The US Food and Drug Administration (USFDA) recorded a significant decline in serious regulatory findings at Indian drug manufacturing facilities between January and December 2025. Data reveals that 'official action indicated' (OAI) cases - the most severe classification - nearly halved over the past year.
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.
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.
According to the chairman, there will be an annual loss of Rs 100 crore due to the MHRA alert on Waluj plant
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.
Ankleshwar plant is the third such facility to face action
FDA had also issued warning letters to Ranbaxy's Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms.
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).
While the US health regulator did not specify details for issuing the alert, it said 'detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices'.
In March, the FDA had issued an import alert, banning formulations and active pharmaceutical ingredients from the factory.
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.
Hospitals to recover from sluggish Q3; diagnostics' growth rate at pre-Covid levels.
Benchmark BSE Sensex rose by 160 points on Thursday in choppy trade following gains in select banking and auto counters amid mixed global cues. The 30-share index gained 160 points to settle at 62,570.68 as 13 of its components advanced while 17 declined. The barometer opened lower but later gained momentum to touch a high of 62,633.56 in the day's trade.
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.
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
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The company had in May announced that the US Food and Drug Administration had issued an import alert on its Waluj facility, which makes injectables and solid dosages.
Wockhardt might be headed for another crisis, as it has come under the scanner of US health regulator.
Import alert on Ranbaxy's Mohali unit; Strides' injectible arm gets warning letter
The country's drug companies have attracted the highest number of enforcements from the American drug regulator in 2013, a year that has seen the US Food and Drug Administration turning stricter to ensure compliance levels and quality of medicines.
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.
The company had posted a consolidated net profit of Rs 323.31 crore (Rs 3.23 billion) in the same period last fiscal, Wockhardt Ltd said in a filing to the Bombay Stock Exchange.
DCGI, health ministry initiate dialogues with foreign regulators, try to understand global best practices
Ranbaxy Laboratories is recalling 29,790 blister packs of anti-allergy drug in the US, manufactured by its arm Ohms Laboratories, due to defective packaging.
Last month, the US Food and Drugs Administration had placed Wockhardt's facilities in Waluj near Aurangabad on import alert, barring supply of various products from these facilities to the US.
Recently, Ranbaxy and Wockhardt too were hauled up.
The news that exports to the US will not restart before next year as well as the September quarter performance are sentiment dampeners.
The Indian Pharmaceutical Alliance has approached regulator for a dialogue to understand the concern raised by it
This is not just a Ranbaxy or Wockhardt problem, says K Satish Reddy
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes
US drug regulator's fiat on Mohali factory, after strictures on the two other major Indian units, has numerous negative implications.
'Movement of naval forces at sea is often more than just perfunctory deployment -- reading the messages that they send is important,' alerts Vice Admiral Premvir Das (retd).
Ranbaxy's US factory, Ohm Laboratories, is learnt to have got a clean chit from the American regulator. This US facility was under surveillance of the Food and Drug Administration (FDA) since the end of 2012.
The move comes in the wake of many facilities of Ranbaxy in India being barred by the US Food and Drugs Administration for supplying medicines to the US.
The weakness in the stock was because of inspections by the American drug regulator at its Halol plant in Gujarat which resulted in eight observations, as well as a downward revision of speciality drug payoffs.
Import alert on unit-6 facility might be lifted by FDA by Sept.
Company had earlier received an import alert in February this year from the US Food and Drug Administration.
Its Waluj manufacturing facility in Maharashtra failed to meet the good manufacturing norms prescribed by the UK drug regulator.
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.
Dr Reddy's gets warning from US health regulator
The company has received a communication from the Medicines and Healthcare Products Regulatory Agency, United Kingdom, whereby the agency has decided to withdraw the previously issued GMP Certificate to the company's manufacturing facility situated at Kadaiya, Nani Daman, Wockhardt said in a filing to the Bombay Stock Exchange.
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