On the lines of European Union (EU) countries, the Central Drugs Standard Control Organisation (CDSCO) in India will soon extend the validity of Certificate of Pharmaceutical Products (CoPP) from the existing two years to three years which, the exporters say, will be a big relief to the pharma exporters.

Drug Controller General of India (DCGI) Dr Surinder Singh said that the validity of the CoPP will be extended to three years immediately after the supreme court takes a final decision on the CoPP issue, which is expected in two-three months. “Once the CoPP issue is settled by the supreme court, the extension of CoPP from the existing two years to three years is just a formality”, Dr Singh said.

Currently, the issue of centralization of issuance of CoPP is pending in the supreme court. Recently, the supreme court had admitted DCGI's prayer to bring a string of CoPP cases pending in high courts in the different states to the supreme court. Now, the apex court will decide the fate of the issue, which has been pending for the last more than couple of years.

Extension of CoPP validity from two to at least three years, if not five years, has been a long pending demand of the pharma industry in the country. Exporters argue that very often they find it difficult while registering their products abroad due to the CoPP validity as they have to renew it in every two years. Given the complicated official procedures and the subsequent delays in issuing the CoPP by the drug officials, exporters very often lose their export orders as they have to present their CoPP while registering their products abroad. If the CoPP is issued for at least three years, there will be some solace, exporters feel.

Presently, the CoPP has two years validity and is issued by the State Licensing Authorities (SLAs) after a joint inspection by the CDSCO (DCGI office) and state drug control department. After two years, the exporters have to renew the CoPP. The exporters plead that if the validity is raised to three years, the industry can save a lot of time and energy wasted in every two years to get these certificates.

CoPP is a basic document required by the exporters to export their products to the countries where there is no regulatory system of their own. The importing countries accept the CoPP as the proof of quality of the product. CoPP is issued by the SLAs for individual products. While the US, European Union countries, Canada, Australia and other developed countries have their own regulatory system and they import the drugs from the plants inspected and approved by their own agencies like the US FDA, countries in Latin America, Africa, CIS countries and other developing countries accept CoPP as the proof of quality of the product.