August 18, 2007

Life term for making, selling fake medicines proposed

Those producing and selling counterfeit and spurious drugs will face life imprisonment and/or fine of Rs 10 lakh. On the other hand, scientists violating and conducting unsafe and unethical clinical trials may soon face imprisonment of five years and a fine of Rs 20 lakh. The health ministry will table the amended Drugs and Cosmetics Act, 1940, in the current Parliament session.

While one part of the amendment will create the Central Drug Authority (CDA), the other envisages strict punishment for violation of the ethics related to clinical research and spurious drugs. Health Minister A Ramadoss said, “The Bill to provide for stricter penalties, provision for special courts for speedy trial of drug related offences and making all drug related offences cognizable and non-bailable was referred to Parliament's Standing Committee. Its recommendations have been incorporated in the revised Bill."

He added, “A Bill is also being introduced in this session providing for the creation of CDA for strengthening the regulatory system for licensing and control of drugs.”

Even though India is becoming a destination for clinical research for pharma groups looking for faster and more efficient ways to test drugs, with the country's total market for clinical research activities expected to touch $2 billion by 2010, there is at present no law to monitor the research and drug trials being conducted within the country. “The CDA Bill will also propose centralisation of licensing system with the Central government,” Union Health Secretary Naresh Dayal said.

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