Recently The New York Times reported the following:
America Wants to Make More Generic Drugs. India Shows Why
That’s Hard. (2/2)
Cheap labor and global supply chains are among the
obstacles to President Trump’s plan to bring generic drug manufacturing back
home.
By Alex Travelli - Alex Travelli reported from Hyderabad and
Digwal, in the Indian state of Telangana, with photographs by Harsha Vadlamani.
Emily Elconin shot photographs in Riverview, Mich.
Oct. 2, 2026
(continue)
India has other advantages. Mr. DeYoung said factories and
processes that took four years to set up in the United States, Europe or Israel
— home to Teva Pharmaceutical Industries, the biggest generics maker — could be
completed within a year in India. Customized equipment can be made in half the
time it would take in Germany or Austria.
For years, relying so heavily on Indian factories had a downside: quality. A series of scandals beginning in the early 2000s tarnished the industry’s reputation. The most notorious offender, Ranbaxy, sold subpar drugs and lied to the U.S. Food and Drug Administration about its processes before going under more than a decade ago.
A book about the scandal has since become required reading for many industry managers. Its epilogue said that as recently as 2019, the F.D.A. still announced Indian factory inspections days in advance, giving operators time to conceal shoddy practices.
That is no longer the case, at least among big manufacturers. Dr. Reddy’s underwent a surprise inspection two weeks after Mr. Trump declared a tariff on generics. Piramal said its factories, including in Digwal, three hours west of Hyderabad, have undergone 415 inspections since 2012, including 49 from the F.D.A., with zero serious violations detected.
Piramal makes generics, but even more of its business is contract manufacturing for clients that hold drug patents. Keeping smaller factories in the United States makes it easier for some customers to keep tabs on production.
That geographic spread points to another problem with trying
to produce all pharmaceuticals locally. Modern drug supply chains don’t divide
neatly into things made in America and things imported from elsewhere.
One sealed barrel among thousands in Piramal’s main Digwal storeroom was made in India, shipped to Singapore and back, and bore the brand of a Japanese company with an American address.
Another drug, which Mr. DeYoung would describe only as a lifesaving medicine to treat central nervous system conditions, begins its journey in Digwal, then travels 8,000 miles by air to Piramal’s facility in Riverview, Mich.
Riverview, a quiet suburb of Detroit with broad lawns and white steeples, is a far cry from Digwal, where nearby villages still draw water from stone-lined wells. But specialized machines in Piramal’s Indian and American labs collaborate to turn the medicine into its final form.
There are good reasons to pair facilities in India with plants in their destination market, Mr. DeYoung said. Some drugs require especially dangerous chemicals, including some controlled by the Drug Enforcement Administration. Others, like sevoflurane, a generic anesthetic Piramal makes in both India and the United States, must remain available even if international supply chains break down completely.
Which raises a more fundamental question than whether tariffs can force drug manufacturing back to America.
“So what problem are you trying to solve?” Mr. DeYoung asked about the prospect of a tariff on imported generics. Is it to bring back pharmaceutical jobs to American workers? Is it to safeguard supplies of vital medicines?
Even as Indian firms wrestle with the Trump administration’s
push to reduce its dependency on India, they are also grappling with their own
reliance on another country for a critical part of the pharmaceutical supply
chain.
Starting in the 1990s, China became the world’s dominant manufacturer of the active ingredients that most drugs require. India is now trying to reclaim that ability.
That, Mr. Jain said, creates an opportunity for the United States and India to work together, instead of pulling their pharmaceutical industries apart.
“Unless we work together with the U.S., we’ll be dependent on China” for ingredients, he said. That’s why, he added, it makes sense for American buyers “to stockpile from India” instead of making it in the United States “for six, seven or eight times the price.”
Translation
美國希望生產更多仿製藥。印度的例子顯示這有多麼困難 (2/2)
(繼續)
多年來,過度依賴印度工廠存在一個弊端:品質問題。始於2000年代初的一系列醜聞損害了該行業的聲譽。最臭名昭著的違規者Ranbaxy公司在十多年前倒閉前,曾銷售劣質藥品,並就其生產流程向美國食品藥品監督管理局(FDA)撒謊。
一本關於此醜聞的書籍後來成為許多行業管理者的必讀書目。該書的後記指出,直到2019年,FDA仍然會提前幾天宣佈對印度工廠的檢查,這給了生產商時間來掩蓋其不規範的操作。
至少在大型製藥公司中,這種情況已經有所改變。在特朗普宣佈對仿製藥徵收關稅兩週後,Dr. Reddy’s實驗室接受了一次突擊檢查。Piramal公司表示,自2012年以來,其工廠(包括位於Hyderabad以西三小時車程的Digwal工廠)已接受了415次檢查,其中包括FDA的49次檢查,未發現任何嚴重違規行為。
Piramal公司生產仿製藥,但其更大的業務是為擁有藥品專利的客戶提供合約生產服務。在美國保留小型工廠,方便一些客戶追蹤生產情況。
這種地域分散也暴露出試圖在本地生產所有藥品的另一個問題。現代藥品供應鏈並非涇渭分明地分為美國製造和進口兩類藥品。
在Piramal位於Digwal的主要倉庫中,成千上萬個密封桶中有一個產自印度,經新加坡轉運後又返回印度,桶上印著一家日本公司品牌在美國的地址。
另一種藥物,DeYoung只將其描述為治療中樞神經系統疾病的救命藥,從Digwal開始其旅程,然後空運8000英里到達位於密西根州Riverview的Piramal工廠。
Riverview是底特律一個寧靜的郊區,擁有寬闊的草坪和白色的尖頂教堂,與Digwal截然不同,Digwal附近的村莊仍然從石砌水井中取水。但Piramal位於印度和美國的實驗室裡的專用機器協同工作,將藥物轉化為最終形式。
DeYoung表示,將印度的生產設施與目標市場的工廠配對是有許多充分的理由。有些藥物需要特別危險的化學品,包括一些受美國緝毒局管制的化學品。另一些藥物,例如七氟烷(一種通用麻醉劑,由Piramal公司在印度和美國生產),即使國際供應鏈完全斷裂,也必須保持供應。
這引出了一個比關稅能否迫使藥品生產回流美國更為根本的問題。
DeYoung就對進口仿製藥徵收關稅的前景問道: 「那麼,你們究竟想解決什麼問題?」。是為了讓美國工人重獲製藥業的工作機會嗎?還是為了保障重要藥品的供應?
儘管印度企業正努力應對特朗普政府減少對印度依賴的舉措,但它們本身也正努力應對在藥品供應鏈的關鍵環節上對另一個國家的依賴。
自1990年代以來,中國已成為全球大多數藥物所需活性成分的主要生產國。如今,印度正試圖重新奪回這項本領。
Jain表示,這是為美國和印度攜手合作創造了機會,而不是讓兩國的製藥業分崩離析。
他說:「“除非我們與美國合作,否則我們將依賴中國」來獲取原料。因此,他補充說,對美國買家而言,「從印度入貨」比「在美國以六七到八倍的價格」生產更有意思。
So. the scale of India’s pharmaceutical
industry has made it a cornerstone of the global drug supply. India’s ability
to make pills at a small fraction of what they would cost elsewhere has created
an almost insurmountable hurdle for the United States to try to bring that
production home. Comparing to Inia, in America, labor is the highest cost “by a
wide margin,” followed by energy and materials. In India, it’s the opposite. Apparently, it makes sense for
American to buy drugs from India instead of making them by themselves.
