March 16, 2009, 0800 IST -Source : ePharmail of Pharmabiz.com. For more info, visit http://www.pharmabiz.com.
Seeking to end the prevailing confusion among the industry with regard to the WHO-GMP certification, the Drug Controller General of India (DCGI) has made it clear that there is no move to withdraw the system of WHO-GMP certification or replacing it with certificate of pharmaceutical products (COPP).
“The existing system would continue as it is and there is no move to disturb the pattern. We have not taken any decision with regard to discontinuing issuance of WHO-GMP certification or centralising the COPP,” DCGI Dr Surinder Singh told Pharmabiz, reacting to the recent media reports.
“The last DCC meeting actually took up the issue of framing uniform guidelines in this regard and has set up a sub-committee to study all the aspects and recommend guidelines. The effort is to put in place uniform guidelines for both the GMP and COPP. We will centralise the system only when we have sufficient staff strength to operate it smoothly, but not in the immediate future anyway,” he said.
There have been reports that the DCGI wanted to centralise the issuance of WHO-GMP certification system and replace it with COPP for pharma products, creating confusion and apprehension in the industry. Some of the industry associations have already met the DCGI to get clarification in this regard, following the media reports. The industry has also warned that if the system would be centralised, it would only delay the issuing of certificate as the CDSCO is still understaffed.
The DCGI has now categorically made it clear that the existing system of issuing WHO-GMP would continue in the same manner and the State licensing authorities would continue to issue the certificate after joint inspections by the CDSCO and the state drug control department.
He also said no instruction has been gone to the State authorities to withdraw the WHO-GMP certification. “I have clarified it to those industry delegations which met me as there was no decision at all. Only development on this aspect was the creation of the sub-committee by the DCC to study the issue of uniform guidelines,” he added.
WHO-GMP certificate is issued to manufacturing plants and COPP is issued for individual products and both of these are issued by the SLAs for two years. WHO-GMP certificate ensures the quality of a manufacturing unit while the COPP seeks to highlight the quality of the product. The effort by the authorities now is to bring uniform guidelines for both and ultimately centralise the entire system when there would be enough staff with the CDSCO, but will take long time for that.