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A disturbing report by The Economic Times has revealed that over 100 <keyword id="21300086" type="General" weightage="20" keywordseo="cough-syrup" source="keywords">cough syrup</keyword> samples manufactured in India failed quality control tests. The Central Drugs Standard Control Organisation (<keyword id="20109095" type="General" weightage="20" keywordseo="CDSCO" source="keywords">CDSCO</keyword>) analysed over 7,000 batches of cough syrup, finding that 353 did not meet quality standards. The reasons for these failures are particularly concerning. Nine batches contained di<keyword id="21957039" type="General" weightage="20" keywordseo="ethylene-glycol" source="keywords">ethylene glycol</keyword> (DEG) or ethylene glycol (EG), toxins previously linked to the deaths of children in Gambia, Uzbekistan, and Cameroon. These toxins can cause serious health problems, including vomiting, convulsions, circulatory issues, and acute kidney failure. <div type="Article" hostid="261" msid="94675384" title="Indian drug regulator kicks off probe on cough syrup linked to deaths of Gambian children" mstype="2" mssubtype="0"></div> <h2>What are <keyword id="15176477" type="General" weightage="20" keywordseo="diethylene-glycol" source="Orion">diethylene glycol</keyword> and ethylene glycol?</h2>For the unversed, DEG is a colourless, odourless and sweetish chemical. It is also a common industrial liquid used in many products, like antifreeze, car brakes, wallpaper removal solutions and in making fabrics and dyes. Similarly, EG is also a colourless and odourless alcoholic compound with a sweet-tasting and syrupy composition. It has known applications as an automotive antifreeze and as a raw material for manufacturing polyester fibres. It is also usually present in products like hydraulic brake fluids, stamp pad inks, ballpoint pens, solvents, paints, cosmetics and plastics. However, cough syrup manufacturers sometimes use EG and DEG as a replacement to non-toxic solvents like glycerine or propylene glycol simply because they are cheaper. Unfortunately, swallowing DEG and EG can be very dangerous. If someone drinks it, it can cause serious problems throughout their body and nervous system, leading to coma, seizures, nerve damage, and even liver and kidney failure, as per the CDC. <h2>Who is responsible?</h2>According to The Economic Times, the CDSCO blames unsecured supply chains and inadequate testing for the presence of these toxins. This news comes after a series of global alerts issued by the World Health Organization (WHO) in 2022 regarding cough syrups manufactured in India that were linked to the deaths of over 140 children worldwide. The first alert came in October 2022, when the WHO flagged four cough syrups produced by Haryana-based Maiden Pharmaceuticals. Authorities in Gambia linked these medications to 66 deaths, primarily from acute kidney failure. In December 2022, the WHO recommended avoiding two cough syrups made by Marion Biotech after Uzbekistan reported 18 child deaths linked to their Dok 1 Max syrup. Most recently, in August 2023, the WHO issued another alert for a batch of Indian common cold syrup found to contain unacceptable levels of DEG and EG as contaminants. This marked the fifth such alert issued by the WHO since 2022 regarding Indian-made cough syrups. <h2>CDSCO considers waiving testing requirement before exploring cough syrups</h2>The discovery of toxic components in something that’s as commonly sold as cough syrup should have prompted authorities to tighten texting processes. However, the apex drugs regulatory authority, is reportedly examining stakeholders’ proposal to waive the requirement for testing cough syrups being exported to the US, the UK, Canada, the European Union, Japan, Australia, Singapore, Korea and Switzerland at the prescribed laboratory. These repeated failures and global health warnings raise serious concerns about the safety of cough syrups manufactured in India. The Indian government is urged to take immediate action to address these issues by strengthening quality control measures, securing supply chains and ensuring thorough testing to prevent further tragedies. <div type="Article" hostid="261" msid="96935179" title="WHO alert against use of Indian cough syrups in Uzbekistan" mstype="2" mssubtype="0"></div>

Why are over 300 batches of Indian cough syrup being deemed "toxic"?

<ul><li>Government data revealed that 384 persons were arrested after 462 samples of medicines were declared adulterated or spurious during 2019-21.</li><li>The Drugs Rules, 1945 were amended providing that any person who sells or distributes any drug shall be responsible for the quality. </li><li>The cough syrups have been linked with the death of over 60 children in Gambia. </li></ul> While the authorities have swung into action and ordered a detailed investigation into the cough syrups produced and exported to Gambia by an Indian company, government data revealed that 384 persons were arrested after 462 samples of medicines were declared adulterated or spurious during 2019-21. A total of 81,329 drug samples were tested in 2019-20 out of which 2497 samples were declared as not being of standard quality and 199 were declared of spurious nature. Similarly, in 2020-21, out of the total 84874 samples lifted for testing, 2652 samples were declared not of standard quality while 263 were found to be spurious. A total of 220 and 164 people were arrested in 2019-20 and 2020-21 respectively. Officials said that the government has taken a series of measures including strengthening of legal provisions, workshops and training programmes for manufacturers and regulatory officials and steps such as risk based inspection. As per a recent Parliament reply, the government has taken various regulatory measures since 2019 to ensure the quality of medicines in the country. The Drugs Rules, 1945 were amended providing that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported in India shall bear Quick Response Code on its label. The stored data or information shall include the minimum particulars including unique product identification code, Batch No, manufacturing date, expiry date. The Drugs Rules, 1945 were amended providing that any person who sells or distributes any drug shall be responsible for the quality of that drug as well as other regulatory compliances along with the manufacturer under these rules. The rules were amended providing that "in case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the Licensing Authority to the effect that to the best of his knowledge based on search in trademarks registry, central database for brand name or trade name of drugs maintained by <keyword id="170943" type="General" weightage="80" keywordseo="central-drugs-standard-control-organisation" source="Orion">Central Drugs Standard Control Organisation</keyword>, literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market," said the reply by the <keyword id="210071" type="General" weightage="80" keywordseo="ministry-of-health" source="Orion">Ministry of Health</keyword>. The regulatory control over the manufacture, sale and distribution of drugs in the country is exercised through a system of licensing and inspection by the <keyword id="4390963" type="General" weightage="80" keywordseo="state-licensing-authorities" source="Orion">State Licensing Authorities</keyword> (SLAs) appointed by the state governments. Earlier this week, the <keyword id="43588" type="General" weightage="80" keywordseo="world-health-organization" source="Orion">World Health Organization</keyword> (WHO) issued a warning about drugs manufactured by a Haryana-based pharmaceutical company following which the Union government initiated a probe. The cough syrups have been linked with the death of over 60 children in Gambia. An initial enquiry has found that these drugs were not sold in India and were meant for export. The government has also said that the samples of the four syrups have been sent for testing and action will be initiated after the test results. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/international/news/putin-orders-intensified-measures-to-protect-crimea-related-facilities/articleshow/94737748.cms">Putin orders intensified measures to protect Crimea-related facilities</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/careers/news/falling-rupee-makes-studying-abroad-costlier/articleshow/94737652.cms">Falling rupee makes studying abroad costlier</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/international/news/pakistani-rupee-becomes-worlds-best-performing-currency/articleshow/94724119.cms">Pakistani rupee becomes 'world's best performing currency'</a>

You Searched For "adulteration in cough syrups" and got 2 results

Why are over 300 batches of Indian cough syrup being deemed "toxic"?

Ashmita Gupta

Gambian cough syrup issue: 384 people arrested after 462 samples found spurious

IANS

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