Last Updated on March 19, 2025 by The Health Master
Drug Regulation
A Parliamentary Panel has recommended a comprehensive, nationwide, and phased Medicines Regulatory Maturity Enhancement Programme in the country regarding drug regulation.
This initiative has been started after the World Health Organization’s (WHO) vaccine benchmarking process, which aims to elevate the drug regulation system of the country to par with international standards.
Why does this start?
The reason behind this recommendation is that consistent, high-quality drug regulation across all states and Union Territories (UTs) is very important for the want of safe and high-quality drugs.
This initiative directly addresses the need for robust regulatory capacity building, especially in the context of India’s role as a major pharmaceutical hub.
Maturity Enhancement Programme:
The following are the key components:
WHO Benchmarking:
The program will follow the re-benchmarking process for vaccines of WHO’s National Regulatory Authority (NRA).
This involves a thorough scientific review of state and UT drug regulation systems against the WHO Global Benchmarking Tool.
State Audits:
Following state audits will be conducted by a central team of international and national experts:
challenging-mode audits, focusing on the quality, safety, and efficacy of drugs, Active Pharmaceutical Ingredients (APIs), and formulations.
Targeted capacity building:
Based on audit findings and stakeholder consultations, states and UTs will receive targeted drug regulation capacity building and infrastructure upgrades.
Progressive Implementation:
The program will establish clear, time-bound milestones for achieving progressive implementation based on manufacturer turnover, similar to GMP revisions.
Professional Development:
Continuous professional development and training will be provided to the state drug regulatory officials, and they will also take benefits from CDSCO training programs and incorporating international best practices.
Integration of ONDLS:
The Online National Drug Licensing System (ONDLS) will be integrated with the benchmarking process for ensuring uniformity and efficiency.
Strengthening the State Drug Regulation System (SSDRS)
The Parliamentary Panel also emphasized the need for an urgent and proactive engagement strategy with states and UTs regarding the SSDRS scheme.
This strategy aims to:
- Provide clear guidelines, technical assistance, and regular communication to ensure states understand the scheme’s requirements.
- Assist states in developing comprehensive and eligible proposals.
- Regularly monitor fund utilization and provide early feedback to address bottlenecks.
Addressing Fund utilization challenges:
The panel expressed concern over the underutilization of funds allocated to the SSDRS scheme.
To mitigate this, they recommended:
Establishing a dedicated team to conduct workshops and provide proposal templates.
Tracking state progress to ensure effective utilization of allocated funds.
Financial Overview (in Crore Rupees):
| Fiscal Year | Budget Estimate (BE) | Revised Estimate (RE) | Actual Expenditure |
|---|---|---|---|
| 2023-24 | 72.14 | 52 | 48.50 |
| 2024-25 | 75 | 50 | 45.10 (till Jan 31, 2025) |
Current Status:
The SSDRS scheme, which sunsets in FY2024-25, is currently under consideration for a one-year extension by the Department of Expenditure (DoE).
Proposals for funds have been received from states like Bihar, Maharashtra, Meghalaya, and Tamil Nadu for completing approved infrastructure projects.
Q. What is the goal of the Medicines Regulatory Maturity Enhancement Programme?
A. The goal is to elevate India’s drug regulation to international standards, ensuring the quality, safety, and efficacy of drugs.
Q. What is the SSDRS scheme?
A. The Strengthening of State Drug Regulation System (SSDRS) scheme aims to enhance the drug regulation infrastructure in states and UTs.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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