India may soon train select countries on best drug regulatory practices

India may soon start training drug regulators from select foreign countries on drug regulatory practices and pharmacovigilance, officials in the know said on Wednesday.

 

The project could include drug regulators and inspectors from African, South East Asian, and South Asian Association for Regional Cooperation (SAARC) countries on drug and regulatory aspects and the sharing of expertise as part of the Ministry of External Affairs’ (MEA’s) International Training and Education Center for Health (ITECH) programme.

 

“A proposal for the same has been forwarded to the MEA, with the body expecting to get an approval for the programme soon,” an official from the Central Drugs Standard Control Organisation (CDSCO) said.

 

As part of the programme, countries would be informed on how the quality of drugs is monitored through market surveillance, where drug samples are drawn randomly from the market and manufacturing facilities and tested at government laboratories.

 

These training programmes will be held at the National Institute of Health and Family Welfare (NIHFW), an autonomous organisation under the Union health ministry, which has proposed training programmes for the drug regulators.

 

“Training would be imparted on the various aspects of vaccine and drug trials, drug testing laboratories, and marketing authorisation procedures for new vaccines, biologicals, and drugs,” the official said.

 

He also added that, as part of the proposal, the expenditure for the programme would be borne by the Centre.

 

The project will be an extension of the CDSCO and NIHFW’s ongoing training programmes with drug inspectors from the central and state drug authorities.

 

In the last two years, 1,477 drug regulators from the CDSCO and states have been trained on various drug regulatory aspects at the residential programmes at NIHFW.

 

Besides, 672 state drug regulators were also trained across the country in the last two years.

 

NIHFW director Dheeraj Shah said that these trainings are focused on improving skills, knowledge, inspections, investigations, and the review of dossiers by drug inspectors.

 

“The enhanced quality of investigations and prosecution has led to an increased conviction rate by 5 to 10 per cent over the last two years,” the official added.

 

Moreover, the CDSCO has also conducted various workshops across the country on the revised Schedule M standards for good manufacturing practices (GMP), which were attended by 39,107 industry representatives in the last two years.

 

“We are expecting to train another 800 people at NIHFW in the financial year (FY) 2025-26,” he said.