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January 2024
| Free Pharmacist Registration under Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJAP) | Click Here |
December 2023
| The AP Pharmacists Confederation Demands Action Against the Distribution of Illegal Drugs – APDCA | Click Here |
| DCGI Sets Common Cold Medication Warnings for Children Under Four Years | Click Here |
| Mandatory Exit Test for D. Pharma Students – Dr. Montu M Patel | Click Here |
| Urgent Alert: Safety Concerns Surrounding Meftal Spas – The Dangers of Mefenamic Acid Revealed | Click Here |
| DCC Explores Measures to Address Potential Misuse of Tapentadol and Pregabalin: Regulatory Insights and Recommendations | Click Here |
| Opposition Grows Against Proposed NPC Bill 2023: Pharmacy Students Advocate for the Retention of Pharmacy Council of India (PCI) | Click Here |
November 2023
| Unmasking Fake Pharmacists: FSDCA Rajasthan Exposes 101 Sham Registrations | Click Here |
| Ensuring Global Standards: DCC Urged all States to Submit Vaccine Data for WHO Benchmarking | Click Here |
| DCC Proposes QR Code Amendment for Comprehensive Drug Information | Click Here |
| DCC Revolutionizing Drug Regulation: Central Drug Regulator Advances Towards a Digital Era | Click Here |
| Addressing Quality Concerns: DCC Urges Strict Adherence to Pharma-Grade Excipients in Drug Manufacturing | Click Here |
| Navigating Healthcare Growth: The Crucial Role of Medical Representatives | Click Here |
| Empowering Ayurveda: CCRAS Launches ‘Ayurveda Gyan Naipunya Initiative’ (AGNI) to Elevate Evidence-Based Practices | Click Here |
| CDSCO Reveals 5.5% of Drug Samples Not Meeting Standards in October 2023 | Click Here |
| The National Pharmacy Commission Bill 2023: A Closer Look at Education vs. Profession | Click Here |
| Generic Aadhar Expands Its Noble Mission: Adds 111 New Franchise Outlets on Diwali | Click Here |
| Delhi High Court Grants Eight Weeks for Central Government to Frame Policy on Online Sale of Drugs | Click Here |
| Revolutionizing Pharma Safety: Proposed Revised Schedule M Guidelines to Enhance Drug Recall and Pharmacovigilance | Click Here |
| Battle for Pharmacy Autonomy: AIOCD President Vigorously Opposes National Pharmacy Commission Proposal | Click Here |
| Pharmacy Act Transition: Existing Educational Standards Continue Until New Benchmarks Set | Click Here |
| NIPER PhD Scholars Revised Fellowship approved by Department of Pharmaceuticals | Click Here |
| Redwing & Samridh Launches Groundbreaking Drone Network for Healthcare Delivery in Odisha’s Rayagada District | Click Here |
| Unlocking the Sleep-Health Connection: Chronic Sleep Deficiency and Increased Insulin Resistance in Women, Especially Postmenopausal | Click Here |
| National Pharmacy Commission Bill Introduces Pharmacy Advisory Council for Enhanced Regulation | Click Here |
| Health Ministry Unveils Draft National Pharmacy Commission Bill 2023 – What You Need to Know | Click Here |
| The NPPA Sets a Price Cap on Nine Planned Formulations, one of which is a Medication for Brain Cancer | Click Here |
August 2023
Lupin Acquires Brands ONDERO® and ONDERO MET® to expand Diabetes Portfolio in India
Global pharma major Lupin Limited (Lupin) announced today the acquisition of diabetes brands ONDERO® and ONDERO MET®, from Boehringer Ingelheim International GmbH (Boehringer Ingelheim), including the trademark rights associated with these brands. Lupin has been marketing ONDERO® and ONDERO MET® since 2015 in the Indian market as part of a co-marketing agreement with Boehringer Ingelheim India.
US FDA approves Sohonos for FOP fibrodysplasia ossificans progressiva
FOP is a very rare genetic connective tissue disorder characterized by the abnormal development of bone in areas of the body where bone is not normally present (heterotopic ossification), such as the ligaments, tendons, and skeletal muscles. Specifically, this disorder causes the body’s skeletal muscles and soft connective tissues to undergo a metamorphosis, essentially a transformation into bone, progressively locking joints in place and making movement difficult or impossible.
J&K-related Pharmacy (Amendment) Bill introduced in Lok Sabha
On August 3, Bharati Pravin Pawar, the minister of state for health and family welfare, introduced the Pharmacy (Amendment) Bill, 2023 in the Lok Sabha. A new section 32 C, a unique provision pertaining to individuals registered or qualified under the Jammu and Kashmir Pharmacy Act of 2011, is proposed as part of the bill.
July 2023
NIPER JEE 2023 Result Released – Check Now
Indian Pharma Industry has been a global leader in Generic drugs. In order to acquire leadership position in drug discovery and development and to continue to excel in the formulations, Government recognized that human resources/talent pool is very critical. Thus Government of India has set up National Institute of Pharmaceutical Education & Research (NIPER) at SAS Nagar Mohali as a registered society under the Society Registered Act 1860, Subsequently the Institute was given statutory recognition by an act of Parliament, NIPER Act, 1998 and the Institute declared as an Institute of National Importance.
In a significant move aimed at empowering pharmacy professionals and addressing the employment needs in the pharmaceutical sector, the Gujarat State Pharmacy Council has officially launched a state-of-the-art job portal. The momentous occasion was presided over by the esteemed President of the council, Dr. Montukumar Patel, who took the initiative to bridge the gap between job seekers and prospective employers in the pharmaceutical industry.
The World Health Organisation (WHO) has prequalified MenFive, the first conjugate vaccine to provide protection against the five most common types of meningococcal meningitis in Africa, according to Serum Institute of India (SII), a leader in vaccine production.
JUNE 2023
All India Council for Technical Education (AICTE) was set up in November 1945 as a national-level Apex Advisory Body to conduct a survey on the facilities available for technical education and to promote development in the country in a coordinated and integrated manner.
May 2023
Model explaining how the brain obtains needed omega-3 fatty acids is created by researchers.
A zebrafish model created by National Institutes of Health (NIH) researchers and associates sheds new light on how the brain obtains important omega-3 fatty acids like docosahexaenoic acid (DHA) and linolenic acid (ALA). Their research, which was published in Nature Communications, may help us understand how lipids pass the blood-brain barrier and how alterations to this process can cause neurological disorders or birth defects. Researchers may be able to create therapeutic compounds that can directly access the brain using the model.
The success of organ transplants in India is credited to improved organ preservation techniques, cutting-edge surgery, and anti-rejection medications. When a patient has serious organ failure, organ transplantation is a crucial therapy option. Both patient survival and quality of life are enhanced. Various organs such as the kidneys, liver, heart, pancreas, lungs, cornea, and skin are frequently transplanted, but tiny intestines, limbs, and other body parts are now being done as well, according to Dr. Rushi Deshpande, director of nephrology at Jaslok Hospital.
DCGI launches an investigation into antipsychotic drugs made without authorization.
In its most recent meeting, the National Pharmaceutical Pricing Authority (NPPA) set a ceiling price for the antipsychotic medication risperidone injection (long acting) 25 mg. Earlier, the price fixation had been postponed because Johnson & Johnson (J&J) complained that it should not be included in the cost of a formulation that was allegedly manufactured by another company without the Drugs Controller General of India (DCGI)’s (DCGI) consent. Following the NPPA’s request for the status of approval from the drug regulator, the DCGI has opened an investigation into the medicine sold under the brand name Restonorm and produced by HFA Formulations Pvt Ltd and distributed by Aleteus Biogenics Ltd. The medication is used to treat schizophrenia and other mental health conditions.
The US Food and Drug Administration (FDA) has approved Sequana Medical NV’s investigational new drug (IND) application for its second-generation DSR product (DSR 2.0) for the treatment of congestive heart failure. Sequana Medical NV is a pioneer in the treatment of fluid overload in liver disease, heart failure, and cancer. This makes it possible for the business to start its planned Q2 2023 US randomised controlled phase 1/2a MOJAVE research. Sequana Medical’s Oliver Gödje, the company’s chief medical officer, said: “We are pleased to receive clearance of the IND for our DSR 2.0 product and are prepared to start the MOJAVE research in US patients with congestive heart failure as soon as possible. We are currently concentrating on enrolling our first patient, which we anticipate will happen in the second quarter of 2023. By the end of the year, we hope to present data from the three patients in the non-randomized group.
April 2023
AiMeD appreciates the National Medical Devices Policy 2023’s cabinet approval.
The Central Government’s decision to approve the much-needed National Medical Devices Policy (NMDP), 2023, has been applauded by the Association of Indian Medical Device Industry (AiMeD), the umbrella association of Indian manufacturers of medical devices including all types of medical devices such as consumables, disposables, equipments, instruments, electronics, diagnostics and implants. The association has expressed its hope that the policy will help boost the local manufacturing to end the import dependency.
In order to allow the National Institute of Biologicals (NIB), Noida to test more medical devices, including the tools and kits used to diagnose Covid-19, the Union Ministry of Health and Family Welfare has issued a notification. In order to increase the number of tests the Institute offers, the Ministry has published an update to the notification it first published in June 2018. The decision was made in response to both the current regulatory framework for medical devices and the rising number of Covid-19 instances.
With the support of their physician, patients with the uncommon disease Myasthenia gravis (MG) can better understand and manage their condition thanks to a partnership between UCB and Huma Therapeutics (Huma), a leading global digital health company and global biopharmaceutical company. Prior to going global, the digital platform is beginning in Europe. The EU MDR Class IIb regulated Software as a Medical Device (SaMD) by Huma, the only disease-agnostic SaMD to acquire this degree of EU MDR regulatory classification to date, serves as the foundation for the technological platform. Patients will have access to MG-specific, dependable educational resources and will be able to use the MG-Activities of Daily Living Scale (MG-ADL) to report and monitor their symptoms over time. Through a web-based dashboard, these data are shared with clinicians so they can identify symptom exacerbations early and take appropriate action. Finding exacerbation triggers can let clinical decision-making be proactive, which should benefit patients. To make the most of in-person appointments, patients can obtain summary reports of their health data to discuss with their clinician.
The US Food and Drug Administration (FDA) recently granted Abbott two more clearances for the company’s market-leading life support system. The CentriMag Blood Pump for use with the CentriMag System is now approved for longer-term usage in adults where extracorporeal membrane oxygenation (ECMO), a kind of life support for persons whose heart and lungs are not functional, is necessary to save their lives. The approval for longer-term support now gives doctors more time to consider their patients’ needs and determine the best course of action. The CentriMag Pre-connected Pack, a packaged system containing multiple pre-connected CentriMag system components that can speed up the deployment of the life support system, was also given FDA approval by Abbott. When combined, the two clearances strengthen Abbott’s capacity to provide hospitals and doctors with cutting-edge life support systems for critically ill patients.
Following the earlier attempt to invite applications through its portal failing due to some technical issues, the Pharmacy Council of India (PCI) has announced that it will begin accepting the Standard Inspection Format (SIF) from those institutions that are applying for the first time for the academic year 2023–24 on April 26, 2023. The PCI site will be open for new institutions to apply for the 2023–24 academic year from April 3–9, 2023, as the Council had previously declared. Later, it also made the document declarations available for these institutions to upload in order to complete the approval procedure.
Cisplatin, a chemotherapy drug used as a first-line treatment for advanced ovarian cancer, testicular cancer, and bladder carcinoma, has obtained marketing authorization from the UK for Venus Remedies, a distributor of cheap cancer medications throughout the world. One of the strictest healthcare regulatory bodies in the world has granted Venus Pharma GmbH, a subsidiary of Venus Remedies in Germany, a marketing authorization. With this authorization, the company will be able to provide its reasonably priced line of cancer medications to the National Health Service (NHS) in the UK and surrounding nations.
As the leading organisation for sales representatives enters its diamond jubilee year, the Federation of Medical and Sales Representatives’ Associations of India (FMRAI) has declared that it will concentrate on launching a massive campaign among the public for a decrease in the cost of medications and forcing the government to make the Uniform Code on Pharmaceutical Marketing Practises (UCPMP) mandatory. The National Pharmaceutical Pricing Authority’s (NPPA) decision to permit a 12% price increase for a number of important medications in line with an increase in the Wholesale Price Index (WPI) has drawn criticism from the Federation.
According to the drug price regulator, the moving annual turnover (MAT) for consumers on formulations for which the new prices have been finalised until the end of March 2023 is estimated to have decreased by over Rs. 3,500 crore annually as a result of the ceiling price revision and fixation of prices for the new drugs added to the revised Schedule I of the Drugs (Prices Control) Order, 2013. The National List of Essential Medicine (NLEM), 2022, and the DPCO, 2013, through an amendment late last year, have both been added to the schedule of formulations for which the National Pharmaceutical Pricing Authority (NPPA) has been conducting the exercise of revising or fixing the ceiling prices. The ceiling price for 651 formulations has been set until the end of March 31, 2023.
The National Pharmaceutical Pricing Authority (NPPA) has made a number of changes to its Integrated Public Database Management System 2.0 (IPDMS), a cloud-based application to support the industry in statutory filings with the Authority. One of these changes includes a provision to add specific details of the bulk drug in the online product verification form based on suggestions from the stakeholders. Numerous recommendations are made in reference to irregularities in the current forms, and the Authority has said that these issues would be resolved once the forms are changed.
Tenovi offers Tenovi, a leader in US FDA-approved remote patient monitoring (RPM) solutions, recently announced the release of its cellular-enabled remote Peak Expiratory Flow Metre (PFM). The device enables asthma sufferers to quickly communicate peak expiratory flow rate (PEF) and 1-second forced expiratory volume (FEV1) values to clinicians when used in conjunction with Tenovi’s Cellular Gateway. Millions of individuals throughout the world suffer from asthma, a chronic respiratory disorder, and accurate monitoring of asthmatic symptoms is essential for optimal management.
The US Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) unanimously voted 12-0 in favour of approval of sulbactam-durlobactam for the treatment of adults with ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia caused by susceptible strains, according to an announcement from Innoviva, Inc., a diversified holding company with a portfolio of royalties and other healthcare assets. The FDA accepted and awarded Priority Review of the Entasis Therapeutics Inc.’s (a 100% owned subsidiary of Innoviva) sulbactam-durlobactam New Drug Application (NDA) in November 2022, with a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023.
Abbott’s FreeStyle Libre portfolio, the most widely used and reasonably priced continuous glucose monitoring system (CGM) in the United States, will now make more Medicare beneficiaries than ever before eligible for reimbursement when using it. According to Jared Watkin, executive vice president of Abbott’s diabetes care division, “FreeStyle Libre technology was designed from the beginning to be affordable and accessible.” “We’ve concentrated on emphasising the significant advantages of continuous glucose monitoring to assist patients with diabetes in managing their care simply and painlessly. By expanding access, Medicare is taking a huge step towards enabling more people to use FreeStyle Libre, allowing them to worry less and enjoy healthier, better lives.
National Testing Agency (NTA) has released GPAT 2023 Exam date
Examination Date & Schedule for Graduate Pharmacy Aptitude Test (GPAT- 2023) The Graduate Pharmacy Aptitude Test (GPAT) is a National Level Entrance Examination for entry into M.Pharma programmes.
DCO India will begin a nationwide push to encourage the usage of generic medications.
The Drug Control Officers Welfare Association (DCO India) is preparing a pan-Indian campaign to amplify and promote the use of generic formulations in support of the Union government’s programmes for generic medicine promotion. The drug control officers, who are concentrating on the benefits of generic medications, will take immediate action to inform the general public about the use of generic versions and to recommend doctors for the prescription of generics in public health facilities. In order to raise public knowledge of the value of generic drugs and the distinction between generic and branded products, awareness classes will be held in cities and rural areas. Also, the association will assist the producers of generic formulations, according to sources within the association.
Avastin (bevacizumab) plus Tecentriq (atezolizumab) showed a statistically significant improvement in recurrence-free survival (RFS) in patients with hepatocellular carcinoma (HCC) at high risk of disease recurrence following liver resection or ablation with the intention of curing the disease, according to new data from the phase III IMbrave050 study released by Roche. “Four out of five HCC patients who have surgery with the goal of curing their disease may nevertheless experience recurrence. In order to prevent early recurrence and increase survival rates, adjuvant medicines are urgently needed, according to Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development. We are thrilled with the potential of these results and eagerly await the release of more complete data because Tecentriq + Avastin is already the gold standard of therapy for unresectable HCC.
An airlifted donor organ from Bengaluru was used in a difficult small bowel transplant by Dr. Anil Vaidya, director and senior consultant of multi-visceral transplant surgeon at MGM Healthcare in Chennai. Under the direction of Dr Anil Vaidya, who is regarded as a leading authority on all aspects of pancreatic, intestine, and multi-visceral transplant, MGM Healthcare offers a strong clinical programme for these transplants.
The Central Drugs Standard Control Organisation (CDSCO) has instructed the manufacturers and importers of these devices to apply for grant of manufacturing or import licence with all necessary documents and fees in accordance with the regulation in an effort to bring about a smooth transition of the Class C and D non-notified medical devices from the current mandatory registration to licencing regime. The transition to a licencing regime for medical devices that are moderately high risk (Class C) and high risk (Class D) is expected to be finished in 42 months from the date of notification on April 1, 2020. According to this, the licencing system for certain medical devices is anticipated to begin on October 1, 2023.
Experts have advised that it is urgently necessary to create a culture of quality in the pharmaceutical business in view of the sharp increase in US FDA inspections for compliance and quality assurance. They did this by highlighting the fall in the number of Indian pharmaceutical companies gaining permission from the US FDA. These discussions were a part of a training that took place on April 13, 2023 and was titled “Hosting Unannounced Audits and Response to 483.” Sotax was an exhibit partner, FDAlytics was a silver partner, and PharmaMantra was a knowledge partner for the two-day event, which was organised by Bluetech Media. The workshop was presided over by BlueTech Media director Ashish Chauhan.
Alvotech’s BLA for AVT02 receives a comprehensive response letter from the US FDA.
The US Food and Drug Administration (FDA) has responded completely to Alvotech’s Biologics Licence Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira (adalimumab), according to a press release from the international biotech company Alvotech. The FDA’s reinspection of the company’s Reykjavik plant, which finished on March 17, 2023, revealed a number of issues that needed to be addressed before the application could be accepted, according to the CRL. The FDA didn’t find any other issues with the application. Alvotech sent the FDA thorough responses to the inspection observations on April 3, 2023, and is now awaiting word from the organisation evaluating those responses.
To combat fake pharmaceuticals, it is absolutely necessary for patients to be aware of websites that provide medications at discounts. The public’s health is at risk because to the parallel trade of real medical supplies that are moved without the required chain of custody tracking, storage, and oversight, according to experts. By making false claims and taking advantage of consumer demands, the illegal trade preys on people’s limited awareness as well as their fear and bewilderment. The growth of e-commerce both opportunities and challenges for combating the illegal trade in medical supplies.
In order to determine the ceiling prices for these scheduled formulations under the 2013 revision to Schedule I of the Drugs (Prices Control) Order (DPCO), the National Pharmaceutical Pricing Authority (NPPA) has requested the industry to provide the Price To Retailer (PTR) and Moving Annual Turnover (MAT) of a total of 139 formulations. The formulations for which the details were sought include abacavir tablet 60 mg, combination of abacavir 60 mg and lamivudine 30 mg, various strengths of acetylsalicylic acid, amikacin injection, activated charcoal, amoxicillin, combinations of artesunate and sulfadoxine pyrimethamine, barium sulphate, bendamustine hydrochloride, benzylpenicillin powder for injection, budesonide nasal spray, calcium foliage injection, cefadroxil tablet, cefazolin powder for injection, chlorhexidine solution 5%, clarithromycin tablet and capsules, among others.
In the first large-scale clinical study to test a primary cardiovascular prevention strategy in this population, a daily statin medication was found to reduce the increased risk of cardiovascular disease among people living with HIV, leading to the early termination of a National Institutes of Health (NIH) clinical trial. Participants in the Randomized Experiment to Prevent Vascular Events in HIV (REPRIEVE) research who took the daily statin pitavastatin calcium had a 35% lower risk of significant adverse cardiovascular events than those who took a placebo, according to a scheduled interim examination of the project’s data.
Draft ceiling price calculations for 20 formulations are published by NPPA.
Under the 2013 revisions to Schedule I of the Drugs (Prices Control) Order, the National Pharmaceutical Pricing Authority (NPPA) has released the draught version of the ceiling price calculation for 20 formulations, including specific strengths of paracetamol, povidone iodine, risperidone injection, and Japanese encephalitis vaccines. The pricing authority replaced Schedule I of the DPCO, 2013 with the National List of Essential Medicines (NLEM), 2022, in the second half of last year. This is the 15th set of draught calculation sheets that have been provided by the pricing authority since that time.
Regional Reference Laboratory launched by Lupin Diagnostics in Bengaluru
As part of the development of its diagnostics network, multinational pharmaceutical company Lupin Ltd (Lupin) announced the opening of a brand-new, cutting-edge Regional Reference Laboratory in Bengaluru, Karnataka. Given Lupin Diagnostics’ effort to offer accessible and reasonably priced diagnostics and preventive healthcare services across India, the new laboratory represents a significant advancement. The company’s current network of 25 laboratories and more than 410 collection centres across India is supplemented by the Regional Reference Laboratory.
Pharmaceutical companies are today addressing cardiac diseases in women on war footing through promoting usage of potential medicines for managing early risk factors and launch of new molecules. There has been rapid growth in the use of drugs that manage early risk factors for e.g., Angiotensin II Receptor Blockers (ARBS) and statins that significantly reduce cardiac disease related mortality. Similarly, the launch of new molecules, such as Dabigatran and Prasugrel, are expected to reduce mortality and improve the quality of life.
Indian healthcare providers see immense relevance to US FDA Orthopaedic Non-Spinal Bone Plates, Screws and Washers Premarket Notification (510(k)) Submissions Draft Guidance. This is going by the increasing number of orthopaedic surgeries requiring to embed this into the patient depending on the severity of the condition. The regulatory authority said that it expects the industry to revert with its comments to add on the needs as Orthopaedic Non-Spinal Bone Plates, Screws and Washers are becoming extremely relevant to modern bone surgeries.
According to GlobalData, a leading data and analytics company, Ansell Limited, an Australian manufacturer of personal protective equipment, is expected to propel the Indian surgical glove market, advance sustainable manufacturing, and support the “Made in India” initiative with its new manufacturing facility in Tamil Nadu. Ansell recently celebrated the $20 million first investment in the first phase of the commissioning of its packaging and irradiation activities at its new production site in Kovai, Tamil Nadu.
Based on risk-based inspections, the Gujarat Food and Drug Control Agency (FDCA) has revoked 15 product licences from 6 pharmaceutical companies. Ahmedabad is where the majority of these businesses are based. The risk-based inspections discovered that some of the businesses providing commonly prescribed gastrointestinal medications and supplements had items that weren’t up to par (NSQ). Other products include oral rehydration salt (ORS), antibiotics such as amoxicillin for bacterial infections and azithromycin for colds, as well as antimalarial medications.
CDSCO updates its list of FDCs considered reasonable to reflect some adjustments.
The list of fixed dose combinations (FDCs), previously released in February and deemed rational by the Prof. Kokate Committee, has been reissued by the Central Drugs Standard Control Organization (CDSCO) with some corrections. These corrections are related to the FDCs’ new drug status and the application process that applicants must follow when approaching the state licencing authority.
According to GlobalData, a leading data and analytics company, the development of a new biopsy device by physicians and academics from the Gujarat Cancer Research Institute (GCRI) and the Institute of Infrastructure Technology Research and Management (IITRAM) may improve the landscape of bone cancer treatment in India. One of the most common cancers in India, bone marrow cancer affects a sizable portion of the country’s population. Chemotherapy, radiation treatment, and bone marrow transplantation are frequently used as treatment alternatives. A bone marrow biopsy is an essential diagnostic tool to determine these treatment options.
The Pharmacy Act, 1948 should be renamed as the National Pharmacy Commission Act, 2023, according to a suggestion made to the government by the Karnataka State Registered Pharmacists Association (KSRPA). It should be updated to reflect changes in the pharmaceutical industry. The KSRPA believes that the Pharmacy Act of 1948 should be repealed and that a new law, to be called as the National Pharmacy Commission Act of 2023, should be drafted along the lines of the National Medical Commission Act of 2019.
Ayushman Bharat Health Account (ABHA) can help streamline the management of healthcare services by making it simpler to store and share patient information across healthcare providers, according to Deepak Tuli, co-founder and COO of Ekacare. This is because digital technologies make it possible to create and manage electronic health records (EHRs). He continues by saying that digitalization also enables data-driven decision-making, increasing healthcare outcomes by enabling healthcare providers to track patient health in real-time, precisely spot potential problems, and offer individualised therapies.
The Association of Pharmacy Teachers of India (APTI) demanded that the Union Health Ministry appoint representatives from stakeholder associations like the Indian Pharmaceutical Association (IPA), APTI, and the Central regulatory body CDSCO as additional members to the panel of experts formed to review the Pharmacy Act of 1948. The APTI claimed that the government had given medical professionals unnecessarily greater weight in the panel of experts committee. The two organisations that speak for those involved in the pharmacy profession and pharmacy education in the nation are IPA and APTI. According to APTI, they also provide services and inputs to the regulating body.
Ten AMCs from around the nation are delisted by IPC due to poor performance in reporting ADRs
Out of the 701 Adverse Drug Reaction Monitoring Centers (AMCs) across the nation, 10 have been delisted by the Indian Pharmacopoeia Commission (IPC) due to poor performance in ADR reporting. The delisted hospitals include the Aundh Chest Hospital in Aundh, Maharashtra; Babu Ishwar Saran District Hospital in Gonda, Uttar Pradesh (UP); Combined District Hospital in Shrawasti, Uttar Pradesh (UP); District Hospital in Bahraich, Uttar Pradesh; District Hospital (Male), Pratapgarh, Uttar Pradesh; Glocal Group of Hospitals in Rajarhat, West Bengal; Government Medical College in Jalaun, Uttar Pradesh; Sri Krishna Medical College and Hospital.
An exclusive agreement between CareDx, Inc. and Miromatrix Medical, Inc. has been announced with the goal of increasing the use of fully transplantable human bioengineered organs in the next wave of innovation. In order to assess acute allograft rejection in Miromatrix’s pipeline of human bioengineered organs non-invasively, CareDx will create an innovative testing solution for the company to use in pre-clinical animal models and will be the sole supplier of donor-derived cell-free DNA (dd-cfDNA) testing services for use in human clinical studies.
According to the findings of a clinical experiment done by scientists at the National Institutes of Health (NIH), individuals with low-grade lymphomatoid granulomatosis who receive immunotherapy known as interferon alfa-2b can live for decades after being diagnosed. Epstein-Barr virus infection is the unusual precancerous illness known as lymphomatoid granulomatosis. If the condition is not treated, it can develop into a high-grade variant that has a worse prognosis and swiftly transform into an aggressive and deadly B-cell lymphoma.
The Central Government Health Services (CGHS) chemists have provided some comprehensive suggestions to the expert panel for their review and consideration following the establishment of a 16-member expert committee by the Union health ministry to review the Pharmacy Act and make recommendations for a complete revamping of the structure of the pharmacy profession, education, and the PCI.
Veteran academic and professional pharmacy experts say the Union government should take into consideration the name of former PCI chairman Dr. B Suresh to be included in the panel as co-chairman. They are unhappy with the way the Union health ministry recently formed an expert panel to review the Pharmacy Act 1948 and make recommendations accordingly to restructure the Pharmacy Council of India (PCI).
For disposable insulin glargine 100 IU/ml pens, the NPPA establishes a specific price ceiling.
After taking into account the arguments made by Sanofi India Ltd, the Organization of Pharmaceutical Producers of India (OPPI), and the US-India Strategic Partnership Forum, the National Pharmaceutical Pricing Authority (NPPA) has established separate ceiling prices for insulin glargine 100 IU/ml formulation in disposable pens as compared to vials and cartridges (USISPF).
All makers of the 16 fixed dose combinations (FDCs) that were previously deemed to be illogical in a report by an expert panel have been requested by the Central Drugs Standard Control Organization (CDSCO) to submit the information in the prescribed format for additional review. The decision is related to the one made at the 86th meeting of the Drugs Technical Advisory Board (DTAB) on April 13, 2021, which looked at the report of the expert committee led by Prof. Kokate about the FDCs deemed to be illogical. The meeting recommended that the sub-committee led by Dr. Nilima Kshirsagar, Emeritus Scientist and Former Chair in Clinical Pharmacology, ICMR, Mumbai, examine the 16 irrational FDCs in detail in accordance with the procedures. The meeting in general agreed with the recommendations of the Committee.
According to a pilot study conducted by NITI Aayog and Terumo Blood and Cell Technologies (TBCT), the public-private partnerships (PPP) model has improved the functioning of blood transfusion services by 37% in districts of Uttar Pradesh (UP). The areas that underwent the greatest improvement when delivering blood transfusion services. The prompt supply of safe blood and blood components is essential to the efficient operation of contemporary healthcare facilities. The World Health Organization (WHO) suggests that 1% of the population donate blood as the minimal standard for a country to be able to supply its own blood needs. Despite consistent advancements over the years, there was a 4% deficit of blood units collected in 2018 compared to the WHO baseline.
The Organisation of Rare Diseases of India (ORDI) now argues that the Union government would need to simplify the documentation process for all imported medicines that are free from customs duties. A recent announcement from the Union government allowed complete exemption from basic customs duty for all medications and commodities imported for personal use to cure all unusual diseases.
In line with its efforts to revise the ceiling price of formulations under the revised Schedule I of the Drugs (Prices Control) Order, 2013, which was amended last year with the National List of Essential Medicines (NLEM), 2022, the National Pharmaceutical Pricing Authority (NPPA) revised or fixed ceiling prices for over 160 scheduled formulations in its most recent meeting. Following the application of the Wholesale Price Index (WPI) rise of 12.128% in accordance with the Authority’s ruling on March 27, 2023, the new ceiling prices for all formulas may be announced.
Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the generic version of Compazine®1 Tablets, 5 mg and 10 mg, of GlaxoSmithKline, have been given final approval by the United States Food & Drug Administration (U.S. FDA). Glenmark Pharmaceuticals Ltd. (Glenmark) is an innovation-driven, international pharmaceuticals company. Glenmark Pharmaceuticals Inc., USA will market Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, in the United States.
Hutchmed (China) Limited reports that it has finished the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib, a highly potent and selective oral inhibitor of VEGFR-1, -2, and -3, for the treatment of metastatic colorectal cancer that is resistant to current therapies (CRC).
The Pharmacopoeia Commission of Indian Medicine and Homoeopathy (PCIM&H) may soon start developing pharmacopoeia standards for the Ayurvedic, Siddha, Unani, and Homoeopathic medications under the “One Herb One Standard” (OHOS) among other projects during the budget year 2023–2024.
The US Food and Drug Administration has approved the company’s investigational new drug (IND) application for CABA-201, a fully human CD19-CAR T cell investigational therapy that contains the 4-1BB protein, according to Cabaletta Bio, Inc., a clinical-stage biotechnology company focused on creating and marketing the first curative targeted cell therapies for patients with autoimmune diseases (FDA).
The phase 2 recruitment for Hansa Biopharma’s imlifidase research in Guillain-Barré syndrome has been completed, according to the company, a pioneer in enzyme technology for uncommon immunological disorders (GBS). The second half of 2023 is anticipated to see the release of top-line figures.
The Pharmacy Council of India (PCI), a statutory body established for the regulation of pharmacy education, profession, and practise in the nation, has been reorganised. An expert committee has been established by the Union Ministry of Health to evaluate the regulations governing pharmacy education.
In a patent dispute involving the former’s diabetes drug linagliptin, a single judge of the Delhi High Court declined to grant an interim injunction in favour of German pharmaceutical giant Boehringer Ingelheim against Indian generic manufacturers, noting that the patent is presumptively voidable and the company has made efforts to evergreen the invention and re-monopolize it.
March 2023
According to the National AIDS Control Organization, the risk of HIV transmission through blood transfusions has decreased from 15% to less than 1%. (NACO). It has been estimated that heterosexual routes account for over 83% of all transmission in India. It is estimated that 6% of cases are brought on by contaminated syringes and needles, 4% are caused by gay relationships, 3% are passed from parent to kid, and the other 4% are attributed to unidentified sources.
The US Food and Drug Administration (FDA) has fully approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by an FDA-approved test, that have progressed after prior treatment and who have no satisfactory alternative therapies. Merck, known as MSD outside of the United States and Canada,
Abbott’s Epic Max tissue valve is approved by the US FDA to treat aortic valve disease.
In order to treat persons with aortic regurgitation or stenosis, Abbott announced that the US Food and Drug Administration (FDA) has approved the company’s Epic Max stented tissue valve. With an enhanced design to further increase valve blood flow, this device is the newest addition to Abbott’s Epic surgical valve platform, which has a long history of safety and positive clinical outcomes.
The OTC naloxone nasal spray from Emergent BioSolutions has received FDA approval.
The first naloxone medication to be approved for use without a prescription is Narcan, a 4 milligramme (mg) naloxone hydrochloride nasal spray, according to the US Food and Drug Administration (FDA). The conventional treatment for opioid overdose is naloxone, a drug that quickly reverses the effects of an overdose. The decision made today opens the door for the life-saving treatment to reverse an opioid overdose to be sold online and directly to consumers in locations including gas stations, convenience stores, grocery stores, and drug stores. The US FDA granted the OTC approval of Narcan to Emergent BioSolutions.
The NIH discovers a novel autoinflammatory disease and suggests a target for potential treatments.
Scientists have discovered an autoinflammatory illness brought on by mutations in the LYN gene, a crucial immune response regulator in both health and disease. The discovery, known as Lyn kinase-associated vasculopathy and liver fibrosis (LAVLI), provides insight into the possibility of using already-approved medications to target genes associated with certain diseases.
According to senior CDSCO officials involved in the process, the risk-based inspections that the Central Drugs Standard Control Organization (CDSCO) scheduled for December of last year resulted in the cancellation of licences for 18 Indian pharmaceutical companies for producing fake medications.
In order to address pigmented and vascular under-eye dark circles, Entod Beauty London has recently introduced a unique gel serum called “Eyecirque Advance.” A powerful anti-vascular, anti-pigmentation, and anti-aging nanomolecule blend of tranexamic acid, alpha arbutin, glycolic acid, moringa extract, and aquaxyl 3D hydration complex is used in this advanced collagen-boosting retinol complex.
MrMed releases a mobile app for easy access to cost-effective super-specialty medications.
The best online pharmacy in India for super-specialty drugs, MrMed, has announced the release of its mobile app. The app, which is accessible on iOS and Android devices, makes it simple for patients and carers to get specialised medications at reasonable costs. With the launch of this programme, patients and carers all over India (including tier-2 and tier-3 cities, towns, and villages) will have access to more than 5,000 speciality medications for illnesses like cancer, transplants, kidney/liver diseases, and many others by simply uploading their prescriptions.
The cap on the trade margin for oxygen concentrators and five other medical devices that was imposed in 2021 has been further extended by the National Pharmaceutical Pricing Authority (NPPA) for three more months. Since the virus continues to pose a threat to the nation’s public health, the pricing restrictions that were put in place during the Covid-19 epidemic to ensure the ongoing availability of these drugs have been further expanded. According to a ruling made at the end of December 2022, the price restrictions put on these products would end at the end of March 2023.
DoP will shortly request additional funding from the finance ministry for the proposed PRIP scheme.
The Department of Pharmaceuticals (DoP) may approach the Ministry of Finance for additional funding for the proposed new scheme for Promotion of Research and Innovation in Pharma-MedTech Sector (PRIP), with an outlay of Rs. 7,150 crore and the establishment of an Indian Council of Research & Development, in accordance with the announcement in the Union Budget 2023–24 regarding a new programme for research and innovation in pharmaceuticals and multidisciplinary courses for medical devices (ICPMR).
The second preplanned interim analysis of Baudax Bio, Inc.’s phase 2 trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery showed promising results. Baudax Bio, Inc. is a pharmaceutical company that specialises in developing novel products for hospitals and related settings.
The drug regulator has revoked the licences of several pharmaceutical enterprises operating in about 20 states nationwide due to concerns expressed by numerous public health experts and even certain pharmaceutical manufacturers regarding the prevalence of substandard quality medicines in the nation. According to sources, a large-scale campaign against attempts to manufacture fake or inferior pharmaceuticals in the nation has been underway. A seminar on increasing medicine quality was previously held by the health ministry in Hyderabad. During this meeting, several topics linked to guaranteeing the quality of pharmaceutical products were thoroughly discussed. The ministry has also hinted that it will take enforcement action against medicine makers who produce subpar or fake products.
Patient advocacy groups are awaiting clarification on whether specific conditions will be covered by the National Policy of Rare Disorders (NPRD) 2021. This comes after the Union government recently allowed patients to receive treatment for six rare diseases by including them under the NPRD.
The Rho kinase (ROCK) inhibitor NRL-1049, a potential treatment for people with cerebral cavernous malformations (CCM), a condition marked by abnormally enlarged capillary cavities in the brain and spinal cord, was dosed in the first two cohorts of the investigational clinical trial, according to Neurelis, Inc., a commercial-stage neuroscience company. This first-in-human study aims to determine NRL-1049’s safety, tolerability, and pharmacokinetic properties.
Using proprietary technology that enables real-time GPS tracking, LiveOnNY, a nonprofit, federally recognised organ procurement organisation, and MediGO, a digital healthcare supply chain technology company, announced that they are collaborating to track organs as they travel across the nation. In order to identify problems proactively and ensure that more lives will be saved through donation, the aim of this collaboration is to increase openness as organs move across the nation.
Moderna, Inc., a biotechnology company that invented messenger RNA (mRNA) therapeutics and vaccines, and Generation Bio Co., a biotechnology company developing genetic medicines for people with common and rare diseases, recently announced that they have formed a strategic partnership to combine Moderna’s biological and technical expertise with the foundational technologies of Generation Bio’s non-viral genetic medicine platform.
Tofersen, an investigational antisense drug for the treatment of people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis, was discussed at the Peripheral and Central Nervous System Drugs Advisory Committee meeting by the US Food and Drug Administration (FDA), according to a statement released by Ionis (ALS). A rare hereditary variant of ALS called SOD1-ALS causes loss of daily functioning and eventually death.
When concerns about drug resistance arise, Indian healthcare practitioners and pharmaceutical corporations step up their efforts to control the spread of tuberculosis through early identification and research for new medications. TB poses a serious risk to public health, with an estimated 10 million infections each year. With 2.69 million cases and 4.5 lakh fatalities per year, India has the greatest TB burden. This year’s World TB Day theme is “Put a Complete End on TB,” which is marked on March 24 every year. The pharmaceutical industry and medical professionals agree that point-of-care diagnostics and new medications need to be researched.
The Drugs Controller General of India (DCGI) will receive data from Eyestem for approval of a phase 2a first-in-human research for its product called Eyesight RPE for dry age-related macular degeneration (AMD). The approval will mark a key turning point since dry AMD causes the destruction of the retina’s layer on which the photoreceptors are located, the retinal pigment epithelium. There is no solution for it anywhere in the globe, although around 3 crore people in this country suffer from it. There is now no such injection available for dry AMD, but there is another variety known as wet AMD for which injections can be given.
The US Food and Drug Administration (FDA) has designated NTLA-2002 for the treatment of hereditary angioedema as a Regenerative Medicine Advanced Treatment (RMAT), according to Intellia Therapeutics, Inc., a leading clinical-stage genome editing business (HAE). NTLA-2002 is a CRISPR-based in vivo experimental therapy intended to inactivate the target gene, kallikrein B1 (KLKB1), in order to perhaps stop HAE patients from experiencing potentially fatal swelling attacks.
An investigational new drug (IND) application for SNS-101, a conditionally active VISTA-blocking antibody, has been submitted to the US Food and Drug Administration (FDA) for a phase 1/2 clinical trial in patients with solid tumours, according to Sensei Biotherapeutics, Inc., an immuno-oncology company.
Draft guidelines for the management of urinary bladder cancer are published by the ICMR.
The draught consensus statement for the treatment of urinary bladder cancer has been made public by the Indian Council of Medical Research (ICMR). Over a period of four weeks, from March 17 to April 14, 2023, the ICMR expert group’s draught consensus text will be made available online for comments from a larger segment of the scientific community.
The US Food and Drug Administration (FDA) has granted PBP1510 (international non-proprietary name: ulenistamab), a biopharmaceutical product manufactured by Singapore-based Prestige Biopharma, Fast Track designation for the treatment of metastatic or unresectable pancreatic adenocarcinoma (PDAC) that has relapsed after and/or is resistant to at least one line of prior therapy.
First patient dosed in phase 1 clinical study (NCT05482893) of PT886, a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47 for the treatment of gastric, gastroesophageal junction, and pancreatic adenocarcinomas, according to Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology. The FDA last year designated PT886 as an orphan drug (ODD) for the treatment of pancreatic cancer. It was constructed utilising Phanes’ proprietary bispecific antibody platforms PACbody and SPECpair.
The Central Government is taking a stand that the sale of medicines should strictly adhere to the provisions of the existing regulations and that the State Licensing Authorities (SLAs) are legally empowered to act against violations of the legal provisions. Chemists and druggists across the country are opposed to the sale of drugs through online channels. While the Ministry of Health and Family Welfare (MoHFW) stated in the previous session of Parliament in February 2023 that the government had produced draught guidelines to thoroughly regulate the internet selling of medications, it made no mention of this endeavour in its most recent response.
A medical technology business called NeuroOne Medical Technologies Corporation said that the first animal implant of its innovative thin-film paddle leads for spinal cord stimulation had been successfully completed. The devices are designed to treat individuals with numerous failed back surgeries syndrome, chronic low back pain, and persistent leg discomfort.
The FDA provided encouraging input on Kuria Therapeutics’ development plan for KTX-1161 for corneal endothelial dysfunction during a pre-Investigational New Drug (IND) interaction, according to the pharmaceutical company, which is working on innovative ophthalmic and dermal treatments.
HIV Positive होना मौत की सजा नहीं है: ASICON के विशेषज्ञ
Unless HIV positive patient status is established by early diagnosis and prompt therapy, being HIV positive is not a death sentence. The 14th National Conference of AIDS Society of India (ASICON), AIDS Society of India (ASI), and Governing Council member of International AIDS Society (IAS) began on March 17, 2023, in New Delhi, and will end on March 19, 2023. The conference’s theme was “Energize, Empathize, Equalize,” and experts discussed the availability of numerous time-tested ART therapies and effective and cost-effective drugs today with fewer side effects.
The three district pharmacy officers who were chosen will soon receive appointment orders from the Nagaland State Pharmacy Council (NSPC) appointing them as pharmacy inspectors. Three inspectors will first be hired to inspect pharmacies for compliance with the Pharmaceutical Act of 1948. According to Khele Thorie, the council’s registrar, all selection procedures have been finished, and the office is currently distributing appointment orders.
The UK Medicines and Healthcare products Regulatory Agency is testing the CellQualia Intelligent Cell Processing System, a novel robotic robot that cultivates stem cells (MHRA). This robotic technology has the potential to offer patients with a variety of ailments safer and more affordable therapies. Throughout the globe today, outside of Japan, where it was created, it is the only one. It is only possible for stem cells to differentiate into various cell types with specialised functions. Because they can replace cells that have been lost or destroyed by disease, they are particularly helpful in medicine because they can, for instance, restore eyesight following corneal disease.
The open-label portion of the non-registrational phase 2 KeyVibe-002 trial received an update from Merck, also known as MSD outside of the United States and Canada. For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have progressive disease after receiving immunotherapy and platinum-doublet chemotherapy, KeyVibe-002 is evaluating MK-7684A, a coformulation of vibostolimab, an anti-TIGIT therapy, and pembrolizumab (Keytruda), a Merck anti-PD-1 therapy, with or without docetaxel.
According to a report from Pfizer Inc., the Antimicrobial Drugs Advisory Committee (AMDAC) of the US Food and Drug Administration (FDA) voted 16 to 1 in favour of the safety and efficacy of Paxlovid (nirmatrelvir and ritonavir tablets) for the treatment of mild-to-moderate Covid-19 in adult patients who are at a high risk of developing severe illness. The FDA will take into account the AMDAC’s vote even though it is not legally binding when deciding whether to approve Paxlovid.
Centralization of drug licencing does not improve the drug quality, according to SPIC.
According to SME Pharma Industries Confederation (SPIC), the country’s leading organisation for small and medium-sized pharmaceutical businesses, empowering the Central Drugs Standard Control Organization (CDSCO) through the centralization of drug licencing may not be the best way to increase the quality of medicines manufactured in the nation for both domestic and foreign markets. The way forward for ensuring the quality of medications, it was said, should be to empower state licencing authorities for better testing and staff training as well as subsidised funding for tests with a cluster strategy.
A Covid testing alternative approach has been created by the Indian Institute of Science (IISc), Bengaluru, and it can be used in areas where resources are scarce. The quantitative end point RPA is a gadget that the chemical engineering department’s researchers have developed (qeRPA). Recombinant Polymerase Amplification (RPA), a different testing approach that allows reactions to be observed at room temperature and doesn’t require a heat cycler, is preferred.
Netherlands startup and Oxford Nanopore Technologies The world’s first nanopore sequencing-based technology for ultra-sensitive detection of circulating tumour DNA has been made available to developers by Cyclomics (ctDNA). The procedure finds and evaluates cell-free DNA (cfDNA) in the blood. As a cancerous tumour releases its dying cells’ DNA, any specific mutations found in the DNA of those cells can be detected in the tumor’s complementary DNA (ctDNA). It has generally been difficult to identify ctDNA because only a little portion of the cfDNA in blood typically comes from the tumour.
The first participant in Alterity Therapeutics’ phase 2 clinical trial of ATH434 in multiple system atrophy (MSA), a rare and severely handicapping Parkinson’s disease, has been dosed in the US, according to the biotechnology company’s announcement. Alterity Therapeutics is dedicated to developing disease-modifying therapies for neurodegenerative diseases.
H3N2 Influenza: Sings and Symptoms, Treatments and Precautions
A subtype of influenza called H3N2 In India, a virus has been rapidly spreading, resulting in 90 cases and 2 fatalities thus far. According to reports, the ailment causes a fever that lasts three to five days as well as a cough and cold that can last up to three weeks. Compared to other influenza viruses, the H3N2 subtype is more likely to result in hospitalisations, and symptoms can include a persistent cough, headache, fever, and sinus-related symptoms.
All medical colleges are required by NMC to enrol with IPC as AMCs in order to report ADRs.
As part of the Pharmacovigilance Plan of India, the National Medical Commission (NMC) has ordered all accredited medical colleges and independent PG institutions to enrol as Adverse Drug Reaction Monitoring Centers (AMCs) with the Indian Pharmacopoeia Commission (IPC) as soon as possible (PvPI).
Helping the vulnerable Indian community survive sudden cardiac arrests is MedLern HeartCode
A vulnerable population in India is now being helped to survive abrupt cardiac arrests thanks to MedLern HeartCode full training. The MedLern platform is made exclusively for hospitals in India to standardise and enhance training for their medical staff. It has an intuitive UI. Through training effect evaluation and nursing recruiting assessments, this platform aids hospitals in streamlining and measuring training implementation and hiring results.
The first patient with hepatocellular carcinoma (HCC) has begun treatment in phase 2a with the candidate drug fostroxacitabine bralpamide (fostrox) in combination with Lenvima, according to Medivir AB, a pharmaceutical company dedicated to creating novel cancer treatments in regions with a high unmet medical need. In the ongoing phase 1b/2a research by Medivir, fostrox is administered along with either Lenvima, a tyrosine kinase inhibitor, or Keytruda, an inhibitor of the PD-1 checkpoint. Patients with HCC whose first- or second-line treatment has been ineffective or intolerable are included in the open-label, multicenter research. The phase 1b portion of the study evaluates the ideal fostrox dose for the following phase. This dose is subsequently utilised in phase 2a of the trial, which is when safety and effectiveness signals are further assessed.
One of the top manufacturers of minimally invasive structural heart disease devices, Occlutech Holding AG (Occlutech), has announced the enrollment of the first patient in the FROST-HF study. In the FROST-HF study, patients with heart failure with either preserved ejection fraction (HFpEF) or reduced ejection fraction (HFrEF) are being treated using Occlutech’s Atrial Flow Regulator (AFR) (HFrEF).
BRIDGEWATER, N.J.–(BUSINESS WIRE)– Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug Application (ANDA) for naloxone hydrochloride nasal spray, USP, 4mg, which is the generic version of Narcan® and is used in the treatment of a known or suspected opioid overdose emergency.
Zydus receives final approval from the USFDA for Lenalidomide Capsules, 2.5 mg and 20 mg
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Lenalidomide Capsules, 2.5 mg and 20 mg (USRLD: Revlimid® Capsules). Lenalidomide Capsules are used to treat various types of cancers.
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged its member companies to submit their expressions of interest (EOI) to export levothyroxine and levonorgestrel from India if they have operations in Latin American Countries (LAC) or are interested in expanding their businesses in the region.
Two more medical device testing facilities are approved by CDSCO.
According to the 2017 Medical Devices Regulations (MDR), the Central Drugs Standard Control Organization (CDSCO) has authorised two more Medical Device Testing Labs (MDTL) to conduct tests or evaluations of medical devices on behalf of the manufacturers. With this, there are now 30 MDTLs nationwide that the regulator has approved. Bharat Test House Pvt Ltd in North West Delhi and Manisha Analytical Labs Pvt Ltd in Mumbai are the two recently added laboratories. Under the MDR, 2017, Bharat Test House has been given permission to test 20 products, including surgical and diagnostic lamps, operating tables, ultrasonic physiotherapy equipment, infant incubators, and medical electrical equipment in a variety of classes.
The US FDA has approved Pfizer’s Zavzpret nasal spray for migraines
Zavzpret (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray, has been approved by the US Food and Drug Administration (FDA) for the immediate treatment of migraine in adults with or without aura. Zavzpret was statistically better to placebo on the co-primary objectives of pain freedom and freedom from the most bothersome symptom at two hours after dosage in its pivotal phase 3 study. As a secondary endpoint that was predetermined, the pivotal study also showed that there was pain reduction versus placebo as early as 15 minutes later.
Statistically significant and clinically meaningful improvements in overall survival (OS), a crucial secondary endpoint, were seen with AstraZeneca’s Tagrisso (osimertinib) compared to placebo in the adjuvant treatment of patients with early-stage (IB, II, and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), following complete tumour resection with curative intent. AstraZeneca reported that Tagrisso had improved disease-free survival (DFS) in this situation by a statistically significant and clinically meaningful amount in May 2020. Updated findings from September 2022 showed a median DFS of about five and a half years.
Researchers from the Department of Organic Chemistry (DOC) and the Materials Research Center (MRC) at the Indian Institute of Science (IISc) have demonstrated that surface modifications of two-dimensional molybdenum disulphide (2D-MoS) nanosheets can greatly increase their effectiveness for uses like delivering drugs to diseased cells. Depending on the application, nanomaterials typically need to be customised or modified to increase their effectiveness. Functionalization, a method of chemically modifying nanomaterials, entails binding ligands (small or big molecules) to the surface of the nanomaterial.
A group of pharmacists from the state of Maharashtra who have a degree and higher education credentials (B Pharm, M Pharm, and Pharm D) have complained that the upper age limit of 25 is being purposefully imposed on the position of pharmacy officer in some central government departments, particularly in the Defence.
The USFDA has given approval for fluorouracil injection, a cancer medication, to Alembic Pharma.
Alembic Pharmaceuticals Ltd (Alembic) declared that its Abbreviated New Drug Application (ANDA) fluorouracil injection USP, 2.5 g/50 mL (50 mg/mL) pharmacy bulk vial has been given final FDA approval.
Further findings from in vitro MODIF-Y tests from the Janssen Pharmaceutical Companies of Johnson & Johnson reinforce the idea that not all IL-23 inhibitors work the same way by showing that Tremfya (guselkumab) and risankizumab have different binding mechanisms. According to research, guselkumab can attach to CD64+a myeloid cells, which are the main cause of IL-23-induced inflammation in the gut, in a dose-dependent manner. This is one of the 22 oral and poster presentations that Janssen will be making at the 18th Congress of the European Crohn’s and Colitis Organization (ECCO), which will be held March 1–4 in Copenhagen, Denmark.
Faricimab intravitreal injection, manufactured by Swiss multinational pharmaceutical company Roche, has been approved for import and marketing in India, with the local phase III clinical trial being waived subject to conditions, according to the expert committee’s recommendation. To treat Neto vascular (wet) age-related macular degeneration (nAMD) and diabetic macular edoema (DME), Roche Products (I) Pvt Ltd has offered the drug faricimab 6 mg/0.05 ml solution for intravitreal injection. The medicine was introduced in the US under the brand name Vabysmo.
The InnovaBurn placental extracellular matrix medical device from Convatec has been approved by the US Food and Drug Administration for the care of difficult surgical wounds and burns, including partial-thickness second-degree burns. According to the American Burn Association’s ameriburn.org, which uses the most recent data available from the Centers for Disease Control and Prevention, about 500,000 people seek medical attention each year for burn injuries. Over 40,000 of these people had to be hospitalised for burn wounds.
ShanMukha Innovations creates the first ever locally produced sickle-cell anaemia diagnostic kit.
The sickle-cell anaemia diagnostic kit developed by ShanMukha Innovations, an incubator company at the Indian Institute of Science (IISc), is now available. The endeavour will provide the Union government’s goal of eradicating sickle cell anaemia by the year 2047 a boost. The Bengaluru-based ShanMukha Innovations, a start-up nurtured by the Society for Innovation and Development (SID) at the IISc, is the name behind India’s first ever sickle-cell anaemia diagnostic kit manufactured domestically. The test kit, SickleCert, uses a HaemoCube portable analyzer and High Performance Optical Spectroscopy (HPOS) as its foundation.
Based on the National List of Essential Medicines (NLEM), 2022, the National Pharmaceutical Pricing Authority (NPPA) updated and established the ceiling price for 79 scheduled formulations in the revised Schedule I of the Pharmaceuticals (Prices Regulation) Order, 2013. The Authority evaluated 84 formulas at its most recent meeting on February 21, 2023, for which it had already made draught working sheets available and had used the pricing regulator’s allotted 10-day period for companies to react. The Authority evaluated and accepted the remaining 84 formulations after taking the industry submissions into account. Of the 84 formulations, the Authority disagreed on the establishment of ceiling pricing for five formulations for various reasons.
February 2023
LR 09, a novel metabolic immune checkpoint inhibitor, has been given Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of patients with haematological malignancies who have been identified with a relapse following allogeneic stem cell transplant. This information was released by Laevoroc Immunology (Laevoroc), a privately held Swiss oncology development company (SCT).
The first patient infusion and the start of a clinical investigation of JWATM214 in people with advanced hepatocellular carcinoma (HCC) were both reported by JW Therapeutics, an independent and creative biotechnology business.
The All India Organisation of Chemists and Druggists (AIOCD), which claims to have more than 10 lakh members throughout the nation, has urged the Central government to stop the e-pharmacy business in India on numerous occasions. However, the other traders’ group, the All India Chemists and Druggists Federation (AICDF), has stated that the government of India cannot stop the online medicine business unless appropriate guidelines are framed. The group asserts that the latest show-cause notifications sent by CDSCO to 20 operators of online pharmacies, including Tata 1mg, Amazon, and Flipkart, were merely a charade and had no legitimate purpose. In terms of the operators and their operations, the government is well aware.
Adalimumab has started to be sold commercially for the treatment of rheumatoid arthritis and ankylosing spondylitis, according to Enzene Biosciences Ltd., a technology-focused biotechnology business based in Pune. This is the business’s fourth biosimilar launch in recent years, and the company thinks that this first commercial launch utilising continuous manufacturing technology would help in lowering the cost of RA therapy for millions of patients throughout India.
The performance of the MiniMed 780G advanced hybrid closed loop system (AHCL) versus multiple daily insulin injections (MDI) with an intermittently scanned CGM was compared in the first multi-national randomised controlled study, or “ADAPT,” conducted by Medtronic plc, the world leader in medical technology, and was revealed after one year of data from the study (n=82) (isCGM).
The US FDA has authorised COVI-Go, a COvid-19 fast antigen self-test, for emergency use at home.
Mologic Inc., a leading provider of lateral flow and quick diagnostic technologies, products, and services, disclosed that the US Food and Drug Administration (FDA) had granted emergency use approval (EUA) for its proprietary COVI-Go SARS-CoV-2 Ag Self-Test for over-the-counter use at home. With the US National Institutes of Health (NIH) RADx initiative, the test’s development was financed.
Researchers from the Indian Institute of Science (IISc), Bengaluru demonstrate how a brain-inspired image sensor can identify minute items like cellular components or nanoparticles that are undetectable to modern microscopes by going beyond the diffraction limit of light. Their ground-breaking method, which combines optical microscopy with a neuromorphic camera and machine learning algorithms, represents a significant advancement in the ability to locate objects smaller than 50 nanometers.
The Product Ignition & Development Enabler (mPRiDE) programme of the Indian Council of Medical Research (ICMR) has shortlisted three companies: Udyog Yantra Technologies Pvt Ltd, LVP Eye Innovations, Hyderabad, and Evelabs Technologies Pvt Ltd, Kollam. The programme aims to accelerate the commercialization of medical devices for general use. By assisting medical device firms, the mPRiDE programme will hasten the development, scaling, and commercialization of medical device products. Companies with a wealth of knowledge and proven abilities can create an enabling ecosystem to hasten the adoption of products with a positive social impact.
The Kyasanur Forest Disease Vaccine (KFDV) isolate will be used in R&D activities by experienced vaccine manufacturers, pharmaceutical corporations, and research and development organisations for the development of a vaccine against KFD and its manufacture or commercialization. In order to create a novel vaccine candidate with improved efficacy and recipient safety, the ICMR-National Institute of Virology (NIV) Pune has isolated and analysed KFDV isolates from recent KFD outbreaks in Karnataka State.
Altuviiio [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], formerly known as efanesoctocog alfa, is a first-in-class, highly sustained factor VIII replacement therapy that has received FDA approval. For both adults and children with haemophilia A, the use of altuviiio is recommended for routine prophylaxis, on-demand treatment to stop bleeding episodes, and perioperative care (surgery). In comparison to previous factor VIII prophylaxis, bleeding is greatly reduced with altuviiio, the first and only haemophilia A medication that offers normal to near-normal factor activity levels (above 40%) for the majority of the week with once-weekly dose.
PCI ने Faculty की जानकारी अपडेट नहीं करने वाले संस्थानों के खिलाफ कानूनी कार्रवाई की चेतावनी दी है
The Pharmacy Council of India (PCI) has threatened legal action, including the revocation of approval, against pharmacy colleges that fail to update the details of faculty resignations or appointments through the online portal, which would be available all year. The choice would assist the Council in obtaining an accurate view of the institutions’ teaching staff situations. The PCI has observed that in some instances, the teaching staff has left the institution but has not been let go by the institution or the principal. As a result, even when the faculty has changed institutions, they are still listed in the old institution since they are unable to update their information, which prevents an accurate representation of the teaching staff’s status from being provided. Also, it has come to light that schools are submitting faculty names without permission.
The phase III FIGARO-DKD study’s findings on cardiovascular (CV) outcomes received approval from the European Commission for inclusion on Kerendia’s (finerenone) label in the European Union (EU). According to the study, Kerendia decreased the risk of cardiovascular events in a large group of individuals with stages 1-4 CKD and T2D. The early phases of CKD linked to T2D are now included in the indication for Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist. Adults with type 2 diabetes and chronic renal disease (accompanied by albuminuria) can now be treated with Kerendia.
Single-dose antibiotic avoids maternal sepsis and death, according to NIH-funded research
According to a significant multi-country clinical trial supported by the National Institutes of Health, a single oral dose of the antibiotic azithromycin can reduce the likelihood of postpartum sepsis and death among women who give birth vaginally by one-third (NIH). Contrary to 2.4% of those who received placebo, only 1.6% of research participants who were given azithromycin during labour experienced sepsis or lost their lives within six weeks of giving birth. The risk of miscarriage, infant sepsis, or newborn death was not decreased by azithromycin.
Results from the study, which included more than 29,000 women in seven low- and middle-income nations, were presented at the Society for Maternal-Fetal Medicine’s 43rd Annual Pregnancy Meeting in San Francisco and were published today in the New England Journal of Medicine.
फार्मा और हेल्थकेयर के लिए एक प्रगतिशील बजट
Nirmala Sitharaman, the union finance minister, has proposed a number of initiatives for the pharmaceutical and healthcare sectors in the union budget for 2023. The Finance Minister stated during her budget statement in Parliament that a new initiative would be implemented to support pharmaceutical research and innovation through centres of excellence. It is obvious that the government is focusing on improving the healthcare infrastructure of the nation through these efforts, therefore it is of course a positive step on their part. And without a doubt, this will inspire business to invest in R&D in particular key areas, helping India emerge as a leader in pharmaceutical innovation on a global scale.
Strip cutting of medications has been a significant problem for lakhs of pharmaceutical sellers in the nation, one that has eluded a permanent resolution because to the drug authorities’ callous attitude. Arguments and counterarguments have long flown thick and fast for and against the practise of strip cutting by pharmacists due to the lack of explicit prohibitions in the Drugs and Cosmetics Act. It is true that both regulatory officials and the community of pharmacists are very unclear on the subject. Regulatory officials hold varying opinions on the issue because there is no explicit legal provision stating whether strip cutting is permitted or not.
Online pharmacies, including Tata 1mg, have received a show cause notice from the Drug Controller General of India (DCGI) for allegedly stocking and selling drugs in violation of the Drugs and Cosmetics Act, 1940 and Rules. This has once again brought to light the long-standing problem of the absence of regulations on e-pharmacies under the country’s current drug regulations. It’s interesting that this is happening at the same time as the government is establishing rules for the purchase of drugs online.
The Drugs (Prices Control) Order (DPCO), 2013, and its existing reference have led the National Pharmaceutical Pricing Authority (NPPA) to decide to set a price cap on newly scheduled medications from the same manufacturer with significant inter-brand price variation at the cost of the least expensive brand or pack size plus 10%. The National List of Essential Medicines (NLEM), 2022, has been released by the NPPA and contains a total of 384 medications, 34 of which are new medications that have been added to the list and 26 from the previous list that have been removed for a variety of reasons.
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