WHO evaluates India’s top drug regulator, vaccine manufacturing practices

New Delhi: The World Health Organization (WHO) carried out assessment of National Regulatory Authority (NRA) of India’s top drug regulator Central Drugs Standard Control Organization (CDSCO) and Drugs Controller General of India (DCGI) to determine the status of the country's vaccine regulatory system and its various functions, three officials aware of the matter said.

A team comprising lead experts from WHO's headquarters in Geneva, India office, and drug regulators from other nations evaluated India’s vaccine regulations, regulatory protocols followed by drug regulator, new vaccines being developed, and the good manufacturing practice (GMP) followed by Indian vaccine makers, the officials said.

“This is a regular sort of assessment by WHO happening at CDSCO to understand the quality of vaccines being developed in the country and how Indian regulatory authority is working, how is vaccine approval done, what are the quality, efficacy and safety compliance for vaccines and GMP standards,” the first of the three officials said, all of whom spoke on the condition of anonymity.

The official added that WHO conducts NRA assessment of countries every 5 years.

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The international procurement agencies source huge quantities of vaccines from India. Therefore, it is important for the country to get qualified by WHO. "This to maintain the highest quality and efficacy of the products that are manufactured in our country,” the official added.

The assessment started on 16 September and concluded on 20 September.

Maintaining quality

India is known as the pharmacy of the world, with around 60-70% of WHO’s vaccines for immunization sourced from the country. Therefore, measuring up to WHO's safety and manufacturing standards becomes critical for the country's drug makers.

The assessment comes in the backdrop of some incidents in the past two years where India-made cough syrups failed quality test overseas due to alleged contamination. In 2022, poor-quality Indian-made cough syrups were linked to the deaths of 66 children in Gambia and 18 kids in Uzbekistan.

The WHO assessment measures NRA's maturity level and compliance with the UN health agency's regulatory standards.

“Right now, WHO is evaluating whether the NRA is functional or not and what is the maturity level of the system. This is called re-benchmarking of the NRA and suggest where it needs improvement,” said a second official who is a state drugs regulator.

As a part of the assessment exercise, the WHO uses the global benchmarking tool (GBT) to evaluate the regulatory systems of countries. Previously, this exercise was successfully done in 2017.

Queries sent to the Union health ministry spokesperson remained unanswered till press time.

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India is one of the biggest manufacturers and exporters of vaccines globally, currently supplying several vaccines to the UN agencies, including UNICEF, WHO, and Pan American Health Organization.

Around 60-70% of WHO’s vaccines (essentially used for immunization) are sourced from India. As a part of the procurement, WHO also inspects manufacturers separately and assesses the regulatory protocols, inspect labs, adverse event following immunization (AEFI) cases, etc.

Aniket Dani, director research, Crisil Market Intelligence & Analytics, said that the domestic vaccines market size stood at about Rs. 17.3 billion in FY24. This segment contributed about 1% of the overall domestic formulations market.

The audit

The WHO assessment involves audit of registration and marketing authorization, vigilance, laboratory access and testing, regulatory inspection, clinical trial oversight, NRA lot release, licensing premises, and market surveillance and control.

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WHO's NRA assessment scores the maturity level on a scale of 1 to 4. In 2017, when WHO conducted the audit of CDSCO, it received the maturity level 3, which indicates a stable, well-functioning regulatory system.

“WHO has set passing grade for the regulators in terms of maturity level. In 2017, when WHO conducted the audit, NRA of Indian regulator was at maturity level 3 which is good one. However, maturity level 4 is considered the strongest. After 2017, the re-benchmarking is being done again for the regulator,” the third official said.

“This assessment results will let us know what the maturity level of India is and will set the benchmark for the country as per WHO standards. This will give confidence to other countries that Indian vaccines are safe, efficacious and high quality.” said the official.