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EDITOR'S EMULSION
At present, the National Health system of our Nation is struggling to comprehend the swine flu outbreak that has killed more than 800 people since it took hold in mid-December 2014. PSM- India mourns for the patients and their families who have lost their lives or are suffering from the outrageous attack of Swine Flu virus across the nation. Our Team advises every individual to maintain proper safety measures to prevent oneself from falling prey to the deadly H1N1 virus.
Read more on Swine Flu under PSM India capsules. Catch on news related to fake swine Flu drugs and their illegal racket to stay vigilant under the National injections section. Know more on the upcoming policies, project implementations in various states and most importantly that retail drugs would be barcoded soon. Read this under our Drug laws and policy injections.
Global Injections section brings in fresh news of WHO draft guidelines on Good Pharmacopoeial Practices, a 15 minute breakthrough Ebola test and much more. Read more on Deadly Fixed Dose combinations, new drug for HIV vaccine under Pharma Injections. Find out on freshly approved drugs under Drug Dopes Section. In this issue, under frequently asked questions, we take up the query on biosimilars.
Dont forget to mark your calendar for important upcoming Pharma events featured in this issue.
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Happy Reading !
Stay Safe. Stay Healthy !
Pooja Khaitan
Chief Editor ,
The PRESCRIPTION
Partnership for Safe Medicines India.
DOSE OF THE DAY
‘With a view to reduce India's dependency on other countries for bulk drugs, Government will come out with strategies to improve bulk drug capacity in India in two months'.
Dr. V. K. Subburaj,
Secretary,
Department of Pharmaceuticals,
Ministry of Chemical and Fertilizer,
Government of India
PSM India Capsules
The swine flu menace is back in the country with over 10,000 people testing positive for the virus and around 800 deaths across different states. Every day the papers and internet are full of swine flu numbers formed across the country which makes us wondering what the symptoms are, how it can be treated and why it’s dangerous. Here are a few facts that you need to know about swine flu so that you can protect yourself and your loved ones from getting affected or if attacked, get properly treated at an early stage itself.
What is swine flu?
An infection caused by one of the multiple types of influenza viruses, particularly the new strain of virus H1N1 influenza is commonly referred to as swine flu, pig flu or swine influenza.
Swine influenza is common in the pig population worldwide. Generally, the pig to human transmission of virus does not occur and develop into a human flu; however, it may generate certain antibodies in the blood.
Causes of swine flu
Primarily, swine flu occurs only as a result of H1N1 virus but it is important to note that the influenza virus changes on constant basis to produce many strains and swine flu is caused due to one such strain. While some strains of virus infect birds, pigs and humans, some strains infect pigs only.
People who are heavily exposed to poultry and pigs are most likely to be affected. The mode of transmission of virus from one person to another may be any of the following:
National Injections
DCGI directs state drug controllers to ensure accessibility of swine flu drugs & monitor irrational usage Mumbai, Feb 2015: Even as cases of swine flu have surged dramatically over the past few months leading to over 600 reported deaths across the country, Drug Controller General of India (DCGI) has instructed all the State Drug Controllers to ensure that antiviral medicine, oseltamivir be made available to the needy patients taking also into account its rational usage for the sake of patient safety.
J-K Govt suspends license of 5 local drug manufacturing units Jammu, Feb 2015: Jammu and Kashmir government today suspended the licenses of five local manufacturing units after sub-standard drugs worth Rs 21 lakh were seized by the drug control authority. "The Drug and Food control organization in Jammu and Kashmir have seized sub-standard drugs worth Rs 21 lakh and also suspended the license of five drug manufacturing units," an official spokesman said here today.
The truth about weight loss medicinesFeb, 2015 : If you've ever watched late night television, you must have stumbled across endless advertisements about magical weight loss pills. Each advertisement begins with the wondrous promise of 'eat all you want, don't exercise, and still watch those kilos melt away’. And with obesity on the rise the world over, the business of weight loss medicines becomes more lucrative with each passing day. But is there any merit to these weight loss pills? Can healthy weight loss really be that simple? Today we're taking a look at what the truth behind these weight loss medicines really is.
FDA crackdown on chemists selling 'swine flu vaccines'Pune, Feb 2015: While public panic reigns large over the current outbreak of the H1N1 virus across the country, authorities have begun to notice the first signs of individuals attempting to take advantage of the situation.cines' According to officials of the Food and Drugs Administration (FDA), Pune, they have come across a startling piece of information that has prompted them to swing into action, after it was discovered that some medical shop owners are 'illegally' selling viral infection vaccines at a high price that claim to prevent H1N1 .
Drug Laws & Policy Injections
IMA to promote affordable and efficacious branded generics through Nirmalaya Mumbai, Feb 2015: Based on a study done in the remote parts of Maharashtra over the past few years, the Indian Medical Association (IMA), Maharashtra branch is planning to promote affordable and efficacious medicines available through a ready reckoner named Nirmalaya. Nirmalaya would enable around 35,000 allopaths across Maharashtra to prescribe branded generics of standard drug companies at the lowest price available without compromising on the quality, informed an official associated with the development.
Karnataka gearing up to implement National Urban Health Mission FBengaluru, Feb 2015: Karnataka is now gearing up to implement the National Urban Health Mission (NUHM) in the first week of March. As part of the initiative, 13 Urban Public Health Centres including eight in Bengaluru will be brought under the scheme with the aim to prevent spread of communicable and non-communicable diseases. The thrust for the NUHM was undertaken under the 12th Five Year Plan with a budget allocation of Rs.30, 000 crore which ceases to exist under the new government and replaced with Niti Aayog.
New FDA software to make system centralised Mumbai, Feb 2015: The Food and Drug Department (FDA) will introduce a new software, called online extended licensing node (XLN), as substitute for massive manpower shortage while making the system paperless and centralised. The announcement comes soon after a RTI query filed by activist Anil Galgali revealed that over 31 per cent of seats in the FDA were lying vacant with only 811 of the 1,176 posts allotted to the department occupied. The query found that currently, for every 1.35 lakh people, only one FDA official was available.
Retail drugs to be ‘barcoded’ for genuineness, soon Mumbai, Feb 2015: Patients will soon be able to check if the medicine they are taking is genuine or spurious. Over the next few weeks, the government plans to launch a 'track & trace' mechanism, which will involve strips of pills and vials sporting a unique code for authentication. The code will provide details of the product, including that of the manufacturer.
Pharma Injections
Big boost: New drug raises hope for an HIV vaccine WASHINGTON: Scientists have developed a novel drug candidate that may lead to a potent and universally effective HIV vaccine. Researchers found that the new drug candidate blocks every strain of HIV-1, HIV-2 and SIV (simian immunodeficiency virus) that has been isolated from humans or rhesus macaques, including the hardest-to-stop variants. It also protects against much-higher doses of virus than occur in most human transmission and does so for at least eight months after injection.
Drug Act aiding harmful combo of meds: Lancet Mumbai, Feb 2015: India's Drug Act has aided proliferation of harmful combination drugs, many of it available on retail shelves, without any clinical trials and with little medical rationale, a study has found. This has helped harmful fixed dose combinations of metformin, used for managing diabetes, to evade approval as well as price controls, reputed medical journal Lancet has said.
Mobike ambulance service launched in Bengaluru Bengaluru, Feb 2015: Chris Hospital Saturday launched a two-wheeler mobike ambulance service here to reach accident victims by navigating through the city's notorious traffic at the earliest and provide emergency treatment to save lives.
Global Injections
WHO approves breakthrough 15-minute Ebola test Geneva, Feb 2015: The World Health Organization has approved the first rapid test for Ebola in a potential breakthrough for ending an epidemic that has killed almost 10,000 people in West Africa, it said on Friday.
WHO issues draft guidelines on Good Pharmacopoeial Practices; invites comment by March 10 Bengaluru, Feb 2015: The World Health Organization (WHO) has issued draft guidelines on Good Pharmacopoeial Practices (GPhP) and is looking for the industry to comment before March 10, 2015. 
Drug Dopes
CDSCO LIST OF APPROVED DRUG of Jan’ 2015Click here to view the list
IISc, Bengaluru develops shock wave induced drug delivery patch for vaccines, insulin & antibiotics Bengaluru, Feb 2015: The Indian Institute of Science (IISc), Bengaluru has now developed a novel shock wave induced drug delivery patch that will replace the painful injections and stall needle stick injuries. The patch developed with hydro collide material is designed to hold on active molecules like vaccines, insulin and antibiotics. The pre-clinical studies are complete and now the Institute is set to scout for bio-pharma industry partners to take the research to human trials and technology transfer for commercialisation thereafter.
New nano-gel to deliver multiple drugs New York, Feb 2015: Scientists have designed a new type of self-healing hydrogel that could be injected through a syringe. It can be used in killing tumours, among other applications. The gel can carry one or two drugs at a time and could be useful for treating cancer, macular degeneration or heart disease, among other diseases, the researchers say.
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PSM PILL
Tim Mackey Presents GIS Research on Counterfeit Cancer Medication At Interchange 2014
During a research presentation at Partnership for Safe Medicines Interchange 2014 in Washington D.C. Tim Mackey, Assistant Professor, University of California, San Diego’s Department of Anaesthesiology, addressed the effect counterfeit Avastin has had on efforts to protect the American public from fake medications.
Dr. Tim Mackey shared his American Cancer Society funded research with attendees at Interchange 2014. Titled After Avastin, What Have We Learned and What Can Be Done? Mackey’s research took a multidisciplinary approach to examining the data, using FDA warnings plus GIS and network analysis to try to draw conclusions as to what can be done to prevent another counterfeit Avastin-type incident in the United States..
Frequently Asked Questions Q1. What are Biosimilars?
Answer: A Biosimilar medicine is a follow-on version of original or innovator’s biological medicines (Reference biologicals) that is similar but not identical to the original biological medicine. Biosimilar products are similar in terms of quality, safety and efficacy to a reference biologicals, but not essentially identical copies, to reference products like conventional generics. Biosimilar medicines are intended to have the same mechanism of action as the original biological medicines, and are designed to treat the same diseases as the innovator’s product, however don’t utilize the same living cell line, production process, or raw material as the innovator product.
Biosimilars of vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and proteins are widely available in India and International Market.
Q2. Can a Biosimilar medicine be used instead of the original biological medicine?
Answer: Yes. It is possible to be switched from one biological medicine to a Biosimilar version of that medicine under the supervision of a medical practitioner.
However, while a pharmacist can, with your permission, dispense a generic version of a small molecule medicine instead of the original medicine, they cannot substitute a biosimilar version of a medicine for the original product (or another biosimilar) if that is the one prescribed. You should not switch back and forth between a biosimilar medicine and the original product (or vice versa) unless your doctor determines it is appropriate to do so.
Biosimilar medicines should always be prescribed by name of the active components. This name will not be exactly the same as that of the original biological medicine, so that the two products will not be confused. With biological medicines you should only take the brand of the medicine that is prescribed for you.
Blog Addicts
Neeraj Roshan Association for elderly ones blogs: : We wish lots of success to PSM-India and aspire them to continue their good work in creating patient awareness regarding fake medicines all across India!
Right to good health Foundation tweets: We should rise against all types of crime related to health and medicine much like Partnership for Safe Medicines- India!
Mr. Sourav Aggarwal, Retired Scientist tweets:
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