In a major setback to the industry's revolt against the centralisation of Certificate of Pharmaceutical Products (COPP) issuance, the Madras High Court has dismissed the COPP cases filed by the state drug controllers and manufacturers against the DCGI's order to centralise the issuance of COPP in 2009. COPP is a certificate issued by the state drug authorities after a joint inspection with the CDSCO officials to a specific pharma product.
According to sources, the court has dismissed all the three cases related to COPP which have been pending in the court for final verdict for the last more than two years. In fact, the arguments in this case in Madras High Court had concluded as early as February 16, 2010 and a decision has been pending since then. However, details of the verdict are yet to be ascertained.
With the Madras High Court dismissing the COPP cases, the only case related to COPP is now pending in the Karnataka High Court. The COPP cases were earlier pending in High Courts of Madras, Karnataka and Mumbai. The case in Mumbai was later withdrawn by the petitioner.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.