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
Monsoon Greetings!
Apart from India being gripped in heavenly showers, we are flooded and surrounded with fake news and fake health content. Over 25% of the messages that Shammas Oliyath, co-founder of fake news busting website Check4Spam.com debunks are fake medical posts. Social media is rife with such medical posts. PSM India Initiative urges its readers to abstain from posting or forwarding medical content on social media platforms without verifying its authenticity from a doctor or medical personnel. Know more on this and learn 5 tips for protecting your brand against online counterfeiting under PSM India capsules section.
While CDSCO releases artwork guidelines for compliance with label change norms, an expert panel reviewing efficacy of banned 349 FDCs is working on reinforcing the ban; while the ministry of health has proposed a draft amendment to the Drugs and Cosmetics (D&C) Rules of 1945 to make a digital declaration mechanism mandatory for all firms licensed to manufacture medicines in India, Supreme Court rejects Association of Lab Technicians’ review plea on its December order barring technicians from certifying medical reports. Read more such interesting news in our Drug laws and Policy Injections.
Get an insight on the articles featured in Pharma injections and National injections especially on the controversial issue on ban of retail sale of oxytocin. Doctors are shocked to learn that the Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), the public sector company will now have a monopoly on manufacturing oxytocin and will be selling it.
Read More>>>
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
DOSE OF THE DAY
“Medical professionals are concerned about spurious and substandard drugs in the market, and this has still not been addressed completely by the government. There are only 1,800 drug inspectors in the entire country, which is not adequate to monitor the pharmaceutical industry.”
Padma Shri Dr K.K. Aggarwal
Physician and Cardiologist;
Past President of the Heart Care Foundation of India and the Indian Medical Association (IMA)
PSM India Capsules
Blockchain coming to India’s aid in war on fake drugs
Himani Chandna 26 July, 2018: The government plans to track and authenticate the drugs at each stage of their journey from pharmaceutical companies to the patient’s home.
New Delhi: The NITI Aayog has planned to put the entire stock of medicines made in India on blockchain, in an effort to combat fake and spurious drugs. The government has hired US-based tech giant Oracle to implement the pilot project and work is expected to begin by November. The problem is not small: The Washington-based International Policy Network says over 7 lakh people die every year across the world due to the consumption of fake or spurious drugs.
Fake Health Advice Forwards A New Headache For Doctors
“Kick off “Breast Cancer”… Avoid black bra in summer; Always cover your chest completely with your dupatta or scarf when you are under the sun… Pass it to All the Ladies you Care for without Hesitating. This forward, pretending to be an advisory from Tata Memorial Hospital, started doing the rounds on WhatsApp last week after actor Sonali Bendre’s announcement that she has cancer.
5 tips for protecting your brand against online counterfeit
Counterfeiting is an issue that has plagued the industry for many years. However, the advent of the internet has provided a unique global platform for counterfeiters to sell illegal products online, with little to no repercussions. Beyond the obvious reputational damages counterfeit products can have on a business, in some cases, it can pose an even greater threat to customers’ health and safety.
Drug Laws & Policy Injections
CDSCO Releases Artwork Guidelines For Compliance With Label Change NormsMumbai, 24 July 2018: The Central Drugs Standard Control Organization (CDSCO) has released checklist for preparation of artworks for drug pack labels as per notification on generic and brand name and schedule H implementation.
Fixation Of Prices Of Medicines Resulted In Savings Of Rs. 11,463 Crores To Public: Shri Mansukh L. Mandaviya New Delhi, 24 July 2018: Minister of State for Ministry of Road Transport & Highways, Shipping and Chemicals & Fertilizers, Shri Mansukh L. Mandaviya, while giving a written reply to a question on benefits accrued to citizens due to reduction in the prices of essential medicines in recent past, in Lok Sabha today, said that fixation of ceiling prices/MRP of medicines has resulted in a total saving of Rs. 11,463 crores to the public after implementation of DPCO, 2013.
Panel Reviewing Efficacy Of 349 FDCs May Reinforce BanNew Delhi, 23 July 2018: Pharmaceutical companies awaiting report on the safety of those fixed dose combinations (FDCs) that were earlier banned by the ministry of health and family welfare are unlikely to get a breather.
Govt Proposes Amendment To Make Uploading Of Drug Licence Data, Product List To Sugam Portal MandatoryNew Delhi, 20 July 2018: The ministry of health has proposed a draft amendment to the Drugs and Cosmetics (D&C) Rules of 1945 to make a digital declaration mechanism mandatory for all firms licensed to manufacture medicines in India. Once the proposed amendment takes effect, all drug makers have to upload the details of their manufacturing licences and list of products on Sugam, an online portal developed by the ministry.
Govt Plans Two New Labs To Test Drug SamplesNEW DELHI, 19 JULY 2018: In a move to ensure safer medicines, the Centre plans to designate two new laboratories — in Mumbai and Chennai — as ‘appellate testing laboratories’, to check drug samples collected by regulators as part of market surveillance and plant inspections.
SC Rejects Assn Of Lab Technicians' Review Plea On Its Dec-2017 Order Barring Technicians From Certifying Medical ReportsMumbai, 17 July 2018: The Supreme Court has rejected the review petition of Gujarat-based Association of Laboratory Technicians seeking review of the apex court’s December 2017 ruling that laboratory report can be countersigned only by a registered medical practitioner with a post graduate qualification in pathology.
Pharma Injections
Govt Unit's Oxytocin Price Three Times Prevailing RatesThiruvananthapuram, 25 JULY 2018: The generic version of the drug oxytocin used in Maharashtra public health services costs Rs 4.82 per vial. Kerala health services procured the generic version for Rs 5.9 per vial. Now doctors are shocked to learn that Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), the public sector company that will have a monopoly on manufacturing oxytocin will be selling it at Rs 15.58 plus 12% GST, which is Rs 17.78 per vial, more than three times the cost of the generic versions. Ironically, this is more even than what the multinational Pfizer charges (Rs 13.77) for its brand.
Use Of A Trade Name Similar Or Deceptively Similar Would Not Constitute Infringement Of Trade Marks Act: Delhi HCNew Delhi, 16 July 2018: “What has been constituted as infringement under Section 29(5) is use of the registered trade mark as trade name or part of the trade name,” Justice Rajiv Sahai Endlaw
The Delhi high court drew a distinction between cases of infringement by use of ‘trade name’ under Section 29(5) of the Trade Marks Act, and the cases of infringement by use of ‘trademark’ under sub-sections (1) to (4) of Section 29. The court held that to make out a case of infringement by use of ‘trade name’ under Section 29(5), mere similarity or deceptive similarity with the registered trademark was not sufficient, and that there has to be exact use of registered trademark or part of it as the trade name of the business.
Govt Grants Four-Month Relaxation To Tramadol Manufacturers And Exporters To Clear The Existing Stock Mumbai, 18 July 2018: The central government has granted four-month relaxation to licensed manufacturers, importers and exporters of Tramadol to clear their existing stock. A synthetic opioid and a prescription painkiller Tramadol, listed in the Schedule-H1 of the Drugs and Cosmetics Act, was brought under the purview of Narcotic Drugs and Psychotropic Substance (NDPS) Act, 1985 on April 26, 2018 to control its misuse.
More Than 500 Medical Stores Of Mumbai Indulging In Illegal Sale Of Drugs Mumbai, 15 July 2018: Recently number of complaints highlighting irregularities of more than 500 medical stores Mumbai, Thane and Navi Mumbai have been filed in the office of PMO, Chief Minister, FDA Minister, FDA Commissioner. Strangely the controlling authority FDA has been found very irresponsible and inactive against these complaints as alleged by complainant Bharat Sarge.
Research Organisations Flout Norms To Recruit Clinical Trial Volunteers Despite New CTRI Registration Rules New Delhi, 17 July 2018: Though the Central government has tightened norms for registration of clinical trials with human participants in recent months, many clinical research organisations (CROs) in the country continue to blatantly violate regulations to recruit healthy volunteers (HVs) for bioavailability and bioequivalent (BA/BE) studies, say researchers.
To Build Data Bank, MoH Asks Pharma Companies For Details NEW DELHI, 14 JULY 2018: In a major regulatory move to collect data about the Rs 1 lakh crore drug market in India, the health ministry has made it mandatory for companies to disclose detailed information about their operations, products, production and sales among other things.
Drug Dopes
Updated LIST OF NEW DRUGS APPROVED FROM 01-01-2018 TILL DATE BY NEW DRUGS DIVISION, CDSCO, FDA Bhawan, New Delhi List of New Drug Approved by FDA 
Huge Quantity Of Phensedyl Seized Near Khetri, Two ArrestedGUWAHATI, 23 JULY 2018: Following a tip off, the Khetri police arrested two individuals who were later identified as Syed Bahrul Alam and Md Bahirul Islam allegedly for transporting illegal phensedyl on Monday from 22th Mile under Khetri police station.
2 Kids Die During Gujarat Vaccination DriveAhmedabad, 25 July 2018: At least two children have died in the last three days during the Gujarat government's ongoing Measles-Rubella (MR) vaccination drive. The family members of the deceased have blamed the "adverse reactions" caused by the vaccination as the reason behind the deaths. As many as 30 children in Bhiloda taluka in tribal-dominated Arvalli district had taken ill after receiving the MR vaccine, a health official said on Tuesday.
Peddlers Found Selling Drugs Through Quacks, Chemist Shops Gurugram, 20 July 2018: The recent raid by the food and the drug administration revealed a dangerous trend of how drug peddlers are now using the route of quacks and unlicensed medical shops to sell the psychotropic drugs. Large amounts of drugs namely Diphenoxylate and Tramadol that are used as opioid substances and Nitrazepam and Pitocin that are used as muscle relaxants were seized from the shops.
India Launches Probe As China Co Recalls BP Drug MUMBAI, 20 JULY 2018: India’s drug controller has initiated an investigation on Thursday against all companies importing key raw material valsartan for commonly used hypertension drugs from Chinese manufacturer Zhejiang Huahai Pharmaceuticals.
Three Health Officials Arrested In Hiring Scam JAIPUR, 20 JULY 2018: Five persons including three retired government officers of the health department of the state were arrested by ACB on Thursday in connection with an alleged scam in the recruitment of the contractual employees in the state under the National Mental Health Programme (NMHP).
Criminal Clinical Trials Kill Kids In Khammam Hyderabad, 17 July 2018: A Parliamentary Standing Committee (PSC) came down heavily against ‘criminal’ clinical trials conducted on poor Indian children in the name of ‘observation’ and demonstration. The PSC could reach conclusion that this American commercial experiment was facilitated by the Government officers in Centre and Andhra Pradesh and Gujarat. It all happens in the name of ‘charity’.
National Injections
Doctor Warned Against Offering Magical Cure THIRUVANANTHAPURAM, 23 JULY 2018: Travancore-Cochin Medical Council for Indian Systems of Medicines has issued a warning to an ayurveda doctor for running advertisements on 'magic cures' in newspapers. The council has also brought the issue before the state human rights commission. "K Sidharthan has been asked to stop placing advertisements on magical ayurvedic remedies in the print media.
HC Stays Baba Ramdev’s Karauli Dream ProjectJaipur, 24 July 2018: The Rajasthan High Court has stayed the dream project of Baba Ramdev at Karauli district in Rajasthan. The Bharat Swabhiman Trust of Baba Ram Dev and the Govind Devji Trust had entered into an agreement on August 11, 2016 for 401 bigha of land of the Govind Devji Trust on lease to the trust of Baba Ramdev for the setting up of a Yogpeeth, Gurukul, Ayuveda Hosptial, Ayurveda pharma unit and a goshala at a cost of Rs 500 crore. The lease was for 20 years.
Doctors Panic As Ban On Oxytocin Retailing Kicks In NEW DELHI, 23 JULY 2018: The Union health ministry’s ban on retail sale of oxytocin has sent gynaecologists and obstetricians into panic mode. While they’ve stocked up as much as possible before the ban set in, it is unclear to doctors how a single public sector company, Karnataka Antibiotics and Pharmaceuticals Ltd (KAPL), will replace production and country-wide distribution of the lifesaving injection by about 60 big and small companies.
IIT Kanpur Develops TreadWill, Online Tool To Help People Deal With Mental Health Issues Kanpur, 22 July 2018: The Indian Institute of Technology (IIT), Kanpur, has developed an online tool, TreadWill, to help people cope with issues related to their mental health. TreadWill is a website designed to help people deal with stress, low mood, lethargy and other depressive symptoms through different online exercises, questionnaires and games, Nitin Gupta, a professor at the Biological Sciences and Bioengineering department of the IIT, said.
Draft Of Standardized Patient Consent Form Presented By IMA, Law School TRICHY, 19 JULY 2018: For long, the absence of a uniform template for getting patient consent for medical treatment has been causing confusion among doctors. Addressing the issue, Indian Medical Association (IMA), Trichy, Tamil Nadu Orthopaedic Association (TNOA) and National Law School of India University (NLSIU), Bengaluru have jointly drafted a consent template and presented it at a seminar in Trichy. It is expected to become statutory after discussions, inputs, modifications and amendments.
Gujarat FDCA Leads In Terms Of Quality Of Drugs Produced In The Country Based On Monitoring Of Retail Drug Supplies Mumbai, 20 July 2018: Taking forward its actions on spurious drugs through post-marketing surveillance programme, the Gujarat Food and Drug Control Administration (FDCA) is leading in terms of quality of drugs produced in the country based on monitoring of retail drug supplies with 1.69 per cent not-of-standard quality (NSQ) drugs found in the state as compared to 4.62 per cent NSQ drugs supplied from other states for the year 2017-18.
Global Injections
Adrenaline Medication May Double Brain Damage Risk: Study LONDON, 21 JULY 2018: Using adrenaline medication to restart the heart, during a cardiac arrest event, may double the risk of severe brain damage among the survivors, a study claims.
Rabies Scandal Rocks China’s Vaccine Industry Beijing, 22 July 2018: A brewing scandal over violations of drug production regulations by one of China's largest vaccine manufacturers, which has sparked nationwide outrage.
Global Action Plan On Antimicrobial Resistance - Message From WHO DG
Geneva, 18 July 2018: Countries are making significant steps in tackling antimicrobial resistance (AMR), but serious gaps remain and require urgent action, according to a report released today by the Food and Agriculture Organization of the United Nations (FAO), World Organisation for Animal Health (OIE) and the World Health Organization (WHO).
Novel Eye Drop May Treat Age-Related Vision Loss: Study
London, 20 July 2018: Scientists are developing an eye drop that could revolutionise the treatment for age-related macular degeneration (AMD), the leading cause of blindness in the developed world.
Omega-3 supplements don’t really do anything for your heart, new study concludes
As if climate change wasn’t bringing enough problems, a new study reports that rising temperatures will cause more suicides. If you’re not experiencing massive heatwaves (and living in the Northern Hemisphere) — consider yourself lucky. Most areas from the US, Mexico, Western Europe, Northern Europe, China, and even Japan are experiencing temperatures significantly higher than usual. We’ve actually been on a continuous streak of 400 hotter-than-average months, in a striking indication that whether we care to admit it or not, global warming is upon us.
Creating medicines without side effects: Big benefits expected in battle against cancer, autism, Alzheimer's, more
A new technique for precisely targeting molecules within cells is paving the way for safer medicines that are free of side effects. Researcher J. Julius Zhu, PhD, of the University of Virginia School of Medicine, and his colleagues have developed a way to manipulate molecules from compartment to compartment within individual cells.
FDA Releases Draft ICH Guidance Revision on Elemental Impurities
The US Food and Drug Administration (FDA) on Thursday released draft guidance for industry that was prepared by the International Council for Harmonisation (ICH) on elemental impurities.
PSM PILL
Foreign Hosted Online Pharmacy Sold Counterfeit Pills Made With Fentanyl Analogues To Americans
July 23, 2018: In a first of its kind case, the U.S. Department of Justice (DOJ) announced indictments in New York against two individuals from New Jersey for allegedly running multiple sham online pharmacies that shipped customers counterfeit pills made with U-47700, a fentanyl analogue.
Partnership For Safe Medicines Statement On FDA Working Group On Drug Importation
Washington (July 19, 2018): Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, released the following statement regarding today’s announcement by the Department of Health and Human Services to create a drug importation working group at FDA: “We are deeply concerned about today’s announcement, particularly given the deaths of Americans in at least 26 states over the last two years due to fentanyl-laced counterfeit medications. As a country, we simply cannot let down our guard at a time when illegally-imported fentanyl is infiltrating our drug supply. We agree with Secretary Azar’s recent characterization of legalized importation as a ‘gimmick.’ Allowing any form of drug importation exposes Americans to greater risk and sets a dangerous precedent.
Frequently Asked Questions
Q. What are bacteria and viruses?
Ans: Bacteria are single-celled organisms found all over the inside and outside of our bodies. Many bacteria are not harmful. In fact, some are actually helpful, including the majority of bacteria that live in our intestines (guts). However, disease-causing bacteria can cause illnesses such as strep throat. Viruses, on the other hand, are microbes that are even smaller than bacteria and cannot survive outside the body’s cells. They cause illness by invading healthy cells. Read More>>>
SUBSCRIBER'S SYMPTOM
Accurately diagnosing antibiotic allergies
Article contributed by Ms.Aarti Pollisetty
Drug allergy, as defined by the British Society for Allergy and Clinical Immunology, is an adverse drug reaction with an established immunological mechanism. All forms of natural and semisynthetic penicillins or drugs with a similar structure, such as cephalosporins or carbapenems, can cause allergy. These drugs, which have a beta-lactam ring, are recognised as one of the most frequent causes of immediate (within 1 hour) and delayed (after 72 hours) drug reactions.
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 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.
