Editor’s EmulsionPatient Safety Capsules Drug Laws & Policy Injections Pharma Injections DRUG DOPES National Injections Global Injections PSAIIF Pill
DOSE OF THE DAY FAQ Subscriber's Symptom UpComing Events Laughter Dose Blog Addict Contact Us
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
“Tuberculosis is associated with a 2.1-fold increased risk of severe Covid-19 disease. In addition, TB patients also tend to have co-morbid or living conditions (malnutrition, diabetes, smoking, HIV etc) that increase their vulnerability.
As a country we must try to achieve a mortality rate of less than one percent and healthcare should be available, affordable, and accessible to all."
Rajesh Bhushan
Secretary, Ministry of Health and Family Welfare
Government of India
Sponsor
Patient Safety Capsules
Finally, CDC Acknowledges Aerosol As A ‘Main Way’ Of Coronavirus Spread
Chennai, 21 Sept 2020: In a major development, the Atlanta-based Centers for Disease Control and Prevention (CDC) has revised its guidelines to acknowledge that the “main way” the novel coronavirus (SARS-CoV-2) spreads is through aerosols.
No Approval To Any Ayurvedic Covid-19 Vaccine: Govt
New Delhi, 23 Sept 2020: Ministry of AYUSH in the Central Government has not given approval to any Ayurvedic Covid-19 Vaccine. It is not legally permitted nor feasible under the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder to manufacture Ayurvedic medicines for parenteral route administration. Accordingly, no Government agency under the purview of Ministry of AYUSH is involved in the development of Ayurvedic vaccine.
The Minister Health and Family Welfare, Dr. Harsh Vardhan stated this in a written reply to Unstarred Question No. 2239 in the Lok Sabha here today. DMS
Drug Laws & Policy Injections
Can't Directly Deal With Complaints Of Unethical Practices: DoPNew Delhi, 23 Sept 2020: The Department of pharmaceuticals (DoP) has admitted in Parliament that under the uniform code of ethical marketing promotion (UCPMP), there is no provision for it to directly deal with complaints received regarding unethical practices by pharma companies. Yet, a big exercise is underway to make pharma associations submit quarterly reports to drug price regulator.
Govt Drops Mandatory Pharma Ethics Code Plan NEW DELHI, 24 SEPT 2020: For over four years the government has been maintaining that it was drafting a mandatory code on ethical marketing of pharmaceuticals with penal provisions since the voluntary code had not worked. But it has now admitted in Rajya Sabha that it has no intention of making the code mandatory.
Centre Asks DCs To Submit ‘Action Taken’ Report In Black Marketing CasesNEW DELHI, 22 SEPT 2020: Amid reports of oxygen being sold at inflated prices and hospitals facing supply crunch, the department of pharmaceuticals, which is under the Union ministry of chemicals and fertilisers, has issued directions to drug controllers in all states to submit “action taken” reports in cases of non-availability, black marketing and hoarding of medical oxygen.
Fake PPE Products Under Label Of KARAM Industries Seized In DelhiMumbai, 23 Sept 2020: Fake Personal Protective Equipment (PPE) products under the label of KARAM Industries were seized in a raid conducted by Delhi Police upon a complaint filed by KARAM Industries.
Kerala To Have One Of The First Medical Device ParksNEW DELHI, 22 SEPT 2020: Kerala will soon house one of the first medical device parks in the country, focusing on the high-risk medical device sector to provide a full range of services for the medical devices industry like Research and Development (R and D) support, testing, and evaluation.
Illegal Immunity Drugs And Medicinal Formulas For COVID-19New Delhi, 23 Sept 2020: A number of medicinal products for immunity and health promotion have come in the market after Ministry of AYUSH issued public advisories of Ayush-based healthcare during COVID-19 outbreak and promulgated a generic formulation called Ayush Kwath/Ayush Kudineer/Ayush Joshanda comprising of Tulsi (Ocimum sanctum) leaves: 4 parts, Dalchini (Cinnamomum zeylanicum) stem bark: 2 parts, Sunthi ( Zingiber officinale) rhizome: 2 parts and Krishna Marich (Piper nigrum) fruits:1 part.
Pharma Injections
India's Serum Institute Starts Manufacturing Codagenix's Potential Covid-19 VaccineWashington, 23 Sept 2020: Codagenix Inc said on Tuesday Serum Institute of India has started manufacturing the U.S. biotech firm's potential Covid-19 vaccine and it expects to begin early-stage human trial of the vaccine by the end of 2020 in the UK.
Madras HC Orders Feasibility Check On Fixing Time Limit For RTI ResponsesNew Delhi, 23 Sept 2020: In an order that could have a far-reaching impact on the speedy disposal of appeals filed under the Right to Information Act, the Madras high court recently asked the additional advocate general to “get instructions on the feasibility of fixing the time limit” for the disposal of first appeals and the second appeals. It also directed the AAG to get instructions on the provisions of creating a separate email ID for giving lesser time, preferably 48 hours, for cases involving life and liberty.
Implementation Date For Track And Trace System For Exports Of Drug Formulations Extended New Delhi, 22 Sept 2020: The government on Tuesday again extended the date for implementation of track and trace system for exports of drug formulations till April 1 next year. The decision is applicable for both non-SSI (small scale industry) and SSI-manufactured drugs.
Health Ministry Issues Draft Guidelines For Development Of Vaccines Mumbai, 22 Sept 2020: The Union health ministry has issued draft regulatory guidelines for development of vaccines with special consideration for COVID-19 vaccine to provide guidance to the vaccine developers to ensure that vaccines are well-characterized and manufactured consistently.
New Players Enter Hand Sanitiser Biz, Consolidation Certain, Say FMCG Firms Mumbai, 23 Sept 2020: Biscuit major Parle Products has been quietly pushing its hand sanitiser brand under its flagship name Parle for a few months now. The maker of glucose biscuits is an unusual player in the hygiene market. But it isn't the only such company to have launched a hand sanitiser during the Covid-19 pandemic.
China Hikes Prices Of Key Drug Ingredients Mumbai, 22 Sept 2020: China has increased prices of key starting materials (KSMs), which are used for making medicines, by 10-20%, leaving those of basic raw materials — or active pharmaceutical ingredients (APIs) — largely unchanged. Both KSMs and APIs are imported in India for making life-saving antibiotics, steroids and other medicines.
Drug Dopes
Supply Delays, Rise In Covid Cases Lead To Remdesivir Shortage: Maha HMMUMBAI, 25 SEPT 2020: Remdesivir, the antiviral used in the treatment of Covid-19, is in shortage again, as a delay in the supply of the drug from pharma companies and an increase in the number of new cases have kept hospitals in queue. 
IIT Madras Develops Magnesium Alloy To Fix Bone FracturesNEW DELHI, 21 SEPT 2020: Researchers at Indian Institute of Technology (IIT) Madras have developed nano-coated magnesium alloys that can repair bone fractures.
Task Force Arrests Two For Selling Mephentermine Injection Hyderabad, 19 Sept 2020: In a joint operation the sleuths of Commissioner’s Task Force, South Zone Team, Hyderabad along with Drug inspector apprehended two persons who illegally supplying Mephentermine sulphate 30mg/ml injections without any valid licence.
NPPA Asks State DCs To Prevent Hoarding, Black Marketing Of Medical Oxygen New Delhi, 20 Sept 2020: The National Pharmaceutical Pricing Authority (NPPA) has written a letter to all state drug controllers to take strong action to prevent hoarding and black marketing of medical oxygen in their states. In the letter, NPPA Chairperson Shubhra Singh said the increase in number of COVID-19 cases in the country has resulted in surge of demand for medical oxygen.
S Aparna Appointed As Secretary, DoP New delhi, 18 Sept 2020: S Aparna, an IAS officer from the Gujarat cadre 1988, has been appointed as Secretary, Department of Pharmaceuticals (DoP), under the Ministry of Chemicals and Fertilizers. She will succeed PD Vaghela, assuming the post when he demits the office on his superannuation on September 30, 2020, as per an order issued by the Department of Personnel and Training.
RS Passes Epidemic Diseases Amendment Bill, 2020 To Protect Healthcare WorkersNew delhi, 19 Sept 2020: The Upper House on Saturday passed the Epidemic Diseases Amendment Bill, 2020 to bring a law that punishes those who attack health workers or doctors who are fighting the coronavirus outbreak or during any situation similar to the current Covid-19 pandemic. The legislation provides for up to five years in jail for those who attack doctors and health care personnel.
National Injections
Parliament Passes Institute Of Teaching And Research In Ayurveda Bill 2020 New Delhi, 17 Sept 2020: The Rajya Sabha on Wednesday passed the Institute of Teaching and Research in Ayurveda Bill, 2020. This paves the way for the establishment of a state-of-the-art Ayurvedic institution called the Institute of Teaching and Research in Ayurveda (ITRA) at Jamnagar, Gujarat, and conferment of the status of Institution of National Importance (INI) to it, the Ministry of AYUSH said in a statement.
RPMA Urge State Govt To Come Up With Pharma PolicyMumbai, 21 Sept 2020: The Rajasthan Pharmaceutical Manufacturers Association (RPMA) has urged the state government to come up with a pharmaceutical policy to attract pharma investors to Rajasthan and take steps to get one bulk drug park out of three parks announced by the Central government with a grant-in-aid of Rs. 1,000 crore each.
Govt Rejects Mylan’s Proposal To Test Low-Cost Hepatitis Drug Combo Against Covid New Delhi, 17 Sept 2020: The Modi government’s panel of experts has rejected a request by the American pharma giant Mylan for a second time. The company had sought approvals for conducting a phase 3 trial using blockbuster hepatitis C drug, Sofosbuvir for Covid patients.
Draft Guidelines On Misleading Ads Prescribe Criteria On Valid Ads, Claims New Delhi, 16 Sept 2020: The Ministry of Consumer Affairs has issued a draft for guidelines aimed at preventing unfair trade practices and protecting consumers’ interest. Called the Central Consumer Protection Authority (Prevention of Misleading Advertisements and Necessary Due Diligence for Endorsement of Advertisements) Guidelines, 2020, these guidelines cover all advertising and marketing communications regardless of form, format or medium.
‘Maha Govt’s Circular Shouldn’t Affect Oxygen Supply To Covid-19 Patients In MP’: HC Bhopal/ Indore, 16 Sept 2020: In an interim relief to Madhya Pradesh government, MP High court’s Indore bench on Wednesday ordered that supply of liquid medical oxygen will continue uninterrupted to the state without being influenced by a Maharashtra government’s circular.
DGFT To Disallow Export/Import Without Standard UQCs From Nov 01, 2020 Mumbai, 17 Sept 2020: The Directorate General of Foreign Trade (DGFT) has announced that it will not allow exports/imports without standard Unit Quantity Codes (UQCs) from November 1, 2020. The directorate has taken this step to streamline standardization of UQCs for purposes of export/import declarations filed on its Electronic Data Interchange (EDI) and Customs’ ICEGATE.
Global Injections
AstraZeneca, Under Fire For Coronavirus Vaccine Safety, Releases Trial BlueprintsWashington, 21 Sept 2020: AstraZeneca revealed details of its large coronavirus vaccine trials Saturday, the third in a wave of rare disclosures by drug companies under pressure to be more transparent about how they are testing products that are the world’s best hope for ending the pandemic.
DCGI Approves Commercial Launch Of Low Cost Covid Test "Feluda"NEW DELHI, 20 SEPT 2020: The Drugs Controller General of India has approved the commercial launch of 'Feluda', the Tata CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) COVID-19 test, the Council of Scientific and Industrial Research (CSIR) said on Saturday.
Are Natural Products Are Really Natural?
New Delhi, 18 Sept 2020: Humans have a natural urge of looking attractive. Different societies used different ways to fulfil this urge stating from using the ornaments to colouring the eyebrows or eyelashes since ancient times. Even some of our Vedic literature, such as Manusmiriti or Vishnu Purana, has mentioned the codes of personal hygiene. Archaeological excavation has also confirmed the use of personal hygiene products in ancient times.
Russian Coronavirus Vaccine: 1 In 7 Volunteers Report Side-Effects
Mumbai, 18 Sept 2020: Around 14 per cent or one in seven volunteers who have been administered the Russian coronavirus vaccine Sputnik V have complained of side effects, according to the country's health minister Mikhail Murashko. The minister said that more than 300 out of the announced 40,000 volunteers have been vaccinated with Sputnik V.
US FDA Updates Benzodiazepine Boxed Warning
Maryland, 23 Sept 2020: The US. Food and Drug Administration (FDA) is requiring that the boxed warning on benzodiazepines be updated to provide a uniform description of the risks associated with all medications in the class.
Historic Reform In Medical Education: National Medical Commission (NMC) Constituted
New Delhi, 25 Sept 2020: Historic reform in the field of medical education has been effected by the Union Government with the constitution of the National Medical Commission (NMC), along with four Autonomous Boards. With this, the decades old institution of the Medical Council of India (MCI) stands abolished. Along with NMC, the four Autonomous Boards of UG and PG Medical Education Boards, Medical Assessment and Rating Board, and Ethics and Medical Registration Board have also been constituted to help the NMC in day to day functioning.
PSAIIF PILL
T Cells May Be Dealing The Killer Blow To Coronavirus More Than Antibodies, Say Researchers
Mumbai, 18 Sept 2020: Antibodies alone are not enough to protect an individual from the coronavirus that causes Covid-19, and what could help more in fighting the disease is a strong T cell response, a new study from California-based La Jolla Institute for Immunology has shown.
Govt Plans Rs. 15,000-Crore PLI Scheme To Boost Local Drug Production
NEW DELHI, 26 SEPT 2020: The government is working on a ₹ 15,000-crore production linked incentive (PLI) scheme for the pharmaceutical industry, a senior official told ET. The scheme intends to promote indigenous manufacture of complete generics, biosimilars and high value-add medicines, to boost domestic drug production and cut dependence on costly imports.
Frequently Asked Questions
Ayush Ministry To Take Up Clinical Study On Vasa And Guduchi
New Delhi, 25 Sept 2020: In view of the need for accelerated solutions for Covid-19, the Ministry of AYUSH has taken up systematic studies on different possible solutions through multiple channels. As part of this effort, a proposal for a clinical study to assess the role of Vasa Ghana, Guduchi Ghana and Vasa-Guduchi Ghana in therapeutic management of symptoms in Covid-19 positive cases has recently been approved. This will be a “randomized, open label three armed” study, and will be conducted at the All India Institute of Ayurveda (AIIA), New Delhi, in collaboration with the IGIB unit of CSIR. Read More>>>
SUBSCRIBER'S SYMPTOM
Hetero Launches Pack Of Generic COVID-19 Drug Favipiravir At Rs 2,640
New Delhi, 25 Sept 2020: Drug firm Hetero on Friday said it has launched a pack of its generic oral antiviral drug-- Favivir 800/200-- for the treatment of mild-to-moderate symptomatic COVID-19 patients in India. Favivir 800/200 will be available in a pack containing 16 tablets of favipiravir 800 mg and 2 tablets of favipiravir 200 mg priced at ₹ 2,640 per pack, Hetero said in a statement.
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.
This Newsletter is brought to you by
Patient Safety And Access Initiative of India Foundation
F-9, 2nd floor, Kailash Colony, New Delhi -110048
jagograhakjago.com; www.jagograhakjago.com;
Disclaimer : Our newsletter endeavors to compile patient safety information from various sources .
PSAIIF may not be held responsible for any article published in The Prescription.
