Express Pharma

Industry positive about CDSCO’s move to digitalise regulatory approvals

Stakeholders share suggestions for a smooth transition

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Central Drugs Standard Control Organisation (CDSCO) plans to adopt a paperless office culture and is in the process of going completely digital for regulatory approvals. Recently, Dr S Eswara Reddy, Joint Drugs Controller, CDSCO had informed that the office is working in revamping the Drugs and Cosmetic Act 1940 and planning to launch Sugam Version II.

The industry appreciates the move but share suggestions for a smooth transition.

Dr B R Jagashetty, former National Advisor (Drugs Control) to Ministry of Health and Family Welfare commented, “The process of adopting paperless culture in the CDSCO office is an encouraging move with hopes to encourage ease of doing activities. However, along with digital adoption, there is a dire need to fix the timeline for each and every issue, without which it won’t serve the purpose and will not benefit the Indian pharma industry.”

He suggested, “Although, initially the timeline could be fixed for longer periods, later, based on experience in handling the applications it can be reduced considerably. However, overall there should be fixed timelines for disbursing the requisite applications.”

Narendra Ahooja, State Drug Controller, Haryana, said, “The CDSCO is coming out with a portal which should be customised as per the need of the concerned states, as per their hierarchy.”

Dr Viranchi Shah, National Vice President, IDMA expressed, “It is a welcome move of adoption of digitalisation at the CDSCO office. We have seen that technology adoption expedites the process along with efficiency. It also enables and enhances capabilities. Although for the initial period it is likely, that both at regulators and as well as in the industry, there will be some technical glitches which might delay the process, ultimately it will be a win-win situation for both industry as well as regulators.”

George Patani, General Secretary, IDMA said, “We are happy to note that CDSCO is planning to adopt a paperless office environment. However, it is important that the paperless environment must be user-friendly and simple to use.  Adequate testing must be ensured before the launch of the paperless portal/interface. Meaningful disposition of applications in a time-dependent manner will be a key factor for the success of this system. This will help increase transparency and greatly improve the image of the pharma regulatory system in India.”

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