Advances in Biopharmaceutical Technology in India
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Chapter 11:   Vaccine Industry in India

Abstract:
Vaccines are important preventive medicines for primary health care and are a critical component to any nation’s health security. The currently available vaccines have hugely contributed towards reducing worldwide mortality and morbidity due to many serious infectious diseases. Though new vaccine development has generally occurred more in the developed world, India has also contributed significantly to worldwide vaccination programs. India has traditionally aimed at self-reliance in vaccine development. The history of vaccine production in India dates back to 1892, when Dr. Waldemar Haffkine developed a cholera vaccine, followed by a plague vaccine in 1897. The initial vaccines made in India were rabies vaccine, small pox, and cholera. Today, among the other prominent private manufacturers, are Shantha Biotechnics., Ltd, Panacea Biotech Ltd, Biological Evans Ltd, Zydus Cadila Healthcare Ltd, Wockhardt Ltd, and Bharat Biotech Ltd. After more than a century, the Indian industry has established an effective system for vaccine research and development, production and control. The Indian National Regulatory Authority is the Drugs controller General of India (DCGI), New Delhi and is recognized by the World health Organization (WHO). In 1978, India introduced six childhood vaccines (BCG, TT, DTP, DT, Polio, and typhoid) under its expanded programme of immunization (EPI). Vaccine requirements for India’s UIP have been mainly met through the government vaccine institutes. But with the 27 million new births every year, the Indian UIP is the largest in the world and the private sector has filled the gap in the demand and supply of vaccines. These vaccines are exported globally for supplies to developing nations through UNICEF and Pan American Health Organization (PAHO). At the total estimated vaccine market in India ranging from US $100 to $300 million, private companies are growing rapidly; and also international major companies like Glaxo SmithKline Beecham, Sanofi Pasteur, and Wyeth have introduced some high-end vaccines. This chapter provides an overview of the Indian vaccine manufacturers, scientific advances in vaccine research, vaccine market, immunization policy, and regulatory aspects in India.

About the Authors:

Dr. Prasad S. Kulkarni, M.D.
Deputy Medical Director
Serum Institute of India Ltd.
PUNE INDIA

Suresh S. Jadhav, Ph.D.
President
Developing Countries Vaccine Manufacturers’ Network Executive Director
Serum Institute of India Ltd.
PUNE INDIA


Prasad S. Kulkarni, M.D., is a graduate and post-graduate of B.J. Medical College, Pune with specialization in Clinical Pharmacology. His first assignment was of a teacher of Pharmacology in a Medical School in Pune. He joined Serum Institute of India Ltd., Pune in 2000 as Assistant. Medical Director, and is now its Deputy Medical Director, since 2005. Today, Serum Institute is the largest manufacturer in the world for DPT and MMR Group of Vaccines. Dr. Kulkarni has undertaken many vaccine clinical trials in India, especially on MMR, Hepatitis B, DTP-Hepatitis B Combination, Rabies, and others. He is an expert on Vaccine against Respiratory Infection. He has published scientific papers in national and international journals like Vaccine, Clinical & Vaccine Immunology, Indian Journal of Gastroenterology etc. Currently he is associated with two international projects i.e. Meningococcal A Conjugate Vaccine (collaboration with WHO & PATH) and Aerosol Measles Vaccine (collaboration with WHO), which are being conducted in India and abroad.

Suresh Sakharam Jadhav, Ph. D. is M.Pharm. from Nagpur University & Ph.D. by research at Haffkine Institute, Mumbai. He joined Serum Institute of India Ltd., Pune in 1979, and is its Executive Director since 1992. He has played a vital role in securing accreditation for Serum Institute from World Health Organization. He has 35 years technical expertise covering areas including QC/QA/cGMP/GLP/GCP techniques, and he holds various academic/professional memberships. He extensively travels throughout the world, and has attended over 164 conferences abroad. He has presented 43 technical papers in international journals/seminars and also at the workshops organized by NIBSC/UK, EDQM/Europe, CBER, USFDA/U.S.A., NIH/USA, NVI/The Netherlands, WHO/Geneva, and participated in several international collaborative studies. He is affiliated with several universities. He has been a WHO Advisor on various WHO Programs since 1988. He was the Chairman of Local Scientific Committee for the 54th Indian Pharmaceutical Congress held in 2002. Appointed by the Ministry of Environment & Forests, Government of India, as “Convener-cum- Chairman of the Committee on Alternatives & Harmonization with Global Guidelines on Alternatives”, July’03. He has been elected as a President for 3 years: 2004-06 of the Developing Countries Vaccine Manufacturers Network (DCVMN). He was a member on the GAVI Board of Directors for 2 years & is a member on the Working Group of GAVI; and presently a member on WHO’s Expert Committee on Biological Standardization (ECBS), as also on the Albert A. Sabin Institute Task Force on Harmonization for Vaccine Supply. He is also a member of an Independent Committee for validation of The High Containment Laboratory with BSL-3 facilities at Microbial Containment Complex of National Institute of Virology/Pune.

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