The Prescription: 17th December Issue
PSM INDIA Capsules National Injections Drug Laws & Policy Injections Global Injections Pharma Injections PSM PillDRUG DOPES UpComing Events Editor’s Emulsion FAQ Laughter Dose Blog Addict
News Archive
EDITOR'S EMULSION

Pooja Khaitan

This edition of THE PRESCRIPTION brings up news on the miserable tragedy that occurred in Punjab state of India where poor elderly people lost their sight after use of suspected infected equipment to remove cataracts by doctors at a free eye surgery camp. Such news makes us feel sad and worried about the dilapidated state of healthcare in our nation. Though we find that states like Maharashtra are taking and making actions against non-compliance (find under National Injections) to bring in back good health within the state but still there is much lagging all across our country in medicine, devices, diagnostic kits and patient care.

Read this issue to know more on the newly released draft Schedule M-III requirements, IP addendum and other policies under Drug laws and policies. Also find newer developments on for fake medicine detection under Global injections Section. You shall find the current updates of approved / banned drugs in India under Drug Dopes. This issue also brings forward important facts on Oral Rehydration therapy and Salts (ORS) under Frequently Asked Questions.

Mark your calendar for upcoming events featured in this issue.


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.
Please visit our website www.safemedicinesindia.in if you wish to learn about us .
To register a complaint kindly visit our consumer redressal website www.consumerconexion.org

Happy Reading !
Stay Safe. Stay Healthy !

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

DOSE OF THE DAY

"This could be a silver lining that comes out of the Ebola crisis, because it really does underline very strongly the message about the importance of local health care systems."

Mr. Anthony Lake
UNICEF Executive -Director (CEO)

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PSM India Capsules
PSM INDIA OBSERVES PATIENT SOLIDARITY DAY

MUMBAI, 9th December,2014 :

PSM India and Consumer Online Foundation along with various stakeholders in the Healthcare sector gathered in Mumbai to celebrate Patient Solidarity Day on 9th December 2014 over a roundtable discussion to deliberate on UNIVERSAL HEALTH COVERAGE and patients' right to access quality healthcare.
For more pics click http://www.safemedicinesindia.in/PATIENT%20SOLIDARITY%20DAY.php
Or visit our facebook page "partnership for Safe Medicines India "

NEW DELHI 6th December 2014:

Leading Consumer Organisations and Patients Groups celebrated the Patient Solidarity Day today at Mayur Vihar Housing Complex with Senior Citizens today to demonstrate their solidarity to demand access to safe and quality Healthcare for all and Universal Health Coverage for the Senior Citizens similar to the Rashtriya Swasthya Bima Yojana started in April 2008 by Government of India. Partnership for Safe Medicines (PSM) India, Healthy You Foundation, Consumer Online Foundation and International Alliance of Patients’ Organisation (IAPO) have come together to celebrate this day to highlight the importance of patient-centric healthcare and urgent need to take care of the elderly population growing significantly and is forecasted to hit almost 300 million in around two decades.

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ARE VACCINATIONS REALLY SAFE AND EFFICIENT?

Vaccination in our Country like India each year claims lives of innocent children. Vaccination is itself a risk based approach as they are administered to healthy patients and generally at a very tender age. Each day newer vaccines are rolling out into the market. But, are they really safe and efficient and how aseptically manufactured? This is a matter of great concern. Regarding this context,
PSM India brings up for readers an interesting piece of article - “Stop unnecessary vaccination: eminent doctors, scientists to the PM”

Read more of it at http://www.moneylife.in/article/stop-unnecessary-vaccination-eminent-doctors-scientists-to-the-pm/39645.html and also find enclosed the letter sent to The Prime Minister, Shri Narendra Modi regarding views/ suggestions on curbing of unnecessary vaccination by various healthcare professionals.

National Injections
Fifteen Indians blinded after surgery with suspected infected tools New Delhi, Dec 2014: Fifteen Indians lost their sight after a doctor used suspected infected equipment to remove cataracts at a free eye surgery camp, the latest incident to highlight the dangers of shoddy medical treatment in the country. Read More
Six kids develop adverse drug reaction, FDA swoops down on hospital Mumbai, Dec 2014: Six children in a BMC-run hospital in Vikhroli developed severe drug reaction after being injected antibiotics on Tuesday. Children aged between 1.5 and 12 years were being treated in the paediatric ward of Mahatma Phule Hospital. Read More
Maha FDA takes action against cos for supplying spurious productsMumbai, Dec 2014: To ensure compliance to the conditions of licence, Maharashtra Food and Drug Administration (FDA) has issued show cause notice to a Mumbai based stockist Alpha Enterprises and filed cases at Metropolitan Court, Sewri against marketing company for allegedly supplying spurious drugs to a reputed Mumbai based hospital and endangering patients life. Licenses have also been cancelled for violating the conditions of license. Read More
Drug Laws & Policy Injections
IPC releases IP Addendum-2015 to IP-2014, consisting of 82 new monographs New Delhi, Dec 2014: Continuing with its commitment to improve the health of the people by ensuring quality, safety and efficacy of medicines, the Indian Pharmacopeia Commission (IPC) released its IP Addendum-2015 to IP-2014 last week in Delhi. Read More
Kerala govt brings new rule to check unauthorised sale of preparations in Ayurveda Chennai, Dec 2014: In a significant move, the government of Kerala is gearing up to bring in a Rule to regulate the preparation and sale of Arishtams and Aasavams (spirituous preparations in Ayurveda) in order to help the public avail pure and unadulterated products for their medicinal needs, sources informed Pharmabiz. Read More
CDSCO issues draft Schedule M III--requirements for factory premises for medical devices & in-vitro diagnostic products Mumbai, Dec 2014: The Central Drugs Standard Control Organization (CDSCO) has issued the draft Schedule M III-Good Manufacturing Practices and requirements of premises, plant and equipment for medical devices and in-vitro diagnostic kits & reagents. Read More
WHO's UMC to extend collaboration with IPC in PvPL initiative Dec, 2014: Impressed by the ongoing efforts of the Indian Pharmacopoeia Commission (IPC) in effectively monitoring and implementing the Pharmacovigilance Programme of India (PvPI), the World Health Organisation's (WHO's) Uppsala Monitoring Centre (UMC) has decided to further extend its collaboration by strengthening training and education programme with IPC. Read More
Pharma Injections
Doctors must write generic drugs name in capital letters New Delhi, Dec 2014: The Union Government has amended rules in Indian Medical Council Regulations 2002, directing physicians to prescribe drugs with generic names in legible and capital letters, the Lok Sabha informed on Friday. Read More
New WHO guide to prevent and control cervical cancer Melbourne Dec 2014 : New guidance from WHO aims to help countries better prevent and control cervical cancer. The disease is one of the world’s deadliest – but most easily preventable – forms of cancer for women, responsible for more than 270 000 deaths annually, 85% of which occur in developing countries. Read More
Global Injections
New test successful in finding fake medicines A spectroscopy technology has proved effective in sorting genuine medicinal products from counterfeits. Read More
Oregon hospital: Medication error killed patient PORTLAND, Ore. (AP), Dec 2014: An Oregon hospital is acknowledging that it administered the wrong medication to a patient, causing her death. Read More

WHO warns that progress towards eliminating measles has stalled 2015 targets will not be metGENEVA, DEC 2014: WHO warned that progress towards the elimination of measles has stalled. The number of deaths from measles increased from an estimated 122 000 in 2012 to 145 700 in 2013, according to new data published in the WHO Weekly Epidemiological Report and the Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Report. The estimated number of measles deaths in 2013 represents a 75% decline in mortality since 2000, significantly below the target of a 95% reduction in deaths between 2000 and 2015.Read More

Drug Dopes
List of New Drugs approved for marketing in India CDSCO, Dec 2014: CDSCO (Central Drugs Standard Control Organization) has updated the list of new Drugs approved for Marketing In India in the Year 2014 for consumer awareness.
Know more of it at:
http://www.cdsco.nic.in/forms/list.aspx?lid=1820&Id=11 and
http://www.cdsco.nic.in/writereaddata/Updated%20list%202014.xls
EU bans imports from Ranbaxy unit New Delhi, Dec, 2014: Ranbaxy Laboratories is in trouble once again with Germany citing a unit of the drug maker’s Dewas plant late last month for non-compliance and imposing a ban on products manufactured at the unit. Read More

Zydus's biosimilar product Adalimumab now accessible in India

Mumbai, Dec 2014: Zydus Cadila, an innovative, global pharmaceutical company that discovers, develops, manufactures and market a broad range of healthcare therapies has announced the launch of the biosimilar of Adalimumab, the world's largest selling therapy. Zydus becomes the first company in the world to launch this biosimilar product. Read More

FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products

December, 2014: The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding. Read More

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PSM PILL
Daniel Burke Shares His Perspective on the Danger Fake Online Pharmacies Pose @ Interchange 2014

Special Agent Daniel Burke, Senior Operations Manager in Charge of Cybercrime Investigations for the Office of Criminal Investigations at the U. S. Food and Drug Administration acted as moderator for Interchange 2014’s panel concerning the impacts that fake online pharmacies have on patient safety. During his opening presentation he shared stories from his investigations.
In his opening presentation for Panel 3: The Impacts of Fake Online Pharmacies on Patient Safety, Special Agent Burke explained the dangers consumers face when shopping for medication online and just how little control FDA has over quality and purity when a medication is manufactured and sold outside the secure U.S. drug supply chain.

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Frequently Asked Questions Q1. What is meant by ORS and its importance?
Answer: Rapid evacuation of fluids from the body, which can be caused by cholera or other diarrheal diseases, may lead to chronic dehydration and eventually death. Oral Rehydration Salts (ORS - also known as Oral Rehydration Therapy (ORT)) are a solution of sugars and salts which helps to slow the evacuation of fluids, allowing for the absorption of electrolytes in the intestines. WHO and UNICEF jointly maintain official guidelines for the manufacture of ORS and recommend various alternative preparations, depending on material availability. Commercial preparations are available as either pre-prepared fluids or packets of oral rehydration salts (ORS) ready for mixing with the fluid.

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Q2. What is the composition of ORS and how to make it?
Answer:WHO/UNICEF guidelines suggest ORT should begin at the first sign of diarrhea in order to prevent dehydration. WHO/UNICEF's formula for ORS consists of
2.6 grams salt (NaCl),
2.9 grams trisodium citrate dihydrate,
1.5 grams KCl,
13.5 grams anhydrous glucose C per litre of fluid.
A basic oral rehydration therapy solution is composed of salt and sugar in water, made using a standard ratio and is appropriate for use in situations when ORS must be prepared without the standard ingredient. The simple formula is:-
• 30 ml sugar : 2.5 ml salt : 1 litre fluid
• 6 teaspoons sugar : 0.5 teaspoon salt : 1 quart fluid (approx. 1 litre)
But a short piece of advice from PSM Desk is that degree of dehydration should be assessed before initiating ORT. ORT is suitable for people who are not dehydrated and those who show signs and symptoms of mild to moderate level of dehydration. People who have severe degree of dehydration should seek professional medical help immediately and receive intravenous rehydration as soon as possible to replenish fluid volume in the body.

Laughter Dose
Blog Addicts
Dr. Aditya, Prof. Medicinal Chemistry tweets Fake medicines are of either minimal or no therapeutic effect. So, we should try to be cautious about them. Thanks to PSM-India for helping us in understanding them better!
Shri. Rakesh Mahajan says “The Prescription” is providing us with much needed guidance to get rid of spurious medicines from India and we appreciate its hard work!
Deepak Goel, academician blogs Grateful to PSM India for keeping us updated with various happenings on unsafe medicines in our country!
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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.