INDIAN PRIDE IN THE DISCOVERY OF NOVEL APIs
Prasanta Kumar Ghosh
July 07, 2021
Sixteen novel active pharmaceutical ingredients(APIs) , namely Urea stibamine, Methaqualone, Enfenamic acid, Hamycin, Centimizole, Centbutindole, Ormiloxifene, Centpropazine, Centbucridine, Alpha-beta-arteether, Bulaquine, Chandonium Iodide, Sintamil, Amoscanate, Saroglitizar, and Diperoxochloric Acid (DPOCL), were discovered from India. Six formulations, namely of Ormiloxifene, Alpha-beta-arteether, Bulaquine, Sintamil, Saroglitizar, and DPOCL, are in the market. The Indian pharmaceutical industry uses nearly 2200 active pharmaceutical ingredients (APIs) for the manufacture of nearly 60,000 branded generic and generic formulations from its nearly 3000 manufacturing units. The industry manufactures nearly 1000 APIs locally and imports about another 1200 APIs; the manufacture of generic APIs as well as formulations is heavily dependent on imports. To remain a dominant manufacturer, India needs to invest in the discovery of novel APIs.
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. In two recent papers published by the author, suggestions[1] , [2]have been made to improve the present situation.
[1] Ghosh PK. Novel active pharmaceutical ingredients from India: The actors-Part-I. MGM J Med Sci 2021;8:73-82. http://www.mgmjms.com/article.asp?issn=2347-7946;year=2021;volume=8;issue=1;spage=73;epage=82;aulast=Ghosh
[2] Ghosh PK. Novel active pharmaceutical ingredients from India: The issues-Part-II. MGM J Med Sci 2021; 8: Issue -2 : 155-165.-http://www.mgmjms.com/article.asp?issn=2347-7946;year=2021;volume=8;issue=2;spage=155;epage=165;aulast=Ghosh
