Last Updated on May 22, 2023 by The Health Master
Introduction:
Download GSR 371(E) dt 15-05-2023 Draft notification Cosmetics Rules, (Amendment) Rules, 2021, the link is given below: The Union Ministry of Health and Family Welfare has recently issued a draft notification to amend the Cosmetics Rules of 2020 in order to enhance the regulation of cosmetics manufactured in India.
The proposed changes cover various aspects, including the cancellation and suspension of licenses, definitions of ‘use before’ and ‘date of expiry,’ and labeling requirements for export-oriented cosmetics.
Introduction of Rule 31A:
Cancellation and Suspension of Licenses: Under the draft amendment, a new rule called Rule 31A will be added to Chapter IV, which specifically addresses the manufacturing of cosmetics for sale or distribution.
This rule empowers the state licensing authority to cancel or suspend a license if the licensee fails to comply with license conditions, provisions of the Act, or related rules.
The authority must provide the licensee with an opportunity to present their case before issuing a written order stating the reasons for the cancellation or suspension.
Appeals Process for Suspended or Canceled Licenses:
In the event of license suspension or cancellation, the licensee has the right to appeal within three months of receiving the order.
The appeal will be reviewed by the State Government, which will consider the arguments presented by the licensee. The decision made by the State Government following the appeal will be final.
Simplification of Sub-Rule 10 of Rule 34:
Labeling Requirements for Export-oriented Cosmetics: The draft amendment seeks to simplify the requirements for labeling cosmetics meant for export.
The revised sub-rule states that the labels on packages or containers of exported cosmetics should adhere to the specific legal requirements of the destination country.
This amendment eliminates the need to include certain particulars on the innermost pack and every outer covering of the cosmetic.
Central Cosmetics Laboratory:
To streamline the testing and analysis of cosmetics, the amendment replaces the existing Rule 11. The Central Drugs Laboratory established under the Act will now serve as the Central Cosmetics Laboratory for these purposes.
Additionally, the central government may designate or notify other laboratories under its control that have the necessary facilities for testing and evaluating cosmetics.
Changes in Manufacturer License Requirements:
The draft amendment proposes a modification to the conditions for manufacturers to obtain a license or loan license.
Instead of the current requirement to collaborate with a laboratory approved by the Central Licensing Authority, manufacturers can now make arrangements with a laboratory approved by the State licensing authority for conducting tests.
Record-keeping Duration:
Regarding record-keeping, the amendment suggests a change to the existing rule.
Licensees will be required to retain records of each batch of cosmetics and the raw materials used for either three years or six months after the batch’s expiry, whichever is later.
Definition of ‘Use Before’ and ‘Date of Expiry’:
An explanation is included to clarify the definitions of ‘use before’ and ‘date of expiry.’
The ‘use before’ term indicates that the cosmetic should be used before the first day of the month specified on the label, while the ‘date of expiry’ signifies that the cosmetic will expire on the last day of the month mentioned.
Streamlining Licensing Authority:
The draft amendment proposes the omission of Clause II of Sub-rule 2 of Rule 4, which designates the State Drugs Controller as the licensing authority responsible for enforcing rules pertaining to the sale, stock, exhibition, or distribution of all categories of cosmetics.
This change aims to streamline the regulatory process.
Substitution of ‘Controlling Officer’ with ‘Controlling Authority’:
Certain rules will be updated to replace the term ‘Controlling Officer’ with ‘Controlling Authority‘ for greater clarity and consistency in terminology.
Conclusion:
The proposed amendment to the Cosmetics Rules aims to strengthen regulations and enhance the quality control of cosmetics manufactured in India.
These changes, encompassing license cancellation, labeling requirements for export, central cosmetics laboratory designation, and other adjustments, will contribute to ensuring consumer safety and adherence to regulatory standards in the cosmetics industry.
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