|
Task force recommends strengthening of CDSCO and to create a regulatory cell in NIPERs & other institutes
|
|
Ramesh Shankar, Mumbai
June 29 , 2015
|
|
|
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.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|