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 The Federation of Pharmaceutical Entrepreneurs (FOPE) has urged the Union government to issue the final notification on the Jan Vishwas Act which will streamline the process, ensure transparency, and provide a consistent approach to the compounding of offences.
In a communication, Jagdish Kumar, executive director, FOPE said that the draft rules notified on July 10, 2024, via GSR 374(E), introduce a structured framework for the compounding of offences. Going by the objective of the Jan Vishwas Act, there is a need to speed up the final notification after considering feedback submitted, if any.
Efforts to decriminalize minor offences under the Drugs and Cosmetics Act (D&C Act), 1940, are focused to foster trust-based governance and reduce regulatory burden. While these initiatives signal a progressive move towards modernizing the legal framework and encouraging compliance, key measures are still in the early stages of implementation.
“Therefore a speedy implementation of the final notification will go a long way in doing business for the pharma entrepreneurs as well as meeting the objectives of the Jan Vishwas Act.
Kumar further continued to indicate to the Union government that ever since the inception of FOPE it has been trying to create a bridge between the drug regulatory authority and the pharma companies. In case of concerns it has been helping to raise it at the right platform so that it can be resolved at the earliest.
In this regard, the Jan Vishwas Act too mandates to create a compounding authority with designated officials tasked with overseeing and deciding the compounding of offences. There should also be a reporting authority responsible for monitoring and documenting the compounding process. A prescribed form will be introduced, standardizing the procedure for individuals or entities applying for compounding offences.
The rules of Jan Vishwas Act outline clear steps to be followed by the applicants on the submission of applications in the specified format with requisite details. There will be the compounding authority who will evaluate the decision-making processes for compounding requests. Also the reporting officer will record and report compliance with the prescribed procedures. All these measures aim to streamline the process, ensure transparency, and provide a consistent approach to the compounding of offences. Therefore FOPE urges the government to issue final notification of the much-awaited Jan Vishwas Act, said Kumar.
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