Updated on 15 October 2012
Ms Kumkum Sen is an Advocate on Record (AOR) of the Supreme Court of India since 1988 and is a current partner at Bharucha & Partners, New Delhi
Clinical trial is a process which involves testing of efficacy of drugs for the purpose of determination of safety, proper dosage range and side effects, prior to the drug being certified and released in the market. A treatment could be an oral medication, medical or biologic device, blood production, gene therapy. Before being prescribed on patients, items having acceptable safety profiles, undergo clinical trials on human beings.
While there is basis for clinical trials to be treated as matters of concern, such trials are indispensible - to put it bluntly, to improve quality of treatment, to determine if a new medication is safe and effective, to find more ways to treat, prevent, or diagnose diseases, reduce toxicity and lower side effects of treatment, so that patients can be given better cure and comfort, there is no alternative to clinical trials.
The question is how such trials should be conducted. From the technical perspective there are stages and phases; the initial stage is that of study on laboratory animals, before being escalated to the human level. There are concerns about animal testing as well, but there is no alternative as the initial process which involves co-relation.
At the human being level, the trials are divided into four phases; the first phase is restricted to a small group of 20-to-80 persons and the purpose is to determine the level of tolerance and adverse reactions, if any. The second phase is more exploratory and involves a larger group of people that is, 100-to-200 in number. In the third phase which is confirmatory in character approximately 1000-to-3000 persons are administered. The last phase is usually conducted after the drug or treatment has been marketed for continuous study and monitoring of the drug by collecting information from the affected population, particularly in its long term use.
There are certain laws, rules and regulations which govern clinical trials in India, of these the major one are the Drugs & Cosmetics Act specifically Schedule Y thereof contain provisions which require a license to be obtained before manufacturing, importing or marketing a new drug in India. Part XA (Rules 122A to 122E) of the Rules lay down the conditions and procedure for making applications for the grant of a license and the ICMA guidelines which seek to introduce and regulate effective ethic guidelines for the tests to be conducted.