India’s Drug Controller General to Take Over COPP and GMP Drug Certification

The Certificate of Pharmaceutical Products (COPP) and Good Manufacturing Practice (GMP) under World Health Organization (WHO) certification will be taken over by the Drug Controller General of India (DCGI). Previously, State Drug Controllers were responsible for issuing these two certificates. However, the WHO has expressed concern on the implementation and the quality of pharmaceutical products entering international commerce.

The DCGI of the Centre of Drug Standards Control Office (CDSCO) took over this certification process in October 2009. The COPPs will be issued after inspection of manufacturing facilities by CDSCO regulatory officials. Facilities must comply with WHO-GMP guidelines. The COPP will be issued only in the format recommended by the WHO. COPPs already issued are valid until expiration.

The application forms will include details such as a product summary sheet, site master file as per WHO-GMP requirements, a list of master documents such as quality manuals and master validation plan, manufacturing layout, personnel list, etc.

The main purpose of the COPP establishes the status of the pharmaceutical product and of the applicant in the exporting country. Therefore, a country importing a COPP-certified Indian drug can be assured that the product complies with WHO mandated GMP certification.