India’s Quality Control Disease

Recent incidents highlight the recurring issue of toxic drug poisoning in India, especially involving cough syrups. These events expose significant gaps in the drug quality control and regulatory mechanisms in the country.

Notable Incidents of DEG Poisoning

• Since September 2, 2023, at least 20 children in Madhya Pradesh have died due to toxic cough syrup containing diethylene glycol (DEG).
• Historical DEG poisoning incidents include: 
  • 1937, USA: Over 100 deaths, leading to the 1938 Federal Food, Drug, and Cosmetic Act.
  • 1969, South Africa: 7 children died.
  • 1990 & 2008, Nigeria: 47 and then 84 deaths respectively.
  • 1990-92, Bangladesh: 236 deaths.
  • 1992, Argentina: 29 elderly deaths.
  • 1996, Haiti: 75, mostly children, died.
  • 2007, Panama: Over 400 deaths.
• In India, prior incidents include: 
  • 1972, Madras: 15 children died.
  • 1986, Mumbai’s JJ Hospital: 14 deaths.
  • 1988, Bihar: 11 deaths.
  • 1998, Gurgaon: 33 children died.
  • 2019, Jammu: 12 children died.

International Concerns and WHO Alerts

• In 2022, WHO issued alerts regarding contaminated cough syrups made in India, linked to child deaths in Gambia (69 children) and Uzbekistan (18 children).
• Different manufacturers were responsible, highlighting systemic issues in the industry.

Regulatory Response and Challenges

• India mandates cough syrups be tested before export, but not for domestic sales, raising concerns about the valuation of Indian lives.
• Many Indian pharmaceutical companies fail to adhere to good manufacturing practices (GMP) due to inadequate facilities and corrupt practices.
• Recent amendments to the Drugs and Cosmetic Act allow fines instead of imprisonment for substandard drug manufacturers, reducing deterrence.

Judicial and Administrative Actions

• Post-1986 Mumbai incident, an inquiry led by Justice Bakhtavar Lentin called for public health administration overhaul, yet the case remains unresolved 40 years later.
• There is an urgent need for a stringent regulatory framework to ensure drug quality and consumer safety.

Overall, India must prioritize the safety and quality of pharmaceuticals to maintain its reputation as the "pharmacy of the world" and safeguard its citizens, especially children.