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News Archive

EDITOR'S EMULSION

Pooja Khaitan

As the world celebrated CONSUMER RIGHTS DAY on 15th March with this year’s theme being Healthy Diet, PSM India too appeals to its subscribers to abide by the same. Unhealthy diets contribute to more than 11 million deaths a year. This means it is now a bigger killer than tobacco. Obesity is a serious concern. Our past issues of the Prescription have carried detailed articles on this. Obesity isn’t just a ‘rich world’ problem - some of the biggest increases in diet-related diseases are in developing countries. It really is time the world woke up to the concern of unhealthy diets.

The Union Budget 2015 was announced on 28th February 2015 and unfortunately again Health had very little to gain. This opens several opportunities for PSM India to mobilize the voice of the Patients on the issue of Universal and SAFE and quality Healthcare access. Read our issue to know more on the health announcements in the budget of 2015.

Slowly but steadily the National Health system of India has put up a tough fight against the deadly swine flu outbreak across the Nation claiming lots of lives leaving families shattered.
We feature the upcoming developments in combating Swine Flu epidemic by newer researches, guidelines, and increased availability of required medicine from various sections in this edition of ‘The Prescription’.
We have been successful in implementing the Bar coding on medicine packs. Its time to get our drug labels right too. Be informed about making labelling of drugs with storage conditions mandatory under our Drug laws and policy inhjections. Know more on various interesting news on counterfeit medication across the globe too in this issue.
Ever heard about a Prodrug and Parenterals? Find out more on it in our frequently asked questions section. While we bring you news on freshly approved drugs under Drug Dopes; don’t forget to mark your calendar for the upcoming events while taking a quick peek at our laughter dose. Its sure to bring a smile on your face.

If you have any suggestions, comments or queries, please email me at pooja@jagograhakjago.com.
You may find our previous issues on jagograhakjago.com or in the NEWS ARCHIVE section of every issue of The PRESCRIPTION, in case you’ve missed any of them. You may also look us up on Facebook under Partnership for Safe Medicines India

"Call PSM India toll free helpline 1800 - 11- 4424, to bring cases of spurious medicines or any kind of adverse drug reaction to the notice of the authorities.
Please visit our website jagograhakjago.com if you wish to learn about us .
To register a complaint kindly visit our consumer redressal website jagograhakjago.com
Happy Reading !
Stay Safe. Stay Healthy !

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

DOSE OF THE DAY

‘In view of the outbreak of Swine Flu in the country, State Drugs Controllers have been requested to create “Swine Flu Drug Availability Monitoring Cells”, which would function round the clock with necessary helplines to ensure availability of the drugs, vaccine and diagnostic kits’.

Dr. G.N Singh
Drugs Controller General of India

PSM India Capsules

Founder PSM INDIA, Mr.Bejon Misra speaks for the People on TIMES NOW

Can VVIPS be allowed on the Tarmac while some ailing patients are denied wheelchairs??!!
To know more on it like our facebook page…PARTERNSHIP FOR SAFE MEDICINES India or visit our website jagograhakjago.com

HIGHLIGHTS of HEALTH RELATED announcements in the BUDGET, 2015

Finance Minister Sh. Arun Jaitley announced the Union Budget 2015-16 on 28th February, 2015. To know more on the budget click here

WOMEN EMPOWERMENT for BETTER HEALTH

International Women’s Day Media Statement by Dr Poonam Khetrapal Singh, Regional Director, World Health Organization, South-East Asia Region
New Delhi, Mar 09, 2015 - On International Woman’s Day, WHO celebrates the economic, political and social achievements of women while calling for urgent action to make gender equality and empowerment a reality which is critical for improving women’s health.

National Injections

Mohali research body finds weed, conifer for Tamiflu production Chandigarh, March 2015: In the face of many swine flu deaths, spread of the virus across the country and reports of Tamiflu - drug used to treat swine flu - disappearing from pharmacies at many places, the Indian Council of Medical Research (ICMR), has firmed up a plan to enable production of the anti-viral drug by using indigenous raw material like weeds and conifers.

Compulsory licensing soon for export of generic drugs by India New Delhi, March 2015: The Indian pharmaceutical industry is expected to receive a massive boost if a recent attempt by the World Trade Organization (WTO) to amend its TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement on the access to essential medicines goes through. If it happens, it will enable India to export generic versions of some costly life-saving drugs made under compulsory licensing to Third world countries, especially in Africa, which do not have the production capacity for such medicines.

March 12 : World Kidney Day; Kidney Health for All!New Delhi, March 2015: The prevalence of chronic kidney disease or CKD has increased in the past few years in India. Early diagnosis and management delays progression and improves outcomes.
Patients who have diabetes, high blood pressure, atherosclerotic heart disease, peripheral vascular disease and a family history of kidney failure are especially at high risk of developing CKD, said Padma Shri Awardee Dr. A Marthanda Pillai, National President IMA and Padma Shri, Dr B C Roy National Awardee & DST National Science Communication Awardee, Dr K.K Aggarwal, President Heart Care Foundation of India and Honorary Secretary General IMA.

Union Government concerned over 80 per cent mortality among neonatal population caused by pneumonia & diarrhoeaBengaluru, March 2015: Union government is concerned about high neonatal mortality and fatality coming from pneumonia and diarrhoea cases. “These diseases continue to be leading causes of deaths in the country attributing to about 80 per cent of the overall under-5 mortality, says Dr. Rakesh Kumar, Joint Secretary, Ministry of Health and Family Welfare. Speaking at a National seminar on Post 2015 Sustainable Development Agenda and the Global Strategy for Women’s, Children’s and Adolescent Health’ held early this week at New Delhi , Dr. Kumar said interventions such as continuum of care, reaching the unreached, improving quality of care, introduction of 3 new paediatric vaccines in the Universal Immunization Programme, Project Indradhanush, Corticosteroids injections

Drug Laws & Policy Injections

Health ministry to amend Rule 96 of D&C Rule to make labelling of drugs with storage conditions mandatory Mumbai, March 2015: The Union Health Ministry will soon amend the Rule 96 of the Drugs and Cosmetics Rules, 1945 for making a provision for labelling of drugs with the storage conditions. A decision to this effect was taken by the Drugs Technical Advisory Board (DTAB) at its 68th meeting held on February 16 this year. In the meeting, the DTAB members were briefed that Rule 96 related to manner of labelling does not make it mandatory for the manufacturers to provide storage conditions in the label of the drug with specific temperature range at which the drugs should be stored. In view of this, some manufacturers indicate storage conditions on their own while majority of drug formulations do not provide such information.

Government may include oseltamivir into Sch H1 to step up availability for swine flu patients Mumbai, March 2015: Based on the Drugs Technical Advisory Board (DTAB) meet recently, government is mulling over the proposal to include oseltamivir phosphate and zanamivir formulations, antiviral drug used to treat swine flu under the Schedule H1 of the Drugs and Cosmetics Rules. Pharma companies has also proposed to the government to rescind the notification dated September 15, 2009 restricting the sale of these drugs as specified under Schedule X to overcome its restrictive sale.

Government to frame guidelines for companies to set up pharmacovigilance system Mumbai, March 2015: In order to strengthen the pharmacovigilance system for collection, processing and forwarding of Adverse Drug Reaction reports (ADRs), Government has formed a high level committee to prepare guidelines for manufacturers on the same to effectively monitor drug safety. Setting up of a pharmacovigilance system was recommended in a recent meeting with officials from the Pharmacy Council of India (PCI) and Indian Council of Medical Research (ICMR). It was suggested that the manufacturer or applicant should have a pharmacovigilance system in place for collection, processing and forwarding of the ADR report.

IMA to frame guidelines for swine flu, dengue Chennai, March 2015: With diseases like swine flu and dengue affecting the population across the country every year, the Indian Medical Association (IMA) is formulating a set of guidelines that will help the government prepare for disease outbreaks. The guidelines will stress the need to standardise testing, vaccinations (if available), treatment and cost of medication for various disease outbreaks. According to Dr. K.K. Aggarwal, Secretary General, IMA, there is currently no government policy to deal with outbreaks and epidemics.

Pharma Injections

Medical ethics & communication training to give shot in arm for doctor-patient relationship Mumbai, March 2015: Against the backdrop of incidents of violence against doctors by aggrieved relatives due to a patient's death during the course of treatment at the point of care, Maharashtra University of Health Sciences (MUHS) in consultation with Maharashtra Medical Council (MMC) is likely to introduce a separate subject in medical ethics and communication as a part of medical degree course by next year across the state.

LIVING WITH RARE DISEASES March, 2015 : February 28 is observed as Rare Diseases Day worldwide in support of millions of patients suffering from various kinds of debilitating medical conditions with hardly any approved medicines or cure available for treatment. Among these groups of patients are a large number of babies and children with serious genetic disorders. In India alone, there are over 70 million patients suffering from an estimated 7000 rare diseases.

Global Injections

NAFDAC Destroys N500m Counterfeit Drugs in Anambra The National Agency for Food, Drug Administration and Control (NAFDAC), has destroyed counterfeit and unwholesome drugs worth N500 million in Anambra.

COPD - Could you be at risk? Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the U.S. It is a progressive lung disease that makes breathing difficult due to lung airway obstruction.

WHA mechanism on falsified drugs gaining momentumA World Health Assembly-led initiative to tackle the trade in falsified and substandard medicines is starting to progress. The World Health Organization (WHO) executive board met in January to agree an agenda for the WHA in May, with one session focusing on the member state mechanism (MSM) on so-called substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFCs), with a view to signing off on a technical report and work plan drawn up last year.

Tagging drugs to stop counterfeit medicineMarch 2015: The U.S. and other countries are enacting rules to clamp down on the sales of fake pharmaceuticals, which pose a public health threat. But figuring out a system to track and authenticate legitimate drugs still faces significant obstacles, according to an article in Chemical & Engineering News (C&EN), the weekly newsmagazine of the American Chemical Society.

Drug Dopes

Mankind Pharma launches 'Heal-o-Kind' 4-in-one gel for wounds Mumbai, March 2015: The OTC business division of Mankind Pharma has launched “Heal-o-Kind- First Aid ka all-rounder”, a four-in-one gel containing nano crystalline silver to treat multiple injuries like wounds, burns, bruises and cuts. The product has been introduced pan India.

US FDA introduces mobile app to identify drug shortages Maryland, March 2015: The US Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

Hospira recalls one lot of magnesium sulphate in 5% dextrose injection due to incorrect barcode labeling Illinois, March 2015: Hospira, Inc., one of the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, has announced a voluntary recall of one lot of magnesium sulphate in 5% dextrose, inj., USP, 10 mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabelled with the barcode for heparin sodium 2000 USP units/1000 mL in 0.9% sodium chloride inj. The product is labelled with the correct printed name on the primary container and overwrap.

Sun Pharma recalls over 5,000 bottles of Ketorolac eye drop in US New Delhi, Mar 11, 2015: Sun Pharma is voluntarily recalling 5,322 bottles of Ketorolac Tromethamine ophthalmic solution in the US market for failing to meet specifications. As per the information available on the USFDA website, Sun Pharma Global , a US—based unit of the company, is recalling the eye drops for “presence of particulate matter” in the 5,322 batch of bottles.

FDA Approves First Biosimilar Product Zarxio (filgrastim-sndz) March, 2015: The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.

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SAFEMEDICINES Tools to help Pharmacists protect Patients from Counterfeit Medication

Pharmacists are in a unique position to both prevent counterfeit medication use and diagnose the tell-tale signs of counterfeit drugs in their patients. With risks to patients coming from direct-retail channels, such as fake online pharmacies, as well as from dubious distributors, pharmacists need to be on their guard to insure their patients receive only certifiably authentic U.S. FDA approved medication.

Frequently Asked Questions Q1. What are Prodrugs?
Answer: A prodrug is a precursor chemical compound of a drug. It is a medication that is administered in a pharmacologically inactive form which is then converted to an active form through a normal metabolic process such as hydrolysis of an ester.
Instead of administering a drug, a prodrug might be used instead to improve how a medicine is absorbed, distributed, metabolized, and excreted (ADME).Prodrugs are often designed to improve bioavailability when a drug itself is poorly absorbed from the gastrointestinal tract. A prodrug may be used to improve how selectively the drug interacts with cells or processes that are not its intended target. This reduces adverse or unintended effects of a drug, especially important in treatments like chemotherapy, which can have severe unintended and undesirable side effects.

Q2. What are Parenterals?
Answer: Parenteral is derived from the two words ‘‘para’’ and ‘‘enteron’’ meaning to avoid the intestine. Parenteral preparations are sterile preparations containing one or more active ingredients intended for injection, infusion or implantation into the body through the skin or other external boundary tissue, rather than through the alimentary canal, so that the active substances they contain are administered using gravity or force directly into a blood vessel, organ, tissue, or lesion. Parenteral products are prepared carefully by methods designed to ensure that they meet pharmacopeial requirements for sterility, pyrogens, particulate matter, and other contaminants, and, where appropriate, contain inhibitors of growth of microorganisms.They are packaged in either single-dose or multidose containers.

Laughter Dose

Blog Addicts

Koshish Association blogs: Loads of well-wishes to PSM-India for making us very much aware of the consequences of fake medicines!

Mrs. Hanshika, Socialite chirps: PSM –India has taught us to take safe medicines, get good treatment and remain protected from health ailments with its various messages and key news covered in “The Prescription” newsletter!

Mr. Nitin Bansal, Retired Professor blogs: We should all appreciate and wilfully participate in the fight for fakes supported by PSM India to curb all kinds of malpractices against medicines!

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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.