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IPA suggests nine proposals to Union govt to be included in D&C Amendment Bill 2015

Peethaambaran Kunnathoor, Chennai
Thursday, February 19, 2015, 08:00 Hrs  [IST]

While the Union government is preparing for amendment of Drugs and Cosmetics Act and Rules, the Indian Pharmaceutical Association (IPA) has submitted nine proposals to the department of health and family welfare to be considered for inclusion in the Draft D&C Amendment Bill, 2015.

While the association puts major recommendations for the growth of Indian pharmacy profession and public health, it is also concerned about the centralisation of regulatory power by the Union government. It has said that the provisions proposed in the draft are aimed to centralise the power in the hands of the Union government or the Central Licencing Authority (CLA) which will undermine the function of state licencing authorities who have large and capable infrastructure.

IPA argues that the draft contains so many conflicting provisions which if not reviewed, would hinder the growth of the pharma industry, especially the SMEs. Empowering only CLA to regulate medical devices and clinical trials throughout the country will seriously hinder proper vigilance leading to significantly poor compliance of regulatory mandates and ultimately hamper the consumer interests.

The recommendations sent by IPA general secretary, Kaushik Deshai, pointed out that some of the proposals in the draft bill showed a marked deviation from the recommendation of Parliamentary Standing Committee (79th report).

The association suggests that the definition of ‘new drug’ should be in tune with Rule 122E of the Drugs and Cosmetics Rules, where a specific period has been fixed for a new drug. If the period is not fixed, it will encourage monopoly of the particular manufacturing company.

The draft replaces the terms ‘drug inspector’ as ‘drug control officer’. As per the Bill, the drugs control officer authorised by CLA has been empowered to inspect any institution conducting clinical trials. He is also empowered to initiate prosecution under Section 4T.

According to IPA, for effective regulation, state drugs control officers should also be given power in both Section 4H and Section 4T.

While constituting Medical Devices Technical Advisory Board (MDTAB), one expert with pharmacy education nominated by pharmacy council of India and one pharmacist from drugs control administration should be included in the Board.

The state licencing authorities should also be empowered to issue licence for manufacture or sale or distribution or marketing of any medical device. The power should not be vested exclusively with the Central Licencing Authority, IPA wants.


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