In a bid to decriminalise and rationalise offences to further enhance trust-based governance for ease of living and doing business, the Jan Vishwas (Amendment of Provisions) Act, 2023 was published in the Gazette of India, Extraordinary, Part II – Section 1, No. 21 on the 11th August, 2023. This Act has altogether amended 42 Central Acts including the Drugs and Cosmetics Act, 1940 (XXIII of 1940) [at Sl. No. 6 in The Schedule]. Sub-section (2) of Section 1 of this Act states that it shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint; and different dates may be appointed for amendments relating to different enactments mentioned in the Schedule.
Ministry of Health and Family Welfare (Department of Health and Family Welfare) vide S.O. 1577(E), issued notification in the Gazette of India, Extaordinary, PART II—Section 3—Sub-section (ii), No. 1496 dated New Delhi, the 28th March, 2024 in exercise of the powers conferred by sub-section (2) of section 1 of the Jan Vishwas (Amendment of Provisions) Act, 2023(18 of 2023) that the Central Government appoints 31st December, 2024 from which the amendments mentioned to the Drugs and Cosmetics Act, 1940 (23 of 1940) mentioned in column (5) of the Schedule to the said Act, against serial number 6 mentioned in column (1) of the said Schedule, shall come into force. Therefore, from 31st December, 2024 these amendments shall come into force.
Meanwhile,Central Government has published draft of the Drugs and Cosmetics (Compounding of Offences) Rules, 2023 in the Gazette of India, Extraordinary, Part II - Section 3 - Sub-section (i), No. 351 dated 10th July, 2024 vide G.S.R. 374(E) inviting objections and suggestions which may be received from any person within 45 days for consideration by the Central Government. Thus the process of making the rules has also started and before 31st December, 2024 the Rules may be notified so that enforcement will be possible from the appointed date.
Reference Id : PHARMATUTOR-ART-3019
In the Drugs and Cosmetics Act, three amendments have been made in Sections 29, 30, and 32B of Chapter IV of this Act that deals in manufacture, sale and distribution of drugs and cosmetics.These amendments relate to Penalty for use of Government Analyst’s report for advertising, Penalty for subsequent offences, and Compounding of certain offences. The amendments made by the Jan Vishwas(Amendment of Provisions) Act, 2023vide column 5 of the Schedule are reproduced below :
In light of the amendment in Section 29 of the Drugs and Cosmetics Act, 1940 which relates to Penalty for use of Government Analyst’s report for advertising, a comparison of the existing and new content of it is presented in Table 1.
Table 1. Section 29 of the Drugs and Cosmetics Act
The new amendment increases the quantum of penalty from up to five thousand rupees to up to one lakh rupees.
The next amendment relates to Section 30 which deals in penalty for subsequent offences under the Drugs and Cosmetic Actfor use of Government Analyst's report for advertising. The amendment has been made in sub-section (2) of Section 30. A comparison of the content is presented in Table 2.
Table 2. Section 30(2) of the Drugs and Cosmetics Act
The net effect of this amendment is that the provision of imprisonment has been deleted i.e. no imprisonment up to two years. However, the amount of fine which is presently ten thousand rupees will be five lakh rupees on subsequent conviction for use of Government Analyst's report for advertisingw.e.f. 31.12.2024.
The third amendment relates to sub-section (1) of Section 32B which has expanded the ambit of this sub-section by inserting clause (d) of section 27 and clause (ii) of section 27A to cover adulterated or spurious drugs and cosmetics. A comparison of the content is presented in Table 3 and the insertion is indicated in bold letters.
Table 3. Section 32B(1) of the Drugs and Cosmetics Act
All these amendments will be effective from 31-12-2024 as notified by the Central government on 28th March, 2024 as detailed earlier.
Another important feature is that Section 3 of the Jan Vishwas(Amendment of Provisions) Act, 2023 provides for dynamic increase in fine and penalty every three years as depicted below :
Hence the first increase of fine by ten percent of the minimum amount will be effective from 31.12.2027 and after every three years shall continue to increase.
.png)
