Smart Safety Surveillance (3S) programme

Syllabus subtopic: Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

News: The central government is planning to expand the reach of the Smart Safety Surveillance, or 3S, programme.

This is being done to optimize post-marketing surveillance of priority drugs and vaccines, and ensure the vaccines distributed under the universal immunization programme are safe.

Prelims focus: About 3S programme

Mains focus: Its significance, challenges in implementation and their redressal

Context: According to WHO, access to medicines and vaccines in low- and middle-income countries has improved in the past two decades. However, there has not been a proportionate improvement in pharmacovigilance infrastructure and activities to monitor adverse events and address safety issues.

About 3S project

The 3S project was recommended by the World Health Organization (WHO), considering the limited safety data on vaccines introduced in India.

As part of the 3S project, India is evaluating the recently-introduced rotavirus vaccines. It is also trying to strengthen the collaboration among key stakeholders, such as ministry of health and Central Drugs Standard Control Organisation (CDSCO), to ensure high levels of vigilance.

Need for and significance of this programme for India:

According to the ministry of health and family welfare, new medical products often enter the market with limited safety data from clinical trials, which evaluate small controlled populations. Therefore, for immunization programmes, post-marketing safety surveillance is essential to monitor the risk-benefit profile of a product in the wider population.
WHO has been prodding countries to adopt the 3S programme, with the support of the Bill and Melinda Gates Foundation, to strengthen pharmacovigilance systems in developing nations.

Source: The Hindu

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