Last Updated on December 23, 2023 by Hitesh Goyal
Drugs and Cosmetics Act
In a significant move, the Central government is poised to unveil the draft rules for compounding offences under Section 32B of the Drugs and Cosmetics Act, 1940.
This development follows the enactment of the Jan Vishwas (Amendment of Provisions) Act, 2023, a legislative triumph that passed both the Lok Sabha and Rajya Sabha earlier this year.
Jan Vishwas Act’s Impact on Section 32B
1. The Amended Section 32B
The Jan Vishwas Act introduces amendments to Section 32B, specifically targeting “clause (d) of Section 27 and clause (ii) of Section 27A,” broadening the scope of the subsection (1).
2. Compounding Certain Offences
The amended Section 32B empowers the Central or state government to compound offences related to the manufacturing of drugs under Section 27 and any cosmetic contravening chapter provisions or other rules.
Drafting Rules: A Deliberate Process
3. DCC Meeting Insights
In a recent Drugs Consultative Committee (DCC) meeting chaired by Drugs Controller General (India) Dr. Rajeev Singh Raghuvanshi, held on September 26, it was revealed that a draft for laying down rules, aligning with the new amendments, is in the works.
The matter is undergoing thorough examination and consideration.
4. Historical Context of Section 32B
The DCC highlighted that Section 32B was incorporated into the Drugs and Cosmetics Act in 2008, with enforcement starting on August 10, 2009.
Despite this, no specific rules were framed for compounding offences punishable under Section 13(1)(b), Section 28, and Section 28A of the Act.
Understanding the Offences and Penalties
5. Section 13(1)(b): Import Prohibitions
Section 13(1)(b) penalizes the import of drugs or cosmetics prohibited under Section 10 or any rule made under this chapter.
The penalty may extend to imprisonment for six months, a fine of up to five hundred rupees, or both.
6. Section 28: Non-Disclosure of Manufacturer’s Name
Section 28 addresses penalties for non-disclosure of the manufacturer’s name.
Violators may face imprisonment for up to one year, a fine not less than twenty thousand rupees, or both.
7. Section 28A: Penalties for Documentation Lapses
Section 28A deals with penalties for not maintaining documents and non-disclosure of information, emphasizing the importance of compliance in the pharmaceutical sector.
DCC Recommendations
8. DCC’s Call for Rule Framing
Acknowledging the government’s amendments to Section 32B through the Jan Vishwas Act, the DCC recommended the drug regulator to frame rules for compounding offences under this section.
9. Ongoing Examination and Consideration
The minutes of the Committee meeting disclosed that a draft addressing this recommendation has been prepared and is currently under further examination and consideration.
Conclusion
In conclusion, the imminent release of draft rules for compounding offences under Section 32B signifies a crucial step towards strengthening regulatory frameworks in the pharmaceutical sector.
These amendments underscore the government’s commitment to ensuring compliance and accountability.
FAQs
1. What is Section 32B of the Drugs and Cosmetics Act, 1940?
Section 32B focuses on compounding certain offences related to the manufacturing of drugs and cosmetics.
2. How will the amendments impact pharmaceutical manufacturers?
The amendments empower the government to compound offences, providing a more nuanced approach to regulatory violations.
3. What penalties are outlined in Section 13(1)(b)?
Section 13(1)(b) prescribes imprisonment, fines, or both for the import of prohibited drugs or cosmetics.
4. Why were rules not framed earlier for Section 32B offences?
Despite the enactment in 2009, rules for compounding offences under Section 32B were not explicitly formulated, prompting recent considerations.
5. When can stakeholders expect the finalization of the draft rules?
The timeline for finalizing the draft rules is currently under examination, with ongoing considerations by regulatory authorities.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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