The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has asked the drug control administration, Andhra Pradesh, to discontinue the administration's current system of issuing country-specific Certificate of Pharmaceutical Products (CoPPs) instead of product specific CoPPs like in other states.

In a letter addressed to Dr BL Meena, director general of drugs and copyrights, drug control administration, Andhra Pradesh, Pharmexcil director general Dr P V Appaji asked the administration to consider issuing CoPPs at Rs.500 per product instead of Rs.500 per country being issued presently. This would help the exporters to enhance their exports to various countries, thus helping India to achieve the targeted exports of US$ 25 billion by March 2014, he said.

In other states of India, CoPPs are being issued to the companies, free of cost, for the products manufactured by them without specifying the country name in which they are interested to register. This enables them to use the same certificate for registering the products in any country. CoPPs are issued as per WHO GMP norms, to the pharmaceutical companies, which enable them to register their products in various countries.

“However, in case of Andhra Pradesh, we understand that CoPPs are being issued, at a cost of Rs.500 per country, for the products manufactured by the companies, indicating the country in which they are registering the product. It may kindly be appreciated that by issuing the CoPPs specific to countries, the exporters will not be able to use the same certificate for different countries and they are required to obtain many certificates for the same product. This will not only increase the transaction cost and time consuming, but also make their products incompatible in the international markets,” Dr Appaji in his letter said.

The Pharmexcil's letter comes in the wake of complaints from its members that some of them are facing problems in obtaining CoPPs from drug control administration of AP.

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.