annual report 2012

2011-12

Annual Report 2011-12

Government of IndiaMinistry of Chemicals & Fertilizers

Department of Pharmaceuticals

Annual Report | 2011-12

Contents1. IntroduCtIon

2. An overvIew of PhArmACeutICAls Industry

3. PhArmACeutICAls Industry

4. nAtIonAl PhArmACeutICAls PrICIng AuthorIty

5. PublIC seCtor undertAkIngs

6. nAtIonAl InstItute of PhArmACeutICAl eduCAtIon & reseArCh (nIPer)

7. new InItIAtIves

8. ImPlementAtIon of rAjbhAshA

9. generAl AdmInIstrAtIon

10. PerformAnCe evAluAtIon And mAnAgement system

11. CItIzen CentrIC governAnCe

12. InformAtIon And teChnology

13. Annexure


brief Contents1. IntroduCtIon 7

1.1 mandate of department of Pharmaceuticals 71.2 vision and mission of the department 8

2. An overvIew of PhArmACeutICAls Industry 112.1 financial Performance of the drugs and Pharmaceuticals Industry 112.2 Imports 122.3 exports 122.4 share in national trade 132.5 Pharma export Promotion Council (Pharmexcil) 132.6 International Cooperation/export Promotion of Pharmaceuticals 142.7 Proposed major areas of International Conference 142.8 India Pharma summit - 2011 142.9 growth in Indian Pharmaceutical Industry 16

3. PhArmACeutICAls Industry 233.1 Product Patent 233.2 Creation of IPr facilitation Centers in Phamexcil 233.3 data Protection as per Article 39.3 of trIPs Agreement 243.4 Pharmaceutical Policy 243.5 Pharmaceutical Advisory forum 25

4. nAtIonAl PhArmACeutICAls PrICIng AuthorIty 294.1 nPPA 294.2 drug Price equalization Account (dPeA) 32

5. PublIC seCtor undertAkIngs 355.1 Central Public sector undertakings 355.2 joint sector undertakings 445.3 wholly owned subsidiaries 455.4 status of Annual Accounts 465.5 generic drugs Campaign the jan Aushadhi Campaign 46

6. nAtIonAl InstItute of PhArmACeutICAl eduCAtIon & reseArCh (nIPer) 51

7. new InItIAtIves 69

8. ImPlementAtIon of rAjbhAshA 73


9. generAl AdmInIstrAtIon 779.1 organisation set up 779.2 record management 799.3 grievance Cell 79

10. PerformAnCe evAluAtIon And mAnAgement system 8310.1 our vision 8310.2 our mission 8310.3 our objective 8310.4 functions 83

11. CItIzen CentrIC governAnCe 8711.1 our vision 8711.2 our mission 8711.3 our Clients 8711.4 our Commitment 8711.5 our services 8711.6 our Activities 8711.7 rtI-2005 8711.8 CPgrAms 88

12. InformAtIon And teChnology 9112.1 local Area network (lAn) 9112.2 It Infrastructure 9112.3 website 9112.4 video Conferencing 9112.5 file tracking system 9112.6 voice mail facility 9212.7 e. governance 92

13. Annexure 95Annexure I 95Annexure II 99Annexure III 101Annexure III (A) 103Annexure III (b) 105Annexure - Iv 107

Chapter 1IntroductIon

1.1 MandateofDepartmentofPharmaceuticals

1.2 VisionandMissionoftheDepartment


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ChAPter 1IntroduCtIon

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.

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.

10) All matters relating to National Institutes for Pharmaceuticals Education and Research (NIPERs).

11) Planning, development and control of; and assistance to, all industries dealt with by the Department.

12) Bengal Chemicals and Pharmaceuticals Limited.

13) Hindustan Antibiotics Limited & its subsidiaries as & JVs.

14) Indian Drugs and Pharmaceuticals Limited & its subsidiaries.

15) Karnataka Antibiotics and Pharmaceuticals Limited.

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).

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.

National Institutes of Pharmaceuticals Education & Research (NIPERs) are autonomous institutions under this Department.


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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

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 2An overvIew of PhArmAceutIcAls Industry2.1 FinancialPerformanceoftheDrugsandPharmaceuticalsIndustry2.2 Imports2.3 ExportofDrugsandPharmaceuticalsIndustry2.4 ShareinNationalTrade2.5 PharmaExportPromotionCouncil(Pharmexcil)2.6 InternationalCooperation/ExportPromotionofPharmaceuticals2.7 ProposedMajorareasofInternationalConference2.8 IndiaPharmaSummit-20112.9 GrowthinIndianPharmaceuticalIndustry


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ChAPter -2An overvIew of PhArmACeutICAls Industry

2.1 financial 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 annualJune11 sept.11 dec.11 March12 2009-10 2010-11 2011-12

estimates forcast forcast forcast1 Income 10.9 10.0 17.9 17.4 15.0 10.9 14.12 Net sales 9.2 11.0 17.1 16.3 11.9 12.4 13.53 Total expenses 11.6 -1.8 18.8 14.8 3.1 19.2 10.34 Raw materials 13.6 14.0 19.0 16.8 8.0 14.8 15.95 Salaries & wages 15.5 13.0 13.3 13.6 18.2 21.1 13.86 Power & fuel 10.2 24.0 24.0 10.0 2.5 20.1 17.17 Selling & marketing 9.0 15.1 10.0 9.0 0.1 11.9 10.78 Other expenses 2.8 28.0 11.1 12.1 -19.3 15.9 13.79 Depreciation 9.1 13.0 11.5 12.0 14.3 12.4 11.410 Interest expenses 15.6 20.0 25.0 18.0 -0.3 6.6 19.411 Tax provision 37.5 -78.6 90.6 75.9 108.8 73.6 -37.212 PBDIT 17.3 -4.3 19.9 18.9 105.7 -1.1 12.613 PAT 15.7 - 7.1 25.8 210.8 -31.6 55.614 PBDIT/Net Sales (%) 18.8 17.2 21.5 17.1 21.4 19.0 18.715 PBDIT/Income (%) 22.8 20.8 24.9 20.9 25.4 22.7 22.416 PAT/Income (%) 13.7 11.4 14.5 10.9 15.0 9.2 12.6

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 sectors 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.


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2.2 iMports: 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

(Source : Directorate General of Commercial Intelligence and Statistics (DGCIS), Kolkata)

0

2,000

4,000

6,000

8,000

10,000

12,000

2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11

2,865 2,956 3,139

4,515

5,8666,734

8,6499,959

10,937

Rs.inCrores

Years

VALUE OF IMPORT OF "MEDICINAL &PHARMACEUTICALS PRODUCTS"

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.

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.

2.3 eXports

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)

year 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

2006-07 25,666 20.89

2007-08 29,354 14.37

2008-09- 39,821 35.66

2009-10 42,456 6.62

2010-11 47,551 12.00

(DGCIS), Kolkata)

05,000

10,00015,00020,00025,00030,00035,00040,00045,00050,000

2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09- 2009-10 2010-11

12,82615,213 17,228

21,23025,666

29,354

39,82142,456

47,551

Rs.in

Crores

Years

Value of Export of "Drugs Pharmaceuticals andFine chemicals"


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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 12

Import 3 6 44 30 15 28 15 10

03 6

44

30

15

28

1510

0

19 13

23

21

14

36

7 12

0

10

20

30

40

50

60

70

80

Indices

Growth of Import "Medicinal andPharmaceuticals Products" & "Export Drugs

Pharmaceuticals and Fine chemicals"

(Source : DGCIS, Kolkata)

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 2006-07 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.

2.5 pharMa eXport proMotion council (pharmexcil)

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

1,142,649.00

47,551.00 Total National ExportsDrugs and Pharmaceuticals andFine Chemicals

1,683,467

10,937Total National ImportsMedicinal and PharmaceuticalsProducts

2.4 share in national trade(Rs. in Crore)

items/years 2006-07 2007-08 2008-09 2009-10 2010-11a: total national exports 571779 655864 840755 845534 1142649(a) Drugs Pharmaceuticals and

Fine chemicals25666 29354 39821 42456 47551

share in total export % 4.5 4.5 4.7 5.0 4.2B: total national imports 840506 1012312 1374436 1363736 1683467(b) Medicinal and

Pharmaceuticals Products5866 6734 8649 9959 10937

share in total import % 0.7 0.7 0.6 0.7 0.6(c) Trade Balance (a)-(b) 19800 22620 31172 32497 36614


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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 Inter-Governmental 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.

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 Indias 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.


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2.9 GrowTH In InDIan PHarMaCeUTICal InDUsTry

Table-1: export and Domestic Growth(Rs. in crore)

year exports growth% domestic growth% total growth%%

Mar 2006 21230 23.23 39989 17.17 61219 19.21Mar 2007 25666 20.89 45367 13.45 71033 16.03Mar 2008 29354 14.37 50946 12.30 80300 13.04Mar 2009 39821 35.66 55454 8.85 95275 18.65Mar 2010 42154* 5.86 62055 11.90 104209 9.38

Table 2: International sales on consolidated basis

Consolidated net sales

Internationalsales

Exports as % of net sales 2010-11

Ranbaxy Labs 8960.77 6771.74 75.6Dr Reddys Labs 7236.80 5940.70 82.1Lupin 5706.82 3983.08 69.8Cipla 6130.31 3361.49 54.8Sun Pharma 5721.43 2898.20 50.7Wockhardt 3751.24 2709.91 72.2Jubilant Lifescience 3433.40 2369.11 69.0


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Consolidated net sales

Internationalsales

Exports as % of net sales 2010-11

Cadila Healthcare 4464.70 2288.70 51.3Biocon 2300.52 1956.79 85.1Glenmark Pharma 3089.59 1955.83 63.3Stride Arcolab 1695.84 1637.67 96.6Plethico Pharma 1535.20 1367.22 89.1Piramal Healthcare 2509.86 1280.58 51.0Divis Labs 1307.11 1204.95 92.2Aurobindo Pharma 4381.48 1112.06 25.4Torrent Pharma 2121.97 1101.57 51.9Ipca Laboratories 1882.54 1025.18 54.5Dishman Pharma 990.84 911.56 92.0Orchid Chemicals 1781.79 725.85 40.7Shasun Chemicals 799.42 676.78 84.7Panacea Biotec 1143.78 610.44 53.4

Table-3: Geographical Distribution of Pharma Companies

S.No. State Number of Manufacturing Units TotalFormulation Bulk Drugs

1. Maharashtra 1928 1211 31392. Gujarat 1129 397 15263. West Bengal 694 62 7564. Andhra Pradesh 528 199 7275. Tamil Nadu 472 98 5706. Others 3423 422 3845

Total 8174 2389 10563

Table-4: Market Turnover of Major Therapeutic segments

Major Therapies MaT DeC05 (Val in crs)

% Contribution MaT DeC10 (Val in crs)

% Contribution

Anti-infectives 4,056 17.6 8,060 17.2Cardiac 2,378 10.3 5,318 11.4Gastro Intestinal 2,537 11.0 5,099 10.9Respiratory 2,170 9.4 4,080 8.7Pain / Analgesics 2,059 8.9 4,038 8.6Vitamins/ Minerals/ Nutrients 2,105 9.1 3,625 7.7Anti Diabetic 998 4.3 2,743 5.9Gynaecology 1,261 5.5 2,658 5.7Neuro / CNS 1,231 5.3 2,633 5.6Derma 1,255 5.4 2,554 5.5


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Table-5: Bulk Industry Growth

(Rs. in Crores)2007-08 2008-09 2009-10 cagr

12,647.51 16,360.71 17,307.02 16.98%

Table-6: The Global Market for Biologics in 2009

Country 2009 sales ($ bn)US 69.02Europe 41.68Japan 10.29Asia/Africa/Australasia 14.4.0Latin America 1.20Total Biologic Drugs Market 136.59

Table-7: The 10 Top selling Biologics in 2009

Brand drug name 2009 sales ($ bn)Avastin bevacizumab 5.74Rituxan rituximab 5.62Humira adalimumab 5.48Herceptin trastuzumab 4.86Lantus insulin glarine 4.29Enbrele tanercept 3.87Remicade infliximab 3.51

Table-8: The Global Market for Biosimilars in 2009

Country 2009 sales ($ bn)

Market share of Biosimilars (%)

US 0.06 4.9Europe 0.14 11.4Other Countries (incl. China and India)

1.03 83.7

Total Biosimilars Market

1.23 100

Table-10: export Growth

year exports (rs.crores)

growth %

Mar 2007 25666 20.89Mar 2008 29354 14.37Mar 2009 39821 35.66Mar 2010 42154 6.6Mar 2011 45745 7.7

Table-11: Human resource position in India

sl item total numbers

1 No of Universities 4092 No of colleges 259903 No of science colleges 46964 Annual student output at degree

level in science2000374

5 Annual student output at degree level in engineering

1663619

6 Total no of pharmacy colleges 11627 Number of B Pharm colleges 8488 Number of Masters in

pharmaceuticals area and PhD offering colleges

191

9 No of B Pharm students in pharma

51716

10 No of Masters and Phd students output in pharma

5648

Table-12: Global Phama market growth rate

year Market in Billion Us$

%growth rate

2004 620 7.92005 664 7.22006 710 6.92007 756 6.42008 801 4.9

Table-9: Projected Growth(Value in Rs crs / Growth in %)

year domestic exports totalValue Growth Value 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%


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Table-13: Top Global Generic Players

rank Company1 Teva2 Sandoz3 Mylan/Merck GX4 Watson Andrx5 Barr

Table 14: research and Development expenditure

yearGrowth in r&D expenditure rs Cr r&d expenditure as % of sales

domestic companies foreign companies domestic companiesforeign

companiesMar 1995 80.61 64.13 1.34 0.77Mar 1996 142.50 83.37 1.71 0.91Mar 1997 148.12 89.41 1.55 0.95Mar 1998 154.15 90.65 1.43 0.88Mar 1999 218.66 79.78 1.56 0.70Mar 2000 256.80 90.17 1.56 0.66Mar 2001 435.07 109.81 2.30 0.72Mar 2002 597.91 110.04 2.64 0.65Mar 2003 686.74 232.73 2.93 0.71Mar 2004 1084.26 346.69 3.81 1.10Mar 2005 1527.24 510.50 4.98 1.63Mar 2006 1850.97 816.02 5.35 2.39Mar 2007 2371.79 695.62 5.01 2.67Mar 2008 2772.63 700.18 4.78 2.86Mar 2009 3316.14 846.05 4.89 3.84Mar 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 Companiesrank 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 8,5702 Dr. Reddys 89 5 GlaxoSmithKlin, UK 6,2863 Sun Pharma 67 10 Elli Lilly, USA 4,3004 Cipla 51 25 Lundbeck, DNK 6155 Lupin Labs 50 50 Watson, USA 197

rank Company6 Actavis7 Ratiopharm8 Stada9 Ranbaxy10 Perrigo


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Table 16: employment Data for pharmaceutical sector

year no of employeesMar 1995 1,81,497Mar 1996 2,04,609Mar 1997 2,11,614Mar 1998 1,89,295Mar 1999 2,13,999Mar 2000 2,43,410Mar 2001 2,33,704Mar 2002 2,26,416Mar 2003 2,23,556Mar 2004 2,40,791Mar 2005 2,65,396Mar 2006 2,90,021Mar2007 3,36,211Mar 2008 3,53,692

Table 17: Percentage distribution of Man-power in Pharma Industry

function DistributionProduction & Quality Control 50% 50%Research/Lab/Testing 20%Sales, Marketing, Medical assistance 5-10%Purchase, Logistics, Supply Chain 5-10%Support functions (HR, Finance, etc.)

10-12%

Table 18: Qualifications of personnel employed in the Chemicals and

pharmaceuticals segment

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

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

parameter Kapl rdpl Bcpl hal idpl totalSales (08-09) 225.01 80.75 77.63 147.39 56.70 594.37TO/Employees Rs lacs 30 52 10 11 23 19TO/Sales employees Rs lacs 65 304 134 134 236 106PAT Rs cr 5.88 0.01 -5.35 -22.08 -37900.9Total Employees 739 181 742 1224 243 3129Sales Strength 345 31 58 105 24 563Sales (08-09) 225.01 80.75 77.63 147.39 56.70 594.37

Table-21: sales Projection of CPsUs (Rs in Crores)year idpl hal Bcpl Kapl rdpl2012-13 51.7 189 153.37 320 1082013-14 70 215 176.57 360 1222014-15 80 264 204.73 425 1352015-16 92 290 237.6 490 1502016-17 125.4 319 275.83 560 165

Chapter 3PhArmAceutIcAls Industry3.1 Product Patent3.2 CreationofIPRFacilitationCentersinPhamexcil3.3 DataProtectionasperArticle39.3ofTRIPSAgreement3.4 PharmaceuticalPolicy

3.5 PharmaceuticalAdvisoryForum


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ChAPter 3PhArmACeutICAl 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 countrys 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 Anti-infectives, 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.

3.2 creation of ipr facilitation centres in pharMeXcil

The Working Group on Drugs and Pharmaceuticals for the 11th Five Year Plan (2007-2012) recommended


24

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.

3.3 data 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.

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 Agro-Chemicals, the Department of Agriculture & Co-operation 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.

3.4 pharMaceutical policy

This Department has been exercising Drug Price Control on the basis of criteria mentioned in


25

Modifications in Drug Policy, 1986 announced in September, 1994, which is based on production data of 1990.

The Government announced the Pharmaceutical Policy 2002 in February 2002. However, a public interest litigation filed in the High Court of Karnataka at Bangalore resulted in an Order dated 12-11-02, which stopped the Government from implementing the price control regime of the Pharmaceutical Policy 2002. This Department filed a Special Leave Petition (SLP) before the Supreme Court of India against the Order of the Karnataka High Court. The Supreme Court vide its order dated 10.3.2003 directed the Government to consider and formulate appropriate criteria for ensuring essential and life saving drugs not to fall out of price control.

Accordingly, a draft National Pharmaceuticals Policy was prepared by this Department after extensive discussions with various stakeholders, and in line with the declared objective of the Government in the National Common Minimum Programme(NCMP). This Policy was submitted to the Cabinet for its approval. The Cabinet considered the Policy in its meeting held on 11th January, 2007 decided that in the first instance be considered by a Group of Ministers(GoM). The GoM Chaired by Shri Sharad Pawar, Minister of Agriculture and Minister of Consumer Affairs, Food and Public Distribution held for meetings.

Following the formations of the new Government, the Department with the approval of the Minister of Chemicals and Fertilizers recommended continuation of GoM. The GoM has been accordingly constituted with the ministers of the notified Departments in the earlier GoM. The new GoM is yet to give its recommendation on the draft of National Pharmaceuticals Policy, 2006.

Further the Department of Pharmaceuticals prepared a draft National Pharmaceutical Pricing Policy, 2011[NPPP-2011] based on the criteria of essentiality

and requirements as stipulated by Ministry of Health & Family Welfare. The draft National Pharmaceutical Pricing Policy, 2011[NPPP-2011] was circulated among the concerned Ministries/Stakeholders. The draft Policy is also available on the Departments website www.pharmaceuticals.gov.in for comments by 30.11.2011 of any other interested person. In the draft policy it is proposed to bring the NLEM-2011 & associated medicines under price control.

3.5 pharMaceutical adVisory foruM

Through Drug policies announced from time to time, Government of India has been trying to ensure abundant availability of good quality essential Pharmaceuticals of mass consumption at reasonable prices. At the same time strengthening the indigenous capability for cost effective quality production of medicines has been an important objective. To help realize his and in order to provide a Forum for a meaningful dialogue amongst all the stakeholders on various issues concerning the drug, policy it was decided to constitute a Pharmaceuticals Advisory Forum in the Department of Chemicals and Petrochemicals(now Department of Pharmaceuticals).

A Pharmaceuticals Advisory Forum was constituted in July 2004 under the Chairmanship of Honble Minister of Chemicals & Fertilizers having Honble Minister of Sate of Chemicals & Fertilizers, Health Ministers of All States/UTs, Secretary, Department of Chemicals & Petrochemicals(now Department of Pharmaceuticals), Secretary(Health), Chairman, NPPA, Drugs Controller General of India, other concerned senior Center and State Government Officers and representatives of other stakeholders as its Members.

After the formation of the new Government the Pharma Advisory Forum has been reconstituted vide OM No. 5/12/2004-PI-I dated 27th July, 2009 which is also available on the Departments website www.pharmaceuticals.gov.in.

Chapter 4nAtIonAl PhArmAceutIcAls PrIcIng AuthorIty

4.1 NPPA

4.2 DrugPriceEqualizationAccount(DPEA)


29

4.1 nppa

The National Pharmaceutical Pricing Authority (NPPA) was established as an independent body of experts under the Ministry of Chemicals and Fertilizers by Gazette notification dated 29.08.1997. The Authority is entrusted with the task of price fixation / revision of the 74 scheduled bulk drugs and formulation containing any of the scheduled drugs under the Drugs (Prices Control) Order, 1995 as well as monitoring and enforcement of prices. NPPA also provides inputs to the Government for policy formulation and on other specific issues concerning affordable medicines to the consumer.

The functions of the National Pharmaceutical Pricing Authority (NPPA) are:

(1) To implement and enforce the provisions of the Drugs (Price Control) Order (DPCO), 1995 in accordance with the power delegated to it.

(2) To undertake and/or sponsor relevant studies in respect of pricing of drugs/formulations.

(3) To monitor the availability of drugs, identify shortages, if any, and to take remedial steps.

(4) To collect/maintain data on production, exports and imports, market share of individual companies, profitability of companies etc. for bulk drugs and formulations.

(5) To deal with all legal matters arising out of the decisions of the Authority.

(6) To render advice to the Central Government of changes/revisions in the drug policy.

(7) To render assistance to the Central Government in parliamentary matters relating to drug pricing.

The organizational structure of NPPA is given at annexure IV.

The performance of NPPA since its inception (up to 15.01.2012) is as under:

The National Pharmaceutical Pricing Authority (NPPA) since its inception has fixed / revised the prices of scheduled bulk drugs in 522 cases, which includes 334 bulk drugs and 188 derivatives of scheduled bulk drugs. Of these, the prices of 15 scheduled bulk drugs and 6 derivative and 607 formulations were fixed / revised during the period from 01.04.2011 to 15.01.2012.

The NPPA compiles the annual data on production of selected monitored bulk drugs. The data on production for the years 2008-09, 2009-10, 2010-2011 and 2011-2012 (upto September, 2011) is give in the annexure - I.

The price of scheduled bulk drugs fixed during the last four years & since inception are given in annexure ii and summarized below:

ChAPter - 4nAtIonAl PhArmACeutICAl PrICIng AuthorIty (nPPA)

BulK drugs prices

particulars 2008-09 2009-10 2010-11 2011-12 (upto 15th jan., 2012

since inceptionof nppa

No. of Bulk Drugs Where Price Increased

22 15 10 19 152

No. of Bulk DrugsWhere Price decreased

9 10 07 01 343

No. of Bulk DrugsWhere price fixed For First Time

0 02 01 0 17

No changeIn Price

0 01 03 01 10

total 31 28 21 21 522


30

Monitoring of prices

The NPPA monitors and analyses month-wise price movements of non-scheduled formulations based on the reports of ORG-IMS now renamed as IMS Health. The prices of these formulations are fixed / determined by manufacturers themselves depending on various factors like the cost of production, market competition, companys profitability status etc. NPPA monitors the prices of non-scheduled formulations through various methods like (a) scrutiny of price lists submitted by manufacturers (b) analysis of monthly Stockiest Secondary Audit Reports published by IMS Health, and (c) complaints / references received from official and non-official sources. Wherever price increase beyond 10% is noticed, manufacturers of such formulations are asked to clarify the reasons for such price increases.

The manufacturers are impressed upon to bring down the prices voluntarily and to maintain the price level. So far 33 companies have reduced prices of 65 non-scheduled formulation packs voluntarily after intervention of NPPA. This is an on-going process. Further, NPPA has fixed the price of 30 non-scheduled formulations under para 10(b) of DPCO, 1995. Thus prices of 95 non-scheduled formulation packs have been reduced through the intervention of NPPA till 15th January, 2012.

creation of enforceMent diVision & its perforMance

A separate Enforcement Division was created in NPPA in June, 2007 to facilitate suo-motu detection of violation of DPCO 1995. Since inception 3208 samples were analysed leading to prima facie detection of 1169 cases of overcharging and 547 cases of selling of scheduled medicines without price approval.

forMulation pacKs

particulars 2008-09 2009-10 2010-11 2011-12(upto 15th jan., 12)

since inception of nppa

No. of Packs Approved 1577 1824 713 607 11660

Price Increased 190 184 223 257 1789

Price Decreased 89 450 60 50 3409

Price fixed for first time 1256 1155 371 239 6062

No change in prices 42 35 59 61 400

total 1577 1824 713 607 11660

Performance of enforcement Division

year no. of samples collected

prima facie Violations detected

referred for overcharging

Identified for Price fixation

2007-08 1450 840 456 384

2008-09 520 284 172 112

2009-10 464 246 208 38

2010-11 533 225 216 9

2011-12(upto Dec. 2011)*

307 121 117 4

* 29 cases are under process


31

recoVery of oVercharged aMount

There are a total no. of 810 cases wherein demand notices have been issued (including cases suo-moto recovery) involving total overcharged amount of Rs. 2318.54 crores since inception of NPPA till December, 2011. An amount of Rs. 217.42 crores has been recovered till 31.12.2011 which also includes recovery through Court orders. During the year 2011-12 (upto 31.12.11) Demand Notice for an amount of Rs. 21.23 crores have been issued and Rs. 8.71 crores has been recovered. As on 31.12.11 out of 78 cases referred to Collectors of various States for recovery under land and revenue arrears, 25 cases are under litigation, 48 cases are pending for recovery with Collectors of various States and in the balance 5 cases amount

has been recovered. The recovery of the overcharged amount is affected due to various Court orders passed by various High Court and also Supreme Court in various cases filed by Pharmaceuticals Companies challenging the price fixation / notification issued by NPPA / Government and complaints filed by various drug control authorities against Pharma companies for not following the notified price. Inclusion of some bulk drugs under price control (scheduled-I of DPCO95) has also been challenged by the Pharma companies in different courts of India. NPPA / Government is defending such cases through SG, ASGs and Senior Government Counsels. Whenever necessary NPPA files urgent application in the Courts for vacation of interim orders and also for early hearing / disposal of the case.

The status of cases of overcharging since inception till 31st December, 2011(Rs. in Crores)

si no.

particulars aug, 1997 to March 2006

2006-07 2007-08 2008-09 2009-10 2010-11 2011-12(upto Dec, 11)

Cummulative(aug, 97 to Dec., 2011)

1. No. of Cases 335 67 118 135 89 42* 24 810

2. Overcharged amount demanded alongwith interest

700.22 38.01 820.31 435.62 156.22 146.93 21.23 2318.54

3. Amount Realized 99.16 0.96 4.51 51.41 35.41 17.26 8.71 217.42

4. Amount Outstanding 601.06 37.05 815.80 384.21 120.81 129.67 12.52 2101.12

5. Amount still under litigation including cases referred to collector and contested by the companies in the court of law

-- -- -- -- -- -- -- 1933.90

6. Cases referred to collector & amount still to be recovered

-- -- -- -- -- -- -- 44.16

7. Amount pending relating to the overcharging cases under process

-- -- -- -- -- -- -- 123.06

*note : Demand issued in the year 2010-11 withdrawn in 7 cases during the year 2011-12 with the approval of Department of Legal Affairs/Department of Revenue (TRU)/Competent Authority.


32

4.2 drug prices equalisation account (dpea)

Drug Prices Equalisation Account (DPEA) has been maintained by Government under the provisions of Drugs (prices Control) Order, 1979. Under the Drugs (Prices Control) order, 1979 (DPCO, 1979), there were 345 bulk drugs under price control. The Department computed tentative liabilities in respect of 47 bulk drugs only on suo-motu basis covering 172 cases till the Interim stay dated 30.6.1997 was granted by the Honble Bombay High court in the Writ petition No. 2368/1996 filed by the Indian Drugs Manufacturers Association (IDMA) and Organisation of pharmaceutical producers of India (OPPI) restraining the Department and its committees etc., from issuing fresh notices to the drug companies calling for information required for determining liabilities. Out of these 172 cases where the liabilities have already been determined tentatively and communicated to the companies, only 72 such cases during the period 1994-97 could be referred to the Drugs Prices Liabilities Review Committee (DPLRC) constituted on 21.3.1994 under the Chairmanship of a judge of Honble Delhi High Court retired in October, 1994) alongwith two members to review/ determine the liability in such cases. Out of these 72 cases, the Committee after deliberation in each case and giving adequate opportunity of hearing to

the drug companies to present their point of view gave reports in 47 cases. In view of the stay granted by the Honble Bombay High Court the Committee had not taken up the other 25 cases and also any fresh case. On the basis of the recommendations of the DPLRC, Department issued demand notices in 45 cases (no liability in one cases and one case inked with another case). Most of these companies filed Writ petition in the different High Courts against the demand notices. The total amount of liability on the basis of the recommendations of the DPLRC is to the tune of Rs. 228.47 crore (appx) till November, 2011 Rs. 1,62,90,23,696/- have been collected and deposited in DPEA.

Since, no new cases could be taken up by DPLRC for determination of the DPEA liability because of the stay granted by the Honble Bombay High Court, there was no work with the DPLRC. Hence a conscious decision was taken by the Government to keep the DPLRC under suspended animation w.e.f. 31 December, 2005 vide Resolution dated 16th December, 2005. At that time 25 cases were pending with the DPLRC because of stay, where no quantification could be done. In addition to these 25 cases, there may be a large number of DPEA liability cases in respect of 298 bulk drugs where information from the companies concerned are to be gathered for determination of the DPEA liability.

Chapter 5PublIc sector undertAkIngs5.1 CentralPublicSectorUndertakings5.2 JointSectorUndertakings5.3 WhollyOwnedSubsidiaries5.4 StatusofAnnualAccounts5.5 GenericDrugsCampaignTheJanAushadhiCampaign


35

ChAPter 5PublIC seCtor undertAkIngs

5.1 central puBlic sector undertaKings

The total production and sales of five Pharma Central

Public Sector Undertakings (CPSUs) under the control of this Department for the last four years are as under:-

(` in crore)

* Provisional

i) KarnataKa antiBiotics & PHarMaCeUTICals lIMITeD (KaPl), Bangalore.

Karnataka Antibiotics & Pharmaceuticals Limited (KAPL) is a profit making Mini Ratna Central PSU having 59% of the equity shares of GoI and 41% of equity shares of Karnataka State Industrial and Investment Development Corporation (KSIIDC).

The paid up share capital of the company as on date is `7.49 crores. The Company was incorporated on 13th March, 1981 and the commercial production started from August, 1984. The manufacturing units and the registered office of the company is located at Bangalore (Karnataka). The main products are Pharmaceuticals formulations like tablets, capsules, injectables, etc. It is an MOU signing company.


36

Earlier it was a Joint Sector Undertaking of HAL in collaboration with KSIIDC. But in the interest of continued growth and development of the company, Government has implemented the delinking of KAPL from HAL and transferred the shareholding of HAL in KAPL to Government of India. Government of India had also invested Rs. 7.10 crore in KAPL for upgrading its manufacturing facilities conforming to WHO-GMP standards and setting up a new WHO-GMP compliant Cephalosporin plant. Other joint venture partner, viz. Karnataka State Industrial and Investment Development Corporation (KSIIDC) would bring in additional investment of ` 4.90 crore in KAPL. The company has also ISO-9001 and ISO 14001 accreditation.

It has been continuously generating profits for the last 11 years and the performance of the company has further improved and gone up especially on account of Purchase Preference Policy announced by the Department in August, 2006 for a period of five years.

product at an estimated cost of Rs.22.23 crores. The Project is likely to be completed by end of the financial year 2011-12. When the project is completed, it will be possible for the Company to increase its exports, as new range of products can be added to export.

ii) raJasthan drugs & PHarMaCeUTICals lIMITeD (rDPl), Jaipur.

Rajasthan Drugs and Pharmaceuticals Limited (RDPL) is a consistently profit making Central Public Sector Unit in Joint Sector with a total paid-up equity capital of ` 4.98 crores where Government of India (GoI) and Rajasthan State Industrial Development & Investment Corporation Limited (RIICO) hold 51% and 49% respectively. It was incorporated in 1978 and commercial production started in 1981. The Company has its manufacturing facilities & registered office at Road no. 12, VKI Industrial Area, Jaipur (Rajasthan).

production & sales(` In crore)

* Provisional

Product range of the company includes Antibiotics, Anti-diabetic, cardiovasculars, pain management, general medicines and animal health products. Presently the Company is undertaking creation of separate manufacturing facilities for Cephalosporin

This is a formulation unit engaged in production of Tablets, Capsules, Liquid Orals, ORS Powder & Opthalmic medicines in a Schedule M compliant facility.

The company, under the quality management, has a existence of a well-equipped laboratory with modern equipments like HPLC, FTIR, etc., for ensuring high quality parameters.


37

production & sales(` In crore)

* Provisional

In the interest of continued growth and development of the company, Government has delinked RDPL from IDPL (the original promoter representing GOI) and transferred the shareholding of IDPL in RDPL to Government of India in August 2010.

The Company has since then enhanced its manufacturing capacities by installing new machines and at the same time the workers have also acquired skills and expertise for attaining high productivity. The Company has changed its outlook and entered in the arena of select Public Sector Companies showing consistent profits amidst stiff competition. It is now fairly on the path of growth.

proJects undertaKen & future proJects

The Company has almost completed the Phase-I (Schedule M) of the expansion and modernization plan has embarked upon Phase-II programme to qualify for WHO (GMP) requirements to become eligible for exploring International Markets as well as for participating in the Internationally Funded Projects of GOI and other Governments.

The company has carved for itself a name in the institutional market in India as a reputed manufacturer of high quality life saving drugs and other specialized medicines, with its marketing activities spread throughout the country.

The company is engaged in manufacture and selling of medicines of high quality at reasonable rates to the Govt. of Rajasthan, Central Government Institutions, viz ESIC, Defence, Railways, other PSUs and also to other State Govt. Institutions.

The company is further diversifying its marketing activities into Pharma Prescription Markets (Open Trade Sales), Veterinary Markets, Marketing of Ayurvedic and other Indian system of medicines in order to enhance its market share and also in its endeavour to improve the profitability of the organization.


38

iii) hindustan antiBiotics liMited (Hal), PIMPrI, PUne

Hindustan Antibiotics Ltd. (HAL), Pimpri, Pune was incorporated on 30th March, 1954. This was the first Public Sector Company in drugs and Pharmaceuticals. HAL has its plant located at Pimpri. The company produces a wide range of Pharmaceutical formulations including agro-vet products. There are two joint sector units promoted by HAL in collaboration with the respective State Governments. These are Maharashtra Antibiotics & Pharmaceuticals Ltd. (MAPL) at Nagpur (Maharashtra-since closed) and Manipur State Drugs & Pharmaceuticals Ltd. (MSDPL) at Imphal (Manipur-since closed). Karnataka Antibiotics & Pharmaceuticals Limited (KAPL), Bangalore, which was earlier a Joint Sector Undertaking of HAL in collaboration with Karnataka Government, has since been de-linked from HAL after approval of the Government.

After establishment, the company made profits for several years. However, as the company started incurring continuous losses since 1993-94, it was referred to the BIFR in January, 1997. BIFR declared the company formally sick on 31.3.1997 and appointed Industrial Development Bank of India (IDBI), Mumbai as the Operating Agency for a Techno-Economic Viability Study and Report. Accordingly, a Rehabilitation Scheme was prepared by HAL which was later revised on the directions of the BIFR and the Government.

Based on the Scheme, the Government approved the Rehabilitation of the company on 9th March 2006 followed by BIFR approval on 5th June 2007. The Rehabilitation Scheme inter alia involved the following:-

s. no. particulars amount (` in crores)

1. Cash infusion 137.59*

2. Write off/exemptions from Government of India

267.57

3. Sacrifices by Banks, financial institutions and PSUs

103.34

total 508.50

(* This includes interest free loan of ` 56.96 crores to be repaid by HAL by sale of land within a period of two years.)

The entire cash infusion of ` 137.59 crores has been released to the company. Parliament has approved writing off of loan and waiver of interest to the extent of ` 259.43 crores. As regards generation of ` 56.96 crore as part of Cash Infusion, BIFR issued guidelines for sale of land as per the Rehabilitation Scheme through an Assets Sale Committee. Action is under progress by HAL in this regard.

Further, Government has additionally approved proposals of ` 30.17 crore received from HAL for setting up new powder injectable facilities for Cephalosporin and upgradation of existing vialling facilities for Betalactum (Penicillin) Antibiotics complying to WHO-GMP standards at an estimated cost of ` 20.17 crores and for upgradation of manufacturing facilities of Tablet, Capsule and Liquid Sections complying to WHO-GMP standards at an estimated cost of ` 10.00 crore in order to make the company further viable.


39future proJects

sl.no. Project estimated cost

(` in crore)1. Multi Product Sterile facilities

for Betalactum Antibiotics complying to WHO-GMP

20.76

2. Upgradation of Large Volum Parenteral with facilities complying to WHO-GMP

40.00

total 60.76

HAL has completed the work on Cephalosporin in record time of 9 months. It has commissioned commercial production in February, 2009 and also obtained WHO-Certification for the same. Work relating to upgradation of existing vialling facilities for Betalactum Antibiotics has also been completed and production will start by the end of the year 2011-12.

production & sales

Details of Production & Sales of HAL from 2008-09 onwards are as under:

(` In crore)

* Provisional

New Cephalosporin Plant Building of Hindustan Antibiotics Ltd. Pimpri, Pune.

iV) Bengal cheMicals & PHarMaCeUTICals lIMITeD (BCPl), KolKata

BCPL was a chemicals manufacturing company set up in the private sector in 1901 by Dr. Acharya P.C. Roy, the great visionary and scientist. Later on being sick, it was taken over by the Government and nationalized on 15th December, 1980. A new public sector company in the name and style of Bengal Chemicals & Pharmaceuticals Limited (BCPL) was incorporated on the 17th March, 1981.

The company has four manufacturing units one each at Maniktala (Kolkata), Panihati at North 24 Parganas (West Bengal), one at Mumbai (Maharashtra) and one at Kanpur (UP). Besides, the company is having nine sales outlets and three C&F agencies spread all over India. The company manufactures and markets a wide range of industrial chemicals, drugs and Pharmaceuticals besides cosmetics and home products. In the home products, the well known products include Cantharidine Hair Oil and Lamp Brand Phenol are quite popular.

Post 1980, company continued its operations. However, due to continued losses, the company was declared sick by the Board for Industrial and Financial Reconstruction (BIFR) on 14th January, 1993. A Revival Package was accordingly prepared & approved by the BIFR on 4th April, 1995. The package was reviewed by BIFR from time to time, based on which a Modified Revised Rehabilitation Scheme was


40

then prepared. BIFR approved this Modified Scheme on 14.1.2004.

Finally, based on the requirements for modernization of plants & machinery and taking into account the earlier schemes, the Board for Reconstruction of Public Sector Enterprises (BRPSE) at its meeting held on 25.8.2006 recommended a modified revival plan for revival of BCPL.

The recommendations of BRPSE were confirmed by the Cabinet Committee on Economic Affairs (CCEA) which approved the BRPSE Scheme in its meeting held on 21st December 2006. The Revival Scheme which include interalia:

(i) Cash infusion by GOI - ` 207.19 crore

(ii) Write off/Waiver of Loans/Interest - ` 233.41 crore

Parliament has approved writing off of GOI loans & interest of ` 233.41 crore and cash infusion component of ` 207.19 crore. The components as approved by the Government have been released. The company

production & sales

Details of Production & Sales of BCPL from 2008-09 onwards are as under:

(` In crore)

* Provisional

UnITs, ProDUCT ProfIle & ManPower

unit Maniktala panihati Mumbai Kanpur

Products Tablets, Capsules, Ointment, Spirituous preparations, Non-spirituous preparations, Antiseptic preparations, Injectables, Anti snake venom serum (ASVS), Syrup, Hair oil etc.

Alumina ferric, Phenol, Naphthalene balls, Bleaching powder, Floor Cleanser, Liquid soap.

Hair oil Tablet, Non-spirituous preparations, Hair oil

Manpower as on 01.11.2011

296 158 15 21

Total Manpower as on 01.11.2011: 656, Officers: 119 Non-Officers: 537

has appointed Consultants for undertaking the work of upgradation & modernization of plant & machinery including compliance with Schedule M/WHO-GMP standard.


41

steps taKen for upgradation & ModerniZation

Upgradation & Modernization Projects including capacity augmentation for Chemical Plants at Panihati(West Bengal) and in Pharmaceutical Plants at Maniktala (Kolkata) and Kanpur have been undertaken. In addition, Greenfield Projects for Cephalosporin and Betalactum range of products (in dosage forms of Capsule, Tablet, Dry Powder Injectables & Dry Syrup) at Maniktala, upgradation of Ointment, Liquid antiseptic, Liquid Orals and ASVS are in progress and expected to be completed during 2011-12. Upgraded Phenol Manufacturing and filling, Composite Production Block, Renovated Alum Plant, QC Block, Finished Goods Stores, Administrative Block and other allied services are in operation at Panihati.

The Upgradation & Modernization of Tablet, ORS Powder, Liquid and Home Product Sections at Kanpur are in progress. It is expected to complete the modernization work by June, 2012. Setting up of GLP Compliant Laboratory, Product Development Laboratory is on the verge of completion.

future proJects

A project for manufacture of Anti-Rabies and other vaccines and a Biological Park at Panihati under Joint Venture/PPP mode have been considered.

V) indian drugs & pharMaceuticals lIMITeD (IDPl), GUrGaon

Indian Drugs and Pharmaceuticals Ltd (IDPL) was incorporated on 5th April, 1961 for achieving Indias march towards self-sufficiency and self-reliance in the field of drugs and pharmaceuticals, particularly with the primary objective of creating self sufficiency in essential life saving drugs and medicines.


42

IDPL was formally declared sick by the Board for Industrial & Financial Reconstruction (BIFR) on 12th August, 1992. A revival package for the company was formulated and approved by BIFR on 10th February, 1994. However, after taking into account the performance of the company which fell short of the targets, the BIFR on 23.1.1996 treated the sanctioned package as failure, and thereafter in its meeting held on 4.12.2003 BIFR confirmed its prima-facie opinion about winding up of IDPL in terms of Section 20(1) of the Sick Industrial Companies (Special Provisions) Act, 1985.

However, given the possibility of revival of the company, Department of Chemicals & Petrochemicals (Now Department of Pharmaceuticals) filed an appeal against the opinion of BIFR in Appellate Authority for Industrial & Financial Reconstruction (AAIFR) on 10.2.2004.

IDPL is the largest Central Pharma Public Sector Undertaking in India with plants at Rishikesh (Uttarakhand), Hyderabad (Andhra Pradesh) and Gurgaon (Haryana) and wholly owned subsidiaries, namely, IDPL (Tamil Nadu) Ltd., Chennai (Tamil Nadu) and Bihar Drugs & Organic Chemicals Ltd.(BDOCL) at Muzaffarpur (Bihar). In addition, IDPL has one joint sector undertaking, promoted in collaboration with the Orissa State Government, namely, Orissa Drugs & Chemicals Ltd. (ODCL) Bhubaneswar.

Consequently, an Expert Committee was appointed in September, 2004, to study the Techno-Financial Feasibility of rehabilitating IDPL. In this connection, a Technical Audit of various plants of IDPL was also assigned to National Institute of Pharmaceutical Education and Research (NIPER). NIPER in its report submitted to the Department on 31.8.2005, recommended revival of all plants of IDPL and its subsidiaries in phases for production of existing and new products. IDBI, the Monitoring Agency on behalf of BIFR, supported the recommendations for revival of IDPL subject to certain conditions.

Accordingly, in a meeting held under the Chairmanship of the then Minister (C&F&S), it was decided to revive all the five units of IDPL in a phased manner. Honble AAIFR at its hearing on 13.9.2005 set aside the impugned order of BIFR dated 4.12.2003 and remanded the matter back to BIFR for taking further action for rehabilitation of IDPL.

A Draft Rehabilitation Scheme for revival of Indian Drugs & Pharmaceuticals Limited (IDPL) was considered by the Board for Reconstruction of Public Sector Enterprises (BRPSE) at its meeting held on 9.3.2007 and recommended for approval. The scheme was placed before the Cabinet for approval. Cabinet considered the proposal at its meeting held on 17.5.2007 and referred it to GoM for consideration at the first instance. GoM was constituted on 1.6.2007. The first meeting of the GoM was held on 11.10.2007. Based on the recommendation of GoM and Draft scheme prepared earlier, a Pre-feasibility Report was prepared by an expert agency, Ernst & Young. Now the revival scheme of the company is under the consideration of Central Government.

Despite being a sick company, during the countrys calamity of outbreak of Plague in 1994, IDPL was the only company which played the sheet anchor


43

Cephalosporin Plant at an estimated cost of ` 13 Cr. at its premises in Gurgaon.

production and sales progress

Details of Production & Sales figures of IDPL from 2008-09 onwards are as under:

(` In crore)

* Provisional

role in supplying Tetracycline for the entire Nation. Similarly, company had made uninterrupted supply of Chloroquine to combat Malaria epidemic in different parts of the country. In 2005 to combat national emergency (Leptospirosis) arising due to floods in Maharastra, IDPL had supplied required Doxycycline Caps within no time.

Vi) Bengal iMMunity liMited (Bil)

BIL was a sick company in the private sector in the name and style of Bengal Immunity Company Limited. The management of the company was taken over by the Central Government with effect from the 18th May, 1978. It was nationalized w.e.f. 1st October, 1984 and a new public sector company in the name and style of Bengal Immunity Limited was incorporated on the 1st October, 1984. The company has two manufacturing units, one each at Baranagar at Kolkata (West Bengal) and at Dehradun (Uttrakhand).

The Board for Industrial and Financial Reconstruction (BIFR) formally declared the company sick on 9th March, 1993. BIFR heard the case from time to time. In the hearing held on 13th September, 2002, BIFR formed its prima-facie opinion to wind up the company. The opinion was confirmed by BIFR in the hearing held on 25th February, 2003. With the approval of the Cabinet, VSS was introduced in the company. The company has since relieved all employees under VSS as on 30th September, 2003.

The company is closed. The Official Liquidator has already been appointed by the Kolkata High Court. However, on a Writ Petition filed by the BIL Employees Union, the appointment of Liquidator in respect of BIL has been stayed by High Court of Kolkata by its order dated 08.08.2005. High court of Kolkata also directed that AAIFR shall hear and dispose of the application

Presently, under different Class of Therapeutic Medicines, around 87 generic/branded drugs covering tablets, capsules, injections, vitamins, ORS pouches etc. are being manufactured in various plants of IDPL. The implementation of schedule-M at Rishikesh and Gurgaon Plants has been partly completed and the balance work is in progress. IDPL is engaged in setting up of a new


44

of BIL Employees Unions. AAIFR in its order dated 9.11.2005 directed that possibility of revival through some other alternative Pharmaceuticals company or some firm producing some other goods using the available assets should be considered. Thereafter a Committee was constituted in this Department to look into the issue of revival of BIL looking to the order passed by AAIFR.

The Committee, constituted to explore the possibility of revival of Bengal Immunity Limited (BIL), recommended revival of BIL through Public Private Partnership (PPP) mode. Bids were then called on revival proposals and in continuation of orders of AAIFR dated 03.03.2008, 5 short listed companies were asked to give their proposals. Meanwhile, SBI Caps have also been appointed for preparation of Bid/RFP document for subsequent bidding by the 5 short listed companies. SBI Caps has since submitted its report which is under examination.

Vii) sMith stanistreet pharMaceuticals liMited (sspl)

It was a sick company in the private sector in the name and style of Smith Stanistreet Company Limited set up in 1821 and its management was taken over by the Government of India with effect from 4th May, 1972. The company was nationalized on 1st October, 1977, and a new public sector company in the name and style of Smith Stanistreet Pharmaceuticals Limited (SSPL) was incorporated on 19th July, 1978. The company has its registered office at 18, Convent Road, Kolkata (West Bengal)

The company was formally declared sick by the Board for Industrial and Financial Reconstruction (BIFR) on 21st December, 1992. The BIFR approved a revival package for the company on 31st August, 1994. The revival package was for a period of ten years beginning from 1994-95. The same was declared as having failed during the hearing on October, 17, 2000.

The BIFR heard the case on 3rd December, 2001 and confirmed its prima facie opinion that it was just, equitable and in public interest that the company should be wound up. With the approval of the Cabinet,

VSS was introduced in the company. The company has since relieved all the employees under VSS as on 30th September, 2003. The company is closed.

The Official Liquidator has been appointed by the Honble High Court of Kolkata Order dated 12.1.2006. The Registered Office, Plant & Machinery and other assets have since been taken over by the Official Liquidator.

5.2 Joint sector undertaKings

i) Maharashtra antiBiotics & pharMaceuticals ltd (Mapl)

This is a Joint Sector Undertaking promoted by Hindustan Antibiotics Limited (HAL) and State Industrial & Investment Corporation of Maharashtra (SIICOM) based at Nagpur (Maharashtra). HAL holds 52% of the equity shares, 38% is with SIICOM and 10% with IDBI. The company was incorporated in November, 1979, and the commercial production started in May, 1981.

After initial operations, the company could not be run profitably and had to incur continuous losses. Accordingly, BIFR formally declared MAPL as sick on 14.1.1997. BIFR has since heard the case from time to time. In the hearing held on 04.07.2000, BIFR formed opinion for winding up of the company under Section 20(1) of the SICA, 1985. Appeals filed in AAIFR by M/s Environmental Engineers Inc. and a group of employees were also dismissed. At present, the company is closed and is before the High Court of Mumbai, Nagpur Bench for appointing a Liquidator. However, Writ Petitions have been filed by M/s Environmental Engineers Inc. in the Nagpur Bench of the Mumbai High Court against the liquidation proceedings of MAPL. No further order has been issued by the Bench in this connection.

Meanwhile, as winding up requirements and additionally in accordance with the direction of the Nagpur Bench of the High Court of Mumbai, Government introduced VSS in MAPL. Accordingly all employees were released under VSS.


45

ii) Manipur state drugs & pharMaceuticals liMited (Msdpl)

This is a joint sector undertaking promoted by Hindustan Antibiotics Limited (HAL) in collaboration with Manipur Industrial Development Corporation (MANIDO). HAL holds 51% of the equity shares and 49% is with MANIDO. The company was incorporated on the 18th July, 1989. The manufacturing unit and the registered office is at Imphal (Manipur).

After initial operations, there were losses on account of law & order and connected reasons. The Company has since been closed as per recommendations of the State Govt. of Manipur. Consequently, there has been separation of employees with retrenchment benefits under the Industrial Disputes Act/Worksmens Compensation Act. At present, the company is closed.

iii) orissa drugs & cheMicals ltd. (odcl)

This is a joint sector undertaking promoted by Indian Drugs & Pharmaceuticals Limited (IDPL) and the Industrial Promotion and Investment Corporation of Odisha (IPICOL). IDPL holds 51% of the equity shares and 49% is with IPICOL. The company was incorporated in 1979 and commissioned fully for production from September, 1983. The company has its manufacturing unit and its registered Office in Mancheshwar Industrial Area, Bhubaneshwar in the State of Odisha. The company is engaged in the manufacture of Pharmaceutical formulations in the form of Tablets, Capsules, Powders, Ointments etc.

After initial profitable operations, ODCL was formally declared sick by the Board of Industrial and Financial Reconstruction (BIFR) on 26th October, 1992. On the basis of the report of the Operating Agency, appointed by the BIFR and the support extended by the promoters, the BIFR approved a revival package for ODCL on the 18th August, 1994. However the package could not be implemented due to lack of support from the State Government. Accordingly, BIFR in the hearing on 18.12.2000, declared this scheme as failure and issued a show cause notice for winding up of the company in the absence of a

fully tied up proposal for revival. In the hearing held on 8.7.2002, the BIFR, inter-alia, directed the O.A. to issue advertisement inviting offers for sale of the assets of the company under Section18(2) (i) without any liability or under Section 18(ii).

Later on, BIFR in its order dated 8th April, 2003 has finally passed orders for winding up of the company under the provisions of Sick Industrial Companies (Special Provisions) Act, 1985. The appeal filed by ODCL employees against the winding up order of BIFR has been dismissed by the AAIFR vide its order dated 23.6.2005. High Court of Odisha had appointed a provisional Liquidator. This has since been stayed by a larger Bench of the Odisha High Court.

After intervention of IDPL in the day to day activities of ODCL from March 2007 the production and sales have visibly gone up in comparison since the inception of the unit. The unit has generated profit in 2010-11. The target for production in 2011-12 is ` 11 crores. The Ministry has sanctioned ` 1.21 cr. for implementation of Schedule-M .

5.3 wHolly owneD sUBsIDIarIesa) IDPl (TaMIl naDU) lIMITeD, CHennaI.

IDPL (Tamil Nadu) Ltd, Chennai was incorporated in September 1965 is a sick unit of IDPL. In terms of the revival package approved by BIFR in 1994 in the case of IDPL, the Surgical and Formulation Unit of IDPL at Chennai was converted into a wholly owned subsidiary in the name and style of IDPL (Tamil Nadu) Limited, Chennai with effect from 1st April, 1994. IDPL holds the entire equity capital of this unit. At present, it is engaged in the manufacture of pharmaceutical formulations. Most of the work of Schedule M has been completed at the plant. The production for the year 2010-11 was ` 553.45 Lakhs and for the year 2011-12 (until Nov. 11 provisionally) amounted to ` 392.09 Lakhs. The implementation of Schedule-M has been partly completed and the balance work is in progress.

b) Bihar drugs & organic cheMicals ltd (BDoCl), MUZaffarPUr

Bihar Drugs & Organic Chemicals Ltd (BDOCL), Muzaffarpur was earlier a Organic Chemicals and


46

Drug Manufacturing unit of IDPL at Muzaffarpur (Bihar). It was incorporated in November 1979. In terms of the revival package approved by the Board for Industrial & Financial Reconstruction (BIFR), the Organic Chemicals and Drug Manufacturing unit of IDPL at Muzaffarpur (Bihar), was converted into a wholly owned subsidiary in the name and style of Bihar Drugs & Organic Chemicals Limited, Muzaffarpur with effect from 1st April, 1994. IDPL holds the entire equity capital of this Unit. The past long-term liabilities amounting to ` 36 crore as on 31.3.1994 were taken over by IDPL. At present there is no production activity in the unit and is closed since November 1996.

5.4 status of annual accounts

Details of Annual Accounts finalized till date are as under:-

Karnataka Antibiotics & Pharmaceuticals Limited

2010-11

Rajasthan Drugs & Pharmaceuticals Limited

2008-09

Hindustan Antibiotics Limited 2009-10

Indian Drugs & Pharmaceuticals Limited 2008-09

Bengal Chemicals & Pharmaceuticals Limited

2007-08

Bengal Immunity Limited 2005-06

Smith Stani-Street Pharmaceuticals Limited

2004-05

5.5 GenerIC DrUGs CaMPaIGn THe Jan aushadhi caMpaign

Access to quality medicines at affordable prices is a key challenge for the Government. The prices of branded medicines are generally higher than generic medicines due to various reasons as having patent protection and having limited regulation through the Drug Prices Control Order, 1995 etc.

For fulfilling this goal, a Campaign in the name of Jan Aushadhi Campaign has been launched. The purpose of this campaign is to make available medicines at affordable prices for all, especially the

poor and the disadvantaged. Under this campaign, less priced quality unbranded generic medicines will be made available through Jan Aushadhi Stores which inherently are less priced but are of same and equivalent quality, efficacy and safety as compared to branded generic medicines.

Under this Scheme, the State Government has to provide space in Government Hospital premises for the running of the Jan Aushadhi Stores (JAS). Government hospitals, NGOs, Charitable Organizations and public societies like Red Cross Society, Rogi Kalyan Samitis typically constituted for the purpose can be operating agencies for the JAS. The operating agency for JAS is nominated on the basis of the recommendations of the State government. Operational expenditure is met from trade margins admissible for the medicines. The State Government has to ensure prescription of unbranded generic medicines by the Government doctors.

The Bureau of Pharma Public Sector Undertakings of India (BPPI), comprising of all the Central Pharma PSUs (CPSUs), namely, IDPL, RDPL, KAPL, HAL and BCPL, was set up on 1st December 2008 with the major objective to have a focused & empowered structure to implement the Jan Aushadhi Campaign initiated by the Department of Pharmaceuticals. Initially it was as an independent, unincorporated body but subsequently, it was registered as a Society under the Societies Registration Act, 1860 by the Govt. of NCT of Delhi on 21st April, 2010. BPPI is monitoring the opening of Jan Aushadhi Stores. It is also involved in promotion of the unbranded generic drugs and the Generic Drug Campaign.

The first Jan Aushadhi Generic Drug Store was opened in Civil Hospital, Amritsar on 25th November, 2008 and with the active support and cooperation of the State Government of Punjab, the stores were opened not only in all districts of Punjab but also being opened at block levels too. The campaign has now been spread besides in Punjab, also in the States of Haryana, Uttrakhand, Rajasthan, Andhra Pradesh, Odisha, West Bengal, Jammu & Kashmir, Himachal


47

Pradesh & UT of Delhi and Chandigarh by having opened 117 Jan Aushadhi Generic Drug Stores so far (till 29.02.2012). Efforts are on to open more number of stores.

The Jan Aushadhi Campaign will help:

i) Improve access to healthcare in as much as cost of treatment would come down substantially. This would enable the Public Health System to increase the coverage.

ii) Secure a socio- economically viable mechanism / institutional arrangement for efficacious sales of Pharma CPSU products, thereby improving their viability.

iii) Promote & encourage private industry to sell their quality unbranded generic products through

these retail outlets.

iv) Ensure successful implementation of the Jan Aushadhi campaign would dispel the myth that quality of medicines is linked to price and demonstrate that quality medicines can be sold at substantially lower prices.

v) Educate doctors that unbranded generic medicines provide a better option than branded products since quality of generic medicines can be equally efficacious and safe at much lower prices.

vi) Create Consumer awareness & involve private & charitable bodies & NGOs by making them part of the campaign.

vii) Reduce promotional cost and profits for the benefit of patients etc.

Chapter 6nAtIonAl InstItute of PhArmAceutIcAl Education & REsEaRch (niPER)


51

ChAPter - 6nAtIonAl InstItute of PhArmACeutICAl eduCAtIon & reseArCh (nIPer), s.A.s. nAgAr

disciplines:

The first batch of students was admitted in 1998. NIPER offers Masters and ph.d. degrees in 15 streams and caters to the various needs of pharmaceutical industry:

1. Medicinal Chemistry2. Natural Products3. Traditional Medicine4. Pharmaceutical Analysis5. Pharmacology & Toxicology6. Regulatory Toxicology7. Pharmaceutical Technology (Biotechnology)8. Pharmaceutical Technology (Formulations)9. Pharmaceutical Technology (Process Chemistry)10. Pharmaceutics11. Biotechnology12. Pharmacy Practice13. Clinical Research14. Pharmacoinformatics15. Pharmaceutical Management

infrastructure:

NIPER conducts regular education programmes for academia and industry in various disciplines and helps the Indian Pharmaceutical Industry in solving their R&D related requirements. NIPER has upgraded facilities for achieving the highest level of efficiency in imparting education and events.

There are state-of-art classrooms with installation of TV panels and laptop systems. NIPER laboratories are fully equipped with modern equipments that are equivalent to other state-of-the-art laboratories in the world. All the available facilities are of international level and standards. A Technology Development Centre has also been set up. In addition, there has been significant improvement in research infrastructure as several high value sophisticated instruments have been added which has helped in increased thrust in R&D activities.

NIPER, SAS Nagar, Mohali was initially registered as a society under the Societies Act. The faculty for the institute was appointed in 1994. In 1998, Parliament enacted National Institute of Pharmaceutical Education Act, 1998. NIPER was declared as an Institute of National Importance under the Act of Parliament on 26th June 1998. NIPER is a member of Association of Indian Universities.

The main objectives of the Institute:

1. Nurture and promote quality and excellence in pharmaceutical education & research.

2. Toning up the level of pharmaceutical education and research by training the future teachers, research scientists and managers for the industry and profession.

3. Creation of National Centers to cater to the needs of the pharmaceutical industryand other research and teaching institutes.

4. Collaboration with Indian industry to help it meet global challenges.

5. National/International collaborative research.6. Study of sociological aspects of drug use and

abuse and rural pharmacy etc.7. Running programmes in drug surveillance,

community pharmacy and pharmaceutical management.

niper has nine departments and one centre:

1. Medicinal Chemistry2. Pharmaceutics3. Natural Products4. Pharmacology & Toxicology5. Pharmaceutical Analysis6. Biotechnology7. Pharmaceutical Technology 8. Pharmacy Practice9. Pharmaceutical Management10. Pharmacoinformatics


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central research facilities:

Following central facilities provide support to the research groups within the Institute as well as from outside:

1. Central Instrument Laboratory2. Computer Centre3. Library and Information Centre4. Central Animal facility5. National Toxicology Centre (GLP compliant)6. Technology Development Centre7. National Bioavailability Centre (WHO accredited)8. Impurity Profiling & Stability Testing Laboratory

9. Pharmacological & Toxicological (GLP compliant) Screening Facilities

seats for admission to P.G. Courses, Ph. D in nIPer, s.a.s. nagar:

Since 2010, NIPER, S.A.S. Nagar, has increased seats for admission to postgraduate courses and Ph.D. programme

courses students admitted in year

2010

students admitted in year

2011

PhD. 46 34M.S. 250 239M.B.A. 61 58total 357 331

In July 2011, 147 Masters students [including M.S. (Pharm.), M. Pharm. and M.Tech. (Pharm.)], 43 M.B.A. (Pharm.) and 24 Ph.D. candidates graduated from the Institute.

academic excellence: A new course leading to M. Pharm. in Clinical Research has been started in 2011 with an initial intake of 9

annual report 2012

Documents

pharmaceuticals sector

annexure annual report

indian pharmaceutical

mandate of department

joint sector undertakings

national trade

pharmaceutical policy

management system