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

Pooja Khaitan
At a recent function presided over by His excellency, Hon’ble President Shri Pranab Mukherjee, at Rashtrapati Bhawan, Our Hon’ble Prime Minister Shri Narendra Modi called upon IITs to bring about a “positive change” in the quality of life of the people of India. Here Shri Modi was referring to HEALTH and defence. In a country where health seems to be a major concern even in todays times , he urged the IITs to instil among them a sense of service towards the nation by coming up with innovative equipments in the health sector. This has been a major breakthrough by all organisations including PSM India Initiative who have been crusading against the menace of fake medicines and seeking good health for our nation. Read More>>

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, 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 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

“While the government will do its duty of framing policies and schemes and implementing them, it would require the cooperation and involvement of all to make ‘health for all’ a social movement”

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

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PSM India Capsules
AN 8 STEP CHECKLIST FOR MEDICINE SAFETY :
This eight-step checklist will help you judge whether your medications are safe and provides tips on what to do if you think a drug has been compromised.
Sample: Request a sample from your physician when you are first prescribed a medication to help you establish a “baseline” of a product’s characteristics, including its appearance, taste, texture, reactions and packaging. Please note that manufacturer samples are usually only available for brand name medications and not generic products. Generics may differ in shape or color but still be a safe and effective product. For specific questions on identification of medications, talk to your pharmacist.
Appearance: Compare the prescription medicine you receive with what it is supposed to look like by taking pictures of the original manufacturer's drug and all associated packaging with the drug you are taking. You can also find pictures in the Physicians Desk Reference. When comparing packaging, look for differences in paper, printing, color, and fonts (i.e. is it the same size, raised print, embossed, etc.).Read More
National Injections
Delhi Government to crack down on quacks in the Capital New Delhi, Aug 2014: A recent sting operation by a popular television news channel exposing the nexus between doctors and pharmaceutical companies early this week has forced the Delhi Health Department to take a re-look at ‘quacks working in the Capital’. “One of the ‘doctors’ caught in the sting operation was a quack,” said Delhi Medical Council (DMC) member Dr. Anil Bansal. Read More
Gujarat FDCA embarks on vigilance drive to ensure presence of pharmacists in retail outlets across state Mumbai, August 2014: The Gujarat FDCA has embarked on a massive vigilance drive across the state to crack down on incidents of malpractices among the strong 17000 plus retail outlets and over 40,000 plus pharmacists. The regulators informed that the main aim behind this drive is to ensure and check whether the retailers and pharmacists are adhering to the provisions of the drugs and cosmetics Act and rules especially relating to the clause that stresses on presence of pharmacists in the retail outlets.The drive that was initiated last month has already covered around 5000 retail outlets across the state, from which over 400 retailers have been issued show cause notices, while license of over 25 plus chemist shops have been canceled so far for flouting the D&C Act. It is understood that these retail outlets were dispensing drugs without the presence of pharmacists in their shops, while displaying rented pharmacy certificates. Read More
Assam Pharmacy Council scrutinises documents of 1500 pharmacists named in registration racketMumbai, August 2014: In the wake of Guwahati High Court directing the state government to cancel registrations of unqualified pharmacists in the state, the Assam Pharmacy Council (APC) is in the process of scrutinising 1500 documents related to a fake registration racket involving 2900 pharmacists in the state. These pharmacists were earlier registered with the Registration Tribunals of Nagaland and Manipur.Read More
Sessions Court in Kerala orders imprisonment of MD of hospital for violation of D&C Act Chennai, August 2014: The additional sessions judge in Kollam in Kerala sentenced the managing director of Navabharath Hospital, Sasthamcotta in Kollam district to imprisonment till the rising of the court after convicting him for violation of provisions of drugs acts. The court also sentenced a fine of Rs.1, 20, 000 (Rupees one lakh, twenty thousand) in addition to detaining the doctor in the courtroom for a full day. Dr P Kamalasanan.. Read More
Drug Laws & Policy Injections
IPC launches medicines adverse effect reporting form for patients Mumbai, August 2014: In a strategic move that involves direct participation of patients in the Pharmacovigilance Programme of India (PvPI), the Indian Pharmacopoeia Commission (IPC) has recently launched the ambitious medicines adverse effect reporting form for consumers i.e. the patients. Interestingly, this will be first done on pilot basis across all the 150 adverse drug reaction (ADR) centres to gauge the impact it creates among the patients and on whether they are comfortable with the module prepared by them for reporting of ADRs in future. Read More
CDCSO Establishes New Testing Requirements for Blood Glucose Strips New Delhi, Aug 2014: The Central Drugs Standard Control Organization (CDSCO) is looking to tighten the regulation of blood glucose testing supplies, it announced last week. In a 7 August 2014 notice issued to all local State Drugs Controllers and port authorities, CDSCO ordered that importers and manufacturers of blood glucose test strips and analyzer based glucose reagents must provide three batches for testing at the National Institute of Biologicals in Noida. Read More
Apex court notice to Centre, States on promoting use of generic drugs New Delhi, August 2014: The Supreme Court on Wednesday issued notice to the Centre, all States and Union Territories and Drugs Controller of India on a public interest writ petition seeking a direction for promotion of generic drugs instead of branded drugs by medical practitioners. A Bench of Justices Dipak Misra and V Gopala Gowda issued notice returnable in six weeks on the PIL filed by Reepak Kansal seeking court intervention with respect to flagrant violations and abuse of health norms due to non-enforcement and non-implementation norms/prohibitions established under the Drugs and Cosmetics Act, 1940 and for not implementing the recommendations mentioned in the Sixth Plan. Read More
DCGI issues uniform procedures in regulatory inspection for issuance of CoPP, GMP certificates Mumbai, August 2014: In order to ensure uniform implementation of regulatory inspection procedures for issuance of CoPP and other GMP certificates by both the state drug authorities and the CDSCO, the Drugs Controller General of India (DCGI) has issued new uniform procedures. As per the new procedures, all GMP inspections including that of CoPP will be focussing mainly on the requirements of Schedule M of Drugs and Cosmetics Rules, 1945 with respect to establishing shelf life, conducting validation studies, and ensuring prompt and effective recall besides WHO GMP requirement. Read More
Pharma Injections
Mangalore, Udupi have most malaria cases in Karnataka Mangalore, August 2014 - Nearly 85 per cent of malaria cases in Karnataka are observed in two urban centres of Mangalore and Udupi. This was revealed at a meeting of officials convened by the National Vector Borne Diseases Control Programme (NVBDCP) in Mangalore on Tuesday.
A Prakash, who represented NVBDCP, said that Mangalore and Udupi have been witnessing cases of malaria since 1996.
Read More
Many pharma companies wrongly labelling drugs under Sch H1 causing confusion to chemists Mumbai, August 2014: Concerned over the rising incidence of mislabelling of certain drugs as Schedule H1, pharmacists across the country have urged the regulatory body to urgently look into this matter to clear the confusion among the stakeholders. It was observed by pharmacists that many pharma companies have been wrongly labeling drugs under Schedule H1 category even though they do not fall under the same, creating a lot of skepticism and extra work for the pharmacists. Read More

Health ministry unveils ‘Phool Khil Jayenge’ song to reiterate its commitment to immunize all Indian children

Bengaluru, August 2014: Union Ministry of Health and Family Welfare reiterated its commitment to immunise all Indian children on the occasion of the India’s 68 Independence Day. The government launched a public service message in the form of a music video ‘Phool Khil Jayenge’ which was unveiled by the Minister of Health and Family Welfare Dr. Harsh Vardhan. Read More

Global Injections
US FDA warns consumers about fake Ebola drugs Maryland, Aug 2014: The Food and Drug Administration is warning consumers about fake drugs, vaccines and supplements being sold online as treatments to cure or prevent Ebola. Read More
Procter & Gamble patents counterfeit detection kit Cincinnati, Aug 2014: Consumer product giant Procter & Gamble has been awarded a US patent on a chemical test kit that could be used to detect counterfeit versions of its products. Read More

P2-M fake drugs seized; 7 doctors probedBaguio City, Aug 2014 — The Philippine Drug Enforcement Agency (PDEA) has cracked down on a syndicate distributing counterfeit medicines in the city through seven doctors believed to be prescribing the bogus drugs to their patients.Read More

Turkish man pleads guilty to importing illegal cancer drugsTurkey, August, 2014 - Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.Read More

Drug Dopes
US FDA approves B Braun's Nutrilipid 20% Bethlehem, Pennsylvania, August 2014: The US Food and Drug Administration (US FDA) has granted approval to B. Braun Medical's Nutrilipid 20 per cent (I.V. fat emulsion) for parenteral nutrition therapy in adult & paediatric patients. Nutrilipid 20 per cent is indicated as a source of calories and essential fatty acids for parenteral nutrition and as a source of essential fatty acids when a deficiency occurs when oral or enteral nutrition is not possible, insufficient, or contraindicated. Read More
Merck's insomnia drug, Belsomra receives US FDA approval Whitehouse Station, New Jersey, August 2014: The US Food and Drug Administration (FDA) has approved Merck's Belsomra (suvorexant) for adults with insomnia who have difficulty falling asleep and/or staying asleep. Read More

Baxter begins recall of two lots of peritoneal dialysis solution from US market due to presence of particulate matter

Deerfield, Illinois, 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. Read More

US FDA approves Biogen's Plegridy for multiple sclerosis treatment

Cambridge, August 2014: The US Food and Drug Administration (FDA) has approved Biogen Idec's Plegridy (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). Plegridy, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the Plegridy PEN, a new, ready-to-use autoinjector, or a prefilled syringe. Plegridy offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments,” said George A. Scangos, chief executive officer of Biogen Idec. “Plegridy represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them.” Read More

US FDA grants orphan drug designation to Mirati Therapeutics' mocetinostat for diffuse large B-cell lymphoma

SanDiego, August 2014: The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Mirati Therapeutics' mocetinostat, a spectrum selective HDAC inhibitor, for diffuse large B-cell lymphoma (DLBCL). In June, mocetinostat was granted Orphan Drug Designation as a treatment for myelodysplastic syndrome (MDS). Orphan drug designation is also being sought for bladder cancer patients with specific genetic alterations. Read More

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PSM PILL
Why Prescriptions Are Important? Our laws require that certain drugs can only be dispensed with a valid prescription because they are not safe for use without the supervision of a licensed healthcare practitioner. Before a healthcare practitioner issues a prescription for a drug the patient has never taken, he or she must first examine the patient to determine the appropriate treatment. Then the patient receives the drug from a registered pharmacist, working in a licensed pharmacy that meets state practice standards. Read More
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 are multivitamin preparations?
Answer: A multivitamin is a preparation intended to be a dietary supplement with vitamins, dietary minerals, and other nutritional elements. Such preparations are available in the form of tablets, capsules, pastilles, powders, liquids, and injectable formulations. Multivitamins are popular amongst majority of people ( from child to aged population) as they believe that these vitamins, minerals and herbs will cure colds, strengthen immunity, build muscles, improve memory, digestive disorders and generally benefit their health and lifespan.

Q2. Are multivitamins safe for regular intake?
Answer: Multivitamins are a good way to help supplement a diet for those who don't always have time to shop for fresh vegetables, fruit and whole grains. But most health experts agree that a multivitamin is no replacement for a good, well-balanced diet. Also, studies have found that an overdose of vitamins A, D, E, or K and minerals can cause serious or life-threatening side effects, serious hypersensitivity, allergies and critical medical conditions. So, a tender advice from PSM India Desk that next time before popping up a one-a-day vitamin supplement please discuss it with your doctor and tell him about all your medical conditions and allergies. In some cases, you may not be able to use multivitamins, or you may need a dose adjustment or special precautions (especially in pregnancy, lactation, etc).

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