National

New body to streamline drug licensing, imports

CHENNAI: The Central government is set to introduce a bill in the monsoon session of Parliament to bring about changes to the body that regulates the manufacture, import, storage, promotion and use of medicines, cosmetics and other pharmaceuticals.

The new structure is designed to centralise drug approvals and tighten the lax manufacturing practices that have led to a proliferation of poor ethical practices and substandard drugs, endangered lives and given the pharmaceutical industry a bad name.

According to a Cabinet note, a new independent Central Drugs Authority of India (CDAI) will replace the Central Drugs Standard Control Organisation, along the lines suggested by the former CSIR Director, Dr. R.A. Mashelkar’s expert committee in 2003.

The CDAI is to “be responsible for the development and definition of basic standards,” “provide technical vision” and ensure that “for every activity there [is] a clear policy framework and efficient supervision to ensure a uniform legislation.”

Ten new divisions headquartered in Delhi are to take up specific roles, including regulation, enforcement, legal and consumer affairs; biotechnology products; pharmacovigilance/drugs safety; medical devices/diagnostics; imports; quality control; and Indian systems of medicine.

The States will continue to grant drugs sales licences, but responsibility for the manufacturing licences is to move over a five-year period to the CDAI. Additionally, the penalty for conducting clinical trials without permission is to be raised to 10 years’ imprisonment with a fine of Rs.20 lakh.

The Drugs Controller General (DCG) is to become Additional Secretary, and two Additional Drugs Controllers will work under him, one on Indian systems of medicine and the other on the remaining issues.

Two new zonal offices are to be set up in Hyderabad and Chandigarh, and 114 posts created on top of the 82 currently sanctioned, of which 29 lie vacant. The extra cost of expansion, estimated at Rs.3 crore, is to be met through new fees for inspection and registration, and licenses for manufacturers, new products and clinical trials.

Both pharmaceutical stakeholders and public health groups feel that having a Central authority with greater manpower will streamline licensing and improve quality control monitoring. “The authority on drugs control today is overloaded,” said D.G. Shah of the Indian Pharmaceutical Alliance.

“If the DCG is away or attending parliamentary questions, the drug approval process comes to a standstill. The changes should bring in more efficiency and allow time for in-depth study of applications.”

“Across the world, there is one central drugs authority. I would go for it,” Ranjit Shahani said on behalf of the Organisation of Pharmaceutical Producers of India.

“At present, there are a lot of gaps, especially when it comes to registering drugs for clinical trails. Companies slip through the net easily,” said Kajal Bhardwaj from the Lawyers Collective, a non-governmental organisation that provides public interest legal services.

“Greater centralising of drug approvals will help. Almost all approvals for combination drugs over the past few years should not have been allowed,” said Dr. Amit Sengupta of the People’s Health Movement.

The DCG on Tuesday banned 12 combination drugs, and the State regulators are to act on 34 others.

The lack of adequate staff is another reason for the absence of quality control, Dr. Sengupta said. Since many large companies, both domestic and multinational, subcontract their manufacturing to small dispersed units, determining quality without enough inspectors is difficult.

The new legislation will address these concerns.

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