WHO Evaluates India’s Vaccine Regulatory Framework Amid Global Demand

New Delhi, Sep 21 (KNN) The World Health Organisation (WHO) has conducted a thorough assessment of India’s National Regulatory Authority (NRA), focusing on the Central Drugs Standard Control Organization (CDSCO) and the Drugs Controller General of India (DCGI). 

This evaluation, which took place from September 16 to 20, aimed to scrutinise the efficacy and safety protocols of India's vaccine regulatory system.

A specialised team, comprising lead experts from WHO’s Geneva headquarters, its India office, and international drug regulators, undertook the evaluation. 

Their objective was to review India’s regulatory frameworks, the approval process for new vaccines, and the Good Manufacturing Practices (GMP) adhered to by domestic vaccine manufacturers.

“This assessment is a routine part of WHO's efforts to ensure the quality of vaccines being developed in India,” stated an official familiar with the process, who preferred to remain anonymous. 

The WHO conducts these evaluations every five years to assess a country’s compliance with global health standards.

India holds a significant position in the global vaccine market, supplying approximately 60-70% of WHO’s immunization vaccines. As such, it is crucial for the country to meet WHO qualifications to sustain the quality and efficacy of its pharmaceutical products. 

past incidents involving contaminated Indian-made cough syrups, which were linked to the deaths of children in Gambia and Uzbekistan, have underscored the importance of stringent regulatory measures.

During this assessment, WHO employed a global benchmarking tool to measure the maturity level of India's regulatory system, which was last evaluated in 2017. 

At that time, CDSCO achieved a maturity level of 3, indicating a stable and functioning regulatory framework. However, achieving the highest level, 4, remains a goal for the Indian regulator.

"The assessment is not merely a formality; it serves as a critical re-benchmarking of the NRA," said another official involved in the evaluation. "It will identify areas needing improvement, ensuring the system remains robust and responsive."

The assessment encompasses various factors, including marketing authorisation, clinical trial oversight, laboratory access, and market surveillance. 

The results will play a pivotal role in enhancing global confidence in Indian vaccines, particularly as the nation continues to be a primary supplier for organizations like UNICEF and the Pan American Health Organization.

Aniket Dani, director of research at Crisil Market Intelligence & Analytics, highlighted that the domestic vaccine market is projected to reach approximately Rs. 17.3 billion in FY24, contributing about 1% to India’s overall domestic formulations market.

As the WHO completes its evaluation, the results will not only benchmark India's regulatory status but also reassure international stakeholders of the safety and quality of Indian vaccines in the global market.

(KNN Bureau)