「经济学人」Bitter syrup苦涩的糖浆

「经济学人」A bitter syrup

Bitter syrup苦涩的糖浆

A scandal rocks India’s pharmaceutical industryCan the world’s pharmacy escape a reputation for poor quality control?

丑闻动摇印度制药工业

世界制药工厂能摆脱质量控制薄弱的恶名吗?

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.

1. 这是父母的梦魇。7月到10月期间,冈比亚有70名儿童死于肾衰竭。12月8号,乌兹别克斯坦有18人因肾病和呼吸系统疾病而亡。据冈比亚议会委员会和乌兹别克当局称,这两起事件中,印度生产的咳嗽糖浆可能是罪魁祸首。

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.

2. Pharmexcil,是有印度政府背景的出口企业集团,主要从事药品出口业务。该公司已经暂停乌兹别克涉事制药厂马里奥生物科技的业务,马里奥网站似乎也下线了。冈比亚事件涉及药厂Maiden Pharma的一名高管向一家印度报纸透露,公司对死亡事件深表震惊和难过。在公司脸书主页上,公司发布了一份报告,声明经印度国家药物检测实验室检测,未发现公司生产的咳嗽糖浆有任何问题。而冈比亚议会成员拒绝接受该说法,建议对Maiden 公司加以处罚。面对《经济学人》的质询,公司未给予回应。

「经济学人」Bittersyrup苦涩的糖浆

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.

3. 这两家公司规模较小,且为私营。尚无法证明其产品与死亡之间没有必然联系。印度样品检测目前看来可以洗脱Maiden公司的嫌疑。针对Marion的调查才刚开始。然而,这两期事件刺痛了印度大规模制药产业的神经。在印度约有3000家企业的1万个制药工厂,每年大量制造价值近500亿美元的药品,占全球产值的20%,相当于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.

「经济学人」Bittersyrup苦涩的糖浆

4. 印度药企喜欢自称为全球药品工厂,对这写丑闻不足为奇。2022年,美国食品药品监督局给四大印度药企发出“严重警示”,警示后通常会对外国药厂进行检查。没有实际证据证明是某批运输发货出了问题,这类警示可能导致产品向美国出口受阻。

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.

5. 过去几十年来,印度制药产业快速兴起得益于产品价格低廉,另一方面,药厂偷工减料、缺乏质量控制问题由来已久。Dinesh Singh Thakur先生曾经是一名制药厂高管,Prashant Reddy是一名律师。二人的新书《药丸真相:印度药品制度的神话》记录了至少5起流入市场的危险药品,从1970起,每个事件都造成多起死亡。大多数情况下,简陋的生产方法可能导致药物无效。雷迪先生说,复杂而模糊的检查制度掩盖了这些问题。像他和Thakur这样的批评人士的关注往往得不到重视,甚至,收到政府的威胁通知,称其蓄意抹黑国内制药产业。

「经济学人」Bittersyrup苦涩的糖浆

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.

6. 政府开始对于最近事件的反应一直很迟钝,缺乏对相关供应链详细的调查,Reddy先生表示。历史经验告诉我们不要期待有快速的相应结论。孟买事件中1988年造成大医院中有14人死亡,目前仍在诉讼过程中。这种拖沓让更多病人生命冒着风险。最终也会伤及印度制药厂。药厂的健康与病人的健康息息相关。

This article appeared in the Business section of the print edition under the headline "A bitter syrup" (Jan 5th 2023)