India-made cough syrups and deaths in Gambia
Source: Indian Express
GS II: Health

What is discussed under India-made cough syrups and deaths in Gambia?

1. Key Facts
2. Central Drugs Standard Control Organisation (CDSCO)

Why in News?

The WHO has issued an alert on four cough and cold syrups manufactured in India by Maiden Pharmaceuticals, saying that they may be related to the deaths of 66 children in the Gambia.

Key Facts

• The four cough and cold syrups implicated in the deaths of 66 infants in the Gambia are:
  • Promethazine Oral Solution
  • Kofexmalin Baby Cough Syrup
  • Makoff Baby Cough Syrup
  • Magrip N Cold Syrup
• The WHO stated that Maiden Pharmaceuticals has yet to give guarantees on the safety and quality of these items.
• Laboratory examination of samples from each of the four items indicates that contaminants such as diethylene glycol and ethylene glycol are present in excessive concentrations.
  • According to the WHO, diethylene glycol and ethylene glycol are poisonous to humans and can be deadly if swallowed.
  • Abdominal discomfort, vomiting, diarrhoea, difficulty to pass urine, headache, changed mental state, and severe renal damage, which may result in death, are all toxic consequences.
• To prevent additional harm to people, WHO has advised all nations to detect and remove these items from circulation.

Central Drugs Standard Control Organisation (CDSCO)

• The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory body for:
  • Cosmetics

    

  • Pharmaceuticals
  • Medical devices
• It performs a similar job to the:
  • European Union’s European Medicines Agency
  • Japan’s PMDA
  • The United States’ Food and Drug Administration (FDA)
  • The United Kingdom’s Medicines and Healthcare Products Regulatory Agency
  • China’s National Medical Products Administration (NMPA)
• The Indian government has announced a proposal to have the CDSCO assess all medical devices, including implants and contraception.
• The Drug Controller General of India (DCGI) supervises pharmaceuticals and medical devices under the CDSCO.
• It is positioned inside the Ministry of Health and Family Welfare.
• The Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC) advise the DCGI.
• Each zonal office is responsible for:
  • Pre- and post-licensing inspections
  • Post-market surveillance
  • Medication recalls (where necessary)
• Manufacturers who deal with the authority must choose an Authorized Indian Representative (AIR) to represent them in all CDSCO interactions in India.

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