The Prescription: 17th April 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

Advertisements play a huge impact on the Indian audience. Be it on television, in print media or at the movies, consumers are greatly influenced by what they see. This issue of THE PRESCRIPTION captures some ads on health and personal care that are deceptive and misleading. Do give it a read as an aware citizen.
Catch up with malpractices, illegal activities related to counterfeit medicine, inspection drive across Tamil Nadu and Karnataka, IPA letter regarding misuse of prescription drugs from our National Injections section too.
Barcoding sets off from 1st April on secondary packaging as well. Now every carton needs to have a tracking and tracing applicable bar code on it if going for export. More on it under our Drug laws and Policy injections.
Get to know more on essential medicines, iatrogenesis from FAQs, newly found pharmacological effects of commonly used medicines from the Pharma Injections Section. Feel light and refreshed with our laughter dose and don’t forget to mark your calendar with the important upcoming events across India and the world over.

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

“Universal Health Coverage is relevant to every person on this planet. It is a powerful equalizer that abolishes distinctions between the rich and the poor, the privileged and the marginalized, the young and the old, ethnic groups, and women and men”.

Dr. Margaret Chan
Director-General, WHO

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PSM India Capsules
WATCH OUT for WHAT YOU SEE !

Advertisements are ever so often deceptive and they cannot be claimed as the index of a product. Below is an interesting article on known advertisements which are constantly aired on television that are misleading, untrue and illegal. Advertising Standard Council of India(ASCI), a subsidiary of Consumer Complaints Council (CCC) in January 2015 upheld complaints against 151 out of 201 advertisements. Out of 151 advertisements against which complaints were upheld, 90 belonged to Personal and Healthcare category, followed by the Education category with 40 advertisements.
To know more, click on : http://www.exchange4media.com/59491_asci-upholds-complaints-against-151-out-of-201-advertisements.html

World Health Day addressed by Hon’ble Prime Minister, Shri Narendra Modi

On the eve of World Health Day , Prime Minister of India, Shri. Narendra Modi stated, “On World Health Day, I pray that all of you remain in the best of health and at the same time inspire others to lead a healthy life. Theme of this year’s World Health Day, Food Safety is an essential pre-condition for good health and we all must focus on it. Government is working tirelessly to realise the dream of a Healthy India where every citizen has access to proper and affordable healthcare”.

Read More
National Injections
Quacks 'borrow' legit doctors' names New Delhi: The trend of quacks or illegal doctors practising medicine in the Capital by misusing names of registered doctors is on the rise, said a senior member of the Delhi Medical Council.
Members of the council have not ruled out a racket between the qualified doctors and the illegal doctors either.
Read More
Drug Licensing to be Made Online to End Irregularities PUDUCHERRY: The Puducherry Government has decided to take drug licensing online from April 1 after irregularities in licensing came to the front in 2012-13 in Puducherry. The case is being investigated by the CBI. In order to bring about transparency and to ensure disposal of licence applications for drugs manufacture and sale within a timeframe, the Department of Drugs Control has decided to use the e-governance platform to process licence applications through the online web portal www.xinindia.gov.in from April 1, said Health Secretary V. Candavelou.Read More
Quack on the run held after a yearMumbai: After a year of evading arrest, "miracle-doctor" Munir Khan was arrested by the Versova police following complaints lodged against him by the Food and Drug Administration (FDA) regarding television advertisements that claimed his "Body Revival" medicine could cure cancer, tuberculosis and several other diseases. The FDA's contention was that the advertisements were in violation of the conditions the court had set for him while granting him bail in 2010, after his first arrest. These conditions forbade him from exaggerating the qualities of his medicines, the FDA argued. Read More
IPA asks government to take immediate measures to curb the menace of misuse of prescription drugsConcerned by the growing incidence of misuse of prescription drugs throughout the country, the Indian Pharmaceutical Association (IPA) has asked the government to take immediate measures to curb the menace. It has asked the Centre to come out with short, medium and long term strategies to curb this problem in a phased manner with active involvement of all the stakeholders. The IPA having already chalked out an action plan to tackle this issue recently proposed and offered its full support to work with the government. The Association pointed out that it can play a major role in educating pharmacists and the pharmacy staff on various aspects relating to drug use, which if done in partnership with the government can be taken to a higher level. Read More
Drug Laws & Policy Injections
Periodic Safety Update Reports( PSURs) shall be linked with pharmacovigilance programme of India (PvPI) The Drugs Controller General of India (DCGI) is planning to integrate the Periodic Safety Update Reports (PSURs) submitted by the pharma companies, under the Pharmacovigilance Programme of India (PvPI) with a motive to strengthen Pharmacovigilance Programme in India . This strategic decision was taken during a high level meeting that was organized in Delhi between the CDSCO and IPC officials on March 30. The periodic safety update report for marketed drugs (PSUR) is a stand-alone document that allows a periodic but comprehensive assessment of the worldwide safety data of a marketed drug or biological product. The PSUR can be an important source for the identification of new safety signals, a means of determining changes in the benefit-risk profile, an effective means of risk communication to regulatory authorities and an indicator for the need for risk management initiatives, as well as a tracking mechanism monitoring the effectiveness of such initiatives. For these reasons, the PSUR can be an important pharmacovigilance tool. Read More
Barcoding on secondary packaging including mono cartons comes into effect from April 1, 2015 The track and trace system for export of pharmaceuticals and drug consignments on secondary level packaging including mono cartons has come into effect in the country from April 1, 2015. In a notification issued by the Union commerce ministry, the Directorate General of Foreign Trade (DGFT) has said that the ministry has inserted Para 2.89 A in Handbook of Procedure, 2015-2020, under which the manufacturer of drug for formulations will print the barcode as per GS1 Global Standard at different packaging levels to facilitate tracking and tracing of their products. Read More
Health ministry to amend Form 12-B of D&C Rules to allow import of small quantities of drugs for personal use The Union health ministry will soon amend Form 12-B of the Drugs and Cosmetics Rules for giving permission for import of small quantities of drugs for personal use. The newly formed Drugs Technical Advisory Board (DTAB) has also given its final nod to amend the D&C Rules in this regard. The DTAB in its meeting held recently deliberated on the issue in detail. Read More
Pharma Injections
Government of India is likely to expand list of essential medicines he government is likely to add HIV/AIDS and tuberculosis drugs to a list of essential medicines that are subject to price controls. The move is expected to improve the affordability of medicines. Read More
Interesting updates on commonly used medicines Zinc acetate may be effective for common cold
Taking high dose zinc acetate lozenges might shorten the duration of common cold associated runny nose by 34%, scratchy throat by 33%, nasal congestion by 37% and cough symptoms by 46%, according to a meta-analysis published in BMC Family Practice.
Read More
Global Injections
Trade in harmful counterfeit pills going global Bangkok, Thailand: Wedged between tables stacked with perfume and fake designer handbags, a stallholder peddled his merchandise - dozens of neatly organised boxes and blister packs of pills. Read More
US FDA has released draft guidance on cGMP for combination products and opened for comments The US FDA has released the draft norms which explains the current good manufacturing practices (cGMP) for combination products. Read More
Drug Dopes
First of its kind Centre for Control of Chronic Conditions (CCCC) launched in India New Delhi: Advancing evidence-based solutions for a growing health crisis, the Centre is an international partnership between All India Institute of Medical Sciences New Delhi, Emory University, the London School of Hygiene & Tropical Medicine and the Public Health Foundation of India. Read More
Global pharma & academia discover TAP as a promising drug candidate for malaria; ready for human studies An international pharma collaboration of AstraZeneca, GlaxoSmithKline, Columbia University and Harvard Medical School have discovered triaminopyrimidine (TAP) as a promising drug candidate for malaria that kills the parasite rapidly and over a long duration. Read More
MedPlus launches India’s first pharmacy e-tailer service in Hyderabad MedPlus, a leading pharmacy retailer with over 1240 stores across India, has launched India’s first of its kind pharmacy e-commerce service – ‘Click, Pick & Save’ in Hyderabad. Very soon the company is planning to expand this service to more than 50 cities in the country Read More
Novartis's Jadenu receives FDA approval to treat chronic iron overload Novartis has received approval from the US Food and Drug Administration (FDA) for its Jadenu (Deferasirox) tablets to treat patients with chronic iron overload. Chronic iron overload is a life-threatening cumulative toxicity, which results from blood transfusions required to treat sickle cell disease, myelodysplastic syndromes, thalassemia and other conditions. Read More
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PSM PILL

Interchange 2014 Highlights: Jim Dahl on The Medicrime Convention and other efforts to Work across jurisdictions to catch and prosecute Drug Counterfeiters

PSM board member Jim Dahl, the retired Assistant Director of the FDA’s Office of Criminal Investigations, spoke on our international panel about the Medicrime Convention, a new cross-European effort to address criminal issues involving medical products. Dahl also spoke about extending law enforcement to counterfeiters working abroad:

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The Parternship for Safemedicines publishes FACT PACK on Counterfeit Drugs

{A dangerous threat to American Patients}
Read at - http://www.safemedicines.org/PSM-book6_sm.pdf-

Frequently Asked Questions Q1. What are meant by Essential Medicines?
Answer: Essential medicines are those that satisfy the priority health care needs of the population. They are defined by the World Health Organization (WHO) are those drugs that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in appropriate dosage forms, at a price the individual and community can afford. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness.
Essential medicines lists have been shown to improve the quality and cost-effectiveness of health care delivery when combined with proper procurement policies and good prescribing practices. The WHO has published a model list of essential medicines. Each country is encouraged to prepare their own lists taking into consideration local priorities. Over 150 countries have published an official essential medicines list. The essential medicines list enables health authorities, especially in developing countries, to optimize pharmaceutical resources.
The Ministry of Health, Government of India had revised the National List of Essential Medicines of India (NLEMI 2011) in June 2011 and soon shall introduce some new drugs.
To catch hold, the previous list of essential medicines follow, http://pharmaceuticals.gov.in/nlem.pdf

Q2. What is meant by Iatrogenesis?
Answer: Iatrogenesis (from the Greek for "brought forth by the healer") refers to any effect on a person, resulting from any activity of one or more persons acting as healthcare professionals or promoting products or services as beneficial to health, that does not support a goal of the person affected. Some iatrogenic effects are clearly defined and easily recognized, such as a complication following a surgical procedure (e.g. Lymphedema as a result of breast cancer surgery) and some are unpredictable such as complex drug interactions which may require significant investigation to detect.
Causes of iatrogenesis include side effects of possible drug interactions, medical error, wrong prescription dispensing possibly due to illegible handwriting, typos on compute negligence, unexamined instrument design ,anxiety or annoyance in the physician or treatment provider in relation to medical procedures or treatments or unnecessary treatment for profit.
Professionals like physicians, pharmacists, nurses, dentists, psychologists, and therapists can be the cause of iatrogenic effect. Iatrogenesis can also result from complementary and alternative medicine treatments.

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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.