DRUG MANUFACTURING COMPLIANCE
USFDA issues Form 483 with 8 observations to Aurobindo's Telangana unit
Aurobindo Pharma faces scrutiny. The US FDA inspected its Bachupally, Telangana plant. The inspection occurred between August 25 and September 5. Following the inspection, the US FDA issued a Form 483. The form contained eight observations. Aurobindo Pharma stated the observations are procedural. The company plans to respond to the US FDA within the given timeframe.
Biocon shares rise 2% after USFDA concludes inspection with 5 observations
Biocon shares: The inspection, carried out from August 26 to September 3, 2025, spanned multiple operational areas such as drug substance manufacturing, analytical quality control labs, microbiology facilities, and warehouses.
A GST 'Budget' for aspiring citizens
The Indian government has implemented significant economic reforms. These reforms include GST rate rationalization and structural changes. The aim is to boost India's competitiveness and economic growth. Rate reductions on essential goods will benefit citizens. This will lead to increased consumption and GDP growth. Simplified tax structure and trade facilitation are also key components. MSMEs will experience easier business operations.
GST 2.0: Tax cuts offer hope, but not a cure for Trump’s 50% tariff blow to exporters
The GST Council, chaired by Finance Minister Nirmala Sitharaman, on Wednesday rationalised the tax structure by moving most items from the 12% and 18% brackets to 5%.
Stricter shelf life rule a bitter pill to swallow for pharma companies
A new regulation by the CDSCO mandates that exported drugs must have at least 60% shelf life remaining, causing significant losses to the Indian pharma industry. Manufacturers are now forced to destroy stocks to comply with this rule. The industry is urging for a revision, citing unnecessary losses and questioning the need when importing countries permit shorter shelf lives.
Can Granules India leverage its strong product pipeline to offset recent profit declines?
Granules India's stock shows a slight recovery despite reporting lower profits in the June quarter. Investors are positive about the company's product pipeline and business stabilisation. The company anticipates better growth in FY27. Approvals for six products in Europe are awaited. Granules focuses on CNS, ADHD, and oncology products. The Gagillapur facility remediation is progressing well with US FDA.
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These mousse and ‘whipped’ sunscreens are not safe, FDA warns five companies; check if your sunscreen is on the list
The FDA in the US has issued warnings to several mousse sunscreen brands for failing to prove their safety and effectiveness. There are also concerns about misleading packaging. Companies have a limited time to respond, and if they don’t, their products might be taken off the shelves. The FDA also issued a warning in a post on X for consumers to “beware of sunscreen products in mousse form because they might not be effective.”
Trump tariffs to push up US drug prices, won’t change India’s pharma growth playbook: Pharmexcil
India’s pharma strategy is long-term and not reactive to tariffs, said Pharmexcil.
Obesity drugs gain weight in labs: Several clinical trials by big and small pharma cos underway
Driven by the success of Wegovy and Mounjaro, numerous pharma companies are developing anti-obesity drugs, with over 170 in various stages. While giants like Novartis and GSK are cautious, Eli Lilly and Novo Nordisk lead the race. Research expands beyond GLP-1 targets, exploring oral options and addressing conditions like MASH and CVD.
Consumers are now actively seeking generic substitutes for branded medicines: Sujit Paul, Zota Healthcare
Today’s consumers view quality-tested generics as reliable and effective alternatives to branded medications, says Sujit Paul, Group CEO, Zota Healthcare.
Are fundamental tailwinds a stronger play than volatile markets? 6 mid-cap pharma stocks with an upside potential of over 22%
The Indian pharmaceutical sector has undergone significant changes over the past decade, marking a transition from a period of consolidation and valuation readjustment to one where the focus has shifted towards more sustainable and compliant operational practices. This transformation is a shift in the strategic approach adopted by pharma companies. Historically, the expansion strategies of many companies were driven by optimistic PowerPoint presentations that forecast market growth. Then came the reality check, where the US FDA made all of them relook at what they were doing. After a long time, some of the mid-sized players have also reached an inflection point where it might be time to look at them without the bias of the past.
India-UK FTA prescribes a booster dose for Indian pharma and medtech exports
The India-UK FTA is poised to significantly boost India's pharmaceutical and medical device sectors. Tariff relief and streamlined regulations are expected to drive exports, granting easier access to the UK market. Indian companies, particularly in generics and biosimilars, can anticipate expanded market presence and faster product approvals.
Brookfield, EQT close in on Gland Pharma, but rising stock a pain
The Chinese parent has diversified investments that range from healthcare to football clubs, asset management, banks, estate, hospitality, fashion and industrials. The conglomerate has a presence across the pharma value chain from manufacturing to diagnostics and medical devices. Shanghai Fosun Pharmaceutical Co. had acquired an 86% stake in Gland Pharma in 2016 from KKR for a record deal value of $1.26 billion.
Dr Reddy's gets seven observations from USFDA for Andhra plant
Dr Reddy's Laboratories faces scrutiny. The USFDA issued a Form 483 after inspecting their Srikakulam facility. The inspection, which occurred in July 2025, revealed seven observations. These observations relate to potential violations of the Food, Drug and Cosmetic Act. Dr Reddy's plans to address these concerns promptly. The company aims to resolve the issues within the given timeframe.
Wipro’s Q1 report; Former Nexus MD’s new fund
Happy Friday! IT major Wipro reported an 11% rise in net profit, just ahead of Street expectations. This and more in today’s ETtech Morning Dispatch.
Pills & Profits: Can India's pharma sector handle Trump's planned 200% tariff dose?
India's pharmaceutical sector, a global leader in generic medicines and vaccines, faces a significant challenge with proposed US tariffs potentially reaching 200%. This move threatens India's competitiveness in its largest export market, the US, impacting major firms and potentially forcing a shift towards diversification into other regions like Europe and Southeast Asia. The sector contributes significantly to India's GDP.
Pharma lobby flags 'cumbersome' export rule, seeks change
Pharma lobby groups are urging for changes to the centralized no-objection certification (NOC) for drug exports due to a significant export decline. The requirement for approvals from importing countries or Indian regulators has increased trade diversions. Industry experts are calling for a review of the provision, citing burdens on exporters and potential stifling of innovation, especially for MSMEs.
Sun Pharma says working towards full regulatory resolution at 3 plants facing USFDA action
Sun Pharma focuses on compliance across its manufacturing units. It aims for full regulatory resolution at facilities facing USFDA action. The company has completed CAPA implementation at Halol. CAPA implementation is in process at Mohali and Dadra. R&D investment is expected to be 6-8% of sales. The company anticipates mid to high single-digit consolidated topline growth in FY26.
Delhi HC seeks regulator's reply after PIL questions Ozempic, Mounjaro nod
The Delhi High Court has instructed India's drug regulator to address concerns about the approval process for drugs like Ozempic and Mounjaro. A public interest litigation raised questions about safety data and clinical trials. The court wants the regulator to consult experts and manufacturers. Ozempic is available in the grey market, though not officially sold in India.
After a robust march, pharma exports slow
India's pharmaceutical exports experienced a modest 1.5% growth in April and May, following a significant 31.2% surge in March driven by year-end targets and anticipation of US tariffs. Despite pricing pressures and regulatory scrutiny, shipments to the US rose 20.4% to $10.5 billion.
Analysts betting on these four pharma, hospital stocks due to Indian healthcare sector’s strong growth prospects
The healthcare sector, particularly pharmaceuticals and hospitals, have demonstrated strong performance in the March 2025 quarter, with revenue growth exceeding that of Nifty 500 companies. Even though the pharmaceutical segment faces challenges in the short-run, due to potential US tariffs and other factors, long-term prospects remain positive. There has been growth in the hospital sector as well, fueled by rising lifestyle diseases and increased healthcare accessibility.
Pharma companies may lose licence if drugs fail tests
The health ministry is considering strict actions, including immediate license suspensions, for drugmakers producing substandard drugs. This proposal follows concerns about quality control and aims to safeguard public health. Pharma lobby groups have raised objections, citing technical issues and questioning the standards of government testing laboratories, while advocating for a stronger recall mechanism.
Go on, pop the innovation pill: ₹5,000 cr push signals India’s shift from copy to create
India's pharma sector is poised for innovation-led growth, fueled by patent expirations and government support. The ₹5,000-cr PRIP scheme aims to attract significant R&D investment, while companies like Zydus and Sun Pharma invest in new drug discovery. MNCs are partnering with Indian firms, and initiatives like Jan Aushadhi Kendras are improving access to affordable medicines, creating a dynamic landscape.
Hims stock tanks over 20% after Wegovy deal collapse — why Novo Nordisk’s breakup over weight loss drugs is shaking up Wall Street
Hims stock took a major hit after Novo Nordisk suddenly ended their Wegovy partnership, causing shares to drop over 20% in a single day. The breakup came after Novo raised concerns about Hims selling compounded semaglutide versions of its weight loss drug, Wegovy. This move follows the FDA's decision to remove semaglutide from the shortage list, tightening regulations. The fallout is shaking investor confidence and raising legal questions.
Granules India shares in focus after US FDA flags observation at Telangana API facility
The US FDA issued a Form 483 observation for its Telangana API facility. While not a final non-compliance verdict, the company plans a timely response. The facility is key for paracetamol API production. The stock has fallen 19% YTD but remains a ‘Strong Buy’.
1,394 batches of drugs recalled in 2023-24 for failing quality tests: Minister
Drug recalls due to failed quality tests have seen a concerning rise in India, from 950 batches in 2019-20 to a provisional 1,394 in 2023-24. Over 2,900 drug samples failed quality checks this year, with 282 deemed spurious or adulterated, leading to over 600 prosecutions.
CDSCO and state body conducting joint inspection of drug manufacturing units
A committee of two joint drugs controllers has been constituted at the CDSCO headquarters to monitor the process of inspection, reporting and subsequent action so as to ensure compliance with the Drugs and Cosmetics Act, 1940 and Rules, the statement said.
Drug regulator maps out new site inspection norms for safer medicines
According to some GMP experts, CDSCO’s proposed move may be different from the risk-based inspection system followed by the US Food and Drug Administration.
DCGI asked to check quality of drugs sold by Ranbaxy: Government
The government today said it has ordered the Drug Controller General of India (DCGI) to check the quality of drugs produced by Ranbaxy Laboratories.
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