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News Archive

EDITOR'S EMULSION

Pooja Khaitan

On behalf of PSM India, I wish heartiest greetings to all our pharmacist friends on WORLD PHARMACISTS DAY which is to be observed on 25th September!
As an acknowledgement to pharmacists efforts, PSM INDIA announces a competition for the “BEST PHARMACIST AWARD”open to pharmacists all over India. Check our website jagograhakjago.com for more details on the competition.
Pharmacists work towards a greater role in patient care as patients generally seek advice from their pharmacists on medicines and health in general. PSM India wishes to recognize honest and dedicated pharmacists who have contributed invalaubly to the cause of SAFE MEDICINES and SAFE MEDICATION.
Hope this issue provides for an interesting read.

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, incase 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

‘Building a new generation of healthy women has a salutary effect on family, society and nation because each woman multitasks as professional in her chosen field, mother and teacher of her children, and, above all, custodian of collective values’

Dr. Harsh Vardhan
Hon’ble Minister of Health and Family Welfare
Government of India

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PSM INDIA partners with FIGHT THE FAKES

National Injections

Separate counters for generics opened in medical stores in all districts of Haryana Chennai, September, 2014: Under a strong initiative taken by the Haryana drugs control administration, the Gurgaon Chemists & Druggists Association (GCDA) has decided to open separate counters for generic medicines in all their pharmacies. The move to popularise generic drugs through private medical stores will be expanded to all the 21 districts in the state within two years. Separate counters will be opened in all the medical stores exclusively for generics.

Maharashtra FDA orders to stop use of cefotaxime injection following death of a patient Mumbai, August 2014: Following the death of 47-year-old Saira Shaikh hours after suffering from adverse drug reaction (ADR) in civic run Kurla Bhabha Hospital, FDA officials have instructed stockists and hospitals to stop use of cefotaxime injection manufactured under the brand name, Sanocef, by Sanjivini Parenteral Drugs, Navi Mumbai.

Seize all spurious drugs immediately: High Court to Government, CDSCOSrinagar, Aug 2014: The J&K High Court Tuesday directed government and Central Drugs Standard Control Organization (CDSCO) to seize “immediately” all drugs declared as spurious or substandard in Jammu and Kashmir.

Probe into drugs lab malpracticesBangalore, Aug 2014: The Drugs Controller will hold an internal inquiry into the alleged malpractices in testing and analysis at the Drugs Testing Laboratory. An inquiry conducted by the Upalokayukta had found that certain 'unqualified’ drugs were certified as 'qualified,’ despite negative report

NHRC notice to Odisha government on expired medicines Bhubaneswar, Aug 2014: The National Human Rights Commission (NHRC) has sought an action-taken report from Odisha government on the reports that low-quality and time-expired medicines were administered to patients in the state, a petitioner said Wednesday.

MMC serves notices to 11 doctors of top Mumbai hospital for practicing without registration Mumbai, September, 2014: Maharashtra Medical Council (MMC) has served show cause notices to 11 Mumbai based doctors for getting engaged in medical practice in a hospital without MMC registrations. Section 33 of the Maharashtra Medical Practitioners Act, 1961 prohibits medical practice by unregistered and unlisted persons. The show cause notices served comes close on the heels of a Right to Information (RTI Act) application filed by a Mumbai based finance consultant in a medical negligence case. MMC in its reply on the RTI application revealed that 11 doctors of a reputed hospital are not registered with MMC.

Drug Laws & Policy Injections

Government to provide Cobalt-60 through DAE to cancer patients in 240 hospitals free of cost Mumbai, September, 2014: The Government has formed a committee under Department of Atomic Energy (DAE) to provide radioactive source (Cobalt-60) to around 240 odd cancer hospitals free of cost. This is a part of Government's policy for enhancing radiotherapy facilities for cancer treatment.

IPC to work with NACO to monitor safety of ARV drugs as part of PvPI programme Mumbai, September, 2014: With a view to have a tab on the antiretroviral (ARV) drugs available in the market, the Indian Pharmacopoeia Commission (IPC), the national coordinating centre for the pharmacovigilance programme of India, recently agreed to work closely with the National AIDS Control Organisation (NACO) for reporting ADRs on ARV drugs. Under this ambitious project, both the organisation will work to generate data all the ARV drugs used under the national AIDS control programme (NACP). It is understood that the outcome of the long term use of many of the ARV drugs that are currently running in the market is still not known, which experts feel is a matter of serious concern. With anti-retroviral therapy now available free of cost to all those who need it through the ART centres located in every medical colleges, district hospitals, regulators feel that it is high time to concentrate on having an efficient ADR reporting system for ARV drugs as well.

DCGI sets up ICC within CDSCO to address issues of exporters Mumbai, September, 2014: The Drugs Controller General of India (DCGI) has established an International Co-operation Cell (ICC) within the office of the CDSCO to address export related queries more efficiently. Through this initiative, the DCGI hopes to boost the confidence of the exporters further with a single window for better delivery of services through a systematic and organised network specifically for exports. ICC, an initiative of the DCGI and the commerce ministry is designed to aid exporters address issues on a fast track basis so that the long delays in addressing regulatory issues do not affect the exports. The cell is headed by Dr A Chandra Sekhara Rao, deputy drugs controller (India) comprising of ten members which includes drug inspectors and ADC's who have been selected to exclusively deal with all the exports related issues, while also attending to the queries of the commerce ministry.

ICMR issues draft guidelines for diagnosis & management of Rickettsial diseases in India Mumbai, September 2014: The Indian Council of Medical Research (ICMR) has issued a set of draft guidelines for diagnosis & management of Rickettsial diseases which are considered some of the most covert, emerging and re-emerging diseases and are being increasingly recognized. Acute fever is the most common presenting symptom often associated with breathlessness, cough, nausea, vomiting, myalgia and headache. Rickettsial infections are generally incapacitating and difficult to diagnose; untreated cases have fatality rates as high as 30-45% with multiple organ dysfunction, if not promptly diagnosed and appropriately treated. The vast variability and non-specific presentation of this infection have often made it difficult to diagnose clinically.

Pharma Injections

Lack of clarity on Schedule K of D&C rules creates confusion between private hospitals & DC dept. in Kerala Chennai, Aug 2014: A confusion centered round the meaning of a clause in the Drugs and Cosmetics Rules is creating controversial interpretations and causes rivalry between the drugs control department and the private hospital managements in Kerala for the last 24 years.

Metropolis launches Multiplex PCR test to detect any of seven diseases causing fever Bengaluru, Aug 2014: Metropolis Healthcare Ltd, a leading multinational chain of diagnostic centres, has launched India’s first single test for seven diseases which cause fever. The Multiplex PCR test helps diagnose seven common diseases causing fevers Malaria, Dengue, Typhoid, Leptospirosis, Chikungunya, West Nile Fever and Rickettsia. The test is seen to save cost and provide doctors to help faster diagnosis. The Multiple PCR is done in real-time which extract nucleic acid of pathogens from whole blood.

Scientists say Himalayan herb is modern-day sanjeevani

Leh, Aug 2014: In the high, hostile peaks of the Himalayas where sustaining life is a challenge in itself, scientists say they have found a “wonder herb” that can regulate the immune system, help adapt to the mountain environment and, above all, protect from radioactivity.

Government plans more cancer centres : Dr Harsh Vardhan opens linear accelerator at Indore Cancer Foundation

New Delhi, August, 2014 - The government has planned 20 new advanced cancer treatment facilities across the country (one in each state) over the next few years to meet the rising burden of the disease. For Madhya Pradesh, the Centre has planned a new State Cancer Institute (SCI), along with two Tertiary Care Cancer Centres (TCCC).

Chemists forum urges government to amend D&C Act to bar doctors from stocking and selling of medicines

Chennai, Sept 2014: The regional committee of the Retail Chemists Forum (RCF) functioning in the Malabar area of Kerala has urged the union government to amend Drugs and Cosmetics Act (D&C Act) by quashing the powers given to medical doctors for stocking and selling of medicines directly to their patients. The demand of the Forum has come in the wake of the union government’s efforts to bring in reforms in the health sector by amending various outdated laws in the health and allied sectors.

Global Injections

Crackdown On International Fake Drugs Crime Ring London, Sept 2014: Two men have been arrested in London by police investigating the sale of millions of pounds worth of counterfeit medicines.

European operation smashes fake medicines ring September, 2014: Police from several European countries have seized millions of fake medicines, mainly erectile dysfunction drugs, worth an estimated €10m.

Brazil issues reporting guidance for drug traceability schemeSept, 2014: Brazil's regulatory authority ANVISA has published guidance on the reporting requirements for its medicine track-and-trace system, which is due to come fully online in 2016. After four years in development, the broad outline of the National Drug Control System (SNCM) was published last December and - like many similar approaches around the world - is based on the serialization of medicine packs using 2D data matrix and human-readable codes.

4 jailed for selling fake drugsShanghai, Sept 2014: our people have been sent to prison for selling counterfeit medicines and health tonics online, the Shanghai Food and Drug Administration said yesterday.

US Pharmacopeia joins safe online pharmacy groupThe US Pharmacopeial Convention (USP) has joined a group campaigning to raise awareness of illegal online medicines sales. USP has lent its support to the Alliance for Safe Online Pharmacies (ASOP), an advocacy organisation set up to protect consumers from the scourge of rogue online pharmacies though measures such as public education, data collection and dissemination, best practices development and encouraging policy and legislative change.

4 Family Members accused of running Fake Online Pharmacy Network operating in Florida, Canada and IndiaSeptember , 2014: Two brothers, their mother and a cousin are accused of operating a large-scale fake online pharmacy scam that shipped to consumers all over the globe. The danger that fake online pharmacies pose to U.S. consumers is one of the primary topics we will be discussing September 18 at Interchange2014 in Washington D.C.

Drug Dopes

Wockhardt recalls Metoprolol Succinate for third time due to Dissolution Failure Delhi, September , 2014 - Wockhardt is voluntarily recalling two lots of metoprolol succinate extended-release tablets, USP, 200 mg in 100-count and 500-count bottles due to failed dissolution specifications in the US. This is the company's third recall of the same drug in the past four months. The recall is for 11,661 bottles. Metoprolol is a generic form of AstraZenecas branded drug Toprol.

US FDA finalizes new hydrocodone regulations KNOXVILLE (WBIR), AUG 2014 - The Drug Enforcement Administration said prescription drugs take the lives of more than 20,000 Americans every year. The federal government has taken notice to these alarming statistics and is finalizing new restrictions on the most common form of painkiller in the country. There will now be stricter rules when it comes to hydrocodone, which is the most widely prescribed painkiller in the United States.

US FDA approves ViiV Healthcare's new single-pill regimen, Triumeq to treat HIV-1 infection

London, August 2014: Baxter International, a global, diversified healthcare company, announced that the company has voluntarily initiating a recall in the United States of two lots of Dianeal Low Calcium (2.5mEq/L) peritoneal dialysis Solution with 2.5 per cent Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated due to the presence of oxidised stainless steel, garment fibre, and PVC particulate matter identified during the manufacturing process.

Strides gets USFDA nod for generic anti-anxiety tablets

New Delhi, August , 2014 - Drug firm Strides Arcolab today received approval from the US health regulator for its generic Buspirone Hydrochloride tablets used for treating anxiety disorders.

Martin Avenue Pharmacy, Inc. Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility

August 2014: Naperville, Illinois,- Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Upcoming Events

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PSM PILL

The Partnership for Safe Medicines offers several tools, including "Tips for Safe Online Buying" and "Warning Signs," to teach consumers how to safely order prescription drugs over the Internet.

PSM's 5th annual conference will be held onSeptember 18, 2014 at the KnightConference Center at The Newseum, 555 Pennsylvania Av., NW, Washington, D.C. Each year, the PSM Interchange brings together policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies to discuss the problem and solutions to the global scourge of pharmaceutical counterfeiting. Tickets on sale

Frequently Asked Questions Q1. WHAT IS IMMUNIZATION?
Answer: Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. Vaccines stimulate the body’s own immune system to protect the person against subsequent infection or disease. Immunization is a proven tool for controlling and eliminating life-threatening infectious diseases and it is one of the most cost-effective health investments, with proven strategies that make it accessible to even the most hard-to-reach and vulnerable populations.

Q2. WHAT’S THE DIFFERENCE BETWEEN IMMUNISATION AND VACCINATION?
Answer: • Vaccination means having a vaccine - that is actually getting the injection.
• Immunisation means both receiving a vaccine and becoming immune to a disease, as a result of being vaccinated.
Most people use the terms 'vaccination' and 'immunisation' interchangeably but their meanings are not exactly the same.

Q3. WHAT IS THE NEED OF IMMUNIZATION OF A CHILD?
Answer: Immunisation is the safest and most effective way of giving protection against the disease. In the first months of life, a baby is protected from most infectious diseases by antibodies from her or his mother, which are transferred to the baby during pregnancy. When these antibodies wear off, the baby is at risk of serious infections and so the first immunisations are given before these antibodies have gone.
 After immunisation, the child is far less likely to catch the disease if there are cases in the community. The benefit of protection against the disease far outweighs the very small risks of immunisation.

Laughter Dose

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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.