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.
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).
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.
The present and past Olympians of the country will get a platform to air their grievances with the formation of Olympian Association of India (OAI), in New Delhi, on Monday, says IOA Secretary General Randhir Singh.
The Olympians Association of India (OAI) has advised bollywood star Shah Rukh Khan to disassociate himself from the IPL and rather promote a sport that brings glory to the nation.
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.
Altman said he was "looking forward" to returning to his previous role at the AI firm.
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.
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.
OAIS would start the taxi service in Mumbai and Bangalore with 100 cars each and expand the fleet in phases as per instructions by the local authorities in the two metros. The investment for launching the taxis in Mumbai and Bangalore would be Rs 10-12 crore (Rs 100-Rs 120 million).
Assam government has given a firm assurance to the Olympic Association of India to hold the forthcoming 33rd National Games under tight security to keep the banned United Liberation Front of Asom militants at bay.
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
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