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EDITOR'S EMULSION
Warm Greetings!
Welcome to yet another exciting month and a most pleasant Reading of our newsletter.
Please do not hesitate to mail your comments on this edition to help us further improve so 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
“At the onset of the Covid-19 pandemic, there was a global crisis of testing kits and reagents, as India was heavily reliant on imported products for molecular detection of viruses. As such in mid-March, no rates for RT-PCR test for coronavirus were available for ready reference in the country. Keeping in view the cost of imported kits and efforts involved in carrying out the test, ICMR suggested the upper limit of a single test at Rs 4,500”
Dr. Balram Bhargava
ICMR Director-general
Government of India
Sponsor
Patient Safety Capsules
Traditional Drug Companies Begin Immunity Trials
Mumbai/New Delhi, 9 June 2020: More than 20 manufacturers of Ayurvedic, Unani and Homeopathy medicines have launched clinical trials for Covid-19 immunity booster therapies, hoping to validate their non-allopathic products during the epidemic and shore up support from the medical fraternity.
Targets For Coronavirus Vaccine Identified By Scientists
New Delhi, 10 June 2020: Scientists have identified regions of the SARS-CoV-2 virus that causes COVID-19 to target with a vaccine, by harnessing tools used for the development of cancer immunotherapies. The researchers at Children's Hospital of Philadelphia (CHOP) in the US employed the same approach used to elicit an immune response against cancer cells to stimulate an immune response against COVID-19.
Drug Laws & Policy Injections
Export Ban On HCQ Could Be LiftedNEW DELHI, 10 JUNE 2020: India is considering lifting the ban on export of hydroxychloroquine (HCQ) used in the treatment of Covid-19, people in the know told ET.
Centre Deploys High-Level Teams To Assist 15 States That Saw Cases Spurt NEW DELHI, 10 JUNE 2020: Amid rising Covid-19 cases, the health ministry on Tuesday deployed high-level multi-disciplinary central teams in 15 states and Union Territories with more than 50 districts or municipal bodies witnessing a high case load and a spurt of cases to provide technical support for containment and to facilitate management of the outbreak.
Use Hand Sanitiser Only When There Is No Availability Of Soap, Expert RecommendsNew Delhi, 9 June 2020: While COVID-19 pandemic has hit hard on human lives, people from every stratum of the society are keeping themselves aware and updated with the information available on public domain – by maintaining distance, wearing a mask and carrying a bottle of sanitisers necessarily if not soap. However, experts have recommended to use sanitiser only when soap is unavailable and also cautioned about its over use.
FSSAI Guidance And Notification On Nutraceuticals – An InsightVisakhapatnam, 8 June 2020: A nutraceutical is a food or food related component that intends for health benefits even in treatment and prevention of aliments. Many people rely on dietary supplements as alternative therapy that are medicinal herbs and nutraceuticals. There is rising demand for nutraceuticals worldwide.
ICMR, DCGI Jointly Release Guidelines For Validation And Batch Testing Of COVID-19 Diagnostic KitsMumbai, 9 June 2020: The Indian Council of Medical Research (ICMR) and Drugs Controller General of India (DCGI) have jointly come out with guidelines for validation and batch testing of COVID-19 diagnostic kits.
5 Firms Await Regulator’s Nod To Make RemdesivirNEW DELHI, 8 JUNE 2020: Despite rapidly rising Covid-19 deaths and an approval to use Remdesivir for treatment of severe cases, Indian patients are still waiting for the drug to be available in the country as companies are awaiting marketing approval from the Drugs Controller General of India (DCGI).
Pharma Injections
Transasia Bio Medicals Sets Up Asia's Largest Factory For Coronavirus Testing KitsMumbai, 9 June 2020: Mumbai-based Transasia Bio Medicals, the largest domestic laboratory diagnostics maker, has set up a factory at Andhra Pradesh MedTech Zone in Visakhapatnam to manufacture various COVID-19 diagnostic kits. The unit is claimed to be the largest in Asia for its capacity.
Drugs, Medical Devices Worth Rs 5.50 Lakh Seized In FDA RaidNagpur, 10 June 2020: Food and Drugs Administration (FDA) Nagpur division has seized drugs and medical devices worth Rs 5.50 lakh from unauthorised traders having no licence to sell these items, on Tuesday.
Complaints Lodged Against Bihar DC For Delaying Licences For Manufacturing Hand Sanitizers Chennai, 9 June 2020: In spite of all possible measures taken by the health department of Bihar to contain the outbreak of COVID-19 pandemic and maintain availability of all essential drugs during the present crisis period, the state pharma industry alleges that all the healthcare efforts of the state government is torpedoed by the state drugs controller by deliberately delaying licensing processes and resorting to illegal actions.
AYUSH Manufacturers In Spot Over False Covid Cure Claims New Delhi, 6 June 2020: Coming down heavily on AYUSH manufacturers for flooding markets with products claiming to have anti-Covid properties, the Centre has directed states to crack down on those indulging in the malpractice.
WHO Changes Stance, Calls For 3-Layer Covid-19 Masks In Public New Delhi, 7 June 2020: In a big shift from its earlier position, the World Health Organisation (WHO) has issued new guidelines that say everyone should wear a three-layer fabric or non-medical mask in public to prevent the spread of the coronavirus disease (Covid-19).
Centre Relaxes Norms For Import Of Certain Drugs New Delhi, 8 June 2020: The Union health ministry has issued a draft notification to allow import and manufacturing of certain unapproved drugs on compassionate grounds in small volumes based on a prescription from a medical institution. The move is aimed at making experimental drugs for treating coronavirus disease (Covid-19) accessible for severely-ill patients in India.
Drug Dopes
Major Fire Erupts In Factory Making Sanitisers In SolanBaddi, 5 June 2020: A major fire has erupted in a factory manufacturing sanitizers in Buddi region of Solan district in Himachal Pradesh. The fire department has responded to the call and fire brigades have arrived on the spot. 
Samples Declared Inappropriate Before TestingBhopal, 8 June 2020: A series of copies of communication between the Mahatma Gandhi Memorial Medical College, Indore, and its virology laboratory tasked with testing samples for COVID-19 has revealed that authorities directed the testing in-charge to declare clutches of samples “inappropriate”, without testing them or consulting virologists.
New Rules For Setting Up Sanitiser Manufacturing Unit In Telangana Hyderabad, 5 June 2020: The State Drug Control Administration (DCA) has released detailed guidelines and regulatory requirements for companies who are wishing to start manufacturing hand sanitisers in the State.
Mumbai: Local Medical Device Industry Slams Delays In Getting Government Approval MUMBAI, 4 JUNE 2020: Faced with delays in getting regulatory approvals for Covid diagnostic kits, the domestic medical device industry has said that the government is discriminating, and sought a level playing field with importers, in line with the “Make in India” vision.
Mumbai: ICMR Pulls Up Nair Hospital For Sharing Plasma With Private Hospitals Not In Covid-Cure Trial MUMBAI, 2 JUNE 2020: The Indian Council of Medical Research (ICMR) recently sought an explanation from the BMC-run B Y L Nair Hospital over the distribution of plasma units to hospitals not registered for the Covid-19 treatment trial. TOI has learnt that the hospital has given a written explanation to the ICMR, whose move was possibly triggered by reports that plasma was being sold in the grey market.
DRDO Develops Device To Keep PPE Wearers ComfortableNew Delhi, 4 June 2020: The Defence Research Development Organisation (DRDO) has developed a device -- SUMERU-PACS -- that helps wearers of Personal Protective Equipment (PPE) comfortable without sweating.
National Injections
To Cut Dependence On China For APIs, Centre Offers Incentives To Desi Firms NEW DELHI, 3 JUNE 2020: With an aim to reduce its import dependence on China for sourcing drug raw material and spur production in India, the government proposes to offer local manufacturers of active pharmaceutical ingredients (APIs) production and viability-linked incentives up to Rs 10 crore.
NPPA Releases Draft Guidelines For Discontinuation Of Scheduled FormulationsMumbai, 3 June 2020: The National Pharmaceutical Pricing Authority (NPPA) has released draft guidelines for dealing with cases of discontinuation of scheduled formulations under paragraph 21(2) of Drugs Prices Control Order (DPCO)- 2013 for stakeholders suggestions and comments. The national drug pricing regulator has directed stakeholders or drug manufacturers to send suggestions or comments on draft guidelines by June 15, 2020 to the NPPA office or email at monitoring-nppa@gov.in.
Ten States Unable To Ensure Food Security; 15% Of All Samples Sub-Standard New Delhi, 2 June 2020: India is facing a food fraud problem with about ten states unable to ensure food safety and 15% of food samples failing to pass quality tests. “The food regulator analyses a total of 106,459 samples across India and finds over 15.8% food samples as sub-standard, 3.7% unsafe, and 9% mislabeled during the year 2018-19,”
NPPA Fixes Retail Prices Of 40 Formulations Mumbai, 2 June 2020: NPPA has fixed retail prices of 40 formulations under Drugs Prices Control Order (DPCO)- 2013 based on its 75th authority meeting held on May 20, 2020.
FSSAI Launches New Online Platform To Issue License To Food Biz New Delhi, 31 May 2020: Food Safety and Standards Authority of India (FSSAI) has announced the launch of its cloud based food safety compliance online platform. The platform will be called ‘Food Safety Compliance System (FoSCoS)," as per the statement released by the FSSAI.
Cabinet Approves Re-Establishing Of Pharmacopoeia Commission For Indian Medicine & Homoeopathy New Delhi, 3 June 2020: In a bid to improve the standardization outcomes and effective regulation and quality control of Ayurveda, Siddha, Unani and Homoeopathy drugs, the Union Cabinet chaired by the Prime Minister, Narendra Modi on Wednesday gave its approval to re-establish Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) as Subordinate Office under Ministry of AYUSH by merging into it
Global Injections
US Sues Chinese Firm Over Half-Million 'Fake' N95 MasksNew York, 6 June 2020: The US Justice Department sued a Chinese company for selling nearly a half million fake and substandard N95 respirator to US buyers in April as the COVID-19 pandemic swept the country.
A Potential New Weapon In The War Against SuperbugsParkville, 4 June 2020: As bacteria evolve, they develop strategies that undermine antibiotics and morph into 'superbugs' that can resist most available treatments and cause potentially lethal infections.
US FDA Issues 69 New And Revised Draft Product-Specific Guidances
Maryland, 3 June 2020: The US Food and Drug Administration (FDA) on Wednesday released 26 new and 43 revised draft product-specific guidances to support the development of generic drugs.
Researchers Find New Way To Detect Blood Clots
Texas, 4 June 2020: Researchers in the Department of Biomedical Engineering at Texas A&M University are working on an entirely new way to detect blood clots, especially in pediatric patients.
US FDA Updates Hand Sanitizer Guidance
Maryland, 2 June 2020: The U.S. Food and Drug Administration on June 1 updated guidance to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizer products to help ensure that harmful levels of impurities are not present in ethanol used in hand sanitizer. The Renewable Fuels Association said the guidance provides clarity, but won’t resolve the shortage of hand sanitizer products.
US FDA Approves Drug Combo To Treat Heavy Bleeding Related To Fibroids
Maryland, 1 June 2020: The Food and Drug Administration approved a medication for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The medication, marketed as Oriahnn, is an estrogen and progestin combination product that consists of elagolix, estradiol, and norethindrone acetate capsules packaged together for oral use, according to an FDA announcement.
PSAIIF PILL
Over 50 Covid-19 Candidates Under Clinical Trials In India
New Delhi, 26 May 2020: Over 50 clinical trials for a Covid-19 vaccine have started in India as researchers globally look for ways to stop the ravaging pandemic. Data from the country’s clinical research directory shows that generic anti-viral, anti-cancer drugs, BCG vaccine, plasma therapy and Ayurvedic medications are being studied across 100 medical institutions and hospitals in the country for a potential cure for Covid-19.
DGFT Allows Exports Of Hand Sanitisers
New Delhi, 1 June 2020: The Directorate General of Foreign Trade (DGFT), an arm of the Ministry of Commerce and Industry has lifted export restrictions on hand sanitisers.
Frequently Asked Questions
Can Certain Environmental Chemicals Increase CKD Risk ?
Maryland, 22 May 2020: Declining renal function may predict an increased likelihood of urinary stone development, according to new data presented at the American Urological Association 2020 Virtual Experience. In a retrospective study of 3450 stone-forming and 112,072 non-stone forming patients, each 1 mL/min/1.73 m2 decline in estimated glomerular filtration rate (eGFR) was associated with a 3.7% increased risk of stone development in the following 2 years in a fully adjusted model, Sudarshan Srirangapatanam, BA, a medical student, and David Bayne, MD, MPH, of the University of California San Francisco, and colleagues reported in a poster presentation. Read More>>>
SUBSCRIBER'S SYMPTOM
Mumbai Company Gets Green Signal From ICMR To Make Indigenous RT-PCR Kits
New Delhi, 1 June 2020: As the country becomes self reliant in manufacturing RT-PCR testing kits, adding to the arsenal in India's fight against COVID-19, Mumbai-based speciality diagnostic company iGenetic Diagnostics and Thane-based Biogenomics have jointly developed RT-PCR testing kits.
Blog Addicts
Mr Harsh Bhasin, MD Very good e-newsletter that is interesting and enjoyable to read.
Ms Vineeta Salve, Pharma expertAll the editions I have read so far are extremely insightful and capture the events in the Pharma world very well. Keep up the good work.
Mr Gaurav Diwedi, MBBS
Like to read articles in the publications that are sent twice every month. Congrats to the Prescription team.
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