The Union Health Ministry's renewed attempt to establish the controversial Central Drug Authority (CDA), aimed at centralising the drug regulatory mechanism in the country, may not be a smooth affair. More than 12 major states in the country are vehemently opposing the formation of the authority, it is learnt.

Sources close to the development said that major states where the concentration of the pharma industry is the most, are in favour of continuing the present system of drug licensing under which the state drug authorities are authorised to issue drug licenses. However, the sources refused to divulge the states which are opposing the CDA formation. Major states where the pharma industry matters in the country include Gujarat, Maharashtra, Karnataka, Tamil Nadu, Andhra Pradesh, Goa, Uttarakhand, Himachal Pradesh, Punjab, Madhya Pradesh, West Bengal and Rajasthan.

The Union Health Ministry in September last year had asked all the states in the country to make fresh suggestions on the formation of the CDA. While union health minister Ghulam Nabi Azad had written to all the chief ministers to make fresh suggestions, the union health secretary had written letters to the state health secretaries in this regard. Sources said that all the states have already given their opinion on the issue to the health ministry.

The state governments' stiff opposition against CDA may put the union health ministry in a quandary, especially at a time when Azad is learnt to be showing interest in the formation of the authority which was a dream project of former Union health minister Dr Anbumani Ramadoss. Though initially not in favour of the CDA, Azad is now convinced about the need for CDA as the senior officials in the ministry have been able to convince him about the need for the formation of such an authority in the country, sources said.

The formation of the CDA was a contentious issue between the government and the industry, especially the small and medium drug manufacturers. Though the Bill proposing to make amendments in the Drugs and Cosmetics Act, 1940, to facilitate the creation of CDA was to be introduced in Parliament during the last session of the last government in March 2009, the government shelved the move at the eleventh hour, presumably under pressure from the small scale industry associations and other interest groups.

When the government announced its intentions to form the CDA more than three years back to centralise the drug regulatory system in the country, there were protests from the small scale sector and other interested groups against the CDA. As the protest against the formation of CDA reached its crescendo, the central government formed a Parliamentary panel under Amar Singh to get the feedback of different stakeholders on the issue. To elicit the opinion of the stakeholders, the panel had sittings in different parts of the country. During its sittings, the committee interacted with representatives of small and large drug manufacturers associations, experts, organisations, NGOs, consumer forums and officials of the state drug departments.

Apart from the small and medium scale units, the state drug authorities have also been opposing the formation of CDA. The state authorities had appraised their views to the Amar Singh committee. After hearing all the stakeholders, the Amar Singh committee had also opposed the formation of a totally new central authority but called for strengthening the existing set-up to streamline the sector by setting up Central Drug Administration.