Govt moots single regulatory portal for drugs

The Health Ministry is planning a unified portal for digital drug regulatory mechanism. The portal will include the details of stakeholders, such as manufacturers, distributors, and procurement agencies, among others.

Components of the Digital Regulatory System, according to the draft document, will include a single window / dashboard; a mobile application; alerts and delivery notifications across different messaging platforms via e-mail or SMS; chatbots and a dashboard with access to the Central Drugs Standard Control Organisation (CDSCO) and other authorities.

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The portal will also integrate other existing IT portals of the CDSCO, including Sugam (an online licensing division), MD online (granting licences for manufacturing and import of medical devices and in-vitro diagnosis devices), Sugam Labs (lab information management system), Online National Drug Licensing System for State authorities (ONLDS), and Import Clearance Sytem (ICS).

“These platforms have been developed and implemented by the CDSCO over a period of time. They operate through separate domain name and are not easily accessible, and their performance has often been slow. They are also not able to handle peak time demand most of the time. Integration of data with other government agencies, or in-built checking system are also not up to the mark. Hence, there is a proposal to integrate it all into a single digital regulatory system,” an official aware of the discussion, told businessline.

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The revamped system will have the databases of manufacturers, recipients, and marketers, among others; database of consumption patterns, including area-wise sales and seasonal trends; maintaining data of adulterated or spurious products; and a complaint and redress mechanism for users; among other factors.

The portal will be hosted through a MEITY-empanelled cloud service provider, and it will be integrated with Central agencies such as PAN, Aadhar, DGFT and Customs.

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Provisions for stricter regulation comes in the wakes of India pharma companies, particularly cough sysrup makers, drawing flak for alleged deaths of children in places like Gambia and Uzbekistan. Investigations by India too had revealed that there were violations in good manufacturing practices in some cases.

India will also consider a new drugs Bill during the upcoming Monsoon session of the Parliament. The Drugs, Medical Devices and Cosmetics Bill 2023 reportedly is awaiting Cabinet approval, and which will replace an earlier drugs law, The Drugs and Cosmetics Act, 1940 – a pre-Independence era legislation.

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“The bill seeks to regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics....clinical investigation of medical devices and clinical performance evaluation of new in-vitro diagnostic medical device...,” those aware said.

The Bill also proposes regulation of traditional medicines.

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