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].

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Core Points - Two Indian drugmakers, Sresan Pharmaceuticals and Kaysons Pharma, are under regulatory scrutiny due to cough syrups linked to child deaths in Madhya Pradesh and Rajasthan [1][2][3] - The central drug regulator found toxic contaminants, specifically diethylene glycol, in cough syrup samples, prompting bans on sales in several states [4][5] - A total of 11 children under the age of five have died, with the cough syrup Coldrif from Sresan Pharmaceuticals being at the center of the controversy [3][5] - The Indian health ministry reported that Coldrif contained 48.6% diethylene glycol, a harmful industrial chemical [4][5] - Following the incidents, sales of Coldrif have been banned in Madhya Pradesh, Tamil Nadu, and Kerala, and a case has been registered against Sresan Pharmaceuticals [6] - Rajasthan has suspended sales of 19 medicines from Kaysons Pharma due to adverse effects linked to its cough syrups, and health officials have faced disciplinary actions [7] Industry Insights - The issue of cough syrup safety in India is not new, with previous incidents of child deaths linked to Indian-made cough syrups reported in countries like Uzbekistan and The Gambia [2][11] - The fragmented public health regulatory system in India complicates enforcement of drug safety, as regulations are divided between central and state authorities [12] - Medical experts emphasize the need for strict dosing and caution against over-the-counter cough syrups for children under two years old due to potential serious side effects [8][9][10]