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EDITOR'S EMULSION
Warm Greetings!!!
Welcome to yet another most pleasant Reading of our newsletter.
It is always my privilege to reach you on 1st & 17th of every month, since the last 13 years. Please do not hesitate to share your comments on this edition to enable us to constantly improve. Please feel free to get in touch with us. You may find our previous issues on our website jagograhakjago.com or in the NEWS ARCHIVE section of every issue of The Prescription, in case you’ve missed any of them. You may also look us up on Facebook.
Stay Healthy. Stay Protected.
Pyush Misra
Editor-in-Chief
DOSE OF THE DAY
"While it is important to learn from global best practices and follow SOPs, let us learn from the national examples of emergency and disaster response in the past few decades and enrich our model from learning and insights from these.
The multi-sectoral and multi-layered learning need to be incorporated in the training and capacity building modules of the national architecture of emergency response and management"
Dr. Mansukh Mandaviya
Minister of Health and Family Welfare; Chemicals and Fertilizers
Govt of India
Sponsor
Patient Safety Capsules
Number of registered practitioners in Ayush systems sees 2% decline in five years
New Delhi, January 27, 2023 : The total number of registered practitioners in Ayurveda, Yoga & Naturopathy, Unani, Siddha, Homoeopathy and Sowa Rigpa (Ayush) systems of medicine has seen a decline of two per cent in five years from 7,73,668 doctors in the year 2017, to 7,55,780 doctors in 2021, according to the Union Ministry of Ayush.
Sales under PMBJP grows 33% in first nine months of the fiscal year 2022-23
New Delhi, January 23, 2023: Sales of medicines and related products through the Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJK) has grown 33.32 per cent during the first nine months of the current fiscal year compared to the same period of last year, even as the total number of outlets touched 9,000, according to data from Department of Pharmaceuticals (DoP).
Drug Laws & Policy Injections
SEC advices CDSCO to incorporate FDE associated to Paracetamol and Piroxicam in PIL
New Delhi, January 23, 2023: An expert panel, that advises the central drug regulator on new drug approvals and clinical trials among others, has recommended to the Central Drugs Standard Control Organisation (CDSCO) to take steps to include occurrence of Fixed Drug Eruption (FDE) associated to two drugs - paracetamol and piroxicam - in the Prescription Information Leaflet (PIL).
NPPA panel recommends retail price of anti-diabetes drugs after cutting the price of off-patent component by 50%
New Delhi, January 30, 2023 : The expert panel which advices the National Pharmaceutical Pricing Authority (NPPA) has recommended retail price fixation of various anti-diabetes formulations comprising dapagliflozin, sitagliptin, and vildagliptin in various dosages
DCGI allows relabeling & re-stickering of drugs under Rule 104A of D&C RulesMumbai, February 1, 2023 : With reference to the re-stickering of price controlled scheduled drugs and National List of Essential Medicines (NLEM), the Drugs Controller General of India (DCGI) has issued a circular to the state drug controllers (SDCs) stating that it has no objection for relabeling and stickering of the drugs under Rule 104A of Drugs and Cosmetics (D&C) Rules and directed them not to intervene on the same.
Regulators & experts extend support to IPA’s mission to train pharmacists to make them competent vaccinators
Chennai, January 28, 2023 : Regulatory officers and associations of pharmacy professionals including AIDCOC, IPGA and IHPA have extended support to Indian Pharmaceutical Association (IPA)’s mission to train the practicing pharmacists in the country to become competent vaccinators to be utilized for the country’s immunization programmes.
Indian medical experts stress on need for USFDA advice to reduce risk of transfusion transmitted malaria
Bengaluru, January 21, 2023 : Indian medical experts stress on the need for USFDA advice to reduce the risk of transfusion-transmitted malaria. This is because the life-threatening infectious disease is a major health challenge not just in the country but many developing countries.
Movement of counterfeits in Indian pharma attributed to supply chain inefficienciesBengaluru, January 27, 2023: Supply chain inefficiencies hinder the fight against counterfeit medicines and medical devices in India. This is despite the methods to check counterfeits like security labels, tamper evident seals, security tear tapes, tagger foils, security blister foils and serialization adopted by the Indian pharma industry.
Pharma Injections
NPPA proposes revised ceiling price of gentamicin injection 10m/ml by over 70%
New Delhi, January 31, 2023: The National Pharmaceutical Pricing Authority (NPPA) has proposed a ceiling price reduction of over 70 per cent for a certain formulation of antibiotic drug gentamicin injection from the current price, while leaving the ceiling price of certain compositions of formulations like anticholinergic drug atropine ointment and dermatology drug betamethasone cream unchanged.
SEC recommends waiver of local phase III and IV trials for Sanofi's orphan drug to treat Pompe disease
New Delhi, January 30, 2023: The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinical trials in India for Sanofi Healthcare India's orphan drug to treat the Pompe disease.
Delhi HC quashes Patent Office's order against Allergan's ophthalmic implant patent applicationNew Delhi, January 25, 2023: The Delhi High Court has quashed an order by the Controller of Patents against US-based Allergan denying patent for an intracameral sustained release implant for ocular ailment and remanded the application back to the Controller for fresh consideration.
Macleods Pharma gets favourable order from Delhi High Court on trademark dispute
New Delhi, January 27, 2023 : The Delhi High Court has confirmed its earlier order for an ad interim interlocutory injunction in favour of Mumbai-based Macleods Pharmaceuticals, restraining its competitor Navi-Mumbai-based Areen Healthcare Pvt Ltd from manufacturing and selling a herbal supplement for alleged trademark infringement.
Five samples of Maiden Pharma's cough syrup declared as NSQ by CDSCO; NSQ list include names of GSK, Cipla and KAPL
New Delhi, January 19, 2023 : The sample tests conducted by the Central Drugs Standard Control Organisation (CDSCO) for Not of Standard Quality (NSQ), spurious and misbranded drugs during the month of December, 2022 has identified five batches of cough syrup manufactured by Haryana-based Maiden Pharmaceuticals
IISc & Unilever to develop computational models of bacterial cell walls to speed up screening of antimicrobialsBengaluru, January 20, 2023 : The Indian Institute of Science (IISc) and Unilever have collaborated to develop computational models of bacterial cell walls that can speed up the screening of antimicrobials. These are molecules which can kill disease-causing bacteria.
Drug Dopes
Experts concerned over young adults becoming victims to heart attacks due to sedentary lifestyle
Mumbai, January 21, 2023 : Heart attacks were once common in elderly people, but now it has become a huge concern because young adults are becoming victims due to sedentary lifestyle. Experts raise an alarm over the development saying that India is the country with the most people suffering from heart disease. 
Med-tech sector scouts for export incentives under RoDTEP to boost R&D eco-systemBengaluru, January 14, 2023 : Indian med-tech industry now sees the increasing need for favourable policies in line with the current inflationary challenges. This along with export incentives under the Remission of Duties and Taxes on Export Products Scheme (RoDTEP) would boost R&D ecosystem in the sector.
NPPA directs Bayer Zydus Pharma to continue selling four scheduled formulations of UrografinNew Delhi, January 21, 2023 : The National Pharmaceutical Pricing Authority (NPPA) has directed Bayer Zydus Pharma, a joint venture between Bayer (South East Asia) and Cadila Healthcare, to continue production and sales of various strengths and sizes of diagnostic agent Urografin as against the company’s application to discontinue the scheduled formulations.
Medical devices industry seeks clarity on misbranded and adulterated medical devices in New Drugs BillMumbai, January 25, 2023 : The medical device industry has sought clarity from the Centre on misbranded and adulterated medical devices with reference to Draft New Drugs, Medical Devices and Cosmetics Bill, 2022.
TNCD Amaipu to begin agitation against unethical trade practices by corporate entitiesChennai, January 31, 2023: The Tamil Nadu Chemists and Druggists Amaipu (TNCD Amaipu), the trade body of the splinter group of the state chemists and druggists association enjoying support of 23 district committees, has decided to prepare for agitation programmes from the first week of March against inaction from government agencies on unethical trade practices by corporate entities by indulging in predatory pricing.
Pharmexcil invites Indian companies to be part of business delegation to CIS region in March 2023Mumbai, January 31, 2023 : The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has invited Indian companies to be part of the Pharmexcil’s business delegation to CIS region in the month of March 2023.
National Injections
Maharashtra FDA makes massive crackdown on illegal sale of steroidal drugs misused for body buildingMumbai, January 28, 2023 : The Maharashtra Food and Drugs Administration (FDA) has recently made a massive crackdown on rampant and illegal sale of steroidal drugs misused for body building and seized stock of Rs. 51.27 lakhs based on the Maharashtra FDA intelligence department’s reports.
Delhi High Court orders director of Triveni Interchem to pay Rs. 2 crore to Pfizer
New Delhi, January 28, 2023 : The Delhi High Court has ordered a director of a domestic firm Triveni Interchem Pvt Ltd to pay Rs. 2 crore to global pharma major Pfizer Inc finding that the former has committed willful and contumacious contempt of the court by violating its earlier order to restrain from making, selling, distributing or advertising drugs with the ingredient palbociclib.
Kerala DCA to crack the whip on erring medical shops to make the state completely antibiotic literate in 2023
Chennai, January 18, 2023 : As part of making Kerala a ‘completely antibiotic literate state’, the state health department has strengthened its action to curb OTC sale of antibiotics and directed the drug control administration to take strong action against pharmacies violating rules.
Karnataka pharmacy colleges aver that students have adequate skills to vaccinate & treat minor ailments
Bengaluru, January 25, 2023 : Pharmacy colleges in Karnataka have averred that their students have the adequate training and skills to administer vaccine and treat minor ailments. The Union and state governments have also introduced skilling of health science professionals which helped the budding pharmacists to widen their horizon to serve the community.
DBT calls for LoI to support development of drugs to treat cancerNew Delhi, January 31, 2023 : The Department of Biotechnology (DBT) has initiated efforts to support research and development of affordable and effective therapies to reduce the incidence of cancer in the country, with an aim to make the nation cancer free by 2047.
Making OPDs cashless will ensure more people consider preventive healthcare as a priority
Mumbai, January 20, 2023 : Making Out Patient Departments (OPDs) cashless will ensure more people consider preventive healthcare as a priority, according to HealthTech experts on the pre-Budget expectations on HealthTech sector.
Global Injections
Canadian province experiments with decriminalising hard drugsJanuary 31, 2023: Canada's province of British Columbia is starting a first-in-the-nation trial decriminalising small amounts of hard drugs such as cocaine and heroin.
Covid in China: Officials say current wave is 'coming to an end'
January 31, 2023: The number of severe Covid cases and deaths is trending downward, the country's Center for Disease Control and Prevention (CDC) said in a report.
Aptar creates metal-free nasal spray pump to boost recyclabilityJanuary 31, 2023: Aptar Pharma wants to reduce the waste generated by your nasal spray pumps. With the launch of APF Futurity, the drug delivery specialist has made a metal-free, multi-dose nasal spray pump available to meet demand for recyclable products.
Israel says has not found a link between Pfizer COVID shot and stroke
January 20, 2023: Israel has not identified any evidence linking strokes to an updated coronavirus vaccine made by United States (US) drugmaker Pfizer and its German partner BioNTech, according to a health ministry official.
Eli Lilly to invest $450 million more to expand capacity as obesity drug decision loomsJanuary 25, 2023: Eli Lilly plans to invest an additional $450 million to expand capacity of a plant in North Carolina, the drugmaker said yesterday, as it races to boost production ahead of a decision on its promising obesity treatment.
Novartis warns US plan to curb drug prices could hit key researchJanuary 23, 2023 : The United States (US) government plans to rein in drug prices could discourage work in some of Novar-tis’s most promising areas of research, the Swiss drugmaker warned recently, urging Washington to re-think the “unintended” effects of its new rules.
PSAIIF PILL
Health minister unveils India’s first intra-nasal COVID vaccine
New Delhi, January 27, 2023: Union Minister of Health and Family Welfare Dr Mansukh Mandaviya unveiled the iNNCOVACC COVID-19 vaccine yesterday in the presence of Dr Jitendra Singh, Union Minister of State (IC), Science and Technology. iNNCOVACC is the world’s first intra-nasal COVID-19 vaccine to receive approval for the primary two-dose schedule, and as a heterologous booster dose. It is developed by Bharat Biotech, in collaboration with Biotechnology Industry Research Assistance Council (BIRAC).
Why the next era in pharma and healthcare will be about patient-centric innovation
New Delhi, January 25, 2023: While the lifesciences and healthcare industry has always been important to health and wellness, its impact was especially evident during the COVID-19 breakout. All eyes were on pharma companies as they raced against time to develop medicines that would treat the disease, along with vaccines that would control it. Terminology around molecules, biomolecules, DNA and mRNA recombinants became part of our collective vocabulary.
Frequently Asked Questions
What is Drug Fever?
Drug fever is a common condition that is frequently misdiagnosed. It may be defined as a disorder characterized by fever coinciding with administration of a drug and disappearing after the discontinuation of the drug, when no other cause for the fever is evident after a careful physical examination and laboratory investigation. Drug-induced fever is a symptom of an adverse drug reaction wherein the administration of drugs intended to help a patient causes a hypermetabolic state resulting in fever. The drug may interfere with heat dissipation peripherally, increase the rate of metabolism, evoke a cellular or humoral immune response, mimic endogenous pyrogen, or damage tissues. Onset of fever occurs usually between 7 and 10 days after the medication has begun. Return to normal occurs after 2-3 days of discontinuation of the drug.
SUBSCRIBER'S SYMPTOM
How Bacteria Nearly Killed By Antibiotics Can Recover — And Gain Resistance
Mostly dead bacteria can sometimes be resurrected as antibiotic-resistant cells. A protein that pumps toxic chemicals out of E. coli bacterial cells can buy time for even nearly dead mi-crobes to become antibiotic resistant. The protein, known as the AcrAB-TolC multidrug efflux pump, doesn’t work well enough to defeat antibiotics on its own. But it can move enough antibiotic molecules out of bacterial cells to allow production of real resistance proteins, researchers report in the May 24 Science.
Consumer Online Foundation: The first and only organisation certified as per international standard ISO 9001:2015 for Consumer Complaint Redressal Services
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Blog Addicts
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Dr. Swati blogs “ PSAII has shaped a vision to build a nation of counterfeit free medicine”.
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