The office of the DCGI has issued guidelines for grant of WHO-GMP Certificate of Pharmaceutical Product (CoPP) by the CDSCO offices from October 1 this year. Apart from DCGI himself, 12 other CDSCO officers including all heads of CDSCO zonal and sub-zonal offices have been authorised to issue CoPP from October 1. However, those who are already holding CoPP can continue to hold it till its expiry.
"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," a DCGI directive said.
The CoPP will be issued only in the format recommended by WHO. Initially, fees is not going to be charged for application till final decision is taken and published in this matter.
The DCGI has issued the general requirements for submission of application for issue of COPP. As per the DCGI directive, a forwarding letter/application shall be addressed to DDC(I)/ADC(I) of respective CDSCO zonal/sub zonal offices with copy of covering letter and product summary sheet to DCG(I) (WHO-cell) by authorized persons 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) and notarized product summary sheet, site master file as per WHO-GMP requirement.
The applicant should provide the list of major/master documents like master validation plan, quality manuals, specifications, master formula records maintained by firm and list of SOP's (to indicate the documentation system of firm) and also manufacturing layout (it is preferred if men and material flow, pressure flow drawing are also given).
The applications should also include the HVAC schematics and details of areas (Where in clearly specify the filtration level & classification of core areas & rooms as required in section 3.3 of SMF) and Water system -- Schematic diagrams along with the components and list of personnel (with designation, qualification & experience), list of equipments, instruments, utilities along with make and model and capacity. It should also include list of primary & secondary Impurity and Reference standards/cultures available with the firm (relevant to the applied product for the grant of CoPP).
In the DCGI office in Delhi, deputy drug controllers Dr V G Somani and M Mitra; and assistant drug controllers Arvind Kukrety and Dr S Eswara Reddy have been authorised by the DCGI to issue CoPP.
From zonal/sub zonal offices, Dr R Ramakrishna (Mumbai), Dr D Roy (Ghaziabad), Shanti Gunashekaran (Chennai), Rubina Bose (Kolkata), A C S Rao (Hyderabad), Dr A Ramkishan (Ahmedabad), Soumen Mukhopadhyay (Kolkata) and D K Chauhan (Mumbai) will be the authorised signatory to issue the CoPP from October 1 this year.