U.S. health regulator pulls up Jagsonpal Pharmaceuticals for manufacturing lapses at API plant
The Hindu
USFDA issues warning letter to Jagsonpal Pharmaceuticals for manufacturing lapses at Rajasthan plant, demands corrective action within 15 days.
The U.S. health regulator has pulled up Jagsonpal Pharmaceuticals for significant manufacturing lapses at its Rajasthan-based active pharmaceutical ingredients (APIs) plant.
In a warning letter issued to the company's Managing Director Manish Gupta, the U.S. Food and Drug Administration (USFDA) noted that the correspondence summarizes significant deviations from Current Good Manufacturing Practice for APIs.
The U.S. health regulator stated that it inspected the company's Bhiwadi- based plant in Rajasthan on March 20, March 27, and April 3, 2024. "This warning letter summarises significant deviations from Current Good Manufacturing Practice (CGMP) for APIs. Because the methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated," the USFDA stated in the warning letter.
A warning letter issued by the USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.
The letter also makes clear that the company must correct the problem and provides directions and a timeframe of its plans for correction. FDA then checks to ensure that the company's corrections are adequate. The USFDA noted that the company's quality systems were inadequate.
It pointed out failure of the company's quality unit to exercise its responsibility to ensure the API manufactured at the contract facility is in compliance with CGMP.
"FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labellers. FDA regards contractors as extensions of the manufacturer. You are responsible for the quality of your drugs regardless of agreements in place with your contract facility," it noted.
Pinarayi Vijayan criticizes Rahul Gandhi and Congress for allegedly aiding BJP's rise in various states during Kerala polls.
Sonia Gandhi is responding well to treatment for a systemic infection and remains under observation at a Delhi hospital.
J&K Police's Counter Intelligence Wing conducts raids in three districts linked to a transnational terror module operated by Lashkar-e-Taiba.
Vaccination policies must prioritize saving human lives over individual choice amid rising vaccine skepticism, asserts scientist Dr. Virander Singh Chauhan.
Seven Indian fishermen from Rameswaram arrested by Sri Lankan Navy, sparking protests and calls for government intervention.
Kerala cyber police file a case against X for an AI video allegedly defaming PM Modi and the Election Commission.
iKure and Izawa Co. partner to combat avoidable blindness by integrating innovative eye care technology into rural healthcare networks.
Thousand Lights MLA from the DMK N. Ezhilan, in an interview to The Hindu, observes that any popular personality entering politics will attract the limelight. But only a structured party machinery combined with popularity can ensure success. In this interview, he speaks about his tenure as first-time MLA from Thousand Lights Assembly constituency in Chennai, Vijay’s political entry shaping the 2026 elections, redressal of key grievances and more.
Abhishek Banerjee challenges BJP's Suvendu Adhikari in Nandigram, pledging community health initiatives if Trinamool Congress wins.
Rising LPG shortages in Karnataka boost firewood demand, reviving an informal market as households and hotels seek alternatives.
Against the backdrop of intense poll activity, a 400-metre stretch of an arterial road in the outskirts of Chennai (technically in Madurapakkam panchayat under Tambaram assembly constituency) presents a salute to the idea of res publica, which underpins India’s system of governance, where citizens have a say, at least before a government is securely ensconced in the seat of power. A Republic Day initiative shines bright every night
Fadnavis claims zero FIR in Ajit Pawar crash is a defamation attempt by Karnataka against Maharashtra's investigation efforts.
Set to unfold as a one-day pop-up on April 5, the Easter Sadya brings together both vegetarian and non-vegetarian menus, offering a peek into the food traditions of the Syrian Christian (Nasrani) community. While the traditional Sadya is often associated with dishes such as sambar, avial, and rice, this version expands to include community-specific festive dishes.