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文章来源：《经济学人》Jan 4th 2023 期 Business 栏目
A scandal rocks India’s pharmaceutical industry
一桩撼动了印度制药行业的丑闻
Bitter syrup
Can the world’s pharmacy escape a reputation for poor quality control?
“世界药房”能否逃脱质量控制不良的名声?
Jan 5th 2023 | MUMBAI
It is the stuff of parental nightmares. Between July and October 70 children in Gambia died of kidney failure. In December 18 perished in Uzbekistan from renal problems and acute respiratory disease. In both cases Indian-made cough syrups may have been at fault, according to allegations by a Gambian parliamentary committee and the Uzbek authorities.
这是父母的噩梦。7月至10月间，冈比亚有70名儿童死于肾衰竭。12月，乌兹别克斯坦有18人死于肾脏疾病和急性呼吸道疾病。根据冈比亚议会委员会和乌兹别克斯坦当局的指控，在这两起案件中，印度制造的咳嗽糖浆是有责任的。
The manufacturer in the Uzbek case, Marion Biotech, has been suspended from Pharmexcil, an Indian government-linked trade group that plays a role in pharmaceutical exports; the firm’s website appears to be down. An executive for Maiden Pharma, which produced the medicine used in Gambia, told an Indian newspaper that the company was shocked and saddened by the deaths. The firm posted a report on its Facebook page claiming that a government drug-testing lab in India had found its syrup to be problem-free; unpersuaded Gambian parliamentarians recommended that Maiden should be prosecuted. Neither firm responded to The Economist’s requests for comment.
乌兹别克斯坦案件中的制造商马立昂生物技术公司已被印度政府关联的贸易组织Pharmexcil(药品出口促进委员会)暂停销售，该组织在药品出口方面发挥作用; 该公司的网站似乎瘫痪了。生产冈比亚使用的药物的Maiden Pharma公司的一名高管告诉一家印度报纸，该公司对死亡事件感到震惊和悲伤。该公司在其Facebook页面上发布了一份报告，声称印度政府的一个药物测试实验室发现其糖浆没有问题; 未被说服的冈比亚议员建议起诉Maiden。两家公司都没有回应《经济学人》的置评请求。
Both companies are small and privately held. A causal link between their products and the deaths has not been proved. Sample tests in India have so far cleared Maiden of blame; an investigation of Marion has just begun. Yet the incidents have touched a raw nerve in India’s vast pharmaceutical industry, where around 10,000 factories operated by 3,000 firms churn out nearly $50bn-worth of drugs a year, accounting for 20% of the world’s and 40% of America’s generics supply by value.
这两家公司都是小型私营企业。他们的产品与死亡之间的因果关系尚未得到证实。到目前为止，印度的样本测试已经证明了Maiden无罪; 对马立昂的调查才刚刚开始。然而，这些事件触动了印度庞大制药业的痛处。在印度，3000家公司经营的约1万家工厂每年生产价值近500亿美元的药品，占全球仿制药供应量的20%，占美国仿制药供应量的40%。
The world’s pharmacy, as India’s drugmakers like to call themselves, is no stranger to scandal. In 2022 America’s Food and Drug Administration issued “import alerts” to four large Indian companies. Such notifications, which usually follow inspections of foreign factories, could lead to exports to America being blocked without physical evidence that a particular shipment is bad.
印度制药商喜欢称自己为“世界药房”，它对丑闻并不陌生。2022年，美国食品和药物管理局(FDA)向四家大型印度公司发布了“进口警报”。这类通知通常是在对外国工厂进行检查之后发出的，可能会导致对美国的出口在没有实物证据表明某批货物质量不好地情况下被阻止。
Concerns about corner-cutting and poor quality control are the long-standing flip-side of the rock-bottom prices that have fuelled the industry’s rise in India in the past few decades. In a new book, “The Truth Pill: The Myth of Drug Regulation in India”, Dinesh Singh Thakur, a former industry executive, and Prashant Reddy, a lawyer, document at least five cases of dangerous medications entering the market, each causing multiple fatalities, since the 1970s. In many more instances shabby manufacturing methods could lead to medicines that are ineffective. These shortcomings are obscured by a complex and opaque inspection regime, says Mr Reddy. Concerns aired by critics like him and Mr Thakur are often ignored—or met with threatening legal notices from the government for supposedly tarnishing the domestic industry’s reputation.
过去几十年，印度制药业的崛起是由于其极低的价格，然后极低价格的另一面则是长期以来对偷工减料和质量控制不力的担忧。在一本名为《真相药丸:印度药品监管的神话》的新书中，前行业高管Dinesh Singh Thakur和律师Prashant Reddy记录了自20世纪70年代以来，至少5起危险药物进入市场的案例，每一起都造成多人死亡。在更多的情况下，拙劣的制造方法可能导致药物无效。Reddy先生说，这些缺点被复杂而不透明的检查制度所掩盖。像他和Thakur这样的评论家所表达的担忧经常被忽视，或者遭到政府的法律通知，因为他们被认为玷污了国内制药业的声誉。
The government’s initial response to the latest tragedies has been lethargic and has lacked a detailed public examination of the relevant supply chains, says Mr Reddy. History offers little hope of a swift conclusion. One case in Mumbai, which involved the deaths of 14 people in a big hospital in 1988, is still being litigated. Such foot-dragging risks the lives of more patients. It also ultimately harms India’s drugmakers, whose health is inextricably bound up with that of their customers. ■
Reddy表示，政府对最近几起悲剧的最初反应是平淡的，而且缺乏对相关供应链的详细公开审查。从历史上看，迅速得出结论的希望不大。1988年孟买一家大医院14人死亡的案件仍在诉讼中。这种拖拖拉拉的做法可能会危及更多患者的生命。它最终也危害到印度制药商，它们的状况可与他们的客户的健康密不可分。■ |
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发表于 2023-3-11 12:29:15
