Can the world’s pharmacy escape a reputation for poor quality control?

“世界藥房”能否逃脫質(zhì)量控制不良的名聲?

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.

這是父母的噩夢(mèng)。7月至10月間，岡比亞有70名兒童死于腎衰竭。12月，烏茲別克斯坦有18人死于腎臟疾病和急性呼吸道疾病。根據(jù)岡比亞議會(huì)委員會(huì)和烏茲別克斯坦當(dāng)局的指控，在這兩起案件中，印度制造的咳嗽糖漿是有責(zé)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.

烏茲別克斯坦案件中的制造商馬立昂生物技術(shù)公司已被印度政府關(guān)聯(lián)的貿(mào)易組織Pharmexcil(藥品出口促進(jìn)委員會(huì))暫停銷(xiāo)售，該組織在藥品出口方面發(fā)揮作用; 該公司的網(wǎng)站似乎癱瘓了。生產(chǎn)岡比亞使用的藥物的Maiden Pharma公司的一名高管告訴一家印度報(bào)紙，該公司對(duì)死亡事件感到震驚和悲傷。該公司在其Facebook頁(yè)面上發(fā)布了一份報(bào)告，聲稱(chēng)印度政府的一個(gè)藥物測(cè)試實(shí)驗(yàn)室發(fā)現(xiàn)其糖漿沒(méi)有問(wèn)題; 未被說(shuō)服的岡比亞議員建議起訴Maiden。兩家公司都沒(méi)有回應(yīng)《經(jīng)濟(jì)學(xué)人》的置評(píng)請(qǐng)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.

這兩家公司都是小型私營(yíng)企業(yè)。他們的產(chǎn)品與死亡之間的因果關(guān)系尚未得到證實(shí)。到目前為止，印度的樣本測(cè)試已經(jīng)證明了Maiden無(wú)罪; 對(duì)馬立昂的調(diào)查才剛剛開(kāi)始。然而，這些事件觸動(dòng)了印度龐大制藥業(yè)的痛處。在印度，3000家公司經(jīng)營(yíng)的約1萬(wàn)家工廠每年生產(chǎn)價(jià)值近500億美元的藥品，占全球仿制藥供應(yīng)量的20%，占美國(guó)仿制藥供應(yīng)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.

印度制藥商喜歡稱(chēng)自己為“世界藥房”，它對(duì)丑聞并不陌生。2022年，美國(guó)食品和藥物管理局(FDA)向四家大型印度公司發(fā)布了“進(jìn)口警報(bào)”。這類(lèi)通知通常是在對(duì)外國(guó)工廠進(jìn)行檢查之后發(fā)出的，可能會(huì)導(dǎo)致對(duì)美國(guó)的出口在沒(méi)有實(shí)物證據(jù)表明某批貨物質(zhì)量不好地情況下被阻止。

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.

過(guò)去幾十年，印度制藥業(yè)的崛起是由于其極低的價(jià)格，然后極低價(jià)格的另一面則是長(zhǎng)期以來(lái)對(duì)偷工減料和質(zhì)量控制不力的擔(dān)憂(yōu)。在一本名為《真相藥丸:印度藥品監(jiān)管的神話》的新書(shū)中，前行業(yè)高管Dinesh Singh Thakur和律師Prashant Reddy記錄了自20世紀(jì)70年代以來(lái)，至少5起危險(xiǎn)藥物進(jìn)入市場(chǎng)的案例，每一起都造成多人死亡。在更多的情況下，拙劣的制造方法可能導(dǎo)致藥物無(wú)效。Reddy先生說(shuō)，這些缺點(diǎn)被復(fù)雜而不透明的檢查制度所掩蓋。像他和Thakur這樣的評(píng)論家所表達(dá)的擔(dān)憂(yōu)經(jīng)常被忽視，或者遭到政府的法律通知，因?yàn)樗麄儽徽J(rèn)為玷污了國(guó)內(nèi)制藥業(yè)的聲譽(yù)。

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，政府對(duì)最近幾起悲劇的最初反應(yīng)是平淡的，而且缺乏對(duì)相關(guān)供應(yīng)鏈的詳細(xì)公開(kāi)審查。從歷史上看，迅速得出結(jié)論的希望不大。1988年孟買(mǎi)一家大醫(yī)院14人死亡的案件仍在訴訟中。這種拖拖拉拉的做法可能會(huì)危及更多患者的生命。它最終也危害到印度制藥商，它們的狀況可與他們的客戶(hù)的健康密不可分。