Centre moots unified portal for drug regulation to build trust in quality

Move seeks to harmonise regulatory requirements at central and state level

The Indian drug regulatory system is set for an overhaul. The Centre is working on a digital drugs regulatory system (DRS) -- a unified online portal for all regulatory activities.

A proposal for the same was recently shared by Drugs Controller General of India (DCGI) Rajiv Singh Raghuvanshi with all state drug controllers, pharma manufacturing associations, Customs, Bureau of Indian Standards, Indian Council of Medical Research, Department of Consumer Affairs, etc, seeking their comments and suggestions. Business Standard has seen a copy of the proposal.

A committee headed by the pharmaceuticals department secretary was set up to present a road map for regulatory changes following a two-day ‘chintan shivir’ (brainstorming conclave) in Hyderabad in February, which discussed problems faced by drug regulators and stakeholders. The panel included the DCGI, joint secretary (drugs) of the Union health ministry, and nodal officers from states. The Centre has now set the ball rolling for the unified portal.

The proposal notes that the Central Drugs Standard Control Organisation (CDSCO) has taken multiple initiatives in the past to create stakeholder engagement through online platforms, but these have been mostly developed and implemented in silos over the years and are hosted and operated from individual domain names. Therefore, it does not offer a single-window experience for applicants and government officials.

At present, apart from the CDSCO website, there are several regulatory portals such as the Sugam portal (online licensing portal of the CDSCO, launched in 2016), MD online (to apply for manufacturing and import of medical devices), Sugam labs (information management system for Central Drugs Testing Laboratories), and ONDLS (licensing system for state authorities).

The DRS aims to “build trust and confidence on quality of drugs in the domestic and global market, transparency and accountability in the regulation of quality of drugs, effective enforcement of quality, safety and efficacy at the field level and ensuring compliance to the Indian pharmacopeia and standards”,  the proposal said.

The new system will take care of the integration of multiple government agencies in drug licensing and permission; create a database of manufacturers, excipients, intermediates, marketers, and primary packaging material suppliers; registration of all vendors and stakeholders for track and trace of supply chain; master registration of drugs  -- online database of licensed entities and permitted products; database of non-standard, adulterated drugs in public domain; measure and monitor corrective outcomes of vigilance among others.

Industry experts have said India’s fragmented regulatory system is a challenge for procurers and quality assurance. “Manufacturers change the source of the active pharmaceutical ingredients (APIs) or even excipients, and these key changes are not necessarily reported to the state regulator,” said an industry insider.

A senior government official had told Business Standard earlier: “India follows a system where both the Centre and the state governments have important roles to play in issuing manufacturing licences and regulating the drugs sector. The ‘chintan shivir’ recognised the need for a common set of standards and regulations accepted by both the central and state authorities.”