DCGI issues norms to make clinical trials more ethical

The apex drug regulator — Drugs Controller General of India (DCGI) — has come out with a comprehensive clinical trial inspection programme for the country.

Specific guidelines and checklists prepared as part of this exercise are expected to make clinical trial regulation more stringent and uniform.

The programme turns significant, as India, with over 500 clinical trials getting approved on an average in a year, is one of the hot destinations for such studies conducted by global pharmaceutical companies.

Leading players with active presence in India are Glaxosmithkline, Johnson & Johnson, Sanofiaventis, MSD, Eli Lilly, Novartis, Bristol Myers Sqibb, Bayer Healthcare, Astra Zeneca and Pfizer, and clinical research organisations (CROs) like Quintiles, ICON, GVK BIO Siro Clinpharm, Parexel, PRA International PPD, Covance, Omnicare and Kendle, among others.

According to a senior health ministry official, the guideline will help India boost its image as a destination for ethical clinical trials. “The manner in which clinical trials are conducted are important as the data generated may result in the final marketing approval of a new medicine. Through the comprehensive guideline we are now showcasing how it’s done in the country,” he said.

The objective of the programme is to verify the good clinical practice compliance and to protect the rights, safety and well-being of the subjects involved in clinical trial. The credibility and integrity of clinical trial data generated and the compliance with various regulatory provisions according to Drugs & Cosmetics Rules will also be ensured through the structured programme.

It will provide a direction to drug department officers for conducting inspection of clinical trial sites, facilities of the company or organisation that sponsors such trials and also the facilities of clinical research organisations that undertake the trials.

According to ministry statistics, the number of deaths among clinical trial volunteers were 132 in 2007, 288 in 2008, 637 in 2009 and 462 up to June this year. Most of these deaths were due to diseases like cancer as patients undergoing clinical trials were critical or terminally ill. Side-effects of unrelated cause can also prove fatal on some occasions.