Even after more than four years, the controversial Certificate of Pharmaceutical Products (CoPP) issue is still pending in Karnataka High Court as the court is yet to take up the issue for final hearing. The CoPP issue pertains to the Union health ministry's proposal to centralise the issuance of CoPP in the country.

The CoPP case has been pending in the Karnataka High Court for quite some time for the final hearing.  In fact, the case was listed for final hearing in the Karnataka High Court some months back but it could not be taken up as the judge hearing the matter did not get time.  A final decision on CoPP case from the Karnataka High Court is significant because once the government wins the case, the authorities will start the process of centralising the issuance of CoPP in the country.

The controversy involving the CoPP began way back in September 2009 when the then drug controller general of India (DCGI) Dr Surinder Singh issued an order, centralising 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 Bombay.  There were 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. According to the industry, centralisation of CoPP would 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.

While the Madras High Court dismissed the case in July 2012, the case in Mumbai was later withdrawn by the petitioner.  The hearing in this CoPP case in the Karnataka high court is crucial as this is the only case related to CoPP which is pending in the court now.

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.