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BDMAI urges DCGI to consider gradual transition while switching over to digital application system
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Gireesh Babu, New Delhi
July 10 , 2025
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The Bulk Drug Manufacturers Association of India (BDMAI) has requested the Central drug regulator to consider facilitation of smooth transition through various measures when the regulator digitalises the application and approval processes.
The latest of such digitisation is where the Central Drugs Standard Control Organisation (CDSCO) mandated that the application for World Health Organization (WHO) Good Manufacturing Practices (GMP) Certificate of Pharmaceutical Product (CoPP) should be submitted only online through the Online National Drugs Licensing System (ONDLS) from July 15, 2025.
"We appreciate the regulator's efforts to switch to digital platforms, but we request that the switch over process should be gradual," said R K Agarwal, national president of BDMAI.
He said that the regulator may consider providing some transition time, a timeframe that it feels necessary, for the switch over rather than implementing such changes all of a sudden.
A representation sent by the BDMAI to the Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi said, "While the industry appreciates CDSCO’s continued efforts in streamlining regulatory procedures through digital platforms, there is growing concern that the implementation of such a critical regulatory process via an online system, without adequate guidance and support, may adversely affect product registrations and international supply commitments."
There is apprehension that Indian exporters could lose valuable business opportunities in global markets due to potential challenges in navigating the new system. The industry is already facing a lot of issues with respect to the online system (NSW) for obtaining test licenses etc.
The Association requested the drug regulator to consider certain measures for a smooth transition.
This includes making a detailed user manual or step-by-step guidance document available for the new portal to assist applicants in understanding and navigating the system, and organising zonal-level stakeholder meetings or webinars, including a live demonstration of the portal, to address user queries and concerns.
It also requested the drug regulator to offer a parallel offline system, where it continue to accept offline applications for WHO-GMP CoPPs alongside the new online system for a limited period, until the latter is fully stabilized and users are well-versed in its operation.
This could ensure business continuity for exporters, since a delay in certification would be critical as the exporter may get into trouble with different regulators across the world and delay in shipments.
The regulator is organising interactive sessions with the industry, where the industry representatives hope that the issue would be discussed and resolved favourable to the continuity of business.
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