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EDITOR'S EMULSION

Pooja Khaitan

Fake medicine crimes are making news worldwide. Fake medicines are passed off as both brand-name and generic medicines— the most prevalent counterfeits are common antibiotics, tuberculosis and malaria medicines. Counterfeit medicines are first and foremost a crime against patients. Spurious medicines represent a risk to public health, patient safety, and threaten the full spectrum of legitimate medicines– both originators and generics, prescription and over-the-counter medicines. Also, it’s a fact that fake medicines which contain the wrong dosage of active ingredients can result in drug resistance and this has happened in case of malaria and therefore treatment of malaria has become a challenge at present. Fight the Fakes campaign has started a worldwide propaganda to curb the menace. PSM India supports its action and joins hands in working for patient safety by fighting these counterfeiters. Read More>>>

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Pooja Khaitan
Chief Editor , The PRESCRIPTION Partnership for Safe Medicines India.

DOSE OF THE DAY

“The low cost generic medicines produced by the Indian pharmaceutical industry have been instrumental in scaling up access to HIV treatment not only in India but in other parts of the world, especially in the developing countries most affected by this scourge”.

Shri JP Nadda
Union Minister of Health and Family Welfare
Government of India

PSM India Capsules

5th Universal Health camp conducted

12,June,2016: PSM India, conducted the 5th Universal Health Camp on Sunday under the aegis of Patient Safety and Access Initiative of India Foundation and Mata Anandmayee Hospital in Kalvari, Madihan, Mirzapur on Sunday. The camp to register citizens for the Medical Card was held at the local school premises in Village Kalvari, Madihan, Mirzapur.

Monitoring of medicine market in India; more Pharma inspectors needed

Recently, there was news coming across various states of our country regarding the lack of proper inspections and stringent actions against medicine crimes, scarce number of Drug Inspectors, lack of prompt regularity action and pharma Inspectors’ poor work proficiency.

WHA69: Empowering People in the Fight against Fake Medicines

Fight the Fakes , which partners the International Pharmaceutical Students’ Federation (IPSF) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), hosted on 27 May 2016 an event at the 69th annual World Health Assembly (WHA69).The event was made up of a panel discussion with speakers from IPSF, the International Pharmaceutical Federation (FIP), Médecins Sans Frontières (MSF), and the Tanzanian Food and Drugs Authority, and moderated by Catherine Fiankan Bokonga.

Drug Laws & Policy Injections

Government to develop six bulk drugs, medical devices parksNEW DELHI, JUNE 2016: To reduce import dependence, the government has decided to establish six bulk drug and medical devices parks, which will entail a combined investment of Rs 60,000 crore.

DTAB turns down Government proposal to empower chemists to supply alternative cheaper drugs with same ingredients Mumbai, June 2016: The Drugs Technical Advisory Board (DTAB) of the Union Health Ministry has turned down a proposal by the ministry to amend Rule 65 of the Drugs and Cosmetics Rules, 1945 to provide that the chemist may offer for supply a drug formulation containing the same ingredients but in generic or other cheaper brand name.

Health ministry to bring steroid-based skin creams under Schedule H drugs for patient safetyMumbai, May 2016: In order to address the concerns over sale of steroid or other prescription-drugs-based skin creams advertised and sold without prescription for cosmetic and skin problems, government has considered the proposal to amend abolishing a footnote in the country's rule book on medicines that currently exempts skin creams from being labeled as Schedule H drugs.

IPC releases IP national reference standards, IPRS-VaccinesGhaziabad, June 2016: Keen to focus on setting the quality standards of vaccines throughout the country, the Indian Pharmacopoeia Commission (IPC) released the much anticipated National Reference Standards, the Indian Pharmacopoeia Reference Substances (IPRS-Vaccines).

Health Minister Shri J P Nadda addresses UNGA High Level Meeting on HIV/AIDS - Highlights India’s success in containing HIV June, 2016 : Shri Jagat Prakash Nadda, Union Minister of Health & Family Welfare addressed the UNGA High Level Meeting on HIV/AIDS at New York.
Following was the text of the address:
I am happy to join all of you today for this High Level meeting on HIV/AIDS. I also commend the efforts of the Permanent Representatives of Switzerland and Zambia for steering the difficult negotiations of the draft Declaration to a successful conclusion.

Pharma Injections

Overuse of antibiotics has created the superbug that nothing can killJune 2016: For years health experts, especially holistic and alternative medical professionals, have been warning that traditional medical practitioners, in cahoots with Big Pharma, were over-prescribing antibiotic medications, and that someday, because too few listened, that would lead to the creation of a “superbug” that no antibiotic could kill. Well, that day has arrived.

Commonly Used Drug Combo Leads to Unexpected Rhabdomyolysis As obesity continues to rise, so do the number of drugs used to combat the complications (diabetes, dyslipidemia, coronary artery disease [CAD]) associated with high body mass index (BMI). While clinical trials investigate potential drug interactions with the medications used to treat these illnesses, the possibility of an unexpected side effect still exists.

Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk June, 2016: The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin.

Drug Dopes

Scientist find internal protein defence against Zika virus Washington D.C. June, 2016 : A tiny protein called interferon-induced protein 3 (IFITM3) has been found to reduce the ability of the Zika virus to infect human cells. A team of scientists has offered the first look at how our cells can “swallow up and quarantine” Zika, defending themselves against the virus’ attack.

Scientist identify enzymes that may help fight Alzheimer’s disease June, 2016 : Scientists have identified an enzyme that may help protect against the debilitating effects of certain degenerative brain diseases such as Alzheimer's, an advance which could assist in the development of new drugs.

Doctors, scientists merge tech and medicine - a micro bubble to function as lung June 2016: Third lung inserted into body cavity from ventilators to contraptions fitted with wires, complex devices have been employed to imitate the lungs in patients struggling to breathe.

USFDA approved Tecentriq June 2016: The United States Food and Drug Administration (USFDA) has approved Tecentriq (Atezolizumab) for the treatment of urothelial carcinoma. Tecentriq is the first PD-1/PD-L1 inhibitor that has been approved for urothelial carcinoma. Tecentriq is indicated for advanced or metastatic urothelial carcinoma patients who are unresponsive to platinum-based chemotherapy or worsening of disease after surgical treatment.

National Injections

Maharashtra FDA begins probe into sale of counterfeit version of cancer drug BiCNU by Taj Pharma Mumbai, June, 2016 : The Maharashtra FDA in coordination with the DCGI office has initiated investigation into the alleged sale of counterfeit version of Emcure Pharmaceuticals' chemotherapy agent BiCNU (Carmustine for injection) by Mumbai based Taj Pharmaceuticals violating Drugs & Cosmetics Act, 1940 and Rules made thereunder.

More than 2,000 Indians contract HIV after transfusions NEW DELHI, JUNE 2016: More than 2,000 Indians contracted HIV over a 17-month period after receiving blood transfusions, data from the national AIDS body showed Wednesday. In response to a Right to Information request filed by Mumbai-based activist Chetan Kothari, the National AIDS Control Organization (NACO) said 2,234 people had been infected between October 2014 and March 2016.

Child dies as given nitrous oxide instead of oxygen INDORE, MAY 2016: An eight-year-old boy died and a toddler is in a critical condition after they were mistakenly administered nitrous oxide, a widely used anaesthetic and analgesic agent, in place of oxygen at Maharaja Yeshwantrao hospital .

E-pharmacy crackdown: Five web-portals under FDA scanner for selling drugs, FIRs against three Mumbai, June 2016: Five web-portals have come under the radar of the Food and Drug Administration (FDA) for selling prescription drugs online. While the FDA has already registered First Information Reports (FIRs) against three such e-pharmacies - MeraPharmacy.com, mChemist.com and Healercart.com, the process of initiating action against the other two - Pharmeasy.in and Netmed.com - is under way.

MNC mandates smart cards for nurses to scroll down illegal nursing services in Maharashtra Mumbai, June 2016: The Maharashtra Nursing Council (MNC) has mandated the smart cards for registered nurses in Maharashtra to scroll down the illegal nursing services in the state. The smart cards will contain the details of a nurse, including qualification, registration number and place of employment. The cards document all information from the time nurses enroll for training. Previously, nurses were provided with an A4 certificate.

Global Injections

UK public 'unsure how to spot a fake pharmacy' June 2016: More than half (54 per cent) of UK consumers have said they have no idea how to spot a rogue online pharmacy, according to a new survey.

Pharma anti-counterfeit set to rise "substantially" June, 2016: Pharmaceutical anti-counterfeiting technology market will almost double in the next few years, rising from $3.4bn last year to $6.5bn by 2020, says a new study.

World Health Organization (WHO) Unveils Global Regulatory Framework For Medical DevicesJune, 2016: The World Health Organization (WHO) has released a draft proposal for its global regulatory framework for medical devices and in vitro diagnostics (IVDs). A WHO working group started to develop its model for regulating medical devices in 2015, based on an agency resolution that called for the establishment and strengthening of “regional and subregional areas of regulation of health products that are the least developed, such as regulation of medical devices including diagnostics.”

PSM PILL

Convicted bleach-cure creator is in prison, but his mineral miracle solution is still being pushed by deluded believers

Creator of the “Mineral Miracle Solution” sentenced to prison for peddling a compound not fit for human consumption. Some of his followers still advocate its use, however.
In 2015, the Department of Justice (DOJ) reported that Louis Daniel Smith had been sentenced to 4 years and 3 months in prison for creating and marketing a toxic bleach brew that he convinced others could cure cancer, malaria, HIV and other diseases. He sold his “Mineral Miracle Solution” via his Project Green life (PGL) website. The product he sold was in fact a toxic mix of Sodium Chlorite and water. According to the DOJ, “Sodium chlorite is an industrial chemical used as a pesticide, for hydraulic fracturing and for wastewater treatment. Sodium chlorite cannot be sold for human consumption, and suppliers of the chemical include a warning sheet stating that it can cause potentially fatal side effects if swallowed.”

Frequently Asked Questions Q1. What is off label drug use?
Answer: 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. Read More>>>

Q2. What is meant by biological marker in medicine?
Answer: 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>>>

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Blog Addicts

Dr. Antony Gomes, Scientist/ Pharma Academician tweets: 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 chirpsMore scholarly articles on various new findings of medicine are appreciable. I cherish reading all your sections!

Prof. Sarkar, Academician blogs PSM India has laid out the path forward to fight against unscrupulous medicine crimes! Joining the campaign with all zeal and effort!

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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.