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1.媒体来源:
路透社
2.记者署名:
By Krishna N. Das
3.完整新闻标题:
Exclusive: India considers policy change after cough syrup deaths - Modi's
office
独家：印度考虑在止咳糖浆死亡事件后对制药业采取新规范-莫迪办公室
4.完整新闻内文:
Exclusive: India considers policy change after cough syrup deaths - Modi's
office
By Krishna N. Das
As African children died, doctors fought to get toxic Indian cough syrup
banned
Ebrima Sagnia prays at the graveside of his 3-year-old son Lamin in Old
Yundum, Gambia,November 1, 2022. Lamin died of Acute Kidney Injury in
September 2022. In October, the deaths of more than 70 Gambian children from
Acute Kidney Injury were linked by global health officials to cough syrups
made in India and contaminated with ethylene glycol and diethylene glycol.
REUTERS/Edward McAllister
Lamin 于 2022 年 9 月死于急性肾损伤。10 月，70 多名冈比亚儿童因急性肾损伤死亡
全球卫生官员将受伤与印度制造并被乙二醇和二甘醇污染的止咳糖浆联系起来。路透社/
爱德华麦卡利斯特
NEW DELHI, May 18 (Reuters) - India is considering a change to its
pharmaceutical industry policy after cough syrups made in the country were
linked to the deaths of children overseas, according to a document from Prime
Minister Narendra Modi's office, which noted that "important things" about
the industry had been "overlooked".
A brainstorming session was held in the southern Indian city of Hyderabad "to
find a solution to exported cough syrups that killed children," Modi's office
said in the document dated May 15 and reviewed by Reuters.
新德里，5 月 18 日（路透社）——根据总理纳伦德拉·莫迪 (Narendra Modi) 办公室
的一份文件，印度正在考虑改变其制药业政策，因为该国生产的止咳糖浆与海外儿童的死
亡有关，该文件指出：“关于这个行业的重要规范被忽视了”。
莫迪办公室在 5 月 15 日的一份文件中说，在印度南部城市海得拉巴举行了一次脑力激荡
，“以找到导致儿童死亡的出口止咳糖浆的解决方案”，路透社看到了这份文件。
Health Minister Mansukh Mandaviya and federal and state regulators attended
the session in February, according to a statement from the health ministry
that did not mention cough syrups.
"Tweak in policy is mooted," the document from the prime minister's office
said, adding that "important things" had been "overlooked". It did not
elaborate.
A source with knowledge of the matter said the policy change could mean
increased oversight of India's $41 billion pharmaceutical industry, which is
the world's largest supplier of generic medicines.
根据卫生部未提及止咳糖浆的声明，卫生部长 Mansukh Mandaviya 以及联邦和州监
管机构参加了2 月份的会议。
总理办公室的文件称，“正在讨论调整政策”，并补充说“重要的事情”被“忽视了”。
它没有详细说明。
一位了解此事的消息人士称，政策变化可能意味着加强对印度价值 410 亿美元的制药业
的监管，该行业是世界上最大的制药供应商。
Increased testing of cough syrups as well as of raw materials for drugs in
general is one of the steps being considered, said the source.
The statement, which has not been previously reported, appears to be the
first time the prime minister's office has addressed the cough syrup
controversy. Modi's office and the health ministry did not respond to a
request for comment.
India's drug regulator, the Central Drugs Standard Control Organisation
(CDSCO), has proposed testing cough syrups in government laboratories before
they are exported, media outlet News18.com reported on Tuesday.
增加对止咳糖浆以及一般药物原材料的检测是正在考虑的步骤之一。
该声明此前未曾被报导过，它似乎是总理办公室首次处理止咳糖浆争议。莫迪办公室和卫
生部没有回应。
据媒体 News18.com 周二报导，印度药品监管机构中央药品标准控制组织 (CDSCO) 已提
议在出口前在政府实验室对止咳糖浆进行检测。
The World Health Organization (WHO) found last year that cough syrups made by
an Indian drugmaker contained dangerous levels of two known toxins,
diethylene glycol and ethylene glycol, leading to the deaths of at least 70
children in Gambia. India denies a connection between the syrups and the
deaths.
The WHO says it is still seeking the culprit within the supply chain, but has
been frustrated in its efforts, Reuters reported earlier this month.
世界卫生组织 (WHO) 去年发现，一家印度制药商生产的止咳糖浆含有两种已知剧毒毒素，
即二甘醇和乙二醇，导致冈比亚至少 70 名儿童死亡。印度否认糖浆与死亡之间存在联系
。
据路透社本月早些时候报导，世卫组织表示仍在寻找供应链中的罪魁祸首，但进度不如
预期。
India has acted against a second Indian company whose cough syrups were
linked to the deaths of 19 kids in Uzbekistan, including the arrest of three
of its employees. A third Indian drugmaker was found by the WHO to have sold
tainted syrups to the Marshall Islands and Micronesia.
Indian health officials have expressed concern that the incidents of
contaminated syrups will harm its pharmaceutical industry. An Indian
representative participated in a meeting of global drug regulators in
Indonesia earlier this month to discuss ways to ensure the safety of the
pharmaceutical supply chain.
印度已对第二家印度公司采取行动，该公司的止咳糖浆与乌兹别克斯坦 19 名儿童的死亡有
关，其中三名员工被捕。世界卫生组织发现第三家印度制药商向马绍尔群岛和密克罗尼
西亚出售受污染的糖浆。
印度卫生官员表示担心，受污染的糖浆事件会损害其制药业。本月早些时候，一名印度代
表参加了在印度尼西亚举行的全球药品监管机构会议，讨论确保药品供应链安全的方法。
"The participating authorities expressed their deep commitment for immediate,
short, medium, and long-term actions to strengthen the regulatory systems in
safeguarding patients from contamination in medicines," a WHO spokesperson
told Reuters.
According to an advisory sent by Indian regulator CDSCO to all states on
April 21 and seen by Reuters, drug officials must ensure that drugs meet the
standards of the Indian Pharmacopoeia (IP).
The CDSCO said it was reiterating the need for standards after receiving a
public complaint about the standards of drug ingredients in the country. It
did not say who filed the complaint.
世卫组织发言人告诉路透社：“当局表达了他们对立即、短期、中期和长期行动的坚
定承诺，以加强监管系统，保护患者免受药物污染。”
根据路透社看到的印度监管机构 CDSCO 于 4 月 21 日向所有邦发送的建议，药品官员必
须确保药品符合印度药典 (IP) 的标准。
CDSCO 表示，在收到公众对该国药物成分标准的投诉后，它重申了制定标准的必要性。它
没有说明是谁提出了投诉。
If a drug is not included in the IP, "the standards of identity, purity and
strength specified for drugs in the current edition of Pharmacopoeia of any
other country ... are applicable and such standards as may be prescribed,
shall be followed."
"It is once again requested to ensure compliance with the said standards,"
said the advisory from Rajeev Singh Raghuvanshi, the drugs controller general
of India.
Reporting by Krishna N. Das in New Delhi; Additional reporting by Jennifer
Rigby in London; Editing by Michele Gershberg and Raju Gopalakrishnan
如果一种药物未包含在 IP 中，“任何其他国家/地区现行版本的药典中规定的药物特性
、纯度和强度标准……都适用，并且应遵循可能规定的标准。”
“再次要求确保遵守上述标准，”印度药物管制长拉吉夫·辛格·拉古万希 (Rajeev
Singh Raghuvanshi) 的建议说。
5.完整新闻连结 (或短网址)不可用YAHOO、LINE、MSN等转载媒体:
https://reurl.cc/a16onX
6.备注:
印度人毒不死不代表非洲人也毒不死啊？
二甘醇对人类及动物均具毒性，如摄取过量，可损害肝脏和肾脏，严重者可引致死亡。中
毒初期可出现呕吐、腹泻及腹痛，情况严重者在其后数天可出现急性肾衰竭及其它症状。
人体的二甘醇致死剂量约为每公斤体重1毫升，不过有报告指儿童口服5毫升、成人口服20
毫升已可致命。它的毒性来自人体摄入后，会代谢为肾毒性极强的草酸，导致急性肾衰竭
症状。
乙二醇对动物有毒性，人类致死剂量估计为1.6 g/kg，不过成人服食30毫升已有可能
引致死亡。