Context

A few days ago, 12 children died in Udhampur district of Jammu due to poisoned cough syrup (Coldbest-PC).

Fourth mass glycol poisoning

• What was the cause of the poisoning? A team of doctors at the Post Graduate Institute of Medical Education & Research, Chandigarh, attributed the deaths to the presence of diethylene glycol in the cough syrup.
• What is Diethylene glycol? It is an anti-freezing agent that causes acute renal failure in the human body followed by paralysis, breathing difficulties and ultimately death.
• This is the fourth mass glycol poisoning event in India that has been caused due to a pharmaceutical drug.

Measures required and example from the US

• Preventing further deaths: The immediate concern for doctors, pharmacists and the drug regulators should be to prevent any more deaths.
  • The only way to do so is to account for each and every bottle of the poisoned syrup that has ever been sold in the Indian market and stop patients from consuming this drug any further.
• The US example in such case: United States Food and Drug Administration (USFDA), in 1937, when the United States faced a similar situation with glycol poisoning.
  • Tracking down every bottle: Entire field force of inspectors and chemists were assigned to the task of tracking down every single bottle of the drug.
  • Even if a patient claimed to have thrown out the bottle, the investigators scoured the street until they found the discarded bottle.
  • This effort was accompanied by a publicity blitz over radio and television.
• What is being done in India? We do not see such public health measures being undertaken here.
  • Seriousness not communicated to the pubic: Authorities are simply not communicating the seriousness of the issue to the general public.
  • A general statement: At most, the authorities in Himachal Pradesh (H.P.), who are responsible for oversight of the manufacturer of this syrup, have made general statements that they have ordered the withdrawal of the drug from all the other States where it was marketed.
  • Lack of transparency: There is no transparency in the recall process and information about recalls and batch numbers is not being communicated through authoritative channels.
  • No public announcement by the DCGI: There is no public announcement by the Drug Controller General of India (DCGI), which is responsible for overall regulation of the entire Indian market.
  • The suspect product, although manufactured in H.P., has been sold across the country.
  • The website of the DCGI, which is supposed to communicate drug alerts and product recalls, has no mention of Coldbest-PC as being dangerous as of this writing.

Need for the recall policy

• No rules or binding guidelines on recall: One of the key reasons why the DCGI and state drug authorities have been so sloppy is because unlike other countries, India has not notified any binding guidelines or rules on recalling dangerous drugs from the market.
• Warnings to the DGCI on lack of framework: The 59th report of the Parliamentary Standing Committee on Health as well as the World Health Organization (in its national regulatory assessment) had warned the DCGI on the lack of a national recall framework in India.
  • A set of recall guidelines was drafted in 2012 but never notified into law.

Conclusion

The drug regulator needs to take the urgent steps to avoid the repeat of such tragedies in the future and formulate a policy on the drug recall at the earliest.

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