India Postpones the Establishment of an Independent Cosmetics Legislative Framework

India is expected to establish a separate legislative framework to regulate the manufacture, sale and import of cosmetics in the country. India has placed the establishment of an independent cosmetics legislative framework on hiatus until the second half of 2019.

At present, cosmetics are regulated with reference to Drugs and Cosmetics Rules 1945 (hereinafter referred to as “Rules”). In November 2018, 71 draft regulations pertaining to the management of cosmetics manufacture, import, registration and sale were released which will supersede and ultimately replace the outdated provisions in the 1945 rules. The new regulations have already passed a 45-day period of public comment on Jan. 13, 2019 ^[1] but still have not come into force.

According to INTERTEK ^[2], a senior official of India Ministry of Health said that the incorporation of the 71 draft regulations proposed last year in the Drug and Cosmetics Rules is not appropriate as the rules primarily concern pharmaceuticals.

The need to develop a separate legislation for the special management of cosmetics is the main reason why the government has delayed notifying the draft regulations as official rules. Due to the proposed broad changes and the necessity to enact new legislation through a bill, this could happen as early as the second half of the year after national elections.

The official also noted, it is necessary to strengthen the capabilities of executing agencies such as the Central Drug Standards Control Organization (CDSCO) and the Bureau of Indian Standards (BIS).

The BIS shall formulate packaging specifications because the draft regulations state that all cosmetic packaging and labels are subject to BIS standards.
The CDSCO will continue to manage and implement any separate cosmetic legislation. The CDSCO shall also establish standard safety benchmarks in conjunction with the Drugs Technical Advisory Board (DTAB) which is the government’s top statutory body for technical issues related to the existing Drugs and Cosmetic Act, to deal with cosmetic companies' mandatory submission of safety data under the draft cosmetics regulations.

Additionally, the official indicated that the new legislative framework is required to identify and authorize existing agencies to inspect cosmetic manufacturing and testing facilities and to confiscate goods in violation of the rules.