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P.T. Jyothi Datta

Parliament likely to amend Drugs Act in monsoon session

Mumbai June 21 The proposed regulatory Central Drug Administration (CDA) is set to take one step closer to being eventually established, with Parliament expected to take up the amendment of the Drugs and Cosmetics Act 1940, in the monsoon session next month.

The amendment would pave the way for the autonomous CDA that combines several roles — from centralised regulatory approvals to market medicines in the country, to monitoring clinical trials, medical devices, biotechnology drugs and so on.

At present, State-level regulatory clearances are given to drug companies.

A Union Health Ministry official told Business Line that centralising regulatory approvals would be brought in over a five-year period, till the CDA has its systems and people in place.

For the domestic drug industry, the centralised authority is expected to bring in uniformity and transparency in dealing with the regulator, said an industry-hand.

Despite repeated suggestions in the past for a central regulatory body, it was a Mashelkar committee report in 2003 that hammered home the need for a dynamic regulatory system to keep pace with the changing environment in the pharmaceutical industry. At present, the regulatory Drug Controller-General of India's (DCGI) office has its hands full with monitoring whether globally recalled medical devices such as stents are sold in India, and watching whether safety warnings are required on diabetes drugs or weight-loss medicines, to mention a few recent instances.

The proposed CDA is expected to have a five-member body under a Chairman, who is likely to be an "eminent" person in the scientific field, said an official with the Chemicals and Fertiliser Ministry, handling the pharmaceutical sector.

The board would handle policy decisions, and the DCGI would be the executive arm, the Health Ministry source said.

Modelled on the lines of the United States' Food and Drug Administration, the proposed CDA assumes significance against the backdrop of more research work on new and biotech medicines being done in India.

The pharmaceutical industry is estimated to have clocked over Rs 62,000 crore sales, including domestic sales of about Rs 35,000 crore.

India is increasingly being touted as a destination for clinical trials.

Related Stories:
Health Ministry proposes independent drug regulator
Mashelkar panel favours centralised drug licensing

More Stories on : Pharmaceuticals | Regulatory Bodies & Rulings | Policy

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