Even after the Madras High Court staying the Drug Controller General of India (DCGI)'s order of centralization of the issuance of Certificate of Pharmaceutical Product (CoPP) around three weeks ago, the Central Drugs Standard Control Organisation (CDSCO) officials are still continuing their mandatory inspections of the drug manufacturing sites in several parts of the country for issuing the CoPP.
According to sources, after the Madras High Court stay orders the CDSCO (DCGI office) officials are still continuing their inspections, especially in states like Punjab and Haryana. The officials have already inspected the sites of Unichem, Ranbaxy, etc in Punjab and are scheduled to inspect the manufacturing sites of Dabur in Baddi, Himachal Pradesh in a day or two, it is learnt.
When contacted, the Deputy Drugs Controller (north zone) Dr D Roy refused to divulge anything. “We might be conducting several inspections, but I cannot disclose these things, especially when the issue is sub-judice. You can contact DCGI in this regard,” he said.
Meanwhile, the state drug authorities of these states have been kept in dark about the continuing inspections. The drug authorities in these states said they have no information about the inspections. But, they have confirmed that the officials of the CDSCO are conducting the inspections.
Meanwhile, the DCGI office is preparing to file an application in the Madras High Court for the early vacation of the stay orders. During the last around three weeks, the Madras High Court had granted three stay orders on the issue to three different parties.
Three stay orders are pending in the Madras High Court. The court granted the first stay order on the DCGI's order on CoPP on October 13 against a petition filed by D I Dileep Kumar, the secretary of the Tamil Nadu Drug Inspectors Association. Again the court granted stay on this issue on October 16. This time the petition was moved by B Sethuraman, chairman of the Federation of South Indian Pharma Manufacturers Association which has members across four states of the South India. The third stay was granted by the Madras High Court on October 23, and the petition was filed by Confederation of Indian Pharmaceutical Industries (CIPI) which has members across the country.