Final hearing in CoPP issuance case to begin soon in Karnataka High Court

The final hearing in the controversial Certificate of Pharmaceutical Products (CoPP) case, which has been pending in the Karnataka High Court for a long time, will begin very soon, it is learnt. The CoPP case pertains to the Union health ministry's proposal to centralise the issuance of CoPP in the country.

According to sources, the case is listed for hearing in the Karnataka High Court and the final hearing will start soon. When the judge gets time, it will be heard, sources said and added that the once the government wins the case, the authorities will start the process of centralizing the issuance of CoPP.

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, 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.

While the Madras High Court dismissed the case in July 2012, the case in Mumbai was later withdrawn by the petitioner.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.

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2/15/2014 12:05:43 PM