印度提议出台新规，要求监管机构立即暂停未能通过政府检测、不符合特定质量标准的药品生产许可证，从而收紧对世界最大制药产业之一的监管。
India has proposed rules requiring regulators to immediately suspend manufacturing licences for medicines that fail specified quality standards in government testing, tightening oversight of one of the world's biggest pharmaceutical industries.
根据新规，如果政府检测发现药品在杂质、无菌性、含量测定（测量活性成分含量）或溶出度（评估药物释放活性成分的情况）方面不符合质量标准，即适用该规定。
The rules would apply if government testing finds the drug fails quality standards for impurities or sterility or assay, which measures the amount of active ingredient, or dissolution, which assesses how the drug releases that ingredient.
现行规则要求监管机构在暂停或吊销许可证前发出说明原因通知，而草案规定对特定质量不合格情况实施即时暂停。
Existing rules require regulators to issue a show-cause notice before suspending or cancelling a licence, while the draft mandates immediate suspension for specified quality failures.
卫生部周三表示，现行的正当程序要求可能导致药品被判定为“不符合标准质量”（NSQ）与监管采取行动之间出现时间滞后。在此期间，该药品可能继续流通，构成潜在公共卫生风险，并增加有效召回的难度。
The health ministry said on Wednesday that the existing due-process requirements can create a time lag between a drug being declared "not of standard quality", or NSQ, and regulatory action. During that period, the drug could remain in circulation, posing potential public-health risks and making an effective recall more difficult.
许可证将保持暂停状态，直到制造商开展有效的根因分析，并实施令监管机构满意的纠正和预防措施（CAPA）。只有在监管机构核实这些措施已落实后，许可证才能恢复。
The licence would remain suspended until the manufacturer conducts an effective root-cause analysis and implements corrective and preventive action, or CAPA, to the regulator's satisfaction. It could be restored only after regulators verify those measures have been implemented.
这份日期为10月28日、于周三发布的提议草案，强化了质量检测不合格的后果。在该国，监管机构定期查出不符合既定标准的药品批次。
The proposal draft, which is dated October 28 but published on Wednesday, strengthens the consequences of failed quality tests in a country where regulators regularly identify batches of medicines that do not meet prescribed standards.
近年来，印度制造的止咳糖浆与印度以及冈比亚、乌兹别克斯坦等国儿童死亡事件有关联，导致印度药品质量标准在国内外面临更严格的审视。
India's drug quality standards have come under increased scrutiny at home and overseas in recent years after locally made cough syrups were linked to deaths of children in India and countries including Gambia and Uzbekistan.
路透社上周报道，监管机构在发现质量管理体系存在缺陷后，已责令该国按营收计算最大的制药企业——太阳制药工业公司，停止生产、销售和分销其阿萨姆邦工厂生产的眼科产品。
Reuters reported last week that the regulator ordered the country's largest drugmaker by revenue, Sun Pharmaceutical Industries, to stop manufacturing, selling and distributing ophthalmic products made at its Assam facility after finding failures in its quality management system.
中央药品标准控制组织（CDSCO）每月发布警示，列出中央和州实验室认定为“不符合标准质量”的药品样品。
The Central Drugs Standard Control Organisation, or CDSCO, publishes monthly alerts identifying drug samples declared "not of standard quality" by central and state laboratories.
印度还制定了涵盖质量缺陷药品召回的指南，其中包括被认定为不符合标准质量的产品。
India also has guidelines covering recalls of quality-defective drugs, including products deemed not of standard quality.
新规还将授权中央许可机关要求制造商提交调查报告、根因分析和纠正措施，以及州监管机构采取的行动详情。
It would also allow the central licensing authority to seek manufacturers' investigation reports, root-cause analyses and corrective measures, as well as details of action taken by state regulators.
政府分析师的报告将送交印度药品总监、相关州或联邦属地监管机构，以及标签上注明的制造商和销售商。
Government analysts' reports would be sent to the Drugs Controller General of India, the relevant state or union territory regulator, and the manufacturer and marketer named on the label.
政府将考虑在30天内提交的意见。这些规则将在最终于《官方公报》发布后生效。
The government will consider comments submitted within 30 days. The rules would take effect upon final publication in the Official Gazette.