In a new twist to the long pending CoPP (Certificate of Pharmaceutical Products) issue for which cases are pending in the High Courts of Madras, Karnataka and Mumbai for quite some time, the Supreme Court has admitted a prayer by the Drug Controller General of India (DCGI) for hearing the issue in the apex court of the country.
According to sources, the Supreme Court has admitted a petition filed by the DCGI on the issue 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 has sent notices to three High Courts in Madras, Karnataka and Mumbai, staying further proceedings in the CoPP issue in these courts as the matter will now be decided by the Supreme Court.
Sources said that since the cases related to CoPP are pending in three different High Courts, there may be different interpretations by these courts on the issue which may create confusion among the industry as well as the regulatory authorities. It is in order to avoid such a scenario that the DCGI moved Supreme Court to transfer all the CoPP related cases from the different High Courts to the Supreme Court for finding a uniform solution to the issue, which has been hanging in balance since October 13, 2009 for a lasting solution.
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 different high courts. In fact, the arguments in the case in Madras High Court concluded on February 16, 2010 and a decision has been pending since then.
There are apprehensions among the industry that given the infrastructure available with the CDSCO, it will not be possible for it to issue hundreds of CoPPs in a month all over the country. In Gujarat alone, around 800 CoPPs are issued every month. Industry sources said that the centralisation of CoPP will prove to be another bottleneck for the exporters, especially for the small and medium exporters, as they have to approach the DCGI office for each product in every two years.
CoPP is a certificate issued by the state drug authorities after a joint inspection with the CDSCO officials to a specific product. Presently CoPP is issued for two years. It 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.