Even as the Drug Controller General of India (DCGI) has taken steps to centralise the issuance of certificate of pharmaceutical product (CoPP) amid widespread resentment from the industry and the state authorities, the pharmaceutical department is also taking up the issue at the highest level to convey the feelings of the industry and solve it.
The pharma department, being the administrative department for the pharma industry, will take up the matter with the health department at the secretary level as the industry in general had resented to the centralization of the CoPP, it is learnt. The issue of CoPP was one of the main concerns of the industry when the associations had an interaction with the pharma secretary some time back and the secretary was briefed on the difficulties to be faced by the industry, especially the small scale units, sources said.
"The department also has got representations from associations expressing concerns on the centralization of the CoPP and the department is looking into all options to help the industry. As the CDSCO is falling under the health department, a secretary-level meeting apart from conveying the concern in writing is being planned on the issue. The pharma department has the obligation to address the grievances of the industry and take it up with the concerned authorities," sources said.
Besides, the department also is seeking the support of the MSME commissioner as the small scale units are going to be more affected by the decision. It hopes that a combined pressure by different quarters will have some effect on the health department to intervene in the issue and address the grievances of the industry.
After the DCGI initiated steps to centralise the CoPP from October 1, there has been widespread opposition from different sides including the industry and the state licensing authorities. The DCGI had taken the step citing the concerns by the WHO on the lack of a single authority in issuing CoPP for the entire country. Besides, the confusion created by some licensing authorities by issuing 'WHO-GMP Certificate' also prompted him to streamline the system.