The much-delayed case against the union health ministry's proposal to centralise the issuance of Certificate of Pharmaceutical Products (CoPP) will come come up for hearing in the Karnataka high court very soon.
The final hearing in the case will be held any day now as the case is listed for hearing in the Karnataka High Court. When the judge gets time, it will be heard, according to a source in the union health ministry.
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. Earlier in 2009, state drug controllers and manufacturers had filed cases in High Courts in Madras, Bombay and Karnataka against the union health ministry's order issued in September 2009 for centralisation of CoPP issuance. While the Madras High Court dismissed the case in July last year, the case in Mumbai was later withdrawn by the petitioner.
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.
Later, the DCGI filed a transfer petition in the Supreme Court for transferring all the pending cases related to CoPP from different High Courts to the Supreme Court for a final and uniform decision on the issue. But, the Supreme Court dismissed the transfer petition filed by the DCGI and asked the DCGI to get the verdict on the issue from the High Courts.
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.