The Central Drugs Standard Control Organisation (CDSCO) attached to the Directorate General of Health Services (DGHS) has invited expert opinion on the existing guidelines on good clinical practices for clinical research and the draft guidelines for bio-availability / bio-equivalence studies on conventional and extended release dosage forms. The CDSCO is currently reviewing the guidelines to release contemporary guidelines that are in tune with the current scientific knowledge on the subjects. The opinion of the concerned professionals and stakeholders are expected by the end of April 2003 for facilitating the review.

The draft guidelines for bio-availability / bio-equivalence studies on conventional and extended release dosage forms brought out by CDSCO, once finalized, are to be an annexure to Schedule Y of the Drugs & Cosmetics Act, 1940. The current draft describes in vivo bioavailability / bioequivalence studies and in vitro dissolution testing recommended to applicants intending to submit Abbreviated New Drugs Applications (NDAs) for conventional and extended release dosage forms administered orally.

The guidelines spell out the standards on procedures, norms, design, conduct, interpretation and evaluation of data from these studies. The existing guidelines say that these studies should be conducted for oral dosage forms that are systematically absorbed. "For formulations existing in multiple strengths of a given dosage form, bioequivalence studies may be conducted on the highest strength only, provided the lower strengths have excipients identical to the highest strength and their dissolution profile matches that of the innovator and shows linear dissolution kinetics," it says.

The good clinical practice guidelines for clinical research in India has been prepared by an expert committee set up by CDSCO for generation of clinical data on drugs after it was realized that clinical research is the key to the discovery of latest diagnostic methods and to develop modern drugs for treatment of diseases.

Good Clinical Practices (GCP) is an ethical and scientific quality standard for designing, conducting and recording trials that involve the participation of human subjects. Compliance with this standard provides assurance to public that the rights, safety and well being of trial subjects are protected, consistent with the principles enshrined in the Declaration of Helsinki and ensures that clinical trial data are credible.

It has been widely recognized that India offers unique opportunities for conducting clinical trials in view of the large patient pool, well- trained and enthusiastic investigators and premiere medical institutes available in the country along with considerable low per patient trial cost, as compared to developed countries.

The review of the guidelines would help India update its own guidelines and ensure uniform quality of clinical research throughout the country and to generate data for registration for new drugs before use in the Indian population.