The Centre may tone down the much-criticised provision of issuing manufacturing licences only by a centralised agency based in Delhi under the proposed Central Drug Authority of India, by empowering the zonal offices of the Central Drugs Standard Control Organisation (CDSCO) also to issue licences.
The Parliamentary standing committee on health and family welfare, which has been examining the Drugs and Cosmetics (Amendment) Bill 2007 seeking to set up the CDA, is likely to make a recommendation in this regard. The Committee has recommended that instead of entrusting entire powers of the State licensing authorities with the CDA, four zonal offices of the CDSCO should also be made licensing authorities for the respective regions, it is learnt.
The clause in the bill to centralise the licensing system had invited wrath from different quarters especially the small and medium scale companies and associations representing them during the sittings of the parliamentary panel headed by Amar Singh. The small scale drug manufacturers accused the proposed CDA as a 'tool' to make their lives worse. It would be nearly impossible for the manufacturers based in different corners of the country to come and seek licences from Delhi for every drug, they claimed.
Taking into consideration these difficulties, the Parliamentary committee is understood to have made the suggestion for devolution of the powers to the zonal offices, so that the original goals of having a centralised regime for streamlining and monitoring the sector could still be met even while ensuring better logistics for the industry. As zonal wings are directly manned by the Central office, the entire licensing system still remain centralised. This would also lead to procedural delays which could happen due to piling up of applications at one point.
The House panel, which held extensive discussions with industry bodies, NGOs, government officials and other stakeholders, is reportedly finalising its recommendations which will be tabled during the forthcoming monsoon session, slated to commence from October 17. The bill, which was presented in the Rajya Sabha on August 21, was referred to the panel for examination and report. The panel had been granted extension till the first week of Monsoon session 2008. It has not sought for further extension now as it has concluded the deliberations, sources said.