The Drugs and Cosmetics Act, 1940 and rules 1945 have entrusted various responsibilities to Central and State Government regulators for regulation of drugs and cosmetics. It envisages uniform implementation of the provisions of the Act and Rules made there under for ensuring the safety, rights, and well-being of the patients by regulating the drugs and cosmetics.

The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health and Family Welfare, regulatory Authority in this sector.

Under the Drugs and Cosmetics Act, CDSCO is constantly thriving upon to bring out transparency, accountability, and uniformity in its services to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country. It is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

However, at present, there are several online platforms which are regulating Drugs and Cosmetics industry including website of CDSCO, Sugam, MD Online, Corpseeds, ONDLS, Import Clearance System and others for registration of Manufacturers, laboratories. Controllers, importers, distributors, procurement agencies etc.

In pursuit to achieve uniform implementation of registrations, brining transparency in system, and most importantly harmonize regulatory requirement of State and Centre, the Indian drug regulatory system is introducing DRS – Digital Regulatory System, a unified portal for all regulatory activities.

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. The new digital regime will aim to bring multiple platforms under the SINGLE WINDOW show. This will further build the trust of international agencies and create confidence in the sector in the global market in terms of quality, transparency, and accountability.

Key Features –

1. Integration of Multiple Government Agencies
2. Single window registration of various stakeholders in the supply chain for monitoring and systematic tracking
3. Unified creation of Database of manufacturers, intermediaries, marketers, dealers, suppliers of drugs
4. Central data base for identification of products under category of permitted, non-permitted, adulterated Drugs,
5. Facilitating mechanism for creating vigilance, due diligence, monitoring corrective measures and developing compliant redressal system.

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

In the light of above, The Drugs and Cosmetics Bill 2023 is awaiting Cabinet approval, and will replace earlier law.

CS Nandini Raj Gupta