The Ministry of Health and Family Welfare has notified the Cosmetics Rules, 2020 (“2020 Rules”) under the provisions of the Drugs and Cosmetics Act, 1940 (“Act”).
The 2020 Rules have gained effect immediately.
Background:
The Ministry had earlier issued Draft Rules and had invited comments and suggestions from the public. Now, objections and suggestions received from the public on the said Draft Rules have been considered by the Central Government and 2020 Rules have been issued.
Applicability:
The 2020 Rules apply to the cosmetic as defined in clause (aaa) of section 3 of the Act:
“cosmetic” means any article intended to be rubbed, poured, sprinkled or or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.
As per the 2020 Rules, “Actual manufacturer” in relation to import of cosmetics, means a person who manufactures cosmetics at his own manufacturing site in a country other than India approved by National Regulatory Authority or any authorised competent authority in that country for that purpose, by whatever name called.
Key Takeaways:
- The 2020 Rules has provisions regarding the following:
- Import of cosmetics
- Manufacture of cosmetics for sale / distribution
- Labelling, Packing And Standards For Sale Or Distribution Of Cosmetics
- Procedure of sampling for test or analysis , seizure and report
- Approval Of Laboratory For Carrying Out Tests On Cosmetics And Their Raw Materials
- The procedure of Sampling for Test Or Analysis, Seizure And Report include the manner of certifying copies of seized documents is also provided in the 2020 Rules
- Voluntary Recall of Cosmetics:
If a manufacturer or authorised agent, as the case may be, considers or has reasons to believe that a cosmetics, which has been imported, manufactured, sold or distributed, is likely to pose risk to the health of a user during its use and therefore may be unsafe, such manufacturer or authorised agent must immediately initiate procedures to withdraw the cosmetics in question from the market, indicating reasons for its withdrawal and inform the State Licensing Authority or Central Licensing Authority, as the case may be, of the details relating thereto.
- Digitization of Forms: Please note that the Forms prescribed under the 2020 Rules may be suitably modified by the Central Drugs Standard Control Organisation for the purpose of digitalisation and such conversion into digital forms modification shall be deemed legally valid for all purposes
- Amendment to the Drugs and Cosmetics Rules, 1945:
The Drugs and Cosmetics Rules, 1945 is amended as per Thirteenth Schedule of the 2020 Rules to the extent that the word cosmetics is omitted from various provisions
Please note that notwithstanding the non-applicability of the Drugs and Cosmetics Rules, 1945, (“1945 Rules”) the approvals or permissions or licenses or certificates issued under the provisions of the Act and the 1945 rules in respect of cosmetics prior to commencement of the 2020 Rules, will be deemed to be valid for all purpose till its expiry or for a period of 18 months from the date on these rules are notified, whichever is later, under the corresponding provisions of said rules.
Source: Ministry of Health and Family Welfare
