The Drug Controller General of India has made it mandatory for pharma
companies and clinical research organisation in the country to submit
information on serious adverse reactions during clinical trials within
14 days of occurrence in a standardised format.
The drug controller has asked the drug firms to clearly
mention whether a specific adverse effect is related to the clinical
trials, whether it has resulted in fatality of the volunteer and whether
compensation for the injury or death has been provided. This comes in
the backdrop of the civil societies and drug experts raising concerns on
the laxity in implementation of protocols by pharma firms, CROs in
clinical trials across the country.
While the law already provides for reporting of such incidents
through schedule Y of Drug and Cosmetic Act, it is the strict
implementation of the Act that DCGI is aiming at. The drug regulator
also made it compulsory.
