Friday 24 October 2014

Importance of India in Generic


                                         EXAMPLES OF THE IMPORTANCE OF INDIA

                                   AS THE “PHARMACY FOR THE DEVELOPING WORLD”

 

QUICK OVERVIEW:

• India is the main supplier of essential medicines for developing countries.

• 67 % of medicines exports from India go to developing countries.

• Main procurement agencies for developing countries’ health programmes purchase their

medicines in India, where there are quality products and low prices.

• Approx. 50% of the essential medicines that UNICEF distributes in developing countries

come from India

• 75-80% of all medicines distributed by the International Dispensary Association (IDA) to

developing countries are manufactured in India. (IDA is a medical supplier operating on a

not-for-profit basis for distribution of essential medicines to developing countries.)

• In Zimbabwe, 75% of tenders for medicines for all public sector health facilities come from

Indian manufacturers

• The state procurement agency in Lesotho, NDSO, states it buys nearly 95% of all ARVs

from India.

Antiretroviral medicines (ARVs) for AIDS treatment:

India is the world’s primary source of affordable ARVs, as it is one of the few countries with the apacity to produce these newer medicines as generics. Therefore, all AIDS programmes use India as their main source of products.

• 80% of ARVs MSF uses are purchased in India and are distributed in treatment projects in
over 30 countries.

• Globally, 70% of the treatment for patients in 87 developing countries, purchased by

UNICEF, IDA, the Global Fund (GFATM) and the Clinton Foundation since July 2005

has come from Indian suppliers.

• PEPFAR, the US President’s AIDS initiative also purchases ARVs from India for

distribution in developing countries, thus resulting in cost-savings up to 90%.

• 91% of the generic ARVs approved by the US Food and Drug Administration for PEPFAR

are from India.

• 90% of the ARVs used in Zimbabwe’s national treatment programme come from India.

Raw materials:

In addition, raw materials are exported from India to other countries for local production of

affordable medicines. This has been crucial to enabling national AIDS programmes, such as

those in Brazil or Thailand, to provide universal free access to ARVs.

IN DETAIL:

India is the main supplier of essential medicines for developing countries. This applies not only to AIDS medicines, but to medicines to treat other diseases, as well. India is the world’s leading supplier of inexpensive generic medicines, with approximately 67% of medicines exports going to developing countries.

1) International procurement agencies

The main procurement agencies for health programmes in developing countries, as well as national procurement agencies, purchase their medicines in India, where quality products can be purchased at low prices.

MSF:

40% of the money MSF spends on oral medicines is used to buy drugs from India (if injectables are included, the average lies at 26,5%).

UNICEF:

India ranks second on the list of suppliers for UNICEF programmes (see figure 1)

• On medicines, India has a considerable lead over all countries below it on the list, and

Belgium only ranks first because of vaccines (e.g. combination vaccines are not yet being

produced in India).

• If vaccines are excluded, India is the source of approx. 50% of the essential medicines UNICEF distributes in developing countries.

Figure 1: Top 20 supplier countries for UNICEF2



IDA (International Dispensary Association)

75-80% of all medicines distributed by IDA to developing countries are manufactured in India (IDA is a medical supplier operating on a not-for-profit basis for distribution of essential medicines to developing countries.)

2) National supply stores for public/non profit sector:

Zimbabwe

The National Pharmaceutical Company, Natpharm, (formerly Governmental Central Stores), states 75% of tenders for supply to national health facilities are won by Indian manufacturers.

3) Antiretrovirals – ARVs

India is the world’s primary source of affordable ARVs, as it is one of the few countries with the capacity to produce these newer medicines as generics. Therefore, all AIDS programmes use India as their main source of products.

• 80% of ARVs MSF uses are purchased in India and are distributed in treatment projects in

more than 30 countries.

• Globally, 70% or more of the antiretroviral pills currently used in developing countries to treat nearly two million people are manufactured by generic suppliers in India.

• PEPFAR, the US President’s AIDS initiative also purchases ARVs from India for distribution in developing countries. « In every case generic prices present an opportunity for cost savings; in some cases, the branded price per pack of a drug is up to 11 times the cost of the approved generic version”

• 91% of the generic ARVs approved by the US Food and Drug Administration for PEPFAR

are from India.

• 90% of the ARVs used in Zimbabwe’s national treatment programme come from India.

• The state procurement agency in Lesotho, NDSO, states it buys nearly 95% of all ARVs

from India.

4) Active Pharmaceutical Ingredients (APIs)

Raw materials from India are also exported to other countries for production of affordable medicines. This has been key in the success of national AIDS programmes’ ability to provide universal free access to ARVs.

As an example, generic production of medicines in Brazil is heavily dependent on APIs purchased from India. At the third meeting of the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH)6, Brazil stated: “Brazil is concerned whether the application of TRIPS in India and China may affect access to APIs, and thus their treatment programme.”

The same is true for Thailand, where the Government Pharmaceutical Organization of Thailand “gets 90% of its raw materials for ARV production from India. More specifically, the Thai Public Health Ministry has clearly stated that their ambitious antiretroviral treatment programme would not exist without generic drugs, which would not have been possible without Indian API supply”

Thursday 16 October 2014

Belly Fat Burning Foods – What To Eat To Get Rid of Belly Fat


Belly Fat Burning Foods – What To Eat To Get Rid of Belly Fat

 

Belly fat is linked with higher risk for developing various health issues, but belly fat burning foods can help you lose belly fat when combined with exercise. It is normal for every person to have some belly fat, even for people with flat abs. A healthy body needs some fat which contains essential nutrients. Our body uses fat to make tissue and create biochemicals, such as hormones.


Some of our fat is close to the surface right under our skin. Other fat can be found deeper inside our body around the organs, such as around our heart, lungs and liver. This deeper fat is called “visceral” fat and too much of it can affect our health.

Why belly fat is dangerous?

Too much belly fat (or what is called the “apple” shape) increases the risk of many health problems such as diabetes, heart disease, high blood pressure, stroke and even certain types of cancers.

The ironic thing is that even slim people can have hidden belly fat that is folded deep inside the belly around the stomach organs and is visible only by medical imaging. This might be due to genetic issues, unhealthy lifestyle and lack of exercising and puts them at risk just like the other people with a more visible belly fat.

Men tend to store more belly fat than women and it’s one of the reasons men have more coronary disease than women. Women tend to be protected before menopause, when their fat tends to be stored on the buttocks and thighs (the “pear” shape”). At menopause, however, women’s fat tends to settle in the belly, and this fat is much more dangerous than buttocks fat and greatly increases a woman’s risk of death from heart disease.

Diet is just part of the picture?

While your genetics may play a role in belly fat, this is just part of the picture. Most of belly fat is related to unhealthy lifestyle - being physically inactive and consuming too much calories. Being physically active is a key in losing belly fat and should be combined with healthy nutrition. If you only eat foods that seem to target belly fat without exercising, you will see much slower results. Find activity that you enjoy and do it on a regular basis, such as walking, running or biking. It’s also good if you can find a support group to help you with moral support to maintain the results.

Another part of the picture is sleep. I’ve written in the past about the dangers of sleep deprivation which one of them was weight gain. When we maintain enough hours of sleep we burn more calories. Recent studies (both in humans and animals) have linked insufficient sleep and a tendency to gain weight. Sleep duration affects the hunger and satiety, as well as the production of various hormones and has a direct effect on the metabolism of the body. In addition, it was found that people who don’t sleep enough are less active the next day and burn fewer calories. It was found that 8 hours of sleep provide the best metabolism. Some even claim that stress is part of the picture as we all know how emotional eating affects our diet.

What is the common link between the various lists of foods that fight belly fat?

Looking at various websites with lists of foods that fight belly fat can be quite confusing. The lists vary quite significantly in the length and content. It’s hard to know where to start from. After all, there is no magic diet for belly fat, but when you lose weight on any diet, belly fat usually goes first. So here I would like to concentrate in food categories that will help you to better maintain your weight over time:

1. Fiber rich foods

Research shows that eating 10 grams of soluble fiber per day helped to build less visceral fat over time. This is why many lists contain fiber rich foods, such as beans, legumes, various fruits and vegetables with the skin, whole grains and oats. Try to include soluble fiber in every meal and snack throughout the day. If you’re not used to eating this much fiber, add it gradually to avoid gas and diarrhea and be sure to drink at least 6 to 8 glasses of water daily.

2. Foods containing protein

Protein keeps you satisfied for longer and takes longer to digest. The reason for this is that protein molecules are long chains with strong links which are harder to break down, and the whole process is more time consuming. It has been calculated that to obtain 100 calories from a protein food, the system must use 30 calories (but only 12 calories for fat and 7 for carbohydrates). This is why many lists contain low-fat and low-sugar yogurt, skim milk, lean meat, fish and eggs, or plant based proteins such as beans, legumes, whole grains, nuts and seeds and certain vegetables. 1 egg, for example, contains 7 grams of protein. 1 cup of quinoa has 8 grams of protein and 5 grams of fiber. Tabouli is also high in fiber and protein. Also nuts are high in protein, fiber and healthy fats, so if you eat them in moderation, they are excellent to curb hunger between meals.

3. Foods those are high in water content

These foods take up more space in the gut which signals the body that you ate enough so you have less room for other foods. Many fruits and vegetables contain a lot of water and nutrients, but are low in calories, and this is why they appear in many lists, especially watermelon. Other fruits with high content water are berries, grapefruit, melons, oranges, apples, pears and more. Vegetables that have high water content are cucumber, lettuce, celery, radish, zucchini, tomato, cabbage and more. What’s good in general about fruits and vegetables is that these foods are generally full of water and they are also a good source of fiber and many other nutrients and antioxidants. Fruits have other benefit – being sweet, so can satisfy your sweet tooth for much less calories than cookies or other sweets. Vegetables, on the other hand, satisfy the desire to crunch and can be a healthy snack and a substitute to other unhealthy snacks. Try to munch on carrot and celery sticks or a sweet potato instead of chips, or make an interesting salad (but be careful about the dressing).

4. Hot foods

Hot foods can be of a high temperature or spicy (or both). Hot food takes longer to eat and with added bonuses such as fiber and water content that make you feel full. This is why oatmeal can be found in many lists, or homemade soups (broth based and not cream based). Also cayenne peppers appear in some lists as people tend to eat less when their food is spicy, and because they are believed to increase metabolism.

5. Foods that increase metabolism 

Some of these foods are green tea which has a phytochemical called EGCG that promotes weight loss by promoting the internal heat of the body and fat oxidation. Cayenne pepper contains capsaicin which is known to increase metabolism. Capsaicin increases the internal heat of the body, and in order to increase heat, energy is needed, and thus cayenne pepper contributes to increase metabolism. Also some studies suggest that vinegar may help the body break down fat, hence you can find it in some lists.

I know there are probably other foods that can get into the list, but I think you’ve got the idea. There are no miracles in how to lose belly fat. Lifestyle changes are key to a long term success.

Tuesday 14 October 2014

Low Birth Weight and Preterm Multiple Births


Low Birth Weight and Preterm Multiple Births.

 


Over the past two decades, there has been a dramatic rise in the number of multiple births in Canada. Between 1994 and 2003, the rate of multiples (per 100 total births) increased 35%. The recent increase has a significant impact on perinatal health. Although multiples represent only 1 in 34 births, they account for 1 in 5 preterm births, 1 in 4 low birth weight births and 1 in 3.5 very low birth weight births. Families with twins or higher order multiples have special needs that are not always fully understood or appreciated. While babies are a special gift to a family, with multiples there is a greater risk of immediate and long-term health risks, plus substantial social, emotional and other consequences for the family. Compared to single born babies, multiple birth infants are at greater risk of suffering from long term disability, particularly cerebral palsy and of dying during the first year. Even when the babies are healthy, many parents experience overwhelming challenges in caring for, feeding and transporting two, three or more infants. As multiple birth children grow, they are also more likely to experience slower language development, behavioural disorders, challenges in school, and relationship difficulties. It is possible to reduce the risks and associated costs, and to improve health outcomes and the functioning of families by linking multiple birth families to a range of appropriate supports and services.

FREQUENCY OF MULTIPLE BIRTHS

There are about 120,000 multiple birth children in Canada under the age of 13 and 48,000 multiple birth children age 5 and under.

Each year there are close to 10,000 twin babies and 400 higher order multiple birth babies born in Canada.

Approximately 41% of multiple birth children born in Canada live in the province of Ontario.

TYPES OF MULTIPLES

There are two types of multiples: monozygotic and dizygotic. Although the expressions “identical” and “fraternal” are commonly used by the media and general population, experts and parents of multiples consider these terms to be inaccurate labels that can have a negative impact on the multiples. For instance, using the term identical to describe monozygotic (MZ) multiples causes confusion. Although genetically identical, no two children are the same. Parents distinguish between their MZ babies by identifying their differences, and strive to foster their children’s individuality. Similarly, the term fraternal means a close brotherly relationship, and therefore does not describe boy/girl or all girl dizygotic (DZ) multiples.

MONOZYGOTIC (MZ) multiples result from the splitting of a fertilized egg during the first two weeks after conception. Monozygotic twins have the same genetic makeup and therefore are of the same sex.

co Authors
 

DIZYGOTIC (DZ) twins resulting from the fertilization of two different eggs.They can be either the same or of different sex, and genetically they are no more alike than any siblings.

TRIZYGOTIC (TZ) – Triplets resulting from three fertilized eggs. No more genetically alike than singleton siblings.

QUADRAZYGOTIC (QZ) – Quadruplets resulting from four fertilized eggs. No more genetically alike than singleton siblings.

• HIGHER ORDER MULTIPLE BIRTHS is the term used for births involving three or more babies (e.g. triplets, quadruplets, quintuplets). There can be many variations of zygosity within a higher order multiple set. For example, a set of quintuplets can consist of two MZ (monozygotic) children and three TZ (trizygotic) children resulting from four fertilized eggs.

INFLUENCING FACTORS

The odds of having multiples are influenced by many factors, and multiple birth rates have changed throughout the years due to some of those factors. The widespread use of fertility drugs and high-tech procedures such as in vitro fertilization (IVF), and increased maternal age are considered to be the major contributing factors to the increase in multiple births.

Multiple Births by Maternal Age

Multiple births are more frequent among women in their thirties and forties. In 2002, approximately 55% of multiple birth babies were born to women age 30 and older. Infertility Treatments

Approximately 35% of multiple pregnancies result from infertility treatments (fertility drugs and/or reproductive technologies). However, it is estimated that over 80% of higher order multiples result from these treatments.

The incidence of monozygotic multiples is doubled in multiples conceived through the use of ovulation stimulation treatments.

Maternal Weight

Women with a pre-pregnancy Body Mass Index (BMI) of 30 or greater are at a significantly increased risk of conceiving dizygotic multiples.

THE IMPACT OF MULTIPLE BIRTHS

Multiple birth infants have a disproportionately high risk of preterm birth, perinatal death and illness which places enormous stress on families as well as health, social and education services.

Maternal Health

Multiple pregnancies present significant complications for pregnant women, such as gestational hypertension, preeclampsia, anemia, gestational diabetes, premature rupture of membranes, and postpartum hemorrhage.

Reduced activity, withdrawal from employment, and prescribed bed rest (at home or hospital) during pregnancy are common for expectant mothers of multiples. Prolonged bed rest can lead to cardiac and/or respiratory problems and muscular wasting, and recovery from these problems may take several weeks.

Cesarean section is needed for over 50% of twin pregnancies, and is almost always required for higher order multiples.

Since infection, prolonged pain, and delayed recovery are more common with caesarean deliveries, new mothers of multiples frequently have difficulty in holding, carrying and caring for their infants.

Problems Unique to Multiple Pregnancy

Monozygotic multiples who share one placenta (monochorionic) have a high incidence of umbilical cord entanglement, Twin-to-Twin Transfusion Syndrome (TTTS)* and fetal death.

* TTTS is a condition in which blood from one monozygotic twin fetus transfuses into the other fetus via blood vessels i the placenta. TTTS can also occur between monozygotic multiples in a triplet or more pregnancy.

Poor and differing fetal growth between the babies is common. Perinatal Death

Occasionally one fetus dies in early pregnancy and is reabsorbed (Vanishing Twin Syndrome).

Compared to mothers expecting a single baby, mothers expecting multiples are nearly three times more likely to lose one, more or all of their babies before birth.

Preterm Birth

The average length of pregnancy is 36 weeks for twins, 33 weeks for triplets, 31 weeks for quadruplets, and 29 weeks for quintuplets.

Most multiple birth babies are born before full term (40 weeks), and 57% of twins and 98% of higher order multiples are born preterm (before 37 weeks).

Multiple births are the fastest growing segment of the preterm birth infant population,

representing 20% of all preterm births.

• Due to their prematurity, multiple birth infants frequently have ongoing health problems such as respiratory and neuro-developmental challenges, requiring prolonged and frequent hospitalization.

Infant Death

Infant death is 4 to 5 times more likely to occur among multiple births than among singleton births.

• Multiple birth babies are more vulnerable to Sudden Infant Death Syndrome (SIDS).

Low Birth Weight

Low birth weight (<2500 grams, or 5.5 lbs) and very low birth weight (<1500 grams, or 3.3 lbs) occur about nine times more frequently among multiple than singleton births.

Multiples represent about 25% of all low birth weight infants and 28% of the very low birth weight infant population.
 

The average birth weight for each multiple birth baby is approximately:

– Twins 2,500 grams (5-l/2 pounds)

– Triplets 1,800 grams (4 pounds)

– Quadruplets 1,400 grams (3 pounds)

Given that multiple birth infants are more likely to be born with a low birth weight, they often have short and long term health and developmental problems, require more feedings during the early weeks or months, and tend to require more care.

Disabilities

• Complications during pregnancy, delivery and in the early weeks of life may result in one, more or all of the babies having special needs.

• Compared to singletons, twins are 1.4 times more likely to have a disability. Similarly, triplets are 3 times more likely to have a severe disability and 1.7 times more likely to have a moderate disability.

• Multiples are at a significantly increased risk of having Cerebral Palsy (CP). In contrast with single born children, twins are 10 times more likely, triplets 30 times more likely, and quadruplets 110 times more likely to have CP.

• Since disabilities and/or developmental delays are more common in multiples, parents often must commit to intensive and ongoing involvement in therapies throughout the first few years.

Psychosocial and Financial Issues

Since death is much higher among multiple births than singletons, parents who lose one, more or all of their babies face extremely difficult situations. In the case of losing all of the babies, the parents have lost not only their babies but a unique parenting experience. If there are survivors, the parents find it hard to celebrate the birth and the anguish of death at the same time. As a result, some parents find it difficult to attach emotionally with the survivor(s). For those who have experienced years of infertility, the loss of one or more of the babies can be particularly heartbreaking.

These additional issues can make the grieving process more complex.

Some centres that offer assisted conception, also offer Multifetal Pegnancy Reduction as an option to women who conceive higher order multiple pregnancies. Multifetal Pregnancy Reduction aims to increase a woman’s chance of a near term delivery of a singleton baby or twins instead of three or more babies.This procedure and associated decisions are not straight forward and the long term psychological effects may be profound. In particular, the decision whether or not to undergo this procedure can be extremely distressing. For many, after experiencing the emotional and financial strains of infertility, the decision to reduce seems to be in conflict with the goal of conception.

The total cost of raising multiples is higher than the cost of raising the same number of singletons. Parents must purchase clothing and equipment all at once (e.g. cribs, special stroller, car seats, high chairs, etc.), preventing an opportunity to pass along hand-me-downs. The first year “start up” cost for basic essentials of infants for families with triplets is approximately $12,000 higher than families raising a single baby. This amount does not include: the cost of disposable diapers; transportation needs when a larger vehicle is required to accommodate three, four or more infant car seats; the cost of moving to larger accommodation or renovations to existing accommodation; childcare costs; or the loss of a second family income if the mother does not return to the paid labour force.

Caring for multiples is more difficult and physically demanding than caring for one child, especially during infancy and childhood, and with higher order multiples. One Australian study showed that mothers of triplets spend an average of 197.5 hours per week (unfortunately there are only 168 hours in a week) between themselves and paid/volunteer assistance, on caring for their babies and managing the household. This situation can place extraordinary stress on the couple relationship.

Parenting multiples presents unique situations and experiences yet information, support and advice regarding multiple births is often difficult to find.

Compared to a single baby, the maternal and paternal attachment process takes longer and is more complex with two, three or more babies.

• Since most new mothers of multiples suffer from sleep deprivation and chronic fatigue, they are at higher risk of Post-partum Depression (PPD) than mothers of singletons.

• Parents of multiples are at risk of maternal isolation, marital stress, financial difficulties and illness. This stress, in combination with the lack of access to special information and support, places multiple birth families at an increased risk of family problems.

As a result of the unrelenting parental demands, the associated fatigue, and the attention that multiple birth babies attract, the birth of twins, triplets or more can have a negative impact on other children in the family (e.g. behavioural changes).

• Due to the extraordinary parental stress, multiple birth infants are at a greater risk of abuse such as Shaken Baby Syndrome.

PREVENTION

In order to avoid short and long term problems, families with multiple birth children require timely access to preventative health care and social support that is specifically designed for parents of multiples.

• Physicians need to inform families who seek infertility treatments, about the known risks of multiple pregnancy, multi-fetal reduction, and parenting demands before starting therapy.

• Physicians need to refer patients to appropriate specialists for infertility management and high-risk multiple gestations.

• To ensure that the pregnancy goes as near to term as possible, women expecting multiples require:

Early diagnosis of the multiple pregnancy (before 16 weeks) in order to :

• Identify monozygotic multiples sharing a single placenta (monochorionic)

• Put into place an appropriate obstetrical care management plan

• Allow the mother and her family adequate time to adjust

– Early nutritional counselling and dietary resources to support a weight gain of 18-27 kilos (40-60 pound)

Education regarding preterm labour

– Obstetrical care which follows the protocols of best practice for multiple birth

• Multiple birth families need to receive special support. In particular:

– The primary antenatal care provider should identify all those involved in the care of the family and

ensure that close links are sustained throughout the pregnancy and postpartum period;

– Early prenatal classes designed for parents expecting multiples;

– Practical help and referral to local resources;

– Multiples-specific breastfeeding support.

– Links with other parents who share their unique experience (e.g. Multiple Births Canada, local parents of multiples support group).

– When the health of the mother or family circumstances indicates, limited activity, greater work restrictions and increased bed rest are often recommended. In these situations, mothers may also require in-home nursing support and household help, especially if there are older siblings.

• Creation of healthy public policies must recognize the need for and benefits of additional supports for multiple birth families. Programming must address barriers to supports and services for multiple birth families including lack of services, long waiting lists for services, and the need for service coordination.

Saturday 11 October 2014

REGULATORY BODIES IN INDIA

                                    REGULATORY BODIES IN INDIA

 In India, the central government, via the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare, largely works on developing standards and regulatory measures for drugs, diagnostics and devices; laying down regulatory measures by amending acts and rules; and regulating the market authorization of new drugs – all in an effort to standardize clinical research in India and bring safer drugs to the market.

CDSO Head Quarters New Delhi


                                   Regulatory bodies in India involved in pharmaceutical regulation
 
Body
Function
DCGI
Drug Control General India
Regulatory apex body under the government of India that oversees all
ICMR
Indian Council of Medical Research
Apex body that formulates, co-ordinates and promotes biomedical
GEAC
Genetic Engineering Approval Committee
Consists of experts in the field of genetic engineering and molecular biology;
clinical trials involving the use of biotech products would be
referred by DCGI to GEAC for recommendations
DBT
Department of Biotechnology
 
Apex body that oversees the new impetus to develop the field of modern
biology and biotechnology in India
AERB
Atomic Energy Review Board
Authority that exercises regulatory control over the approval of new types
of radiation equipment, and for the registration/commissioning of new
radiation equipment, inspection and decommissioning of installations
BARC
Baba Atomic Research Centre
Apex body that oversees and approves all radiation related projects in India.
DCGI refers all clinical trials that involve the use of radiopharmaceuticals
to BARC for its expert opinion
DCC
Drugs Consultative Committee
Provides technical guidance to the Central Drugs Standard Control
Organization
CDL
Central Drugs Laboratory
National statutory laboratory of the Indian government for quality control
of drugs
DTAB
Drugs Technical Advisory Board
Provides technical guidance to the CDSCO