Even as the implementation date for centralisation of issuance of Certificate of Pharmaceutical Products (CoPP) on October 1 is fast approaching, the exporters, especially the small and medium ones, are fuming and fretting over the Drugs Controller General of India (DCGI)'s decision which they fear will only help eliminate the SMEs from the pharma exporting scene.
While Central Drugs Standard Control Organisation (CDSCO) North Zone deputy drug controller Dr D Roy has convened a meeting of all the concerned pharma associations on September 24 at Ghaziabad near Delhi to discuss the modalities on the implementation of the centralisation of issuance of CoPP, the industry is bracing up itself to convince the authorities to desist from this retrograde move which will prove to be a big disadvantage to them as they have to rush to Delhi or a few Zonal offices for CoPP for every product. They have to get separate CoPPs for the same product to different countries also.
There are apprehensions among the industry that given the infrastructure available with the CDSCO, it will not be possible for it to issue hundreds of CoPPs in a month all over the country. In Gujarat alone, around 800 CoPPs are issued every month. 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 for each product.
The exporters' apprehensions in this regard are not out of place as hundreds of applications regarding blood banks, rDNA-based vaccines, biologicals and large volume parenterals are learnt to be pending in the DCGI office for months, if not years. The power to issue licenses for these are lying with the DCGI office.
Exporters say that same is going to happen in the issuance of CoPP also affecting the export.
While the DCGI's move to centralise CoPP comes in the wake of concerns expressed by the WHO, the SME industry views it as yet another move by the government at the behest of large industries and MNCs to eliminate the SMEs which provide competitive pricing in the market. "WHO has sought only a uniform format in issuing CoPP, and not centralisation which has been misinterpreted by the DCGI to further the agenda of the MNCs, an industry leader said.
So far, since the WHO-GMP certificate was 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 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.