India Seeks WHO Audit to Fortify Its Global Pharmacy Reputation

India plans to have its drug regulatory system audited by the World Health Organization. This move aims to identify specific strengths and weaknesses. The goal is to create a foolproof framework for medicine safety.

According to government documents, the initiative follows several international drug safety incidents. These events questioned the quality of medicines from India. The country is often called the ‘pharmacy of the world’.

A Proactive Step Following Safety Concerns

The proposed WHO assessment will evaluate India’s entire regulatory system. It will rate the system’s maturity on a scale from 1 to 4. This rating is a global gold standard for medicine quality.

A high rating can help restore global confidence. It also speeds up the qualification process for major international tenders. According to Reuters, similar WHO benchmarks are used worldwide for drug procurement.

India has already succeeded with this model for vaccines. In 2024, the WHO awarded India a “Maturity Level 3” rating for vaccine regulation. Officials now want to replicate this success for general medicines.

Navigating Scale and State-Level Challenges

The task is immense due to India’s vast pharmaceutical industry. The country has over 10,500 manufacturing units. Enforcing uniform standards across all states is a significant hurdle.

The government proposes a flexible, voluntary approach. States with stronger systems may undergo assessment first. This strategy acknowledges different regional capabilities and resources.

A successful audit would bring major benefits. It would enhance global market access for Indian generics. It would also ensure higher quality medicines for domestic patients.

This WHO audit plan represents a critical reset for India’s pharmaceutical oversight. It directly addresses past quality control failures. The initiative seeks to secure India’s position as a trusted global medicine supplier.

Thought you’d like to know

What is a WHO regulatory system audit?

It is a comprehensive evaluation of a country’s drug oversight. The WHO assesses functions like inspections, approvals, and enforcement. The system receives a maturity rating from 1 to 4 based on its stability and functionality.

Why is India doing this now?

The move comes after safety incidents linked to Indian-made cough syrups. These incidents occurred in countries like Gambia and Uzbekistan. The audit aims to proactively strengthen systems and restore global trust.

How will this affect medicine exports?

A positive WHO rating can streamline export processes. Many global agencies require WHO benchmarks for tender participation. This could open new high-value markets for Indian manufacturers.

Will this improve medicine quality in India?

Yes, that is a major goal. The audit will pinpoint weaknesses in the current system. Fixing these gaps should lead to more consistent drug quality for Indian patients.

Has India done this before?

Yes, but only for vaccines. India’s vaccine regulatory system achieved WHO Maturity Level 3 in 2024. The new plan is to extend this rigorous assessment to all pharmaceutical products..