The All India Drugs Control Officers' Confederation (AIDCOC) has raised alarm over the proposed move of the Union health ministry to centralise the drug licencing system of the country stating that it can jeopardise the availability of safe, efficacious and rational drugs to the people.
In a strong message directed at the Centre, the association pointed out that vesting enormous power on the CDSCO when the organisation is very weak and ineffective in terms of inadequate and inexperienced manpower will not be able to deliver the desired results. On the contrary, they fear it will lead to a chaotic regulatory situation, leading to delay and hardship to all the stakeholders.
Section 18 of the recently released draft Amendment Bill, 2015 to the Drugs & Cosmetics Act proposes to give powers to grant manufacturing licences to central licencing authority. Under this, Centre shall have exclusive power to issue a licence in respect of manufacture for sale or for distribution or for marketing of drugs specified in the third Schedule, which includes 17 categories of drugs.
AIDCOC informed that the proposal to bring the licencing of 17 categories of drugs into the purview of Central government, which comprises major portion of the drugs manufactured in India, including the fixed dose combinations, is done with complete disregard to the observations of the parliamentary committee.
Practically, every manufacturer will have fixed dose combinations in his product list. Therefore, every manufacturer will have to obtain licence from the central licencing authority in addition to obtaining license from the state licencing authority. Thus, inclusion of fixed dose combinations in the third Schedule amounts to taking over entire manufacturing licencing by the Centre, claimed AIDCOC.
The association argues that centralising the licensing system is not a solution to the problem of spurious and sub-standard drugs in India. Ravi Uday Bhaskar, secretary general of the AIDCOC stressed, “The solution to the problem lies in building competence in the state drugs control organisations by strengthening the drugs control organization at state level and by enhancing technical, managerial, legal and investigation skills of the officers through scientifically designed training programmes.”
He further added that the state drug control administration is completely marginalised and their role in the licencing of manufacturing is completely ignored. Further he pointed out that if manufacturing activity is controlled by one agency and the sale and distribution is regulated by another agency it can lead to problems of jurisdiction, investigation, enforcement and co-ordination between state and central government.
AIDCOC informs that at present, there are about 175 regulatory officers in CDSCO, of which, 90 per cent were recruited recently. On the other hand there are about 3000 regulatory officers in various states of the country, wherein 50 per cent of them have more than 15 years of regulatory experience in dealing with the enforcement and licensing system.
“Having regard to the existing scenario and the state of affairs in CDSCO, it is clear that CDSCO is not in a position to undertake additional responsibilities. Thus we strongly feel that rather than focusing on centralising the licensing system, stress should be on strengthening the drugs control organisations at state level as recommended by Dr Mashelkar Committee,” Bhaskar said.