Mumbai: A delayed draft legislation proposing a central drug administration and a centralized drug licensing system has been pushed back further because it was not placed before Parliament on time.
The ministry of health and family affairs did not have a final draft of the Drugs and Cosmetics (Amendment) Bill, 2007, ready in time for the winter session that ends on Tuesday.
The ministry has been revising the draft Bill to include suggestions from a Parliamentary committee report that suggested changes in the proposed drug administration recommended in the original draft, which was tabled in Parliament in October 2007, before being sent to the Parliamentary committee for review.
The committee report, presented to both Houses of Parliament in October this year, suggested a drug administration that would be a restructured form of the existing Central Drugs Standard Control Organisation, which oversees quality regulation and marketing authorization of new drugs in India, and is headed by the drug controller general of India.
The original draft of the Bill was based on the recommendations of a 2003 committee headed by R.A. Mashelkar, former director general of the state-funded Council of Scientific and Industrial Research, which suggested a national regulatory agency to oversee the drugs and cosmetics industry.
The establishing mandate of the Mashelkar committee was that there “has not been a comprehensive review of the Drugs and Cosmetics Act, 1940, since its enactment, although rules have been amended from time to time to keep them up to date. There is also a national concern regarding the problem of spurious drugs”.
The original draft aimed to bring the process of drug approval and manufacturing licensing across the country under the proposed administration instead of the current dual-licensing structure shared between the Central and state governments for issuing licences for making and selling of drugs. The proposed switch was in line with Mashelkar committee recommendations.
The current regulator issues marketing authorization for new drugs, approves drug imports and clinical trials, and gives licences for vaccine and blood products. State drug control departments issue licences for drug manufacturing units, drug stores and selling of older drugs that have completed four years of first approval in the country.
This dual-licensing structure often results in varying drug quality, though medicines licensed by any state department can be sold across India.
“The new central licensing regime is going to clear up this menace,” said M. Venkateswarlu, who retired as drug controller general of India last year and in 2007 banned thousands of combination drugs licensed by various state drug controllers following safety concerns.
However, he cautioned that “in the absence of autonomous powers, the new regime will again get into hurdles of bureaucracy”.
According to the Parliamentary committee, the proposed administration would have 10 units, such as regulatory affairs and enforcement, new drugs and clinical trials, biological and biotechnology products, pharmacovigilance and drug safety, medical devices and diagnostics, quality control affairs, Indian systems of medicine and homeopathy, and training and international cooperation.
The panel also suggested amendments to the Drugs and Cosmetics Act to include provisions for clinical trials of medical devices and drugs based on Indian medicinal systems such as Ayurveda, Siddha and Unani, which is currently regulated by the department of Ayush (Ayurveda, Yoga, Unani, Siddha and homoeopathy) of the health ministry.
However, the new Bill may not push for a stringent clinical trial requirement for cosmetics and beauty-care products, following demands from the cosmetics industry, said an industry executive. He requested anonymity because the Bill is yet to be tabled.
The committee also recommended setting up regional offices and laboratories with information technology systems to expand and ease the reach of the proposed central drug administration, and to avoid inconveniencing the industry.