Chennai: The draft bill proposed by the Union government to amend the Drugs and Cosmetics Act 1940 will divest the powers of the state licensing authorities besides adversely affect the small and medium pharma enterprises in the country, say experts. The Drugs and Cosmetics (Amendment) Bill, 2015 (to amend the Drugs and Cosmetics Act, 1940) proposed by the Union health and family welfare department is set to be introduced in this Budget Session of Parliament.

The Bill, among the other things, aims at expanding the scope of the Act to cover new areas and will regulate the import, manufacture, distribution and sale of drugs, cosmetics, medical devices and conduct of clinical trials and for matters connected therewith or incidental thereto. Opposing the bill in its present form, the Chennai branch of the Drugs Control Department Retired Officers Association (DCDOA) has demanded the Centre to consult state governments before introducing the Bill. The ‘Third Schedule’ introduced in the draft should be dropped as it prescribes licences to be obtained from the central licencing authority.

This will reduce the powers vested with the state licencing authorities to a maximum extent, and it will adversely affect the small and medium pharma enterprises in the country, the association said. Interestingly, the Bill proposes to insert a separate chapter on clinical trial, Chapter 4A, according to which “no person, sponsor, clinical research organisation or any other organisation or investigator, shall conduct any clinical trial in respect of a new drug, investigational new drug, notified category of new medical device and investigational new medical device, new cosmetic, bioavailability or bioequivalence study of any new drug, in human participants except under, and in accordance with, the permission granted by the Central Licencing Authority in such form and manner as may be prescribed.”

Another major amendment in the medical devices sector, proposes to constitute Medical Devices Technical Advisory Board to advise the Central and state governments on technical matters pertaining to medical devices, arising out of administration of this Act.