印度从2025年12月29日起禁止因肝脏风险而使用高剂量口服硝基磺酸。
India bans high-dose oral nimesulide due to liver risks, effective Dec. 29, 2025.
印度从2025年12月29日起,禁止以即时释放形式制造、销售和分销超过100毫克的口服硝基硫化物配方,并列举了肝脏毒性和严重不利影响的风险。
India has banned the manufacture, sale, and distribution of oral nimesulide formulations exceeding 100 mg in immediate-release forms, effective December 29, 2025, citing risks of liver toxicity and serious adverse effects.
根据《药品和化妆品法》第26A节,该举措遵循了药物技术咨询委员会和《国际公路货运公约》的建议,强调有更安全的替代方案。
The move, under Section 26A of the Drugs and Cosmetics Act, follows recommendations from the Drugs Technical Advisory Board and ICMR, emphasizing safer alternatives are available.
禁令仅适用于高剂量口服人体使用产品,而非所有制剂,并以先前的限制为基础,包括2011年的儿科禁令和2025年的兽医禁令。
The ban applies only to high-dose oral human use products, not all formulations, and builds on prior restrictions, including a 2011 pediatric ban and a 2025 veterinary prohibition.
政府也提议更严格地规定咳嗽糖浆的规则, 因为世卫组织的警报将一批儿童死亡与一批儿童死亡联系起来,
The government also proposed stricter rules for cough syrups after a WHO alert linked a batch to child deaths, aiming to regulate medicines by ingredient risk, not form.