The Indian government has ordered pharmaceutical company Riemann Labs to cease operations following allegations that the cough syrup it manufactures led to the death of at least six children in the western African nation of Cameroon in March.
The move comes amid New Delhi’s crackdown on drug makers whose medicines exported internationally have been linked to dozens of fatalities across several countries in Africa and Central Asia.
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Riemann, which operates out of Indore in the central Indian state of Madhya Pradesh, has been banned from manufacturing medicines following an inspection by state and federal drug regulators, Deputy Minister for Health & Family Welfare Bharati Pravin Pawar told the parliament, according to Reuters. The official did not specify whether the drugmaker’s license has also been suspended.
The government’s move comes close on the heels of the World Health Organization’s (WHO) revelation in June that a batch of cough and cold syrup sold in Cameroon under the brand name Naturcold contained extremely high levels of a toxic ingredient.
Earlier, the licenses of three cough syrup manufacturers – Maiden Pharmaceuticals Ltd, Marion Biotech and QP Pharmachem – were suspended and their exports were stopped after two of the firms were linked to the deaths of at least 70 children in Gambia and 19 in Uzbekistan last year. The companies have denied the allegations.
The crackdown addresses the reputational risks for India’s $41 billion pharmaceutical industry, after tests conducted by the WHO and other agencies showed that medicines supplied from India contained toxins.
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Last year’s findings by the WHO suggested that the cough syrups made by Maiden Pharmaceuticals and administered to children in Gambia contained the lethal toxins ethylene glycol and diethylene glycol, which are used in car-brake fluid. These toxins could have been substituted for propylene glycol because they are less than half the price of the key ingredient for cough syrups. The majority of the children who died after being given the cough syrups were younger than five years old.
In its probe of contaminated cough syrups, the WHO flagged that seven India-made products and 13 drugs produced in Indonesia led to more than 200 deaths.
Indian health officials have admitted that the global body’s allegations “adversely impacted the image.” In an attempt at damage control, the government introduced a new rule that took effect on June 1 that requires companies to obtain a certificate of analysis from a government laboratory before exporting medicines. Globally, India ranks third in terms of pharmaceutical production by volume and 14th by value. India’s pharmaceutical industry comprises an estimated 3,000 drug companies and around 10,500 manufacturing units.