Government sets up panel to review Drugs and Cosmetics Rules

NEW DELHI: The government has constituted a committee to examine and recommend amendments to the Drugs and Cosmetics Rules, 1945.

"The Committee will revisit the Drugs and Cosmetics Rules, 1945 and make recommendations for amending the same in order to make these rules contemporary while keeping in view the requirements of quality, safety and efficacy of medical products and also the efficiency of regulatory structures and the industry to keep pace with changing scenario of drugs and medical devices and cosmetics industry," according to a Health Ministry order dated December 24.

"In 2012, the government had finally given a green signal to foreign pharmaceutical companies to invest in India as clinical trial is a very positive requirement to strive towards the growing developments in the present Pharmaceutical market worldwide," a Ministry official said.

"With that, awareness about concept of Good Clinical Practices (GCP) was created. However, till some time back, the provisions of compensation to the vulnerable subjects who suffer injury or death during participation in clinical trial of a new drug were not covered under the Drug and Cosmetics Rule, 1945.

"However, the insertion of the new Rules 122-DAB, Rule 122-DAC and Rule 122 DD vide first, second and third amendments respectively in 2013 have been able to fulfil the lacuna of the need of such compensatory provisions," the official added.

The Committee members included Joint Secretary (Regulation) and Director (Drugs) from Health Ministry, Dr B R Jagashetty, National Advisor (Drugs Control) and Project in-charge, S R Dhaleta, retired Joint Secretary and Legislative Counsel, Legislative Department, Ministry of Law and Justice, and representatives of Department of Pharmaceuticals from Ministry of Chemicals and Fertilisers, a representative from Legal Affairs, Ministry of Law and Justice.