Unified portal to lead drug regulation

To do away with the fragmented nature of the pharmaceutical regulatory system and move towards an integrated superstructure, the Indian drug regulatory system is putting together a unified online portal that will bring all regulatory activities under one address, the Business Standard has reported. A proposal to this effect was circulated among all state drug controllers, pharmaceutical companies, Bureau of Indian Standards, Customs, Indian Council of Medical Research by Rajiv Singh Raghuvanshi, Drugs Controller General of India.

The proposed new structure will integrate and harmonise the functioning of several government agencies in drug licensing that right now work under separate entities with little communication or information sharing between them. To end this silo-type functioning, the new system will put together a one-stop shop of information and data that will create a database of drug manufacturers, excipients, intermediaries, marketers and packaging material suppliers.

It will also put in one place registration of all vendors and stakeholders for tracing supply chains, master register of drugs, database for licensed entities and also substandard, adulterated drugs available in the public domain. It will also monitor corrective vigilant actions in this regard.

Drug industry experts think that once the superstructure comes through, it might end quality assurance and procurement challenges that the fragmented regulatory systems breeds. An industry veteran told the newspaper, “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.”

The new proposal that has been put together says that the Central Drugs Standard Control Organisation has taken steps to engage stakeholders through online platforms, but these efforts have remained isolated and fragmented with no attempt to integrate them.

Right now there are a few regulatory portals that function with virtually no coordination with one another. These are the website for Central Drugs Standard Control Organisation (CDSCO), Sugam portal which is the online licensing portal of the CDSCO, MD online which is used to apply for import and manufacture of medical devices, Sugam labs which is the information management system for Central Drug Testing Laboratories and ONDLS that is the licensing system for state authorities.

The unified portal would integrate all these and more.