India Consults on the Draft Cosmetics Rules 2018

On Nov. 29, India Ministry of Health and Family Welfare issued a draft cosmetics regulation—Cosmetics Rules 2018 which consists of 71 rules, 13 schedules and 24 appended forms for public consultation until Jan. 13, 2019...

Drugs and Cosmetics Act, 1945 VS. Cosmetics Rules, 2018

Currently cosmetics in India fall under the oversight of Drugs and Cosmetics Rules, which was firstly issued in 1945 and last updated in December 2016.

The existing regulation was primarily developed to manage pharmaceutical agents and only 7 of the 169 rules pertain to the control of cosmetics. The new cosmetics legislation was drafted to specifically regulate the manufacture, import, registration and sale of cosmetics as well as foster increased enterprise accountability and ensure cosmetic safety.

The draft also stipulates that the provisions of the new Rules will prevail over the existing Drugs and Cosmetics Act, 1945 if there is any inconsistency between them.

Significant Changes

Compared with the Drugs and Cosmetics Rules 1945, the new draft Rule encompasses several significant changes, which are outlined below:

Obligations and powers of the state and central licensing authorities
Establishment and duties of the Central Cosmetic Laboratory
Laboratory approval for cosmetics and raw materials
Introduction of a specified online portal for cosmetic registration
Details of import and registration process
Import or manufacture of new cosmetics
Labeling, packaging, sampling, testing and reporting standards
Cosmetics exemption, recalls, fees, and payments requirements
Compliances requirements of Good Manufacturing Practices
Cosmetic norms issued by the Bureau of Indian Standards
…

Prohibitions and exemptions

The following cosmetic categories are prohibited from importation:

Cosmetics prohibited from manufacture, sale or distribution in the country of origin;
Cosmetics without a “Use Before” or “Use By’’ date that shall be later than six months from the date of import on their labels or packaging;
Cosmetics with the addition of hexachlorophene;
Cosmetics tested on animals after Oct. 13th, 2014.

The following cosmetic categories are subject to exemptions from import and registration:

Cosmetics in bulk for repackaging for 100% export to other countries;
Cosmetics for research and development purposes like packaging trials, consumer studies, shelf-life and transport studies;
Cosmetics for sale to overseas passengers in duty-free shops at international airports
Cosmetics in amenity kits sold in duty-free and for exclusive use by international passengers
Cosmetics imported for use in hotels