The question of bringing medical devices under the Drugs and Cosmetics Act has been engaging the attention of the Government for sometime. As of now, there is no separate regulation to control the manufacturing and marketing of medical devices in the country. However, under Section 3(b)(iv) of Drugs and Cosmetics Act, the Central Government has scope to regulate medical devices as may be appropriate from time to time. The meeting of the DCC has decided to enlarge the regulatory overview on medical devices. The meeting has decided to bring all “sterile medical devices” under Section 3(b)(iv) of the Act.
The meeting of the State Drugs Controllers has also decided to incorporate registration of imported cosmetics in the Act.
While registration requirements are already in place for import of any drug in the country, there are, at present, no similar requirements for import of cosmetics.
The move to bring cosmetics under the Act's purview has been initiated so as to ensure that the labeling and quality/safety profile is in conformity with the provisions under the Drugs and Cosmetics Act.
The recommendations of the DCC would be brought before the Drugs Technical Advisory Board (DTAB) headed by the Director General of Health Services, Dr. S.P. Aggarwal before being sent to the Health Ministry for framing new policies and amended rules.thethe Drugs Technical Advisory Board (DTAB) headed by the Director General of Health Services, Dr. S.P. Aggarwal before being sent to the Health Ministry for framing new policies and amended rules.
Press Information Bureau Government of India