Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
Uttar Pradesh Food and Drug Authority (FDA) says it has found excess lead in the Yippee noodles of domestic giant ITC.
And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined, according to a July 18 letter from the US Food and Drug Administration to Wockhardt, which makes sterile injectable drugs and various forms of insulin.
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
With 62 filings, domestic pharma companies have filed the maximum number of drug master filings with the US Food and Drug Administration in the July-September 2006 quarter.
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
Maharashtra's Food and Drugs Administration on Wednesday argued in the Bombay High Court that Nestle India.
The letter mentions certain cGMP violation based on site inspections conducted between July and August 2009.
Under fire from some United States senators for allegedly taking lenient positions in granting product approvals to generic companies from countries like India, the US FDA is planning to speed up its plans to set up offices in India by 2009. FDA, in its latest newsletter dated July 21, has said that the agency will set up offices in Mumbai and Delhi to intensify its monitoring efforts.
The Indian Pharmaceutical Alliance has approached regulator for a dialogue to understand the concern raised by it
The FDA has stepped up its efforts to ensure drug safety in recent months.
Its factory in Chikalthana in western India was last month hit by the British drug regulator's curb on imports from the plant over manufacturing deficiencies.
Recently, Ranbaxy and Wockhardt too were hauled up.
A civic body in North Goa has banned the sale of the popular street food 'Gobi Manchurian' at roadside stalls in its jurisdiction after concerns were raised about the unhygienic conditions in which the dish was prepared, an official said on Tuesday.
Earlier, Jaslok Hospital had issued an advisory to its doctors to avoid prescribing drugs manufactured by Ranbaxy.
The fees for facility inspection of foreign companies have been reduced
Aurobindo Pharma on Thursday said it had received US FDA approval for anti-retroviral Lamivudine, thus enabling it to participate in the president's emergency plan for AIDS relief), a US government initiative.
The Maharashtra Food and Drug Adminstration has served a notice to Wipro for allegedly "misbranding and mislabelling" its baby oil.
Industry insiders in India warn that any such move in the pharmaceutical sector could be counterproductive for the US as it may face increased drug shortages if tariffs are imposed on such imports.
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Former Maharashtra minister Baba Siddique, who was shot dead in Mumbai, was a popular figure in Bollywood circles and had earned praise for supplying life-saving medicines to patients during the Covid pandemic.
Biotech major Biocon will file an application with the US Federal Drug Administration to begin clinical trials for oral insulin, which, it says, would be the world's first insulin that could be consumed orally.
Retail chain Subhiksha feels it is being unfairly targeted by the Food and Drugs Administration (FDA) of Maharashtra in initiating enquiries and hygiene checks on grounds that it is selling repackaged goods. The company would present its case in a hearing scheduled on August 8.
Inspections only in domestic authorities' presence, visiting US drug regulator told
On her maiden visit to India, US Food and Drug Administrator Margaret A Hamburg has said recent lapses in quality by a handful of pharma companies has overshadowed the good things done by other Indian companies, who emphasise on quality products and practices.
Ranbaxy Laboratories Ltd today said it has received tentative approval from the US Food and Drug Administration to manufacture and market Glimepiride tablets of 1 mg, 2 mg, 4 mg and 8 mg.
Sunovion Pharmaceuticals Inc is the owner of the Eszopiclone drug.
A report was positive for the presence of two dead and one live insect, FDA Commissioner Uttam Khobargade said in Mumbai.
Ranbaxy Laboratories on Monday said it has received the US Food and Drug Administration's approval to manufacture and market Isotretinoin capsules, a generic version of Hoffman LaRoche's Accutane.
In a shocker, the US Food and Drug Administration has discovered the presence of mice, ants and cockroaches in food served on airlines in the country.
Rise in raids on illicit drug manufacturing units, alongside arrests for the production, sale, or distribution of spurious or adulterated drugs.
To be called Central Drug Administration or National Drug Authority, it will have 10 sub-authorities to deal with areas like cosmetics, blood safety, medical equipment, etc.
Acting swiftly on the controversy regarding illegal drug-coated stents, the Maharashtra Food and Drug Administration has asked all stent manufacturers and importers to get valid licenses within the next two months from the Drugs Controller General of
The move assumes significance because a go-ahead from the US Food and Drug Administration for the new unit in Visakhapatnam is likely to give a huge boost to the company's revenues in upcoming quarters.
Westlife Foodworld, fast-food chain McDonald's operator in West and South India, on Tuesday said food safety regulator FSSAI has verified the cheese used by it and is now allowed to use the word cheese in the name of its products. Additionally, an independent NABL (National Accreditation Board for Testing and Calibration Laboratories) has also confirmed that Westlife Foodworld uses authentic cheese in its food preparation and not cheese analogues or substitutes, its managing director Saurabh Kalra said.
