Killer Cough Syrup Scandal: How a Factory’s 350 Violations Cost Lives

Killer Cough Syrup Scandal: How a Factory’s 350 Violations Cost Lives

In a shocking exposé, a Tamil Nadu government report has laid bare the nightmarish reality behind the manufacture of Coldrif cough syrup — a product now blamed for the deaths of 16 children across Madhya Pradesh and Rajasthan. What the inspectors found in the Kancheepuram facility owned by Sresan Pharmaceutical is not just regulatory negligence, but a full-blown travesty of life endangering malpractice.

A Factory Out of Control

When the inspection team entered the premises, they encountered scenes straight out of a horror story. Over 350 violations were catalogued — some deemed “critical,” others “major,” but all with the potential to kill. The facility was operating under a complete absence of good manufacturing practices:

  • Filthy environment: The factory lacked air handling units, had no effective ventilation, and equipment was rusted and damaged.
  • No quality department: There was no quality assurance team, no authorized person for batch release, and no documented standard operating procedures (SOPs) for recalls or failures.
  • Storage in corridors: Instead of designated, secure, sanitary places, products were stored in open corridors where cross contamination was virtually inevitable.
  • Lack of hygiene protocols: There were no pest control measures, no cleaning protocols, and even the purified water systems were compromised.

This is not a case of minor lapses — it’s systemic collapse.

The Most Alarming Discovery: Toxic Chemicals

Perhaps the most egregious wrongdoing was the use of non pharma grade chemicals in a medicinal syrup intended for children.

  • The report found the company had procured 50 kg of propylene glycol (a chemical used in food and cosmetics) without invoices, indicating procurement outside regulated supply chains.
  • Worse still, traces of diethylene glycol (DEG) — a deadly industrial solvent commonly found in brake fluids or plastics — were detected in the syrup.
  • In pharmaceutical history, substitution of DEG for propylene glycol is notorious for causing mass poisonings and fatalities.

This was not a mistake — it was gross recklessness that turned a medicine into a killer.

Breakdown Across the Board: From Raw Materials to Distribution

The violations extended to every stage of production:

  • Raw materials released without testing or approval from vendors.
  • Open sampling: Samples meant for quality checks were drawn in unfiltered, open air — a perfect breeding ground for contamination.
  • No preventive measures against rodents or insects; the facility lacked even basic fly catchers or air curtains.
  • No skilled manpower: Analysis methods, cleaning validations, and critical controls were never performed.
  • Effluent mismanagement: Chemical waste was pumped directly into general drains, and even purified water tanks were filthy.

In effect, the factory was a ticking time bomb — every part of its operation was compromised.

The Fallout Begins: A Statewide and National Clampdown

Once the report was published, authorities acted swiftly:

  • Tamil Nadu banned the sale of Coldrif syrup effective October 1 and ordered existing stocks removed.
  • Production has been halted, pending explanations and further orders.
  • The children’s deaths in Madhya Pradesh prompted suspension of officials and the transfer of the state drug controller.
  • Most damningly, the findings indicate these tragic deaths could have been prevented if even the most basic drug safety norms had been observed.

      • Lessons from a Preventable Tragedy

      The Coldrif saga should serve as a grave warning to regulators, industry, and consumers alike:

      1. Regulation must be relentless — Regulatory authorities need stronger enforcement, surprise inspections, and consequences for noncompliance.
      2. Traceability & accountability — Medicines, especially those for children, must have fully documented, verifiable supply chains and stringent audits.
      3. Whistleblower protection — Internal dissent or alerts must be taken seriously, not suppressed, to prevent disasters in corporate silence.
      4. Consumer vigilance — Citizens should demand transparency about drug manufacturers, safety certifications, and inspection histories.

      This is not merely a story of scandal — it’s a harsh reminder that negligence in pharmaceutical production is not an abstract violation; it costs lives. The 350 violations inside the Coldrif factory were not “mistakes.” They were deadly decisions. And now India must reckon with how to prevent this from ever happening again.