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.
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Amid controversy over USPresident Donald Trump's comments linking the use of Tylenol and other related paracetamol products by pregnant women to autism in children, experts and industry executives say that since India's export of the drug to the US is less, it will hardly affect the country's pharma exports to America.
Altaf Ahmed Lal, country head of the US Food and Drug Administration (US FDA) in India, has quit and so have a few other key officials at the American drug regulator's India office.
The Central Drugs Standard Control Organisation (CDSCO) will conduct testing, inspection and auditing of cough syrup manufacturers.
Sandwiched between a Hero MotoCorp showroom and a shop that hires out cooking utensils is a small, dingy building that's been locked up. The non-descript two-room building is a manufacturing unit of Sresan Pharmaceuticals, the pharma company made its Coldriff cough syrup that has allegedly killed 25 children in Madhya Pradesh.
Madhya Pradesh Deputy Chief Minister Rajendra Shukla confirmed that 20 children have died after consuming contaminated cough syrup. An investigation is underway, and action has been taken against the manufacturer, doctor, and FDA officials.
The Indian pharmaceutical industry is likely to benefit from a major wave of patent expiries in the US, as small-molecule drugs worth $63.7 billion are expected to go off-patent between 2025-29, a 65 per cent rise over the previous five years, according to a report by Antique stock broking limited.
A non-cognisable offence is being filed against Shiv Sena MLA Sanjay Gaikwad in connection with the assault of a canteen worker at the MLA hostel. The incident sparked outrage after a video surfaced showing Gaikwad assaulting the worker over allegedly stale food.
'We recently launched Yesintek in the immunology space.'
Indian pharmaceutical companies have made major strides in adhering to stringent US Food and Drug Administration (USFDA) norms in 2024, with data suggesting a decline in the number of adverse classification outcomes of inspections across biologics, drugs, and devices. In 2023, the USFDA conducted 225 inspections, which led to 18 cases of Official Action Indicated (OAI) and 117 cases of Voluntary Action Indicated (VAI).
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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.
After falling 17 per cent since the start of the year to its March lows, the stock of the country's largest pharmaceutical (pharma) company, Sun Pharmaceutical Industries, has clawed back nearly half of those losses. Recent acquisitions, a favourable court ruling in the case of the hair loss drug Leqselvi, an edge over peers owing to its specialty portfolio, and a diversified global presence have supported the recovery.
US, the largest market for Indian shrimp exporters, is peeved over the use of banned antibiotics.
It is one of 42 drug-making factories in India that the FDA has banned in recent years
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
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.
Maharashtra's Food and Drugs Administration on Wednesday argued in the Bombay High Court that Nestle India.
Formal warning to Indian unit of deficiencies noted during inspection at facility near Chennai; firm says will remedy
Wockhardt MD Murtaza Khorakiwala said his firm had responded to the FDA's observations but declined to give details.
Since 2013, the FDA has banned around 30 Indian drug manufacturing units for various violations
FDA had cancelled Ranbaxy's approvals to launch generic Nexium, Valcyte
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
Rise in raids on illicit drug manufacturing units, alongside arrests for the production, sale, or distribution of spurious or adulterated drugs.
The US Food and Drug Administration has seized drug products manufactured by Caraco Pharmaceutical, at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom, the US FDA said on Thursday. The FDA seeks to immediately stop Caraco from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements, it added.
Inspections only in domestic authorities' presence, visiting US drug regulator told
Uttar Pradesh Food and Drug Authority (FDA) says it has found excess lead in the Yippee noodles of domestic giant ITC.
The FDA Commissioner Margaret Hamburg is slated to travel to India soon.
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.
Rising Indian driver Jaden R Pariat has been invited to the Ferrari Driver Academy (FDA) selection trials.
Indian drug firms continue to work closely with the FDA, and most have also appointed consultants to help them grasp the regulatory minutiae in the US.
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
Recently, Ranbaxy and Wockhardt too were hauled up.
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
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.
Earlier, Jaslok Hospital had issued an advisory to its doctors to avoid prescribing drugs manufactured by Ranbaxy.
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.
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