. 5 12. 0 14. 3 12. 4 11. 4 10 Interest expenses 15. 6 20. 0 25. 0 18. 0 -0. 3 6. 6 19. 4 11 Tax provision 37. 5 -78. 6 90. 6 75. 9 108. 8 73. 6 -37. 2 12 PBDIT 17. 3 -4. 3 19. 9 18. 9 105. 7 -1. 1 12. 6 13 PAT 15. 7 7. 1 25. 8 210. 8 -31. 6 55. 6 14 PBDIT/Net Sales (%) 18. 8 17. 2 21. 5 17. 1 21. 4 19. 0 18. 7 15 PBDIT/Income (%).
22. 8 20. 8 24. 9 20. 9 25. 4 22. 7 22. 4 16 PAT/Income (%) 13. 7 11. 4 14. 5 10. 9 15. 0 9. 2 12. 6 – Forcast Source: Center for Monitoring Indian Economy (CMIE) Report November 2011. Net sales of the Drugs & Pharmaceuticals sector are expected to grow by 17. 1 percent y-o-y in the December 2011 quarter as against an estimated 11 per cent growth in the September 2011 quarter. The improvement in sales growth will be largely driven by higher realization of export oriented Pharma companies. The sector generates around 40 percent of its sales from exports.
A sharp depreciation in the rupees is expected to result in higher export realisations, which will enhance the over all growth of the sector. The sector’s profitability is expected to remain under pressure. A sharp rise in expenses like raw materials, power & fuel and interest cost is expected to restrict the growth in profits. Raw material expenses are expected to rise by 19 percent in the December 2011 quarter.
The Pharma sector imports raw materials like chemicals intermediates and active pharmaceuticals ingredients (APIs). Imports accounts for 38 percent of the overall raw material cost. A weak rupee will make imports costlier, resulting in a higher rise in raw material cost. Power & fuel cost is expected to increase by 24 percent. With this the PBDIT margin is expected to remain flats at 24. 9 percent y-o-y. The net profit of the sector is expected to grow by a modest seven percent as interest cost is expected to rise by 25 percent & the net profit margin is expected to be around 14. 5 percent in the December 2011 quarter. 11 Annual Report | 2011-12 2. 2IMPORTS:
As per the Directorate General of Commercial Intelligence and Statistics (D. G. C. I. S. ) Kolkata, value of imports of “Medicinal and Pharmaceuticals Products” for the period 2002-03 to 2010-11 is as under: (Rs. in Crore) Year Value of Import of “Medicinal and Pharmaceuticals Products” Growth (%) 2002-03 2,865 – 2003-04 2,956 3. 18 2004-05 3,139 6. 19 2005-06 4,515 43. 84 2006-07 5,866 29. 92 2007-08 6,734 14. 79 2008-09 8,649 28. 43 2009-10 9,959 15. 15 2010-11 10,937 9. 82 Rs.
In Crores 12,000 10,000 8,649 5,866 6,000 9,959 10,937 6,734 4,515 4,000 2,865 2,956 As Per DGCIS, Kolkata Exports of “Drugs and Pharmaceuticals and Fine Chemicals” for the period 2002-03 to 2010-11 are below:(Rs. in crore) 3,139 2,000 0 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11 Value of Exports of “Drugs and Pharmaceuticals and Fine Chemicals” Growth (%) 2002-03 12,826 – 2003-04 15,213 18. 61 2004-05 17,228 13. 25 2005-06 21,230 23. 23 25,666 20. 89 2007-08 29,354 14. 37 2008-09- 39,821 35.
66 2009-10 42,456 6. 62 2010-11 VALUE OF IMPORT OF “MEDICINAL & PHARMACEUTICALS PRODUCTS” 8,000 2. 3EXPORTS 2006-07 (Source : Directorate General of Commercial Intelligence and Statistics (DGCIS), Kolkata) Year 47,551 12. 00 (DGCIS), Kolkata) Years It may be observed that the imports shown declined in growth in the year 2010-11 compared to previous year. The country is almost self-sufficient in production of most of formulations/ pharmaceuticals products.
As such imports are being resorted to on quality & economic considerations and not necessarily due to non-availability from domestic sources. Manufacturers of Drugs & Pharmaceuticals are free to produce any drugs approved by the Drug control authorities. Value of Export of “Drugs Pharmaceuticals and Fine chemicals” Rs. in Crores 12 Import of Drugs & Pharmaceuticals is regulated as per the Foreign Trade Policy of Government of India. Import of some drugs and drug intermediates are restricted under current Foreign Trade Policy.
These restrictions are basically due to common HS codes assigned to some narcotic substances or similarity to some Ozone Depleting Substances (ODS) with pharmaceutical products. 50,000 45,000 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 0 39,821 12,826 15,213 17,228 21,230 25,666 42,456 47,551 29,354 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11 Years Annual Report | 2011-12.
Growth of Import “Medicinal and Pharmaceuticals Products” & “Export Drugs Pharmaceuticals and Fine chemicals” 10,937 80 70 23 Indices 60 50 36 21 44 40 30 30 19 20 10 0 Total National Imports Medicinal and Pharmaceuticals Products 14 13 28 12 7 15 15 10 6 3 0 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11 Export 19 13 23 21 14 36 7 Import 3 6 44 30 15 28 15 1,683,467 12 10 (Source : DGCIS, Kolkata) 2.
4 Share in National Trade Items/Years (Rs. in Crore) 2006-07 2007-08 2008-09 2009-10 2010-11 A: Total National Exports 571779 655864 840755 845534 1142649 (a) Drugs Pharmaceuticals and Fine chemicals 25666 29354 39821 42456 47551 4. 5 4. 5 4. 7 5. 0 4. 2 840506 1012312 1374436 1363736 1683467 5866 6734 8649 9959 10937 0. 7 0. 7 0. 6 0. 7 0. 6 19800 22620 31172 32497 36614 Share in Total Export % B: Total National Imports (b) Medicinal and Pharmaceuticals Products Share in Total Import % (c) Trade Balance (a)-(b) 47,551. 00 Total National Exports Drugs and Pharmaceuticals and Fine Chemicals The share of Exports of the “Drugs.
Pharmaceuticals and Fine Chemicals” in the total National Exports declined from 4. 50% to 4. 20% during the period 200607 to 2010-11, However in the absolute terms there is growth in Exports. The share of imports is declined 0. 7% to 0. 6% in the corresponding period. 2. 5PHARMA EXPORT PROMOTION COUNCIL (Pharmexcil) 1,142,649. 00 The Department had played a pivotal role in the formation of Pharmexcil consequent to the recommendation from 9th Five Year Plan Working Group Report on Drugs and Pharmaceuticals. In the light of this, the Department constantly interacts with Pharmexcil in their work areas. The role of Pharmexcil 13.
Annual Report | 2011-12 is for facilitation of exports of Drugs, Pharmaceuticals, Biotechnology products, Herbal medicines and Diagnostics, to name a few. It is authorised to issue Registration-cum-Membership Certificate (RCMC) which is one of the requirements for the importers and exporters of commodities. In addition to this, Pharmexcil is concerned with giving export thrust to the various products through visits of delegations to various markets abroad, organizing of seminars, workshops and exhibitions.
As a major area of work, Pharmexcil also holds Buyers/Sellers meets and compiles detailed data base on pharma exports and problems in exporting pharma products. 2. 6 International Cooperation/ Export Promotion of Pharmaceuticals An important focus area for the Department of Pharmaceuticals is promotion of Indian pharma exports. The Department participated in the following International Cooperation events during 2011-2012 :1. Participation in 9th Session of India-Uzbek InterGovernmental Commission on Trade, Economic, Scientific & Technological Cooperation held on 4-5 May, 2011 in Tashkent.
2. Participation in the Meeting of Biotechnology and Life Sciences Working Group under India-US High Technology Cooperation Group held in July, 2011 in New Delhi. 14 3.
Participation in India Russia Forum on Trade and Investment held in November, 2011 in Moscow and the Roundtable on Pharmaceuticals. 4. Participation in Seminars organized by the Embassy of India, Jakarta in cooperation with PT. Strategic Asia held in Jakarta, Indonesia. The Department of Pharmaceuticals also provided financial assistance for the following activities/events for promotion and development of the Pharma sector: 1. Preparing detailed scope of work, preparation of Expression of Interest for selection of Global Consultants for developing India as a Global Innovation Hub by 2020.
2. Assistance to Institute of Economic Growth for conducting a study on “Growth of Pharmaceutical Industry in India” 2. 7 Proposed Major areas of International Conference. The Department proposes to leverage Inter-Country partnership through MoUs for formulating greater market access to Indian Pharma in key markets like Russia, Ukraine, Kazakhstan etc amongst the CIS, Mexico, Brazil, Venezuela, etc in LAC region, Japan, ASEAN, etc in the East, South Africa, Nigeria, Kenya, etc in Africa and some key Gulf Countries like Saudi Arabia, UAE, etc. It is also targeting focus on European countries like Spain, Greece, Germany, France and Italy for APIs and niche formulations. 2.
8 INDIA PHARMA SUMMIT-2011 The Department of Pharmaceuticals in collaboration with Federation of Indian Chamber of Commerce and Industry (FICCI) and WHO India organized “India Pharma Summit 2011”, on 29th November, 2011 in New Delhi. The theme of India Pharma Summit 2011 was “Indian Pharma– Road Map for Global Leadership in Generic Medicines”. The India Pharma Summit was a one day event to showcase India’s capability in the Pharma Sector before all the stakeholders as well as to provide the networking opportunities to the Indian Pharma Industry for having a meaningful interaction with various stakeholders.
It provided a platform that brings all the stakeholders such as policy makers from Government of India, State Governments, Indian Pharma Industry, Regulatory Authorities from focus countries, Academia, Global Pharma Leaders/ Experts on one platform and facilitate a meaningful interaction so as to generate a healthy debate as well as to come up with the solutions to issues of the problems being faced by Pharma Sector. India Pharma Summit 2011 was the 3rd event in successful series after the Department of Pharmaceuticals was carved out of Department of Chemicals & Petrochemicals in July 2008. Annual Report | 2011-12 15 Annual Report | 2011-12 2.
9 Growth in Indian Pharmaceutical Industry Table-1: Export and Domestic Growth Year (Rs. in crore) Exports Growth% Domestic Growth% Total Growth%% Mar 2006 21230 23. 23 39989 17. 17 61219 19. 21 Mar 2007 25666 20. 89 45367 13. 45 71033 16. 03 Mar 2008 29354 14. 37 50946 12. 30 80300 13. 04 Mar 2009 39821 35. 66 55454 8. 85 95275 18. 65 Mar 2010 42154* 5. 86 62055 11. 90 104209 9. 38 Table – 2: International sales on consolidated basis 16 Consolidated net sales International sales Exports as % of net sales 2010-11 Ranbaxy Labs 8960. 77 6771. 74 75. 6 Dr Reddy’s Labs 7236. 80 5940. 70 82. 1 Lupin 5706. 82 3983. 08 69. 8 Cipla.
6130. 31 3361. 49 54. 8 Sun Pharma 5721. 43 2898. 20 50. 7 Wockhardt 3751. 24 2709. 91 72. 2 Jubilant Lifescience 3433. 40 2369. 11 69. 0 Annual Report | 2011-12 Consolidated net sales International sales Exports as % of net sales 2010-11 Cadila Healthcare 4464. 70 2288. 70 51. 3 Biocon 2300. 52 1956. 79 85. 1 Glenmark Pharma 3089. 59 1955. 83 63. 3 Stride Arcolab 1695. 84 1637. 67 96. 6 Plethico Pharma 1535. 20 1367. 22 89. 1 Piramal Healthcare 2509. 86 1280. 58 51. 0 Divi’s Labs 1307. 11 1204. 95 92. 2 Aurobindo Pharma 4381. 48 1112. 06 25. 4 Torrent Pharma 2121. 97 1101. 57 51. 9 Ipca Laboratories 1882. 54 1025. 18 54. 5.
Dishman Pharma 990. 84 911. 56 92. 0 Orchid Chemicals 1781. 79 725. 85 40. 7 Shasun Chemicals 799. 42 676. 78 84. 7 Panacea Biotec 1143. 78 610. 44 53. 4 Table-3: Geographical Distribution of Pharma Companies S. No. 1. 2. 3. 4. 5. 6. State Maharashtra Gujarat West Bengal Andhra Pradesh Tamil Nadu Others Total Number of Manufacturing Units Formulation Bulk Drugs 1928 1211 1129 397 694 62 528 199 472 98 3423 422 8174 2389 Total 3139 1526 756 727 570 3845 10563 Table-4: Market Turnover of Major Therapeutic Segments Major Therapies Anti-infectives Cardiac Gastro Intestinal Respiratory Pain / Analgesics Vitamins/ Minerals/ Nutrients.
Anti Diabetic Gynaecology Neuro / CNS Derma MAT DEC’05 (Val in Crs) 4,056 2,378 2,537 2,170 2,059 2,105 998 1,261 1,231 1,255 % Contribution 17. 6 10. 3 11. 0 9. 4 8. 9 9. 1 4. 3 5. 5 5. 3 5. 4 MAT DEC’10 (Val in Crs) 8,060 5,318 5,099 4,080 4,038 3,625 2,743 2,658 2,633 2,554 % Contribution 17. 2 11. 4 10. 9 8. 7 8. 6 7. 7 5. 9 5. 7 5. 6 5. 5 17 Annual Report | 2011-12 Table-5: Bulk Industry Growth Table-10: Export Growth Year (Rs. in Crores) 2007-08 12,647. 51 2008-09 16,360. 71 2009-10 17,307. 02 CAGR 16. 98% Mar 2007 Mar 2008 Mar 2009 Mar 2010 Mar 2011 Table-6: The Global Market for Biologics in 2009 Country US Europe Japan.
Asia/Africa/Australasia Latin America Total Biologic Drugs Market 2009 Sales ($ bn) 69. 02 41. 68 10. 29 14. 4. 0 1. 20 136. 59 Drug Name bevacizumab 1 2 3 4 No of Universities No of colleges No of science colleges Annual student output at degree level in science 5 Annual student output at degree level in engineering 6 Total no of pharmacy colleges 7 Number of B Pharm colleges 8 Number of Masters in pharmaceuticals area and PhD offering colleges 9 No of B Pharm students in pharma 10 No of Masters and Phd students output in pharma 5. 74 Rituxan rituximab 5. 62 Humira adalimumab 5. 48 Herceptin trastuzumab 4. 86 Lantus insulin glarine.
4. 29 Enbrele tanercept 3. 87 Remicade infliximab 3. 51 Table-8: The Global Market for Biosimilars in 2009 Country 18 US Europe Other Countries (incl. China and India) Total Biosimilars Market 2009 Sales ($ bn) 0. 06 0. 14 1. 03 20. 89 14. 37 35. 66 6. 6 7. 7 Sl Item 2009 Sales ($ bn) Avastin Growth % Table-11: Human resource position in India Table-7: The 10 Top Selling Biologics in 2009 Brand Exports (Rs. crores) 25666 29354 39821 42154 45745 Total numbers 409 25990 4696 2000374 1663619 1162 848 191 51716 5648 Table-12: Global Phama market growth rate Market Share of Biosimilars (%) 4. 9 11. 4 83. 7 %growth rate 2004 620 7. 9 2005.
664 7. 2 710 6. 9 2007 756 6. 4 2008 100 Market in Billion US$ 2006 1. 23 Year 801 4. 9 Table-9: Projected Growth (Value in Rs crs / Growth in %) Year Domestic Value Exports Growth Value Total Growth Value Growth 2016-17 130,000 21% 158,000 16% 288,000 18% 2019-20 233,000 22% 248,000 17% 481,000 19% Annual Report | 2011-12 Table-13: Top Global Generic Players Rank Company Rank Company 1 Teva 6 Actavis 2 Sandoz 7 Ratiopharm 3 Mylan/Merck GX 8 Stada 4 Watson Andrx 9 Ranbaxy 5 Barr 10 Perrigo Table 14: Research and Development Expenditure Growth in R&D Expenditure – Rs Cr Year R&D Expenditure As % of Sales Domestic Foreign Companies.
Companies Domestic Companies Foreign Companies Mar 1995 80. 61 64. 13 1. 34 0. 77 Mar 1996 142. 50 83. 37 1. 71 0. 91 Mar 1997 148. 12 89. 41 1. 55 0. 95 Mar 1998 154. 15 90. 65 1. 43 0. 88 Mar 1999 218. 66 79. 78 1. 56 0. 70 Mar 2000 256. 80 90. 17 1. 56 0. 66 Mar 2001 435. 07 109. 81 2. 30 0. 72 Mar 2002 597. 91 110. 04 2. 64 0. 65 Mar 2003 686. 74 232. 73 2. 93 0. 71 Mar 2004 1084. 26 346. 69 3. 81 1. 10 Mar 2005 1527. 24 510. 50 4. 98 1. 63 Mar 2006 1850. 97 816. 02 5. 35 2. 39 Mar 2007 2371. 79 695. 62 5. 01 2. 67 Mar 2008 2772. 63 700. 18 4. 78 2. 86 Mar 2009 3316. 14 846. 05 4. 89 3. 84 Mar 2010 3342. 32 934. 40 4. 50 4. 01.
Table-15: R&D spending of leading Indian and Global pharmaceutical MNEs, FY 2009 Indian Pharmaceutical Companies Global Pharmaceutical Companies Rank in R&D spending Company R&D exp. FY 2008/09, million US$ Rank in R&D spending Company R&D exp. 2009, million US$ 1 Ranbaxy* 99 1 Roche, CH 8,570 2 Dr. Reddy’s 89 5 GlaxoSmithKlin, UK 6,286 3 Sun Pharma 67 10 Elli Lilly, USA 4,300 4 Cipla 51 25 Lundbeck, DNK 615 5 Lupin Labs 50 50 Watson, USA 197 19 Annual Report | 2011-12 Table – 16: Employment Data for Pharmaceutical Sector Year No of Employees Mar 1995 Mar 1996 Mar 1997 Mar 1998 Mar 1999 Mar 2000 Mar 2001 Mar 2002 Mar 2003 Mar 2004 Mar 2005.
Mar 2006 Mar2007 Mar 2008 Table 18: Qualifications of personnel employed in the Chemicals and Pharmaceuticals Segment 1,81,497 2,04,609 2,11,614 1,89,295 2,13,999 2,43,410 2,33,704 2,26,416 2,23,556 2,40,791 2,65,396 2,90,021 3,36,211 3,53,692 Qualification Distribution Ph. D / MTech / MSc etc. 5-8% Graduate Engineers 15-25% Diploma Engineers 10% ITI and other vocational courses 15-20% Graduates (BA/BSc/BCom/others) 15-25% 12th standard or below 20-25% Table-19: Turnover-wise distribution Table 17: Percentage distribution of Manpower in Pharma Industry Function Distribution Production & Quality Control 50% 50% Research/Lab/Testing 20%.
Sales, Marketing, Medical assistance 5-10% Purchase, Logistics, Supply Chain 5-10% Support functions (HR, Finance, 10-12% etc. ) Turnover % Distribution 0-10 Cr. 70 10-50 Cr. 20 50-100 Cr. 5 100-500 Cr. 3 500 + Cr. 2 Table-20: Performance of CPSUs 20 Parameter Sales (08-09) TO/Employees Rs lacs TO/Sales employees Rs lacs PAT Rs cr Total Employees Sales Strength Sales (08-09) KAPL 225. 01 30 65 5. 88 739 345 225. 01 RDPL 80. 75 52 304 0. 01 181 31 80. 75 BCPL 77. 63 10 134 -5. 35 742 58 77. 63 HAL 147. 39 11 134 -22. 08 1224 105 147. 39 IDPL 56. 70 23 236 -37900. 9 243 24 56. 70 Table-21: Sales Projection of CPSUs TOTAL 594. 37 19 106 3129.
563 594. 37 Year 2012-13 IDPL 51. 7 HAL 189 BCPL 153. 37 KAPL 320 RDPL 108 2013-14 2014-15 2015-16 2016-17 70 80 92 125. 4 215 264 290 319 176. 57 204. 73 237. 6 275. 83 360 425 490 560 122 135 150 165 (Rs in Crores) Chapter 3 Pharmaceuticals Industry 3. 1 Product Patent 3. 2 Creation of IPR Facilitation Centers in Phamexcil 3. 3 Data Protection as per Article 39. 3 of TRIPS Agreement 3. 4 Pharmaceutical Policy 3. 5 Pharmaceutical Advisory Forum Annual Report | 2011-12 CHAPTER – 3 PHARMACEUTICAL INDUSTRY The annual turnover of the Indian Pharmaceutical Industry is estimated to be about Rs. 1,04,944. 351 Crores during the year 2010-11.
The share of export of Drugs, Pharmaceuticals and Fine Chemicals is more than Rs. 47551. 26 crore. This segment of Industry has shown tremendous progress in terms of infrastructure development, technology base and wide range of products. The industry has developed excellent GMP (Good Manufacturing Practices) compliant facilities for the production of different dosage forms. The strength of the industry is in developing cost effective technologies in the shortest possible time for drug intermediates and bulk activities without compromising on quality.
This is realized through the country’s strengths in organic chemicals’ synthesis and process engineering. The domestic Pharma Industry has recently achieved some historic milestones through a leadership position and global presence as a world class cost effective generic drugs’ manufacturer of AIDS medicines.
Many Indian companies are part of an agreement where major AIDS drugs based on Lamivudine, Stavudine, Zidovudine, Nevirapine are supplied to Mozambique, Rwanda, South Africa and Tanzania which have about 33% of all people living with AIDS in Africa. Many US Schemes are sourcing Anti Retrovirals from Indian companies whose products are already US FDA approved.
Many Indian companies maintain highest standards in Purity, Stability and International Safety, Health and Environmental(SHE) protection in production and supply of bulk drugs even to some innovator companies. This speaks of the high quality standards maintained by a large number of Indian Pharma companies as these bulk actives are used by the buyer companies in manufacture of dosage forms which are again subjected to stringent assessment by various regulatory authorities in the importing countries. More of Indian companies are now seeking regulatory approvals in USA in specialized segments like Antiinfectives, Cardiovasculars, CNS group.
Along with Brazil & PR China, India has carved a niche for itself by being a top generic Pharma player. 1 Source CMIE Many Indian companies have got various international regulatory approvals for their plants, from agencies like USFDA, MHRA-UK, TGA-Australia, MCC-South Africa etc. Outside USA India is the only country having the highest number of USFDA approved plants for generic drugs’ manufacture outside USA. Major share of Indian Pharma exports is going to developed western countries and it speaks not only about excellent quality of Indian pharmaceuticals but also about the reasonableness of the prices.
Some of the leading Indian Pharma companies derive 50% of their turnover from International business. 3. 1 PRODUCT PATENT- Impact on medicine prices With the enactment of Patents (Amendment) Act 2005, the process of bringing Patents Act in line with the TRIPS Agreement has been completed. The new patent regime is not expected to have much impact on prices/availability of medicines for the following reasons: (a) At any given points of time, globally only 5-10 percent of the drugs would be under patent protection. (b) The price competition among different drugs in the same therapeutic group should keep the prices under control.
(c) Since majority of the patients in India pay from their pocket, the limited purchasing power will act as a check on very high price. (d) Govt. continues to have powers to regulate the prices of medicines. (e) Safe-guards like compulsory licensing, parallel imports etc. exists. (f) The drugs covered in the list of Essential Medicines are not likely to be covered by patent these would continue to be abundantly available at reasonable prices.
3. 2CREATION OF IPR FACILITATION CENTRES IN PHARMEXCIL The Working Group on Drugs and Pharmaceuticals for the 11th Five Year Plan (2007-2012) recommended 23 Annual Report | 2011-12.setting up of 3 IPR Facilitation Centres at 3 offices of Pharmexcil in order to disseminate information on IPRs and related issues to the Pharma Industry in an effective manner.
For this purpose, a fund Rs. 5 crores was proposed by the Working Group for the 11th Five Year Plan. The first centre was opened at Hyderabad on 11th July, 2008. Subsequently, centre at Mohali was opened. These centres are offering various services to the members like General Information on Patents, Patent status of pharmaceutical products in India and other countries, Interpretation of search information etc.
Keeping in view the importance of this scheme, it has been recommended to Planning Commission to continue and further strengthen this scheme in the 12th Five Year Plan. 3. 3DATA PROTECTION as per ARTICLE 39. 3 OF TRIPS AGREEMENT The TRIPS Agreement expects WTO member countries to adopt minimum standards on the patent laws as stipulated therein. Article 39.
3 of the TRIPs Agreement reads: “Members when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use.
In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use”. 24 On the request of Department of Commerce the Department of Chemicals and Petrochemicals set up a high level Inter-Ministerial Consultative Committee in February 2004 under the Chairmanship of Secretary (C&PC) to examine whether the provisions applicable under common laws of India and existing IPR laws are adequate and sufficient to address the issues and concerns of Article 39. 3 of TRIPs Agreement.
The Committee submitted its report to the Department of Commerce on 31. 5. 2007. The same is also available on the Website of the Department of Chemicals and Petrochemicals (www. chemicals. gov. in). A meeting was convened by Department of Commerce on 6th August 2007 and decisions taken are as follows: (a) In order to follow-up on the recommendations made by the Committee in respect of AgroChemicals, the Department of Agriculture & Cooperation would draft necessary amendments to the Insecticides Act 1968 and process the matter further to obtain Cabinet approval;
(b) As regards Traditional Medicines, AYUSH would process for acceptance of the recommendations of the Committee by the Government; (c) The Department of Health & Family Welfare would give wide publicity to the recommendations in the Report and carry out consultations with stakeholders before proposing appropriate amendments to Drugs & Cosmetics Act 1940 and its Rules.
As India has been put on priority watch list 2009 by US, the issue of data protection has gained importance. US Special 301 Report mentions US concerns about weak IPR protection and enforcement in India and it urges India to improve the same. The report especially mentions about effective protection against unfair commercial use of undisclosed test and other data generated to obtain marketing approvals for pharmaceuticals and agrochemical products.
The pressure on India has mounted as China has already enacted a law which gives six years data exclusivity. Keeping in view the importance of the subject, inter-Departmental meetings are being held to sort the issue out. It has been noted that Ministry of Health are still examining the recommendation of the Committee. The Department of AYUSH has informed the Department of Commerce that they strongly endorses the recommendation of Satwant Reddy.
Committee for data protection for ASU Drugs for a period of five years from the date of registration in India, however data protection of ASU Drugs should be considered independently of pharmaceuticals. Ministry of Agriculture and Cooperation has initiated the action on data protection for three years with the introduction of the Pesticides Management Bill 2008 in Parliament. 3. 4PHARMACEUTICAL POLICY This Department has been exercising Drug Price Control on the basis of criteria mentioned in Annual Report | 2011-12 ‘Modifications in Drug Policy, 1986’ announced in September, 1994, which is based on produ.