To ensure post-marketing safety of vaccines, govt to expand the reach of 3S project

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News:The central government has decided to expand the reach of the Smart Safety Surveillance or 3S programme to optimize post-marketing surveillance of priority drugs and vaccines.

Facts:

About Smart Safety Surveillance(3S) Programme:

  • The programme was introduced by the World Health Organization(WHO) in India considering limited safety data on vaccines in the country.
  • The programme is implemented with the support of the Bill and Melinda Gates Foundation to strengthen pharmacovigilance systems in developing nations.
  • Under the programme,Government of India is trying to strengthen the collaboration among key stakeholders such as the Ministry of Health and Central Drugs Standard Control Organisation(CDSCO) to ensure high levels of vigilance.
  • Currently,under the programme India is evaluating the safety of recently introduced rotavirus vaccines.

Significance of the programme:

  • 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 and surveillance is essential to monitor the risk-benefit profile of a product in the wider population.

Additional information:

About Rotavirus:

  • Rotavirus is the most common cause of severe diarrhea among infants and children throughout the world.
  • Rotavirus is transmitted by the faecal-oral route via contact with contaminated hands,surfaces and objects and possibly by the respiratory route.
  • Every year in India,37 out of every 1,000 children born are unable to celebrate their fifth birthday and one of the major reasons for this is deaths due to diarrhoea.Rotavirus is a leading cause of diarrhoea in children less than five years of age.

About CDSCO:

  • The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical device 
  • CDSCO functions under the Drugs and Cosmetics Act.It comes under Directorate General of Health Services,Ministry of Health & Family Welfare.
  • CDSCO is responsible for (a)approval of New Drugs (b)Conduct of Clinical Trials, (c)laying down the standards for Drugs (d)control over the quality of imported Drugs in the country and (e)coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.