Confusion prevails in the country over the issuance of the Certificate of Pharmaceutical Products (CoPP) on whether the present system will be continued in which the certificate will be issued by the state licensing authorities (SLAs) or the system will be centralized and will be issued by the DCGI office in Delhi.
The confusion is triggered by the conflicting reports emanating from none other than the DCGI Dr Surinder Singh himself. Recently, the DCGI had told Pharmabiz, "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 CPP." But to another newspaper more recently the DCGI is reported to have said that his office has decided to withdraw the powers given to State-level regulators to issue export quality licence, technically called Certificate of Pharmaceutical Products (CoPP).
"The power to issue CoPP was given to the State regulators earlier outside the Concurrent List. Therefore, now we are going to take it back to bring uniformity in regulations. We will notify this in over the next month or so," the newspaper has quoted him as saying.
Interestingly, the state drug authorities have not received any information about the decision of the DCGI on centralizing the CoPP. "We have not received any information in this regard and we have also read in the newspapers that the DCGI is going to centralize the issuance of CoPP," a senior FDA official said.
CoPP is a certificate issued by the state drug authorities after a joint inspection with the CDSCO officials to a specific product. It is accepted as a proof of the quality of a product. Presently CoPP is issued for two years. It is accepted internationally as proof of quality of a product especially in countries where there is no regulatory system of their own. While the US, European Union countries, Canada, Australia and other developed countries have their own regulatory system and they import the drugs approved by their own agencies like the US FDA, countries in Latin America, Africa, CIS countries and other developing countries accept CoPP as proof of the quality of the product.
Meanwhile, industry sources said that the centralisation of CoPP will prove to be another bottleneck for the exporters, especially for the small and medium exporters, as they have to approach the DCGI office for each product in every two years.