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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
"India is working towards robust innovation landscape awareness, innovation facilitators such as human capital investment in research and development, safety-legal environment, regulatory environment to provide truly world class biopharma research.The government has carried out far-reaching reforms to streamline the clinical trial and regulatory approval process to facilitate drug discovery in partnership with the private sector. Prime Minister (Narendra Modi) launched the National Digital Health Commission on our Independence Day, (now) electronic health records will be created for individuals which will be immensely valuable for research purposes"
Amitabh Kant
CEO, NITI Aayog
Government of India
Sponsor
Patient Safety Capsules
High Sales, Health Focus Make E-Pharmacy Hot
Bengaluru, 24 Aug 2020: Consumer stickiness, average order size increasing to $15-20 and the possibility of selling other healthcare services like online doctor consultation and diagnostics services have caught the interest of large strategic names like Reliance Industries and Amazon, driving them to the e-pharmacy sector.
Central Scheme Announced To Boost Cultivation Of Medicinal Plants
Panaji, 10 Sept 2020: The Goa state medicinal plants board has invited applications from farmers interested in cultivation of medicinal plants under national AYUSH mission’s scheme titled ‘scheme for development and cultivation of medicinal plants’.
Drug Laws & Policy Injections
Serum Institute Halts Coronavirus Vaccine Trials In India After NoticeNew Delhi, 10 Sept 2020: The Serum Institute of India (SII), which was conducting the India trials for the coronavirus vaccine being developed by Oxford University, has halted clinical trials of the vaccine in India. The coronavirus vaccine trials have been paused till further instructions from the Drug Controller General of India (DCGI).
3 Banned Drug Cocktails Get All-Clear But Could Have Few Takers In Pharma Sector New Delhi, 9 Sept 2020: Three more drugs that were banned as part of the Indian government’s first crackdown on fixed-dose combinations (FDCs) or “drug cocktails” in 2007 have received the all-clear from the Government, ThePrint has learnt.
Control Use Of Pain Reliever Tapentadol: Child Rights Panel Urges GovernmentNew Delhi, 9 Sept 2020: The National Commission for Protection of Child Rights has urged the government to stop over-the-counter sale of pain reliever Tapentadol, saying school children were misusing the drug to get high. The commission has also started framing guidelines for action against substance abuse, a government official said.
Govt Reaches Out To Firms To Make Sputnik VNew Delhi, 9 Sept 2020: Russia has reached out to India to seek collaboration of Indian companies in manufacturing vaccines against Covid-19 and also whether phase 3 or bridging studies could be done here. The Centre said there has been significant movement on both the fronts. Outreach has been extended to many companies and several have agreed. The regulator will also facilitate phase 3 or bridging studies on Indian patients for the Russian vaccine.
Text To 8632330909 To Fight Fake Drug Menace In APVIJAYAWADA, 8 SEPT 2020: DCA DG S Ravi Shankar Narayan on Monday launched WhatsApp helpline number 8632330909 and an e-mail ID to receive complaints from the public regarding quality of drugs, availability and prices of medicines. Earlier, Chief Minister YS Jagan Mohan Reddy directed the Drug Control Administration (DCA) officials to crack the whip on illegal manufacture and marketing of medicines.
ICMR Reviewing Use Of Tocilizumab For Treatment Of Coronavirus PandemicNEW DELHI, 8 SEPT 2020: The government is reconsidering the inclusion of tocilizumab in its treatment protocol for Covid-19 after new evidence emerged that it does not improve the condition of people with the disease.
Pharma Injections
India Syringe Maker Boosts Production To Meet Virus Vaccine DemandFaridabad, 9 Sept 2020: India's biggest syringe manufacturer is ramping up production to churn out a billion units, anticipating a surge in demand as the global race to find a coronavirus vaccine heats up.
Panel To Decide On AstraZeneca Covid Vax Trials After Unexplained Illness In UKNew Delhi, 10 Sept 2020: Pharma major AstraZeneca has said it is working to expedite the review of the single event to minimise any potential impact on the trial timeline of its Covid-19 vaccine candidate.
Odisha Govt Appoints AS Das As DC, Mamina Patnaik To Continue As SLA Chennai, 8 Sept 2020: The government of Odisha has appointed the senior most drugs control officer, Annada Sankar Das, as the drugs controller of the state drugs control administration (Odisha DCA).
Disinfection Tunnels 'Clinically And Psychologically Harmful': Centre Tells SC New Delhi, 7 Aug 2020: The central government told the Supreme Court on Monday that the use of the disinfection tunnel to prevent the spread of the COVID-19 infection was "clinically and psychologically harmful", following which the apex court asked the Centre why it had not banned the disinfection tunnels set up to disinfect human beings.
India Initiates Probe Against Alleged Dumping Of Vitamin C From China NEW DELHI, 7 SEPT 2020: India has initiated a probe into the alleged dumping of Vitamin C, used by pharmaceutical firms for the production of medicines, from China following complaint by a domestic manufacturer.
Non-Legible Disclaimers To Be Treated As Misleading Ads: Draft Guidelines New Delhi, 6 Sept 2020: The government has come out with a comprehensive set of draft guidelines on advertising under which ‘disclaimers’ that are not easily noticeable by or legible or easily understandable to an ordinary consumer will be treated as misleading advertisements under the Consumer Protection Act.
Drug Dopes
India Imposes Anti-Dumping Duty On Ciprofloxacin Imported From ChinaNew delhi, 3 Sept 2020: India has imposed anti-dumping duty on commonly-used anti-bacterial drug Ciprofloxacin imported from China. In a notification dated September 2, the Finance Ministry said: ‘Made in China’ drug, imported from China or any other country will attract anti-dumping duty. If the said drug has origin in any other country but export taking place from China, then also it will attract anti-dumping duty. 
Govt Inks MoU With CSIR To Set Up Bulk Drug Pharma ParkAMARAVATI, 3 AUG 2020: Andhra Pradesh Industrial Infrastructure Corporation Ltd (APIIC) on Wednesday inked an MoU with CSIR-IICT, a premier R & D institute in the country to to set up a bulk drug pharma park in the state of with the Centre’s support.
DCGI Extends Deadline By 4 Months To Submit Notarized Documents For Import Of Medical Devices And IVDs Mumbai, 3 Sept 2020: The Drugs Controller General of India (DCGI) has further extended deadline up till 4 months or till normalization of COVID-19 scenario to submit notarized documents through online Sugam portal for import of medical devices and in-vitro diagnostics (IVDs) from the earlier deadline of April 24, 2020. In its April 24, 2020 notice, it had directed all the concerned to do the needful.
CDSCO Plans To Revamp D&C Act 1940, Launch Sugam Portal Version II: Dr Eswara Reddy New Delhi, 2 Sept 2020: The Central Drugs Standard Control Organisation (CDSCO) is in the process of strengthening the functioning mechanism of its administration including its nomenclature. The office is also working in revamping the Drugs and Cosmetic Act 1940 and planning to launch the Sugam Version II, informed Dr S Eswara Reddy, Joint Drugs Controller, CDSCO..
DGFT Lays Out Procedure To Seek Licence For Exports Of N95 Masks New Delhi, 31 Aug 2020: Online applications filed by exporters only from September 7 to 9 will be considered for getting licence or permission from the Directorate General of Foreign Trade (DGFT) for shipments of N95 masks, according to a notice.
Drug Peddlers Run Their Business Under Garb Of Chemist ShopsChandigarh, 2 Sept 2020: Police investigation in connection with at least four cases of peddling medicine drugs established that the apprehended peddlers were running chemist shops
National Injections
Health Ministry Soon To Classify Non-Notified Medical Devices For Its Effective Regulation Mumbai, 8 Sept 2020: The Union health ministry will soon classify non-notified medical devices like adhesive drapes, gowns and coveralls under Class A, and surgical drapes and non- notified in-vitro diagnostic (IVD) as Class B medical device for its effective regulation.
Infosys To Acquire US-Based Firm Kaleidoscope For $42 MnBengaluru, 5 Sept 2020: Infosys said it would acquire product design and development firm, Kaleidoscope Innovation for up to $42 million. With this acquisition, the company aims to expand its engineering services portfolio and strengthen presence in medical devices, consumer and industrial markets across the US.
IGIB Scientists Develop Rapid And Sensitive Test For Coronavirus Detection NEW DELHI, 3 SEPT 2020: Scientists at the Institute of Genomics and Integrative Biology have developed a rapid and sensitive method to detect coronavirus infection in 30 minutes using a mass spectrometer.
ASCI Expands Ad Monitoring To 3,000 Digital Platforms For Misleading Claims Mumbai, 4 Sept 2020: The Advertising Standards Council of India (ASCI) has partnered with TAM Media Research to add the monitoring of digital platforms to the already tracked print and television media under its National Advertising Monitoring Service (NAMS) for identifying potentially misleading advertisements. Initially, ASCI will track the food and beverage, healthcare and education sectors on digital media as they accounted for 79% of the complaints processed by ASCI last year.
India Considers Allowing Import Of Raw Material For Manufacturing Crude Heparin New Delhi, 4 Sept 2020: India is considering allowing import of raw material for manufacturing crude heparin, an anticoagulant being used for treatment of Covid-19 patients, a move aimed at reducing dependence on China.
Why The Maha FDA Can’t Control The Sales Of Sub-Standard Hand Sanitizers MUMBAI, 4 SEPT 2020: After the outbreak of covid-19 in India, the demand for hand sanitizers went through the roof. The Union government issued a circular in March asking the state governments to ramp up production “on a priority basis". The state food and drug administrations (FDAs) were asked to issue licences within three days of receiving an application. The new rules also allowed sugar mills and distilleries to manufacture hand sanitizers.
Global Injections
N-Nitrosamine Impurities: US FDA Issues Detection, Prevention GuidanceMaryland, 2 Sept 2020: An immediately effective guidance from the US Food and Drug Administration (FDA) details steps to be taken to detect and prevent the introduction of potentially carcinogenic nitrosamine impurities into finished drug products and active pharmaceutical ingredients.
Russia Releases First Batch Of Covid-19 Vaccine Sputnik V Into PublicMoscow, 8 Sept 2020: The first batch of the Sputnik V vaccine against Covid-19, developed by Russia’s Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) has been released into civil circulation, regional deliveries are planned in the nearest future, the Russian health ministry informs.
India Scaling Up Production Of APIs
WASHINGTON, 8 SEPT 2020: India, a global hub for generic drugs, has launched a new scheme to boost production of active pharmaceutical ingredients that are greatly dependent on the Chinese supply chain, according to NITI Aayog CEO Amitabh Kant.
COVID-19 Vaccine Maker Pledge
New York, 8 Sept 2020: The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi, have made a historic pledge to the world, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential regulatory filings and approvals of the first COVID-19 vaccines.
Gene Test Can Predict Risk Of Medications Causing Liver Injury
Tokyo, 7 Sept 2020: Scientists who were working on a way to determine the viability of batches of tiny liver organoids have discovered a testing method that may have far broader implications.
Scientists Develop New Way To Deliver More Drugs Through The Skin
Singapore, 4 Aug 2020: Scientists from Nanyang Technological University, Singapore (NTU Singapore) and the Agency for Science, Technology and Research (A*STAR) have showed that applying "temporal pressure" to the skin of mice can create a new way to deliver drugs.
PSAIIF PILL
Uncertainty Over Long-Term Immune Response Has Implications For Vaccine Efficacy: Experts
NEW DELHI, 6 SEPT 2020: The rapid spread of Covid-19 in communities across the globe and the resurgence (second wave) suggest the possible role of asymptomatic persons in its transmission, while the uncertainty over long-term immune response has potential implications for the efficacy of vaccines, experts have said.
No Correlation Between Ct Values Of PCR Test And COVID-19 Severity
Bengaluru, 5 Sept 2020: Currently in India, RT-PCR tests can tell if a person is infected with novel coronavirus or not. It does not tell the amount of virus (viral load in scientific parlance) present in the person. But there is an indirect way of knowing the amount of virus that a person might be harbouring.
Frequently Asked Questions
India To Have Its Dedicated Vaccine Portal Soon !
New Delhi, 22 Aug 2020: In a first in India, the country`s top medical research body is working to create an Indian Council of Medical Research (ICMR) vaccine portal, as a repository for all information related to vaccine development in India.. Read More>>>
SUBSCRIBER'S SYMPTOM
Fighting Fakes With Technology
Noida, 6 Sept 2020: The COVID-19 pandemic has radically changed the way consumers behave when it comes to shopping. There has been a significant increase of ~70 per cent in online shopping after Mar 2020. The world is moving towards contactless purchase and delivery and the consumer wants to know more about the provenance and authenticity of the products before they buy it. Yet, as per WHO, 30-50 per cent of drugs bought online are fake.
Blog Addicts
Mr Oscar, Professional Thank you PSM India for always providing insightful articles that are always interesting reading. It is always a pleasure to read the updated news on pharma and keep my self informed. Well done !
Dr. Hari Nigam, MDReally enjoy all the articles that are published in your newsletter. All the best.
Ms Sonali Verma, Pharma Consultant
"The Prescription" always gives me validating information on healthcare. I commend them for the excellent work.
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PSAIIF may not be held responsible for any article published in The Prescription.
