NEW DELHI:
With an aim to remove lacuna in existing Drugs and Cosmetics Act covering cosmetics and make manufacturers and importers more accountable for safety and efficacy of cosmetics being sold in the country, the Union ministry of health and family welfare has come out with draft Cosmetics Rules, 2018.
This will be applicable to the cosmetic as defined in clause (aaa) of the section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940). At present, there is a gap in D&C Act governing testing and regulatory aspects of cosmetics. The draft once notified will help regulate cosmetic industry in a more stringent way.
As per the draft rules, DCGI will enforce rules pertaining to import of all categories of cosmetics, grant of approval to the laboratory which applies for carrying out tests on cosmetics and their raw materials under rule 57. The central licensing authority will co-ordinate with the state licensing authorities in enforcement of these rules. The state drugs controller will enforce rules related to manufacture for sale or distribution of all categories of cosmetics and rules pertaining to sale, stock, exhibit or offer for sale or distribution of all categories of cosmetics.
A manufacturer can make an application for grant of a licence or loan licence to manufacture for sale or for distribution to the state licensing authority through online portal/offline in Form COS-5 for licence or in Form COS-6 for loan licence accompanied with a fee. In case of a new cosmetic, the applicant shall obtain prior permission from the central licensing authority and no licence to manufacture any cosmetic shall be granted by the state licensing authority without such permission. In addition to requisite documents, the applicant shall furnish a self-declaration conforming compliance with Good Manufacturing Practices, requirements of premises, plants and equipment for manufacture of cosmetics.
The state licensing authority shall grant manufacturing licence after conducting inspection of the site and verification of requisite information. If cosmetics are manufactured at more than one premises, a separate application for each of such premises shall be made and a separate license obtained for each such premises.
The manufacturer shall provide and maintain adequate staff, premises and laboratory equipment for testing the cosmetics manufactured, and the raw materials used for manufacture in such cosmetics, or make arrangements with a laboratory approved by the central licensing authority and accredited by NABL for carrying out such tests.
The licencee shall keep record of the details of each batch of cosmetic manufactured by him and of the raw materials used therein for a period of three years after the date of expiry of the batch.
The premises licensed for manufacturing cosmetics shall be inspected by inspector appointed by the central government and state government to verify the compliance with the conditions of licence at least once in two years.
Any person who intends to import or manufacture a new cosmetic, shall apply to the central licensing authority along with the data on safety and effectiveness of cosmetic. 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.
No person shall distribute any cosmetic unless the cosmetic, if of Indian origin, is manufactured by a licensed manufacturer and labelled and packed in accordance with standards prescribed by the Bureau of Indian Standards (BIS).
A cosmetic shall carry on both the inner and outer labels containing the name of the cosmetics, name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured, use before or date of expiry, a batch number, manufacturing licence number.
In case of cosmetics; where a hazard exists, every inner label shall clearly indicate adequate directions for safe use. In the case of imported cosmetics to be marketed in India, import registration certificate number shall be mentioned on the label along with name & address of the importer.
If a manufacturer or authorised agent finds that a cosmetics, which has been imported, manufactured, sold or distributed, is likely to pose risk to the health of a user, they shall immediately recall the cosmetics from the market and inform the licensing authority in this regard.
No cosmetic shall be imported into India unless the product has been registered in accordance with these rules by the central licensing authority.
The import registration certificate to be issued by central licensing authority shall, unless it is suspended or cancelled, earlier be valid for a period of five years from the date of its issue. Provided that if application for a fresh registration certificate is made within six months before the expiry of the said certificate, the existing registration certificate shall be deemed to continue to remain in force until orders are passed on the application.
A cosmetic manufactured in a foreign site and already registered for import and sale in India, may be imported by any person by giving an undertaking to the port office. No cosmetic, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.
No cosmetics shall be imported unless the “use before or use by’’ date shown on the label, wrapper or container of the cosmetic is later than six months from the date of import. No cosmetic containing hexachlorophene shall be imported. No cosmetic that has been tested on animals after October 13, 2014 shall be imported into the country.
Small quantities of cosmetics the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use, stated the draft. The draft was issued by the health ministry on November 29, 2018 seeking comments from the stakeholders within 45 days.
