New Delhi: One more Indian drugmaker is under the scanner for potentially supplying contaminated cough syrup, this time to Micronesia and the Marshall Islands. The World Health Organisation (WHO) issued a product alert on Tuesday, April 25. However, the manufacturer has told The Wire that while this syrup is sold in India, the allegations have been levelled against a counterfeit product.
According to the WHO alert, Guaifenesin TG Syrup, was found to have diethylene glycol (DEG) and ethylene glycol (EG) – two contaminants which were also found in medicines exported by Indian makers to Uzbekistan and Gambia earlier, according to the WHO. Eighteen children had died due to consumption of such cough syrup in Uzbekistan and another 70 in Gambia. The Government of India had accepted contamination in the case of Uzbekistan but not in Gambia, though a WHO lab report had revealed that DEG up to 21% was found in the syrups exported to the African country.
In yet another case, the US’s Centers for Disease Control and Prevention (CDC) had earlier investigated and found eye drops exported to the country were contaminated with Pseudomonas aeruginosa bacteria – that led to blindness for eight people and death for three others, besides other adverse effects. There has been no official statement from the Indian government in this case but the Tamil Nadu state drug controller had said that their investigation found no contamination.
The latest alert issued by the WHO states that Guaifenesin is an expectorant used to relieve chest congestion and the symptoms of cough. Punjab-based QP Pharmachem Ltd is the manufacturer of this syrup and it is marketed by Haryana-based Trillium Pharma.
“To date, neither the stated manufacturer nor the marketer have provided guarantees to WHO on the safety and quality of these products,” the WHO said. The organisation also said that the product might have got authorisation for sale in other countries of the Western Pacific region or elsewhere through informal means. Drug regulators across the world have been asked to ensure that this syrup is recalled from the market, and consumers who would have already purchased it have been asked not to consume it.
The drugmaker has confirmed to The Wire that the product was sold in the Indian market too.
In the case of incidents in Gambia, Uzbekistan and the US, the Indian authorities had said that those products were meant for export only.
The WHO alert said the latest issue in Guaifenesin was reported to it on April 6, 2023. Usually the WHO sounds the drug regulatory authority from where the drug is exported – in this case, India – around the same time. After the issue was reported to the WHO, it sent the samples for testing to the laboratories of the Therapeutic Goods Administration (TGA) of Australia which confirmed the presence of DEG and EG.
“The substandard product referenced in this alert is unsafe and its use, especially in children, may result in serious injury or death,” the WHO said. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death, it added.
Sudhir Pathak, the managing director of QP Pharmachem Ltd, told The Wire that he had not sold these products in Micronesia and Marshall Islands.
“In 2020, I exported this medicine to Cambodia through a buyer called Telpha. There were about 18,336 bottles. They were supposed to expire in 2022.”
Asked when the label annexed in the alert bears October 2023 expiry date, he said, “That is a counterfeit product and not mine. I don’t know why the buyer sent it to these two nations (where contaminated cough syrup has been found) because I am not authorised to sell there as the company doesn’t meet their safety standards.”
Pathak also said that the WHO had not contacted his company.
The Wire also wrote to the Cambodia-based buyer – Telpha – whom Pathak had named. The email did not fetch a response till the time of publication.
Pathak also revealed that he had sold the same product in India and “no adverse event was reported.” He said that a team of Punjab Food and Drug Administration and Central Drugs Standard Control Organisation (CDSCO) had visited the plant on April 21 and collected the control samples. There has been no official statement from Indian regulatory authorities yet.
When The Wire initially reached WHO for clarifications, it said, “When we have something we will let you know”.
Later, at 5.39 pm, in response to The Wire’s queries regarding the manufacturer’s concerns, a WHO’s spokesperson replied thus:
“This investigation is ongoing by the impacted countries (Marshall Islands & Micronesia), the country of manufacture (India) & WHO. [The] WHO cautiously issues such alerts only after due diligence and receiving actionable information from those impacted.
Actionable information could include, for example:
· Reports or evidence of substandard or lack of therapeutic effects supported by results of any study conducted on quality or efficacy of the products e.g. laboratory test results and bioavailability data, that identifies product, batches, dates of manufacture, manufacturer or distributor and market where product was acquired
· Information of any complaints received against any of the mentioned products.
In this case, WHO received information and packaging from the implicated countries. Both Islands have issued alerts in their countries. WHO alerted the Director General of CDSCO India, as is our routine practice, on 14 and 24 April. We informed him of the incidents and [the] forthcoming alert. We rely on the countries impacted to connect with manufacturers and suppliers.
This is an ongoing investigation.
Note: This report has been updated at 4 pm, almost 5 hours since publication, with the QP Pharmachem managing director’s quotes and a note on organisations which have not yet responded to The Wire or released statements. At 5.57 pm, it was updated again with WHO’s response in full.