Archive · 10 Dec 2025
India to Audit Drug System
India wants the World Health Organization (WHO) to check its medicine rules to make sure they are good.
India makes a lot of medicines and sells them all over the world, but sometimes there have been problems with the quality.
The WHO will look at how India checks its medicines and give it a score.
This will help India make better medicines and sell them more easily to other countries.
India has already done this for vaccines and got a good score.
Now, they want to do the same for all medicines.
This will help keep people safe and make India's medicines more trusted around the world.
India plans to have its drug regulatory system audited by the WHO to improve quality and safety standards.
The WHO will evaluate and rate India's regulatory system on a scale of 1 to 4 for maturity.
India has already achieved a high rating (Maturity Level 3) for its vaccine regulatory system in 2024.
Recent incidents of poor-quality drugs, particularly cough syrups, have highlighted the need for stricter regulations.
The audit aims to enhance India's global reputation and qualify it for international drug tenders.
- Who
- India's Central Drugs Standard Control Organisation (CDSCO) and the World Health Organization (WHO)
- What
- An audit of India's drug regulatory system to evaluate quality, safety, and efficacy of medicines
- When
- The assessment is planned, with recent workshops held in November 2025
- Where
- India, with a focus on improving regulatory standards nationwide
- Why
- To address recent incidents of poor-quality drugs, enhance global reputation, and qualify for international tenders
- WHO Assessment
- Evaluation of India's drug regulatory system for quality, safety, and efficacy
- Maturity Level
- Rating scale from 1 to 4 for regulatory system maturity
- Vaccine Success
- India achieved Maturity Level 3 for vaccine regulation in 2024
- Pharmaceutical Exports
- $30 billion in FY24-25, supplying 20% of global generic medicines
- Manufacturing Units
- Approximately 10,500 pharmaceutical manufacturing units in India
- Global Tenders
- WHO assessment required for participation in international drug tenders
- Regulatory Challenges
- Variability in state-level drug regulations and compliance issues