Task force recommends strengthening of CDSCO and to create a regulatory cell in NIPERs & other institutes

Ramesh Shankar, Mumbai Monday, June 29, 2015, 08:00 Hrs  [IST]

The task force on 'Enabling the private sector to lead the growth of pharmaceutical sector in the country', constituted by the Department of Pharmaceuticals (DoP) in November last year, has recommended to the government to create a regulatory cell in NIPERs and other institutes to support the Indian pharma sector understand the global regulatory landscape.

The regulatory cells in NIPERs will play a key role across the functionalities of process support, capacity building and infrastructure support. These cells should have working relationships with other regulatory institutes like Centre for Innovation in Regulatory Sciences UK, DIA (USA), Centre for Regulatory Excellence at the Duke- NUS Graduate Medical School (Singapore), etc, the task force in its recommendation said.

The task force, headed by secretary, DoP, also recommended that the CDSCO needs to be strengthened and empowered both in terms of providing infrastructure support, capacity building etc. to address the growing challenges and demands of the pharmaceutical industry.

As on 2013-14, CDSCO has only 340 sanctioned posts including
administrative personnel as compared to US FDA’s 13,000 sanctioned posts of technical and administrative staff. Moreover, out of these 340 seats, only a few have been recruited so far. Henceforth, CDSCO needs to recruit manpower at various levels/designations; and to increase the number of sanctioned posts to manage the daily operations efficiently.
The drug inspectors need to be recruited for effective control and monitoring of various units and outlets. One drug inspector per 50 manufacturing units and one drugs inspector per 200 sales/distribution outlets is required for effective implementation of functions assigned to state drug regulatory authorities. There are approximately 600,000 retail sales outlets and around 10,500 manufacturing units in the country, which require over 3,200 drugs inspectors. However, in reality, there were only 846 drug inspectors in place against 1,349 sanctioned posts in the states, the task force observed in its recommendation.

The task force was set up to identify the challenges before the Indian pharmaceutical industry pertaining to various government departments and agencies and was asked to focus on the need for integrated and coordinated thinking to promote the growth of the private sector in pharmaceutical sector.

The task force was also mandated to identify areas of duplication, if any, among different government agencies and departments on issues relating to pharmaceutical industry including research. The task force was also asked to suggest suitable changes in the administrative arrangements or administrative mandate of government agencies and departments to enable better and coordinated facilitation and support to the industry. Other terms of reference of the task force include, exploring the possibility of having a single window clearance type of facilitation for the industry for the required regulatory approvals; working out the mechanism for a regular and institutionalised forum for government industry partnership where the industry issues can be redressed periodically and in a time bound manner; and exploring the possibility of linking the Indian pharmaceutical industry with various educational and research institutions in the government sector like NIPERs, Research Institutes under Department of Health Research, Department of Biotechnology, Department of Science and Technology and others.