United States Senator Jim Banks has urged the Food and Drug Administration (FDA) to step up inspections of overseas pharmaceutical manufacturing facilities, expressing concern over poor-quality drugs being imported from countries like India and China.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
Sun Pharmaceutical Industries Ltd on Thursday said its Halol facility in Gujarat has been listed under import alert by the USFDA with products manufactured at the unit now are subject to refusal of admission in the US market. The development follows an inspection of the facility by the US Food and Drug Administration (USFDA) from April 26 to May 9, 2022. "We now wish to inform you that the company has received a communication from the USFDA stating that the facility has been listed under Import Alert," Sun Pharma said in a regulatory filing.
The US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai.
The regulator has given the company 15 days to take corrective measures and report back to it.
In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.
The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015
Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Marksans Pharma is recalling diabetes drug, Zydus Pharmaceuticals (USA) is recalling drug which is used to reduce stomach acid. Similarly, Aurobindo Pharma (USA) is recalling pain relieving drug, while Jubilant Cadista is recalling a medication used to treat schizophrenia.
These centres will undertake stem cell clinical research procedures relating to diabetes, cancer, cardiovascular disease, and neurological ischemia.
Suit alleges fraud by hiding significant deficiencies in CGMP regulations enforced by US health regulator.
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
The novel mRNA vaccine candidate, HGCO19, is supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology. The mRNA vaccines do not use the conventional model to produce immune response. Instead, they carry molecular instructions to make the protein in the body through a synthetic RNA of the virus.
Formal warning to Indian unit of deficiencies noted during inspection at facility near Chennai; firm says will remedy
The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories, Ltd in the US while manufactured in India by Sun Pharmaceutical Industries Ltd.
The FDA issued the letter on October 15, and has given the company 15 days to respond.
Large pharmaceutical firms feel that if the quality parameters and assurance levels are brought up to the level of branded generics, then Jan Aushadhi medicines would find it difficult to retain their affordability.
Popular antacid Mucaine Gel, manufactured by Pfizer's subsidiary Wyeth Laboratories, was also found laced with the heavy metals as well as cadmium.
Dr Reddy's gets warning from US health regulator
Ranbaxy Laboratories on Thursday said it will co-operate fully with any regulator from anywhere in the world wanting to investigate its manufacturing practices.
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