Volume : X, Issue : IV, April - 2020

An analysis of Drug approvals in India over past 10 years

Dr. Ashwini V. Karve, Dr. Amod P. Sheth, Dr. Shaikh Sana Perveen

Abstract :

Background – Drug development is a tedious process and takes a long time for approval by regulatory authorities. With time, India has revised rules and regulations for conducting clinical trials as well as for marketing of drug. This can impact the number of drugs been approved. Objective – To analyse trends of drug approvals by CDSCO in India from 2009–2019. Methods – List of drugs approved by CDSCO for human use over past 10 years was obtained from cdsco.gov.in. The drugs were analysed according to the type of drug approval. Results – The total number of drugs approved were 853. Total drug approvals in 2009 and 2019 were 210 and 19 respectively. Maximum drugs were approved in the year 2010 (224) and minimum in 2019 (19) with median of 42. Maximum approvals were seen in oncology(108), CVS(102), and pain(115). With regards to the type of drugs approvals, maximum were FDDC(247) but with no FDDC approved in last 5 years Conclusion – There is a decline in number of approvals of drugs over last 10 years and it coincides with the implementation of new rules and regulations. With strict vigilance on FDDC being approved, the number has declined tremendously.

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Article: Download PDF    DOI : 10.36106/ijar  

Cite This Article:

AN ANALYSIS OF DRUG APPROVALS IN INDIA OVER PAST 10 YEARS, Dr. Ashwini V. Karve, Dr. Amod P. Sheth, Dr. Shaikh Sana Perveen INDIAN JOURNAL OF APPLIED RESEARCH : Volume-10 | Issue-4 | April-2020

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