Almost four years after the idea was mooted, the government has introduced a bill in Parliament proposing creation of a Central Drug Authority, which will not only curb the spurious drug menace but also regulate the emerging clinical trial market.
The bill, which seeks to amend the drugs and cosmetics act, was introduced in the Rajya Sabha by union health minister Anbumani Ramadoss on Tuesday.
While the Central Drug Authority (CDA) will have the power to issue manufacturing licences, its permission will be mandatory for conducting clinical trials. Currently the licences are issued by the state authorities.
Creation of the CDA and adoption of a centralised licensing system were first suggested by an expert committee, headed by then CSIR director general R A Mashelkar. The panel was set up in 2003 to look into the spurious drug menace and proposes ways to plug the loopholes.
Spurious drugs
Dr Ramadoss had earlier maintained in the LS that on an average 40,000 samples are tested by the states and the incidence of spurious drugs reported for the years 2004-05, 2005-06 and 2006-07 were between 0.182 and 0.29 per cent.
But other MPs have pointed out that out of Rs 19,000 crore worth of medicines sold in the market every year, medicines worth Rs 4,000 crore are fake. In most of the states almost 20-40 per cent of medicine available in the shops is fake, they said.
For the spurious drug manufacturers, the punishment will be imprisonment not less than five years, but which can go up to a life-term, along with hefty fine.
Besides curbing spurious drug market, the CDA will also regulate the emerging clinical trial market, which is estimated to become a multi-billion dollar business by 2010. Without CDA’s permission, no legal clinical trials can be conducted.
Indian Council of Medical Research (ICMR) officials told Deccan Herald that the ICMR had prepared a separate piece of legislation for regulating trials involving human subjects and the ministry had decided to incorporate the essence of that legislation in this amendment.
Those conducting clinical trials without the CDA approval can be punished for five years with Rs 10 lakh fine. For repeat offence, the punishment provisions can go up to ten years and fine up to Rs 20 lakh.
Under a Rs 354-crore World Bank funded project, the centre is now strengthening seven central and 23 state-level drug testing laboratories.