HEALTH AND PHARMACEUTICALS
Alembic Pharma gets tentative nod from USFDA for Ivosidenib tablets
The company said Ivosidenib tablets are indicated for patients with newly diagnosed Acute Myeloid Leukemia (AML) as monotherapy in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
Warning letter: USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility
"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the USFDA said.
Who is Rishi Shah: The man who defrauded Goldman Sachs, Google of $1 billion
Rishi Shah, co-founder of Outcome Health, has been sentenced to seven and a half years in prison for orchestrating a $1 billion fraud scheme involving his healthcare advertising startup. The case has impacted major investors and drawn attention to corporate accountability.
Government eases rules for global sourcing of medical gear
Pavan Choudary, chairman, Medical Technology Association of India (MTAI), termed the move a path-breaking effort by the government towards equitable policy making, spanning the crucial last mile which was uncovered so far.
Healthtech startup Cloudphysician appoints Oyo's Mandar Vaidya as India CEO
Cloudphysician's new India CEO, Vaidya, drives tech-enabled healthcare with industry expertise, strategic partnerships, and global expansion.
How Indian-American businessman duped Goldman Sachs of Rs 8,300 crore
Rishi Shah, co-founder of Outcome Health, has been sentenced to seven and a half years in prison for his role in a $1 billion fraud scheme involving high-profile investors like Goldman Sachs and Google's parent company, Alphabet. The scheme, which included inflating advertising inventory and deceiving investors and clients, was uncovered in 2017. Shah's extravagant lifestyle, funded by fraudulent activities, included private jets and yachts. His sentencing marks the conclusion of one of the largest corporate fraud cases in recent history, highlighting the consequences of deceptive business practices.
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Health insurer Niva Bupa, Sagility India files draft papers with Sebi for IPOs
The IPO, with each share having a face value of Rs 10, consists of a fresh issuance worth Rs 800 crore and an offer for sale totaling up to Rs 2,200 crore by the promoters and existing investors. As part of the OFS, Bupa Singapore Holdings and Fettle Tone will be divesting their stakes.
US fund Platinum acquires Inventia Health in India foray
Platinum Equity makes its debut in India by acquiring a majority stake in Mumbai's Inventia Healthcare. With a valuation of Rs 2,500 crore, the deal sees PE investors exiting while the promoter retains a minority stake. Platinum Equity, managing over $48 billion in assets, is well-known for its expertise in the healthcare sector.
Risk-based audits of drug units to begin from July 1
The revised Schedule M, which is considered more stringent than the World Health Organization's (WHO) good manufacturing practices (GMP) in certain areas, was notified on December 28, 2023. Companies with turnover of over ₹250 crore will have to comply with the upgraded version of Schedule M, starting July 1, and the remaining others, which are largely micro, small, and medium enterprises (MSMEs), have been given a year's time to comply. Inspections on those firms will begin from January 1, 2025.
Indian regulator says 36% of inspected drug-making units had to be shut
India's drug regulator has ordered the closure of over 36% of its 400 drug manufacturing units since last year due to concerns over sub-standard cough syrups. The country, known as the world's pharmacy due to its large drug production, is working to restore confidence after the deaths of over 300 children worldwide linked to these syrups.
Sun Pharma inks pact with Takeda to introduce gastrointestinal drug in India
Sun Pharmaceutical Industries announced a licensing deal with Takeda Pharmaceutical to market Vonoprazan, a novel gastrointestinal drug, in India. The agreement allows Sun Pharma to commercialize 10 mg and 20 mg tablets of Vonoprazan, an innovative treatment for acid peptic disorders, under a non-exclusive patent license.
Zydus to make Biotax 1g injection available with 10ml sterile water post Nepal regulator's objection
The Indian pharmaceuticals group refuted a media report that the Department of Drug Administration, Nepal has suspended sales and distribution of Biotax 1gm due to "serious health risks" stating these were "misleading and erroneous" as it complies with all quality parameters as per approved specification.
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.
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.
Alembic Pharma gets USFDA nod for generic injection to treat hereditary angioedema
The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Icatibant injection of strengths 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, Alembic Pharmaceuticals said in a regulatory filing.
USFDA issues Form 483 with five observations to Torrent Pharma unit
Torrent Pharmaceuticals announced that the US Food and Drug Administration (USFDA) issued a Form 483 with five observations after inspecting its manufacturing plant in Indrad, Gujarat, from June 3 to June 12. The inspection included a pre-approval inspection (PAI) and a Good Manufacturing Practice (GMP) inspection. The company stated that there were no observations related to data integrity. Torrent Pharma plans to respond to the USFDA within the prescribed time frame and work closely with the agency to address the observations promptly.
Ozempic: Bengaluru is the secret ingredient behind the wonder weight loss drugs' success
Novo Nordisk's India team played a pivotal role in the success of Ozempic, a semaglutide-based drug for diabetes and weight management. The Bengaluru-based Global Business Services unit collaborated on clinical trials and biostatistics. Despite global demand, Ozempic's availability in India remains uncertain due to supply challenges, with significant hiring planned to bolster Novo Nordisk's workforce in India.
Pharma industry raises concerns over new Schedule M's impact on cosmetic manufacturing
The pharmaceutical industry, represented by the Federation of Pharma Enterprises (FoPE), has expressed concerns over the government's new Schedule M, which prohibits the manufacture of any product other than drugs in units licensed for drug production. FoPE argues that setting up a separate plant for cosmetic manufacturing is financially unviable for medium and small-scale enterprises. They are requesting permission to manufacture cosmetics in the area designated for topical products like creams and lotions.
Pill for China plus one
Indian pharma CEOs met senior officials in FDA and other key agencies to start a conversation. Even if a little late, given the looming presidential election, the proposal deserves attention. The basic idea is to capitalise on India's expertise and infra for manufacturing through financial incentives, tech sharing, collaborative research and tech transfers to expand production in both countries. Pursue onshoring in America and friendshoring in India to reduce dependence on China. And aggregate US, Indian and European demand for certain drugs, as IPA secretary general Sudarshan Jain told me.
Gene-based drugs show promise in lowering cholesterol levels, reveals new studies
The studies published in the New England Journal of Medicine highlight the potential of gene-based drugs in lowering cholesterol levels in individuals with naturally high lipid levels. These drugs, plozasiran and zodasiran, are RNA-based and target specific proteins involved in cholesterol regulation. They were found to significantly reduce triglyceride levels in patients with mixed hyperlipidemia, even those already taking cholesterol-lowering statins.
India's pharma export sales to grow faster this year
India's pharmaceutical exports are projected to grow nearly 11% this fiscal year, up from about 10% last year, driven by the U.S. and UK markets, according to Pharmexcil. Exports are expected to surpass $31 billion, rising from nearly $28 billion in fiscal 2024, despite quality concerns following cough syrup-linked deaths.
Panel to examine if nutraceuticals can be produced within drug unit
In a significant development, a five-member expert committee has been appointed to assess the feasibility of allowing the manufacturing of nutraceuticals within drug manufacturing facilities in India. This decision comes after the country's drug regulator had previously warned of taking action against those violating regulations by producing supplements and drugs in the same facility.
Stocks with tailwinds called advantage India: 5 largecap stocks from 3 different sectors with an upside potential of upto 36 %
In terms of valuations and sentiment we are not far from the place where we were in the last quarter of 2023 or early part of this year. When it was not possible to find stocks which can be called as “fairly valued” forget “undervalued”, and the sentiment was very bullish. The only difference between then and now is that we have election results which are coming up. Surely a confirmation on 4th June that continuity in the policy making is a big factor. But there is another thing which long term investors need to look at before investing. Whether the company or the sector has an advantage due to India as a country. A well known example, which has been present for decades is that of the IT industry. India as a country is a factory of software engineers, and that is our strength. So when investing for the long term, look at sectors where we have some strong tailwinds due to our human capital.
Don’t pop that pill daily: Doctors red-flag proton pump inhibitors used to treat acid reflux, heartburns
The reason for the popularity of PPIs among doctors and patients is not tough to gauge. With unhealthy lifestyles and dietary habits, acidity is common among Indians. While many brands of PPIs are sold almost over-the-counter, Pan, Pantop, Omez and Rablet fly off the chemist’s shelves. Doctors warn that overuse of these drugs can have a slow and debilitating impact.
New plant of Sun Pharma inaugurated in Bangladesh
Indian pharmaceutical company, Sun Pharma, inaugurated a new plant in Bangladesh, strengthening economic ties and promoting collaboration in the pharmaceutical sector, including joint R&D efforts.
Bayer acquires remaining 25% stake in Bayer Zydus Pharma Pvt Ltd to secure full ownership
Bayer Pharmaceuticals Private Limited and Zydus Lifesciences Limited have concluded their joint venture, Bayer Zydus Pharma Private Limited (BZPPL), established in 2011 for pharmaceutical sales and marketing in India. Bayer is now acquiring full ownership of the entity as per pre-agreed terms. The joint venture successfully combined Zydus's Indian marketing expertise and distribution network with Bayer's global innovation, making strides in various therapeutic areas.
Glenmark recalls 6,528 bottles of blood pressure drug in US
As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Japanese authorities raid a factory making health supplements linked to 5 deaths
About a dozen people wearing dark suits solemnly walked into the Osaka plant of Kobayashi Pharmaceutical Co. in the raid shown widely on Japanese TV news, including public broadcaster NHK. The company says little is known about the exact cause of the sicknesses, which include kidney failure. An investigation into the products is underway in cooperation with government health authorities.
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