New Delhi: Close to 3,400 bottles of the ColdBest-PC cough syrup from the batch that is suspected to contain a poisonous compound have been sold since September last year, according to a report in the Indian Express.
“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 and added that the best way to track down consumers was 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.
The drug, which has been manufactured by Digital Vision, allegedly led to the death of over 10 children in Ramnagar area of Udhampur district in the Jammu region between December 2019 and January 2020. After the Centre deployed a team of medical experts to probe the cause of deaths, diethylene glycol was detected in the cough syrup by a PGIMER laboratory.
Production of the cough syrup was soon halted and states, where it had been distributed, were asked to stop its sale.
The owner of the drugs maker Digital Vision, Konic Goyal, has said that the cough syrup manufactured by his company had nothing to do with the deaths of children.
Speaking to the Economic Times, Goyal said that his “company maintains good manufacturing practices standards and hence the syrup could not have led to the deaths of children”.
If the government-run laboratory, where the samples of the syrup have been sent for testing confirms that it was contaminated with the presence of chemical diethylene glycol (DEG), Goyal could face criminal charges.
As per the Drugs and Cosmetics Act:
“Any drug deemed to be adulterated under section 17A or spurious under section 6 [17B] (and which) when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860) solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than ten lakh rupees or three times value of the drugs confiscated, whichever is more.”.
The Himachal Pradesh government reportedly also plans to file an FIR against the company.
Approximately 5,500 bottles of the cough syrup were sold in the states of Jammu and Kashmir, Himachal Pradesh, Uttarakhand, Haryana, Uttar Pradesh, Tamil Nadu, Meghalaya and Tripura, in September 2019.
The Himachal Pradesh drug controller said that around 1,500 bottles had been seized or recalled. The state regulator has also suspended the company’s manufacturing licence and is asking for six-hourly status reports of the recall. The Central Drugs Standard Control Organisation (CDSCO) is also looking into the issue.
While several activists have pointed out lapses in regulatory enforcement, Archana Sahadeva, a lawyer specialising in pharmaceutical litigation, has said that the company would not be absolved even if it turns out that the ingredients sold to it were contaminated since drug regulations mandate that manufacturers test the quality of raw materials.
Dinesh Thakur, a public health activist referred to Digital Vision’s “long and dodgy history of producing NSQ (not of standard quality) drugs” and that authorities had not taken any cognizance of whether manufacturing units were testing the raw materials before using them.
Five batches of Digital Vision Pharma’s drugs that included drugs for diabetes and antibiotics, failed quality tests between 2014 and 2019. Thirteen batches of itn’s drugs were labelled sub-standard in Gujarat and Maharashtra between 2011 and 2019.