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.
Quarterly earnings, macroeconomic data announcements and global trends will drive the Indian stock markets in a holiday-shortened week, analysts said. Stock markets would remain closed on Wednesday for the Guru Nanak Gurpurab holiday.
Indian drugmakers Eris Lifesciences, Wockhardt and Lupin are prepping to cash in when Danish company Novo Nordisk bows out of the human insulin pen market by the end of this year and creates an opportunity estimated to be worth Rs 600-800 crore in the domestic market. Some self-use disposable pens are pre-filled with insulin and others can be reused with new cartridges.
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.
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.
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.
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 domestic stock market this week would monitor the geopolitical developments after India and Pakistan reached an understanding to stop military actions, analysts said. Moreover, macroeconomic data announcements, Q4 earnings, trading activity of foreign investors and global market trends are also likely to influence sentiments, traders said.
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.
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.
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.
From Asgard's naughtiest imp to Arsene Lupin's biggest worshipper in Paris, Sukanya Verma notes OTT is full of curious options this week.
The company will now focus on specialty products in Japan; it is open to inorganic opportunities, especially in India.
While domestic sales in the second quarter are expected to be weak for major players, Lupin is likely to outperform the pharma sector on the back of a growing chronic portfolio.
Pharma company Lupin Ltd will discontinue its Rofecoxib formulation, a painkiller, following the government ban on the drug after evidence showed its prolonged use led to increased risk of heart attacks.
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.
The duo bought additional shares in pharmaceutical companies Lupin and Jubilant Life Sciences, along with Agro Tech Foods and NCC during Q2FY21
Drugmaker Lupin Ltd said on Monday it has signed a licensing agreement with leading Italian pharmaceutical company ItalFarmaco for marketing its cardiovascular critical care product in the Indian market.
Once a difficult market to crack, in recent years, China has relatively opened up its drug market, enacting reforms and speeding up approval time.
Check out some of the stocks that will react on the basis of their numbers in the near term.
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.
Teva Women's Health filed a suit this week in the US District Court for New Jersey, claiming that Lupin had filed an abbreviated new drug application with the US Food and Drug Administration, which infringes the patents of Seasonale, its oral contraceptive that limits the number of menstrual periods women have in a year.
The recent recalls come amid increased FDA scrutiny of medicines produced in India.
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.
Pharma shares were the top gainers led by Lupin after the company received EIR from USFDA for its Goa facility
Adani Power will also be dropped from the S&P BSE 100 index
The pharmaceuticals sector is expected to post a revenue growth of around 13.5 per cent and a net profit growth of 30.3 per cent for the third quarter of 2023-24 (FY24), riding on the approval for niche drugs in the US market, fall in raw material prices and correction in shipping rates. In the healthcare segment, hospitals are expected to post revenue growth of 13 per cent during the coverage, while net profit growth would be around 37 per cent, ICICI Securities said in a note. However, the performance may not be comparable on a sequential basis due to the offset of the festive season in Q3FY24, the analysts noted.
Stock markets will be driven by quarterly earnings by index majors, global trends and the RBI's interest rate decision this week after digesting news on budget proposals and US Federal policy outcome, say analysts. The trading activity of foreign investors and the movement of global oil benchmark Brent crude would also dictate trends in equities. "On the domestic front, the MPC (Monetary Policy Committee) meeting is scheduled from February 6-8.
The Indian pharmaceutical market (IPM) grew 6.8 per cent to touch a turnover of ~1.93 trillion in calendar year 2023, despite volumes going down marginally by 0.9 per cent. This indicates the price increase has been the major growth driver. Growth in the moving annual turnover (the previous 12 months' turnover) in December was 5.1 per cent and that in new product introduction 2.6 per cent, while volumes dipped 0.9 per cent, leading to an overall growth rate of 6.8 per cent, according to the data from market research firm Pharmatrac.
At present,Satish Khanna he is associated with companies such as Fullife Healthcare, Kagashin, Hi Tech, Provivi, Status Quo and Concord.
Asian markets were trading mixed with the Nikkei gaining after the US dollar strengthened against the yen.
Hospitals to recover from sluggish Q3; diagnostics' growth rate at pre-Covid levels.
The Securities and Exchange Board of India (Sebi) plans to roll out a new regulatory framework for registrar and transfer agents (RTAs) - the market intermediaries responsible for the record-keeping of bondholders and shareholders after a company offers securities to the public. The markets regulator, sources said, is considering a multifold increase in net-worth requirement, a move that may dissuade companies from having in-house RTAs for record-keeping. At present, the minimum net worth required for RTAs is Rs 50 lakh and Rs 25 lakh in categories I and II, respectively.
A mixed global trend and weakness in rupee influenced the sentiments during the day.
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