Healthy Eating Benefits Heart Failure Patients, Study Says

Healthy eating habits can significantly reduce high blood pressure and improve heart function in heart failure patients, a new study says.

The study included patients, most in their 60s and 70s, who ate only meals that were prepared for them in the kitchen of the University of Michigan Clinical Research Unit.

The meals, which could be picked up and heated at home, followed the DASH (Dietary Approaches to Stop Hypertension) diet eating plan, which is high in potassium, magnesium, calcium and antioxidants. The diet is recommended for high blood pressure treatment by the American Heart Association and the U.S. National Institutes of Health.

The diet used in the study also contained a daily sodium intake of 1,150 milligrams or less, which is much lower than American adults' typical intake of about 4,200 mg a day for men and 3,300 a day for women.

After three weeks of following this diet, patients saw a drop in blood pressure similar to that achieved by taking blood pressure medications, according to the study presented Tuesday at a Heart Failure Society of America meeting.

"Our work suggests diet could play an important role in the progression of heart failure, although patients should always talk to their doctor before making major dietary changes," Dr. Scott Hummel, a cardiologist at the University of Michigan Frankel Cardiovascular Center, said in a university news release.

"We're excited to confirm these results in longer-term studies that also help us understand the challenges patients face when they try to improve their eating habits," he added.

Heart failure means the heart can't pump enough blood to meet the body's needs.

Doctors have long known that the low-sodium DASH diet can lower blood pressure in patients who are sensitive to salt. This study, although small, showed that the DASH diet can improve left ventricular relaxation and reduce diastolic chamber stiffness in heart failure patients, meaning a more efficient transfer of blood between the heart and arteries, Hummel explained.

Data and conclusions presented at meetings should be considered preliminary until published in a peer-reviewed medical journal.

Tips for Preventing, Coping With Pinkeye

SATURDAY Sept. 28, 2013 -- With children back in school, cases of a highly contagious infection called pinkeye (conjunctivitis) are likely to rise, an expert says.

"This common medical condition is around all year. Since it can spread so easily it's more common when school is back is session and kids are in close contact and touching similar surfaces," Dr. Khalilah Babino, an urgent care physician at Loyola University Health System, said in a Loyola news release.

Pinkeye is a hassle for students, parents and teachers, the release noted. The condition occurs when the conjunctiva -- a membrane that lines the inner surface of the eyelids and white portions of the eye -- become red and swollen due to inflammation.

"Contrary to popular belief pinkeye is not always due to a bacterial infection. It can also be caused by viruses, allergens and irritants. These types of conjunctivitis will typically resolve spontaneously without additional treatment," Babino said.

But she noted that bacterial conjunctivitis is extremely contagious and can quickly spread through a household or classroom.

"Bacterial conjunctivitis can be the result of infection from one of several bacterial organisms. Transmission is from person to person contact, secretions from an affected person or infected surfaces. If you suspect you have this type of infection it's best to see your medical provider as soon as possible," Babino said.

She offered the following tips for preventing and dealing with bacterial pinkeye:

• Wash your hands frequently with warm soapy water for at least 15 to 20 seconds each time.
• Use alcohol sanitizer when water and soap are not available.
• Avoid eye make-up during an infection and throw out any used eye make-up as it probably is contaminated.
• Take out contact lenses and wear glasses instead until the infection is cleared.
• Thoroughly clean your contact lens case and throw out disposable contacts.
• Avoid touching your eyes with your fingers -- this is how conjunctivitis is commonly transmitted from one eye to the other.
• Avoid school or work until you have had at least 24 hours of treatment with antibiotics.

USFDA increases inspections of drug facilities in India

The US Food and Drug Administration (USFDA) is increasing its inspections of facilities of drug makers in India, the second largest provider of finished dose products to the US, to ensure compliance of approved manufacturing norms.

The US health regulator, which has been cracking the whip against many Indian pharmaceutical firms,including Ranbaxy Laboratories and Wockhardt, is also recruiting and training additional drugs investigators in India.

"In March 2013, the (US) FDA received approval from the Indian government to add seven additional drugs investigators in India. We are currently recruiting and training staff for these positions," a spokesperson for USFDA, Christopher C Kelly, said in an emailed response.

USFDA's presence in India is being increased to 19 from 12 American staff based in-country, including 10 dedicated specifically to medical products. Other staff include foods and devices inspectors, and policy analysts.

"Having these additional inspectors in-country will assist the agency in meeting our legislative mandates. So we are increasing our rates of inspection," Kelly added.

In order to meet requirements of the new Food and Drug Administration Safety and Innovation Act (FDASIA) - Generic Drug User Fee Amendments (GDUFA), the US health regulator is stepping up the inspections.

Under the FDASIA, the USFDA is required to achieve the same inspectional schedule for foreign facilities as domestic manufacturers, and to clear the backlog of applications by the end of the first five-year user fee authorisation period.

Stressing on the importance for good compliance, Kelly said: "(US)FDA seeks to ensure that Indian manufacturing facilities importing to the United States understand the risks associated with their product's processes and assure they remain compliant to (US)FDA's regulations."

India, as the second largest provider of finished dose products to the US with almost 10 per cent of that market, has, for many years, been a consistent provider of low-cost and quality medical products for many countries of the world.

"Our presence in India allows us to better collaborate with our Indian regulatory counterparts and enables us to leverage our combined resources, harmonise science-based standards and increase regulatory capacity," Kelly added.

In doing so, FDA continues to ensure that medical products moving in international commerce are safe, effective, and of high quality, he said.

"The (US)FDA remains confident that many companies understand and have implemented Good Manufacturing Practices (GMPs). We also remain vigilant and will take appropriate action if, or when, lapses, occur," Kelly said.

Vitamin D Alone Doesn't Boost Bone Health, Study Says

TUESDAY Sept. 24, 2013 -- Calcium supplements improve bone health in postmenopausal women, but vitamin D supplements provide no benefit in women with normal vitamin D levels, a new study finds.

"These findings suggest that vitamin D supplements over the recommended dietary allowance do not protect bone health, whereas calcium supplements do have an effect," study lead author Dr. John Aloia, of Winthrop University Hospital in Mineola, N.Y., said in a news release from the Endocrine Society.

For the study, published Sept. 24 in theJournal of Clinical Endocrinology & Metabolism, the researchers examined bone turnover in 159 postmenopausal women. Bone turnover is the body's natural process for breaking down old bone. Young people produce enough new bone to replace what is lost, but bone mass in women begins to decline after age 30, and this loss speeds up after menopause.

The women in the study were divided into four groups: one group received a combination of vitamin D and calcium; one group took 1,200 milligrams of calcium daily; one group took 4,000 IU of vitamin D daily; and one group took an inactive placebo. Levels of bone turnover markers, such as parathyroid hormone levels in the blood, were assessed for six months.

There was a significant decline in bone turnover markers among women who took daily calcium supplements. The vitamin D supplements had no effect on bone turnover markers, the researchers reported.

"Vitamin D and calcium interact to suppress bone turnover by decreasing parathyroid hormone levels," said Aloia in the news release. "This can be beneficial in women who are vitamin D deficient. In women who already are receiving the recommended daily allowance of vitamin D, however, the study found there was no advantage to adding a vitamin D supplement."

Aloia added: "Women do need to be cautious about the possibility of vascular side effects from too much calcium and should consult their physicians about whether their diet is adequate or whether they should take supplements at all."

By 2020, half of all Americans over age 50 are expected to have low bone density or osteoporosis, according to the National Osteoporosis Foundation. This can lead to painful and debilitating fractures.

Could Obesity Help Older People With Type 2 Diabetes?

WEDNESDAY Sept. 25, 2013 -- Older obese people with type 2 diabetes appear to have a lower death rate than younger people who have diabetes and weigh less, a new study finds.

This so-called "obesity paradox" might mean obesity is actually protective, or type 2 diabetes in older people is somehow different than it is in younger people, the researchers speculate.

Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in New York City, who did not take part in the study, said that "my feeling is that fat is not protective, but the ones who are dying have more bad fat and more aggressive diabetes."

It's not just a matter of weight, but where the weight is and how aggressive the diabetes is that makes the difference, he said.

"What we are seeing nowadays is that young people who develop type 2 diabetes have lots of bad fat," he said. Specifically, that's fat around the middle and around vital organs such as the liver and heart, Zonszein said.

"They come to see me very young, very sick -- their livers are full of fat, their hearts are full of fat. And their diabetes is a much more aggressive disease than what we see in elderly people," he said. "It's also much more difficult to treat."

The findings of the new study were due to be presented Wednesday at the annual meeting of the European Association for the Study of Diabetes in Barcelona, Spain.

For the study, British researchers led by Dr. Pierluigi Costanzo, an academic clinical fellow in cardiology at the Universities of Hull and York, collected data on more than 12,000 patients with diabetes. Of these about 1,700 had type 1 diabetes, while the rest had type 2 disease.

Over an average of 10 years of follow-up, 9 percent of the patients had signs of acute coronary syndrome, 7 percent suffered a stroke, 6 percent were hospitalized for heart failure and 34 percent of patients died.

Acute coronary syndrome is an umbrella term for conditions where the blood supplied to the heart muscle is suddenly blocked, according to the American Heart Association. Heart attack and unstable angina (chest pain) are among these conditions.

The researchers found that episodes of acute coronary syndrome were lowest among people with a normal body weight, but became more common as weight increased and were greatest among those who were obese -- 49 percent higher than people with a normal weight.

In addition, among obese patients, the risk of heart failure was 53 percent higher, and for stroke 25 percent higher compared to normal-weight patients, the study found.

Death rates in those with type 2 diabetes, however, were lower among obese patients compared to normal-weight patients. But this survival benefit was seen only among the oldest patients while the youngest obese patients had a higher risk of dying, the researchers reported.

For overweight and obese diabetic patients aged 67 and older, the risk of dying was between 18 and 25 percent lower compared to diabetic patients with a normal weight, the study found.

Although the study found associations between being older and having a lower death risk among diabetes patients, it did not establish a cause-and-effect relationship.

"The notion of an obesity paradox, that some degrees of obesity in some people may confer a favorable rather than unfavorable influence on health outcomes and survival, has been much under scrutiny," said Dr. David Katz, director of the Yale University Prevention Research Center.

There are three crucial considerations to make sense of this, Katz said. "First, the current study is limited to diabetics. One of the most important reasons why obesity is harmful to health is because it causes type 2 diabetes. Once a study is limited to diabetics, identifying further, independent harms of obesity may be far-fetched," he said.

Second, doctors know that among elderly patients, losing weight is what people should worry about, Katz said.

"It does not surprise me that in older people, obesity does not appear as harmful as in younger people. Older people who are managing to keep weight on are likely eating better and are potentially less isolated and perhaps just more vital than those who are not," he said.

Finally, a recent study showed more deaths among people who were obese for a greater part of their lifetime, Katz said.

"We should recall that obese people in their 70s now did not grow up in a world of epidemic obesity in childhood. Being obese over decades is very different than just gaining weight later in life," he said.

Because the new study was presented at a medical meeting, the data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

More information

To learn more about obesity, visit the U.S. National Library of Medicine.

25 September - WORLD PHARMACISTS DAY!

At the 2009 Council meeting a the FIP Congress in Istanbul, Turkey, the Turkish Pharmacists Association suggested to annually celebrate a World Pharmacists Day, to be organised on September 25 (the day that FIP was founded in 1912).

This proposal was unanimously accepted by the Council and since 2010, World Pharmacists Day has been coordinated by FIP and celebrated through the involvement of its Member Organisations, either with structured, widespread campaigns or small scale projects. Each year welcomes a new theme to developed to showcase the pharmacist in their positive affect on health.

The theme for 2011 is:

I am your most accessible healthcare provider
I am a driving force behind discovering new medicines
I am the key that unlocks all you need to know about your medicines
I am with you in sickness and in health

I am a Pharmacist

To create a sense of continuum for the project that will carry over to WPD 2012, and in turn support the FIP Centennial Congress (within weeks after WPD 2012), it is proposed that for WPD 2012 FIP and its Members look OUTWARD, and gather quotes, media clips (articles, videos, etc) of those outside the profession (other health professionals, patients, business partners, industry, etc) explaining their relationship with and the value of pharmacists. In essence:

I value my pharmacist

In this way, FIP and its Members gather a vast pool of support just as we lead into the Centennial Congress, also opening opportunities for media attention.

It is the goal that all FIP Member Organisations participate in World Pharmacists Day 2011 and raise the awareness of pharmacists' activities in their country, via national campaigns, and world-wide via the I am a Pharmacist campaign (click here for specific information on how to create your OWN I Am a Pharmacist video!).

Both will serve to educate the public on the invaluable role of the pharmacist in health care, and society in general, and provide content for associated FIP projects.

Clinicians must start Choosing Wisely in antipsychotic prescribing

By Mia Burns (mia.burns@ubm.com)

As part of the Choosing Wisely campaign, the American Psychiatric Association has released a list of specific uses of antipsychotic medications that are common, but potentially unnecessary and harmful in some instances. Choosing Wisely is an initiative of the ABIM Foundation. The list identifies five targeted, evidence-based recommendations that can initiate conversations between patients and physicians about what care is necessary.

The APA list includes five recommendations, which include not prescribing antipsychotic medications to patients for any indication without appropriate initial evaluation and appropriate ongoing monitoring and not to routinely prescribe two or more antipsychotic medications concurrently. In addition, the recommendations state that antipsychotics should not become a first choice to treat behavioral and psychological symptoms of dementia and physicians shouldn’t routinely prescribe antipsychotic medications as a first-line intervention for insomnia in adults. Lastly, the APA says that physicians should not routinely prescribe antipsychotic medications as a first-line intervention for children and adolescents for any diagnosis other than psychotic disorders.

The organization developed the Choosing Wisely list after months of careful consideration and review, using the most current evidence and consensus of expert opinion about management and treatment options. A work group of members from the Council on Quality Care developed a proposed list and solicited input from a broad group of APA members and leadership. The APA Board of Trustees Executive Committee approved the final list unanimously.

“Our cautions cover both typical and atypical (second generation) antipsychotics,” says Joel Yager, M.D. and chair of the APA Council on Quality Care. “Substantial differences exist both in the types of adverse effects associated with specific medications. Individual patients also react very differently to various medications. Therefore, clinicians should always be familiar with both the individual medications and their patients’ vulnerabilities to medications before prescribing.”

Presently, more than 80 national and state medical specialty societies, regional health collaboratives and consumer partners have joined the Choosing Wisely effort promoting conversations about appropriate care. During the next year, more than 30 other specialty society partners will release Choosing Wisely lists.

“These ‘Choosing Wisely’ recommendations urge clinicians to avoid routinely prescribing antipsychotic medications in certain circumstances as an initial treatment when other types of effective treatments with fewer adverse effects are available,” Dr. Yager told Med Ad News Daily. “We hope to reduce initial overprescribing. Of course, it’s never a good idea to prescribe higher dosages than are necessary, but here we’re concerned with reducing the types of situations in which some clinicians might routinely prescribe antipsychotic medications as an initial treatment.”

The recommendations are not intended to prevent the use of antipsychotics. “As clinicians, we know we can improve the care we deliver by engaging our patients in conversations about their care,” said Jeffrey Lieberman, MD, APA President.  “The recommendations from APA released today provide valuable information to help patients and physicians start important conversations about treatment options and make informed choices about their healthcare. This is not to preclude the use of antipsychotic medications for these indications and populations, but to suggest that other treatment options should be considered first and patients should be engaged in discussion of the rationale for use and the potential benefits and risks.”

One of the goals in releasing the recommendations is to promote more consideration among clinicians, says Dr. Yager. “We’re hoping to get clinicians to be more thoughtful about their initial use of antipsychotic medications,” he told Med Ad News Daily. “Every patient receiving an antipsychotic medication should be carefully evaluated and monitored in an ongoing fashion, and before clinicians prescribe antipsychotic medications in any of the circumstances we’ve delineated, they should think carefully about alternatives, and understand that patients and their families deserve to be brought into these decisions.”

APA Releases List of Common Uses of Psychiatric Medications to Question

Nail Fungus Drug Might Help Against HIV, Study Suggests

 A common drug used to treat nail fungus may hold promise against HIV, the virus that causes AIDS, according to a new study.

In laboratory research, the anti-fungal drug Ciclopirox allowed HIV-infected cells to get killed off by blocking the cells' mitochondria -- their powerhouse. In addition, Ciclopirox eliminated HIV from cell cultures, and the virus did not return when the anti-fungal drug was stopped, the study authors said.

This does not occur with currently available anti-HIV drugs, which must be taken for the rest of a patient's life, said study leaders Michael Mathews and Hartmut Hanauske-Abel, of the Rutgers New Jersey Medical School.

The effectiveness of Ciclopirox against HIV needs to be confirmed in human clinical trials. But because the drug is already approved by the U.S. Food and Drug Administration for treatment of fungal infection and is considered safe, the clinical trial process for this treatment could be quicker and less costly than usual, the researchers said.

The study is published in the current edition of the journal PLoS One.

The use of combination antiretroviral drugs have vastly improved HIV treatment, the study authors said in a Rutgers news release. These so-called drug cocktails are effective at keeping HIV under control, but they never completely eradicate the infection.

HIV's persistence is partially due to its ability to disable a cell's so-called suicide pathway, which is normally triggered when a cell becomes infected or damaged.

More information

The U.S. National Institute of Allergy and Infectious Diseases has more about HIV treatment.

SMEs Likely to play important in pharma growth story

The small and medium enterprises (SMEs) are expected to play a significant role in the growth story of the country's pharma sector as they contribute 35-40 per cent to the industry in terms of production with a turnover of about Rs 35,000 crore.

"Small and medium scale units have played a crucial role in the growth story of the Indian pharmaceutical industry and form an integral part of the sector," India Micro, Small and Medium Enterprise Report 2013 said here.

It added: "The Indian pharmaceutical industry is highly fragmented and estimated to have 9,456 units in the SME segment, which account for around 87 per cent in production by volume and 40 per cent by value."

Exports of pharmaceuticals products from India increased from USD 6.23 billion in 2006-07 to USD 8.7 billion in 2012-13, a combined annual growth rate of 21.25 per cent.

The Ministry of Commerce has targeted Indian pharma sector exports to reach USD 25 billion by 2014 at an annual growth rate of 25 per cent.

In terms of number of units and employment generation, the SME sector is at the forefront. They also support 48 per cent of the country's pharma exports, the report said.

The country's pharmaceutical sector derives its strength from the SME sector, as it forms an essential part of the supply chain for the larger players.

There are more than 24,000 registered units, which meet 70 per cent of the country's needs. Clearly, MSMEs operating in the domestic pharma sector are recognised as the backbone of the industry.

By and large, they operate in the local market, and mainly manufacture formulations which relate to medicines of mass consumption and therefore have a huge market. To a great extent, survival of these units would depend on how well and quickly these companies are able to adapt to the changing business scenario, the report said.

USFDA issues import alert on Ranbaxy Laboratories' Mohali plant

In yet another setback to Ranbaxy Laboratories, the US Food and Drug Administration (FDA) has issued an import alert on drugs produced by the company at its Mohali plant in Punjab, for violation of current good manufacturing practices.

According to the company's website, the Mohali plant produces oral solids in dosage form.

While the US health regulator did not specify details for issuing the alert, it said "detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's)".

According to information available on the regulator's website, the import alert, dated September 13, will cover all 'drugs and drug products' produced by the company at the Mohali plant.

In May this year, Ranbaxy had pleaded guilty to "felony charges" relating to manufacture and distribution of certain 'adulterated' drugs made at two units in India and agreed to pay $500 million to US authorities as penalty.

FROM OUR ARCHIVES Long way to go before Ranbaxy regains lost faith Ranbaxy has very high credibility even today: CEO Ranbaxy is not a lemon, it's a fantastic company, says former owner

This followed a series of action taken by the USFDA, which in 2008 banned import of 30 generic drugs produced by Ranbaxy at its Dewas (Madhya Pradesh) and Paonta Sahib (Himachal Pradesh) plants for violation of manufacturing norms.

The development had led to a hospital and a pharmacy chain in India to issue advisory against the company's drugs.

The company had admitted to past "shortcomings" but said it has rectified those and insisted that its drugs were safe and efficacious. It had also offered to co-operate fully with any regulator from anywhere in the world wanting to investigate its manufacturing practices.

On the latest warning, a Ranbaxy spokesperson said: "We have so far not received any communication from the USFDA on this subject. We are seeking information from the USFDA in this regard."

Shares of Ranbaxy Laboratories were trading at Rs 332.85 in the afternoon trade, down 27.21 per cent from its previous close, on the Bombay Stock Exchange.

With inputs from PTI

Healthy Lifestyle May Reverse Cellular Aging, Study Suggests

 
 Healthy behaviors such as exercise, good diet and stress management have the potential to reverse aging on a molecular level and partly restore the vitality of a person's cells, according to a new pilot study.

Healthy lifestyle choices can increase the length of DNA sequences found at the end of a person's chromosomes, said lead author Dr. Dean Ornish, founder and president of the nonprofit Preventive Medicine Research Institute in Sausalito, Calif.

What's more, the healthier you live, the stronger your chromosomes become, the researchers said in the Sept. 17 online issue of the journal The Lancet Oncology.

"We may be able to reverse aging on a cellular level," said Ornish, a best-selling author who advocates a lifestyle-driven approach to improve health and combat disease. "Our bodies are much more dynamic than we had once recognized, and the more you change at any age the more you can improve."

But one geneticist cautioned that the study findings are preliminary, and raised several unanswered questions

The DNA sequences, known as telomeres, directly affect how cells age and have been associated with an increased risk of premature death and age-related diseases. As telomeres become shorter and their structural integrity weakens, cells age and die faster.

Shorter telomere length has been tied to unhealthy behaviors such as cigarette smoking, chronic emotional stress and poor diet, Ornish said, as well as diseases including cancer, cardiovascular disease, dementia, obesity, stroke, osteoporosis, infectious diseases and diabetes.

"They're sometimes likened to the plastic tips on the end of shoelaces that keep your laces from unraveling," Ornish said of telomeres. "In this case, they keep your chromosomes from unraveling."

Previous research has shown that adopting a healthy lifestyle can provide many medical benefits, including reversal of heart disease progression. The researchers said, however, that this is the first study to show that the benefits of healthy living may extend down to a person's cellular genetics.

"If validated by large-scale randomized controlled trials, these comprehensive lifestyle changes may significantly reduce the risk of a wide variety of diseases and premature mortality," Ornish said. "Our genes -- and our telomeres -- are a predisposition, but they are not necessarily our fate."

The five-year study focused on two small groups of men diagnosed with low-risk prostate cancer that had not been treated. Ten men were asked to make comprehensive lifestyle changes, while a control group of 25 men maintained their personal status quo.

The lifestyle changes focused on four main areas, Ornish said:

• Eating right. Adoption of a whole-food, plant-based diet that was low in fat and processed carbohydrates.
• Moderate exercise. Thirty-minute walks six days a week.
• Stress management. Participation in meditation, yoga and other relaxation techniques for an hour a day.
• Social support. Attendance at an hour-long support-group meeting once a week.

The researchers took blood samples and measured the length of the participants' telomeres at the start of the study, and again after five years.

The men who made comprehensive lifestyle changes experienced an average 10 percent increase in their telomere length. Men in the control group had their telomeres shrink an average of 3 percent.

Further, there appeared to be a relationship between the "dose" of lifestyle change and the body's response -- the more positive lifestyle choices someone made, the longer their telomeres grew.

"Our bodies in general have a remarkable ability to heal if we simply stop what we're doing," Ornish said. "I've been impressed by how dynamic these mechanisms are and how quickly people can get better."

The pilot study's results are promising, but need to be replicated in a large, randomized trial, said Joseph Lee, a human geneticist and associate professor of clinical epidemiology at the Columbia University Mailman School of Public Health in New York City.

"The participants in the intervention group were highly motivated, as they maintained the intervention regimen for more than five years and they continued to attend meetings when the meetings were not required," Lee said. "One needs to be cautious as to how effective lifestyle changes will be in a large general population where the level of motivation may not be so high."

Lee also regretted that the researchers didn't check health traits such as weight, body-mass index or blood pressure along with the length of the patients' telomeres.

"For example, if the participants in the intervention group with longer telomere length had lower blood pressure, it would have been far more interesting," Lee said. "Even though it may not have been significant statistically due to small sample size, it would have been informative."

The study was not intended to gauge whether lifestyle changes slowed progression of prostate cancer.

Shortage-of-yellow-fever-vaccine has now taken care by GOVT........

At present, there is no shortage of yellow fever vaccine in the country. A total of 6000 ten dose vials of yellow fever vaccine were supplied to various centres all over the country during July, 2013. Earlier, there was a shortage of supply of yellow fever vaccine from CRI, Kasauli. Accordingly, the yellow fever vaccination centres were advised that the travellers traveling to yellow fever affected countries were to purchase single dose yellow fever vaccine vials (manufactured by Sanofi Pasteur) from the open market and receive the vaccination and vaccination certificate from Government authorized yellow fever vaccination centres.
In view of the threat of importation of yellow fever in India, WHO consultation was held in Goa during March, 2011. The WHO recommended continuing existing mechanism of surveillance and quarantine, vector control and building capacities for enhancing diagnostic facilities in the country.
Govt. of India has specific measures in place at Ports of Entry (POEs) for surveillance against introduction of yellow fever into country (including via air travel) as below:
• Travellers: all the travellers who have either traveled to yellow fever affected countries or have transmitted through affected countries are required to possess valid yellow fever vaccination certificate.
• All the incoming international conveyances (ships / aircrafts) are required to submit proof of recommended dis-infection measures for the aircraft.
No such information regarding people obtaining Fake yellow fever vaccination certificates to fly to affected countries has been received.
Following measures have been taken by the Government to make the vaccine available in the country:
1. Emergency procurement of 60,000 doses of yellow fever vaccine from Sanofi Pasteur during the month of April, 2013. The vaccine was delivered during mid-July, 2013 and has been immediately distributed to all the vaccination centers in the country.

2. Government supply order for supply of 2.57 lac doses has been placed with WHO during 2013. The first consignment of 1,28,530 doses has been received at CRI Kasauli. The remaining quantity is expected to be delivered in 4th Quarter of F/Y 2013-14.

Pharma industry hit by worst slowdown in the domestic market for the month of August

The Indian pharma industry, while being on a roll due to the higher export realisations due to the weaker rupee, has suffered badly in the domestic market. According to the latest data released by market research firm AIOCDAWACS, the domestic pharma market grew by mere 1.1% for the month of August, which is a record low for the industry. The last low growth experienced in the market was recorded in November 2012 at 4.3%.

One of the major reasons for the slowdown seems to be the de-stocking done by the trade and companies due to the uncertainty surrounding the implementation of the new drug pricing control order (DPCO). This is evident from the fact that according to the data, the growth of the DPCO portfolio of products dropped by 12.3% whereas the non-DPCO product market grew by 3.3% resulting in an overall growth of 1.1% for the month of August 2013.

The closing stock level, measured as on 10th of every month, stood at 38.8 days as on 10th of April. It however fell to 22.1 days in September 2013. The DPCO 2013 portfolio for GSK Pharma degrew by 30.4% and Ranbaxy degrew by 21.1, whereas Sun Pharma had the least impact with its DPCO 2013 portfolio degrowing at 1.7.

However, the trade-related disruptions ahead of implementation of new drug pricing policy are not the only reason for the slowdown. According to AIOCD, not only value, the market has witnessed drop in volumes too in both the DPCO and non-DPCO categories. This indicates the continuance of the slowdown trend in drug off-take, especially in the acute therapies - a phenomenon seen since more than a year now.

For the month of August 2013, amongst the top 10 companies, Sun Pharma registered the highest growth of 14.9%, Alkem 5.9% and Cipla 4.9%. The multinational drug companies figured among the worst performers with GSK Pharma witnessing a drop of 17.6%, Pfizer of 8% and Abbott 4.6%.

Indian drugmakers draw more FDA scrutiny as US imports rise

US inspectors visiting a factory in India owned by drugmaker Wockhardt in March found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six metres from the entrance to a sterile manufacturing area. And when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined, according to a July 18 letter from the US Food and Drug Administration (FDA) to Wockhardt, which makes sterile injectable drugs and various forms of insulin.

Habil Khorakiwala, chairman of Wockhardt, last week told shareholders that the problem at its Waluj plant "is an inexcusable lapse, but we have taken swift and definitive action, both corrective and pre-emptive," including appointment of a new quality chief and hiring of outside consultants.

India's drugmakers, battered by a rash of US regulatory rebukes, including a record fine for Ranbaxy Laboratories Ltd , face closer FDA scrutiny as the agency ramps up its presence in the country.

Increased on-the-ground oversight reflects India's growing importance as a supplier to the United States, and should ultimately bolster quality and confidence in Indian-made drugs.

In March, India allowed the FDA, guardian of the world's most important pharmaceuticals market, to add seven inspectors, which will bring its staff in India to 19. India produces nearly 40 per cent of generic drugs and over-the-counter products and 10 per cent of finished dosages in the United States.

"As more trade happens, as more drugs are approved and applications are submitted we will have to inspect more," Altaf Lal, the new FDA office director for India, told Reuters.

"Many Indian firms fairly well understand and they know good manufacturing practices. The problems we have seen with some companies are why we choose to make quality as one of our highest priorities," he said.

The FDA's stepped-up presence should also accelerate what some in the domestic industry hope is a more rigorous attitude towards compliance in a country whose cheap generics have made it the low-cost pharmacy to the world.

In the near term, it means Indian drugmakers could be more frequently hit by enforcement measures or inquiries, unnerving investors.

RANBAXY'S SHADOW

Shares of Ranbaxy, controlled by Japan's Daiichi Sankyo Co , fell as much as 42 per cent in the months after it pleaded guilty in May to US felony charges related to drug safety and agreed to $500 million in fines.

Ranbaxy, India's biggest drugmaker by sales, remains barred from making US shipments from its plants at Dewas and Paonta Sahib. Ranbaxy has said the implementation of a consent decree it signed in January 2012 with the FDA to restart shipments has "progressed as per plan".

While Ranbaxy shares have recovered, the case put a cloud over the industry.

"We all know how Indian companies function and issues such as Ranbaxy and other import alerts have brought us a very bad reputation globally," said Ajay Kumar Sharma, director of research at the Organisation of Pharmaceutical Producers of India.

The urgency to be first with a generic version of a drug coming off patent is the main reason for quality problems, Sharma said. The company that first launches such a drug enjoys a 180-day exclusivity period, which can be lucrative for the generic version of a commercial blockbuster.

"We need to be sincere towards quality issues rather than following procedures just for the sake of it," said Sharma. "We are doing things fast but then losing out on certain aspects and facing import alerts."

INSPECTIONS AND VOLATILITY

Wockhardt's once-soaring shares fell as much as 79 per cent in the months after the announcement of an "import alert" banning shipments from the Waluj factory in May. By the middle of this week, the stock was down nearly 59 per cent.

On July 31, Strides Arcolab shares fell as much as 17 per cent on worries over FDA scrutiny of its manufacturing practices, although the Indian company said on that day that it had answered the FDA's queries, made in a so-called form-483 letter, and continued to make US shipments. Its stock has more than recovered.

The FDA's power cuts both ways. Last week, IPCA Laboraties shares gained 7.6 per cent on the day it said the FDA had cleared its oral solid formulations plant in Indore for US shipments. In November, IPCA had voluntarily reported "non-conformances" at the plant to the FDA.

"More inspectors initially could mean some more enforcement actions, but eventually that would end up meaning even fewer enforcement actions going forward," said Macquarie analyst Abhishek Singhal.

OBAMACARE AND EXPORTS

India is the biggest overseas source of medicines to the United States and is home to over 150 FDA-approved plants, including facilities run by global players. Pharmaceutical exports from India to the United States rose nearly 32 per cent last year to $4.23 billion.

As US demand for generics grows, especially under President Barack Obama's healthcare programme, the FDA is under pressure to clear product applications while ensuring quality.

New US legislation requires the agency to inspect global plants on the same schedule as domestic facilities, and to clear its backlog of drug applications within five years. Indian firms account for more than one-third of US drug approval filings.

Lupin was the top Indian drug seller in the US market last year by prescriptions, followed by Dr. Reddy's Laboratories, Cadila Healthcare and Aurobindo Pharma, according to IMS Health. All have had past FDA run-ins.

Many in India note that drugmakers globally, including in the United States and Europe, have also run afoul of increasingly stringent FDA inspection.

"When you are such a major player for the US market, you will also have larger number of inspections," Ranbaxy CEO Arun Sawhney said in June.