The Supreme Court will hear on April 18 the long pending CoPP issue, which has been pending in the Supreme Court for quite some time. In the CoPP case, the industry is challenging the Drug Controller General of India (DCGI)'s order to centralise the issuance of CoPP (Certificate of Pharmaceutical Products) which is a certificate issued by the state drug authorities after a joint inspection with the CDSCO officials to a specific product.
According to sources, the Supreme Court has already brought a string of CoPP cases pending in High Courts in different states to the Supreme Court and the next hearing will be held on April 18. The CoPP cases were earlier pending in High Courts of Madras, Karnataka and Mumbai. The Supreme Court has already conducted two hearings and it will be the third hearing on April 18. This may not be the final hearing as several issues are still to be argued, sources said.
The CoPP controversy began way back in September 2009 when the DCGI issued an order, centralizing the issuance of CoPP in the country and asked the state regulatory agencies to stop issuance of CoPP from October 1, 2009. Till then, the CoPP was issued by the state drug authorities after a joint inspection with the CDSCO (DCGI office) officials.
Challenging the order, the state drug controllers and manufacturers across the country filed petitions in high courts in Madras, Karnataka and Mumbai. In fact, the arguments in the case in Madras High Court concluded on February 16, 2010 and a decision has been pending since then.
In the meantime, the DCGI filed a petition in the Supreme Court for bringing all the pending cases related to CoPP from different High Courts to the Supreme Court for a final and uniform decision on the issue. After admitting the petition, the Supreme Court had sent notices to three High Courts, staying further proceedings in the issue.
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.