The Prescription: 17th January Issue
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News Archive
EDITOR'S EMULSION

Pooja Khaitan

As the new year has kick started with new hopes and brighter dreams for all, the Indian government too has introduced futuristic health programs for its citizens. The Drug laws and policy section of this issue informs readers of the newly drafted National Health Policy, Drugs and Cosmetics Amendment Bill ( 2015), and ‘Mission Indradhanush’ to name a few. This edition of “The Prescription” brings in news on pharmaceuticals starting from expired drugs, adverse drug reactions of medicines, new code of ethics for Hospital, Clinics etc in its National injections Section. Go through global injections to catch news on fake drugs and action being taken against this menace worldwide.
This issue we also have an interesting read on the GAME CHANGER in antibiotic medicine. Read more on it under our Drug dopes section. Mark your calendar for the upcoming events listed in this newsletter.


If you have any suggestions, comments or queries, please email me at pooja@safemedicinesindia.in.
You may find our previous issues on our website www.safemedicinesindia.in 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.
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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

“2015 would be the year for streamlining of regulatory procedures without compromising patient safety”.

Dr. G.N Singh
Drugs Controller General of India

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PSM India Capsules

There have been several notable achievements of the Ministry of Health & Family Welfare during 2014. Ranging from significant improvements in health outcomes under National Health Mission, rolling out of a National Health Assurance Mission, introduction of Indian New-born Action Plan (INAP), Integrated Diarrhoea Control Fortnight (IDCF), National Tobacco Control Programme, Pradhan Mantri Swasthya Suraksha Yojana (PMSSY), National Mental Health Policy to launch of new vaccines against preventable diseases and several others in safeguarding health of people of our Nation.

PSM India through its newsletter “The Prescription” brings frontward the year-end review of Ministry of Health and Family Welfare, Government of India published by The Press Information Bureau, Government of India.

To read more on it, click below
http://pib.nic.in/newsite/erelease.aspx?relid=114211

A Study: Adverse drug reaction cases

It's a fact that medicines can cure ailments but they can also lead to death. Basic Paracetemol drugs, penicillin-based antibiotics and certain epileptic drugs among others can throw up deadly adverse drug reactions (ADRs) in patients.

How serious is ADR?

Although doctors say that reactions like Toxic Epidermal Necrolysis Syndrome (TENS) where a patient's skin peels off entirely are rare, there is no concrete data to prove this. DNA had reported on December 11, that Kalyan resident Heena Khan, 28, had suffered from TENS after consuming Amoxycillin-based antibiotic, which was administered to her for curing fever. Though Heena has fortunately recovered from ill effects of TENS, some are not so lucky. In May, Sharmila Shinde, 57, died of infection after contracting TENS due to tablets she was consuming for controlling her uric acid levels.

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National Injections
Expired drugs worth lakhs found dumped in Azamgarh Varanasi, Jan 2015: Expired medicines including life-saving drugs in huge quantity were found dumped in garbage in Azamgarh, the parliamentary constituency of SP supremo Mulayam Singh Yadav on Wednesday. These unused medicines were from government hospitals and health centre. The district health officials were on their toes with the spread of the news. A team has been constituted to look into the matter. Read More
Maha FDA takes action on companies for supplying spurious products to Tata Hospital Mumbai, Jan 2015: Two Mumbai based companies have been booked under relevant sections of the Drugs and Cosmetics Act, 1940 for supplying spurious products to Tata Memorial Hospital, the leading cancer research institution and hospital in the country.Read More
MP to introduce online licensing of drug firmsIndore, Jan 2015: From January, drug manufacturers and retailers in the state will no longer have to make rounds of the Drug Inspectors' office to apply for license under Food Safety and Standards Act, 2006, as it could be done just at the click of mouse. Taking a cue from Gujarat's model of issuing online licenses in the bulk drug segment, Madhya Pradesh would introduce online license process shortly. Read More
Hospitals, nursing homes get new code of ethicsNew Delhi, Dec 2014: A new code of ethics will now govern hospitals, nursing homes and other similar medical establishments, prohibiting any malpractices such as earning cuts, commissions, inflating patients' bills and accepting freebies. The Indian Medical Association (IMA) has recently issued the broad guidelines for healthcare providers and asked them to put it on display. Read More
Drug Laws & Policy Injections
Health ministry releases draft Drugs and Cosmetics (Amendment) Bill, 2015 to amend D&C Act, 1940 Mumbai, Jan 2015: The Union Health Ministry has released the draft Drugs and Cosmetics (Amendment) Bill, 2015 to amend the Drugs and Cosmetics Act, 1940 for up gradation and introduction of provisions for clinical trials and regulation of medical devices. Read More
Form regulatory body to clear advertisements of medicines: Bombay HC to government Aurangabad, Dec 2014: The Aurangabad bench of the Bombay high court comprising Justice P Dharmadhikari and Justice J J Badar directed the state Food and Drug Administration (FDA), Drug Control of India and the government to evolve a comprehensive policy about advertisements of medicines on the lines of censor board. Read More
Health ministry issues draft National Health Policy 2015 Mumbai, Jan 2015: The Union Health Ministry has issued the much awaited draft National Health Policy 2015 which is a declaration of the determination of the government to leverage economic growth to achieve health outcomes and an explicit acknowledgment that better health contributes immensely to improved productivity as well as to equity. Read More
Shri J P Nadda launches “Mission Indradhanush” - “Will achieve full immunization coverage for all children by 2020 through a Catch-Up campaign” DEC 2014: The Mission Indradhanush, depicting seven colours of the rainbow, aims to cover all those children by 2020 who are either unvaccinated, or are partially vaccinated against seven vaccine preventable diseases which include diphtheria, whooping cough, tetanus, polio, tuberculosis, measles and hepatitis B. Read More
FDI medical devices policy to come into effect from Jan 21 New Delhi, Jan 2015: The government decision to permit 100 per cent Foreign Direct Investment in medical devices will take effect from January 21, the Commerce and Industry Ministry said today. Read More
Pharma Injections
New worry: Resistance to 'last antibiotic' surfaces in India Pune, Dec, 2014: It is the beginning of the end. Hospitals in India are now recording cases of infections resistant to colistin, the last antibiotic available in the world, which was brought back from a 40-year exile in 2005 to treat increasing number of infections resistant to other high-end antibiotics. Read More
Listen Up! Noises Can Damage Your Hearing Jan, 2015: Sounds surround us. We enjoy many of them—like music, birdsong, and conversations with friends. But loud or long-lasting noises—from motors, power tools, and even headphones—can permanently damage your hearing. Take steps to protect your ears from harmful noises.
Loud noise is one of the most common causes of hearing loss. An estimated 26 million Americans between the ages of 20 and 69 already have irreversible hearing loss caused by loud sounds. And up to 16% of teens have hearing loss that may have been caused by loud noise.
Read More
Herbal medicines from quacks hit unborn babies’ brains Mumbai, Jan 2015: A study on 104 mentally challenged children has once again ignited the debate about the extent of damage inappropriate traditional medicines can cause during pregnancy. Presented in the ongoing Indian Science Congress on Monday, the study claimed pregnant women who consumed such medicines or herbs probably ended up damaging the genetic make-up of their new-borns. Read More
Shri J P Nadda at AAPI Health Summit: Focus to shift from ‘sick care’ to ‘healthcare’ New Delhi, Jan 2015: The Government plans to shift the focus from ‘sick care’ to ‘healthcare’ and reduce the need for hospitalization/ tertiary care. Focus will now be on comprehensive and holistic Primary Health Care including preventive and promotive health to improve health and reduce healthcare expenditure. The idea is to empower every person to be an agent of positive health, at individual and community level, and help create a “Social Movement for Health”. Read More
Global Injections
Multi-million peso fake medicines seized Manila, Dec 2014: The Bureau of Customs (BOC) seized on Tuesday 660 kilograms of counterfeit medicines worth millions of pesos at the Pair Cargo warehouse in Paranaque City. Totalling 17 pallets, the shipment arrived in the Philippines on a Thai Airways flight from Karachi, Pakistan via Bangkok, Thailand last December 19. Read More
Surge in illegal sales of drugs as gangs exploit 'phenomenal market' online Washington, Dec 2014: The rise of social media and greater internet access through smartphones are factors behind a huge rise in illicit sales of pharmaceuticals, according to the chief enforcement official at Britain’s medicines regulator. Read More

MHRA helps track and charge counterfeit drugs sellerJan, 2015: The efficacy and safety watchdog for medicines in the UK has helped bring a man alleged to have been selling fake, powerful prescription medicines online. The MHRA confirmed that Dmitrij Selkov has been charged with 17 offences under the Human Medicines Regulations 2012 and Trademarks Act 1994. The 28-year old has been bailed to appear at Westminster Magistrates Court next Monday (January 12). Read More

Drug Dopes
Lupin gets USFDA approval for HIV drug New Delhi, Dec 2014: Drug major Lupin has received US health regulator's approval to market a generic version of ViiV Healthcare's Epivir Tablets, used in treating HIV infection, in the American market.
The Mumbai-based firm has received final approval from the US Food and Drug Administration (USFDA) for its Lamivudine tablets in strengths of 150 mg and 300 mg, Lupin Ltd said in a statement.
Read More
U.S. Discovery Might Be ‘Game Changer’ For Antibiotic Medicine It was nearly three decades ago when the last new class of antibiotics made it to clinic. Since then there has been a drought but a new U.S. discovery, which is being considered as a “game changer,” might be very promising for the future of antibiotic medicine. U.S. scientists have developed a new method for growing bacteria which has provided some 25 new antibiotics, of which one is believed to be “very promising.” Read More
US FDA approves Impax Pharma's Rytary to treat Parkinson's disease Hayward, California Jan, 2015: The US Food and Drug Administration (FDA) has approved Impax Pharmaceuticals' Rytary, an extended-release oral capsule formulation of Carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication. Rytary is not for use in patients using nonselective monoamine oxidase inhibitors (MAO) inhibitors. Read More
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PSM PILL

PSM International brings forward one of the discussions on counterfeit medications- Americans patients exposed to counterfeit and black market medication by Shabbir Imber Safdar, Director of National Outreach, Partnership for Safe Medicines (www.safemedicines.org 415-683-7526 shabbir@safemedicines.org)

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Frequently Asked Questions Q1. What is meant by Track and Trace in medicines?
Answer: Track and trace technology in medicines is a simple and effective way to leverage basic serialization and protect patients and consumers against counterfeiting (spurious) and substandard medicines. Pharmaceuticals companies and governments of countries worldwide believe that drug counterfeiting can be reduced significantly by implementing product serialization. Serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. Every product needs to be identified by a unique serial number in addition to the origin, shelf life and batch number. This will allow the product’s lifecycle to be traced from production, through distribution and finally to dispensation to patients at the drugstore or hospital.

Q2. What is the importance of robust track and trace technologies?
Answer: Basically, a track and trace solution monitors the entire process right from manufacturing to packaging of the drug. It serves as a protective layer of supply chain security and also empowers end users to authenticate the genuineness at the point-of-purchase via an SMS. Track/trace solutions can serve multipurpose at one time starting from accounting for raw materials, product history, authenticating product/dosage, tracing processers products, managing recalls & returns, product distribution, speeding up replenishment time, reducing infiltration of counterfeit pharmaceuticals into the supply chain, reducing errors, providing accurate auditing and inventory forecasting. Track and trace solutions also help in improving artwork management, as businesses move towards more modernized artwork management leading to lesser mistakes and minimizing product recall.

Read More>>>

Laughter Dose
Blog Addicts

Sevayan Foundation blogs Health shouldn’t be compromised with intake of falsified medicines. Better to remain informed and educated. Cheers to PSM India for its honest efforts!

Mr. Apoorva Rahane, Healthcare Professional chirps PSM- India has been putting towards empowerment of every single individual healthcare personnel for further improvement of public health in our country.

Mrs. Ruby Arnold tweets “The Prescription” is creating much awareness for good health amongst us with its exciting capsules, policies, injections section in newsletter!
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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.