DRUGS MEDICINES
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.
Drug regulator to crack down on pharma companies not using barcodes
The drug regulator is also considering setting up a joint task force for fighting the menace of spurious and adulterated drugs in the country, people in the know told ET.
As monsoon sets in, respiratory, malaria drugs see demand rise
The onset of the monsoon in June led to a significant increase in sales of drugs for respiratory, anti-infective, anti-malaria, and gastrointestinal therapies. According to market researcher Pharmarack, these therapies saw double-digit growth compared to June 2023.
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.
Zydus Lifesciences gets tentative approval from USFDA for BP lowering drug
Zydus Lifesciences announced on Thursday that it has received tentative approval from the US Food and Drug Administration (USFDA) to market its generic Azilsartan Medoxomil tablets, which are used to treat high blood pressure. The USFDA's tentative approval covers Azilsartan Medoxomil tablets in strengths of 40 mg and 80 mg.
Weekly-once insulin jab may soon come to India
A new weekly insulin dosage by Novo Nordisk, Insulin Icodec, is on the brink of approval in India, offering potential relief for those who require daily insulin injections. The Subject Expert Committee has recommended permitting the import and sale of this innovative product, expected to revolutionise the insulin market. While further studies are required, doctors anticipate improved patient compliance with this new treatment option.
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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.
Norms soon on disposing of expired medicines
The document is in the final stages of completion. It will include procedures to be followed for disposal, collection, storage and transportation of expired and unused drugs. Improper disposal of medications that have crossed the expiry date mentioned on the label or not used by the individual for whom they were prescribed and purchased may be hazardous to public health, animal health and environment, officials said.
Biocon Biologics gets EMA nod to produce biosimilar Bevacizumab at Bengaluru plant
Biocon Biologics received EMA approval to manufacture biosimilar Bevacizumab in Bengaluru, providing additional capacity to address patients' needs in Europe for treating cancer. The Bengaluru facility was also approved for biosimilar Trastuzumab manufacturing. EMA renewed GMP certificates for Biocon's facilities in Bengaluru and Malaysia. USFDA issued four observations after inspecting Biocon's Andhra Pradesh plant, concluding inspections on June 21, 2024.
Govt widens composition of drug, medical devices pricing reforms panel
The government has expanded a committee to look into pricing reforms for drugs and medical devices, including civil rights activists like All India Drug Action Network (AIDAN), Patient Safety and Access Initiative of India Foundation, and Medecins Sans Frontieres (MSF). The committee will evaluate availability and pricing of essential medicines, incentivize industry growth and exports, and consider a new Drug (Prices Control) Order (DPCO) as the current one is over a decade old.
This new genetic trait can be the key Alzheimer's cure? Here's what we know
Alzheimer's is a very common disease that plagues thousands of Americans in their prime. However, researchers have now stumbled upon a very new kind of genetic trait that can delay the effects of Alzheimer's, according to recent reports. An extended family based in Colombia's Medellin, was analyzed upon, to derive these results.
View: India's pharma giants set sights on superior quality standards
India, known as the 'pharmacy of the world,' ranks third in global drug production and supplies vaccines to over 200 countries. With a target to reach $120-130 billion by 2030, maintaining high quality is crucial. Focus areas include robust investigations, skilled workforce development, and embedding quality in product development. India faces increased scrutiny from global regulators, necessitating adherence to stringent quality standards. Recent moves by CDSCO aim to streamline drug export licensing. Upholding quality is key for India's pharmaceutical industry to remain a reliable global supplier.
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.
Nepal to legalise marijuana cultivation for medicinal purposes
Nepal will legalise marijuana cultivation and consumption for medicinal purposes, Finance Minister Barsha Man Pun announced on Tuesday while presenting the government's budget estimates for the 2024-35 fiscal year. Addressing the joint session of Parliament, Pun said that necessary laws would be framed for commercial production of marijuana in the country.
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.
Delhi HC turns down petition to mandate doctors to inform patients of drug side effects
"Since the legislature in its wisdom has elected to impose this duty on the manufacturer and the pharmacist (to state about side effects), we do not find any ground for issuing a direction as prayed for in this PIL as it would amount to judicial legislation," the HC said in its May 15 order.
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).
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?
Dr Reddy's launches generic anti-bacterial drug in US
The company's product is a therapeutic generic equivalent of Oracea capsules (40 mg) approved by the US Food and Drug Administration (USFDA).
Govt expands committee for drug and medical device pricing reforms, includes more industry representation
The government has expanded a committee to include more industry representation for reviewing drug and medical device pricing reforms. This move aims to ensure better availability of medicines and devices, while also providing incentives for industry growth and export sustainability. The committee will engage with industry experts and associations to evaluate pricing and availability issues. Ultimately, the government will make the final decisions, with the committee focusing on balancing pricing and availability of essential medicines and designing a price moderation framework for medical devices.
Govt mulls allowing sale of common medicines in general stores
India's committee, under Atul Goel's leadership, is pioneering the development of guidelines for over-the-counter medicines to improve accessibility. This initiative marks a significant step towards streamlining non-prescription drug regulations.
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.
Delhi government's outdated essential medicines list has more drugs than national, WHO lists
Last updated in 2013, the Delhi government's EML is under scrutiny now as the national capital is reportedly suffering a severe shortage of medicines and consumables at government hospitals and dispensaries. According to a Times of India report, the list has not been reviewed since 2016, with new drugs and medicines being added to the EML. Ideally, any additions to the EML have to be reviewed by a committee that assesses requirements, availability of drugs in markets, new additions and old medicines that become redundant.
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.
Essential medicines to cost slightly more from April 1
Drug pricing regulator announced an annual change of 0.0055% increase in prices of drugs under the National List of Essential Medicines (NLEM), in line with the annual change in the wholesale price index.
Cholesterol-lowering pill sparks scare in Japan after 2 deaths, over 100 hospitalisations
According to a report by news agency Kyodo, there have been two fatalities and over 100 hospitalizations suspected to be linked to the consumption of red yeast rice supplements produced by Kobayashi Pharmaceutical Co., aimed at reducing cholesterol levels. One death was attributed to kidney disease following prolonged use of "beni-koji" supplements, while the second death was confirmed by the Ministry of Health, Labor and Welfare.
Centre seeks more time to frame policy on online sale of medicines, Delhi High Court grants 'last opportunity'
A bench of Acting Chief Justice Manmohan and Justice Manmeet PS Arora made clear that "if the draft policy is not prepared before the next date of hearing, this court will have no other option but to proceed ahead with the matter". The high court, which was hearing several petitions seeking a ban on the "illegal" sale of drugs online and challenging the draft rules published by the ministry to further amend the Drugs and Cosmetics Rules, listed the matter for further hearing on July 8.
Panel to review prices of drugs, medical devices
The government has constituted a panel to reform the pricing framework for drugs and medical devices. The committee will evaluate the availability and pricing of essential medicines, balance price and availability, and consider institutional reforms within the NPPA. It will also design a price moderation framework for medical devices and minimize imports.
Delhi HC: No customs duties on rare disease medicines
Delhi High Court clarifies no custom duties on medicines for rare diseases, ensuring expedited clearance and access to necessary treatments. Justice Pratibha Singh's order emphasizes swift clearance by customs authorities, avoiding unnecessary delays. The ruling follows a Finance Ministry notification granting full exemption from basic customs duty on drugs and food for rare diseases. The decision benefits children with conditions like Duchenne Muscular Dystrophy, easing the financial burden of treatment.
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