Over 100 Indian Pharma Companies Fail Cough Syrup Quality Tests

Over 100 pharmaceutical companies in India have failed quality tests for their cough syrups, according to an Economic Times report citing government data. This revelation comes after the discovery of the same toxins in these cough syrups that were linked to the deaths of over 141 children in Gambia, Cameroon, and Uzbekistan.

Earlier reports indicated that Indian cough syrups consumed by children in Gambia were contaminated with Diethylene Glycol (DEG) or Ethylene Glycol (EG), leading to an Acute Kidney Injury (AKI) cluster. Following these tragedies, the Indian government has taken decisive action to address the issue.

In response to the deaths linked to Indian cough syrups, the Government of India has directed pharmaceutical companies to meet new manufacturing standards. This move follows increased scrutiny from the Modi government aiming to improve the reputation of the $50 billion pharmaceutical industry.

The Centre has emphasized that manufacturers must assume responsibility for the quality of their products, ensuring they are safe, effective, and compliant with licensing requirements. Companies are now required to obtain satisfactory test results for their ingredients before marketing finished products. Additionally, they must retain sufficient samples for repeated testing and verification.

India’s drug regulator is actively revamping the approval process for pharmaceutical exports in response to global concerns about the quality and safety of Indian medicines. This includes enhancing the Certificate of the Pharmaceutical Product (CoPP) to align with the World Health Organization’s good manufacturing practices certification.

India’s pharmaceutical industry, valued at approximately $50 billion, ranks as the third-largest globally by volume. The country is a leading supplier of generic drugs worldwide, fulfilling over half of the global vaccine demand. India also meets about 40% of the generic drug demand in the US and provides a quarter of all medicines in the UK.

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