Drug contamination crisis: Indian pharma industry faces regulatory crackdown

by Aditya Kumar

Contamination of Drugs by Indian Pharmaceutical Companies Raises Concerns

The Indian drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), recently released a report revealing contamination of drugs produced by two pharmaceutical companies: Fourrts India and Norris Medicines. This incident has raised concerns about drug safety and quality standards in the Indian pharmaceutical industry.

The report stated that certain drugs produced by Fourrts India and Norris Medicines were found to contain diethylene and/or ethylene glycol. This contamination was confirmed by the World Health Organization (WHO) in a sample of the cough syrup COLD OUT, produced by Fourrts India, which was obtained from Iraq in August. Subsequent testing by the Indian drug regulator affirmed the presence of diethylene and ethylene glycol in one batch of COLD OUT, while another batch tested positive for ethylene glycol. Two cough syrups manufactured by Norris Medicines, Trimax Expectorant and Sylpro Plus Syrup, were also found to be contaminated with ethylene glycol.

This is not the first time that drug contamination cases involving diethylene and ethylene glycol (DEG and EG) have come to light in the Indian pharmaceutical industry. In the previous year, Maiden Pharma’s cough syrups were allegedly associated with the deaths of over 65 children in Gambia, and Marion Biotech’s cough syrup was linked to the deaths of 18 children in Uzbekistan. The WHO had also issued an alert regarding a cough syrup produced by Punjab-based QP Pharmachem and marketed by Haryana-based Trillium Pharma, although the Indian government denied any accusations against Maiden Pharma.

In response to these incidents, the Indian government has intensified its crackdown on the pharmaceutical industry. Actions taken include cancelling licenses of 18 pharmaceutical companies allegedly producing counterfeit drugs and implementing mandatory testing of cough syrups at government labs before exportation. However, despite these measures, the recent contamination cases involving Fourrts India and Norris Medicines highlight the need for stricter regulations and better quality control mechanisms in the Indian pharmaceutical sector.

In August 2023, as per the latest notification, a total of 48 drugs were declared substandard. These drugs were manufactured by companies such as Aan Pharma Private Limited, Medisky Pharmaceuticals, Globela Pharma Pvt. Ltd, and Norris Medicines Limited. The list of drugs declared as “Not of Standard Quality” includes various medications such as cough syrups, tablets, injections, and ointments.

The contamination of drugs with harmful substances is a serious public health issue and poses significant risks to patients. The Indian pharmaceutical industry must take immediate steps to address these concerns and ensure that strict quality control measures are in place at every stage of the manufacturing process. Furthermore, the government should continue to monitor and enforce stringent regulations to prevent the production and distribution of substandard drugs.

It is crucial to prioritize the safety and well-being of patients by ensuring that the drugs they consume are of high quality and free from any harmful contaminants. The recent contamination cases serve as a wake-up call for the Indian pharmaceutical industry to prioritize the implementation of robust quality control systems and restore trust in the industry. The government, regulatory authorities, and pharmaceutical companies must work together to ensure the production of safe and effective medications for the benefit of all patients.

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