Editor’s EmulsionPSM INDIA Capsules Drug Laws & Policy Injections Pharma Injections DRUG DOPES National Injections Global Injections PSM Pill DOSE OF THE DAY FAQ Subscriber's Symptom UpComing Events Laughter Dose Blog Addict Contact Us
EDITOR'S EMULSION
Greetings!
We constantly endeavour not only to collate important information from the health and medicine world but also to create a connect with consumers all over. We welcome articles and write ups from our readers and are glad to feature them under the section titled Subscriber’s Symptoms. Mark your calendar with the upcoming events listed in our newsletter and remember to take your laughter dose in the end.
Do not hesitate to mail your comments on this edition to help us further improve. We appreciate your support and trust in us and are happy to have you as our loyal reader.
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
OBITUARY
Pharma veteran DG Shah passes away
Dilip Shah, founder of the Indian Pharmaceutical Alliance (IPA) the organisation that represented the interests of Indian drug makers passed away in Mumbai on Friday 22nd February 2019. He was 77. Known in the industry as "DG", Mr Shah started the IPA when the Indian pharma companies were trying to find their feet in the global pharma landscape that was dominated by the multinational pharma companies predominantly based out of Europe and USA. He was a close associate of Partnership for Safe Medicines India Initiative and always guided us on issues concerning Patient Safety and improving accessibility to quality medicines.
Read More>>>
DOSE OF THE DAY
“India can provide medical and health care of international standards at low costs. As India excels in the state of the art medical facilities, reputed health care professionals, quality nursing facilities and traditional healthcare therapies, India’s medical tourism industry could grow by 200% by 2020, hitting $9 billion.”
KJ Alphons
Union Minister for Culture and Tourism
PSM India Capsules
Razumab drug can cause loss of vision: “drug regulating authorities must not compromise on quality and safety,”Prof. Bejon Misra
Hyderabad: Intravitreal Razumab injections of Batch N. 18020052 have been found to cause intraocular inflammation and have been recalled, according to a patient safety advisory issued by the Vitreo Retina Society of India. In the present batch, the injection was found to have adverse effects on 11 patients where there was inflammation in the eyes and loss of vision.
Is The Price Tag Justified For Cancer Drugs?
New Delhi, 15 Feb 2019: February is when cancer messages become more visible, with campaigns explaining how to prevent the disease, treat it, or live with it. And this is largely because the World Health Organization’s (WHO) Cancer Day falls in the first week of this month.
Chemical added to consumer products impairs response to antibiotic treatment: Triclosan added to toothpaste, mouthwash to kill bacteria inadvertently makes such cells stronger
Grocery store aisles are stocked with products that promise to kill bacteria. People snap up those items to protect themselves from the germs that make them sick. However, new research from Washington University in St. Louis finds that a chemical that is supposed to kill bacteria is actually making them stronger and more capable of surviving antibiotic treatment.
Drug Laws & Policy Injections
Delhi High Court Issues Notices Over CEA Rules 2018Mumbai, 23 Feb 2019: The Delhi High Court has issued notices to Union health and family welfare ministry and directorate general of health services of Delhi government on a public interest litigation (PIL) challenging the constitutional validity of Clinical Establishments (Central Government) Amendment Rules, 2018 as it has no mention of signatory authority in basic composite laboratories (small labs) thus violating the Supreme Court order and Article 21 of the Constitution.
NPPA Fast-Tracks PMRU Initiative After Initial Delay New Delhi, 22 Feb 2019: After an initial delay, the National Pharmaceutical Pricing Authority (NPPA) has fast-tracked its initiative to constitute price monitoring and research units (PMRUs) in states and union territories to ensure ground-level compliance of its orders on ceiling prices for essential medicines. Within a month after taking the decision to implement the scheme, the units are operational in four states.
DCGI Directs State Drug Controllers To Urgently Address Non-Compliance To Schedule H, H1 And XMumbai, 21 Feb 2019: In its ongoing crackdown on illegal sale of narcotic drugs, the Drug Controller General of India (DCGI) has directed all the state drug controllers and the industry to urgently address non-compliance to Schedule H, H1 and X and plug the loopholes in the drug supply chain system.
Can't Make Mockery Of Medical Education: SCNEW DELHI, 19 FEB 2019: Sending a stern message that quality of medical education must be maintained in state-run colleges, the Supreme Court on Monday directed the states of Bihar, UP and Jharkhand to remove deficiencies in their colleges and threatened to direct their closure from the next academic session.
12th Annual ISCR Conference Focusses On New Rules For Clinical TrialsNew Delhi, 18 Feb 2019: The 12th Indian Society for Clinical Research (ISCR) 2019 annual conference was recently held in New Delhi on the theme ‘clinical research advancing the frontiers of health.’ The event saw participation from more than 500 clinical research professionals who focussed on various clinical trial reforms that will build the future research enterprise as well as on emerging research opportunities in India.
Govt Proposes Mandatory BIS Quality Approval For Selected Medical DevicesNew Delhi, 18 Feb 2019: The Department of Pharmaceuticals (DoP) has issued six draft quality control orders (QCOs), setting norms in accordance with the Bureau of Indian Standards(BIS) for some medical devices including clinical electrical thermometers and blood glucose monitoring system or Self Testing in Managing Diabetes Mellitus, to ensure safety and effectiveness.
Pharma Injections
Soon, QR Codes May Become Mandatory On Drug PacksNew Delhi, 22 Feb 2019: All medicine packs will have to carry a unique quick response code (QR) come April. The Department of Pharmaceuticals (DoP) is likely to issue an order to this effect within a few weeks, sources said.
To Cut Import, Govt To Boost Production Of APIsNEW DELHI, 20 FEB 2019: In a move to reduce dependence on China for import of raw material for medicines, the department of pharmaceuticals has charted out a plan to boost local manufacturing of active pharmaceutical ingredients (API) used in formulations.
DTAB Asks Manufacturers Of Flupenthixol+Melitracen FDC To Submit Safety, Efficacy Data New Delhi, 19 Feb 2019: An expert panel of the Drugs Technical Advisory Board (DTAB) has asked the manufacturers of the controversial fixed dose combination (FDC) of flupenthixol and melitracen, an anti-depressant medication, to submit scientific evidence to prove its safety and therapeutic justification by March 15.
India Pharma 2019 and India Medical Device 2019 Inaugurated Bengaluru, 18 Feb 2019: “While India continues to maintain leadership position in manufacturing and supply of high quality generic medicines, the Government’s focus is on improving access to affordable healthcare for all and contribute to the largest Government-funded healthcare programme in the world, Ayushman Bharat”, said Union Minister of Chemicals and Fertilizers, Statistics and Programme Implementation, Shri D.V. Sadananda Gowda.
HC Refuses To Quash Case Against Pharma Firm Bengaluru, 16 Feb 2019: The Karnataka High Court on Friday declined to quash criminal proceedings against Sanofi India Ltd., a pharmaceutical company, by the Central Bureau of Investigation (CBI) for allegedly cheating the Bhabha Atomic Research Centre (BARC), Mysuru, of ₹3.53 lakh during 2012-15 by conspiring with a scientific officer of the BARC.
Agappe Diagnostics Ties Up With Japanese Firm Kochi, 15 Feb 2019: Agappe Diagnostics Ltd, a leading diagnostic reagents and equipment manufacturer, has announced a tie-up with Japanese multinational Toyobo Co Ltd for technology licensing to manufacture early cancer detection devices.
Drug Dopes
Delhi HC Lifts Ban On Another FDC Used For Treatment Of Type II DiabetesNew Delhi, 24 Feb 2019: The Delhi High Court has set aside Central Government Notification banning the manufacture, sale and distribution of drugs having Fixed Dose Combination (FDC) of ‘Pioglitazone 30 mg + Metformin 500 mg’. 
Supreme Court Exempts Saridon From List Of Banned FDCsNew Delhi, 21 Feb 2019: The Supreme Court of India has ruled in favour of Saridon, a heritage brand from the healthcare product portfolio of Piramal Enterprises Limited (PEL), exempting its formulation from the list of banned fixed dose combinations (FDCs).
Delhi HC Lifts Ban On Combikit Used For Syndromic Management Of STDs New Delhi, 20 Feb 2019: In one of several challenges to the ban on the manufacture, sale or distribution of Fixed Dose Combination (FDC) drugs in India, the Delhi High Court has set aside the notification banning the Combikit of Azithromycin, Secnidazole and Fluconazol.
Polio Vaccine Batches Illegally Traded In Open Market Pass Test At CDL, Kasauli Mumbai, 20 Feb 2019: The seized polio vaccine vials which were sent to Central Drugs Laboratory (CDL) at Kasauli in Himachal Pradesh for analysis following Maharashtra Food and Drug Administration (FDA) crackdown have successfully passed standard quality test.
E-Pharma Firm’s Head, 12 Others Booked For Diverting Defence Drugs Mumbai, 15 Feb 2019: The director of online pharmacy company Medlife—Prashant Singh—and 12 others have been booked for allegedly selling drugs meant for defence establishments in the open market.
H1N1: Evidence-Based Medicines To All Categories Of Patients Not RequiredCHANDIGARH, 16 FEB 2019: While highlighting the importance of evidence-based medicines, the PGI doctors say that often doctors prescribe Tamiflu for H1N1 to all categories of patients when it's not required. The PGI doctors said that it’s the pharmaceutical companies who convince the doctors for such unnecessary prescriptions. This was discussed a day before the evidence-based workshop that will commence from Saturday in PGI.
National Injections
National Programme For Elimination Viral Hepatitis Launched New Delhi, 25 Feb 2019: Union minister Ashwini Kumar Choubey launched a national programme aimed at eliminating viral hepatitis, recognized as an important public health problem across the world, on Sunday in Mumbai. The minister of state for health launched the "National Action Plan - Viral Hepatitis" in presence of Amitabh Bachchan, the goodwill ambassador for hepatitis, WHO South-East Asia Region.
UP Government Planning Panel To Monitor Hospital Fee: MLAGREATER NOIDA, 19 FEB 2019: The UP government is exploring the possibility of setting up a regulatory body to keep in check rates charged by private hospitals for treatment. This was revealed by Jewar MLA Dhirendra Singh after a meeting of the legislative Assembly on Monday.
SMS Hosp Begins Supplying Medicines At Patient’s Bedside Jaipur, 19 Feb 2019: Taking on corporate hospitals, Sawai Man Singh (SMS) hospital has started supply of medicines to patients and diagnostic test at their bedside, a facility which was not available earlier. The SMS hospital is taking measures for providing the same comfort to patients which is available in private and corporate hospital chains.
After Kerala, Punjab And Gujarat To Get PMRU New Delhi, 18 Feb 2019: After Kerala, it is now the turn of Punjab and Gujarat to have Price Monitoring & Research Unit (PMRU), set up by the National Pharmaceutical Pricing Authority (NPPA) in collaboration with the Department of Health and State Drug Controller.
Delhi Hospitals Under Lens In Interstate Kidney Racket KANPUR, 18 FEB 2019: In a major breakthrough, the Kanpur police busted an interstate kidney and liver transplant racket by arresting six accused from the city on Sunday.
Centre Fails To Weed Out Substandard Drugs, Reign In Prices: Parl Panel New Delhi, 15 Feb 2019: The Centre has failed to not just reign in escalating drug prices but has also not been able to curb the business of substandard drugs, according to a Parliamentary standing committee report submitted on February 13, 2019.
Global Injections
Making New Drugs With A Dose Of Artificial Intelligence SAN FRANCISCO, 8 FEB 2019: Every two years, hundreds of scientists enter a global competition. Tackling a biological puzzle they call “the protein folding problem”, they try to predict the three-dimensional shape of proteins in the human body.
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.
US FDA Proposes New Regulations For Over-The-Counter Sunscreens
Washington, 22 Feb 2019 (Reuters): The U.S. Food and Drug Administration said on Thursday two of the 16 currently used main chemical ingredients in over-the-counter sunscreen products are considered safe, as part of a proposal here aimed at improving the safety and quality of sunscreen products sold without prescription in the United States.
US Doctors Overprescribed Deadly Drug Fentanyl To Patients
Washington, 19 Feb 2019 (AFP): Fentanyl, a highly dangerous painkiller at the heart of the US opioid epidemic, has been overprescribed by doctors, according to a report Tuesday that accused medical authorities and producers of being too lax in their oversight. The drug is a synthetic opioid up to 100 times more powerful than morphine and which is largely sold on the black market.
Researchers Develop Drug To Rejuvenate Muscle Cells
Washington, 16 Feb 2019: A new study now sees researchers from The University of Texas Medical Branch at Galveston developing a promising drug that has proven to significantly increase muscle size, strength and metabolic state in aged mice.
Cancer Spread And Blood Clots May Be Halted By Platelet Decoys
Boston, 14 Feb 2019: Blood platelets play a critical role in helping blood to clot and stop bleeding after injury. However, activated platelets can also contribute to the formation of unwanted, dangerous blood clots, and are associated with a range of disorders, including cancer.
PSM PILL
Canadian Shelves Would Run Dry” Warns Canadian Health Economist About U.S. Proposals To Raid Canadian Drug Supply
February 21, 2019: A new article on Politico Pro highlighted the inherent danger in seeing the importation of prescription drugs from Canada as the solution to lowering drug prices for U.S. patients: a Canadian expert warned that it would in all likelihood destroy their drug market.
U.S. DOJ Alleges That New Jersey Company Was Selling Misbranded And Unapproved Drugs
February 20, 2019: My Central Jersey reported on the arrest of a man and a woman for allegedly participating in a scheme to market and distribute misbranded and unapproved new drugs. The U.S. Department of Justice (DOJ) filed a charge of conspiring to distribute and cause the receipt and delivery of misbranded new drugs against both Keith Kovaleski of South Amboy and Inew Maltez of Sayreville. According to a court document, between 2014 and January 2019, Kovaleski was the principal of AA Peptide LLC (AAP).
Frequently Asked Questions
Q1. What is off label drug use?
Ans: Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is generally legal unless it violates ethical guidelines or safety regulations. The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers. For example, methotrexate is commonly used off label because its immunomodulatory effects relieve various disorders. However, off-label use can entail health risks and differences in legal liability. Read More>>>
Q2. What is meant by biological marker in medicine?
Ans: A biomarker, or biological marker, generally refers to a measurable indicator of some biological state or condition. Biomarkers (short for biological markers) are biological measures of a biological state. The term is also occasionally used to refer to a substance the presence of which indicates the existence of a living organism. By definition, a biomarker is "a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacological responses to a therapeutic intervention." Read More>>>
SUBSCRIBER'S SYMPTOM
13 Drug Targets For Treating Retinoblastoma Have Been Identified
Article contributed by Samuel Joseph, Kerala
Chennai, 9 Feb 2019: Based on computational modelling, researchers at the Indian Institute of Technology (IIT) Madras have identified the biochemical pathways that eye cancer (retinoblastoma) preferentially chooses for growth and survival. The pathways chosen are very different from the ones that normal, healthy cells choose.
Blog Addicts
Dr. Antony Gomes, Scientist/ Pharma Academician: Fake medicines have become an important source of income for organized crime groups, with extremely high returns, claiming lots of lives. I appreciate PSM India’s effort in raising awareness against it.
Dr. Arvind Gerard:More scholarly articles on various new findings of medicine are appreciable. I cherish reading all your sections!
Prof. Sarkar, Academician:
PSM India’s, The Prescription has laid out the path forward to fight against unscrupulous medicine crimes! Joining the campaign with all zeal and effort!
This Newsletter is brought to you by
© 2011 Partnership for Safe Medicines India
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 .
PSM India may not be held responsible for any article published in The Prescription.
