Blockbuster weight loss and anti-diabetes drugs could soon be available in India
Aditi Tandon New Delhi, August 8 The USFDA-approved blockbuster weight loss and anti-diabetes drugs—Ozempic and Wegovy—could soon make it to the Indian market. The Ministry of Health on Thursday approved local clinical trial waivers for high-end select drugs approved by... Key Points
The TribuneGovt notifies rule for rapid launch of breakthrough drugs in India, bypassing local clinical trials
In an executive order, the DGCI has specified a list of countries under rule 101 of New drugs and Clinical Trials Rules, 2019. List includes US, UK & EU, among others. Key Points
ThePrintClinical trials no longer needed for approval of international drugs in India
The drugs Controller of India has waived the need for local clinical trials for several international drugs to make them more accessible and affordable. This decision is expected to expedite the availability of crucial medications in India and reduce costs for public health schemes. Key Points
India TodayBudget 2024: Drugmakers want Nirmala Sitharaman to prescribe tax relief tablet for the economy
Budget 2024: Indian pharmaceutical companies are looking for tax incentives and financial support in the upcoming Union Budget to boost research on innovative drugs. Industry experts emphasize the importance of thinking creatively and implementing policies to enhance growth in the sector. Key Points
Economic TimesCentral regulator to now give NOC for export of new, unapproved medicines after safety concerns
India’s exports of pharmaceuticals during 2022-23 was valued at $25.4 billion with a growth of almost 3.25 percent over the previous financial year, according to Pharmexcil. Key Points
ThePrint
Lens on cos making drugs, supplements in same facility: Pharma body hopeful of a rethink on govt action
In a recent diktat, the government said action will be taken against pharma units that are flouting the norms by manufacturing nutraceuticals, health supplements and drugs in the same facility. Executives of Fope recently met the health secretary and the Drug Controller General of India (DCGI), seeking an exception to select units as was given earlier. Key Points
Economic TimesDrug regulator gives conditional nod for sale of 5 FDCs, seeks efficacy & safety data for 3 of them
Popular brands using combinations under the scanner include D Cold Total and Dolo Cold. The five FDCs are part of 344 drug combinations that the government had first banned in 2016. Key Points
ThePrintUS employers hire virtual providers as weight-loss drug gatekeepers
U.S. employers facing surging costs from paying for Novo Nordisk’s (NOVOb.CO) Wegovy and similar obesity drugs are hiring virtual healthcare providers like Teladoc (TDOC.N) to implement weight-loss management programs, a dozen consultants, pharmacy benefit managers, analysts, and providers told Reuters. Key Points
ReutersMumbai airport's AIU arrests Nigerian woman with heroin worth ₹2 cr. Details here
Mumbai news: Air Intelligence Unit at Mumbai Airport arrested a Nigerian woman with 350 grams of heroin drugs worth ₹2 crores. The arrested has been sent to 14 days of Judicial Custody. Key Points
mintCorporate America weighs business impact of new weight-loss drugs
U.S. companies across sectors such as food and beverage makers and manufacturers of glucose monitors are facing investor questions over the risk to future sales from the growing popularity of promising weight-loss treatments. Key Points
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FDA panel urges Acrotech to speed up study on cancer drugs
A panel of independent experts to the U.S. health regulator urged Acrotech Biopharma to work with the agency to bring forward the date for releasing trial data that could confirm benefits of the company's blood cancer drugs. Key Points
Reuters70% of antibiotic fixed-dose combination drugs sold in India unapproved or banned, finds study
Govt’s moves to curb irrational fixed-dose combinations may have been insufficient & lack enforcement, say researchers. Study published in Journal of Pharmaceutical Policy and Practice. Key Points
ThePrintWeight loss drugs transforming healthcare, may help with addiction
A new class of weight loss drugs is transforming the U.S. healthcare system in ways that could extend to equally hard-to-treat areas like substance abuse, according to speakers at the Reuters Events Total Health conference in Chicago this week. Key Points
ReutersCorporate America weighs business impact of new weight-loss drugs
U.S. companies across sectors such as food and beverage makers and manufacturers of glucose monitors are facing investor questions over the risk to future sales from the growing popularity of promising weight-loss treatments. Key Points
ReutersWhy brewers aren't worried about Wegovy users drinking less beer
Global brewers AB InBev (ABI.BR) and Carlsberg (CARLb.CO) this week played down concerns among some investors that demand for weight-loss drugs may lead to a sharp drop in beer drinking. Key Points
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Belgium seizes fake weight-loss drugs containing insulin
Belgium’s drug regulator said it had seized counterfeit versions of semaglutide, the active ingredient in Novo Nordisk's (NOVOb.CO) popular obesity drug Wegovy, in which the injector pens contained insulin. Key Points
ReutersED arrests 2 Ashoka University co-founders in money laundering case against their pharma firm
Ashoka University says it has no ties to Chandigarh-based Parabolic drugs Ltd of which Pranav Gupta is MD & Vineet Gupta ‘whole time director’. ED has also arrested CA SK Bansal. Key Points
ThePrintEMA says no evidence GLP-1 drugs like Ozempic linked to thyroid cancer
The European Medicines Agency (EMA) on Friday said its safety panel did not find a causal link between popular GLP-1 drugs such as Novo Nordisk's (NOVOb.CO) Ozempic and thyroid cancer after a months-long review. Key Points
ReutersCVS pulls popular allergy and cold medicines because they don't work
Despite accounting for $1.8 billion in annual sales, an FDA panel said medicine containing phenylephrine simply doesn't work. Key Points
InsiderEU regulator to discuss anaesthesia risk for weight-loss drugs
The European Medicines Agency (EMA) will discuss the risk that patients on Wegovy, Ozempic or similar drugs may suffer certain complications under anaesthesia that can lead to pneumonia, according to an agenda posted on the regulator's website. Key Points
Reuters
Expensive drugs Targeted for First U.S. Price Negotiations
Lower prices would take effect in 2026 depending on talks between the U.S. and drugmakers and the outcome of industry lawsuits Key Points
mintRule mandating doctors to prescribe generics may hit patient safety: IMA
The Indian Medical Association (IMA) has requested the deferment of the implementation of the National Medical Commission's regulation that mandates doctors only prescribe generic drugs. The IMA has stated that just 0.1% of Indias drugs are quality tested, leading them to believe that the regulation is an ill-advised step leading to uncertainty and concerns for patients' care and safety. Key Points
Economic TimesGovt bans two veterinary drugs citing risks to animal health
The use of these substances has been especially rampant in the states of Uttar Pradesh, Haryana, and Punjab, with no regulatory mechanisms to curtail their misuse. Added to this is the issue of improper carcass disposal, further compounding the ecological impact of these drugs. Key Points
mintPackages of top drug brands to have QR codes from today
The National Pharmaceuticals Pricing Authority (NPPA) had last year identified brands including Dolo, Saridon Fabiflu, Ecosprin, Limcee, Sumo, Calpol, Corex syrup, Unwanted 72 and Thyronorm. They were shortlisted on the basis of their moving annual turnover value as per data from market research firm Pharmatrac. Key Points
Economic TimesCentre-run hospitals asked to prescribe generic medicines only: Health Minister Mansukh Mandaviya
The government aims to open 10,000 Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs) by March to improve the common man's access to generic medicines, Union Health Minister Mansukh Mandaviya told the Lok Sabha on Friday. Till June 30, 9,512 PMBJKs have been opened across the country. Key Points
Economic Times
drugs worth Rs 2,416 cr to be destroyed today
Union Home Minister Amit Shah will chair a regional conference on ‘Drugs Smuggling and National Security’ here on Monday, an event during which over 1.44 lakh kg of drugs worth Rs 2,416 crore would be destroyed in various parts of the country. Key Points
The Tribune IndiaGST exemption on medicines for rare diseases is unlikely to provide any relief to those in need: Health ac
The recent GST exemption on medicines for rare diseases in India is unlikely to help many patients as the drugs are still too expensive, say health activists. Activists say they had hoped for a tax exemption for medicines already approved by India's drug regulator and available locally. With patient requests for exemption for Indian medicines, the Supreme Court acknowledged that the health ministry must decide but Indian GST exemption on medicines remains pending. Key Points
Economic TimesGovt set to ban two vet drugs to protect vultures
In the representation, it was mentioned that Ketoprofen and Aceclofenac in cattle as toxic as Diclofenac and can kill vultures. Study showed that the Aceclofenac was rapidly metabolised into Diclofenac and Ketoprofen is toxic to Gyps vultures. Key Points
Economic TimesWegovy maker Novo Nordisk sues Florida pharmacies over copycat drugs
Novo Nordisk (NOVOb.CO) on Thursday accused three Florida pharmacies of illegally selling products claiming to contain semaglutide, the active ingredient in the Danish drugmaker's weight loss and diabetes drugs Wegovy, Ozempic and Rybelsus. Key Points
ReutersAustralia is the first country to let patients with depression or PTSD be prescribed psychedelics
Australian physicians can prescribe doses of MDMA, also known as ecstasy, for PTSD. Psilocybin, the psychoactive ingredient in psychedelic mushrooms, can be given to people who have hard-to-treat depression. The country put the two drugs on the list of approved medicines by the Therapeutic Goods Administration. Key Points
India Today
Will urge Centre to make drug laws harsher: Himachal Governor
Himachal Governor was speaking after flagging of a “Walk Against Drugs” campaign in Una district. He took part in the walk organised from Haroli to Kangar. The campaign is brainchild of deputy CM Mukesh Agnihotri which aims to bring together all sections of society in the war against drugs. Key Points
Hindustan TimesGovernment bans 14 fixed-dose combination drugs, citing risk to people
The banned drugs included those used for treating common infections, cough and fever. The move comes following the recommendations by an expert committee. Key Points
India TodayDrug regulator looks to limit alcohol content in medicines
The drugs Consultative Committee (DCC), which comes under the Central drugs Standard Control Organisation (CDSCO) and comprises a technical body of experts, will deliberate and make a decision on the issue soon. The drug regulatory authority had received a representation from the UP government to amend the provisions in the drugs and Cosmetics Act and rules with respect to the misuse of the drugs containing alcohol/tincture, a person in the know told ET. Key Points
Economic TimesMan arrested for carrying drugs worth ₹36 lakh
The seized drugs include 20.670 gm white crystal MD and 80.340 gm brown crystal MD, and two electronic weighing machines Key Points
Hindustan TimesCentre told to inform outcome of consultations of draft rules to regulate e-pharmacies
The Delhi High Court has granted six weeks' time to the Centre to inform it about the outcome of consultations and deliberations with stakeholders on draft rules to regulate e-pharmacies. On perusing the latest status report filed by the Centre, the court noted it has been categorically stated that the Union of India has not yet finalised the draft notification of August 2018 and it is pending for consultation and deliberations. Key Points
Economic TimesIndia intensified crackdown on drugs with cannabis, opium cultivation destroyed, drugs seized
89,000 football fields size of cannabis, opium cultivation was burnt in the last year by the Indian government. Read the full story on The Hindu. Key Points
The HinduCost of 651 essential medicines down 7 pc from April as govt caps ceiling prices
Starting from April, the capping of ceiling prices of scheduled drugs listed under the National List of Essential Medicines (NLEM) has resulted in a 6.73% reduction of average costs for 651 essential medicines, according to the National Pharmaceutical Pricing Authority (NPPA). The government has been able to fix the ceiling prices of 651 medicines so far out of the total 870 scheduled drugs listed under NLEM. Key Points
Economic TimesLicences of 18 pharma firms cancelled for manufacturing spurious drugs, says report
"Licences of 18 pharma companies have been cancelled for manufacturing spurious and adulterated drugs and for violating GMP (good manufacturing practice).... Besides, 26 firms have been given show-cause notices," an official source said. Key Points
The Indian Express