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EDITOR'S EMULSION
Greetings!
We have constantly briefed our readers on Antimicrobial resistance (AMR or AR) in our past issues and this time too carry a feature on it. Resistant microbes are more difficult to treat, requiring alternative medications or higher doses of antimicrobials. These approaches may be more expensive, more toxic or both. Read more about this top threat in PSM India capsules section and how it has become a global concern.
While the National Human Rights Commission (NHRC) has directed the Union health and family welfare ministry to rectify Clinical Establishment Amendment Rules, 2018, manufacturers now have to pay penalty for the entire batch if a single drug is found substandard; government may fix trade margins on so-called orphan drugs used to treat rare diseases and put ceiling to curb prices of patented medicines; catch the latest drug laws and policy implementations in this issue of The Prescription.
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Feedback is what keeps us going. Should you have any query or question, please feel free to get in touch with us. Write to me on pooja@jagograhakjago.com
Stay Healthy. Stay Protected.
Pooja Khaitan
Editor-in-Chief,
The Prescription
DOSE OF THE DAY
“The key concerns of healthcare in the country are equity, affordability, accessibility and quality”.
Shri Lov Verma,
Former Secretary,
Ministry of Health & Family Welfare, India
PSM India Capsules
Drug Resistance Among Top Threats: WHO
Antimicrobial Resistance (AMR) has been identified as one of the 10 threats to global health in 2019 by World Health Organisation (WHO). The other threats on this list include HIV, Ebola, dengue, vaccine hesitancy, air pollution and climate change.
Antimicrobial resistance: a global concern
New resistance mechanisms are emerging and spreading globally, threatening our ability to treat common infectious diseases, resulting in prolonged illness, disability, and death. Without effective antimicrobials for prevention and treatment of infections, medical procedures such as organ transplantation, cancer chemotherapy, diabetes management and major surgery (for example, caesarean sections or hip replacements) become very high risk.
Drug Laws & Policy Injections
NHRC Directs Union Health Ministry To Rectify Clinical Establishment Amendment Rules, 2018 As Per SC OrderMumbai, 29 Jan 2019: The National Human Rights Commission (NHRC) has directed the Union health and family welfare ministry to rectify Clinical Establishment Amendment Rules, 2018 in view of the Supreme Court orders dated December 12, 2017 and July 10, 2018 which upheld the stand of the Medical Council of India that medical test report can be countersigned only by a registered medical practitioner with a postgraduate qualification in pathology.
Govt's New Proposal: Manufacturer To Pay Penalty For Entire Batch If Single Drug Found Substandard New Delhi, 27 Jan 2019: Govt's new proposal: Manufacturer to pay penalty for entire batch if single drug found substandard Even if a single drug in a batch is found substandard the manufacturer may have to pay a penalty equal to the MRP of the entire batch shipped, according to a new government proposal. There are usually 10,00 to one lakh units in a batch, but the number of drugs - which can be in the form of tablets or liquid - in a batch vary depending on the size of the shipment, a Health Ministry official said.
Govt May Fix Trade Margins On Expensive Orphan, Cancer DrugsNEW DELHI, 25 JAN 2019: The government may fix trade margins on so-called orphan drugs used to treat rare diseases, a health ministry official said, promising partial relief for patients burdened with exorbitant treatment costs. The move, if successful, could hurt multinational pharmaceutical companies such as Sanofi Genzyme, Pfizer and Shire USA, who make these drugs.
Use Compulsory License And Put Ceiling To Curb Prices Of Patented Medicines: Govt PanelNew Delhi, 27 Jan 2019: In order to cut prices of patented medicines for cancer and rare diseases, a high-level government panel has made a series of far reaching recommendations including granting "compulsory license" to any Indian pharma company to produce drugs without the consent of the patent holding firms.
Retail Prices Of 29 Formulations Fixed/RevisedNew Delhi, 25 Jan 2019: The NPPA has fixed the retail price of 29 formulations under Drugs Price Control Order (DPCO), 2013 through a notification dated 25 January 2019.
Barcode Labelling System For Biomedical Waste To Be Implemented By Mid-MarchVISAKHAPATNAM, 23 JAN 2019: Andhra Pradesh Pollution Control Board (APPCB) is set to implement the barcode labelling system for biomedical waste by mid-March. Under the Union environment ministry’s biomedical waste management rules 2016, the Central Pollution Control Board (CPCB) has drafted guidelines for effective management of biomedical waste.
Pharma Injections
Doc To Pay For Inflated Hospital BillNew Delhi, 29 Jan 2019: Asking patients to pay inflated bills for treatment that they haven’t received amounts to unfair trade practice on the part of doctors and hospitals, the National Consumer Disputes Redressal Commission has held.
3 Lose Sight In An Eye Each After Botched-Up SurgeriesMumbai, 28 Jan 2019: Three people are feared to have lost sight in one eye after undergoing cataract surgery at the civic-run Balasaheb Thackeray Trauma Care Hospital in Jogeshwari on January 4. Another four patients, aged 50-75 years, are grappling with varying degrees of vision loss caused by an infection, suspected to be the deadly pseudomonas aeruginosa bacteria.
Delhi Government Seeks To Set Limit On Profits Of Private Hospitals New Delhi, 22 Jan 2019: The Delhi government is looking to cap the profits of private hospitals in the city, Delhi health minister Satyendar Jain has said. Officials and legal experts, however,said the draft notification of the government has no legal standing.
TSDCA To Deliver Entire Range Of Its Services Through Online Mode As It Becomes Part Of TS-IPass Hyderabad, 24 Jan 2019: Bringing the Telangana State Drug Control Administration (TSDCA) under the ambit of Telangana State Industrial Project Approval and Self Certification System (TS-iPass), authorities at the TSDCA have decided to deliver all the services through online mode, to make it more transparent and accountable and take decisions in a time bound manner giving no scope for delays in issuing drug licenses and inspection reports pertaining to pharma companies and medical shops in the state.
IPC To Launch Four Unique Tools On Feb 8 To Ensure Safe Medical Devices In The Country Mumbai, 24 Jan 2019: The Indian Pharmacopoeia Commission (IPC) will launch four unique tools - medical device adverse event (MDAE) reporting form, medical device recall notification form, registered medical device information sharing portal and medical device reference document on February 8, 2019 to create an accountable regulatory ecosystem for medical device industry towards patient safety.
Assam Pharmacy Council Mandates Refresher Course For Registered Pharmacists To Renew Certificates Chennai, 22 Jan 2019: In compliance to the provisions of Pharmacy Practice Regulations 2015 introduced by the PCI, the Assam Pharmacy Council (APC) has decided to start compulsory Refresher Course (RC) for the registered pharmacists in the state.
Drug Dopes
Free Hospital Drugs Being Sold At Medical Stores, Probe OrderedLUCKNOW, 26 NOV 2019: Hospital supply drugs which should be provided free of cost to patients at government hospitals are being sold off the counters in the city. One such incident came to the fore when a cancer patient undergoing treatment at Dr Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) was sold three injections which had “for hospital supply only” stamped on them. 
Paracetamol Samples Fail Laboratory Tests In UPNew Delhi, 23 Jan 2019: The injections of popular medicine Paracetamol have failed in medical tests conducted by a drug inspector, a report published with the Navbharat Times said. The injections, which were supplied to a medical center in Uttar Pradesh’s Unnao by a private company in September 2018 could not withstand the tests, it said, adding the amount of particulate matter in the medicine was not found to be sufficient in the test.
A No-Pain, No-Radiation Way To Detect Breast Cancer THRISSUR, 23 JAN 2019: Now, women do not have to go through the painful mammography for screening of breast cancer. A. Seema, a scientist of C-MET (Centre for Materials and Electronics Technology), Athani, under Ministry of Electronics and Information Technology, has developed a wearable screening device for the early detention of breast cancer.
50 Cancer, Rare Disease Drugs To Get Cheaper NEW DELHI, 23 JAN 2019: In a move to curtail profiteering on crucial medicines, the Centre is set to cap trade margins charged by drug retailers and stockists at around 25-30% for over 50 non-schedule medicines for cancer and rare diseases, which are currently exempted from price regulation, official sources said.
Chennai : Manufacturer In Soup Over Mislabelled Cough Syrup Chennai, 22 Jan 2019: The photo of a wrongly labelled bottle of cough syrup purchased by the Tamil Nadu Medical Services Corporation has created a furore among doctors and drugstore managers in government hospitals across the state.
States Asked To Procure Only ‘Bar Coded’ Drugs From April 1CHENNAI, 21 JAN 2019: The Ministry of Chemicals and Fertilisers has directed all States to procure from domestic manufacturers only the drugs ‘Bar Coded’ at primary-level packaging from April 1. The order, dated January 14, issued by the Ministry of Chemicals and Fertilisers, Department of Pharmaceuticals, said, ”The medicines procured under public procurement from April 1 must have Bar Code at primary level packaging. Such code will mandatorily contain name of the product including strength, brand name, if there is any, MRP, name and address of manufacturer, batch number, manufacturing date, expiry date, special storage conditions required, if any, and manufacturing licence number”.
National Injections
Police Nabs 4 Pharmacists Operating On Fake Degrees Mumbai, 25 Jan 2019: The Maharashtra police has arrested four pharmacists who were operating on a fake D.Pharm. degree. They had allegedly procured fake certificates from a college in Delhi. The state police officials have written a letter to the Food and Drug Administration (FDA), seeking stern action against these racketeers.
Forum Slaps Rs1.15L Penalty On Medical Store For Selling Wrong MedicineNagpur, 29 Jan 2019: Many a times pharmacists hand over a medicine of another brand instead of the one prescribed by the doctor, claiming they have similar contents. A woman handed over a face ointment of another brand by a Mouda-based medicine shopkeeper won Rs1.15 lakh compensation from the consumer court recently, since the alternate medicine caused a reaction on her face leaving dark spots.
Meghalaya Govt Directs Ayush Practitioners Not To Prescribe Allopathy Drugs Chennai, 28 Jan 2019: Citing withdrawal of the bridge course introduced by the Central government for Ayush practitioners to prescribe allopathic medicines in medical emergency situations, the government of Meghalaya has stopped allowing Ayush doctors in the health department to prescribe modern medicines to patients coming to the rural hospitals.
Blood Banks Need Advanced HIV Test Kits BENGALURU, 23 JAN 2019: With almost all the 200-plus blood banks in the state still following the conventional serology testing method to detect HIV virus in blood samples, doctors say a tragedy like the recent one in Tamil Nadu, where an HIV-positive donor’s blood was transfused to — and infected — a pregnant woman, could happen in Karnataka any time.
Google Bans Apps That Promote False Health Tips Or Banned Medical Substances NEW DELHI, 23 JAN 2019: Android apps that provide free health tips and ways to remain fit by promoting illegal substances will no longer remain on Google Play Store. Google has announced that it will be kicking out all apps that “promote or sell unapproved substances, irrespective of any claims of legality.” Google will also ban apps that sell unapproved or misleading pharmaceuticals and supplements and will monitor all such apps for any discrepancies.
Quality Test Of 6,000 Medicine Samples Pending For A Year In Rajasthan JAIPUR, 20 JAN 2019: More than 6,000 samples of medicines are pending for quality test as only one drug-testing laboratory is functional in the state. The laboratory is functional in the state, which was set up in 1962. Since then no new drug-testing laboratory has become functional in past 57 years.
Global Injections
US FDA Identifies Contamination Source In Blood Pressure Medicines Used By Millions Maryland, 25 Jan 2019: Federal regulators say they’ve identified the source of the cancer-causing impurities that have tainted millions of bottles of commonly used generic blood pressure and heart failure medications recalled by drugmakers over the last seven months.
Kidney Research Sheds Light On Harms Of Certain Drugs Washington D.C. [USA], 25 Jan 2019 (ANI): A new study saw scientists identify an enzyme that, if suppressed, can trigger renal failure. Their findings have implications for the use of existing drugs and the development of new pharmaceuticals.
New Treatment For Liver Parasites In Vivax Malaria
Vienna, 26 Jan 2019: Vivax malaria is a serious illness with high fever that, if untreated, can keep people bed-ridden for weeks or even months. But even after successful treatment, it's tricky: although the current, commonly-used drugs successfully treat the blood stage of vivax malaria, they are unable to prevent malaria parasites from invading the liver (liver stage) and causing the disease to recur repeatedly over many years.
Chinese Man Nabbed With Counterfeit ARVs
Nairobi, 25 Jan 2019: A Chinese national, Cheng Xun Tian, was arrested by police with more than 100 cartons of fake anti-retroviral drugs (ARVs). The incident took place in Nairobi on Friday. The police raided Tian’s residence in Kilimani after obtaining a meaningful lead. The suspect is currently being held at the Kilimani Police Station before being processed to be charged in court.
Statins May Help Prevent Diabetes-Related Eye Problems
New York, 12 Jan 2019: Diabetic patients who take statins to treat high cholesterol may get an added benefit: a lower risk of damage to the retina, a new study suggests.
Tiny, Smart Robots Can Swim Through Blood Vessels To Deliver Drugs
Geneva, 20 Jan 2019: Scientists have developed tiny, smart robots that can swim through blood vessels, paving the way for ingestible machines that could deliver drugs directly to diseased tissue in the future. The researchers from Swiss Federal Institute of Technology Lausanne (EPFL) and ETH Zurich in Switzerland drew inspiration from bacteria to design the highly flexible biocompatible micro-robots.
PSM PILL
Police Arrest Bridgewater, Massachusetts Man A Second Time For Selling Fake Pills Made With Fentanyl
January 28, 2019: The Taunton Daily Gazette reported that detectives from the local WEB Task Force arrested a Bridgewater, Massachusetts resident for allegedly selling counterfeit fentanyl pills in the surrounding communities. A tip came into law enforcement in December that led to the eventual arrest and charges against 44-year-old John Bagley. Police executed search warrants on Bagley’s home, business, and vehicle, seizing multiple items associated with drug distribution such as scales, packaging, multiple phones, and 17 pills police suspect to be fake.
Oregon Man Purchased 86,000 Counterfeit Oxycodone Pills Laced With Fentanyl
January 25, 2019: The Oregonian reported that a Beaverton resident received a 97-month federal prison sentence for selling counterfeit oxycodone pills that he purchased online. Federal prosecutors stated that Jared Gillespie originally purchased the pills from a Salt Lake City, Utah-based vendor on AlphaBay, a now-shuttered online marketplace. Gillespie received his shipments of fake pills at a private post office box in Portland. In total, the Salt Lake City vendor received a total of $294,000 in Bitcoin for the pills.
Frequently Asked Questions
Q1. Why Vitamin D is called Sunshine Vitamin
Ans: Vitamin D is a fat-soluble vitamin that acts as a steroid hormone. Vitamin D influences the bones, intestines, immune and cardiovascular systems, pancreas, muscles, brain, and the control of cell cycles. Vitamin D is unique because it can be made in the skin from exposure to sunlight. Thirty to 90 minutes in the sun will give the average person all the daily vitamin D he/she needs. The key is in the skin’s oils -- a derivative of cholesterol called 7-dehydrocholesterol. When exposed to sunshine, this compound is converted to cholecalciferol – which is then converted to the actual vitamin D, known as: 25-hydroxy-cholecalciferol, or D3. Therefore, Vitamin D is called sunshine vitamin. Read More>>>
SUBSCRIBER'S SYMPTOM
IPC In Talks With BHU And IIT-Varanasi To Strategise On ADR Data For Patient Safety
Article contributed by Shri HariOm Saxena, U.P.
Mumbai, 16 Jan 2019: The Indian Pharmacopoeia Commission (IPC) is in talks with Benaras Hindu University (BHU) and Indian Institute of Technology (IIT), Varanasi to strategise on collection and analysis of Adverse Drug Reaction (ADR) data to address patient safety issues in India.
Blog Addicts
Ms. Rohini, Medical Student, New Delhi Thank You @PSM-India! For delivering such an informative and interesting fortnightly newsletter, The Prescription.
Dr. Debasis Mohanthy, Physician, KolkataGreat Applause to PSM-India as they are efficiently promoting awareness against spurious medicine across the country.
Dr. Izra khan, MD, Lucknow
Thank You! PSM-India for helping the people to know their medication closely.
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