INDIAN DRUGS
Can Zaynich do for Wockhardt what Ozempic did for Novo Nordisk?
Wockhardt's Zaynich antibiotic surged stock by 75%. CEO Habil Khorakiwala cited its uniqueness; phase three trials end this fiscal year. Compared to Novo Nordisk's Ozempic, Zaynich’s $25 billion potential counters global antibiotic resistance.
Drugs body flags side effects of heart, Glaucoma medications
The Indian Pharmacopoeia Commission has issued a drug safety alert regarding amlodipine and acetazolamide, highlighting potential adverse reactions. Healthcare professionals are advised to monitor for adverse drug reactions, while patients should be vigilant for any symptoms. Companies may be required to include warnings in drug packaging.
Waiting for a wonder drug? The weight just got longer
Eli Lilly awaits India's approval to sell Tirzepatide, marketed as Mounjaro and Zepbound in the US. CEO David Ricks plans to launch the drug in India in 2025, pending supply. The SEC recommends approval for pre-filled pens and vials, contingent on a phase-IV trial. The Drug Controller General of India will finalize the decision.
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.
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.
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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.
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.
Govt allows global tenders to access 120 key, patented drugs
In what could ease access to some patented medicines, the government has allowed global tenders to be floated for procurement of 120 drugs, including anti-diabetic medication Semaglutide, after the health ministry raised concerns over lack of domestic options.
Torrent Pharma signs non-exclusive patent licensing pact with Takeda Pharma for Vonoprazan
A 2019 study published by the Indian Journal of Gastroenterology revealed that the prevalence of GERD in the Indian population is around 8.2%, with a higher prevalence of around 11.1% in the urban population. According to AWACS MAT April 2024 data, the Indian market for treatments used in GERD is valued at Rs 8,064 crore, growing at 8% CAGR over the last four years.
Anti-diabetic drugs lead growth in pharmaceuticals market
The pharmaceuticals market in India is witnessing significant growth, with anti-diabetic drugs leading the way with over ₹155 crore in value growth among new brands launched in the past year. The respiratory segment and vitamin/mineral/nutrient segment followed closely behind. The anti-diabetes market has grown rapidly in the last five years, driven by factors like the increasing number of patients and the launch of new drug combinations. The pharmaceutical market rebounded in April 2024, with chronic segments showing faster growth compared to acute segments.
India arrested four Lankan ISIS suspects not 'religious extremists': SL Defense secretary
Sri Lankan nationals arrested in India for alleged links with ISIS are described by the Sri Lankan government as drug addicts, not religious extremists.
Big drug hauls in Punjab; nationally, seizures up 160% in a decade
Seizure of drugs by the Narcotics Control Bureau (NCB) across all states have gone up by 160% between 2014 and December 2023 when compared to 2006-2013, according to home ministry data. NCB has registered 210% more drug-related cases during the same period. In Punjab, which goes to polls on June 1, drones have been recovered and drugs seized, making it among one of the top states as far as drug seizures are concerned.
Dr Reddy's, Cipla, Sun Pharma & others to see FY25 revenue boost in key US market, says India Ratings and Research
Indian drugmakers, such as Dr Reddy's, Cipla, and Sun Pharma, are projected to maintain revenue growth in fiscal 2025, driven by drug shortages in the U.S. market. With 233 drugs in short supply, Indian companies are poised to benefit from the challenges faced by U.S.-based generic pharma manufacturers, leading to improved financial performance and increased market share in therapeutic categories.
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.
Lok Sabha polls: Inducements worth Rs 8,889 crore seized; drugs contribute 45 pc of total seizures
Authorities seized cash, drugs, and inducements worth Rs 8,889 crore, including narcotics, precious metals, and liquor, with operations by Indian Coast Guard, Gujarat ATS, and Narcotics Control Bureau, as stated by the poll authority. Analysis of data found states and Union Territories increasingly becoming drug consumption territories.
India's drug regulator cracks down on antibiotic misuse, seeks list of licensed combinations
India's drug regulator has directed state counterparts to provide a list of antibiotic combinations licensed for manufacturing and marketing within two weeks to combat misuse. This move follows recommendations from an expert sub-committee under the Drugs Technical Authority Board (DTAB) to regulate antibiotic use. The regulator seeks to ban inappropriate combinations and monitor unapproved antibiotics in the market. A sub-committee was formed to examine this issue, leading to the recent directive to state drug regulators and port officers.
Set up system for reporting adverse events: Regulator to medical device companies
The government mandates companies to carry out post-market surveillance (PMS) of medical devices with an aim to ensure the safety and performance of the devices.
Alembic Pharma plans to launch 25 drugs in US generics segment this fiscal
The Vadodara-based drug maker, which has been around for over a century, is a late entrant in the US market. It has more than made up for it. It has been on an investment overdrive, spending about ₹700-₹750 crore per annum on R&D to build a complex pipeline of products for the US market.
New Zealand looking into Indian spice brands over contamination
New Zealand's food safety regulator to investigate potential contamination in spice products from Indian brands MDH and Everest, following scrutiny in the US, Australia, and Hong Kong for high levels of ethylene oxide, a cancer-causing pesticide. The brands maintain product safety, while Indian regulators conduct inspections and testing. MDH now faces additional challenges with a significant rejection rate of shipments due to salmonella.
Drug regulator forms panel to evaluate OTC candidates
The sub-committee, which includes various doctors from the country's top government hospitals, representatives from Indian Council of Medical Research (ICMR), drug controllers from various states, will develop a mechanism for the drugs to be sold OTC, considering globally prevalent regulations and practices.
Before global scrutiny, Indian spice maker MDH faced many US rejections
Hong Kong suspended sales last month of three spice blends made by MDH and one by another Indian company, Everest, for apparently containing high levels of a cancer-causing pesticide. Ethylene oxide is unfit for human consumption and a cancer risk with long exposure. India is the world's biggest spice producer and is also the largest consumer and exporter of spices.
Heatwave ignites surge in chronic therapy demand
Rising temperatures across various regions of India are driving increased demand for medications aimed at managing chronic conditions. This includes prescriptions for high blood pressure (antihypertensives), cholesterol (lipid-lowering drugs), and blood clotting (platelet aggregation inhibitors).
USFDA issues Form 483 with 1 inspectional observation to Cipla's Kurkumbh unit
A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the company's manufacturing facility at Kurkumbh, Maharashtra from April 29, 2024, to May 8, 2024, Cipla said in a regulatory filing.
The penicillin war: India's journey from self-sufficiency to dependence on China
After India lost its dominance in making penicillin, a drought of three decades is coming to an end. The drug – which forms the base for a raft of extremely potent antibiotics – is part of the govt’s aggressive push for self-sufficiency in critical areas. Will the plan to claw back to the glorious past work?
Regulator revokes state licensors' power to issue NOC for drug exports
India's drug regulator withdraws state licensing authorities' NOC issuance power for export of unapproved drugs due to substandard products overseas. Industry to reapply via zonal offices online from May 15. Contaminated cough syrups linked to acute kidney injuries in Gambian children.
No jobs, no future: In Canada, drugs are Indian students’ last resort
The grim reality of hefty education loans and joblessness in the land they once hoped would offer prosperity has ensnared numerous Indian students in Canada in a vicious cycle of cocaine, marijuana and liquor as a coping mechanism for unemployment-induced stress
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.
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