Advances in Biopharmaceutical Technology in India
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Chapter 6:   Biogeneric Manufacturing in India

Biogenerics represent a high-growth sector in India, where recombinant Insulin, GCSF, Interferon alpha, Erythropoietin, monoclonal antibody products and recombinant vaccines are already manufactured by local biotech companies. The costs of Western-made biopharma products remain out of reach for much of the world, and many of these products are close to losing their patent protections. To assist the Indian biotech industry in seizing this opportunity, the Indian government has streamlined some of its drug application and review procedures and has offered strong tax incentives. As a result, the Indian biotech industry has been investing heavily in the development of world-class facilities, and it is expected that Indian biogenerics makers will soon receive their first approvals to manufacture products for the European market.

About the Authors:

Ashesh Kumar, Ph.D.
General Manager, Biotechnology
M J Biopharm Pvt. Ltd.
Bombay, India
Director, Medipolis GMP Oy
Oulu, Finland

Dr. Ashesh Kumar is the Director and Head of Medipolis GMP, a Finnish company specializing in small-scale manufacturing and process development. Previously he was General Manager for Biotechnology at M.J. Biopharm, a leading multinational biopharmaceutical company in Mumbai. Dr. Kumar’s work centers on the manufacturing and marketing of recombinant rDNA human insulin products. He currently manages the regulatory submissions for these products to Mexico, Brazil, China and other Asian countries, as well as to the Commonwealth of Independent States (eleven former Soviet Republics). Dr. Kumar received his Master’s Degree in Biosciences from the Indian Institute of Technology in Roorkee, India, with specialized studies in biotechnology, and received his Ph.D. in biosciences & biotechnology from I.I.T. in 1994. He also holds a Diploma in Marketing Management from the Jamnalal Bajaj Institute of Management Studies in Mumbai. In addition to his responsibilities in Finland, Dr. Kumar serves as a visiting faculty member in the postgraduate program in Biotechnology at C.R. Thakur College of Science, Engineering and Technology in Navi, Mumbai. He is a member of the Ethics Committee of the Global Biospectrum clinical research center, also in Mumbai. The center conducts global clinical trials and has two facilities in the USA. The International Society of Pharmaceutical Engineers has appointed Dr. Kumar as a subject matter expert for its ”Certified Pharmaceutical Industry Professional” examination development committee.

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Eric Langer
BioPlan Associates, Inc.
2275 Research Blvd, Suite 500
Rockville, MD 20850
Phone: 301-921-5979; Fax: 301-926-2455