Central Govt Accelerates Funding to Strengthen India’s Drug Regulatory System

The government has allocated INR 1,750 Cr to strengthen drug regulatory bodies, dividing INR 900 Cr for central agencies and INR 850 Cr for state-level systems.

The Central government has disbursed more than 80% of the funds allocated for enhancing the drug regulatory system across India, focusing on upgrading testing infrastructure and existing regulatory offices.

This initiative is part of a broader effort to fortify the drug regulatory mechanisms at both the Central and state levels, ensuring the quality and safety of drugs manufactured in the country.

The government has earmarked a total of INR 1,750 Cr for strengthening drug regulatory structures, with INR 900 Cr allocated to the Central drug regulatory bodies and INR 850 Cr set aside for the Central-sponsored scheme, 'Strengthening of States’ Drug Regulatory System' (SSDRS).

Union Health Minister JP Nadda announced that INR 699.28 Cr has already been released as the Central share under the SSDRS scheme.

This funding is intended to bolster state-level drug regulatory systems, ensuring they are better equipped to maintain and enforce drug quality standards.

Approval & Implementation of SSDRS

The Cabinet Committee on Economic Affairs, chaired by PM Narendra Modi, approved the SSDRS in August 2015. The initiative is designed to enhance and modernize drug regulatory systems across states.

State governments receive funds following the signing of a Memorandum of Understanding (MoU) with the Center, ensuring a coordinated approach to regulatory upgrades.

The SSDRS aims to provide additional equipment and manpower to existing drug testing laboratories, establish new laboratories for testing drugs, medical devices, and cosmetics, and deploy mobile drug testing laboratories.

Furthermore, the initiative includes the creation of additional regulatory positions for emerging areas such as stem cells, regenerative medicine, biologicals, and medical devices.

Digital Transformation & Training Initiatives

In addition to physical infrastructure, the SSDRS seeks to introduce e-governance and IT-enabled services across the drug regulatory framework.

This includes setting up a training academy for regulatory and drug testing officials at both Central and state levels, ensuring that the workforce is well-equipped to handle the complexities of modern drug regulation.

To date, the Central government has conducted 22 training programs for officials from the Central Drugs Standard Control Organisation (CDSCO) and various state drug control bodies during the financial year 2023-24.

These programs are part of a larger strategy to improve the overall efficacy and efficiency of drug regulation in India.

Impact on India’s Pharmaceutical Industry

India’s pharmaceutical industry is a global powerhouse, ranking third in terms of volume and 13th in terms of value. The industry produces over 60,000 generic drugs across 60 therapeutic categories.

To maintain and enhance the quality of its products, the Center has implemented several measures, including amending the Drugs Rules to update Schedule M for Good Manufacturing Practices (GMP).

Additionally, the government is rolling out barcodes or Quick Response (QR) codes on the primary packaging labels of the top 300 drug brands to improve traceability and ensure product quality.