More than 100 pharma companies in India have failed cough syrup quality tests, according to an Economic Times report, citing government data. It also 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 reports earlier stated that Indian cough syrups consumed by Gambia kids were contaminated with Diethylene Glycol [DEG] or Ethylene Glycol [EG], which led to an Acute Kidney Injury (AKI) cluster among them.
Following the string of deaths overseas linked to Indian cough syrups, the Government of India directed pharmaceutical companies to meet new manufacturing standards after the Modi government stepped up scrutiny to clean up the image of the $50 billion 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,” the Centre had said.
Companies should only market a finished product after obtaining “satisfactory results” from testing the ingredients. It said they must also retain sufficient quantities of samples from intermediate and final products to enable repeated testing or verification of a batch.
India’s drug regulator is progressively revamping the approval process for pharmaceutical exports in response to global concerns about the quality and safety of medicines exported from the country, Mint had reported.
The latest initiative includes enhancing India’s Certificate of the Pharmaceutical Product (CoPP) to align with the World Health Organization’s good manufacturing practices certification, according to two officials knowledgeable about the developments.
India’s pharmaceutical industry, worth approximately $50 billion, ranks third-largest globally by volume. It is the leading supplier of generic drugs worldwide, fulfilling more than half of the global vaccine demand. Additionally, India meets about 40% of the generic drug demand in the US and provides a quarter of all medicines in the UK.
