Health secretaries in some of the states in the country have taken strong objection to the decision of the Drug Controller General of India (DCGI) to centralise the issuance of certificate of pharmaceutical product (CoPP). These secretaries have written letters to the central government, asking the Union health secretary to revoke the DCGI order, it is learnt.

According to reliable sources, the state health secretaries have questioned the DCGI's authority in changing a system which has been doing well for the last several decades. They have asked the secretary, Union Health Ministry, to verify whether the DCGI has such powers under the Drugs and Cosmetics Act.

Asking the central government to return to the existing practice of state drug authorities issuing the CoPP, the state secretaries have argued that the existing system is a time tested practice as the CoPP should be issued after verifying the manufacturing license of the manufacturers which is issued by the state drug authorities. So, both these powers should be vested with the state drug authorities for better results, they are learnt to have argued in the letter. The state secretaries have also hinted about the loss of revenue to the state governments due to the new practice.

The DCGI had earlier issued an order under which the CoPP will be issued by the CDSCO (DCGI office) from October 1 this year after the auditing by the CDSCO officials. The DCGI's action of centralisation of CoPP comes in the wake of concerns expressed by the WHO on the lack of a single authority in issuing the CoPP in the entire country.

Since then, there were apprehensions among the industry about the feasibility of the proposal, given the infrastructure available with the CDSCO. So far, since the WHO-GMP certificate used to be issued by the state licensing authorities (SLAs) after a joint inspection by the CDSCO (DCGI office) and state drug control department, there was not much delay in the process. With the DCGI proposing to centralize the issuance of WHO-GMP certificate, there is apprehension among the exporters that there will be avoidable delays in issuing the certificate. Their apprehension stems from the fact that the DCGI office does not have the infrastructure to dispose of the application for WHO-GMP certificates expeditiously.

CoPP is a certificate issued by the drug authorities 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.