Earlier this year, around 17 children from Ramnagar in Jammu and Kashmir were hospitalised. More than half of them died of kidney failure. The cause: A batch of “Coldbest” cough syrup containing a chemical that should never have been there in the first place — diethylene glycol (DEG).
Over a month of investigations, first by a team of doctors from PGIMER-Chandigarh and later by drug control regulators, revealed on March 2 that the syrup was, in fact, the culprit. The September batch of Coldbest, manufactured by Himachal Pradesh-based Digital Vision Pharma and sold in several states, contained 34.97 per cent of the poisonous chemical, according to Chandigarh’s Regional Drugs Testing Laboratory.
Jammu and Kashmir, Himachal Pradesh and Haryana authorities have since filed FIRs, setting in motion further investigations into alleged offences by the company. Last week Himachal Chief Minister Jai Ram Thakur said that the government was seeking “stringent action” — imprisonment of 10 years to life against the company’s executives.
Glaring gaps in the regulatory process together with several failures in the manufacturing chain in the company itself could be behind the toxic batch entering the market.
Red flags were ignored
This is India’s 4th mass glycol poisoning and yet safeguards are lacking. High levels of toxin point to the failure of internal controls within the company. Regulators had raised red flags regarding the firm but yet these gaps went undetected. The role of the pharmacist is limited if the product itself is suspect.
Experts see two possible explanations for why a batch of Coldbest with DEG — reportedly a common impurity in the solvent of such syrups — was in the market. Either it was counterfeit, or Digital Vision, despite reportedly claiming to follow good manufacturing practices, failed to test the quality of its batches..
They suspect the latter.
The company had “poorly” followed manufacturing processes, Drug Controller General of India VG Somani told The Indian Express at the Indian Pharma 2020 conference in Ahmedabad.
“There is no doubt about it. (The syrup) was impure. The person who made it was contravening the provisions of law,” said Somani, who heads CDSCO, India’s top regulator responsible for ensuring safe and effective medicines.
“He has done everything (tests), but poorly done…Validation, calibration — these things are extremely necessary and it has to be done properly. If it is not…it can lead to fatal results sometimes.”
Digital Vision could have detected DEG in “various” stages of Coldbest’s production, starting with the raw material used, said Murali Neelakantan, former global general counsel of Cipla and Glenmark Pharmaceuticals. Depending on its operating procedure, it would “normally” have had to check for “known issues” like impurities and contaminants.
“If you want to, and people do their jobs, you can catch it at any stage. Here, several opportunities to catch the problem have been missed,” he said.
Some say Digital Vision, with its history of making substandard drugs, should have been on the radar of regulators much earlier. In 2015, Karnataka’s drug regulator even attempted to prosecute it over substandard medicines.
“State drug regulators and CDSCO need to conduct a root-cause analysis of why this happened,” said public health activist Dinesh Thakur, questioning why Digital Vision never figured in CDSCO’s risk-based inspections.
“The fact that this high a percentage of DEG made it to the final product points to the failure of internal controls within the company. If CDSCO and state drug regulators have conducted prior inspections of this manufacturing unit, did they not find their internal control procedures lacking?” he said. “What does it say about the efficacy of CDSCO inspections? Who at State drug regulatory authorities and CDSCO is accountable for the death of these 12 children now?”
This is India’s fourth mass glycol poisoning, yet safeguards have not been enforced, feel experts.
To avoid future mishaps, it has been made “mandatory” to test excipients for medicines before using them, said Haryana Drug Controller NK Ahuja. “Every manufacturer or importer of propylene glycol (Coldbest’s excipient) has to test it for presence of toxic impurities like diethylene glycol and ethylene glycol,” he said.
“For this product, there is no gap in law. The company had a manufacturing approval. The approval requires you to perform all these quality checks,” said Neelakantan.”It’s a known impurity. Let’s be clear about that.”
The Ramnagar chemist does not play a major role in the fiasco, as the syrup was adulterated likely during production, say experts. A 10th pass, he has a licence to prescribe and sell ayurvedic drugs and another to sell allopathic drugs, only on a doctor’s prescription.
Around 95 percent of Jammu and Kashmir’s 13,000 drug retailers and 4,000 wholesalers do not have “any diploma or degree in pharmacy”, said its Drug Controller, Lotika Khajuria.
“They were given license as they were either trained medical assistants, or had experience of work at a chemist shop as provided in the then J&K Pharmacy Act,” she said.
“Even if he had been a PhD in pharmacology, how would that have changed the outcome? The death was primarily caused because the product was contaminated,” said Neelakantan.
On March 2, The Indian Express sent an email to Digital Vision and Vellinton Healthcare, in which Digital Vision’s executives are directors, seeking responses to nine queries, including whether the firm had tested the raw materials used to make the syrup, whether it performed quality assurance tests on samples from the batch before releasing it into the market and whether these records had been submitted to drug regulators.
The company is yet to respond to these queries. Despite repeated attempts, managing directors Konic Goyal and Parshottam Goyal were unavailable for comment. However, an employee told The Indian Express on the condition of anonymity that, while reports of samples picked up from the market have been delivered to regulators, the company was still awaiting test results of samples picked up from its manufacturing facility.
The company is yet to issue any statement on the deaths of the children in Jammu and Kashmir.
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