WHO alert on Gambia deaths: Same fatal substances detected in WHO-banned cough syrups killed kids in India earlier
Two poisonous substances which WHO has blamed for the death of 66 children in Gambia has been at the centre of identical tragedies earlier in Gurugram and Jammu.
The two poisonous substances “diethylene glycol and ethylene glycol”, which the World Health Organisation (WHO) has blamed for the death of 66 children in The Gambia after detecting the contamination in four syrups a Haryana-based pharmaceutical unit had exported to the West African nation, has been at the centre of identical tragedies earlier in Gurugram and Jammu.
By raising an alarm over the four cold, cough and fever syrups manufactured in Sonepat and declaring them unsafe as they contained unacceptable amounts of diethylene glycol and ethylene glycol, the WHO alert has also brought under the spotlight how in January 2020, 10 children were suspected to have died in Jammu’s Udhampur due to the presence of diethylene glycol in a paediatric cough syrup.
The origin of this toxic material was traced to Delhi-based traders, who had sold the raw material to a trader in Ambala. And from Ambala, it was sent to a pharmaceutical unit in Kala Amb of Himachal Pradesh.
As per official health records, “poisoning with diethylene glycol” was held as the cause of acute renal failure in 36 children aged two months to six years, who were admitted to two hospitals in Delhi in April-June 1998.
A Haryana government official aware about this incident said among the victims were at least 26 children from Gurugram, who were prescribed a cough syrup manufactured by a company in Gurugram which was later found to be contaminated with diethylene glycol.
The medicines manufactured by companies in Gurugram and surrounding places were collected and tested at the Central Drugs Laboratory, Kolkata, for evidence of contamination and diethylene glycol was established as the cause of acute renal failure in those Gurugram children.
How the toxins travel into pharma units
According to Dr GL Singal, who also remained the drug controller of Haryana from 2012 to 2014, investigators looking into the Sonepat pharmaceutical company’s case should focus on finding out how and where from the diethylene glycol and ethylene glycol came from. It should be investigated as to how and at what point of the manufacturing of the cough syrups the contamination occurred, he said.
He said diethylene glycol/ethylene glycol looks like propylene glycol, which is used for manufacturing cough syrups and this similarity must be removed. Even the containers of three of them are also identical, he said, pointing out that possibilities of unscrupulous suppliers pushing diethylene glycol/ethylene glycol with propylene glycol cannot be ruled out.
While diethylene glycol and ethylene glycol are toxic and fatal, propylene glycol is used as a solvent for making syrups.
“It is imperative to ascertain the stage at which this contamination happened in the Sonepat unit as this tragedy again highlights the issue of gaps in enforcing the laws,” Dr Singal told Hindustan Times.
Officials in the health department say most of the manufacturers, especially small ones, don’t have complete testing facilities and that they outsource the testing which the law permits. The testing is done to check the purity of propylene glycol as per IP (Indian Pharmacopoeia).
Before the manufacturing of medicine begins for sale, it is mandatory to test the raw material. And whenever propylene glycol has been used as a solvent, the testing is mandatory, said an official of the state drug control department.
On the other hand, Dr Singal, the former state drug controller, said, since a gas chromatography test is crucial to rule out the presence of diethylene glycol and ethylene glycol impurities in the syrup, the question is if this test was done as per the prescribed norms by the Sonepat-based firm.
“Had this test been done properly, such problems should not have arisen. That’s why this unfortunate case requires a detailed probe from the supply of raw material to the packing of the medicine so that such tragedies don’t recur. Testing of the final manufactured material should be compulsory to rule out the accidental presence of fatal impurities like diethylene glycol ethylene glycol in the medicine,” said Dr Singal, asking that the raw material of the firm should have been seized as at the core of this tragedy is the raw material used for manufacturing these syrups.