Last Updated on September 30, 2024 by The Health Master

Jan Vishwas Act

Jan Vishwas Act: In the ever-evolving landscape of drug regulations, the Jan Vishwas (Amendment of Provisions) Act, 2023, has introduced significant changes, raising eyebrows among experts.

This article delves into the peculiar inconsistency between penalties associated with offenses related to not-of-standard quality (NSQ) drugs and the advertising of the Government Analyst Report.

Understanding the Jan Vishwas Act

The Central government’s implementation of the Jan Vishwas (Amendment of Provisions) Act, 2023, on August 11, 2023, marked a paradigm shift in drug regulation.

Amendments were made to specific provisions of the Drugs and Cosmetics (D&C) Act, 1940.

Penalties Under the Amended Provisions

1. Advertising Convictions vs. NSQ Drug Offenses

Under the amended provisions, convictions for using the Government Analyst Report for advertising (Section 29 and Section 30(a)) incur a substantial penalty of Rs. 5 lakh for repeat offenses.

This sharp contrast to the Rs. 20,000 fine for offenses related to the manufacture, sale, and distribution of NSQ drugs (Section 27A (ii) and 27(d)) raises eyebrows.

2. Insight from Industry Expert

Nilesh Gandhi, proprietor of Pharm Astute and former assistant commissioner (Drugs), Maharashtra FDA, emphasizes the discrepancy.

Offenses under Section 27A(ii) and 27(d) are deemed more serious due to their connection with quality issues.

However, the compounding fine for these offenses, post-amendments, remains at Rs. 20,000, while subsequent convictions for using the Government Analyst Report for advertising incur a hefty Rs. 5 lakh fine.

Amendments in Section 29

Section 29, pertaining to penalties associated with the use of the Government Analyst’s report for advertising, has undergone notable amendments.

These changes will come into effect upon notification, adding another layer of complexity to the regulatory landscape.

Integration of Section 27A(ii) and 27(d) into Section 32B

1. Compoundable Offenses

The amendments have integrated Section 27A(ii) and 27(d) into Section 32B of the Act, making offenses related to the manufacture, sale, and distribution of NSQ drugs compoundable.

However, concerns are raised about the inclusion of offenses requiring both imprisonment and a fine under Section 32B without a corresponding amendment to Section 27(d).

2. Legal Perspectives

SW Deshpande from Pharmalex Complete Legal Solutions recommends a re-examination of the amendments.

According to Deshpande, offenses like those under Section 27(d), necessitating both imprisonment and a fine, should not have been included under Section 32B without a parallel amendment to Section 27(d).

The Road Ahead: Implications of the Amendments

The implications of these amendments necessitate careful consideration, especially with the proposed D&C Act awaiting enactment.

Industry stakeholders and legal experts are closely watching the unfolding developments to gauge the full impact of the Jan Vishwas (Amendment of Provisions) Act, 2023.

Conclusion

In conclusion, the Jan Vishwas Act introduces crucial amendments with far-reaching consequences.

The disparities in penalties between NSQ drug offenses and Government Analyst Report advertising convictions demand attention.

As the regulatory landscape continues to evolve, stakeholders must navigate these changes judiciously.

FAQs

1. How do the amendments impact offenses related to NSQ drugs?

The amendments bring a compounding option for offenses related to NSQ drugs but with a fixed fine, leaving room for debate on its adequacy.

2. What challenges do legal experts foresee with the integration of Section 27(d) into Section 32B?

Legal experts express concerns about including offenses requiring both imprisonment and a fine under Section 32B without amending Section 27(d) accordingly.

3. Why is the fine for Government Analyst Report advertising convictions significantly higher?

Experts argue that the substantial fine aims to deter repeat offenses and ensure compliance with regulations surrounding the use of the Government Analyst Report.

4. How will the amendments affect pharmaceutical companies?

Pharmaceutical companies may need to reassess their compliance strategies in light of the amended provisions to avoid potential legal pitfalls.

5. What should industry stakeholders anticipate with the proposed D&C Act?

The proposed D&C Act adds another layer of complexity to the regulatory landscape, and stakeholders should stay vigilant for further developments.

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