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Govt yet to notify rules for compounding offences as per amendments introduced through Jan Vishwas Act
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Shardul Nautiyal, Mumbai
January 08 , 2025
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Despite the Government of India’s efforts to decriminalize minor offences and promote trust-based governance under the Drugs and Cosmetics Act (D&C Act), 1940, key initiatives aimed at easing compliance are yet to take effect.
The amendments introduced through the Jan Vishwas (Amendment of Provisions) Act, 2023 remain largely inaccessible to stakeholders due to pending finalization of procedural rules and appointments of compounding authorities.
The amendments to Section 29, Section 30, and Section 32B of the D&C Act, effective from December 31, 2024, introduced the provision for compounding of offences. This move was expected to reduce litigation burdens, foster compliance, and enhance ease of doing business in the pharmaceutical and cosmetics sectors. However, the procedural framework required to operationalize these amendments, outlined in the draft Drugs and Cosmetics (Compounding of Offences) Rules, 2023, remains un-notified.
Expressing concern, S W Deshpande, former joint commissioner, Food and Drug Administration (FDA), Maharashtra pinpointed, "The amendments and draft rules reflect progressive thinking by the government, aiming to strike a balance between regulatory enforcement and industry-friendly measures. However, the lack of final notification of these rules and appointment of compounding authorities has left the stakeholders in limbo.”
He further explained, "For ease of doing business, it is imperative that the Central and State Governments act swiftly to finalize the rules and notify the compounding authorities. Without this, the intended benefits of the Jan Vishwas Act cannot be realized."
The draft rules, notified on July 10, 2024 via GSR 374(E), propose comprehensive procedures for compounding offences. These include definition of roles: designating authorities like the Compounding Authority and Reporting Authority to oversee the process, Application Process: introducing a prescribed form for applying for compounding offences, Detailed Procedures: laying down the steps to be followed by the applicant, compounding authority, and reporting officer.
However, as per Rule 3, both the Central and State Governments need to appoint officials as compounding authorities through official gazette notifications—an essential step that remains pending.
The delay has frustrated industry stakeholders, who are keen to benefit from the streamlined regulatory approach. Many argue that the pending notification hampers the government's larger goal of achieving trust-based governance and ease of doing business.
Stakeholders hope that the final notification of rules and appointment of compounding authorities will occur soon, bringing much-needed relief and clarity to the regulatory landscape.
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