The Department of Health and Family Welfare, under the Ministry of Health and Family Welfare (MoHFW), on 27th July 2020, vide notification no. S.O. 2450(E). notified that for import of drugs for sale or distribution, if an existing Registration Certificate holder under the said rules, makes an application for a fresh Registration Certificate before the expiry of the existing certificate, the existing Registration Certificate shall be valid until orders are passed on the application and shall be deemed to be valid for all purposes.
According to the notification, it has been done by the Central Government because an outbreak of COVID -19 pandemic is prevailing throughout India and worldwide. Several Registration Certificates in Form-41 are in existence and their validity periods of three years are likely to expire shortly
and pharmaceutical companies and their associations have requested for extension of the validity of Registration Certificate (Form-41) for six months in the wake of COVID-19 pandemic. Also it has been stated that the Central Government is of the considered view that supply of drugs may not get affected and the drugs must remain available to the public.
This extension has been done by the Central Government in exercise of the powers conferred by section 26B of the Drugs and Cosmetics Act, 1940.
Copy of notification: S.O. 2450(E).
-Adv. Tushar Kaushik