Child deaths trigger move to end unlicensed cough syrup sales in villages

Core Viewpoint - India's drug regulator is planning to revoke the "household remedy" exemption for cough syrups in rural areas to enhance drug safety and oversight following child deaths linked to contaminated syrups [1][2][4]. Regulatory Changes - The proposed change aims to eliminate the exemption that allows non-pharmacy outlets in small communities to sell cough syrups without a formal drug license, addressing regulatory gaps that have led to untraceable sales [3][5][11]. - Currently, cough syrups and other medicines can be sold in villages with populations under 1,000, which constitutes over half of India's 641,000 villages [3][5]. Health Concerns - Recent incidents of child deaths in Madhya Pradesh and Rajasthan were attributed to contaminated cough syrups containing diethylene glycol (DEG) and ethylene glycol (EG), highlighting the need for stricter controls [2][7][15]. - The absence of licensing for local vendors complicates the ability of regulators to track supply chains and enforce recalls [6][7]. Industry Impact - The Indian pharmaceutical market is valued at $55 billion, with the cough syrup segment valued at $262.5 million in 2024, projected to grow to $743 million by 2035 [12]. - Industry leaders support the removal of the exemption for cough syrups, emphasizing the need for stronger supply chain management and quality control [13][14]. Expert Opinions - Public health experts advocate for tighter quality control and adherence to Good Manufacturing Practices (GMP), stressing the importance of rigorous testing for all medicines with potential impurities [15][16]. - The proposal to remove cough syrups from the household remedy category is seen as a necessary step to prevent misuse and ensure safer access to medications [17].