At least 3,400 bottles of cough syrup ColdBest-PC from the batch suspected to have contained a poisonous compound — which allegedly led to the deaths of 11 children in Ramnagar area of Udhampur district in Jammu region between December 2019 and January 2020 — have been sold since September last year.
“Around 3,400-3,450 (bottles) have been consumed already because the batch was in the market since September,” said Himachal Pradesh Drug Controller Navneet Marwah. “We are trying our best to track down consumers through sales receipts, but this is an old batch. It’s a 60 ml bottle, so if someone took 5-6 ml in each dose, it would finish in 10-12 doses,” he told The Indian Express.
About 5,500 bottles of the cough syrup, manufactured by Himachal Pradesh-based Digital Vision Pharma, were sold in Jammu & Kashmir, Himachal Pradesh, Uttarakhand, Haryana, Uttar Pradesh, Tiruchirapalli (Tamil Nadu), Shillong (Meghalaya) and Tripura, in September 2019.
Between December and January, at least 17 children experienced adverse effects in Ramnagar area of Udhampur. Eleven of these children died from acute kidney failure. While investigations are still on, initial findings point to the cough syrup as the cause of death.
After a PGIMER laboratory found prima facie presence of Diethylene Glycol in the batch, production of the cough syrup was halted and the regions where it was distributed were asked to stop its sale.
According to Marwah, about 1,500 bottles of the batch have either been seized or are being recalled from the market. “More than 500 have been taken by drug inspectors for sampling across India,” he said. As a precaution, the state regulator has suspended the company’s manufacturing licence, demanding six-hourly status reports of the recall.
“We have taken into possession all their (Digital Vision Pharma’s) documents. It is part of the investigation, so it would be premature to say at this stage what happened,” he said, adding that he has sought the results “urgently”. The Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory body, has also taken up the issue, he said.
However, it is unclear what steps the CDSCO has taken so far. The Drug Controller General of India (DCGI), V G Somani, India’s top drug regulator, did not respond to an email or phone calls.
Meanwhile, experts and activists pointed to serious lapses in regulatory enforcement.
If it turns out that the ingredients sold to Digital Vision for the cough syrup were contaminated, it would not absolve the company from responsibility. There are provisions in the country’s drug regulations mandating manufacturers to test the quality of raw materials used in their products, said Archana Sahadeva, a lawyer specialising in pharmaceutical litigation.
Public health activist Dinesh Thakur said Digital Vision’s “long and dodgy history of producing NSQ (not of standard quality) drugs” should have been a red flag for regulators.
Alerts from CDSCO show five batches of Digital Vision Pharma’s drugs, ranging from drugs for diabetes to antibiotics, failed quality tests between 2014 and 2019. J&K’s own alerts flagged the company once for an NSQ drug (in 2015-16) and twice for misbranded drugs (in 2012-13 and 2015-16).
Between 2011 and 2019, 13 batches of Digital Vision’s drugs were labelled sub-standard in Gujarat and Maharashtra, while Karnataka’s regulator failed 14 samples between 2014 and 2020.
Thakur has an ongoing case in the Delhi High Court about how CDSCO has not issued binding guidelines for how an NSQ drug is recalled across India. He has also been asking how the available stock of NSQ drugs in the market is accounted for and how the country establishes chain-of-custody of the recalled stock.
“The fact that we have to go to court to demand such basic regulations be issued and implemented says all there is to be said about the state of our drug regulation,” he said.
“Unfortunately, in this country, authorities have not taken any cognizance of whether the manufacturing units are testing the raw materials before using them and how many batches have been rejected,” said former Maharashtra FDA Commissioner Mahesh Zagade. “It is a failure of implementation, right from the level of the Secretary (Health) down to the last functionary,” he said.
A senior health ministry official said that even where recalls are concerned, there is lack of transparency and enforcement has been ineffective.
In 2017, CDSCO had published guidelines on recalls and a “rapid alert system” for NSQ medicines. However, in some instances, by the time the information reaches the shop floors, the batch is “already consumed” by patients, the official had said earlier.
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