India working on single-window portal for drug regulation processes

System will bring together stakeholders like manufacturers, distributors, state-run agencies to ensure quality

Seeking to revamp India’s drug regulatory system, the government is working on a unified digital portal that will bring together all stakeholders: regulators, manufacturers, distributors, state-run departments, and procurement agencies.

“This will integrate the existing IT (information technology) portal of the Central Drugs Standard Control Organisation (CDSCO)—the Sugam portal—all Central Drug Laboratories, state drug controllers, manufacturers etc,” said an official source.

“This platform will be a single window and single source of truth accessible to all the stakeholders,” said the source.

After controversies about India-made medicines exported to Gambia and Uzbekistan, the government has been considering how to guarantee the country’s drug manufacturing and quality control mechanisms.

A two-day ‘Chintan Shivir’ (brainstorming conclave) late February in Hyderabad discussed problems that drug regulators and stakeholders face. “India follows a system where both Central and the state Governments have important roles to play in issuing manufacturing licenses and regulating the drugs sector. The Chintan Shivir recognised the need for a common set of standards and regulations accepted by both central and state authorities,” the official said, adding that steps are being taken to harmonise regulatory requirements, processes, and databases in states to ensure consistency in evaluating approving drugs.

“This requires significant collaboration from all stakeholders involved,” said the official.

State health secretaries, drug controllers and Central Licensing authorities, drug testing laboratories, industry associations attended the Chintan Shivir and their recommendations is being compiled. A committee has been set up under the pharmaceuticals department secretary to present a road map within the next few weeks.

Government sources said the committee included the Drugs Controller General of India, joint secretary (drugs) of the Union health ministry, and nodal officers from states.

The CDSCO has a dossier approach for each drug it approves. However, when a drug becomes older by more than four years or so, then any manufacturer can seek a license to make it from the state regulator. In this case, the dossier approach is not followed.

Industry experts have said India’s fragmented regulatory system is a challenge for procurers and quality assurance. “The 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.