GENERIC DRUG INDUSTRY
Indian pharma companies faked generic viagra data to gain approval, finds US FDA
FDA's June 18 alert revealed falsified data by Synapse Labs affecting generics like Umedica's Viagra. Europe had earlier warned. Insurers might change coverage. Both Massoud Motamed and Erin Fox highlight ingredient risks. Due to confidentiality, FDA hasn't disclosed all affected drugs, suspended sales, or done significant public outreach. Identified generics include Lupin's Lipitor and Aurobindo's risendronate.
India to make drugs for diabetes, obesity under PLI by 2026, says report
India plans to incentivize local manufacturing of GLP-1 drugs, crucial for treating diabetes and obesity, starting in 2026, as per a government official speaking to Reuters. These drugs, originally approved for diabetes treatment, are also used for obesity due to their ability to slow digestion and reduce appetite. Novo Nordisk's patent on semaglutide, a key ingredient in popular drugs like Wegovy and Ozempic, is set to expire in India by 2026. Indian companies are already preparing to manufacture these drugs under the government's production-linked incentive (PLI) scheme.
Indian Pharma exports: 'USD 10 billion opportunity up for grabs in off patent drug market by 2029'
A senior official of the Pharmexcil said drugs such as Merck's Pembrolizumab (Keytruda) whose revenue were at USD 25 billion and Bristol-Myers Squibb's Eliquis (Apixaban)-USD 12 billion, among others would be off-patented in the next few years.
Excited about gain in market share in US, says Biocon chief Kiran Mazumdar Shaw
Biocon Executive Chairperson Kiran Mazumdar Shaw say we've seen significant market share growth for our biosimilars in the US, exceeding our 20% global insulin market target sooner than expected. Demand has surged, especially for insulins, creating substantial opportunities.
High costs of orphan drugs: Patients pay the price for policy hurdles in India
India manufactures APIs for over 400 FDA-approved orphan drugs, but patients face high costs due to Indian pharmaceutical companies' reluctance to develop these drugs domestically.
Ozempic frenzy lures rich Indians to brave the gray market
People are going to great lengths to obtain popular weight-loss drugs. They are stashing injectables in their carry-on luggage, buying counterfeit formulas online, and importing boxes from Europe. The treatments have sparked extensive media coverage, fueling a high demand. According to Goldman Sachs Research, the anti-obesity medication market could hit $100 billion by 2030. In contrast, Indians have largely been observers in this global frenzy over the new weight-loss solutions.
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Expert panel to soon weigh plan to use generics for prescription drugs
An expert committee is set to discuss the feasibility of allowing generic substitutions for prescription drugs in India. The proposal has sparked a disagreement between the Indian Pharmaceutical Alliance (IPA) and the All India Drug Action Network (AIDAN). The IPA opposes the idea, arguing that it would lead to a surge of demand from trade channels, such as general pharmacy stores, which would not benefit patients.
Fundamental tailwinds are a stronger play than volatile markets? 5 Indian pharma stocks with upside potential of up to 31 %
There is no doubt that the market is going through a volatile phase and bears are once again telling the street to never write them off. Will this correction continue even longer ? It would probably be clear by the end of the day as the election result finally gets settled. Instead of focusing on how much nifty or bank nifty or any other index is down or up, focus on the fact that whether the sector or company is doing well and will it do well in future because the fundamental operating matrix of that sector has changed for better. Because volatile phases come and go, changes in the operating matrix don't happen every day. Pharmaceutical is one sector where there is a fundamental change taking place and it has happened after 8 to 10 years of restructuring and painful readjustment. So, it would be worthwhile to have them on watchlist and if the market remains volatile then it is a sector which probably has a higher probability of outperforming.
They just happen to be listed in India, what matters to them is global developments: 5 stocks from two sectors with upside scope of up to 29%
In the last month of volatility, there are some sectors which have shown a streak of out performance. They haven't fallen as much as nifty and have been able to keep their head above the water even on the worst of days. The reason, their bottom lines are more correlated to what is happening in the country or the continent in which they have exposure both in terms of sales and in some cases in manufacturing. So, one way to take global exposure is to have a look at these companies, also it is a sort of diversification in terms of exposure to the underlying economy. Because they are operating at a global level, their balance sheets are good and in some cases, they have been able to enter amongst the top companies of the world in their sector.
Biosimilars offering a great opportunity in growing market: Kewal Handa
The prices have really been coming down in terms of raw materials and particularly in APIs. There is a lot of stability there. China are also now trying to align themselves to the global market requirements and they are also very keen to see that their factories start producing at the scale they were doing prior to COVID.
Sun Pharma to pursue M&A, licensing to expand speciality business
Sun Pharma, India's leading pharmaceutical company, plans to pursue licensing and acquisitions as part of its strategy to grow its specialty business, according to a senior executive of the company. The executive noted that in recent years, Sun Pharma has been actively working on building a portfolio of products internally. Moving forward, the company intends to adopt a dual approach, combining both mergers and acquisitions with in-house product development.
Quest Labs stock debuts with 60% premium on NSE SME platform
Quest Laboratories made its debut on the NSE SME platform on Thursday, starting with a 60% premium. The stock opened at Rs 155, surpassing its issue price of Rs 97. Before its listing, the company's shares were trading at a premium of Rs 80 in the unlisted market.
From spices to steel to drugs, India's exports are being hammered
India's path to becoming a developed country hinges on boosting exports, as demonstrated by China's growth. Leveraging bilateral agreements and FTAs, India is expanding into new markets like Africa and Latin America. Yet, quality issues and trade restrictions pose challenges, such as recent bans on Indian spices in Hong Kong and Singapore. Additionally, green trade barriers like the EU's CBAM could impact key sectors like steel, potentially affecting Indian exports to the EU. Strengthening regulations and meeting global standards are crucial for India to realize its export potential.
Indian pharmaceutical industry set for major transformation: Dilip Shanghvi
At an annual meeting of the USA-India Chamber of Commerce in Boston, Shanghvi told a gathering of leading multinational drug makers about the "clear positive improvements" that are taking place in India. Sun Pharma itself has built a pipeline of over 10 specialty and innovative drugs in the US. It's done this through acquisitions of late-stage drugs in clinical trials and building commercial teams around them. For Indian companies that have grown by making copies of innovative drugs, gaining presence in innovative drugs is considered tough as this segment is dominated by giant corporations such as Pfizer, Novartis, Roche, Eli Lilly and Bristol Myers Squibb.
Dr Reddy’s, Sun, Cipla and Biocon look to recreate Ozempic magic in India
Doctors say patients come with specific queries regarding weight-loss drugs, which have become both the first preference and the last resort for some. “I would rather go for these short cuts that the pharma industry offers than go under the knife for my appearance,” says Rajput. The drugs — Wegovy and Ozempic — which have the same ingredient, semaglutide, are all the rage ever since entrepreneur Elon Musk tweeted about it.
Delhi HC upholds injunction against Glenmark Pharma
Sun Pharma Laboratories, a wholly-owned subsidiary of Sun Pharmaceutical Industries, and Glenmark are contesting over their right to use drug names “Istamet” and “Indamet”, respectively, which Sun Pharma finds to be deceptively similar and confusing.
Weight-loss medicines: Biocon eyes a $100 billion jackpot with weighty pivot
Weight-loss drugs: Biocon Ltd. is shifting focus to anti-obesity therapies as patents for key medications expire, leading to a surge in generic supply. The Bengaluru-based company secured UK approval for the first generic version of liraglutide injectible, positioning itself as a leader in this evolving market.
Domestic drug firms to witness 8-10 pc revenue growth in FY25: Report
Following the high base of 2023-24, the revenue growth momentum from the US and Europe markets is expected to moderate to 8-10 per cent and 7-9 per cent, respectively, Icra said. The markets are expected to witness a year-on-year expansion of 18-20 per cent and 16-18 per cent, respectively, in the current fiscal year, it added.
Sun Pharma recalls 55,000 bottles of generic drug from US market due to manufacturing norms violation
Sun Pharma is recalling 55,000 bottles of Febuxostat Tablets, in 40 mg and 80 mg strengths, from the American market due to manufacturing practice deviations caused by microbial contamination at their Dadra-based plant.
Sun Pharma recalls around 55k bottles of generic medication in US
Sun Pharma is recalling approximately 55,000 bottles of a generic medication used to treat bowel disease in the US market. The recall is due to "Failed Dissolution Specifications," according to the US Food & Drug Administration (USFDA). The affected Mesalamine extended-release capsules were manufactured at Sun Pharma's Mohali plant and distributed in the US by Sun Pharmaceutical Industries Inc. Mesalamine capsules are indicated for treating mild to moderate ulcerative colitis. The US generic drug market was valued at around USD 115.2 billion in 2019, with Sun Pharma being a major player in the market.
India pharma companies develop versions of Wegovy to get in on weight-loss windfall
Indian drugmakers are developing their versions of Novo Nordisk's weight-loss treatment, Wegovy, aiming to capitalize on the growing weight-loss market, expected to reach $100 billion a year by the end of the decade. Companies like Sun Pharma, Cipla, Dr Reddy's, and Lupin are working on Wegovy alternatives as Novo Nordisk struggles to meet global demand.
India rejects European FTA bloc's 'data exclusivity' demand to protect generic drug firms' interest
India rejects EFTA's demand for 'data exclusivity' provision, protecting the generic drug industry. Secretary Barthwal emphasizes India's support for the industry. Exclusivity is beyond TRIPS agreement. EFTA has 29 FTAs with 40 partner countries, including Canada, Chile, China, Mexico, and Korea.
US leans on India's pharma industry to snub China. There's just one catch
America's reliance on China for drug ingredients has raised alarm bells in Congress. House committees will hold two hearings Tuesday on drug shortages and the US Food and Drug Administration's foreign inspection program, which has seen a large drop in visits to Chinese factories over the last few years, due in large part to the Covid pandemic.
Govt earmarks Rs 1,000 cr for promotion of bulk drug parks
The government has increased the budget for the promotion of bulk drug parks to Rs 1,000 crore for FY25, a significant increase from the previous year. The total outlay for the development of the pharmaceutical industry for FY25 has also been increased to Rs 1,300 crore. Additionally, the budget for the promotion of medical device parks has been raised to Rs 150 crore for FY25. The allocation for assistance to medical device clusters for common facilities has also been increased to Rs 40 crore.
Powered by innovative drugs, pharma industry can be worth $200 billion by 2030, says Biocon chief Kiran Mazumdar-Shaw
Research-based incentives can boost the domestic pharmaceutical sector, making it worth USD 200 billion by 2030, according to Biocon Executive Chairperson Kiran Mazumdar-Shaw. She believes the industry has the potential to grow even further beyond the estimated USD 165 billion by 2030, but this growth must be driven by drug innovation rather than just generics and biosimilars. Mazumdar-Shaw emphasized the need for research incentives to drive this growth and called for stronger government support through research-linked incentive schemes. She also suggested decoupling private sector investment and funding academic research institutes out of the National Research Foundation.
Where to invest within the pharma theme? Industry expert Kewal Handa answers
Indian per capita income increase will lead to increased spending on healthcare and medicines, including both generic and non-generic products. The generic market is attractive, projected to be around $600 billion in 2030. MNCs focus on proprietary products, taking advantage of improved GDP and per capita income. Indian companies are engaged in complex generics and biosimilars research, with potential for huge benefits. Patent expirations in 2025 will create opportunities for Indian companies.
India produces over 60,000 generic drugs, highlights MoS Bhagwant Khuba
India's pharmaceuticals industry is the third largest by volume and the 13th largest by value in the world producing more than 60,000 generic drugs across 60 therapeutic categories, stated Minister of State (MoS) for Chemicals and Fertilizers, Bhagwant Khuba.
Sun Pharma recalls over 24K prefilled syringes of generic medication in the US
In its latest Enforcement Report, the US Food and Drug Administration (USFDA) noted that the Mumbai-based drug major is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection. The company is recalling the affected lot due to the presence of particulate matter, the USFDA said.
View: India's drug industry needs a major overhaul
Despite campaigns for regulatory reform since a corruption and fraud scandal in 2013, India's Central Drugs Standard Control Organisation remains unreformed, and a law on drug recalls has been under discussion since 1976 without resolution. Experts call for overhaul, transparency, and accountability to ensure safer manufacturing and export practices.
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