India may soon start training drug regulators from select foreign countries on drug regulatory practices and pharmacovigilance, officials familiar with the matter said on Wednesday.
The project could involve drug regulators and inspectors from African, Southeast Asian, and South Asian Association for Regional Cooperation (SAARC) countries, focusing on drug 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 initiative has been submitted to the MEA, with approval anticipated soon,” an official from the Central Drugs Standard Control Organisation (CDSCO) said.
As part of the programme, participants will gain insights into how drug quality is monitored through market surveillance. This involves the random sampling of drugs from the market and manufacturing facilities, followed by testing at government laboratories.
These training programmes will be conducted at the National Institute of Health and Family Welfare (NIHFW), an autonomous organisation under the Union health ministry. NIHFW has proposed specialised training sessions covering aspects of vaccine and drug trials, drug testing laboratories, and marketing authorisation procedures for new vaccines, biologicals, and drugs.
The official also noted that the Centre would bear the expenditure for the programme.
This initiative will extend the existing training efforts of the CDSCO and NIHFW, which already conduct training programmes for central and state drug inspectors.
Over the past two years, 1,477 drug regulators from the CDSCO and state agencies have undergone training on various drug regulatory aspects through residential programmes at NIHFW. Additionally, 672 state drug regulators have been trained across the country within the same period.
NIHFW Director Dheeraj Shah stated that these programmes aim to enhance the skills and knowledge of drug regulators, focusing on inspections, investigations, and dossier reviews by drug inspectors.
“The improved quality of investigations and prosecutions has led to a 5 to 10 per cent increase in the conviction rate over the last two years,” the official added.
Furthermore, the CDSCO has organised multiple workshops across the country on the revised Schedule M standards for good manufacturing practices (GMP). These workshops were attended by 39,107 industry representatives over the past two years.
“We plan to train another 800 people at NIHFW in the financial year (FY) 2025-26,” he said.
