India To Train Drug Regulators From Other Countries? NIHFW Proposes Specialized Programs

India is preparing to offer practical training and insights to various countries on best practices in drug regulations and the impactful initiatives undertaken by Indian drug regulators, officials confirmed on Wednesday.

The National Institute of Health and Family Welfare (NIHFW), an autonomous body under the Union Ministry of Health, has proposed specialized training programs for drug regulators from African, Southeast Asian, and SAARC nations. This initiative is being developed as part of the Ministry of External Affairs’ International Training and Education Center for Health (ITECH) program.

Focus on Drug and Vaccine Regulations

According to NIHFW Director Dr. Dheeraj Shah, proposals for the training programmes have been drafted in collaboration with the Central Drugs Standard Control Organisation (CDSCO) and submitted to the health ministry for approval. The training will cover key areas such as:

• Vaccine and drug trials in India
• Procedures for marketing authorization of new drugs and vaccines
• Market surveillance methods for monitoring drug quality
• Testing of drug samples from markets and manufacturing facilities at government labs
• Success stories in drug regulation and enforcement

These training programmes will be conducted at NIHFW headquarters and are expected to equip foreign regulators with valuable knowledge and skills to enhance their own regulatory frameworks.

Enhancing Drug Regulation Standards in India

Over the past two years, NIHFW has been running a residential training program to strengthen India’s own drug regulatory framework. During this time:

• 1,477 drug regulators from CDSCO and state agencies have been trained.
• These programmes have focused on improving skills, knowledge, inspection techniques, investigations, and dossier reviews.
• 672 state drug regulators across India have received additional training.
• The enhanced training has led to a 5-10% increase in conviction rates in drug-related offenses.

Dr. Shah emphasized, “These trainings aim to improve the confidence of drug regulators, enhance the quality of inspections and investigations, and ensure more effective prosecution leading to better conviction rates.”

Industry Participation in Drug Regulation Workshops

In addition to regulatory training, CDSCO has conducted nationwide workshops on the revised Schedule M, which sets new Good Manufacturing Practices (GMP) standards. These workshops have attracted significant participation:

• Conducted in a hybrid format, allowing both physical and virtual attendance.
• Attended by 39,107 industry representatives in the last two years.

India’s initiative to share its expertise with other countries is a step toward strengthening global drug regulatory frameworks.