|
The 36th meeting of the Drugs Consultative Committee (DCC) has decided to include labeling of ingredients on cosmetic products under the Labeling Provisions of the Drugs and Cosmetics Rules. In the light of the recommendations of the DCC, labeling provisions under Rule 148 of the Drugs and Cosmetics Rules will be modified requiring cosmetic products to mention the ingredients on the labels in descending order.
The two-day meeting of the State Drug Controllers which ended today also decided to include statutory provisions relating to Good Laboratory Practices (GLP) under the Drugs and Cosmetics Rules, 1945. It may be recalled that the Mashelkar Committee report vide para 12.7 (A) had recommended that Drugs and Cosmetics Rules should be amended to include GLP norms as statutory requirements for approved testing laboratories and also the in-house testing laboratories of manufacturers. The draft GLP rules framed in the light of the recommendations were considered in the Drugs Consultative Committee and suggestions incorporated.
The Consultative Committee on Drugs also examined the report of the sub-committee on drug testing laboratories and has decided to incorporate development of performance indicators for drug regulatory agencies and possibilities of their audits. The Union Ministry of Health and Family Welfare is keen on developing international regulatory standards for drugs and cosmetics in India and is in the process of implementing a Rs.400 crore capacity building projects in this regard. The first step in this direction has already been initiated with the construction of a Food and Drugs Bhawan in Delhi. The National Pharmacovigilance programme has been launched to create a data bank on adverse drug reactions in the country.
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.
EK/MK
|
