Reviving the long-pending issue of the formation of Central Drug Authority (CDA) which was opposed by many States, the Planning Commission has recommended the creation of the central authority to centralize the operations of drug regulation in the country.

“As recommended by the Mashelkar Committee, a Central Drug Authority needs to be set up. This authority would review the issuance of licenses for manufacture and sale of drugs. Once this Authority is in place, suitable strengthening of its infrastructure and laboratories would be done. The Government would mandate that labels on drugs and food fully disclose all its ingredients,” according to the final Plan document approved by Government for the current 12th Five Year Plan.

The issue of establishing a centralized system of drug regulation has been almost forgotten by both the industry and the authorities, and the recommendation by the Planning Commission could now revive the debate once again. The Steering Committee of the Plan panel had also suggested the same.

When contacted, a senior official of the Health Ministry said the matter was still 'under consideration and further action'. However, he refused to give a timeline for the revival of the pending bill to establish the CDA, when pointed out the recommendation by the Plan panel.

Strong opposition by several States had in fact stalled the move to create CDA, which the industry had also resisted due to several reasons including the practical difficulties. However, the Union Health Ministry wanted to push the bill without any dilution.

The Bill to amend the Drugs and Cosmetics (D&C) Act and create the CDA was introduced in the Rajya Sabha and was referred to the Parliamentary Standing Committee in August 2007 for examination and report. On the basis of the recommendations of the committee as contained in its 30th report on the Bill, the health ministry had redrafted it.

The Ministry had accommodated many recommendations possible in the draft and it was circulated among the States and the Union Territories for their comments as health is in the Concurrent List. However, no final view could be evolved as there was a general opposition by the States against certain clauses in the Bill that sought to centralize the licensing for manufacturing, sale, export and distribution of drugs.

The Parliamentary Committee had virtually shot down the proposal for 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.