Health ministry to inspect clinical trial sites from September

To ensure safety of volunteers participating in clinical trials, the ministry of health and family welfare is planning to conduct regular inspections of trial sites from September.

According to drugs controller general of India, Surinder Singh, inspectors will audit trial sites in Bangalore, Mumbai, New Delhi, Hyderabad, Kolkata, Chennai to check whether mandated protocols while conducting trials to bring new medicines to the market are being adhered to.

This comes just after the recent furore over irregularities in maintaining protocols and guidelines during the trial for cervical cancer vaccines by MNCs Merck and GSK in Gujarat and Andhra Pradesh.

“The objective is to ensure safety of volunteers and generate quality data.  We will also check whether sites have the standard infrastructure to ensure volunteer safety,” said Singh, whose job is to guarantee safety and effectiveness of every medicine sold in the country, and works under the purview of the ministry Of health and family welfare.

About 25 people have been trained for auditing the clinical trial sites according to Singh, and another 20 drug inspectors will be trained for the purpose.

India is big for conducting clinical trials on account of the huge population and low costs. Currently, over 600 trials are taking place in India. According to Associated Chambers of Commerce and Industry, India is set to grab clinical trials business worth approximately $1 billion by end of 2010.

Over 80% of these trials are phase II (done on 100-300 volunteers) and phase III (done on 1000-2000 volunteers).

“Trials are needed and new medicines are imperative, but more than the investment that would come in, the government needs to look at clinical trials from the point of view of the subjects of the trials, whether they are being duly informed about the benefits/risks of the trials, etc and whether the subjects have willingly chosen to participate in them,” says Gopal Dabade, convenor of All India Drug Action Network.

Moreover, the government should bring out in open all that has been observed during the site audits, says Anant Phadke, co- convenor of Jan Arogya Abhiyaan.

“This would bring in transparency and accountability.” Health-care industry experts say it would help if the government requests participation in the audits by various stakeholders like not for profit groups and civil society. “If civil society is asked to participate as observers, it would facilitate the objective of the audits better. These inspections should have stakeholders beyond government circles participating,” says Phadke.

Since June last year, when registration of clinical trials on the website of the central drugs standard control organisation (CDSCO) became mandatory,  trials are increasingly  getting registered, giving information on the objective of the trial, duration, etc.

According to Singh, since 2007, when only 11 trials were registered, at present the number has gone up to over 1000.  “Registration and inspections would be steps towards strengthening the system.”