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.
The US Food and Drug Administration's (USFDA)'s new draft guidelines aimed at speeding up and reducing the cost of developing biosimilars - lower-priced, near-replicas of complex biologic medicines - could significantly benefit Indian biotech companies.
Most first-time investors may be better served by diversified options such as flexicap or multi-cap funds, which already hold pharma and healthcare stocks.
At present, there is no provision under Drugs Rules, 1945 to address issues of wrong information to obtain regulatory approvals.
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).
Any potential tariffs on pharmaceutical imports into the US are unlikely to impact the credit profiles of Indian firms except for a short-term pricing blip, according to a report by India Ratings and Research (Ind-Ra). The report stated that the US generics market contributes around 35 per cent to the total revenue of the leading Indian pharma firms.
India's pharmaceuticals and medical devices industries are still hopeful that trade negotiations with the US could cut a fairer deal for both sides, after President Donald Trump announced a 25 per cent tariff rate on India on a social networking platform without divulging the finer details.
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.
Mumbai-based pharma major Wockhardt, which is gearing up to launch its promising antibiotic candidate Zaynich soon, on Friday announced a shift in its United States (US) operations. The Indian pharma giant revealed that it has decided to exit the generics pharmaceutical segment in the country.
'We are looking at what kind of products, diagnostics or other solutions we can offer to become a well-rounded player in a particular disease area globally.'
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.
'We recently launched Yesintek in the immunology space.'
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.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
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.
India is home to more than 100 million diabetics, and the demand for anti-diabetic drugs is on the rise -- the Rs 20,611 crore anti-diabetic drug market in India is growing at 9 per cent or so.
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.
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 registering a net profit of Rs 25.1 crore in Q3FY25 and consolidated revenues growing by 7 per cent on a like-for-like basis, Siddharth Mittal, chief executive officer (CEO) and managing director, Biocon, told Sohini Das/Business Standard in a virtual interaction that local manufacturing in the US is a trade off between cost and qualifying to do business there.
Orchid Chemicals & Pharmaceuticals Ltd said USFDA was approved by USFDA.
The FDA issued the letter on October 15, and has given the company 15 days to respond.
Pharma major Orchid Chemicals & Pharmaceuticals on Monday said USFDA has completed inspection of its state-of-the-art formulations facility located at Irungattukottai in Chennai.
Wockhardt said it is launching the product immediately in the US market.
A global policy would reward firms which strive for higher quality.
The Ahmedabad-based Claris Lifesciences has received the United States Food & Drug Administration clearance for its sterile injectable manufacturing facility near Ahmedabad.
Lupin Ltd said on Friday it has received the approval from the USFDA for its Abbreviated New Drug Application for Cefdinir Suspension 125mg/5ml.
Ranbaxy Laboratories has received approval from USFDA for manufacturing and marketing Doxycycline tablets in the US market.
Lupin Ltd on Thursday said it has received USFDA approval for its Abbreviated New Drug Application for multiple strengths of antibiotic Cephalexin capsules.
Sun Pharmaceutical Industries said it has received approval from US health regulator to market generic Clarinex tablets and Tiazac capsules, used in treating nasal allergies and hypertension, respectively, in the American market.
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'.
Hyderabad based Dr Reddy's Laboratories has received approval from the US Food and Drugs Administration for multiple strengths of anti-diabetes drug glimepiride tablets.
Shares of Ranbaxy Laboratories on Friday slumped as much as 20 per cent in the morning trade after the USFDA prohibited the company from producing and distributing drugs for the American market from its Toansa plant in Punjab.
The regulator has given the company 15 days to take corrective measures and report back to it.
Lupin Ltd received marketing approval from the US Food and Drug Administration to market its Cefixime oral suspension drug in the US, Ranbaxy Laboratories has received approval to market two strengths of Cefprozil tablets and Cefprozil powder.
Cadila Healthcare Ltd has received approval from USFDA for marketing anti-coagulant, Warfarin tablets.
Last year, the USFDA had banned 30 generic drugs produced at Ranbaxy's plants at Poanta Sahib.
Most of the pharma units are failing in documentation, and validation processes, and many don't have full-fledged quality control laboratories.
Pharma major Ranbaxy Laboratories has set aside Rs 257.4 crore (Rs 2.57 billion) towards the financial impact of a US ban on import of products made at its plant at Toansa.
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.
The United States Food and Drug Administration has given tentative approval to the fixed-dose combination drug products lamivudine and zidovudine tablets -- manufactured by Aurobindo Pharma Ltd.
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