A private laboratory in Delhi had ruled out the presence of the toxic impurity in a solvent used to make the batch of a cough syrup in Himachal Pradesh which is linked with the death of several children in Jammu earlier this year, according to the manufacturer’s reply filed before the drug authorities in Jammu.
Samples from a batch of cough syrup Coldbest-PC made by Sirmaur-based Digital Vision in September 2019, which was reportedly consumed by a number of children at Ramnagar in Jammu, have been found to be contaminated with diethylene glycol (DEG) by the government analyst.
Last week, the PGI flagged the presence of DEG in yet another syrup made by the firm in the same month, the consumption of which is believed to have caused renal failure in a two-year-old girl.
DEG is a toxic impurity found within propylene glycol, a solvent used in this syrup to dissolve paracetamol. The manufacturer had procured propylene glycol from a Haryana-based supplier, but it was manufactured by Manali Petrochemicals in Chennai.
According to Digital Vision’s replies and test reports filed before the drug authorities, a ‘government-approved’ laboratory in Delhi – Shree Sai Test House – tested 10 grams of the solvent from a batch which the company has claimed was used to make the Coldbest syrup batch in question.
The test report stated that the solvent sample “complied” with DEG norms. Drug authorities are also investigating whether the same batch of solvent was used to manufacture Cofset-AC, the syrup which has been recalled this month.
Digital Vision’s reply said that following the analysis of the raw material, the quality control department of the company also issued a certificate of analysis to the finished product, that is 5,575 bottles of the syrup.
It was in January this year that a laboratory in PGI, equipped to qualitatively test the presence of DEG, detected the impurity in the syrup after several children died of renal failure at Ramnagar. Later, samples taken by drug authorities in Jammu, Himachal and Haryana were analysed quantitatively at a Central government laboratory in Chandigarh. The samples contained more than 30 per cent DEG, the lab reports said.
The company has challenged these reports before the drugs controller, and has also claimed that one of the reports from the same batch cleared the test by the analyst.
More samples from the batches concerned are now likely to be sent to another Central government laboratory in Kolkata by the appellate authority. Meanwhile, the matter is also being probed by the police departments of multiple states.
26 random samples tested for DEG
As per the Drugs and Cosmetic Act, and Drugs and Cosmetic Rules, the onus of ensuring the quality and analysis of pharmaceutical products is on the manufacturers.
Drug control authorities, meanwhile, can test randomly collected samples from the market, or from the manufacturing units, to enforce regulation and ensure quality. If a sample fails the test, officials can order recall of the batch from the market and initiate legal action.
After the case hit the limelight in February, the authorities collected 26 samples from various batches and products manufactured by the unit since December 2018, and analysed them for DEG and other quality parameters. All samples passed the test.
The unit’s manufacturing licence was also suspended, and no production has taken place since. The batch of Coldbest was recalled from the market, and state drug authorities across the country asked to test other batches of the syrup.
In April, for instance, eight samples of the syrup failed quality tests in the country, though none was found to be adulterated.
But the company manufactures hundreds of other products, including a number of syrups, and they were already in the market before production stopped.
One of the batches of a syrup has now prima facie tested positive for DEG at the PGI’s paediatric biochemistry lab, and drug officials have sent its samples to the government analyst for confirmation.
📣 The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay updated with the latest headlines