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.
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
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.
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.
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.
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.
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.
Rising Indian driver Jaden R Pariat has been invited to the Ferrari Driver Academy (FDA) selection trials.
This is not just a Ranbaxy or Wockhardt problem, says K Satish Reddy
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.
A report was positive for the presence of two dead and one live insect, FDA Commissioner Uttam Khobargade said in Mumbai.
Rise in raids on illicit drug manufacturing units, alongside arrests for the production, sale, or distribution of spurious or adulterated drugs.
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.
Whistle-blower Dinesh Thakur will speak on Made-in-India drugs at an event in Washington.
The new travel advisory came in the wake of the significant improvement in Covid situation in India.
He is currently on a two-day swing to the crucial State of Iowa. On January 15, Iowa would kick off the 2024 Republican presidential primary season.
'There is no reason why we should break this business up.'
Analysts have turned cautious on Cipla, as the recently issued form 483 by the US FDA with eight observations to its Pithampur (Indore) plant is expected to delay the launch of the company's key generic - Advair - in the US. The Indore plant contributes around 5 per cent of Cipla's revenues, as per analysts' estimates. While the respiratory product, which is used to treat asthma, had cleared the pre-approval inspection of the regulator at the Indore unit; the final approval could be unlikely until the company clears the recent US FDA observations, analysts say.
Sun Pharmaceutical's acquisition of Ranbaxy has received final approvals.
US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.
Nestle, the world's largest food company, is seeking to defend its reputation in India after it pulled Maggi noodles from stores.
In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.
Margaret A Hamburg, the first commissioner of the US Food and Drug Administration (US FDA) to visit India officially, will meet heads of major domestic pharma companies such as Ranbaxy, Wockhardt, Cadila Healthcare and Lupin in New Delhi.
India on Monday raised serious concerns over the USFDA's audit inspections of Indian pharma companies and 'disproportionate penalties' in some instances and said it would submit a discussion document on the issues to the US.
'Rolling out the vaccine is not a major challenge in India.'
Mutual funds (MFs) are betting on a turnaround in the healthcare sector to boost returns but are divided on the prospects of the information technology (IT) sector amid uncertain growth outlook. At the end of June, all of the top 20 fund houses were overweight on the healthcare sector vis--vis the sector's presence in the BSE 200 index, shows a report by Motilal Oswal Financial Services (MOFS). In the case of the IT sector, only six of the 20 fund houses had overweight positions.
When last month's advisory was issued, India was struggling with a second wave of the pandemic with more than 3,00,000 daily new coronavirus cases being reported.
As part of the charm offensive, New Delhi has invited global regulators -- including the FDA -- to visit Indian production units to get first-hand evidence of measures taken to ensure the quality of locally manufactured generics.
The United States has so far allocated only 7.5 million doses of Covid vaccines to India, which is not enough, a top Indian-American Congressman said while urging the Biden Administration to do more.
