The Union health ministry wants to push the pending Drugs and Cosmetics (Amendment) Bill of 2007 seeking to set up the Central Drug Authority (CDA) without diluting the contents as early as possible. However, it is unlikely to come up in the Parliament during the forthcoming Monsoon Session, though the modified draft is ready.
Sources said the Ministry had incorporated some modifications, though not accommodating the entire set of recommendations by the Parliamentary Standing Committee on Health as the Ministry wanted to maintain the punch of the proposed authority. Ministry is in favour of centralising the licensing for manufacturing, sale, export and distribution of drugs, notwithstanding the opposition by several States in this regard.
“The Bill is not dropped yet. The Minister himself is very keen to revive it and get the nod of the Parliament. However, it cannot come in the forthcoming Session starting from August 1, as still formalities are left,” sources added.
The Drugs & Cosmetics (Amendment) Bill 2007 to amend the Drugs & Cosmetics Act, 1940 and to set up the CDA was introduced in the ‘Rajya Sabha’ on August 21, 2007 and was thereafter referred to the Parliamentary Standing Committee of Health and Family Welfare for review.
The Committee also had submitted its recommendations to the Government. The panel 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.
However, the Ministry had taken advices again from the experts on the issue. The CDA will ensure uniform interpretation of the provisions of the Drugs & Cosmetics Act & Rules, standardise procedures and systems for drug control across the country, enable coordinated nationwide action against spurious and substandard drugs, uphold uniform quality standards with respect to exports to foreign countries from anywhere in India, and create a pan-Indian approach to drug control and administration, according to the experts.
The Ministry is also mulling on the suggestion that registration and marketing authorisation for all new drugs and fixed dose combinations should be granted by the DCGI alone till the CDA is in place. This will ensure a smooth transition into the new system.