The Ministry of Health and Family Welfare(“Ministry”) has proposed the Cosmetic Rules,2018(“Draft Rules”), through a notification dated 29^th November,2018 which is applicable to all cosmetics as mentioned under section 3(aaa) of The Drugs and Cosmetics Act,1940.

“Cosmetics-  means any article intended to be rubbed, poured, sprinkled 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.”

The Ministry invites comments and suggestions on the Draft Rules which are to be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in, within 13^th Januaury,2019.

Key Highlights:

1. “manufacturer” in relation to import of cosmetics, means a person who manufactures cosmetics in a country other than India as approved by National Regulatory Authority of that country.
2. “new cosmetic” means a cosmetic, any of the ingredients of which have not been generally regarded as safe by the central licensing authority or the regulatory authority of any other country or by the standard text relating to safety of ingredients of cosmetics.
3. “Import registration certificate” means a certificate issued under rule 13 by the central licensing authority for registration of cosmetics manufactured for import into and use in India.
4. “Licence” means a licence granted by the state licensing authority under rule 25;
5. Licencing Authorities-

• The central licensing authority will be the competent authority for enforcement of these rules in matters relating to-

1. Import of all categories of cosmetics;
2. Grant of approval to the laboratory which applies for carrying out tests on cosmetics and their raw materials under rule 57;
3. Co-ordination with the state licensing authorities.

• The state drugs controller, by whatever name called, will be the state licensing authority and the competent authority for enforcement of these rules in matters relating to-

1. Manufacture for sale or distribution of all categories of cosmetics;
2. Sale, stock, exhibit or offer for sale or distribution of all categories of cosmetics.

6. Import of cosmetics-

1. An application for registration of a cosmetic product intended to be imported into India must be made through the online portal of the Central Government in Form COS-1 either by the manufacturer himself or by his authorised agent or the importer in India or by the subsidiary in India authorised by the manufacturer.
2. An authorization by the manufacturer to his agent in India must be duly authenticated either in India before a First Class Magistrate or in the country of origin before the authority competent under the laws of that country or by an authority specified in the First Schedule.
3. The applicant referred to sub-rule (2) above must furnish along with the application such other information and documents as specified in the Second Schedule:
4. In case of application for import of bulk finished formulation ready to fill, the following additional documents must also be furnished

• A valid manufacturing license for the finished formulation of the cosmetic ready to fill in finished form from the state licencing authority; and
• Details of registered brand owner of the finished product

5. The application for registration in accordance with sub-rule (2) must be accompanied by a copy of the receipt of fee having been deposited as specified in Third Schedule.

6. Till such time, the online portal becomes operational for this purpose, offline application in Form COS- 1 may be made either by the manufacturer himself or by his authorised agent or by the importer in India or by the subsidiary in India authorised by the manufacturer for registration of a cosmetic referred to in sub-rule (1).

7. The applicant must be liable to pay testing fees directly to the testing Laboratory approved by the Central Government for examination, test and analysis of imported cosmetics in respect of cosmetics identified for such examination as specified in the Fifth Schedule.

8. The applicant must pay the fee as specified in the Third Schedule in connection with the expenditure to be incurred for inspecting or visiting the manufacturing premises of cosmetics approved in the foreign countries by officers authorized by central licencing authority.

7. Grant of import registration certificate-

1. After examination of documents furnished with the application under sub-rule (2) of rule 12 the central licensing authority may, on being satisfied, grant import registration certificate in Form COS- 2 or may reject such application for which reasons will be recorded in writing within a period of six months from the date of application.
2. In case of a new cosmetic, the applicant shall obtain prior permission in Form COS- 3 as provided in Chapter V from the central licensing authority before registration of import of new cosmetic into India.
3. A single application may be made and a single registration certificate in Form COS-2 may be issued in respect of import of one or more cosmetics manufactured by the same manufacturer; Provided that the cosmetics are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit for cosmetic intended for registration.
4. A fee as specified in the Third Schedule must be paid for a duplicate copy of the registration certificate, if the original is defaced, damaged or lost.

8. Validity of import registration certificate– A registration certificate granted under rule 13 will be valid for a period of five years from the date of its issue, unless it gets cancelled or suspended before that.

9. Documents to be supplied to the Commissioner of Customs- Before any cosmetics are imported, a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the cosmetics comply with the provisions of Chapter III of the Act, and the rules made thereunder, shall be supplied to the Commissioner of Customs.

Source: Ministry of Health and Family Welfare

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