Rajya Sabha 162
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PARLIAMENT OF INDIA RAJYA SABHA 162 DEPARTMENT - RELATED PARLIAMENTARY STANDING COMMITTEE ON SCIENCE & TECHNOLOGY, ENVIRONMENT & FORESTS ONE HUNDRED - SIXTY SECOND REPORT ON DRUGS AND PHARMACEUTICALS RESEARCH PROGRAMME INCLUDING HERBAL MEDICINES (PRESENTED TO THE RAJYA SABHA ON THE 14TH DECEMBER, 2006) (LAID ON THE TABLE OF THE LOK SABHA ON THE 14TH DECEMBER, 2006) RAJYA SABHA SECRETARIAT NEW DELHI DECEMBER, 2006/AGRAHAYANA, 1928 (SAKA) E-mail:rsc-st @sansad.nic.in Website:http://rajyasabha.nic.in PARLIAMENT OF INDIA RAJYA SABHA DEPARTMENT - RELATED PARLIAMENTARY STANDING COMMITTEE ON SCIENCE & TECHNOLOGY, ENVIRONMENT & FORESTS ONE HUNDRED - SIXTY SECOND REPORT ON DRUGS AND PHARMACEUTICALS RESEARCH PROGRAMME INCLUDING HERBAL MEDICINES (PRESENTED TO THE RAJYA SABHA ON THE 14TH DECEMBER, 2006) (LAID ON THE TABLE OF THE LOK SABHA ON THE 14TH DECEMBER, 2006) RAJYA SABHA SECRETARIAT NEW DELHI DECEMBER, 2006/AGRAHAYANA, 1928 (SAKA) CONTENTS PAGES 1. COMPOSITION OF THE COMMITTEE........................................................................................ (i)-(ii) 2. INTRODUCTION ................................................................................................................ (iii) 3. REPORT .......................................................................................................................... CHAPTER I PREFACE ......................................................................................................... 1 CHAPTER II DEPARTMENT OF SCIENCE & TECHNOLOGY ........................................................... 2-6 CHAPTER III DEPARTMENT OF SCIENCE & INDUSTRIAL RESEARCH ............................................. 7-10 CHAPTER IV DEPARTMENT OF BIOTECHNOLOGY ...................................................................... 11-13 CHAPTER V MINISTRY OF OCEAN DEVELOPMENT .................................................................... 14-17 CHAPTER VI DEPARTMENT OF AYUSH ................................................................................... 18-20 CHAPTER VII GENERAL ASPECTS RELATING TO DRUG RESEARCH ............................................... 21-25 CHAPTER VIII COMMITTEES OBSERVATION/RECOMMENDATIONS ................................................. 26-32 4. ANNEXURE ....................................................................................................................... 33-36 5. MINUTES ........................................................................................................................ 57-58 COMPOSITION OF THE DEPARTMENT-RELATED PARLIAMENTARY STANDING COMMITTEE ON SCIENCE AND TECHNOLOGY, ENVIRONMENT AND FORESTS (2006-2007) 1. Shri P.G.Narayanan –----- Chairman RAJYA SABHA 2. Dr. Prabha Thakur #3. Vacant 4. Shri Suryakantbhai Acharya 5. Shri Bhagirathi Majhi 6. Shri Kamal Akhtar 7. Shri Saman Pathak 8. Shri Jabir Husain 9. Shri Ravula Chandra Sekar Reddy 10. Dr. Barun Mukherjee LOK SABHA 11. Shri Jashubhai Dhanabhai Barad 12. Dr. Sujan Chakraborty 13. Shri Thupstan Chhewang 14. Shri Pankaj Choudhary 15. Shri Francis Fanthome 16. Shri Babubhai K. Katara 17. Shri A. Venkatesh Naik 18. Shri Brahmananda Panda 19. Shrimati Neeta Pateriya 20. Shri Jaysingrao Gaikwad Patil 21. Shri Pratik Prakashbapu Patil 22. Shri Bachi Singh ‘Bachda’ Rawat 23. Shri K.C. Singh “Baba” 24. Shri Kirti Vardhan Singh 25. Shri Rakesh Singh 26. Shri Aruna Kumar Vundavalli 27. Shrimati Jayaben B. Thakkar 28. Shri Akhilesh Yadav 29. Shri Mitrasen Yadav 30. Shri Sita Ram Yadav *31. Shri Rampal Singh SECRETARIAT Shri N.C. Joshi, Additional Secretary Shri R.K. Singh, Officer on Special Duty Shri Alok Kumar Chatterjee, Deputy Secretary Shri Jagmohan Sundriyal, Under Secretary Shri S. Rangarajan, Committee Officer INTRODUCTION I, the Chairman of the Department-related Parliamentary Standing Committee on Science & Technology, Environment & Forests, have been authorized by the Committee to present the Report on its behalf, present this One Hundred-Sixty second Report on the Drugs and Pharmaceuticals Research programme including Herbal Medicines. 2. The Department-related Parliamentary Standing Committee on Science & Technology, Environment & Forests in its meeting held on 6th June, 2005, decided to take up Drugs & Pharmaceuticals Research including herbal medicines for examination and report thereon. The nodal Ministry for Drugs and Pharmaceuticals Research programme in the Ministry of Science and Technology. Other Ministries/Departments involved in the programme are Department of Scientific and Industrial Research, Department of Biotechnology, Ministry of Ocean Development and Department of AYUSH etc. In this regard the Committee heard the Secretaries of the various Ministries/Departments like Department of Science and Technology, Biotechnology, Scientific and Industrial Research, AYUSH and Ministries of Environment and Forests and Ocean Development. In addition of the Committee also heard Director-General, Indian Council of Medical Research and Drugs Controller-General (India). The details of the representatives of various Ministries/Departments who appeared before the Committee for oral evidence are given in Annexure. 3. The Committee expresses its thanks to the Officers of the various Ministries/Departments for replying to the clarifications sought by the Members and placing before it the required material to enable the Committee to scrutinize the same. 4. In the meeting held on 6th November, 2006 the Committee considered the draft report and adopted the same. P. G. NARAYANAN NEW DELHI ; Chairman, 6th November, 2006 Department-related Parliamentary Standing Committee on Science & Technology, Environment & Forests. CHAPTER - I l. PREFACE 1.1 With global revenue of approximately US$ 535 billion in 2005, the healthcare industry is the world’s largest industry. Over the years, the Indian drugs and pharma industry has made tremendous progress in this vital sector. The Indian Industry’s contribution stands at Rs. 50000 crores (US $10 billion). The Indian pharmaceutical sector has achieved global recognition as a low cost producer of quality drugs and formulation products. With the new patent regime coming into effect from January 2005, the Indian pharma industry and R&D sectors are reorienting themselves to face the challenges and exploit the opportunities arising therefrom. 1.2 India has demonstrated its competence in the production of bulk drugs and formulation. Indian companies export bulk and formulations to all major developed countries. The manufacturing competence and cost-competitiveness of India is unrivalled in bulk drugs and formulations. Now the country is emulating the example of information technology and climbing the pharmaceutical value chain. The country has the opportunity to do even better in drug development Biotechnology. 1.3. Further the country has endeavoured to emerge as low cost medical research hub and take an important place in global effort towards drug development. India’s strength includes availability of high-class human resource, vast scientific infrastructure, low cost-high quality clinical trials and efficient and well-established regulatory systems. India’s strength in medicinal chemistry and bio-informatics is an asset. 1.4. The diseases of importance to our country are Leprosy, Malaria, Tuberculosis, Japanese Encephilitis, Syphilis, Leishmaniasis, Filariasis, HIV/AIDS, Tetanus, Measles, Drug resistant enteric fever, Hepatitis-B, Skin disorders like Leucoderma and psoriasis, Gastrointestinal disorders like Diarrhoea and Cholera besides infections leading to Trypansomiasis and Ascariasis, Diabetes, Hypertension, Cardiovascular disorders, Dengue and other prevalent infectious diseases besides neurological diseases like dementia and Parkinson’s Disease. 1.5. The challenge to pharma research and to pharma industry lies in providing adequate medicines at affordable cost to Indian population and that too under the prevailing socio-economic conditions. At the same time, the industry has to compete globally, cost and quality wise, for exports. 1.6. One of the key objectives underlined in the Draft National Pharmaceutical Policy 2006 is to promote greater research and development in the pharmaceuticals sector by providing suitable incentives. India has a vast R&D infrastructure that includes the extensive network of national labs, academic institutes and private R&D labs. It is essential to utilize the expertise of these institutions and make them contribute not only in elimination of killer diseases but also to the development of industry and the national economy. The mettle of Indian scientists is recognized the world over, and many research laboratories in advanced countries have benefited from our national resources that could not be effectively tapped, so far. Further, research in India is far more cost-effective than it is in the west. Therefore, we could well become a source for scientific innovation. CHAPTER - II MINISTRY OF SCIENCE & TECHNOLOGY (DEPARTMENT OF SCIENCE & TECHNOLOGY) 2.1. The nodal Ministry for Drugs and Pharmaceuticals Research programme is the Ministry of Science and Technology. Other Ministries/Departments involved in the programme are Department of Scientific and Industrial Research, Department of Biotechnology, Ministry of Ocean Development and Department of AYUSH etc. The Committee was informed by the Secretary, Department of Science & Technology that the drug development is a long drawn process involving both risk and heavy investments. The Secretary informed that it takes twelve to fifteen years to