New Delhi: The officials associated with the Uttar Pradesh state drug control administration say the manufacturing licence of Marion Biotech, a Noida-based pharma firm whose cough syrup was linked to the deaths of more than 60 children in Uzbekistan last year, continues to remain cancelled as of now.
The licence of the company was cancelled on December 30, 2022 by the Indian authorities as the Uzbekistan government found that Marion Biotech’s samples of ‘Dok1 Max syrup’ and ‘Ambronol cough syrup’ were contaminated with diethylene glycol (DEG) – an industrial solvent that is used as an antifreeze agent. According to the World Health Organisation (WHO), it can be fatal even if consumed in small amounts.
Talking to The Wire late on Wednesday, October 11, Noida drug inspector Vaibhav Babbar, said, “The company’s plant is not opened yet as the [licence] cancellation order prevails.” Asked again, he reiterated that the order “sustains as of now and there is no ambiguity in that”.
For further information, he redirected this correspondent to Uttar Pradesh’s head of drug control administration, Shashi Mohan Gupta.
Gupta told The Wire, “The company has not even submitted the corrective and preventive actions (CAPA) plan. So how can we even think of deliberating on revoking the cancellation order?”
Reuters reported that on September 14, Gupta wrote, “There’s no known case of a lack of quality in other medicines manufactured by the firm.”
“Therefore, in view of natural justice, the appeal of the manufacturing firm is partially accepted. Its permission to make products using (cough syrup ingredient) propylene glycol is cancelled, and it is allowed to make and sell all other products,” Reuters quoted Gupta’s September statement as saying, on October 11.
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While talking to The Wire on Wednesday, he did not comment on the statement, but said, “The licence of the entire plant remains cancelled [and as such it can’t manufacture any drug] and we haven’t deliberated anything upon its reopening since the CAPA plan has not been submitted by the company, yet.”
“Once the CAPA plan is sent [to us], it would be forwarded to the Drug Controller General of India, Rajeev Raghuvanshi, for evaluation,” he added. Gupta also told Reuters on October 11 that Raghuvanshi had asked the company to submit the said plan.
CAPA is a set of guidelines that a pharma firm commits to following once it has been found violating good manufacturing practices in an investigation carried out by drug regulatory authorities.
In the said plan, the company lists out the series of steps it would undertake to avoid repeating the violations. Once the plan is submitted to the regulatory authorities, they evaluate it and take a decision on its suitability, accordingly.
Earlier, in March 2023, three people associated with the firm were arrested by the Noida police on the basis of the investigation done by drug control authorities. Marion Biotech’s owner was also named in the FIR. Asked about his status, the UP drug controller said on Wednesday, “As far as my limited knowledge goes, he got a stay [on arrest] from a court.”
It may be mentioned here that while the WHO had linked drugs of several companies based in India with deaths of children due to the presence of DEG in their respective products, it was only in the case of Marion Biotech that the government of India was also able to establish the contamination on the basis of lab investigations. In no other such instance did the investigation in India establish the contamination.
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Usually, DEG ends up entering these drugs through an ingredient called propylene glycol (PG), which is added to syrups to make them soluble. However, either due to oversight, or to cut costs, pharma companies end up using PG-mixed DG. In case of oversight, they often don’t test PG for any impurities, before production – which they are supposed to. In an earlier instance, Marion Biotech’s Tuhin Bhattacharya told Reuters that his firms had sold drugs without checking PG for impurities for more than a decade.
