The proposed changes cover terminology modifications, the introduction of new rules, the relaxation of certain regulatory requirements, and various other adjustments.

On May 17, 2023, the Ministry of Health and Family Welfare of India initiated a public consultation on proposed amendments to the Cosmetics Rules 2020, with the goal of improving the regulation and quality control of cosmetics in India. The consultation period lasts 45 days, during which stakeholders are encouraged to provide feedback and suggestions to the Ministry, either by mail (see Notes at the end of the article for detailed address) or by email to drugsdiv-mohfw@gov.in.

The proposed amendments encompass several key highlights as follows. For a detailed comparison between the Cosmetics Rules 2020 and the proposed amendments, please download the comparison document via the button provided at the end of this article.

1. Modification of Terminology for Improved Clarity and Consistency

The proposed amendments provide further clarity and explanation of the terms "use before" and "date of expiry." "Use before" means “using the cosmetic product before the first day of the month specified on the label”, while "date of expiry" refers to the last day of the month mentioned.

Furthermore, the amendments update certain terms, replacing "controlling officer" with "controlling authority," "license" with "approval," and "Power of Attorney" with "authorization," among other terminological changes.

2. Addition of Several New Specifications

A new rule, Rule 31A, is introduced into Chapter IV of the Manufacture of Cosmetics for Sale or Distribution, concerning the cancellation and suspension of licenses.

Under this new rule, state licensing authorities are empowered to cancel or suspend licenses in cases where the licensee fails to comply with the license conditions, provisions of the Drugs and Cosmetics Act, 1940, or related rules. Prior to issuing a written order detailing the reasons for cancellation or suspension, the authorities are obliged to provide the licensee with an opportunity to present their case. In the event of a license suspension or cancellation, the licensee retains the right to appeal within three months after receiving the order. The state government will review the appeal, consider the arguments put forward by the licensee, and then make a final decision.

Additionally, the proposed Amendments aim to enhance the requirements for retaining manufacturing records. Currently, licensees are mandated to meticulously document the details of each batch of cosmetics they produce, including the raw materials used, and retain such records for three years following the batch's expiration. The proposed changes indicate that licensees shall retain this information for either a duration of three years, or six months after the batch's expiry, depending on whichever timeframe is later.

3. Relaxation of Some Regulatory Requirements

The proposed amendments streamline the labelling requirements for cosmetics intended for export. Existing provisions that necessitate the inclusion of certain particulars on both the innermost packaging and every outer covering of cosmetics will be removed. Instead, labels on the packaging or container of exported cosmetics will solely be subject to the legal requirements of the destination country.

The proposed amendments also modify the conditions for manufacturers to obtain a license or loan license. In place of the existing requirement, which mandates manufacturers to establish arrangements with laboratories approved by the Central Licensing Authority, the proposed amendments will allow manufacturers to make arrangements with laboratories approved by the State Licensing Authority for conducting tests.

The term "license" refers to a permit granted by the State Licensing Authority in Form COS-8 under the Cosmetics Rules 2020, allowing the manufacturing of cosmetics for sale or distribution. On the other hand, a "loan license" pertains to a license in Form COS-9 that grants licensee A the authority to utilize the manufacturing site of licensee B for producing the cosmetic manufactured by licensee B at that specific location.

4. Other Content Corrections and Adjustments

The proposed amendments bring about revisions to the rules pertaining to the Central Cosmetics Laboratory. It replaces the provision in rule 11 stating that "The Central Government may establish Central Cosmetics Laboratory for analyzing or testing samples of cosmetics and functioning as an appellate laboratory" with "The Central Drugs laboratory established under the Act shall function as Central Cosmetics Laboratory for these purposes."

Furthermore, it revises the qualification requirements for laboratories and proposes the deletion of the definition of "Laboratory" in Rule 3, which currently defines a laboratory as a Central Cosmetics Laboratory established or notified by the Central Government for conducting analysis or test of cosmetics.

*Note:

The detailed address for feedback is Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 437 C Wing, Nirman Bhavan, New Delhi – 110011.

Reference Links

[1] Ministry of Health and Family Welfare Notification: Cosmetics Rules, (......Amendment) Rules, 2021

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