Even as the controversial issue of centralization of CoPP (Certificate of Pharmaceutical Products) is still pending in the Supreme Court for a final decision, the industry has demanded that the government should hand over the power to issue the CoPP to recognized Chamber of Commerce all over the country based on prescribed guidelines.
According to sources, the industry has asked the Union commerce ministry to initiate efforts in this regard to include this demand in the 12th Five Year Plan for which the recommendations are being prepared by different central ministries. The 12th Five Year Plan will begin from next year.
To drive home the points in favour of its demand, the industry has argued that CoPP is required by the pharma companies for each and every export of drug. More importantly, CoPP is required by the exporters within 72 hours of its obligation with the importing parties. Presently, enormous efforts are being made by the manufacturers for obtaining this certificate after receiving an export order. If the recognized Chambers of Commerce in the country are given the power to issue CoPP, it will go a long way in helping the exporters in the country as it can save a lot of time and energy wasted to get these certificates, the industry feels.
Currently, CoPP is issued by respective State Licensing Authorities (SLAs) after a joint inspection by the CDSCO (DCGI office) and state drug control department.
CoPP, which is issued for a period of two years, 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.