Expert committee to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs-comments

Abstract

All is not well with the clinical research industry. Instances of scientific misconduct by investigators, cutting corners by sponsors, irregularities by regulators, have brought a bad name to the industry. These however form a small part of the clinical research done in this country. The US FDA has conducted over 40 audits, and not made any major observations, suggesting that the clinical research in India is by and large above board. Regulators have amended trial rules recently which have cost the industry dear. A committee appointed to formulate the policy and guidelines for approval of new drugs, clinical trials and banning of the drugs has made 25 recommendations of which most are either superfluous or not likely produce the desired effect. Clubbing banning of the drugs with approval of new drugs and clinical trials also does not make sense, since the mechanisms involved are totally different. Barring a few, most recommendations are counterproductive and should be rejected outright. It is time we learnt that appointment of a committee is not the best way to solve a problem.

Keywords

• Clinical research
• drug development
• guidelines
• policies
• regulations