[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-437615-105":59,"doc-detail-437615-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","tiny-lives-big-failures-indias-drug-regulation-crisis-editorial","Tiny lives, big failures - India’s drug regulation crisis - Editorial","","In October 2025, WHO issued a product alert after three substandard contaminated oral liquid medicines manufactured and marketed in India led to the death of 20 children. Contamination involved excipients propylene glycol and glycerine being polluted with toxic industrial chemicals diethylene glycol and ethylene glycol. The editorial reviews India’s regulatory structure led by CDSCO under the Ministry of Health, the Drugs and Cosmetics Act, and recent amendments, arguing that enforcement remains inadequate despite added penalties. It calls for stronger governance, audits, transparency, and a robust drug recall to prevent further deaths.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/tiny-lives-big-failures-indias-drug-regulation-crisis-editorial/437615/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/tiny-lives-big-failures-indias-drug-regulation-crisis-editorial/437615.png","ImageObject",300,407,{"name":92,"@type":93},"Franzy","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-09-30","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":8},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What incident triggered the October 2025 WHO alert?","Question",{"text":112,"@type":113},"WHO reported three substandard contaminated oral liquid medicines in India that resulted in the death of 20 children. The contamination involved excipients being polluted with diethylene glycol and ethylene glycol.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Which authority is described as the key regulator in India for medicines?",{"text":117,"@type":113},"The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health is presented as the key regulatory authority, coordinated with state and district drug control offices.",{"name":119,"@type":110,"acceptedAnswer":120},"What reforms does the editorial recommend to improve patient safety?",{"text":121,"@type":113},"It recommends envisioning an autonomous, community-representative regulatory body with mandatory audits, transparent reporting, a robust recall mechanism, sufficient funding, and clear functions. It also calls for holding manufacturers accountable and linking GMP certificates and inspections to licence renewal.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},437615,1790794170,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":8,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":14,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":24},2336478945519,"https://ap-avatar.wpscdn.com/davatar_085a072bc5b1113ac321206ff7593b45","Editorial  \nTiny lives, big failures: India’s drug regulation crisis  \nIn October 2025, WHO issued a product alert for three substandard (contaminated) oral liquid medicines manufactured and marketed in India resulting in the death of 20 children. The incident involved contamination of the excipients propylene glycol and glycerine, which are commonly used in cough formulations, with the toxic industrial chemicals diethylene glycol (DEG) and ethylene glycol (EG) . Since 1937, over 1000 deaths have been reported globally due to contaminated medicines. The first major incident involving DEG/EG prompted the creation of the US Food and Drug Administration (FDA) and its stringent drug safety standards. While regulations have tightened in highincome countries, these events continue to harm lives in low-income and middle-income countries. Since 2022, WHO has issued seven alerts concerning contaminated liquid oral medicines, almost all of which had manufacturing located in India and the majority of which reported serious adverse events, including over 300 deaths.  \nThese concerns warrant a closer look into the country’s regulatory landscape. The key regulatory authority for the country is the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health, headed by the Drug Control General of India (DCGI) . CDSCO operates in coordination with state and district drug control offices and is supported by drug inspectors at the ground level. It maintains a network of drug testing laboratories to ensure quality standards. Its operations are also governed by the Drugs and Cosmetics Act (DCA), which provides legislation required for pharmaceutical regulation. In response to several quality concerns, the DCA was recently amended and schedule M was also revised with stringent penalties, mandatory inspections, and a requirement for provision of proof of stability and safety of excipients by the manufacturers in line with WHO Good Manufacturing Practices (GMP) . But implementation remains inadequate, as indicated by the government’s continuing extension of the timeline for local manufacturers to comply with this legislation. It is also commendable that imprisonment terms and penalties have been tightened in the new Drugs, Medical Devices and Cosmetics Bill, 2022.  \nAlthough the country has brought in many legal changes to address gaps, without robust enforcement, ensuring legal compliance remains unattainable. A 2012 parliamentary report which highlighted CDSCO’s  \n© 2025 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license ([http://creativecommons.org/licenses/by/](http://creativecommons.org/licenses/by/)[ ](http://creativecommons.org/licenses/by/)[4.0/](4.0/)).  \ndeficiencies prompted a Lancet editorial to even call for its complete overhaul. Over a decade later, concerns about CDSCO prioritising economic goals over patient safety remain and are now more alarming than ever. The 2022 tragedy in The Gambia, where 66 children died from contaminated imported Indian cough syrups, was followed by the introduction of quality control procedures for exported drugs. These included mandatory pre-export testing and a requirement from the Ministry of Commerce for exporters to submit certificates of analysis. However, domestic drug manufacturing continues to face weak regulatory mandates.  \nThe existing mechanism suffers from major shortcomings in both structure and implementation. While organisations like the FDA and European Medicines Agency are well established with tight regulatory mandates, it would be prudent to envision a structure considering the country’s cultural context, infrastructure, and resources. Despite facing similar challenges such as limited manpower and resources, several African countries have achieved higher regulatory maturity, as per the WHO global benchmarking tool. This achievement is a result of dedicated autonomous regulatory bodies, transparent quality management sys","cbCaieSpzwmjvc60","https://ap.wps.com/l/cbCaieSpzwmjvc60","pdf",140154,"English","# Regulatory alerts and consequences\n## India’s regulatory structure and legal framework\n## Enforcement gaps and international comparisons\n## Recommended reforms for patient safety","[{\"question\":\"What incident triggered the October 2025 WHO alert?\",\"answer\":\"WHO reported three substandard contaminated oral liquid medicines in India that resulted in the death of 20 children. The contamination involved excipients being polluted with diethylene glycol and ethylene glycol.\"},{\"question\":\"Which authority is described as the key regulator in India for medicines?\",\"answer\":\"The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health is presented as the key regulatory authority, coordinated with state and district drug control offices.\"},{\"question\":\"What reforms does the editorial recommend to improve patient safety?\",\"answer\":\"It recommends envisioning an autonomous, community-representative regulatory body with mandatory audits, transparent reporting, a robust recall mechanism, sufficient funding, and clear functions. It also calls for holding manufacturers accountable and linking GMP certificates and inspections to licence renewal.\"}]","Tiny lives, big failures - India’s drug regulation crisis - Editorial | PDF",1790682543]