Prescribe generics or face penalty? Govt asks NMC to modify controversial rule for doctors
Rule part of Registered Medical Practitioner (Professional Conduct) Regulations, 2023. Opponents include Indian Medical Association, but some see it as a move in the right direction. Key Points
ThePrint'No brands, prescribe only generic drugs': India's diktat to doctors
The government has been doing this because of the cost. generic medicines are a lot cheaper compared to the branded ones. Key Points
FirstpostVanda Pharmaceuticals sues U.S. government over drug trade secrets
Vanda Pharmaceuticals Inc has sued the federal government in Washington, D.C., federal court over accusations that the U.S. Food and Drug Administration passed trade secrets about its schizophrenia drug Fanapt and sleep-disorder medication Hetlioz to generic competitors. Key Points
ReutersIndia rejects European FTA bloc’s ‘data exclusivity' demand
India on Thursday said it has rejected the demand of the four European nations EFTA bloc for inclusion of a 'data exclusivity' provision in proposed... Key Points
The Tribune IndiaUP doctors told to prescribe only generic medicines
The government doctors in Uttar Pradesh have been told to prescribe only generic drugs to patients as per the new guidelines issued by the medical health department. Issued by the department's principal secretary Partha Sarthi Sen Sharma on Saturday, the circular lists a set of instructions that all chief medical superintendents and government hospital directors must adhere to. Key Points
Economic Times
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. Key Points
Economic TimesIndia's Divi's Labs Q1 profit slumps on drug pricing pressures
Indian pharmaceutical company Divi's Laboratories (DIVI.NS) reported a 49.2% fall in quarterly profit, missing analysts' estimates, as the generic drug maker grappled with pricing pressures in key markets like the United States. Key Points
ReutersIndian drugmaker Cipla tops Q2 profit view on solid domestic, N.America sales
Cipla (CIPL.NS), India's No.3 generic drugmaker by sales, reported a better-than-expected quarterly profit on Friday, boosted by strength in its key domestic and North American businesses. Key Points
ReutersUS Patent Office won't review two Novo Nordisk patents for Wegovy, Ozempic
A U.S. Patent Office tribunal on Monday rejected challenges to two key patents owned by Novo Nordisk (NOVOb.CO) covering the active ingredient in its weight-loss and diabetes drugs Wegovy and Ozempic brought by a generic drugmaker that is hoping to sell generic versions of the blockbuster medications. Key Points
ReutersAid agency urges Johnson & Johnson to improve access to tuberculosis drug
Global health aid agency Unitaid has written to Johnson & Johnson's (JNJ.N) CEO, Joaquin Duato, urging "immediate action" to expand access to the company's tuberculosis drug bedaquiline, which is protected by patents hindering generic alternatives. Key Points
Reuters
Rule 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 TimesDr Reddy's recalls over 8,000 bottles of generic drug in US due to packaging error
Dr Reddy's Laboratories is recalling over 8,000 bottles of Tacrolimus capsules from the US market due to a packaging error. The Hyderabad-based drug major has already recalled 4,000 bottles of the same medication in March 2023. The recall is a Class II recall, initiated on December 15, 2023, due to potential adverse health consequences or a low probability of serious adverse health effects. Key Points
Economic TimesFirst 4 made-in-India drugs for rare diseases launched, 4 more in pipeline, announces govt
All drugs used for treating rare diseases were so far being imported & were prohibitively expensive. Health ministry says new drugs will bring down costs by up to 100-fold. Key Points
ThePrintIndia's Alembic Pharma Q2 profit roughly in-line with estimates
India's Alembic Pharmaceuticals (ALEM.NS) on Tuesday reported second-quarter profit roughly in line with estimates, as higher sales in its domestic and overseas markets offset a jump in expenses. Key Points
ReutersNew tailwinds emerge! 5 midcap pharma stocks with upside potential of up to 37%
If one looks at corporate announcements, a large number of small and mid-caps pharma companies are announcing one or the other thing either about US FDA or European authorities giving approval or inspection. While the large players had moved to international markets a long time back, a number of small companies that had domestic focussed business are also moving into the developed global markets. Will this lead to re-rating? Key Points
Economic Times
Not geopolitical tension, worried more about higher for longer rates: Sampath Reddy
“The domestic facing sectors have been currently doing much better especially the financials. The export-oriented sectors, especially IT, are still facing challenges in terms of overall growth. That is why the domestic facing sectors are much preferred. But within the exports, especially the pharmaceutical export, the generic pharmaceutical exports segment continues to do well. ” Key Points
Economic TimesA Healthy Dose! 4 midcap pharma stocks with upside potential of up to 36%
After a long period of under performance, pharma stocks have seen interest coming back from institutional investors. This is because some tailwinds have emerged recently, shortage in some segments in the generic market in the US have led to sharp spikes in prices in some of the generic medicines. The list is based on upside estimated by the analysts, with the highest potential stock coming on the top of the list. Key Points
Economic TimesAI could help determine who gets laid off
ChatGPT can already write a generic layoffs memo, and Microsoft Corp. is planning to roll out its 365 Copilot to Excel, which could serve as an aid in financial planning. Now a French startup called Pigment SAS is testing a generative AI tool expressly for chief financial officers. Key Points
Economic TimesU.S.FDA observation for Dr. Reddy’s unit
Dr. Reddy’s Laboratories has been issued a Form 483 with one observation by the United States Food and Drug Administration following an inspection of the company’s active pharmaceutical ingredient (API) manufacturing facility in Bollaram, Hyderabad. Key Points
The HinduZydus recalls over 55k bottles of generic drug in US
USFDA said the company is recalling the product due to failed impurities/ degradation specifications . An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine, it added. Zydus commenced the Class III recall on February 24 this year. Key Points
Economic Times