Health Ministry sets 31st December, 2024 as implementation date for Jan Vishwas Act amendments to Drugs and Cosmetics Act, 1940; drug manufacturers may be subject to increased fines for utilizing government analysts’ reports in advertisements

Pursuant to the Update reported earlier on Jan Vishwas (Amendment of Provisions) Act 2023 (please refer to e-mails in trail for details), the Ministry of Health and Family Welfare has appointed 31st December, 2024 as the date on which the amendments pertaining to Drugs and Cosmetics Act, 1940 (“Act”) will gain effect. The Jan Vishwas (Amendment of Provisions) Act, 2023 is with a view to implement updated/ enhanced monetary fines while doing away with the criminal sanctions associated with non-compliance of provisions under the Drugs and Cosmetics Act, 1940.

Key Highlights:

1. The fine for utilizing a Government Analyst’s report for advertising of drugs or cosmetics has been augmented to Rs. 1 Lakh from the erstwhile penalty amount of Rs. 5000/- (five thousand rupees). Subsequent convictions for this could now lead to imprisonment for up to two years, or minimum fine of Rs. 10,000/- (ten thousand rupees), or both. This is now being enhanced with a substantial pecuniary sanction of Rs. 5 Lakhs, thereby obviating the need for imprisonment.

2. Offenses under Section 27(d)* and clause ii of Section 27A** may now be compounded under Section 32B of the Act. Additionally, the compounded sum cannot exceed the maximum fine amount applicable for the compounded offenses.

A copy of the Notification is attached herewith for your ease of reference.

Source: Ministry of Health and Family Welfare

 

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* 27(d) of the Act:

 “…any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made thereunder, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years 5 [and with fine which shall not be less than twenty thousand rupees]”

 **27A(ii) of the Act:

 “…any cosmetic other than a cosmetic referred to in clause (i) in contravention of any provisions of this Chapter or any rule made thereunder shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to twenty thousand rupees, or with both.”

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