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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
"One issue is how the virus changes and what is the chance of reinfection and if that is a big issue, then should we get ourselves vaccinated to prevent the reinfection. We are learning how the virus behaves over the next few months and based on that there will be a decision on how frequently the vaccine is required and whether we have good herd immunity."
Dr Randeep Guleria
Director
All India Institute of Medical Sciences (AIIMS)
Sponsor
Patient Safety Capsules
ASCI Keeps Track Of Brands, Issues Covid-19 Advisory
Mumbai, 16 Nov 2020: On October 20, the Advertising Standards Council of India (ASCI) issued a Covid-19 advertising advisory, “essentially asking brands to make sure that any promises related to the pandemic are substantiated through good scientific literature or tests in accredited laboratories,” says ASCI Secretary General Manisha Kapoor.
Working To Administer Vaccine Nasal Drops: Bharat Biotech CMD
Hyderabad, 16 Nov 2020: Administering the Covid vaccine will be a tough job. To cover the 1.3 billion population in India, there will be a need for a 2.6 billion doses as well as equal number of syringes and needles as the vaccine being developed now is a two-dose vaccine, said Dr Krishna Ella, Chairman and Managing Director of vaccine maker Bharat Biotech.
Drug Laws & Policy Injections
BIS May Soon Come Under Commerce MinistryNEW DELHI, 14 NOV 2020: The consumer affairs department is now initiating a proposal for transfer of the Bureau of Indian Standards (BIS) to commerce ministry, barely eight months after it had opposed a similar proposal from the commerce ministry.
Pfizer Moves US Court Against Aurobindo Pharma, Dr Reddy's On Cancer Drug Palbociclib HYDERABAD, 17 NOV 2020: Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
DCGI Bans Manufacturing, Sale, Distribution Of Ulipristal Acetate Tablets 5 MgMumbai, 17 Nov 2020: The Drugs Controller General of India (DCGI) has directed the state licensing authorities (SLAs) to direct manufacturers to suspend the manufacturing, sale or distribution of ulipristal acetate tablets 5 mg based on the recommendation of European Medicines Agency (EMA).
HC Seeks Delhi Govt Reply On Path LabsNEW DELHI, 16 NOV 2020: Delhi High Court has sought AAP government's reply on a plea for contempt proceedings against its officials for failure to regulate online pathology labs. Justice Sanjeev Sachdeva asked the counsel for Delhi government to take instructions and listed the matter for further hearing on January 29.
Emergency Contraceptive Pills May Soon Be Available In TN After Years Of Shadow BanChennai, 14 Nov 2020: The Directorate of Drugs Control Department is likely to direct pharmacies across Tamil Nadu to make emergency contraceptive pills available for retail sales, in what comes as a win for activists and women’s access to healthcare options in the state. This follows the non-availability and inaccessibility of emergency contraceptive pills due to intra-department instructions and a shadow ban on the pills across the state, which started 13 years ago.
Ayush-DBT Research Into Covid-19 Drug Enters Clinical Trial StageNew Delhi, 24 Nov 2020: The first animal study in India on SARS-CoV-2 virus (the cause of Covid-19) using four oral interventions developed under a collaborative research between the ministry of Ayush and the Department of Bio-Technology (DBT), has moved into its final stages.
Pharma Injections
Pharma Mkt Posts 10% Growth In OctMumbai, 16 Nov 2020: Building on gains made in September, the domestic pharmaceutical retail market marched ahead with a near 10% growth in October. This was led by a higher number of prescriptions, OPD (outpatient department) visits, and an increased sales and marketing push by pharma companies after ‘unlocking’ in most parts of the country.
Pfizer Vaccine Volunteers Report 'Severe' Hangover, Headache, Pain After Getting First ShotNew Delhi, 13 Nov 2020: Volunteers of Pfizer's coronavirus vaccine candidate have reported "severe" hangover after receiving the first shot of the vaccine and said it left them with headaches, fever and muscle aches. The side effects such as 'severe hangover', headache and muscle pain from the Pfizer coronavirus vaccine have been reported days after the US pharmaceutical giant and its German partner, BioNTech, announced the vaccination was 90 per cent effective against the Covid-19 infection.
Sputnik’s ‘Efficacy At 95%’ , To Be Cheaper Than US Vaccines MUMBAI, 25 NOV 2020: Russia’s Sputnik V Covid-19 vaccine, that reported an efficacy of over 95%, will be twice as cheap as those by Pfizer and Moderna with similar positive results. Sputnik V, developed by Gamaleya Institute and RDIF (Russian Direct Investment Fund), will be priced under $20 per person for the two doses in global markets, including India, and may be available here by February.
Health Ministry To Merge PLIM And HPL With PCIM&H For Standardization Of ASU&H Drugs Mumbai, 24 Nov 2020: The Union health ministry will soon merge the Pharmacopoeial Laboratory for Indian Medicine (PLIM) and the Homoeopathic Pharmacopoeia Laboratory (HPL) with the Pharmacopoeia Commission of Indian Medicine and Homoeopathy (PCIM&H), Ghaziabad. The ministry’s effort in this regard is aimed to augment the infrastructural capacity of PCIM&H for standardization of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs.
Health Ministry To Amend Rules To Specify Batch Number On Final Container Label For Vaccines Mumbai, 24 Nov 2020: Union health ministry is planning to amend Drugs and Cosmetics (D&C) Rules to specify batch number on separate final container label of trade pack (final packed unit) for vaccines containing multi-components.
Govt. Exploring Ways For Emergency Authorisation New Delhi, 23 Nov 2020: The Union government is exploring the modalities of emergency authorisation and usage of anti-coronavirus vaccines pending completion of Phase 3 clinical trial and regular licensure.
Drug Dopes
Indian Drug Firms Recall Various Products In US MarketNew Delhi, 15 Nov 2020: Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA).
Ayurveda Drug Companies In Kerala Go UncheckedChennai, 13 Nov 2020: Although Kerala is considered to be the manufacturing capital of Ayurveda medicines, not a single drug manufactured in the state can be taken with a guarantee of hundred percent safety and no factory can be referred to as the one properly scrutinized by an enforcement official.
Docs Raise Alarm Over Antibiotic Misuse Hyderabad, 13 Nov 2020: Pointing to the growing incidence of antibiotic resistance, doctors have sounded an alert over the misuse of antibiotics. Citing incidents where antibiotics were not responding in younger people due to antibiotics abuse, doctors suggest that proper diagnosis by a medical practitioner and stopping use of over-the-counter drugs is essential.
Karnataka Customs Officials Seize Rs 1.2 Crore Worth Ecstasy Pills Bengaluru, 12 Nov 2020: In a major haul, synthetic drugs worth Rs 1.2 crore, concealed inside a massager and sent as a parcel, were seized at the Foreign Post office here by the Customs, an official said on Thursday. The seizure was made on Wednesday when Customs officials opened the parcel that came from a foreign country and declared as ''Foot Massage Machine'' following suspicion that it contained contraband goods, Joint Commissioner of Bengaluru City Customs T Parry Vallal said.
US FDA Approves Casirivimab, Imdevimab For Treating Mild-To-Moderate Covid Symptoms NEW DELHI, 23 NOV 2020: The US Food and Drug Administration (US FDA) has issued an emergency use authorisation (EUA) for a combination of drugs--casirivimab and imdevimab--to be administered together for treatment of mild to moderate covid-19 symptoms in adults and paediatric patients who are 12 years of age or more, weighing at least 40 kilograms and at high risk for progressing to severe covid-19.
Cardiac, Prostate Drugs Found To Have New Side-EffectsNew Delhi, 23 Nov 2020: The Narendra Modi government’s expert drug panel has asked the country’s apex health regulatory body to add the newly found side-effects of cardiac and prostate disease drugs in their pack inserts.
National Injections
India To Get 100 Million Oxford Vaccine Shots By December: Adar Poonawalla Mumbai, 13 Nov 2020: The world's largest vaccine maker is ramping up production of AstraZeneca's Covid-19 shot, aiming to have 100 million doses ready by December for an inoculation drive that could begin across India that same month.
Govt Tells States & UTs To Boost Ways To Report Side EffectsNew Delhi, 23 Nov 2020: The government has asked states and union territories to strengthen the mechanism for reporting side effects of Covid vaccines, anticipating that the immunisation drive will begin soon.
Glenmark Study Shows Favipiravir Provides Significant Benefits In COVID-19 Treatment Mumbai, 23 Nov 2020: Drug firm Glenmark Pharmaceuticals said that as per recently published data, the oral antiviral medication favipiravir was found to provide significant benefits in COVID-19 treatment including faster time to clinical cure.
Govt To Provide Industrial Park Facilities To Grow API, Pharma & Nutraceutical Industry NEW DELHI, 23 NOV 2020: The government is proactively looking to provide industrial park facilities to grow active pharmaceutical ingredient (API), pharmaceutical and nutraceutical industry, Chemicals and Fertilizers Minister D V Sadananda Gowda has said.
Pricing Norms For Private Hospitals May Have Saved Lives: House Panel NEW DELHI, 22 NOV 2020: The parliamentary standing committee on health has asserted that a sustainable pricing model could have averted many Covid deaths in the country as inadequate beds in government hospitals and absence of specific guidelines for treatment amid rising cases resulted in private hospitals charging exorbitant fees.
Centre To Electronically Track Details Of Covid Vaccine Recipients New Delhi, 19 Nov 2020 (IANS) : The Union Health Minister Harsh Vardhan on Thursday informed that the Centre has modified an electronic network to monitor the dosage of Covid vaccines, vaccinators and geographical location of the vaccine recipients.
Global Injections
Amazon Opens Online PharmacyNEW YORK, 17 NOV 2020: Now sold on Amazon: insulin and inhalers. The company opened an online pharmacy Tuesday, giving Amazon shoppers the chance to buy their medication and order refills on their phones and have it delivered to their doorsteps in a couple of days, just like a book or toilet paper.
Baricitinib Drug Can Reduce Mortality In Patients With Moderate To Severe COVID-19Sweden, 16 Nov 2020: The rheumatoid arthritis drug baricitinib can block viral entry and reduce mortality in patients with moderate to severe COVID-19, according to translational research by an international team..
Sanofi Says Its Vaccine Won't Need To Be Super-Cooled, Normal Fridge Will Do
Paris, 16 Nov 2020: The coronavirus vaccine being developed by Sanofi won't need to be super-cooled and a normal refrigerator will suffice, the Paris-based drugmaker's France chief Olivier Bogillot said Sunday.
Steroid Treatment Should Be Reserved For Sickest COVID-19 Patients, Say US Scientists
Washington, 15 Nov 2020: Most adults with moderate-to-severe COVID-19 have a suppressed immune response against the novel coronavirus rather than life-threatening hyper-inflammation, according to a study which suggests steroids such as dexamethasone should be reserved for the sickest patients.
Fluvoxamine May Prevent Worsening Of COVID-19 Infection, Study Suggests
Greater St. Louis, 16 Nov 2020: The antidepressant fluvoxamine appears to prevent COVID-19 infections from worsening and may help keep patients out of the hospital, a trial based on research from the University of Virginia School of Medicine suggests.
Antibody Effector Functions Are Key To Combatting COVID-19, Finds Study
Washington, 23 Nov 2020: Researchers have shown that the effector functions of antibodies targeting SARS-CoV-2 are more important for protecting against COVID-19 (the disease caused by the virus) than their ability to prevent SARS-CoV-2 from infecting cells. The team also observed that combinations of antibodies targeting the coronavirus in different ways were more effective at preventing and treating COVID-19 in rodent models.
PSAIIF PILL
Insomnia, Dementia, Anxiety Most Common Among Those Infected By Covid-19: Lancet Study
New Delhi, 15 Nov 2020: Nearly one-fifth of coronavirus disease (Covid-19) patients presented with a psychiatric diagnosis within 14 to 19 days of being tested positive for the infection, according to a recent Oxford University study published in the medical journal, the Lancet.
India And China Can Produce Sputnik V : Vladimir Putin
Moscov, 17 Nov 2020: President Vladimir Putin on Tuesday called for a joint effort by the BRICS countries on the development of the coronavirus vaccines as he suggested that Russia's Sputnik V vaccine against Covid-19 could be produced in China and India, which are members of the five-nation bloc.
Frequently Asked Questions
Would Herd ImmunityCome Before Covid Vaccine Goes Off The Shelf ? AIIMS Director
New Delhi, 12 Nov 2020: AIIMS Director Randeep Guleria in an interview to IANS said we may reach a stage down the line where we may have a good amount of immunity, and the people may feel that there is now good immunity and the utility of the vaccine is not there. He added, if the virus doesn't mutate or does not cause changes then people may not think to again vaccinate themselves and then, there will be less utilisation of vaccine down the line. Read More>>>
SUBSCRIBER'S SYMPTOM
As Vaccine Trials End, Where Do Covid-19 Treatments Stand?
New Delhi, 24 Nov 2020: Vaccine developers have been racing against time to find a shot that offers immunity against the coronavirus disease (Covid-19). The University of Oxford announced on Monday that its vaccine against the viral disease was up to 90% effective in preventing infection, Pfizer Inc.
Blog Addicts
Dr Shwetambri Bhatt, MD Excellent articles and news updates in the Pharma space. Great work !
Dr Bhushan Tiwary, MDReally enjoy all the articles that are published in your newsletter. All the best.
Ms Victoria Briganza, PhD
Very informative and well developed modules that capture the essence of the Pharma industry and government policies on health and pharma. Kudos to the publication !
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PSAIIF may not be held responsible for any article published in The Prescription.