The Prescription: 17th February 2019 Issue
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
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EDITOR'S EMULSION

Pooja Khaitan

Greetings on yet another edition of The Prescription!

Patient Safety and Access has been the burning topic of discussion with the Indian government, all policy makers and stakeholders in the health sector. This issue features some interesting read on patient rights, their safety and access through initiatives and policy implementations undertaken by the government, and some FAQs on it.

By 2022, all people up to the age of 30 years will not only get free health check-ups but also free medical treatment. Apart from this major positive announcement by our health minister Shri J P Nadda, the health department is constantly on its toes to keep a check on the antibiotic dose prescribed to patients so to limit its usage. This is being done to mainly address the growth of antimicrobial resistance in the country; all this and more in drug laws and policy injections, pharma injections and national injections.

While doctors have been sentenced for medical negligence; wholesalers and pharmacists have been caught red handed with fake medicines. Get an insight into these Fda actions under drug dopes while reading about AIIMS, Delhi being ranked the number one institute.

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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

“Budget 2019 proposals for healthcare sector will create a distress-free, functional and comprehensive healthcare and wellness system in the nation encouraging preventive healthcare over curative. A healthy India is the Ninth Dimension of our Vision. We will be aiming at a healthy society with an environment of health assurance and the support of necessary health infrastructure.”

Shri Piyush Goyal,
Finance Minister, GOI

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PSM India Capsules
Launch of Materiovigilance Programme of India (MvPI) Reporting Tools at IPC


Ghaziabad, February 8, 2019 :
The NCC-MvPI successfully conducted the event for launch of MvPI reporting tools to promote Medical Device safety. Event was graced by Dr. G. N. Singh, Secretary-cum-Scientific Director (IPC), Mr. Somnath Basu, Assistant Drugs Controller (CDSCO), Dr. Vinod Arora, Expert IP Review Committee, Dr. N. Murugesan, Director (CDTL, Chennai), Mr. Bejon Misra, International Consumer Policy Expert and Mr. J. L. Sipahimalani, Expert, IP Review committee.

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17 Rights of Patients, as Tabled in India’s First Charter of Patients’ Rights

As much as hospitals are places of hope, of second chances and recovery, they can also be the cause of severe anxiety and financial burden for many. When a loved one is seriously ill or injured, we tend to completely trust a hospital and its doctors, without so much as a shadow of a doubt. Now, we are not saying that someone can take advantage of this situation, but it is crucial for everyone to know about their rights at every place.

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NPPA Gets A Backhanded Compliment In Budget 2019

Mumbai, 1 Feb 2019: The National Pharmaceutical Pricing Authority (NPPA) had its “how’s the josh” moment when it received a back-handed compliment of sorts in Budget 2019.

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Drug Laws & Policy Injections
Health Ministry Brings 8 New Medical Devices Under Regulatory RegimeNEW DELHI, 9 FEB 2019: Bringing in more high-end medical equipments such as implants, X-ray machines, MRI and CT scan equipment, and dialysis machines under the purview of drug law, the health ministry on Friday notified eight new devices as ‘drugs’ with effect from April 1, 2020.Read More
Experts Panel To Recommend To Govt Need For Separate Medical Devices Law New Delhi, 9 Feb 2019: A committee comprising representatives of medical device industry associations and senior members of the Health Ministry Friday decided to make ten key recommendations to the government, including a proposal to formulate a separate medical devices law.Read More
CDSCO Reaches Consensus To Roll Out Medical Devices Regulations In Phased MannerMumbai, 9 Feb 2019: The Central Drugs Standard Control Organization (CDSCO), the national medical device regulator, on Friday held first meeting to discuss the road map for regulating the sale and use of medical devices. Read More
First Meeting Today On Regulating Medical DevicesNew Delhi, 8 Feb 2019: More than two months after The Indian Express published the Implant Files, a series of investigative reports on the unregulated medical bazaar in India, the government will hold its first meeting Friday to discuss the “road map” for regulating the sale and use of medical devices. Read More
Health Ministry Releases Draft Amendment To MD Rules, 2017 To Exempt Govt Labs From NABL AccreditationMumbai, 7 Feb 2019: The Union ministry of health and family welfare has come out with a draft amendment to the Medical Device Rules, 2017 to exempt testing laboratories of state and central governments from the requirement of accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL) for a period of two years. Read More
Health Dept Looks At Ways To Limit Use Of AntibioticsRaipur, 6 Feb 2019: To keep a check on the antibiotic dose prescribed to patients, the health department has proposed a policy to the state government, said sources. According to sources, the senior doctors of government hospitals including the All India Institute of Medical Sciences (AIIMS), Dr Bhimrao Ambedkar Hospital, Director Medical Education and other medical experts have drafted the antibiotic policy. Read More
Pharma Injections
ICMR To Expand Surveillance Activities To Address Growing Threat Of AMRNew Delhi, 11 Feb 2019: To address the growing threat of antimicrobial resistance (AMR) in the country, the Indian Council of Medical Research (ICMR) is getting ready to expand its surveillance activities to multiple levels of health care by including private nursing homes and district-level government hospitals. Read More
Delhi HC Seeks Progress Report From Centre Over Delay In Issuing E-Pharmacy RulesNew Delhi, 8 Feb 2019: In the wake of an inordinate delay in notifying the final e-pharmacy regulations, the Delhi High Court has directed the Central government to submit a status report on the draft rules at the earliest on a petition filed by a senior dermatologist seeking a ban on online sale of drugs. Read More
Ayurveda, Homeopathy Firms Pulled Up For Misleading Ads HYDERABAD, 6 FEB 2019: Seven city-based homeopathy clinics and companies were pulled up by the Advertisement Standard Council of India (ASCI) and the Ministry of Ayurveda, Yoga and Naturopathy and Unani (AYUSH) for misleading advertisements. Read More
DoP Revises Guidelines For Funding To Develop CFCs At Pharma Parks New Delhi, 7 Feb 2019: The Department of Pharmaceuticals (DoP) has revised the norms for implementing a Centre-state financial assistance scheme to help drug makers develop common facility centres (CFCs) such as testing units, R&D centres and effluent treatment plants at industrial parks. Read More
DIA India To Organise 7th Pharmacovigilance Conference Mumbai, 5 Feb 2019: With innovations revolutionising the entire healthcare development and safety management spectrum, the need of the hour is smarter strategies for delivering safer treatments to patients worldwide. Read More
Nursing Diploma Courses To Be Phased Out By 2022 CHENNAI, 6 FEB 2019: As a step towards standardisation of the nursing qualifications at the entry level, the Union Health Ministry has decided to phase out the General Nursing and Midwifery, a diploma nursing course by 2022, the ministry said in a copy of the discussions of the meeting held in New Delhi last year. Read More
Drug Dopes
Doctors: Bringing Devices Under Drug Category Will Cause ChaosBENGALURU, 10 FEB 2019: A new notification issued by the Union health ministry has brought all implantable devices and most diagnostic equipment under the category of drugs. These include machines for x-ray, MRI and CT scans, dialysis, bone marrow cell separator and PET (positron emission tomography) scan equipment. Read More
Three Docs Sentenced To Over Two Years In Jail For Medical NegligenceGurugram, 4 Feb 2019: A local court in Haryana’s Jhajjar has sentenced three doctors of a private hospital to imprisonment of two years and six months each in a case pertaining to the death of a teenager in Bahadurgarh eight years ago for medical negligence. Read More
Pune: Medicines For Forces Seized From Three Wholesalers PUNE, 8 FEB 2019: Drugs worth Rs3.37 lakh, meant for the defence sector, were confiscated during search operations on the premises of three medicine wholesalers in the city on Wednesday and Thursday. Read More
11% Drug Samples From Government Hospitals Failed Quality Test New Delhi, 7 Feb 2019: Eleven per cent of drug samples collected from Delhi government hospitals and 4% from retail and wholesale shops were declared as not of standard quality, states an RTI reply from the Drug Control Department. Read More
Why Doctors Are Treating UTI With High-End Antibiotics NEW DELHI, 6 FEB 2019: Abuse of antibiotics is making even common problems like urinary tract infection (UTI) complex. Doctors say the regular antibiotics often don’t work because the patients are already over-exposed to the drugs, forcing them to use high-end antibiotics to treat UTI. Read More
Govt Moves Supreme Court Against Delhi HC Order Over Oxytocin BanNew Delhi, 4 Feb 2019: Reiterating its stand to ban the manufacture and sale of Oxytocin, a drug which induces labour and controls bleeding during child birth, by private companies, the government has approached the Supreme Court contesting the Delhi high court’s decision which set aside the government’s 27 April notification imposing the ban. Read More
National Injections
Free treatment to all under 30 by 2022 GORAKHPUR, Feb 11, 2019: By 2022, all people up to the age of 30 years will not only get free health check-ups but also free medical treatment, said Union health minister JP Nadda. He was in Gorakhpur to inaugurate the Guru Gorakhnath Nursing School and College on Sunday.Read More
Maha FDA, State Department To Work Out Reuse Of Medical DevicesMumbai, 11 Feb 2019: Can medical devices and consumables be reused to bring down the cost of procedures? Officials from the Mahatma Jyotiba Phule Jan Arogya Yojana (MJPJAY), the State’s medical insurance scheme for the poor, and the Food and Drug Administration (FDA) are discussing the feasibility of this to reduce costs of procedures.Read More
Dehradun: Nurses To Be Trained To Prescribe Medicines, Refer Patients To Higher Centres DEHRADUN, 10 FEB 2019: In order to bolster health services and tide over shortage of doctors in far-flung areas, nurses in Uttarakhand would be trained to prescribe medicines and refer emergency patients to higher centres. Read More
AIIMS, Delhi Has Been Ranked As Number One Institute New Delhi, 8 Feb 2019: Government has not conducted any survey for ranking of Hospitals in the country. However, there is one IT based ‘Mera Aspataal application’ to collect patients’ feedback about their experiences in public health facilities including AIIMS Delhi. Read More
Delhi HC Seeks Centre's Reply In Plea For Banning Sale Of Medicines Online New Delhi, 6 Feb 2019: The Delhi High Court has today directed the Central Government to respond to an application seeking implementation of an order prohibiting the sale of medicines online through unlicensed e-pharmacies. Read More
Wholesale Medicine Dealer Held For Running Fake Drug Unit Agra, 4 Feb 2019: A local wholesale dealer of medicines has been arrested for running a fake drug manufacturing unit from his house in Deeksha Shree Bakey Bihari Dham here. The fake medicines were packed in original medicine blister packs of a known pharmaceutical company and sold in Agra and neighbouring districts. He is also said to own another fake drug manufacturing unit near Agra-Firozabad border. Read More
Global Injections
Side-Effects Not Fully Reported In More Than 30 Percent Of Healthcare Reviews York, 6 Feb 2019: The potential side-effects of health interventions were not fully reported in more than a third of published health study reviews, research at the University of York has shown. Read More
Falsified Copies Of Leukaemia Drug Iclusig Detected Bern, 4 Feb 2019: Two falsified versions of leukaemia drug Iclusig discovered by the authorities in Switzerland in January, have also reached other markets including Turkey and Argentina. Read More

Medicines Verification System Goes Live Across EU Brussels, 8 Feb 2019: A ground-breaking new high-tech system to catch falsified medicines in the supply chain in Europe went into effect today, allowing prescription medicines to undergo verification for authenticity before reaching patients.Read More

Novel 'Unclonable' Tag May Help Combat Counterfeiters London, 8 Feb 2019: Scientists have created an "unclonable" tag that is based on random patterns that can not be replicated even by the manufacturer, an advance that could help prevent identify counterfeit products. Discovering that your new designer handbag or gold watch is a fake is costly and annoying, and counterfeit medical devices or drugs could have even more serious consequences, researchers said.Read More

US FDA Takes New Steps For Improving That Improve Tracking And Tracing Of Medicines Maryland, 7 Feb 2019: A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products we regulate, including drugs available to consumers, are safe and of high quality. This means working to ensure greater accountability in our nation’s drug supply chain.Read More

ICH Seeks To Harmonize Generic Drug Standards Paris, 6 Feb 2019: With an aim to harmonize the technical and scientific standards for generic drugs across borders, the International Council on Harmonization (ICH) on Wednesday released a reflection paper outlining an approach to begin supporting such efforts.Read More

PSM PILL

PSM Went To Congress To Share Our Concerns About The Threat Of Counterfeit Medicine

February 8, 2019: On Thursday, January 31, 2019, The Partnership for Safe Medicines (PSM) held briefings for the U.S. House of Representatives and the U.S. Senate in Washington, D.C. to highlight the dangers counterfeit medicines pose to American citizens. Over the course of each three-panel event, congressional staffers learned about the impact that counterfeit medicines have had on individuals and on our local, state, and federal law enforcement officers, and learned about the role of international drug cartels and bad actors in the production and distribution of fake medicine.

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A Dozen Americans Opted For Surgeries In Mexico And Ended Up With Antibiotic-Resistant Infections

February 7, 2019: According to The Washington Post, at least a dozen Americans who opted for medical procedures just across the border in Tijuana, Mexico also contracted a rare and potentially deadly strain of bacteria that almost no known antibiotics can treat. One of those patients, Tamika Capone of Jonesboro, Arkansas remains seriously ill four months after her surgery despite doctors treating her with a barrage of drugs, all to no effect.Read More

Frequently Asked Questions

Q1. What is patient access in healthcare?
Ans: In the most basic sense, patient access refers to the ability for patients and their families to take charge of their own health care. This has slowly empowered patients to take control of where and when they receive their medical care. Read More>>>

SUBSCRIBER'S SYMPTOM

Digitization Of Manufacturing Sites & Formulation Data On Sugam Portal

Article contributed by Om Prakash Sinha, Bihar

The Drugs Controller General of India (DCGI) has instructed state drug regulators to take necessary action and direct all the manufacturers to upload their manufacturing sites and formulation data on Sugam portal which will strengthen the drug regulatory system by way of improving the transparency, accountability as well as accessibility of the drugs in the country.Read More

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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.