New Delhi: India is set to share its expertise in drug regulations with select nations, according to officials.
A plan has been put forward by the National Institute of Health and Family Welfare (NIHFW), an autonomous body under the Union health ministry, to train drug regulators from Africa, South-East Asia and the Saarc region.
Saarc is short for South Asian Association for Regional Cooperation.
This initiative, part of the external affairs ministry’s International Training and Education Center for Health (ITECH) programme, aims to strengthen regulatory knowledge and facilitate the exchange of best practices.
In collaboration with the Central Drugs Standard Control Organisation (CDSCO), the NIHFW has developed training proposals that have been submitted to the health ministry, said NIHFW director Dr Dheeraj Shah.
The proposed training sessions will focus on multiple aspects of vaccine and drug trials conducted in India, including the process for granting marketing authorization for new pharmaceutical products, Dr Shah explained.
As part of the programme, participating countries will also be introduced to India’s approach to drug quality surveillance. This involves random sampling of medicines from markets and manufacturing sites, followed by testing at government laboratories to ensure compliance with safety standards.
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The NIHFW will host these training sessions at its campus. Over the past two years, the institute has trained 1,477 drug regulators from CDSCO and various state agencies in a residential programme to enhance their knowledge, skills and capabilities in inspections, investigations and dossier reviews.
“The enhanced quality of investigations and prosecution has led to an increased conviction rate by 5-10% (in India) over the last two years,” Dr Shah said.
“These training programmes are aimed at improving the confidence of drug regulators as well as to improve the quality of inspections and investigations to ensure effective prosecution leading to better conviction rates,” Dr Shah added.
Also, 672 state drug regulators have undergone training nationwide in the past two years.
Further, the CDSCO has organized multiple workshops across the country on the updated Schedule M, which sets the standards for good manufacturing practices. These sessions, held in hybrid mode, have seen participation from 39,107 industry representatives over the past two years.
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