Thursday, May 28, 2009

Drug export quality certificate to be issued only by DGCI

New Delhi: The Drug Controller General of India (DGCI) has decided to withdraw the powers given to State-level regulators to issue export quality licence, technically called Certificate of Pharmaceutical Products (CoPP). The move is to centralise pharmaceutical sector regulating.
Speaking to this reporter, Dr Surinder Singh, DGCI, said, “The power to issue CoPP was given to the State regulators earlier outside the Concurrent List. Therefore, now we are going to take it back to bring uniformity in regulations. We will notify this in over the next month or so.”
CoPP is internationally recognised by national drug regulatory authorities for establishing the status of medicinal products under a national drug product licensing system. The certificate is specific to a product and the country of import. The DGCI gives the certificate for a product for two years.
“Pharmaceutical exporters have been experiencing problems in international markets on account of delays in getting government approvals. By centralising the activity, the DGCI can keep a tab on the time line and ensure that exporters get the certificate without any delay,” said Mr Singh.
However, drug-makers in non-metro areas may find it tedious to get the certificate as they will have to travel to the DGCI headquarters instead of applying to the local authorities. To address such concerns, the DGCI is IT-enabling its systems, which will allow manufacturers to apply and receive approvals online. There is also a proposal to increase the duration of the certificates to five years so that manufacturers need not approach the regulator for renewal every two years

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