The Central Drugs Standard Control Organisation vide its notification dated 1st May 2020 has extended validity of World Health Organization good manufacturing practices (WHO GMP) certificate of pharmaceutical product (CoPP) expiring from March to August 2020 by six months.
The certificate of a pharmaceutical product is issued under the WHO GMP certification scheme for registration of products in foreign countries. It is required by the importing country when the product in question is intended for registration (licensing, authorization) or renewal of registration, with the scope of commercialization in that country. Earlier the validity of CoPP was extended from two years to three years by DCGI through a circular on May 8, 2018. The move aimed at boosting drug export and promoting ease of doing business.
Since the department has been receiving representations from stakeholders requesting to extend the validity of the WHO GMP Certificate and in order to maintain the continuity of export by the pharmaceutical companies amid coronavirus pandemic, the Drugs Controller General of India has extended validity of WHO GMP certificate of pharmaceutical products expiring between March 2020 – August 2020 by six months from date of expiry..
Click here to read the Notification.
