May 1, 2020

 

Central Drugs Standard Control Organization (CDSCO), the Government of India Drug Regulatory Agency has extended the validity of WHO GMP/ Certificate of Pharmaceutical Product (COPP) expiring from March 2020 to August 2020 by six months from the date of expiry.

CDSCO in their Public Notice date 01.05.2020 has stated that “In light of current situation of COVID19 outbreak and in order to maintain the continuity of essential activities by the pharmaceutical industry, it has been decided that validity of WHO GMP/ Certificate of Pharmaceutical Product (COPP) expiring from March to August 2020 may be extended by six months from the date of expiry of the certificate as per WHO GMP Certification guidelines.”

COPP is issued under WHO GMP Certification Scheme for the purpose of International commerce i.e. for registration of products in foreign countries.

It is to be noted that CDSCO has already extended the validity of WHO GMP – COPP from 2 years to 3 years on 08.05.2018 to facilitate Pharmaceutical Industry in India.