Cough Syrup Poisoning

Why in News?

Due to a poisoned cough syrup, 12 children died in Jammu and more are fighting for their life in a hospital.

Why these deaths had occurred?

• The doctors attributed the deaths to the presence of diethylene glycol in the cough syrup which was consumed by all the dead children.
• Diethylene glycol is an anti-freezing agent used in medicines.
• But, it causes acute renal failure in the human body followed by paralysis, breathing difficulties and ultimately death.

Is this the first time such a poisoning has occurred?

• This is the fourth mass glycol poisoning event in India that has been caused due to a pharmaceutical drug.
• This kind of poisoning had occurred in Chennai (1973), Mumbai (1986) and New Delhi (1998).
• In all these three cases, the manufacturers of the suspect syrup failed to contain the level of glycol in the syrup due to negligence or human error.

What should be the immediate concern?

• The immediate concern for doctors, pharmacists and the drug regulators should be to prevent any more deaths.
• For this, all the poisoned syrup that has ever been sold in the Indian market should be accounted and stopped from reaching the patients.
• Any patient who has consumed even a spoon of the syrup should then immediately be referred to a hospital for treatment.

What public health measures were taken?

• When the US faced a similar poisoning situation, its entire field force of inspectors and chemists were tracking down every single drug bottle.
• This effort was accompanied by publicity blitz over radio and television.
• There are no such public health measures undertaken here.
• The Himachal Pradesh authorities who are responsible for oversight of this syrup manufacturer have made statements that they’ve ordered the withdrawal of the drug which is sold across the country.
• However, there is no transparency in this recall process.
• There is no public announcement by the Drug Controller General of India (DCGI).
• [DCGI - Responsible for overall regulation of the entire Indian market.]
• The DCGI website, which is supposed to communicate drug alerts and product recalls, has no mention of suspect product as being dangerous.

What is the need for a recall policy?

• Unlike other countries, India has no binding guidelines or rules on recalling dangerous drugs from the market.
• This is one of the key reasons why the DCGI and state drug authorities have been so sloppy.
• The 59th report of the Parliamentary Standing Committee on Health as well as the WHO (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.

What should be done?

• A national recall of the adulterated medicine is the immediate need.
• The administration needs to quickly identify which other pharmaceutical companies have received this spurious ingredient by the same trader.
• It is important for regulatory enforcement to raid and seize the records of this trader in question and verify the sales.
• The lackadaisical response of drug regulators in India is the result of a larger lethargy and arrogance of the administrative bureaucracy.
• They are the ones who are responsible for ensuring safety by keeping unethical practices of pharmaceutical companies under control.
• National level binding guidelines or rules on recalling dangerous drugs from the market should be notified soon.

Source: The Hindu