The seventh edition of the Indian Pharmacopoeia (IP 2014), officially released in November last year by the Indian Pharmacopoeia Commission (IPC) has come into force in the country with no further extension of its implementation by the regulatory authorities.
The IP 2014 is presented in four volumes. The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use now a days are omitted from this edition.
As per the original plan, the IP 2014 was to come into force from January 1, 2014. But, there were demands from industry to postpone the implementation because of the practical difficulties. This has prompted the Indian Pharmacopoeia Commission to delay the implementation, giving more time to the industry to adopt the changes.
Meanwhile the IPC has received inputs from its stakeholders on IP 2014 which require up-gradation/changes. The IPC has issued draft amendments (proposed) and has invited comments/suggestions from the experts and stakeholders within 30 days.
The IP 2014 incorporates 2548 monographs of drugs out of which 577 are new monographs consisting of APIs, excipients, dosage forms, antibiotic monographs, insulin products and herbal products etc. 19 new radiopharmaceutical monographs and 1 general chapter is first time being included in this edition. It is hoped that this edition would play a significant role in improving the quality of medicines which in turn promote public health and accelerate the growth and development of pharma sector.
The IP-2014 is published in fulfilment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder and it prescribes the standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines.
“A natural, safer alternative to dangerous prescription drugs”
“Can slim you down by reducing hormonal imbalances”
“Prevents Alzheimer’s disease and senility”
All of these claims have been made by marketers of compounded “bio-identical” hormones, also known as “bio-identical hormone replacement therapy” (BHRT). But these claims are unproven. FDA is concerned that claims like these mislead women and health care professionals, giving them a false sense of assurance about using potentially dangerous hormone products.
FDA is providing the facts about “BHRT” drugs and the uncertainties surrounding their safety and effectiveness so that women and their doctors can make informed decisions about their use.
“BHRT” is a marketing term not recognized by FDA. Sellers of compounded “bio-identical” hormones often claim that their products are identical to hormones made by the body and that these “all-natural” pills, creams, lotions, and gels are without the risks of drugs approved by FDA for menopausal hormone therapy (MHT). FDA-approved MHT drugs provide effective relief of the symptoms of menopause such as hot flashes and vaginal dryness. They also can prevent thinning of bones. FDA has not approved compounded “BHRT” drugs and cannot assure their safety or effectiveness.
During menopause, a woman’s body produces less of the hormone estrogen, which may lead to hot flashes, vaginal dryness, and thin bones. MHT drugs contain estrogen or a combination of estrogen and another hormone, a progestin. FDA-approved MHT drugs are sold by prescription only, and FDA advises women who choose to use hormones to use them at the lowest dose that helps, for the shortest time needed.
Some “BHRT” drugs are compounded in pharmacies. Traditional compounding involves combining, mixing, or altering ingredients by a pharmacist, according to a prescription from a licensed health care professional, to produce a drug that meets an individual’s special medical needs. FDA considers traditional compounding to be a valuable service when used appropriately, such as customizing a drug for someone who is allergic to a dye or preservative in an FDA-approved medicine. But some pharmacies that compound “BHRT” drugs make unsupported claims that these drugs are more effective and safer than FDA-approved MHT drugs.
FDA is taking action against pharmacies that make false and misleading claims about “BHRT” drugs and is encouraging consumers to become informed about these products and their risks. Here is some information to help sort the myths from the facts:
Myth: “Bio-identical” hormones are safer and more effective than FDA-approved MHT drugs.
Fact: FDA is not aware of any credible scientific evidence to support claims made regarding the safety and effectiveness of compounded “BHRT” drugs. “They are not safer just because they are ‘natural,'” says Kathleen Uhl, M.D., Director of FDA’s Office of Women’s Health.
Drugs that are approved by FDA must undergo the agency’s rigorous evaluation process, which scrutinizes everything about the drug to ensure its safety and effectiveness—from early testing, to the design and results of large clinical trials, to the severity of side effects, to the conditions under which the drug is manufactured. FDA-approved MHT drugs have undergone this process and met all federal standards for approval. No compounded “BHRT” drug has met these standards.
Pharmacies that compound these “BHRT” drugs may not follow good drug manufacturing requirements that apply to commercial drug manufacturers. Compounding pharmacies custom-mix these products according to a health care professional’s order. The mix contains not only the active hormone, but other inactive ingredients that help hold a pill together or give a cream, lotion, or gel its form and thickness so that it can be applied to the body. It is unknown whether these mixtures, which are not FDA-approved, are properly absorbed or provide the appropriate levels of hormones needed in the body. It is also unknown whether the amount of drug delivered is consistent from pill to pill or each time a cream or gel is applied.
Myth: “Bio-identical” hormone products can prevent or cure heart disease, Alzheimer’s disease, and breast cancer.
Fact: Compounded “BHRT” drugs have not been shown to prevent or cure any of these diseases. In fact, like FDA-approved MHT drugs, they may increase the risk of heart disease, breast cancer, and dementia in some women. (See www.nhlbi.nih.gov/whi/index.html for information on the Women’s Health Initiative, a large, long-term study that tested the effects of FDA-approved MHT drugs.) No large, long-term study has been done to determine the adverse effects of “bio-identical” hormones.
Myth: “Bio-identical” hormone products that contain estriol, a weak form of estrogen, are safer than FDA-approved estrogen products.
Fact: FDA has not approved any drug containing estriol. The safety and effectiveness of estriol are unknown. “No data have been submitted to FDA that demonstrate that estriol is safe and effective,” according to Daniel Shames, M.D., a senior official in the FDA office that oversees reproductive products.
Myth: If “bio-identical” products were unsafe, there would be a lot of reports of bad side effects.
Fact: “Bio-identical” products are typically compounded in pharmacies. “Unlike commercial drug manufacturers, pharmacies aren’t required to report adverse events associated with compounded drugs,” says Steve Silverman, Assistant Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “Also, while some health risks associated with ‘BHRT’ drugs may arise after a relatively short period of use, others may not occur for many years. One of the big problems is that we just don’t know what risks are associated with these so-called ‘bio-identicals.'”
Myth: A pharmacy can make a “BHRT” drug just for you based on hormone levels in a saliva sample.
Fact: “Advertisements that a drug can be created ‘just for you’ based on saliva testing are appealing,” says Uhl, “but unrealistic.” Hormone levels in saliva do not accurately reflect the amount of hormones a woman has in her body for the purpose of adjusting hormone therapy dose levels. A woman’s hormone levels change throughout the day, and from day to day. FDA-approved tests can tell a woman’s hormone level in a specific body fluid, such as saliva, blood, or urine, at that particular point in time. “These tests are useful to tell if a woman is menopausal or not,” says Uhl, “but they have not been shown to be useful for adjusting hormone therapy dosages.”
Myth: FDA wants all compounded hormone therapies off the market.
Fact: “We are not trying to pull all compounded hormone therapies off the market,” says Silverman. “We believe that, like all traditionally compounded drugs, a woman should be able to get a compounded hormone therapy drug when her physician decides that it will best serve her specific medical needs. But we also want women to be informed and careful about choosing products that have not been proven safe and effective. And pharmacies cannot promote compounded drugs with false or misleading claims.”
In addition, FDA has not approved any drug containing the hormone estriol. Pharmacies should not compound drugs containing estriol unless the prescriber has a valid investigational new drug (IND) application. INDs provide benefits that include allowing physicians to treat individual patients with drugs that are not FDA-approved, while also providing additional safeguards for patients.
Myth: All women who take FDA-approved MHT drugs are going to get blood clots, heart attacks, strokes, breast cancer, or gall bladder disease.
Fact: Like all medicines, hormone therapy has risks and benefits. For some women, hormone therapy may increase their chances of getting these conditions. However, there are no convincing data that there is less risk of developing a blood clot, heart attack, stroke, breast cancer, or gall bladder disease with a “BHRT” product. Women should talk to their health care professional about taking hormones. If you decide to use MHT drugs for menopause
- use at the lowest dose that helps
- use for the shortest time needed
If you are taking a compounded “BHRT” drug now, talk to your health care professional about treatment options to determine if compounded drugs are the best option for your particular medical needs.
Original Article can be downloaded from HERE
The guidance is aimed at industry; however, FDA believes it may also help the public gain a better understanding of this important and developing area. The guidance explains the process by which FDA is regulating GE animals.
FDA invited public comments for 60 days after the release of its draft guidance on regulating GE animals in September 2008. The agency received comments from groups and individuals ranging from consumers and animal advocates, to food producers and trade associations, to academics and researchers. FDA considered the approximately 28,000 public comments in producing the final guidance.
Genetic engineering is a process in which scientists use recombinant DNA (rDNA) technology to introduce desirable traits into an organism. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms. Scientists use rDNA techniques to manipulate DNA molecules.
Genetic engineering involves producing and introducing a piece of DNA (the rDNA construct) into an organism so new or changed traits can be given to that organism. The rDNA construct can either come from another existing organism, or be synthesized in a laboratory. Although conventional breeding methods have been used for a long time to select for desirable traits in animals, genetic engineering is a much more targeted and powerful method of actually introducing specific desirable traits into animals.
Genetic engineering is not a new technology. It has been widely used in agriculture, for example, to make crops like corn and soy resistant to pests or tolerant to herbicides. In medicine, genetic engineering is used to develop microbes that can produce pharmaceuticals. And in food, genetic engineering is used to produce enzymes that aid in baking, brewing, and cheese making.
Benefits of GE Animals
GE animals hold great promise for human and animal health, the environment, and agriculture.
- Health protection of animals – Animals are under development to be more resistant to very painful and harmful diseases, such as infection of the udder (mastitis) in dairy cows and “mad cow” disease (bovine spongiform encephalopathy) in all cattle.
- New source of medicines – Animals can be engineered to produce particular substances, such as human antibodies, to make infection-fighting drugs for people. These “biopharm” animals can change the way we treat chronic diseases, such as bleeding disorders, by providing large quantities of safe, health-restoring proteins that previously were available only from human cadavers.
- Transplantation – Pigs are being engineered so that their cells, tissues, or organs could be transplanted into humans with a reduced risk of immune rejection.
- Less environmental impact – Food animals are being engineered to grow more quickly, require less feed, or leave behind less environmentally damaging waste.
- Healthier food – Food animals, such as pigs, are under development to contain increased levels of omega-3 fatty acids, providing a more healthful product. Livestock can also be engineered to provide leaner meat or more milk.
GE Animals Regulated Under New Animal Drug Provisions
FDA regulates GE animals under the “new animal drug” provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), and the agency must approve them before they are allowed on the market. The FFDCA defines a drug as “an article (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, the rDNA construct is a drug because it is intended to change the structure or function of the body of the GE animal.
FDA will review food and animal feed from GE animals before the food or feed can be marketed. “We want the public to understand that food from GE animals will not enter the food supply unless FDA has determined that it is safe,” says Bernadette Dunham, D.V.M., Ph.D., the director of FDA’s Center for Veterinary Medicine.
FDA may exercise “enforcement discretion” over some GE animals, based on their potential risk and on a case-by-case basis. This means that the agency may not require premarket approval for a low-risk animal. For example, the agency is not requiring premarket approval for GE lab animals used for research, and did not require approval of a GE aquarium fish that glows in the dark. FDA does not expect to exercise enforcement discretion for animal species traditionally consumed as food.
The guidance will help industry comply with FDA’s requirements and will help the public understand FDA’s oversight of GE animals and food from such animals.
This article appears on FDA’s Consumer Update page, which features the latest on all FDA-regulated products.
Gone are the days when a hemophilia diagnosis meant you could not live a normal life. Now more treatments are approved by the Food and Drug Administration (FDA), and people with the condition can better manage bleeding. That’s good news as thousands observe World Hemophilia Day on April 17, 2014.
Hemophilia is a rare bleeding disorder. It is usually hereditary, but it can be acquired in rare cases if a person’s body develops antibodies that attack clotting factors in the bloodstream. Hereditary hemophilia usually occurs in males and currently affects about 23,500 Americans.
People with hemophilia are lacking one or more important clotting factors, which are proteins needed for blood clotting. Several types of clotting factors exist and there are two main types of hemophilia, says Nisha Jain, M.D., chief of the Clinical Review Branch in FDA’s Office of Blood Research and Review. Hemophilia A occurs when people have low levels, or missing, clotting factor VIII (8). Hemophilia B occurs when people have low, or missing, clotting factor IX (9).
People with hemophilia may bleed for a longer time than others after injury or surgery. They may also have internal bleeding—especially in knees, ankles, and elbows—that can damage organs and tissues and even be life-threatening.
Treatments for Hemophilia
“We have seen shifting toward the prevention of bleeds,” says Nisha Jain, M.D., chief of the Clinical Review Branch in FDA’s Office of Blood Research and Review.
At present hemophilia is not curable, but treatments have come a long way, Jain says.
Hemophilia is sometimes called the “Royal Disease” because it affected the royal family of England during the 1800s. By the 1960s, hemophilia was treated with whole blood or fresh plasma. But these treatments didn’t have enough factor VIII or IX proteins to stop serious internal bleeding.
Now the primary type of hemophilia treatment is replacement therapy: Concentrates of clotting factor VIII (for hemophilia A) or clotting factor IX (for hemophilia B) are injected into a patient’s vein to replace low or missing factor.
These concentrates have traditionally been made from human blood. Today, an increasing number are made using recombinant DNA technology (a form of artificial DNA), with some made without any material sourced from humans or animals. The final product is a powder that is mixed with sterile water before use.
Some people have regular preventive or “prophylactic” therapy to prevent bleeding. This can be done in less than five minutes, excluding prep time, Jain explains. Others have therapy only as needed.
The type and frequency of treatment varies depending on the severity of hemophilia, which can be classified as mild, moderate or severe.
People with mild hemophilia have 6% to 49% of the normal levels of clotting factors in their blood. They generally only have bleeding problems after serious injury or surgery.
Those with moderate hemophilia—about 15 percent of the hemophilia population, according to the
National Hemophilia Foundation—have 1% to 5% of normal clotting factor levels. They can have bleeding problems after injury and spontaneously.
Those with severe hemophilia—about 60% of the hemophilia population, per NHF—have less than 1% of normal clotting factor levels. They bleed after injury and may have frequent spontaneous bleeding, including bleeds into joints and muscles. In addition to factor replacement, pain medication and physical therapy are also used to lessen pain and swelling if joint bleeds occur.
“The mild patients rarely need treatment. And moderate patients are the same,” explains Jain. In certain situations, such as before dental work, patients with mild hemophilia receive Desmopressin (DDAVP) a man-made hormone that increases the level of factor in the blood. “Patients with severe hemophilia are those who really need treatment to prevent or resolve bleeds.”
A Shift Toward Prevention
Doctors, particularly hematologists who specialize in the study of blood, tend to identify people with severe hemophilia early. “Patients can be diagnosed as infants during circumcision,” says Jain. Then families can work with hematologists and hematology treatment centers.
“In recent times, we have seen shifting toward the prevention of bleeds,” Jain says. “You want to prevent bleeding that causes joint damage. Once joint damage starts, it is difficult to stop progression unless bleeding into joints is reduced.”
The treatments for hemophilia continue to improve, and FDA has approved many replacement factors in recent years. For instance, in March 2014 it approved Alprolix, the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. It also recently approved Rixubis—a factor IX product—to control, prevent and reduce bleeding associated with hemophilia B. And the agency approved Novoeight, a factor VIII product, for control of bleeding and a routine prophylaxis treatment for adults, adolescents and children with hemophilia A.
Of course, the agency continues to carry out its broad responsibility to regulate medicines made from blood and blood components, including clotting factors. Today, due to strengthened FDA safeguards and oversight, these products are safer than they have ever been.
“Patients should stay informed about various treatment options,” Jain adds, “and should consult with their health care providers to obtain, and follow, a comprehensive management plan.”
She says those with hemophilia tend to be well-educated about their health and notes, “With appropriate treatment and care, people with hemophilia can, and do, live normal lives.”
Dr Rao V S V Vadlamudi has been elected as the president of Indian Pharmaceutical Association (IPA), the oldest and biggest association of pharmaceutical professionals in the country, for the term 2014-16.
Dr Rao Vadlamudi has been the editor of Indian Journal of Pharmaceutical Sciences (IJPS), the scientific publication of IPA since 1998 and is currently, the director of St Peter‘s Institute of Pharmaceutical Sciences, Warangal. With a brilliant stint of over three decades in industry and academia, Dr Vadlamudi brings with him an assorted mix of skill sets that are essential for leading IPA that is set to complete 75 glorious years of professionally enriched existence in December this year.
The other office bearers who have also been elected for the term include Kaushik Desai as honorary general secretary, Dr Surendra Manek as honorary treasurer, Dr Alka Mukne as editor-Pharma Times, Dr Divakar Goli as editor-IJPS, Dr T V Narayana as chairperson–education division, Manjiri Gharat as chairperson-community pharmacy division, Dr Subhash Rijhwani as chairperson-industrial pharmacy division, Dr Subhash Mandal as chairperson-regulatory affairs division and Dr Ramesh Adepu as chairperson-hospital pharmacy division. SD Joag has been appointed as secretary general of IPA.