Amendment in D&C Act: Decriminalizing Offences for Trust-Based Governance

This pivotal legislation encompasses amendments to various provisions of the Drugs and Cosmetics Act, 1940 (Amendment in D&C Act), along with 41 other Acts.

Nilesh Gandhi

September 30, 2023

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Nilesh Gandhi

Amendments to Section 29: A Game-Changer for Advertisement Violations

One of the most noteworthy amendments is in Section 29, pertaining to the use of the analyst’s report for advertising purposes.

This alteration has garnered praise from regulatory experts for its potential to reshape the landscape of compliance.

Previously, the maximum penalty for this violation stood at a modest five thousand rupees.

However, with the Jan Vishwas Act in effect, the ceiling for fines has been significantly raised to a substantial one lakh rupees.

This amendment is poised to serve as a powerful deterrent against unlawful advertising practices.

Overhaul of Section 30(2): A Paradigm Shift in Penalties

Section 30(2) has undergone a substantial transformation under the Jan Vishwas Act.

This section previously prescribed a penalty of up to two years of imprisonment for subsequent offenses related to advertising the Government Analyst Report.

With the enactment of this amendment, the punitive aspect of imprisonment has been entirely eliminated.

Instead, a hefty fine of not less than five lakh rupees has been mandated.

This revision is set to fundamentally alter the consequences faced by individuals found guilty of advertising offenses.

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Insight from Industry Experts

SW Deshpande from Pharmalex Complete Legal Solutions and a former joint commissioner at the Maharashtra Food and Drug Administration echoed this sentiment.

He explained, “The removal of imprisonment penalties in Section 30(2) is a significant step towards a more pragmatic approach to enforcement.”

“Now, convicted individuals will face substantial fines but will no longer be subjected to imprisonment.”

Nilesh Gandhi, proprietor of Pharm Astute and former assistant commissioner (drugs) at the Food and Drug Administration in Maharashtra, Mumbai, lauded the amendments.

He emphasized, “These amendments signify a pivotal shift in the enforcement of violations related to government Analyst’s reports.”

“The substantial increase in fines will serve as a powerful deterrent against unlawful advertising practices.”

Future Projections: Incremental Fine Escalation

It is imperative to note that the fines stipulated under the amended provisions will undergo a steady increment.

Specifically, a 10% increase in the minimum amount will be applied every three years from the commencement of the Jan Vishwas (Amendment of Provisions) Act, 2023.

This dynamic aspect ensures that penalties remain relevant and impactful in the evolving landscape of regulatory compliance.

Effective Implementation

The amended provisions outlined in the Jan Vishwas Act will come into effect upon notification of the designated date.

This critical step ensures that stakeholders are duly informed and prepared for the new regulatory framework.

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