The Prescription: 1st November Issue
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News Archive
EDITOR'S EMULSION

Pooja Khaitan

PSM INDIA brings together another memorable event for all healthcare stakeholders. Our 2nd International event at Radisson Blu Hotel, Haridwar from 6th-8th November,2014 primarily focuses on Patient Safety and Access to Quality Healthcare. On behalf of our Chairman, Mr. Wajahat Habibullah,IAS Retd., I cordially invite you all to our 11th Board meeting too on the 6th November 2014. Thank you all for registering for the event. We look forward to your presence. Incase you have not yet made your reservations with us, please go through this issue for further details on the event including the draft agenda. It would be an excellent platform to network and attend interesting and informative sessions throughout the conference. You may also visit our website jagograhakjago.com. for registration.
Read this issue to know more on the latest developments in the drug industry in India and globally. Learn more on Pharmacovigilance under our frequently asked questions section.
Mark your calendars for important upcoming events featured in this issue.

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

“We have one of the strongest drug regulatory systems in the globe, which we keep on upgrading frequently whenever needed. Thus it is high time to clarify our stand and show the world that we are there to give world class services to one and all as patient safety is our top priority.”

Dr. H.G Koshia
Commissioner,
Food & Drugs Control Administration,
Gujarat State, India

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REGISTER NOW!! NETWORK WITH IMPORTANT GOVERNMENT OF INDIA DIGNITARIES, REPUTED CONSUMER ORGANISATIONS, PHARMACEUTICAL HEADS , MEDICAL PRACTITIONERS and other Stake holders of the healthcare sector in PSM India’s 2nd INTERNATIONAL CONFERENCE @RADISSON BLU HOTEL, Haridwar from 6th-8th November 2014.


National Injections
Most drug reactions unreported Kochi, Oct 2014: A state which coughs up one-fifth of the drugs sold in the country and boasts of high health indices has a poor record of reporting adverse drug reactions with the result that all sorts of drugs continue to remain in the market posing a threat to public health. According to Kerala state drug control department officials, hardly one percent of the total drug reactions in the state is being reported a year. “Last year, 90 drug reactions were reported to the pharmacovigilance cell set up for the purpose which now exists in eight districts. This number is very low,” said Mr M.R. Pradeep, deputy drug controller, Kerala.
Maha FDA refers over 200 cases of absence of pharmacists to MSPC for action Mumbai, Oct 2014: The Maharashtra Food and Drug Administration (FDA) has referred over 200 cases related to professional misconduct of pharmacists to the Maharashtra State Pharmacy Council (MSPC) for action. Officials maintain that there is a growing trend of absence of pharmacists due to renting out pharmacy certificates to the drug retail stores and doing employment elsewhere.
Scheme to boost medicinal plants cultivation in JK launchedNew Delhi, Oct 2014: To encourage farmers in the Valley to cultivate medicinal and aromatic plants, the government has come up with Jammu Kashmir Arogya Gram Yojna, under which it will provide saplings and scientific guidance to the people. Speaking at the launch of the programme, Union Minister of State for Science & Technology Jitendra Singh said it would be first implemented in Kathua district of Jammu, which is currently bearing the brunt of firing from across the Line of Control.
Big hospitals connive with stockists to sell cheaper version of heparin to heart patientsMumbai, Oct 2014: Unethical practice of dispensing cheap substitutes of low molecular weight heparin to patients, suffering from cardiac arrest, is found to be flourishing in several parts of India. These products are being sold at four times the actual cost by evading local quality and regulatory regulations and protocols. The practice has become rampant across corporate hospital pharmacies in the country seriously endangering the patient safety. The low molecular weight heparin marketed under the trade names Clexane, among others is an anticoagulant used to prevent and treat deep vein thrombosis or pulmonary embolism, and is given as a subcutaneous injection.
Telengana govt goes tough on striking doctors for not joining rural serviceHyderabad, Oct 2014: The Telangana state government has given an ultimatum to the striking junior doctors to join rural service before October 15, or else face the loss of next academic year. Earlier last week, the Junior Doctors Association (JUDA) in Telangana have tried to block the counselling process and demanded that the Directorate of Medical and Health Education (DMHE) to first resolve their problems before posting them to primary healthcare centers (PHCs) for compulsory rural service.
Drug Laws & Policy Injections
Govt invites regulatory experts & global media to India in November to clear misconceptions on Indian drugs Mumbai, October 2014: Following the brilliant show of confidence building measures during the CPhI Worldwide event concluded recently in Paris, the government has gone a step further by inviting special convoy of foreign investors and media from across the globe to visit India. In a proactive move to further boost exports through stronger trade relation and remove the misconception among the western media, the government has extended the invitation to regulatory experts and global media to come and visit India in the first week of November.
Health ministry bans import of cosmetics tested on animals Mumbai, Oct 2014: The Union health ministry has banned the import of cosmetics tested on animals. The ban comes in the form of Rule 135-B that states, “Prohibition of import of cosmetics tested on animals. - No cosmetic that has been tested on animals after the commencement of Drugs and Cosmetics (Fifth Amendment) Rules, 2014 shall be imported into the country”.
UPFDA to upgrade drug testing infrastructure & manpower for consistent supply of quality drugs Mumbai, October 2014: In order to ensure consistent supply of quality drugs, the Uttar Pradesh Food Safety and Drug Administration (UPFDA) is planning to upgrade the drug testing infrastructure in the state besides strengthening the manpower. There are currently 5 testing labs located at Jhansi, Gorakhpur, Agra, Varanasi and Lucknow. The state testing lab at Lucknow is the only lab which currently analyses drug samples..
IPA plans to release “white paper” on role of pharmacists in National Health Policy Chennai, Oct 2014: A brainstorming convention of the Indian Pharmaceutical Association (IPA) held in Kerala last week decided to release a white paper on the role of pharmacists in the National Healthcare Policy and would submit it to the ministry of health & family welfare soon. This announcement was made in the convention by the president of IPA, Dr VSV Vadlamudi while inaugurating the convention at St. James College of Pharmaceutical Sciences, Chalakudi in Thrissur district.
Pharma Injections
Pharmacists demand strengthening of regulatory mechanism to check irrational use of antibiotics Chennai, Oct 2014: Due to lack of strict regulatory measures, the use of antibiotics is getting proliferated all over the country, especially in Kerala, and measures are needed to control and rationalize its use, a national meeting of pharmacists observed.
Global Injections
EMA expands adverse event reporting website London, Oct 2014: The EMA has expanded the remit of its adverse event reporting website – allowing patients, the public and healthcare professionals to report suspected side effects on any nationally-authorised medicine.
74 websites selling bogus drugs shut down by Japan government Tokyo, Oct 2014: The health ministry forcibly shut down 74 websites from April to September that sold bogus pharmaceutical products, it has been learned. As some counterfeit drugs can have life-threatening effects,

Dallas nurse Nina Pham cleared of Ebola virus, released from hospitalOct, 2014: A Dallas-area nurse infected by the Ebola virus, and who sparked a nationwide search for other possible infections, was declared free of the virus and released from a Maryland hospital Friday.

Trio of Texans indicted for smuggling 100,000 fake pills into United StatesTexas, Oct 2014: 3 Texas residents are alleged to have received more than 30 shipments of fake medications and acted as drop-shippers for a drug counterfeiting operation run from China. Counterfeit versions of painkillers and lifestyle drugs were among the seized fakes.

Drug Dopes
Experts press for early introduction of Injectable Polio Vaccine (IPV) in India Oct, 2014: Injectable vaccine is much more effective than oral vaccine and eliminates the risk of vaccine-polio. There is also a looming threat of virus importation from Pakistan. These were the inferences drawn during deliberations on the sidelines of Ranbaxy Science Foundation’s 32nd Round Table Conference on “Lessons from the Success of Polio Elimination”. Read More
Trivitron Healthcare signs three MOUs with Pranab Mukherjee to ’Make in India’ Finland, October 2014: Labsystems Diagnostics OY, a Trivitron Healthcare Enterprise has signed a MOU today at Helsinki in the presence of Hon. President of India, Mr. Pranab Mukherjee along with The University of Turku, and Indian Translational Health Science Technology Institute (THSTI). This Indo-Finland initiative will be first of its kind in developing an affordable medical point of care diagnostics device for use in India and other developing countries. This diagnostic platform can be used for testing cardiac troponin-I for acute coronary syndrome and the same can be used for high sensitive detection of several other parameters like Infectious diseases, Cancer Markers, New Born Screening panel etc. The research was funded by Indian Department of Biotechnology under the Ministry of Science and Technology, Tekes (the Finnish Funding Agency for Innovation) & the Academy of Finland.

US FDA approves Gilead's Harvoni to treat chronic hepatitis C genotype 1 infection

California, Oct 2014: The US Food and Drug Administration (US FDA) has approved Gilead Sciences' Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the trade name Sovaldi in December 2013. Harvoni's efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.

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PSM PILL

In today’s global environment, it doesn’t matter if you live in United States, Europe, Asia, India or Africa—everyone is at risk from unsafe drugs. Counterfeit drugs defraud consumers and deny patients therapies that can alleviate suffering and save lives. Unfortunately, in some cases, these drugs have caused great harm and fatalities.
But there are ways to minimize risk of getting a counterfeit medicine. The Partnership for Safe Medicines describes the various hidden poisons in form of counterfeit medication that consumers need to be aware of.

 

Frequently Asked Questions Q1. What is Pharmacovigilance?
Answer: Pharmacovigilance is the science and activities relating to the Detection, Assessment, Understanding and Prevention of adverse drug reactions or any other possible drug related problems. Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of drugs, biological products and traditional medicines with a view of identifying new information about hazards associated with medicines and preventing further harm to patients. The word pharmacovigilance has been derived from the Greek word pharmacon means ‘drug’ and the Latin word vigilare means ‘to keep awake or alert, to keep watch.’

Q2. What is the role of Pharmacovigilance Programme of India (PvPI)?
Answer: The mission of PvPI is to safeguard the health of the Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. The purpose of the PvPI is to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public and also detect and assess prescribing, dispensing and administration errors.
At present, Pharmacovigilance Programme of India is the main storehouse of suspected post-marketing adverse drug reactions in India. It ropes in medical colleges as Adverse drug reactions monitoring center (AMC). Once the Medical institute is enrolled as an AMC under PvPI, the AMC starts reporting ICSRs (Individual case safety reports) to NCC (National Coordinating center) via a VigiFlow software. These ICSRs are then assessed at NCC for quality of data and if found valid, they are further committed to the global drug monitoring center “Uppsala Monitoring Centre” in Sweden. PvPI aspires to expand the Pharmacovigilance programme to all hospitals (govt. & private) and centers of public health programs located across India, to develop and implement electronic reporting system (e-reporting) and to make ADR reporting mandatory for all healthcare professionals.
To read more visit at: http://www.ipc.gov.in/PvPI/pv_home.html

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Blog Addicts
Nirmal Jeevan Foundation twits ” PSM- India has set light for Indian consumers to become aware of presence of spurious medicines in market”.
Prof. MK. Pandian blogs “ PSM –India is striving hard in protection of consumer’s health all over our Nation through its various programme and awareness campaigns.”
Dr. Subhankar says “ More efforts like PSM is essential to bring back good health and safe medicines for every Indian .”
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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.