A Cosmetic License is a legal permit granted by the Government of India for businesses related to Drugs & Cosmetics. The Government’s primary concern is the Cosmetic License ensures that everyone has equal and proper access to drugs & cosmetics. But the legal right to manufacture & sell cosmetics has to be provided carefully. Therefore, the Government of India has stringent rules for Cosmetic Licensing to manufacture and sell cosmetics. The Drugs & Cosmetics Act, 1940, is the Act regulating the procedure from manufacturing to selling cosmetics in India. This write-up will discuss Rule 26 of Cosmetics Rules, 2020.
Laws Dealing with Cosmetics – Rule 26 of Cosmetics Rules, 2020
The cosmetic industry has been regulated under the Drugs & Cosmetics Act of 1940 and the Drugs & Cosmetics Rules of 1945. However, in December 2020, the Ministry of Health & Family Welfare notified the new and updated Cosmetics Rules 2020. The new rules separately codify & update the rules about the matters of manufacture, import, sale, labelling, and distribution of cosmetics in India. Though for convenience and smooth transition, the Cosmetic Rules, 2020 allow the earlier granted Cosmetics License under the Cosmetic Rules, 1945 to remain valid until their expiry date of 18 months from the date of notifications of Cosmetic Rules, 2020.
Rule 26 of Cosmetics Rules, 2020: Conditions of License or Loan for Manufacture of Cosmetics
A License in Form CO8-8 shall be subject to the conditions stated therein and to the following other condition, under Rule 26 of Cosmetics Rules, 2020, namely:-
- Manufacture of cosmetics products shall be conducted under the direction & personal supervision of competent technical staff consisting of at least one person who is a whole-time employee and who possesses any one of the following qualifications-
- Holds a Diploma in Pharmacy certified by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948)
- It has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognised by the Licensing Authority (LA) as equivalent to it.
- Hold a bachelor’s degree in Cosmetic Technology from a recognised University.
- The Factory location shall comply with the requirements & conditions specified in the 7th Schedule.
- The manufacturer shall either:-
- Provide & maintain staff, location and laboratory equipment for testing the cosmetics manufactured and the materials used for the manufacture of such cosmetics;
- Make arrangements with an authorised laboratory approved by the Central Licensing Authority (CLA) under Chapter VIII of the Rules & Accredited by the National Accreditation Board for testing and Calibration Laboratories for carrying out such tests.
- The applicant and licensee shall maintain documentary evidence for the following:-
- Documents in respect of the ownership/occupation on rental or another basis of the location specified in the application for License or the License granted.
- Constitution of the firm, or
- Any other documents may be needed to verify the correctness of the statements made by the applicant/ licensee, applying for or after getting the License, as the case may be.
- The applicant shall comply with the provisions of the Act & the Rules made there under and with such further requirements, in case any, as may be specified in any rule to be made hereafter under Chapter IV of the Act.
- The applicant shall keep a record of the information of all batches of cosmetics manufactured by him and the materials used therein according to particulars specified in the 8th Schedule & such records shall be retained for 3 years after the date of expiry of the batch.
- A Cosmetic License in Form COS- 9 shall be deemed to have been cancelled/ suspended in case the License granted, in Form COS- 8, in respect of manufacturing facilities, is cancelled/ suspended.
- The licensee shall test all batches or lots of the materials used for manufacturing the cosmetics and all batches of the final product & shall maintain records or registers showing the particulars in respect of such product tests. The records/registers shall be retained for 3 years from the date of manufacture.
- The licensee or applicant shall allow an Inspector appointed under the Act to enter with/ without prior notice any location where the manufacture of a substance in respect of which the License is granted is carried on, to inspect the location and to take samples of the manufactured cosmetics products for which a receipt shall be issued in Form COS- 10.
- The applicant shall allow an Inspector to inspect all registers & records maintained under these rules and shall supply to the Inspector such details as he may need for ascertaining whether the provisions of the Act & rules made thereunder have been complied with.
- The applicant shall maintain an Inspection book in Form COS-11 to enable an Inspector to record his impression & the defects noticed;
- The manufacturer shall inform the Licensing Authority (LA) within 30 days, in writing, in the event of a change in labelling, composition, testing, and specification or in the documentation of any of the cosmetics about this License and an undertaking that the cosmetic products comply with standards laid down by the BIS as referred in the 9th Schedule.
- The applicant shall inform the Licensing Authority (LA) in writing if there is any change in the constitutions of the firm operating under the License. Where any change in the constitutions of the firm takes place, the current License shall be deemed to be valid for six months from the date on which the change takes place unless, in the meantime, a new license has been taken from the Licensing Authority (LA) in the name of firm with the changed constitution.
- In case of change in name/address of manufacturers, after the issuance of Cosmetic Licence/ Loan licence under sub-rule (5) of Rule 23, an application form for amendment shall be made to the State Government for prior approval through Licensing Authorities for the said changes in the license within 60 days from the date of such change.
It is important to know all the above conditions under Rule 26 of Cosmetics Rules, 2020. Further, provided that clauses (c) & (d) shall not apply to the manufacture of soap and the process for testing of materials and the records to be maintained through a manufacturer of soap shall be like are approved by the Licensing Authority.
Rule 26 of Cosmetics Rules, 2020, has ensured the purpose of customers’ safety. Certain basic regulatory compliance exists for the advantage of the consumers. For example, the rules demand very transparent packaging & labelling guidelines for ingredients. Mention any harmful substance in the case involved or the composition of materials used & any undesirable effect that might occur- each of which transfers the responsibility to the consumers and their discretion in case they want to use the cosmetic product. Further proper license numbers, manufacturing batches, and company contact information have been provided for consumers’ convenience. Though there is always scope for improvements, the new Cosmetics Rules prove to be an efficient effort towards maintaining the control standards & safety details, primarily catering to customers.
Read our Article:Exemptions of Cosmetics under Cosmetics Rules 2020