The Parliamentary standing committee on health and family welfare has virtually shot down the proposal for a new Central Drug Authority (CDA) and instead recommended setting up of a 'central drug administration' as an independent body under the ministry with headquarters in Delhi and its zonal and sub-zonal offices at state-level, by strengthening, modernising and restructuring the CDSCO.
Backing almost all the recommendations made by Mashelkar Committee in 2003 for a strong, well-equipped and professionally managed CDSCO, the panel headed by Amar Singh however approved a centralised licensing system, but with a network of offices at the zonal and sub-zonal levels.
The much-awaited report on the Drugs and Cosmetics (Amendment) Bill, 2007 was tabled in the Rajya Sabha on Tuesday, after a year-long examination involving on-site studies, sittings in different places and elaborate discussions with the industry. The bill now may be redrafted in line with the recommendations and could come up again, possibly during this session itself, sources said.
"The committee fails to understand as to why, instead of implementing, the recommendations of the Mashelkar Committee for strengthening, modernising, restructuring and reforming the existing Central Drugs Standard Control Organisation into a world class system, the government has entered into rigmarole of setting up a new authority, Central Drugs Authority. A small body primarily having members with administrative background taking the place of the two Drug Technical Advisory Boards having technical expertise from allopathic and ASU drug sector is simply not acceptable to the committee," the report said.
The panel, which scrapped the idea of new CDA, chairman and members to run a new set up, however favoured 10 divisions to be included in the central drug administration. "The committee observes that broadly-speaking, the proposed set-up under the CDA is based on the set-up of central drug administration proposed by the Mashelkar Committee. Ten divisions are proposed under both the set-ups, the only difference being a separate division of Indian system of medicine and homoeopathy under the ministry set-up. Another major difference would be replacing the two DTABs and performing their functions and advising the DCGI, who will be the CDA member-secretary on all matters relating to drugs and cosmetics. Since the committee is not in favour of creation of a separate CDA, the central drug administration as suggested by Mashelkar committee may be brought into effect as early as possible," the report stated.
It also shot down the justifications given by the health ministry officials in support of a new authority. The panel also cited statement made in the pharmaceutical policy 2002, which also aimed at modernising and restructuring the existing system.
The panel, which stressed the need for expanding the drug administration, welcomed the special drive to fill up the posts. It also agreed with the proposal to raise the post of DCGI to the level of additional secretary, from the present status of joint secretary and creation of an additional post of Assistant drug controller for Ayush.
The committee felt that by setting up network of zonal and sub-zonal offices to issue licences the problems for the stakeholders arising out of centralised system could be avoided even while meeting the goal of having a centralised set-up. However, it also added that there should be redress mechanisms at these zonal offices too.
Citing the ground realities in majority of states, the panel rejected the contention that existing systems at the state-level were superior to the proposed centralised set-up. At the same time, it suggested a 10-year transition from the current state-level mechanism to a centralised set-up, though the bill originally provided for five years.