DCGI to explore potential of replacing drug testing on animals with alternate test methods

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The Drugs Controller General of India (DCGI) is seriously contemplating to explore the possibilities of replacing drug testing on animals with alternative no animal testing methods. This move aims at curbing the misuse and torture of animals used for animal testing and for safeguarding  their interests as ethically required.

In lines with this, the drug controllers office is working very hard with the Indian Pharmacopoeia Commission (IPC) to replace some of the existing monographs with the alternative modern methods which includes sophisticated tests using human cells and tissues known as ‘in vitro’ methods. While serious thought is also given to adopt advanced computer-modeling techniques referred to as in silico models, and studies with human volunteers.

Dr G N Singh, DCGI informed that since new technologies are available with immense potential to provide conclusions even more accurate than those from animal testing, serious thought should be given to encourage gradual withdrawal of use of drug testing on animals whenever possible. He further stressed that it is with this vision that the Central Drugs Control Organisation (CDSCO) has dedicated the 2014 as ‘patient and animal safety year

“We envision to protect the lives of all the living beings in the country and for that all steps will be taken pro-actively to enhance good governance by strengthening regulatory mechanism further. We understand that experiments on animals are unethical and cruel and we are going to make sure that all steps are being taken to avoid cruelty against animals by ensuring stringent adoption of good laboratory practices (GLP) in all the manufacturing units across the country and also while conducting clinical trials etc,” Dr Singh pointed out.

Interestingly, in a landmark decision, India become the first country in South Asia to ban animal testing for manufacturing cosmetics last year. The Bureau of Indian Standards (BIS) is now required to set down standards to meet the new requirements while the DCGI will make relevant amendments in acts and laws.

Source: PharmaBiz

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Oviya Medsafe signs pact with UK based Assured Information Systems to offer pharmacovigilance solutions to pharma cos

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The pharmacovigilance consulting and drug safety services company, Oviya MedSafe Pvt Ltd based in Coimbatore in Tamil Nadu,  has signed a pact with British software development company, Assured Information Systems Ltd, to provide comprehensive pharmacovigilance solutions to pharmaceutical firms.

Dr Vijay Venkitaraman, the managing director and chief executive officer, of Oviya Medsafe said the company hopes that the strategic alliance will help promote the adoption of drug safety systems, especially among small and mid-sized pharmaceutical companies throughout the world by delivering comprehensive pharmacovigilance solutions in a cost-effective and user-friendly manner. Oviya MedSafe consults with generic pharmaceutical companies to help them develop and maintain their pharmacovigilance departments in line with the emerging global regulations, he added.

He said, “As drug safety regulations begin to tighten globally, investing in pharmacovigilance becomes inevitable for all pharmaceutical companies.  My company’s increasing recognition as a quality-conscious yet cost-effective pharmacovigilance service provider, the understanding with the British software development firm would help in achieving our shared goal of providing affordable, simplified and reliable drug safety supports”.

Dr Alan K Rawling, managing director of Assured Information Systems said the partnership with Oviya Medsafe recognises the need to provide a total pharmacovigilance solution that addresses the challenges of regulatory compliance, electronic reporting and signal detection. Combining their software and services expertise offers a unique proposition to pharmaceutical companies of all sizes within the Asian continent and globally to companies wishing to outsource to India, he said.

Source: PharmaBiz

Fortify Your Knowledge About Vitamins

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Vitamins are essential nutrients that contribute to a healthy life. Although most people get all the vitamins they need from the foods they eat, millions of people worldwide take supplemental vitamins as part of their health regimen.

Why Buy Vitamins?

There are many good reasons to consider taking vitamin supplements, such as over-the-counter multivitamins. According to the American Academy of Family Physicians (AAFP), a doctor may recommend that you take them:

  • for certain health problems
  • if you eat a vegetarian or vegan diet
  • if you are pregnant or breastfeeding

Vitamin Facts

Your body uses vitamins for a variety of biological processes, including growth, digestion, and nerve function. There are 13 vitamins that the body absolutely needs: vitamins A, C, D, E, K, and the B vitamins (thiamine, riboflavin, niacin, pantothenic acid, biotin, vitamin B-6, vitamin B-12 and folate). AAFP cites two categories of vitamins.

  • Water-soluble vitamins are easily absorbed by the body, which doesn’t store large amounts. The kidneys remove those vitamins that are not needed.
  • Fat-soluble vitamins are absorbed into the body with the use of bile acids, which are fluids used to absorb fat. The body stores these for use as needed.

Practice Safety with Dietary Supplements

When it comes to purchasing dietary supplements, Vasilios Frankos, Ph.D., Director of FDA‘s Division of Dietary Supplement Programs, offers this advice: “Be savvy!”

Today’s dietary supplements are not only vitamins and minerals. “They also include other less familiar substances such as herbals, botanicals, amino acids, and enzymes,” Frankos says. “Check with your health care providers before combining or substituting them with other foods or medicines.” Frankos adds, “Do not self-diagnose any health condition. Work with your health care providers to determine how best to achieve optimal health.”

Consider the following tips before buying a dietary supplement:

  • Think twice about chasing the latest headline. Sound health advice is generally based on research over time, not a single study touted by the media. Be wary of results claiming a “quick fix” that departs from scientific research and established dietary guidance.
  • More may not be better. Some products can be harmful when consumed in high amounts, for a long time, or in combination with certain other substances.
  • Learn to spot false claims. If something sounds too good to be true, it probably is. Examples of false claims on product labels include:
    • Quick and effective “cure-all”
    • Can treat or cure disease
    • “Totally safe,” “all natural,” and has “definitely no side effects”

Other red flags include claims about limited availability, offers of “no-risk, money-back guarantees,” and requirements for advance payment.

“Also ask yourself, “Is the product worth the money?'” Frankos advises. “Resist the pressure to buy a product or treatment on the spot. Some supplement products may be expensive or may not provide the benefit you expect. For example, excessive amounts of water-soluble vitamins, like vitamins C and B, are not used by the body and are eliminated in the urine.”

Develop a Vitamin Strategy

It is important for consumers to have an overall strategy for how they will achieve adequate vitamin intakes. The 2005 Dietary Guidelines for Americans advises that nutrient needs be met primarily through consuming foods, with supplementation suggested for certain sensitive populations.

These guidelines, published by the Department of Health and Human Services and the U.S. Department of Agriculture (USDA), provide science-based advice to promote health and to reduce risk for chronic diseases through diet and physical activity. They form the basis for federal food, nutrition education, and information programs.

Barbara Schneeman, Ph.D., Director of FDA’s Office of Nutritional Products, Labeling, and Dietary Supplements, says, “The Guidelines emphasize that supplements may be useful when they fill a specific identified nutrient gap that cannot or is not otherwise being met by the individual’s intake of food.” She adds, “An important point made in the guidelines is that nutrient supplements are not a substitute for a healthful diet.”

Special Nutrient Needs

According to the Dietary Guidelines for Americans, many people consume more calories than they need without taking in recommended amounts of a number of nutrients. The Guidelines warn that there are numerous nutrients—including vitamins—for which low dietary intake may be a cause of concern. These nutrients are:

  • calcium, potassium, fiber, magnesium, and vitamins A (as carotenoids), C, and E (for adults)
  • calcium, potassium, fiber, magnesium, and vitamin E (for children and adolescents)
  • vitamin B-12, iron, folic acid, and vitamins E and D (for specific population groups).

Regarding the use of vitamin supplements, the Dietary guidelines include the following:

  • Consume a variety of nutrient-dense foods and beverages within and among the basic food groups. At the same time, choose foods that limit the intake of saturated and trans fats, cholesterol, added sugars, salt, and alcohol.
  • Meet recommended nutrient intakes within energy needs by adopting a balanced eating pattern, such as one of those recommended in the USDA Food Guide or the National Institute of Health‘s Dietary Approaches to Stop Hypertension (DASH) eating plan.
  • If you’re over age 50, consume vitamin B-12 in its crystalline form, which is found in fortified foods or supplements.
  • If you’re a woman of childbearing age who may become pregnant, eat foods high in heme-iron and/or consume iron-rich plant foods or iron-fortified foods with an iron-absorption enhancer, such as foods high in vitamin C.
  • If you’re a woman of childbearing age who may become pregnant or is in the first trimester of pregnancy, consume adequate synthetic folic acid daily (from fortified foods or supplements) in addition to food forms of folate from a varied diet.
  • If you are an older adult, have dark skin, or are exposed to insufficient ultraviolet band radiation (such as sunlight), consume extra vitamin D from vitamin D-fortified foods and/or supplements.

How Vitamins are Regulated

Vitamin products are regulated by FDA as “Dietary Supplements.” The law defines dietary supplements, in part, as products taken by mouth that contain a “dietary ingredient” intended to supplement the diet.

Listed in the “dietary ingredient” category are not only vitamins, but minerals, botanicals products, amino acids, and substances such as enzymes, microbial probiotics, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms. The Dietary Supplement Health and Education Act of 1994 requires that all such products be labeled as dietary supplements.

In June 2007, FDA established dietary supplement “current Good Manufacturing Practice” (cGMP) regulations requiring that manufacturers evaluate their products through testing identity, purity, strength, and composition.

Risks of Overdoing It

As is the case with all dietary supplements, the decision to use supplemental vitamins should not be taken lightly, says Vasilios Frankos, Ph.D., Director of FDA’s Division of Dietary Supplement Programs.

“Vitamins are not dangerous unless you get too much of them,” he says. “More is not necessarily better with supplements, especially if you take fat-soluble vitamins.” For some vitamins and minerals, the National Academy of Sciences has established upper limits of intake (ULs) that it recommends not be exceeded during any given day. (For more information, visit www.nap.edu/catalog.php?record_id=6432#toc

Also, the AAFP lists the following side effects that are sometimes associated with taking too much of a vitamin.

Fat-soluble Vitamins

  • A (retinol, retinal, retinoic acid): Nausea, vomiting, headache, dizziness, blurred vision, clumsiness, birth defects, liver problems, possible risk of osteoporosis. You may be at greater risk of these effects if you drink high amounts of alcohol or you have liver problems, high cholesterol levels or don’t get enough protein.
  • D (calciferol): Nausea, vomiting, poor appetite, constipation, weakness, weight loss, confusion, heart rhythm problems, deposits of calcium and phosphate in soft tissues.

If you take blood thinners, talk to your doctor before taking vitamin E or vitamin K pills.

Water-soluble Vitamins

  • B-3 (niacin): flushing, redness of the skin, upset stomach.
  • B-6 (pyridoxine, pyridoxal, and pyridoxamine): Nerve damage to the limbs, which may cause numbness, trouble walking, and pain.
  • C (ascorbic acid): Upset stomach, kidney stones, increased iron absorption.
  • Folic Acid (folate): High levels may, especially in older adults, hide signs of B-12 deficiency, a condition that can cause nerve damage

Taking too much of a vitamin can also cause problems with some medical tests or interfere with how some drugs work

Source: USFDA

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GSK, MMV commence phase III programme of tafenoquine for P. vivax malaria

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GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) announced the start of a phase III global programme to evaluate the efficacy and safety of tafenoquine, an investigational medicine which is being developed for the treatment and relapse prevention (radical cure) of Plasmodium vivax (P. vivax) malaria.

P. vivax malaria, a form of the disease caused by one of several species of Plasmodium parasites known to infect humans, occurs primarily in South and South East Asia, Latin America and the horn of Africa. Severe anaemia, malnutrition and respiratory distress are among the most serious consequences described to be caused by the infection.

The phase III programme includes two randomised, double-blind treatment studies to investigate tafenoquine in adult patients with P. vivax malaria. The “DETECTIVE” study (TAF112582) aims to evaluate the efficacy, safety and tolerability of tafenoquine as a radical cure for P. vivax malaria, co-administered with chloroquine, a blood stage anti-malarial treatment. The “GATHER” study (TAF116564) aims to assess the incidence of hemolysis and safety and efficacy of tafenoquine compared to primaquine, the only approved treatment currently available for the radical cure of P. vivax malaria.

Tafenoquine is not yet approved or licensed for use anywhere in the world.

“P. vivax malaria can affect people of all ages and is particularly insidious because it has the potential to remain dormant within the body in excess of a year, and causes some patients to experience repeated episodes of illness after the first mosquito bite,” said Nicholas Cammack, Head, Tres Cantos Medicines Development Centre for Diseases of the Developing World.  “Our investigation of tafenoquine for the treatment of P. vivax malaria is part of GSK’s efforts to tackle the global burden of malaria. Working with our partners, including MMV, we are determined to stop malaria in all its forms.”

“One of the big challenges we face in tackling malaria is to have new medicines to prevent relapse, caused by dormant forms of P. vivax, said Dr Timothy Wells, MMV’s chief scientific officer. “The phase III programme is designed to build upon the promising results of the phase IIb study which showed that treatment with tafenoquine prevented relapses. If successful, tafenoquine has the potential to become a major contributor to malaria elimination.1 It’s a great privilege to be working with GSK on this project; they have a clear commitment to changing the face of public health in the countries in which we are working.”

P. vivax malaria is a neglected tropical disease and a major cause of uncomplicated acute malaria. It has a significant public health and economic impact primarily in South and South East Asia, Latin America and the horn of Africa, where the majority of the estimated 70-390 million annual clinical cases occur. The P. vivax parasite causes relapses from a dormant liver form established immediately after an infected mosquito bite. This dormant form leads to the reappearance of clinical malaria anywhere between a few weeks to several months, and sometimes in excess of a year, after the initial infection.

Tafenoquine is an investigational 8-aminoquinoline derivative with activity against the P. vivax lifecycle, including the form that lies dormant in the liver. Tafenoquine was first discovered by scientists at the Walter Reed Army Institute of Research in 1978 and is being developed in collaboration with GSK and MMV. The clinical programme investigates a single dose of tafenoquine, as part of a 3-day treatment course with chloroquine, in patients with P. vivax malaria.

Tafenoquine was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2013. Breakthrough Therapy designation is the newest of the FDA’s programmes aimed at accelerating the development and review times of drugs for serious or life-threatening conditions.

Medicines for Malaria Venture (MMV) is a leading product development partnership (PDP) in the field of antimalarial drug research and development working towards the vision of a malaria-free world.

Source: PharmaBiz

APDCA officials find 70 pharmacies attached to top hospitals violate D&C Rules

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Several pharmacies attached to the hospitals in Hyderabad have been booked by the state drug regulatory authorities for violating Drugs & Cosmetic Rules. During a special drive conducted by the APDCA officials about 70 pharmacies have been found at fault for not issuing sale bills to the customers in the city.

According to D&C Rules,  all the medical shops should carry out the sales of medicines and other healthcare related drugs in presence of a registered pharmacist. The Rules also stipulate that the pharmacies have to ensure that sale of habit forming and other scheduled drugs should be sold only on the prescription of a doctor.

Upon conducting the special drive to check these violations, out of 98 pharmacies inspected, the inspecting authorities found about 70 of them have been violating these norms. Most of these medical shops were found not issuing sale bills during the sale of the drugs and 50 medical shops were found selling without the supervision of their registered pharmacists.

Having learned about these violations, B L Meena, Director General, Andhra Pradesh Drug Control Administration (APDCA) warned that severe action will be initiated against all the medical shops violating the D&C Act.

As a part of their regular drive the drugs department formed teams had raided pharmacies attached to hospitals across the twin cities of Secunderabad and Hyderabad. The officials inspected high profile areas like Jubilee Hills, Banjara Hills, Somajiguda, Begumpet, Malkajgiri and Miyapur areas.  A part from these areas they have also raided pharmacies in Miyapur, Madinaguda, Ramanthapur, Uppal, Ghatkesar, KPHB, Mothinagar, Medchal, Balanagar, Dilsukhnagar, Barkatpura, Narayanaguda, East Marredpally besides other areas.

Pharmacies which were raided and found violating rules include big names such as Apollo Hospital Enterprise, Cardiology Block, Jubilee Hills; Asian Medicals, a Unit of Asian Institute of Gastroenterology at Somajiguda, Care In-patient Pharmacy at Banjara Hills and Yashoda Super Specialty Hospital Pharmacy at Rajbhavan Road.

The officials carried out the inspection drive for two days and have booked cases against the violators. Commenting on the issue, Patnaik, General Secretary of Andhra Pradesh Drug Trade Association said, “Hospital attached pharmacies are hand in glove with the doctors. They never issue any proper sale bill and more over sell only a certain brand of medicines prescribed by the doctors as they get higher commission. Even the doctor’s prescriptions are not readable for others to understand. For such violators the officials should take strict action.”.

Source: PharmaBiz