Drugs Controller General of India Lays Guidelines For CoPP

The Drugs Controller General of India (DCGI) has issued guidelines for grant of WHO-GMP Certificate of Pharmaceutical Product (CoPP) by the CDSCO offices, starting October 1. DCGI has authorised 12 CDSCO officer, which includes heads of zonal and sub-zonal CDSCO offices. He has also added that the personnel holding CoPP will continue to hold office until the expiry of their tenure.

CDSCO quoted: “The application for grant of WHO GMP (Certificate of Pharmaceutical Product) shall be made to respective zonal/sub zonal officers as per the requirement. The CoPP will be issued by zonal/sub zonal officers on behalf of Drugs Controller General (India) after inspection and satisfactory clearance by CDSCO officers as per WHO-GMP guidelines.”

The CoPP will be issued only in the format recommended by WHO and reportedly no initial fee will be charged until the decision is taken and

DCGI has also laid down guideline for the general requirement for submission of application for issue of COPP. It states that a forwarding letter/application shall be addressed to DDC(I)/ADC(I) of respective CDSCO zonal/sub zonal offices with copy of covering letter & product summary sheet to DCG(I) (WHO-cell) by authorized person only.

The forwarding letter/application shall be accompanied with List of products applied for grant of COPP, along with the product permission copy (manufacturing licence issued by the SLA) & notarized product summary sheet, site master file as per WHO-GMP requirement.

List of major/master documents, which includes, master validation plan, quality manuals, specifications, master formula records maintained by firm and list of SOP’s, should be provided along with the above, along with manufacturing layout.

The application also asks for list of personnel, list of equipments, instruments, utilities along with make and model & capacity.