The strong opposition by several states have put the reintroduction of the Drugs and Cosmetics (amendment) Bill aimed at setting up the Central Drug Authority (CDA) on hold, even as the Union Health Ministry wants to push it without any further dilution.
The Bill, introduced in the Rajya Sabha, had been 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 so far as there is a general opposition to certain provisions of the said bill by the States and UTs,” a senior official of the ministry said.
The government wanted to make amendments to the D&C Act, 1940 in order to make it relevant to present time, especially based on the recommendations of the expert committee headed by Dr R A Mashelkar. “The Ministry is ready to introduce the bill in the Parliament once the States sent in their positive reactions,” he said.
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 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.
However, the Ministry had taken advices again from the experts who supported the CDA to 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 administration.