備註請放最後面 違者新聞文章刪除
1.媒體來源:
路透社
2.記者署名:
By Krishna N. Das
3.完整新聞標題:
Exclusive: India considers policy change after cough syrup deaths - Modi's
office
獨家：印度考慮在止咳糖漿死亡事件後對製藥業採取新規範-莫迪辦公室
4.完整新聞內文:
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 於 2022 年 9 月死於急性腎損傷。10 月，70 多名甘比亞兒童因急性腎損傷死亡
全球衛生官員將受傷與印度製造並被乙二醇和二甘醇污染的止咳糖漿聯繫起來。路透社/
愛德華麥卡利斯特
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）——根據總理納倫德拉·莫迪 (Narendra Modi) 辦公室
的一份文件，印度正在考慮改變其製藥業政策，因為該國生產的止咳糖漿與海外兒童的死
亡有關，該文件指出：“關於這個行業的重要規範被忽視了”。
莫迪辦公室在 5 月 15 日的一份文件中說，在印度南部城市海得拉巴舉行了一次腦力激盪
，“以找到導致兒童死亡的出口止咳糖漿的解決方案”，路透社看到了這份文件。
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.
根據衛生部未提及止咳糖漿的聲明，衛生部長 Mansukh Mandaviya 以及聯邦和州監
管機構參加了2 月份的會議。
總理辦公室的文件稱，“正在討論調整政策”，並補充說“重要的事情”被“忽視了”。
它沒有詳細說明。
一位了解此事的消息人士稱，政策變化可能意味著加強對印度價值 410 億美元的製藥業
的監管，該行業是世界上最大的製藥供應商。
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.
增加對止咳糖漿以及一般藥物原材料的檢測是正在考慮的步驟之一。
該聲明此前未曾被報導過，它似乎是總理辦公室首次處理止咳糖漿爭議。莫迪辦公室和衛
生部沒有回應。
據媒體 News18.com 週二報導，印度藥品監管機構中央藥品標準控制組織 (CDSCO) 已提
議在出口前在政府實驗室對止咳糖漿進行檢測。
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.
世界衛生組織 (WHO) 去年發現，一家印度製藥商生產的止咳糖漿含有兩種已知劇毒毒素，
即二甘醇和乙二醇，導致甘比亞至少 70 名兒童死亡。印度否認糖漿與死亡之間存在聯繫
。
據路透社本月早些時候報導，世衛組織表示仍在尋找供應鏈中的罪魁禍首，但進度不如
預期。
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.
印度已對第二家印度公司採取行動，該公司的止咳糖漿與烏茲別克 19 名兒童的死亡有
關，其中三名員工被捕。世界衛生組織發現第三家印度製藥商向馬紹爾群島和密克羅尼
西亞出售受污染的糖漿。
印度衛生官員表示擔心，受污染的糖漿事件會損害其製藥業。本月早些時候，一名印度代
表參加了在印度尼西亞舉行的全球藥品監管機構會議，討論確保藥品供應鏈安全的方法。
"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.
世衛組織發言人告訴路透社：“當局表達了他們對立即、短期、中期和長期行動的堅
定承諾，以加強監管系統，保護患者免受藥物污染。”
根據路透社看到的印度監管機構 CDSCO 於 4 月 21 日向所有邦發送的建議，藥品官員必
須確保藥品符合印度藥典 (IP) 的標準。
CDSCO 表示，在收到公眾對該國藥物成分標準的投訴後，它重申了製定標準的必要性。它
沒有說明是誰提出了投訴。
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
如果一種藥物未包含在 IP 中，“任何其他國家/地區現行版本的藥典中規定的藥物特性
、純度和強度標準……都適用，並且應遵循可能規定的標準。”
“再次要求確保遵守上述標準，”印度藥物管制長拉吉夫·辛格·拉古萬希 (Rajeev
Singh Raghuvanshi) 的建議說。
5.完整新聞連結 (或短網址)不可用YAHOO、LINE、MSN等轉載媒體:
https://reurl.cc/a16onX
6.備註:
印度人毒不死不代表非洲人也毒不死啊？
二甘醇對人類及動物均具毒性，如攝取過量，可損害肝臟和腎臟，嚴重者可引致死亡。中
毒初期可出現嘔吐、腹瀉及腹痛，情況嚴重者在其後數天可出現急性腎衰竭及其它症狀。
人體的二甘醇致死劑量約為每公斤體重1毫升，不過有報告指兒童口服5毫升、成人口服20
毫升已可致命。它的毒性來自人體攝入後，會代謝為腎毒性極強的草酸，導致急性腎衰竭
症狀。
乙二醇對動物有毒性，人類致死劑量估計為1.6 g/kg，不過成人服食30毫升已有可能
引致死亡。