Cough Syrup (Representational Image)
Hyderabad: More than 100 pharmaceutical units have failed quality tests for cough syrups, as per a recent report by the Central Drugs Standard Control Organisation's (CDSCO).
These standard batches were categorised as "not of standard quality" (NSQ) in the report from the Central Drugs Standard Control Organisation (CDSCO) because of problems with the assay, microbiological growth, pH, volume, ethylene glycol (EG), and diethylene glycol (DEG).
The CDSCO analysed 7,087 batches of cough syrups, out of which 353 were determined to be NSQ. Nine batches were very problematic because of the presence of both ethylene and diethylene glycol.
The report also revealed that these cough syrups contained the same toxins found in the medicines linked to over 141 children's deaths in Gambia, Cameroon, and Uzbekistan.
The earlier reports 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.
After a series of deaths overseas linked to Indian cough syrups, the Government of India directed pharmaceutical companies to meet new manufacturing standards after Modi stepped up scrutiny to clean up the image of the $50 billion industry.
The centre had said, "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 license, and do not place patients at risk due to inadequate safety, quality, or efficacy."
Only after receiving "satisfactory results" from testing the ingredients can companies go forward with marketing the finished product. Additionally, it stated that they had to keep enough samples of the intermediate and finished goods to allow for follow-up testing or batch verification.
In response to global concerns about the quality and safety of medications shipped from the nation, India's drug authority is gradually reforming the licensing procedure for pharmaceutical exports.
According to two individuals who are aware of the developments, the most recent effort entails improving India's Certificate of the Pharmaceutical Product (CoPP) to conform with the World Health Organisation's Good Manufacturing Practices certification.
India has the third-largest pharmaceutical business in the world by volume, with a valuation of about 50 billion dollars. More than half of the demand for vaccines worldwide is met by it, making it the top supplier of generic pharmaceuticals globally. Furthermore, India supplies a quarter of all pharmaceuticals in the UK and almost 40% of the US's demand for generic drugs.
( Source : Deccan Chronicle )
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