Consuming the products leads to ‘active kidney injuries’ in children, said WHO director-general
The World Health Organization (WHO) sounded the alarm on four substandard India-made products typically used to treat cough symptoms in The Gambia.
This could be linked to the death of 66 children in the West African country. Haryana-based Maiden Pharmaceuticals ltd manufactured the four products — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The products contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the global health body observed in an alert issued October 5, 2022.
The union government has reportedly initiated an investigation into the four products after it was informed about the issue by the WHO September 29. Samples of the cough syrups are expected to be tested in the next two days.
“Exact one to one causal relation of death has not yet been provided by WHO,” news channel NDTV reported, citing health ministry sources.
The Union Ministry of Health and Family Welfare has issued an official statement in response to the WHO’s alert October 6.
“The Central Drugs Standard Control Organisation took up the matter immediately with Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of Maiden Pharmaceutical ltd, is located,” the statement read.
A detailed investigation was launched to ascertain the facts or details in the matter in collaboration with State Drugs Controller, Haryana, it added.
According to the tentative results received by WHO, out of the 23 samples of the products under reference which were tested, four were contaminated as they contained Diethylene Glycol or Ethylene Glycol, it stated.
Protocol mandates that the receiving country must test any drugs exported from India. It remains unclear whether The Gambia undertook this step, the NDTV report noted. Calls to the manufacturer by Down To Earth went unanswered till the time of publishing.
Currently, the contaminated products have been found to be in use in The Gambia, but their distribution through informal markets to other countries cannot be ruled out.
Consuming the products leads to ‘active kidney injuries’ in children, said WHO director-general Dr Tedros Adhanom Ghebreyesus in a press conference.
The global health body has advised all batches of the products need to be examined by the National Regulatory Authorities before they can be declared safe for use. The WHO said it is conducting enquiries with the company and the regulatory authorities in India.
“WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products,” the global body added.
Increased surveillance of the informal/unregulated market is also advised, it said. There is no supply of drugs manufactured by Maiden Pharmaceuticals ltd in India, according to the All Indian Origin Chemists and Distributors.
However, this is not the first time India-made cough syrups have been scrutinised.
Some 13 children died in Himachal Pradesh (HP) in 2020 after drinking adulterated cough syrup. Before this, another 12 children died in a village in Jammu after consuming a diethylene-glycol-laden tonic. Both of these were manufactured by HP-based Digital Vision.
This gives us a glimpse into India’s weak drug regulation policy — Digital Vision’s products have failed to clear quality standards at least 19 times since 2009 — which has also allowed cough syrup abuse to thrive in India.
Abuse of codeine-containing cough syrups (CCS) — an opiate-based analgesic primarily used to treat pain, coughing, and diarrhoea — in India has been documented since before the turn of the century.
“The combination of an opioid and a sympathomimetic agent in the CCS may cause a special, distinct (euphoric) effect. This effect, along with the low price, easy availability and ‘pure’ preparation of CCS, may be responsible for the rapidly rising popularity of the CCS as drugs of abuse in India,” a 1997 study conducted by Post Graduate Institute of Medical Education and Research, Chandigarh found.
India has 7.7 million people with opioid use disorders, of whom 2.5 million use pharmaceutical opioids, stated a 2019 report by the ministry of social justice and AIIMS.
Some 83,000 bottles of codeine-based cough syrups were seized in India in the six months through March, stated an exclusive Reuters, a news agency, report released in 2015. The following year, cough syrups were featured on a long list of “irrational” fixed-dose combination drugs to be banned.
Some 950,000 bottles of codeine-based cough syrups and 9.50 kg of codeine phosphate were seized by the Narcotics Control Bureau from across India in 2020, daily Mint reported.
Parliamentarians raised concerns about rising cough syrup misuse in August this year. They pushed for a ban on three different preparations of codeine — codeine with chlorpheniramine, codeine with chlorpheniramine along with menthol and pholcodine along with promethazine.
The Union health minister Mansukh Mandaviya had asked the DCGI to “conduct a review and submit a recommendation” in March.
Consumption of these preparations — which includes syrups such as Tossex, Ascoril C, Codistar, Planokuf, and Tedykoff — was reportedly the highest in Uttar Pradesh, Gujarat, Madhya Pradesh, West Bengal and Karnataka — internal government findings revealed.
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