India Pharma Outlook Team | Thursday, 27 March 2025
According to the directors, India may soon begin training foreign drug regulators on drug regulatory practices and pharmacovigilance.
The initiative may involve regulators and inspectors from African, Southeast Asian, and SAARC nations under the Ministry of External Affairs (MEA) International Training and Education Center for Health (ITECH) program.
The Central Drugs Standard Control Organisation official said, "A proposal for the same has been forwarded to the MEA, with the body expecting to get an approval for the programme soon, 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 programme will focus on quality monitoring of drugs through market surveillance, where drug samples are randomly collected from markets and manufacturing units and tested in government laboratories.
Training sessions will be conducted at the National Institute of Health and Family Welfare (NIHFW), an autonomous body under the Union Health Ministry. NIHFW has already proposed dedicated training programmes for foreign drug regulators.
This project will strengthen and supplement training programs currently underway by the Central Drugs Standard Control Organization (CDSCO) and NIHFW, which have been training central and state drug inspectors.
Over the last two years, 1,477 regulators from CDSCO and state authorities have been trained through residential programs at NIHFW, while 672 state drug regulators have been trained across the nation.
Additionally, the CDSCO has held workshops on revised Schedule M regulating good manufacturing practices (GMP), further enhancing regulatory knowledge and compliance that were attended by a total of 39,107 representatives of the industry during the past 2 years.