New Delhi: India's drug regulator has withdrawn powers delegated to the state licensing authorities to issue no objection certificates (NOC) for manufacture of unapproved, banned or new drugs for export purposes, a move that comes in the wake of substandard Indian drugs causing health concerns in several countries.The industry can apply again from the zonal offices through online mode from May 15, said a notice issued by the Central Drugs Standards Control Organisation (CDSCO).

新德里：印度药品监管机构撤销了授予国家许可主管部门的权力，即为出口目的生产未经批准、禁用或新药而颁发无异议证书（NOC），此举是在印度不合格药品引起多个国家的健康担忧之后采取的。中央药品标准管理组织（CDSCO）发布的一份通知称，从5月15日起，该行业可以通过在线模式从地区办公室再次申请。

It asked the industry to file fresh applications for NOC for manufacture of unapproved, approved new drugs and banned drugs solely for export purposes. 'Accordingly, power delegated to state/UT licensing authority stands withdrawn w.e.f. May 15, 2024 and such NOCs shall be granted by head of CDSCO zonal office,' the notice said.The regulator asked the drug controllers of the states and Union Territories to hand over all NOCs issued from August 2, 2018, to May 14, 2024, to the respective zonal offices of the CDSCO.The move comes in the backdrop of multiple incidents where drugs and cough syrups manufactured in India have allegedly been found to be contaminated.

它要求该行业向国家奥委会提交新的申请，以制造未经批准、已批准的新药和仅用于出口目的的违禁药品。”因此，2024年5月15日，授予州/犹他州许可机构的权力将被撤销，此类国家奥委会将由CDSCO地区办公室负责人授予。监管机构要求各州和联盟地区的药物管制人员将2018年8月2日至2024年5月14日发布的所有国家奥委会移交给CDSCO各自的地区办事处。此举发生在多起事件的背景下，据称印度制造的药品和止咳糖浆被发现受到污染。

Cough syrups imported by The Gambia were allegedly found to be contaminated with diethylene glycol (DEG) and ethylene glycol (EG), resulting in cases of acute kidney injury among kids.An investigation led by the United States Centers for Disease Control and Prevention (CDC) and Gambian scientists in March 'strongly suggested' that medications contaminated with DEG or EG imported into the country led to the cases among children.

据称，冈比亚进口的止咳糖浆被二甘醇（DEG）和乙二醇（EG）污染，导致儿童急性肾损伤。美国疾病控制与预防中心（CDC）和冈比亚科学家在3月份领导的一项调查“强烈建议”进口到该国的受DEG或EG污染的药物导致儿童感染。

'A large cluster of acute kidney injury cases affecting children in The Gambia in 2022 was associated with case fatality rates of more than 80%,' it said.On October 5, 2022, the WHO announced that the deaths of dozen.

它说：“2022年，冈比亚发生了一大批影响儿童的急性肾损伤病例，死亡率超过80%。”。2022年10月5日，世界卫生组织宣布有十几人死亡。