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Formation of IDRA will garner global recognition on par with US FDA & EMA: Dr BR Jagashetty

Formation of IDRA will garner global recognition on par with US FDA & EMA: Dr BR Jagashetty

Posted on March 22, 2024 Updated on March 15, 2024

India must now move towards looking to merge its Central and state enforcement wings and form a single authority. This will be a significant administrative reform. A unified licensing authority titled as Indian Drug Regulatory Authority (IDRA) will garner the much needed recognition globally like US FDA or EMA, said Dr BR Jagashetty, former National Adviser (Drugs Control) to Union health ministry and former Karnataka state drugs controller.

For India, this will streamline the process of obtaining licenses, prevent bureaucratic red tape and make it easier for pharma industry to operate across different states. Following the recent move by the Drugs Technical Advisory Board (DTAB) proposing to the Drugs Consultative Committee (DCC) to ascertain views from the States in the forthcoming meetings on having a single licensing and approval authority in the country, Dr Jagashetty said that while this is a positive move, if merger of entire enforcement wing is considered instead of just licensing powers. However, the practicality of its implementation needs to be seen.

In fact, it was a decade ago that Dr Jagashetty had recommended the same to the Union government in his capacity as the Karnataka drugs controller and national adviser to MoHFW that all state drugs control administrations should be merged with CDCSO and be renamed as the IDRA.

Noting that that IDRA should be on similar lines as that of the central excise department having branches in all states, Dr Jagashetty said that this would simplify compliance, lead to greater efficiency in terms of resource utilization, staffing, and enforcement, potentially resulting reducing expenditure for the government.

With this the present state drugs controllers could be appointed as the licensing authorities under DCGI, which may need suitable amendment in drug rules. Simplifying the licensing process aligns with the government’s efforts to improve India’s ranking in global ease of doing business indices, which can attract more investment and spur economic growth, Dr Jagashetty told Pharmabiz.

Delving into the aspects of the government exploring options including the forming of a centralised drug registration specially that of brand names, he said this was needed. There is also need for a Drug Control Repository which is an information management portal aimed at facilitating the dissemination of information to looking into LASA (look alike and sound alike) drugs which is a serious issue. CDSCO should have a separate wing to approve the brand names with their compositions to avoid LASA medicines.

Also in the interest of common man to ensure medicines are made available at their doorstep, the regulation of e-pharmacy with proper restrictions should be taken in a time-bound manner as directed by Delhi HC, as currently these operations are underway in the absence of required rules. Hence it is important for the government to either have a blanket ban on e-pharmacies or frame proper rules and not just keep this business on tenterhook, he noted.

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