The case regarding the issuance of Certificate of Pharmaceutical Products (CoPP), which is, under the consideration of the Madras High Court, came up for hearing on November 25, but got adjourned for next Wednesday for final hearing.
The lawyer of the petitioner (M Dilip Kumar, secretary of Tamil Nadu Drug Control officers Association) has prayed for some more time for the party to appear in the court for replies and arguments. So justice K Venkitaraman, before him the case came up for adjudication, has 'posted it finally' for next Wednesday.
Assistant Drugs Controller in Central Drugs Standard Control Organisation (CDSCO)’s Chennai office, Shanthy Gunasekaran, has filed two more counter petitions in the high court on November 24 against the writ petitions filed by the Federation of South Indian Pharmaceutical Manufacturers Association and the Confederation of Indian Pharmaceutical Industry. The court may consider them along with the first one in next hearing.
Meanwhile the Karnataka High Court, where the State Manufacturers Association filed a writ petition against the DCGI’s circular, has posted it for final hearing on December 11. The petition was also countered by the CDSCO south zone office located in Chennai.
The Madras High Court had passed an interim stay order on October 13 restraining the implementation of the Drug Controller General of India’s circular dated September 1, 2009 informing all the State Drug Controllers that the WHO-GMP CoPP would be issued by his offices from October 1 this year. The issue relating to the circular has later become a bone of contention between the CDSCO offices and the state drugs regulators who were supported by the manufacturers associations.
All over the country, the manufacturers and state regulators have raised objections against the DCGI directive saying it is unfounded. They have alleged that the DCGI’s office was trying to take away the powers of state drug controllers in granting CoPP. The manufacturers were of the view that the DCGI could not issue such an order as he was not a licensing authority, and said the circular remained as a boon for the small-scale manufacturers of the country.
Along with the circular, the DCGI office has directed all his zonal and sub-zonal offices to issue the certificate from this month onwards. According to manufacturers, the DCGI had decided to centralize the process on the pretext that the certificates issued by states, in many respects, did not conform to the norms of WHO certification scheme and the formats each state used were not matching the prescribed ones approved by WHO.
The certificate is a stamp of compliance with the WHO standards which all member states have been urged by the global organization to adopt and work as a passport for mutual recognition of inspection standards regarding manufacture of drugs.