HP, Punjab oppose DCGI move to centralise licences

State governments such as Himachal Pradesh and Punjab have raised concerns over the national drug regulator’s decision to centralise the issue of export licenses to drug makers. 



    Health department officials from several states have written to the union health ministry objecting to the drugs controller general of India’s (DCGI) move, a health ministry official said. 



    The DCGI recently asked all state drug regulators to stop issuing licenses required for export of drugs. Earlier, states were entitled to issue export licenses or Certificate of Pharmaceutical Products (COPP) to drug manufacturing plants located in their state. 



    COPP, a stamp of compliance with manufacturing standards, is insisted upon by the governments in several countries such as Latin America, Africa, East Europe and South East Asia before they import drugs from other nations. Himachal Pradesh and Punjab have argued that state drug regulators have been issuing export licences for many years now. “Since drug manufacturing facilities are based in the state and manufacturing license is also issued by the state, state authorities say they should have the power to issue certificates to drug firms that will qualify them to export,” the official said. 



    The move will also likely to cause a “huge revenue loss to states as companies have to pay a fee while applying for a COPP,” a state drug regulator, who wished not to be named, said. Instead of centralising the process, the DCGI “should have trained and prescribed standard format to state offices,” he added. The DCGI’s move came in the wake of the World Health Organisation (WHO) recommendation to have a uniform certification system for medicines manufactured in India to facilitate its movement in the international market.