Single Window Portal for Drug Regulation Processes [UPSC Current Affairs]

The Government of India is currently developing a digital platform with the aim of overhauling the country’s drug regulatory system. This is an important development regarding the country’s governance and is hence a relevant topic for the IAS exam.

India working on Single-Window Portal for Drug Regulation Processes

The platform will serve as a unifying hub for all key players involved in the process, including regulators, manufacturers, distributors, state-run entities, and procurement agencies.

• The integration of various stakeholders such as Central Drug Laboratories, state drug controllers, manufacturers, and others will be achieved through the integration of the Sugam portal (existing IT portal of the Central Drugs Standard Control Organisation (CDSCO)) with the new portal.

Background information:

• Earlier, there were controversies over Indian-made medicines exported to Gambia and Uzbekistan and since then the government has been in the process to develop a system which will guarantee the drug manufacturing and quality control mechanisms followed.
• Earlier both central and state governments had important roles in issuing drug manufacturing licences and regulating the drug sector. And this led to the need for the development of harmonised regulatory requirements, processes, and databases in states to ensure consistency in evaluating and approving drugs.
• A committee was formed under the pharmaceuticals department secretary with other members including the Drugs Controller General of India, the joint secretary (drugs) of the Union Health Ministry, and nodal officers from states, to present a road map.

Other Issues Involved:

• CDSCO adopts a dossier-based approach when granting approval to each drug. But when a drug becomes older by more than 4 years, then any drug manufacturer can approach the state regulatory, seeking a licence to manufacture it.
• Experts point out that India’s fragmented regulatory system is a challenge for procurers and quality assurance. Drug manufacturers change the source of the active pharmaceutical ingredients (APIs) or even the excipients without reporting it to the state regulators.

Additional Information:

• Central Drugs Standard Control Organisation: It is India’s national regulatory body for cosmetics, pharmaceuticals and medical devices. It has regulatory control over the import of drugs, approval of new drugs and clinical trials.
• Active Pharmaceutical Ingredient (API): It is the substance in a drug that is responsible for the beneficial health effects experienced by consumers. Know more about active pharmaceutical ingredients in the link.
• Sugam Portal: SUGAM portal is a single window interface for stakeholders to access the online services provided by CDSCO.

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