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Year : 2021  |  Volume : 8  |  Issue : 2  |  Page : 155-165

Novel active pharmaceutical ingredients from India: The issues—part-II

Ex-Adviser, Department of Biotechnology, Ministry of Science and Technology, Government of India and Managing Partner, Sompradip Publishers and Consultants, New Delhi, India

Correspondence Address:
Dr. Prasanta Kumar Ghosh
Ex-Adviser, Department of Biotechnology, Government of India and Managing Partner, Sompradip Publishers and Consultants, C2B, Flat 5A, Janakpuri, New Delhi.
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/mgmj.mgmj_15_21

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India has made a mark by discovering at least 16 novel synthetic active pharmaceutical ingredients (APIs). However, this number is quite small when compared with the number of APIs invented the world over in the allopathic system of medicines, the numbers of which according to the estimate of the author stand at more than 5000, of which presently nearly 3000 numbers are in therapeutic use against human diseases/ailments. In India, nearly 2200 numbers of these APIs are presently in use. India has made a mark in the supply of branded generic and generic formulations for use in the country and abroad in an environment of cut-throat competition. To maintain and improve the mark, India needs to carry out R&D not only for process innovation but would also have to invest and invent novel APIs. The analysis shows that the present investment in R&D and the policies followed for promoting research for new drug development are not adequate for the country to be dominant global player. Suggestions have been made to improve the present situation.

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