On Nov. 29, 2018, India Ministry of Health and Family Welfare issued a draft cosmetics regulation—Cosmetics Rules 2018 for public consultation until Jan. 13, 2019.
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. Therefore, 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 Rules consist of 9 chapters, 71 rules, 13 schedules and 24 appended forms, as shown below:
1. Preliminary
2. Authorities, officers and laboratory
3. Import and registration
4. Manufacture of cosmetics for sale or distribution
5. Permission for import or manufacture of new cosmetic
6. Labelling, packing and standards for sale or distribution of cosmetics
7. Procedure of sampling for test or analysis, seizure and report
8. Approval of laboratory for carrying out tests on cosmetics and their raw materials
9. Miscellaneous
First schedule: Authorization from manufacturer
Second schedule: part I Information and undertaking and part II
Third schedule: Fee payable for licence, permission and registration certificate.
Fourth schedule: List of categories of cosmetics for import
Fifth schedule: Fee for test or analysis by the central cosmetics laboratories
Sixth schedule: Undertaking for the import of cosmetics
Seventh schedule: Good manufacturing practices and requirements of premises, plants and equipment for manufacture of cosmetics
Eighth schedule: Particulars to be shown in the manufacturing records
Ninth schedule: Standards for cosmetics
Tenth schedule: List of dyes, colours and pigments permitted to be used in cosmetics and soaps as given
Eleventh schedule: Good laboratory practices and requirements of premises and equipment
Twelfth schedule: Extent and conditions of exemption
Thirteenth schedule: Amendments