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The Government of Tamil Nadu has formally appointed the state's Controlling Authority, S Gurubharathi, as the designated Compounding Authority under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.
This strategic move follows the mandate of the Jan Vishwas Act, which requires every state to name a senior officer within the drug control department to oversee administrative settlements. The official notification, issued by Additional Chief Secretary P. Senthilkumar, confirms that this appointment aims to exercise the state government's powers for settling specific regulatory violations.
S Gurubharathi, who also serves as the Joint Director of the Tamil Nadu Drugs Control Department, has been vested with these new responsibilities. In his capacity as the Compounding Authority, Gurubharathi will be responsible for reviewing applications from manufacturers and traders seeking to resolve minor or technical lapses through fines rather than traditional criminal trials. This decentralization of authority is intended to ensure that essential regulatory work in the state remains uninterrupted.
This shift toward administrative settlements is a key component of recent legal amendments designed to reduce the compliance burden on legitimate businesses. By allowing for the compounding of offences, particularly those related to Not of Standard Quality (NSQ) drugs, the state hopes to eliminate the fear of lengthy litigation for procedural errors. These rules provide a structured pathway for companies to settle violations while maintaining high standards of drug safety and quality across the pharmaceutical sector.
Industry leaders have reacted positively to the appointment, viewing it as a milestone for the success of the Drugs and Cosmetics Act in the southern region. J Jayaseelan, chairman of the Indian Drug Manufacturers Association (IDMA) Tamil Nadu State Board, welcomed the decision to place a specialized regulator in charge of the compounding process. He said that the new mechanism would allow for the immediate resolution of technical issues, preventing them from escalating into years of judicial proceedings.
The efficiency of this administrative mechanism is expected to significantly alleviate the mounting pressure on the traditional judicial system. By resolving technical and procedural matters through the office of the Compounding Authority, the state can streamline the judicial process and focus court resources on more severe criminal violations.
The appointment is effective immediately, superseding previous notifications as the state transitions to this updated regulatory framework. Stakeholders in the pharmaceutical community are optimistic that the leadership of an experienced officer like Gurubharathi will foster a more supportive environment for the industry while ensuring public health rules are strictly followed.
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