The Madras High Court stayed the order issued by Drug Control General of India directing all the zonal and sub-zonal offices of CDSCO to issue WHO-GMP Certificate of Pharmaceutical Products (CoPP) through their offices from October 1 this year.
The stay order comes as a big blow to the Union Health Ministry's efforts to clip the wings of the state drug controllers in granting CoPP. Justice Jyothi Mani, was hearing the petition (WP No. 20862/2009) filed by D I Dileep Kumar, the secretary of the Tamil Nadu Drug Inspectors Association on Tuesday. The stay will be in force until further orders.
The office of the DCGI had, in last month, issued guidelines for grant of CoPP by the CDSCO offices from October 1. Apart from DCGI, 12 other CDSCO officers including all heads of CDSCO zonal and sub-zonal offices were authorized to issue the Certificate from this month onwards.
According to informed sources, the DCGI has decided to centralize the process on the pretext that the certificates issued by states in many cases do not conform to the norms of WHO certification scheme and in some cases even the prescribed formats are not adhered to. The certificates could be obtained by those who had complied the norms of Good Manufacturing Practices.
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.
Commenting on the judgment, J Jayaseelan, Hon' secretary of Indian Pharmaceutical Association, Tamil Nadu Chapter said the verdict of the court comes as a great relief to all the small and medium manufacturers. "It not only spells victory for the local manufacturers and exporters, but it is a proud moment for the state drug control officials also. We have allegiance to the Central as well as the state administrations, but we want some comfort of our business. That's all," he said.
Earlier in the directive, issued by the DCGI, it has been stated that the application for grant of WHO GMP (CoPP) shall be made to respective zonal or sub zonal officers as per the requirement. The Certificate would be issued by zonal or sub zonal officers on behalf of Drugs Controller General of India after inspection and satisfactory clearance by CDSCO officers as per WHO-GMP guidelines.