The apex health regulatory agency of India has rolled out a major proposal for creating a single-window online portal to digitise the regulation of medicines, cosmetics and medical devices in India. The idea for the project was conceived at a ‘chintan shivir’ organised by the health ministry in February.
The project will be spearheaded by the Central Drugs Standard Control Organisation (CDSCO). In a letter to all stakeholders across states and union territories, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi, who is the head of the CDSCO, called for a unified online portal as “a unique solution to the various problems faced by all the stakeholders”.
“…a unified online portal for all the regulatory activity involving stakes from all the stakeholders is being proposed,” he wrote, calling the proposed portal a “single window” and “single sign-on” system.
According to the proposal, accessed by News18, the dashboard for the online portal will have multiple roles apart from maintaining massive data on drugs. It pitches the need for digital transformation and setting up a digital regulatory system (DRS).
Raghuvanshi, in his letter, explained to stakeholders that the dashboard “can be used for collection and monitoring government policies and scheme as and when required”. (sic)
How a digital regulatory system will work
As explained in 12 points, the digital system aims at creating a database – be it of manufacturers, excipients or intermediate suppliers, marketers, or primary packing material among others. Further, it aims at registering all vendors and stakeholders on the central portal to “track and trace the supply chain”.
The DCGI has also proposed to develop a “master registration of drugs”, which will create an online database of all licensed entities and permitted products manufactured and sold in India. It also aims to collect massive data on the consumption of drugs with respect to category, quantity, area and season.
A critical suggestion is the “maintenance of a database of not of standard quality or spurious or adulterated or misbranded products in the public domain”.
In the sixth point, the proposal aims to improve interstate coordination on issues such as ‘not of standard quality’ (NSQ) medicines or issues to tackle movement of spurious drugs, investigation and launching of prosecution.
“Measure and monitor corrective and/or punitive outcomes of vigilance/enforcement,” states the proposal as one of the objectives of the portal.
The collected data can be used during emergency and pandemic situations, the proposal stated while adding that the system will also create a “complaint redressal mechanism with a dedicated online ticket system”.
It states that one of the main objectives of bringing the regulatory systems online is the “integration of multiple government agencies”, which are involved in the regulation of drugs licensing and permission.
The list includes the names of 11 agencies connected to the system, including all state licensing authorities, National Institute of Biologicals (NIB), Indian Council of Medical Research (ICMR), Atomic Energy Regulatory Board, Bureau of Indian Standards and Department of Consumer Affairs.
What triggered the shift from offline to online
The letter stated that one of the main interventions of the central government is to achieve its public health objectives, which include ensuring that the “drugs available in the country are safe, efficacious and conform to prescribed quality standards”.
“The drug regulatory system is responsible for protecting public health by assuring safety, efficacy and quality of human and veterinary drugs, biological products, medical devices, diagnostics and cosmetics,” Raghuvanshi said in the letter.
He added that the drug regulatory system is also responsible for “advancing public health by keeping its systems contemporary and by helping to speed up innovations that make pharmacotherapy safer and more effective”.
“The regulatory system also helps the consumers in getting accurate and adequate information concerning the appropriate use of medicines and related products,” the letter stated.
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