Last Updated on January 13, 2026 by The Health Master
Compounding Authority
In Karnataka, a crucial change in the regulations concerning pharmaceuticals and cosmetics now involves the Compounding Authority of the nation.
In India’s first, the Commissioner of Food Safety and Drugs Administration (FSDA) has been declared the Compounding Authority appointed under the new Drugs & Cosmetics Compounding Offences Rules, 2025 to facilitate easier compliance for businesses that encounter minor offenses through compounding regulations.
This is not an initiative limited to the state, however, as the central government released a notification in early 2025 mandating state governments to appoint a Compounding Authority to implement the amended Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
The Jan Vishwas Intent
Karnataka’s timely measure also implements the central government’s Jan Vishwas Amendment of Provisions Act, 2023, which aims to reduce administrative burdens by enhancing compliance levels for all stakeholders through an approach of ease of access and transaction across the board—especially in manufacturing and trading efforts across the nation.
Thus, by creating a Compounding Authority, the state makes it easier to circumvent less critical, yet regulated, legal matters involving the Drugs & Cosmetics Act.
What Does a Compounding Authority Do?
The Compounding Authority’s role is simplified yet vastly important.
The Compounding Authority can essentially:
- Compound Offences: Compound specified minor offences related to the manufacture, sale and distribution of drugs and cosmetics;
- Impose Penalties: by merely imposing a defined penalty/fine without recourse to a protracted legal course through criminal court.
Thus, it will serve two main purposes: significantly reducing legal timelines and proactively promoting compliance through safety literacy.
Which Offenses Can Be Compounded?
According to Section 32B of the Drugs & Cosmetics (D&C) Act, only a certain range of offenses can be compounded upon payment of a sum as prescribed by rules. They generally include:
- Import offences of prohibited drugs & cosmetics (Sec. 10; Sec. 13(1)(b));
- Manufacture/sale without registration rights of drugs/cosmetics that are neither adulterated nor spurious (Sec. 27(d)/27A(ii));
- Failure to state name of the manufacturer (Sec. 28);
- Failure to maintain records as prescribed (Sec. 28-A).
Q: What is Compounding Authority?
A Compounding Authority is the Commissioner of FSDA, as appointed to compound minor offenses under the Drugs & Cosmetics Act relative to penalties/fines that can be determined without recourse through criminal court proceedings to expedite time and resources.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Govt. appoints Adnl. DGHS as the Compounding Authority
Drugs and Cosmetics (Compounding of Offences) Rules, 2025: Gist
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