India Proposes Training Programmes For Foreign Drug Regulators

India is likely to provide practical insights to certain countries on the best practices in drug regulations and the impactful initiatives taken by the Indian drug regulators, officials said on Wednesday.

The National Institute of Health and Family Welfare (NIHFW), an autonomous organisation under the Union health ministry, has proposed training programmes for the drug regulators of African, South East Asian and SAARC countries on drug and regulatory aspects and sharing of expertise as part of the Ministry of External Affairs' International Training and Education Center for Health (ITECH) programme.

Proposals for training have been drafted by the NIHFW in collaboration with Central Drugs Standard Control Organisation (CDSCO) and have been sent to the health ministry, said NIHFW Director Dr Dheeraj Shah.

Training would be imparted on the various aspects of vaccine and drug trials that are conducted in India and the procedure of marketing authorisation for new vaccines and drugs, Dr Shah elaborated.

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 market and manufacturing facilities and tested at government laboratories. Success stories would also be shared, he said.

These training programmes will be held at NIHFW.

In the last two years, at the residential programme at NIHFW, 1,477 drug regulators from the CDSCO and states have been trained on various drug regulatory aspects focused on improving their skills, knowledge, inspections, investigations and review of dossiers.

"The enhanced quality of investigations and prosecution has led to an increased conviction rate by 5 to 10 per cent (in India) over the last two years," Dr Shah said.

"These trainings 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 said.

Besides, 672 state drug regulators were also trained across the country in the last two years. Moreover, the CDSCO has also conducted various workshops across the country on revised schedule M (standard for Good Manufacturing Practices), which were attended in hybrid mode by 39,107 industry representatives in the last two years

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