The pharma exporters in the country have asked the union commerce ministry to take up with concerned departments the issue of increasing the validity of the WHO-GMP certificate and the Certificate of Pharmaceutical Products (COPP) from the existing two years to at least three years. 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.
This long pending issue of the pharma exporters was taken up by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with the commerce ministry officials at a meeting held recently. In the meeting, Pharmexcil asked the senior commerce ministry officials to take up the matter of enhancing the validity of COPP from two to three years with the union ministry of health.
Pharmexcil also asked the commerce ministry officials to convince the health ministry officials to postpone or delay the implementation of centralization of issuance of COPP by the CDSCO till the problem of shortage of staff in the CDSCO is addressed. The exporters apprised the commerce ministry officials that the centralization of issuance of COPP will hamper the exports because of severe shortage of staff at CDSCO.
At present, the WHO-GMP certificate and COPP are issued by the state licensing authorities (SLAs) after a joint inspection by the CDSCO (DCGI office) and state drug control department. WHO-GMP certificate is issued to manufacturing plants and COPP is issued for individual products and both of these are issued by the SLAs for two years. WHO-GMP certificate is a basic document required by the exporters to export their products to the 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 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 WHO-GMP certificate as the proof of quality of the manufacturing plant and COPP as the quality of the product.
Apart from senior officials, industry leaders including Ashutosh Gupta, Bhavin Mehta, Nipun Jain and Ranjit Puranik were present in the meeting.