Drug Controller General of India (DCGI) is planning to meet all Deputy Drugs Controllers (DDCs) in charge of different zones and other senior officials in the Central Drugs Standard Control Organisation (CDSCO) to clear the confusion still prevailing on the issue of Certificate of Pharmaceutical Products (CoPP) amidst conflicting reports.

Sources said the DCGI office is collecting details on the current practice of the state licensing authorities (SLAs) issuing the certificates and after the meeting with the DDCs, concrete instructions will be issued to all the States to settle the issue for ever. Trying to clear the air on the issue, DCGI Dr Surinder Singh had explained to Pharmabiz sometime back that current system of 'WHO-GMP certificate' was a misnomer and the present system of SLAs issuing certificates will continue till the headquarters had enough staff strength.

"It is just a small confusion. 'WHO-GMP' certificate is a misnomer. In fact, there are three types of certifications. First one is Schedule M, given to a plant for indigenous production and domestic marketing after assessing whether the unit has complied with GMP guidelines. That is good enough for domestic commerce. Secondly, it is CoPP, being issued by the State, 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. Third one is WHO Prequalification, which is meant for purchasing drugs for WHO and its other bodies. This CoPP, based on guidelines prescribed by WHO, is sufficient for international commerce. This CoPP certificate clearly says that it is in conformity with the WHO-GMP guidelines," he said.

"What is meant by WHO-GMP certificate is in fact CoPP. It is not correct to call it 'WHO-GMP certificate'. As long as we say, it is WHO-GMP, it is true. Because, CoPP is issued for a product based on the WHO-GMP guidelines after assessment jointly by a team from the State and the headquarters. The particular guidelines (TRS 902, 908, 929, 937, 822) are followed with regard to different products. So, CoPP is as per WHO-GMP guidelines," he had explained. The confusion came up after some SLAs issued certificate under the title of `WHO-GMP Certificate' and companies displayed it in the premises. Northzone DDC had noticed it and sent letter to Himachal SLA to clear this confusion. But, it however created lots of confusion in the industry.