LONDON: More than 100 pharmaceutical companies in India have failed cough syrup quality tests due to contamination with toxins associated with fatal incidents in Gambia, Cameroon, and Uzbekistan, according to an Economic Times report, citing government data.
The report revealed that these cough syrups had the same toxins found in the medicine linked to over 141 children’s deaths in Gambia, Cameroon, and Uzbekistan.
The report highlighted that the implicated cough syrups contained Diethylene Glycol (DEG) or Ethylene Glycol (EG), substances that were previously linked to tragic outcomes in children who consumed contaminated medicines abroad, resulting in cases of Acute Kidney Injury (AKI) among young patients.
Following the string of deaths overseas linked to Indian cough syrups, the Government of India directed pharmaceutical companies to adhere to new regulations in an effort to restore credibility to India’s $50 billion pharmaceutical industry.
“The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the licence and do not place patients at risk due to inadequate safety, quality or efficacy,” stated a directive issued by the Centre.
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The regulations also stipulated that companies must conduct thorough testing of ingredients and retain sufficient samples for subsequent verification of each batch before releasing products into the market.
India’s drug regulatory authorities have started overhauling the pharmaceutical export approval process in response to global concerns over the safety and quality of medicines originating from the country.
India’s pharmaceutical sector ranks as the third-largest globally by volume, primarily known for its role as a leading provider of generic drugs worldwide. The industry also supplies more than half of the global demand for vaccines and fulfills a substantial portion of generic drug needs in major markets such as the United States and the UK.
The revelations regarding contaminated cough syrups underscore the critical need for stringent quality control measures within India’s pharmaceutical manufacturing sector to prevent similar incidents in the future.
The Economic Times report has sparked renewed calls for accountability and transparency in the oversight of pharmaceutical production processes.
