At the heart of this debate is Section 3(d) of the Patents Act, a safeguard designed to prevent drugmakers from extending monopoly protection through trivial modifications to existing medicines.
Artificial intelligence (AI) is no longer a side conversation for Indian pharma. It is fast becoming central to how drugs will be discovered, made, and supplied. Along with that shift comes a sharper focus on innovation, on the one hand, and quality and trust, on the other.
Buoyant domestic sales are expected to lift revenues for pharma companies by 8-11 per cent in Q3FY26, even as declining generic Revlimid (cancer drug) sales in the US remain a key drag. Most brokerages forecast a modest 2-4 per cent growth in profit after tax (PAT) for the quarter. Hospitals and diagnostics companies, meanwhile, are likely to post much stronger numbers, with revenues seen growing 20-22 per cent year-on-year (Y-o-Y).
In November, six primary market issuances accounted for more than 13,000 crore of net equity investments by MFs.
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.
In another development, leading Japanese drug maker Takeda Pharmaceutical sued Ahmedabad-based Torrent Pharma in the US for infringing seven patents covering its flagship diabetes drug, Actos. Oracea (doxycycline) is the only US Food and Drug Administration approved oral drug to treat rosacea -- a skin disorder in the face with inflammation, skin redness and spider veins.
Abbott and Astellas dismiss Omnicef violation case.
Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.
Cephalon, a US-based drug maker, has filed a lawsuit against Lupin Ltd and its US subsidiary Lupin Pharmaceuticals for challenging the patents on its sleep disorder drug Nuvigil.
US-based pharma giants Eli Lilly and company has filed a case against two Indian drug makers, Aurobindo Pharma and Lupin alleging infringement of patent of its anti-depressant drug Cymbalta.
Lupin Pharmaceuticals Inc, the wholly owned subsidiary of Lupin, has entered into an alliance with Cornerstone BioPharma Inc.
Indian Pharmaceutical Alliance (IPA) on Friday said US President Donald Trump's move to impose 100 per cent import tariffs on pharmaceutical drugs from October 1 will impact only patented and branded products, not generic medicines.
Lupin Pharmaceuticals Inc, a wholly owned subsidiary of Mumbai-based Lupin Ltd, has forayed into the US pediatric segment by inking an agreement with Allergan Inc to promote 'Zymar' in that country.
The company has received a tentative approval for the company's abbreviated new drug application for Eszopiclone tablets from the US Food and Drug Administration, Lupin said in a filing to the Bombay Stock Exchange.
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The company's US subsidiary, Lupin Pharmaceuticals Inc has launched its Ciprofloxacin for oral suspension in the US market in the strengths of 5 g/100 mL (250mg/5 mL) and 10 g/100 mL (500 mg/5 mL), Lupin said in a statement.
Lupin Pharmaceuticals has bought the US marketing rights of cholestrol-lowering drug Antara and related assets from bankrupt American entity Oscient Pharmaceuticals for $38.61 million
Concerns over weakening demand for Indian pharmaceutical (pharma) drugs in the US - their largest export market - have weighed heavily on investor sentiment this year. While the Nifty 50 has gained 6.02 per cent year - to - date (as on September 15), the Nifty Pharma index has declined 5.18 per cent, National Stock Exchange data shows.
The company's US-based subsidiary Lupin Pharmaceuticals Inc has launched its generic Rabeprazole Sodium delayed-release tablets, 20 mg in the American market after having received approval to market it from the US Food and Drug Administration, according to a statement by Lupin.
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.
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 company has received final approval for its supplemental New Drug Application (sNDA) for Antara (Fenofibrate) capsules in 30 mg and 90 mg strengths from the United States Food and Drug Administration (USFDA), Lupin Ltd said in a statement.
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.
Indian drugmakers supply 47 per cent of the generic medicine requirements in the US, and tariffs would have increased prices in the US domestic market for patients, who are already dealing with drug shortages.
Indian pharmaceutical companies may have units abroad as part of "distributed manufacturing" across various locations, according to industry veterans. This may come about over the next five to 10 years.
"The acquisition will enable us to step up our strategic initiative in the CRAMS segment," Lupin Chairman Desh Bandhu Gupta said.
Indian pharma company Lupin has acquired 80 per cent stake in Kyowa Pharmaceutical Industry (Kyowa), one of the top 10 generic pharmaceutical companies in Japan, for an undisclosed amount.
The company will now focus on specialty products in Japan; it is open to inorganic opportunities, especially in India.
Analysts are expecting pharmaceutical companies to post sales growth of 10-11 per cent in the second quarter this financial year while the Ebitda (earnings before interest, tax, depreciation, and amortisation) margins are anticipated to improve by about 110 basis points. Ebitda improvement will be led by lower input costs because prices of active pharmaceutical ingredients (APIs) are 5-15 per cent lower year-on-year (Y-o-Y). Axis Capital said sales growth would be around 10 per cent, of which growth in the India market would be 11 per cent or so.
United States-based drug major Forest Laboratories has sued three Indian pharmaceutical companies -- Orchid Chemicals and Pharmaceuticals, Lupin and Wockhardt -- along with four other manufacturers for coming up with imitations of patented drugs in the US.
Lupin will fund the buy through $100 mn cash reserves and a bridge loan.
Lupin Ltd will set up a Rs 100-million plant for manufacturing Lovastatin, a cholesterol lowering active pharmaceutical ingredient, at the company's facilities in Tarapur, Maharashtra.
The company said it has acquired 100 per cent equity stake in Laboratorios Grin, Mexico.
Once a difficult market to crack, in recent years, China has relatively opened up its drug market, enacting reforms and speeding up approval time.
Pharmaceutical company Lupin Ltd and US-based Cornerstone BioPharma Inc have entered into a $10.5 million licensing agreement
The duo bought additional shares in pharmaceutical companies Lupin and Jubilant Life Sciences, along with Agro Tech Foods and NCC during Q2FY21
Research and development (R&D) spending by BSE 100 companies has grown steadily, rising from 0.89 per cent of revenue in FY20 to 1.32 per cent in FY24, averaging around 1 per cent over the period in-between, according to data compiled from Bloomberg and company annual reports. Also, these companies more than doubled their R&D spending in absolute terms over these five years: From Rs 25,041 crore to Rs 63,072 crore. While this reflects a prioritisation of innovation, corporate R&D investment remains relatively conservative.
There is a need to incentivise R&D investments, offer corporate tax concessions and establish an effective intellectual property rights regime in order to push the growth of domestic pharmaceutical industry, as per the industry bodies. Outlining the sector's wish list for the upcoming Union Budget, Organisation of Pharmaceutical Producers of India (OPPI) Director General Anil Matai urged the government to explore methods to incentivise R&D investments, such as deductions on R&D expenses, research-linked incentives for MNCs, and corporate tax concessions.
Pfizer, the world's largest pharmaceutical company, has filed patent infringement suits against Sun Pharma, Wockhardt Ltd and Lupin Ltd to prevent these companies from securing marketing approvals for the generic equivalents of its high-selling neuropathic pain management drug Lyrica in the United States.
Leading pharmaceutical company Lupin Ltd on Wednesday said it was looking at acquiring companies and brands in a bid to strengthen its paediatric business in the US market.
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