The Drug Controller General of India from next month will issue Certificates of Pharmaceutical Products (CoPP) and Certificates of Good Manufacturing Practice for medicinal products required for exports.
In a letter to various stake holders, DCGI said, “a considered view has been taken that Certificate of Pharmaceutical Products (CoPP) and Certificate of Good Manufacturing Practise (GMP) under WHO certification shall be taken over by the National Regulatory Authority i.e. DCGI office.”
The notification on the centralisation of the process said both the CoPPs and the GMPs would be issued from October 1 by the national drug regulator.
The CoPP is mandatory in many countries that require World Health Organisation (WHO) accreditation for pharmaceutical products being imported. As laid down by the WHO, the GMP certification is also necessary for the same.
The decision was made in 40th drug consultative committee (DCC) meeting held in June, after WHO raised several issues over the issuance of these certificates.
“The WHO has time and again expressed concerns on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce,” the letter said.
Published - September 07, 2009 03:40 pm IST
