With only few days left for the current Parliament Session, the long-awaited Drugs and Cosmetics (Amendment) Bill, 2013 that seeks to set up the Central Drugs Authority is unlikely to be presented in the House, unless the Union health ministry really pushes it hard.
Though listed for introduction during the session that concludes on August 30, the Parliament could not take up much legislative business so far due to continuous disruptions. Besides, the stalemate over the passing the Food Security Bill also forced the postponement of many scheduled bills. With only seven more sittings left, the chances of the CDA bill coming up for introduction are getting bleaker.
“Notwithstanding the logjams and disruptions, the Ministry was able to table the Mental Health Care Bill, 2013 on Monday and hence efforts are being taken in right earnest to push the CDA bill also,” sources said, still expressing hopes.
However, it is learnt that many states are still not happy with the provisions in the proposed CDA Bill and the Government is expected to face heat from the members. This has also prompted the Ministry to keep the bill on the back burner.
According to the provisions, licenses for manufacturing drugs under 17 key categories will be given only by the centre through the Central Drugs Standard Control Organisation (CDSCO) and not by states. Currently manufacturing licenses for these drugs are granted by state drug controllers after obtaining a no-objection from the central drug controller. The 17 critical categories of drugs include lifesaving drugs, vaccines and DNA products which require specialised manufacturing, it is learnt.
A Central Drugs Authority will be set up to act as an appellate body for central and state drug controllers. The Authority will have the power to review, suspend or cancel licenses granted by the central and state drug authorities.
Currently medical equipment is classified as a ‘drug’ under the D&C Act, 1940. The new Bill creates specific provisions relating to medical equipment in order to regulate, monitor and set standards for medical devices and establishes a Medical Devices Technical Advisory Board.
The Bill also lays down provision for the grant of compensation in the case of death or injury to the individual participating in a clinical trial. There will be a whole chapter to streamline the clinical trial sector, incorporating the guidelines already issued by the CDSCO.
The Mental Health Bill, introduced in the Rajya Sabha, seeks to decriminalizes suicide and states that any person attempting suicide would be presumed to be mentally unwell unless proved otherwise, among many key provisions.
One of the significant features of the bill is that it gives every person the right to make an “advance directive”, which is essentially a written statement stating how they want to be treated when they’re not in a state to make appropriate decisions.