The state drug controllers in the country, with the lone exception of Delhi drugs controller, have vociferously opposed the Drug Controller General of India (DCGI) Dr Surinder Singh's plan to centralize issuance of Certificate of Pharmaceutical Products (CoPP) to the manufacturers. They raised the protest in the recently concluded Drugs Consultative Committee (DCC) meeting.
The state drug controllers are more pained over the way the plan is being pushed through by the DCGI without even taking the state drug controllers into confidence. "Even before the issue was discussed in detail to thrash out its pros and cons in the DCC meeting, the DCGI has forwarded the matter to the DTAB which has almost prepared a draft. All this is happening at a time when the parliamentary committee on health has rejected a proposal to centralize the issuance of manufacturing license in the country. It shows that the DCGI wanted to capture power through back door," sources who were present in the meeting said.
The state drug controllers tried to reason with the DCGI in the meeting on the fact that hundreds of CoPPs are issued every month by the state drug controllers and given the infrastructure available with the DCGI it will not be possible to manage them. In Gujarat alone, around 800 CoPPs are issued every month. Besides, it will prove to be a big disadvantage to the manufacturers as they have to rush to Delhi for CoPP for every product. They have to get separate CoPPs for the same product to different countries.
Interestingly, the strong opposition put up by the state drug controllers will not be included in the minutes of the DCC meeting and they have been asked by the DCGI to register their protest in writing separately. "You can register your protest in writing while you send your reply to the draft proposal," the DCGI is learnt to have told the state drug controllers in the meeting. The DTAB is preparing the draft and will be sent to the state drug controllers soon.
Presently, CoPP is issued by the state licensing authorities after a joint assessment by state drug authorities and the CDSCO (DCGI office). It is issued for an individual product for the purpose of exporting that particular product alone. This is issued after a unit makes an application in a prescribed format along with purchase order from the buyer of that particular product and it is issued for a product based on the WHO-GMP guidelines.