“Personalised treatment for diabetes is the future”

Personalised therapy for diabetes is the way forward, says William T.Cefalu, editor-in-chief, Diabetes Care, an international peer-reviewed journal of the American Diabetes Association.

“We have, at our disposal, many new drugs. The thing now, is how do we personalise therapy? ” Dr. Cefalu asks. “There is no one set way to treat every patient, instead we must be treating every patient individually. Based on the duration of the disease, ability to detect hypoglycaemia [low sugar], adherence to treatment protocols, and compliance, we can work out treatment strategies for each patient, depending on his co-morbid conditions,” he tells The Hindu in an interview, during his recent brief visit to Chennai.

Dr. Cefalu, who is also Chief, Endocrinolgy, Diabetes and Metabolism, Louisiana State University Health Sciences Center, New Orleans, stresses the urgency in diagnosing the condition early. “Diabetes is a progressive disease, and pre diabetes is associated with obesity, and it is important to recognise it early. It is the complications we are concerned about: blindness, cardio vascular disease, kidney disease,” he says. It is important first and foremost because of the huge burden on society, and as far as the costs of treating diabetes goes, takes a toll on the finances and emotions of the patient and his/her family.

Dr. Cefalu was in Chennai to deliver the 21st Dr. Mohan’s Diabetes Specialties Gold Medal Oration. His advice is to professionals to go at diabetes with all guns blazing. “The evidence is pretty clear: tackling glucose control and risk factors aggressively definitely have a good effect,” he says, countering critics who accuse diabetologists of ‘over-treating’ the condition. While, at the pre-diabetes stage, it is possible to prevent progression into diabetes, it is also possible to prevent complications that can oftentimes be fatal.

Focussing on the key question of the play of environment and genes in causing diabetes, Dr. Cefalu is very clear that lifestyle does play a major role. Of late, diabetologists have noticed an increase in childhood obesity and, Type 2 diabetes among this group, he adds. “Diabetes in children may be in a little more aggressive form. What is appropriate for them? As children grow and mature, it becomes difficult assessing the right balance.” However, advocating for a healthy lifestyle – diet and packing greater activity into a day is important.

In addition to new drugs, a lot of exciting new possibilities await the future of treatment of diabetes, Dr. Cefalu says. “A lot of work is happening in the area of islet cells transplants; some procedures have been done. The other exciting area is in artificial pancreas, where there has been significant progress. Also, the questions of what we do with bariatric surgery and at what point we intervene will be decided over the next few years.”

Antipsychotics tied to diabetes in kids and teens

By Andrew M. Seaman

NEW YORK (Reuters Health) – Children and young adults who are prescribed antipsychotic drugs have a three-fold risk of developing diabetes, compared to youths who take other psychotropic drugs, suggests a new study.

The study’s senior researcher said the findings should give doctors pause before prescribing antipsychotics to children and teens.

“If it turns out that the child does ultimately need an antipsychotic, they should be carefully monitored for metabolic effects and the dose should be as low as possible for the shortest amount of time,” Wayne Ray, a health policy researcher at Vanderbilt University in Nashville, told Reuters Health.

Antipsychotics include Risperdal, known generically as risperidone, Zyprexa (olanzapine), Seroquel (quetiapine) and Abilify (aripiprazole).

The drugs are used to treat conditions like bipolar disorder, schizophrenia and irritability and aggression in children with autism.

Ray and his colleagues cannot prove the drugs caused diabetes, but their study adds to growing evidence linking antipsychotics to the development of obesity, insulin resistance and type 2 diabetes.

In 2011, a large study from the University of Massachusetts found kids who took antipsychotic drugs were four times more likely to develop diabetes than their peers who were not taking the medications (see Reuters Health story of November 22, 2011 here: http://reut.rs/MtH5dB.)

Also that year, a U.S. Food and Drug Administration advisory board raised concerns about the drugs and urged the agency to monitor weight gain and other metabolic diseases in children taking antipsychotics (see Reuters story of September 22, 2011 here: http://reut.rs/MtHCwe.)

And last year, a study found that the number of antipsychotic drugs prescribed to kids and teens during psychiatric visits in the U.S. has almost quadrupled since the 1990s (see Reuters Health story of August 7, 2012 here: http://reut.rs/1avkoQw.)

For the new study, Ray and his colleagues used records from Tennessee’s Medicaid program to compare the number of type 2 diabetes cases diagnosed among children and teens that were prescribed antipsychotics to the number of cases among young people prescribed other psychotropic drugs, such as antidepressants and stimulants.

Specifically, the researchers focused on children who were prescribed antipsychotic drugs for conditions that can be treated with other medicines, such as attention-deficit/hyperactivity disorder or mood disorders.

Overall, they had data on 28,858 young people between the ages of six and 24 who were prescribed antipsychotics between 1996 and 2007, and 14,429 children and teens prescribed other psychotropic drugs during that time.

Among those taking antipsychotics, the researchers found 92 cases of type 2 diabetes during an average of just over one year, compared to 14 cases among those taking other medications. That works out to about a three-fold increased risk among those prescribed antipsychotic drugs, according to findings published in JAMA Psychiatry.

The increased risk seemed to show up during the first year of treatment and persisted for at least one year after the kids and teens stopped using the drugs.

“We found that the risk was increased in the first year of use so that would suggest caution even with relatively short term use,” Ray said.

That is one of the findings that stood out to Dr. Jonathan Mink, a child neurologist at the University of Rochester Medical Center in New York.

“I think there is a belief among many prescribing physicians that short term use is safe. It does seem the cumulative use over time increases the risk, but even (with one year of treatment) the risk is significantly higher,” Mink, who wasn’t involved with the study, said.

He added that it’s also important to note the children taking antipsychotics were very closely matched to those taking other medications, which would partially eliminate the effect of obesity on the results.

“I don’t think anyone knows the mechanism yet, but we have the evidence to believe it’s real,” Mink told Reuters Health.

Ray said more research is needed to know which treatments besides antipsychotics are best for specific conditions in childhood.

“I think that there is a lot of work to be done defining the best therapy option in children with mental disorders,” he said.

SOURCE: http://bit.ly/1d7NSVN JAMA Psychiatry, online August 21, 2013.

Avanir Pharma to co-promote Merck's diabetes drugs; shares rise


Mon Aug 12, 2013 5:42pm EDT

(Reuters) – Avanir Pharmaceuticals Inc said it signed a three-year agreement with Merck Co Inc to co-promote Merck’s multibillion-dollar drugs to treat Type 2 diabetes.

Avanir shares rose 11 percent in extended trading after closing at $4.50 on the Nasdaq.

The company said its salesforce will promote Januvia, Janumet and Janumet XR in long-term care facilities such as nursing homes and skilled nursing facilities in the United States from October.

Avanir said in a regulatory filing that it could get up to $60 million from Merck over the three years, from a fixed monthly fee and performance fee.

“I think it’s impressive to sign a deal with Merck and obviously, it’s not going to cost them very much and it’s going to help them get to profitability,” Summer Street Research analyst Carol Werther told Reuters.

“The agreement is just for long-term care centers, which is where a lot of their sales force is right now and where they’ve been most successful.”

Merck recorded $4.09 billion in sales from Januvia and $1.66 billion from Janumet in 2012, according to a regulatory filing dated February 28.

(Reporting By Vrinda Manocha in Bangalore; Editing by Maju Samuel)

FDA serves bitter pill to alternative diabetes treatment

Separately, in a case unrelated to diabetes crackdown, the Indian pharma major Wockhardt was also issued a notice for a range of violations, from manufacturing defects and poor training of personnel to inadequate toilet facilities.

“Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer,” the July 18 letter warned Wockhardt chairman Habil Khorakiwala, accusing the company of impeding FDA inspectors at its Aurangabad plant.

Wockhardt joins Ranbaxy, Sun Pharma, RPG Life Sciences among Indian drug companies that have come under FDA scrutiny for violations that range from poorly trained personnel, to dodgy record keeping, to stinky toilets.

But it was the diabetes medication crackdown that sent shock waves through the industry, because the market for alternative diabetes remedies has grown hugely in the past decade. Sales of diabetes medication has increased 60 per cent — from $14 billion to $22 billion — in the last four years alone, as the world, from developed countries such as U.S to developing nations like India, have gotten sucked into a sugar-starch overdose.

There are some 30 million diabetes patients in the U.S and upward of 60 million in India (out of a world total of 300 million diabetes victims), making the two countries a lucrative market for western Big Pharma. Increasingly, diabetes patients are looking for alternative remedies, but the FDA clearly disapproves that route.

“Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments. Consumers who buy volatile products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management,” FDA Commissioner Margaret A. Hamburg said in a statement.

Medications cited in the ban order included unapproved versions of metformin and Januvia, which is procured from India and sold online in the U.S., and Diexi, manufactured by Amrutam LifeCare of Surat. Amrutam was also cited for dodgy claims with regards to supplements such as Zoom (for erectile dysfunction), Arexi (for arthritis) Allexi (for allergy), Cholexi (for cholesterol control), and Obexi (for obesity).

The FDA letter said some of these drugs may pose serious health risks because patients with underlying medical issues may take it without knowing that it can cause serious harm or interact in dangerous ways with other drugs.

For example, the letter to Amrutam said, “By marketing your products ‘Diexi’ and ‘Zoom’ as ‘all-natural,’ ‘safe and effective’ treatments with ‘no chemically generated compounds,’ consumers are misled to believe your products do not bear unknown risks nor contain APIs found in approved prescription drugs. Accordingly, the failure to disclose the presence of metformin and sildenafil renders these products’ labeling false and misleading.”

FDA serves bitter pill to alternative diabetes treatment

WASHINGTON: The US Food and Drug administration has cracked down on what are widely considered alternative or natural treatment for diabetes, including ayurvedic and homeopathic remedies. Fifteen companies in the US, including some that procure alternative diabetes medications from India, have been served warning letters by the FDA, asking them to stop sale in the US of products claiming to treat, cure, and prevent diabetes.

Separately, in a case unrelated to diabetes crackdown, the Indian pharma major Wockhardt was also issued a notice for a range of violations, from manufacturing defects and poor training of personnel to inadequate toilet facilities.

“Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer,” the July 18 letter warned Wockhardt chairman Habil Khorakiwala, accusing the company of impeding FDA inspectors at its Aurangabad plant.

Wockhardt joins Ranbaxy, Sun Pharma, RPG Life Sciences among Indian drug companies that have come under FDA scrutiny for violations that range from poorly trained personnel, to dodgy record keeping, to stinky toilets.

But it was the diabetes medication crackdown that sent shock waves through the industry, because the market for alternative diabetes remedies has grown hugely in the past decade. Sales of diabetes medication has increased 60 per cent — from $14 billion to $22 billion — in the last four years alone, as the world, from developed countries such as U.S to developing nations like India, have gotten sucked into a sugar-starch overdose.

There are some 30 million diabetes patients in the U.S and upward of 60 million in India (out of a world total of 300 million diabetes victims), making the two countries a lucrative market for western Big Pharma. Increasingly, diabetes patients are looking for alternative remedies, but the FDA clearly disapproves that route.

“Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments. Consumers who buy volatile products that claim to be treatments are not only putting themselves at risk but also may not be seeking necessary medical attention, which could affect their diabetes management,” FDA Commissioner Margaret A. Hamburg said in a statement.

Medications cited in the ban order included unapproved versions of metformin and Januvia, which is procured from India and sold online in the U.S., and Diexi, manufactured by Amrutam LifeCare of Surat. Amrutam was also cited for dodgy claims with regards to supplements such as Zoom (for erectile dysfunction), Arexi (for arthritis) Allexi (for allergy), Cholexi (for cholesterol control), and Obexi (for obesity).

The FDA letter said some of these drugs may pose serious health risks because patients with underlying medical issues may take it without knowing that it can cause serious harm or interact in dangerous ways with other drugs.

For example, the letter to Amrutam said, “By marketing your products ‘Diexi’ and ‘Zoom’ as ‘all-natural,’ ‘safe and effective’ treatments with ‘no chemically generated compounds,’ consumers are misled to believe your products do not bear unknown risks nor contain APIs found in approved prescription drugs. Accordingly, the failure to disclose the presence of metformin and sildenafil renders these products’ labeling false and misleading.”

Merck's $5.7 Billion Diabetes Franchise Vulnerable

A retrospective analysis published by the BMJ supports previously published findings that diabetic patients taking drugs which target the incretin system to control their blood sugars are at greater risk for developing pancreatic problems, such as acute pancreatitis and pancreatic cancer. Could certain big pharma manufacturers be vulnerable to a price collapse, should European and U.S. regulators – whom are now actively reviewing data on adverse events – move to restrict usage or outright remove these therapies from the market due to questionable safety?

MRK Total Return Price Chart

MRK Total Return Price data by YCharts

Incretin-based therapies, such as GLP-1 agonists and dipeptidylpeptidase-4 (DDP-4) inhibitors, mimic the glucose regulating role of intestinal hormones. As they carry a lower risk of hypoglycemia and have observed weight-loss properties, the two drug classes have readily been adopted by physicians for treating type-2 diabetes, with several drugs rapidly growing annual sales in the estimated $40 billion market for diabetes control medications.

MRK Revenue Annual Chart

MRK Revenue Annual data by YCharts

As Merck (MRK) looks to reset its revenue base due to patent losses, its DDP-4 inhibitor, Januvia (sitagliptin), remains critical to its financial health. In FY 2012, global sales of the combined diabetes franchise of Januvia/Janumet (which contains the popular type-2 diabetes drug metformin) grew 23% to $5.7 billion, primarily driven by growth in the United States and Japan. A global ban would wipe out more than 12% of the drug maker’s annual sales!

Though Novartis’ (NVS) DDP-V inhibitor Galvus delivered 34% growth in 2012, its $910 million in sales accounted for less than 2% of the $57 billion in annual drug sales. The Swiss-based company’s growth engines are fueled by oncology and neuroscience drugs, such as Gleevec and Gilenya (multiple sclerosis).

The consumer advocacy group Public Citizen has petitioned the FDA to remove Novo Nordisk’s (NVO) Victoza (liraglutide). Albeit the Danish-based drug maker derives almost 10% of annual sales from this GLP-1 agonist, the current safety debate could actually benefit the company: Insulin products generated almost 60% of the $11.7 billion in drug revenue last year; and, with a global insulin market share of more than 47%, any move back to mainstream diabetic treatment would likely more than offset lost sales from Victoza.

In addition to lost sales, all drug makers of incretin mimetics, including the newer DPP-4 inhibitors – Tradjenta (linagliptin) from Eli Lilly (LLY) and Nesina (alogliptin) from Takeda – will need to put aside reserves due to the possibility of multi-million dollar injury settlements (class action lawsuits are being filed).

David J. Phillips, a contributing editor at YCharts, is a former equity analyst. His journalism has appeared in Bloomberg BusinessWeek, Forbes, and Kiplinger’s Personal Finance. From 2008 to 2011, David was a reporter for CBS News Interactive. He can be reached at editor@ycharts.com. You can also request a demonstration of YCharts Platinum.

Qsymia and Belviq Drugs for Obesity, Weight Loss | Psych Central

Qsymia and Belviq Drugs for Obesity, Weight LossIf you’re obese and are at the end of your ropes looking for weight loss help, there’s good news from the U.S. Food and Drug Administration (FDA). The FDA in the past few months has approved two new weight loss drugs for people who struggle with obesity — Qsymia and Belviq.

It should be noted up-front that these drugs are meant for people who are obese — those with a BMI number 30 or greater. While doctors often prescribe drugs for conditions not specifically approved by the FDA (called “off-label” use), doctors are likely to be more conservative in prescribing these two drugs when they first become available because of their unfamiliarity with them.

Both drugs can also be prescribed to people who are overweight, with a BMI of 27 or more and at least one weight-related condition such as type 2 diabetes, high blood pressure, or high cholesterol.

Qsymia (pronounced kyoo-sim-EE-uh and manufactured by Vivus Pharmaceuticals) and Belviq (pronounced bel-VEEK and manufactured by Arena Pharmaceuticals) have been shown to be effective in their clinical trials to help people lose significant amounts of weight.

Qsymia appears to be the more effective weight loss medication. People taking Qsymia for up to one year had an average weight loss of nearly 9 percent over those taking an inactive placebo. Over 70 percent of people taking Qsymia lost at least 5 percent of their body weight (only 20 percent of patients taking an inactive placebo lost this much weight).

People taking Belviq had an average weight loss that was 3 to 3.7 percent greater than people taking placebo. After taking Belviq for one or two years, some 47 percent of people without diabetes lost at least 5% of their body weight (only 23 percent of patients taking an inactive placebo lost this much weight.)

Although likely to be expensive, both weight loss drugs will likely be approved by insurance companies for treatment of obesity or being overweight with other health conditions. Why? Because obesity is a serious chronic health problem affecting more than one-third of U.S. adults (35.7 percent), according to the U.S. Centers for Disease Control and Prevention. As such, it costs insurers a lot of money. In 2008, medical costs associated with obesity were estimated at $147 billion. Anything to bring those costs down is likely to become approved for payment by insurance companies.

How Do Qsymia and Belviq Work?

Qsymia combines two generic drugs in a new formulation. One half the drug is composed of the seizure and migraine medication called topiramate. Topiramate causes weight loss in several ways, including increasing feelings of fullness, making foods taste less appealing, and increasing calorie burning. The other half of Qsymia is the appetite-suppressant called phentermine. Phentermine is thought to suppress appetite by triggering release of a brain chemical that increases blood concentrations of the appetite-regulating hormone leptin.

Belviq, on the other hand, appears to work by turning on a specific chemical “switch” in the brain that increases levels of serotonin. It’s not clear exactly why this helps a person lose weight.

Who Can’t Take These Drugs?

As with all medications, certain people cannot take these medications.

  • Pregnant or nursing women should not take either Belviq or Qsymia.
  • Qsymia:
    • People with glaucoma
    • People who have been told they have an overactive thyroid
    • People taking a type of antidepressant called a MAOI
    • People allergic to phentermine or topiramate
  • Belviq:
      People taking drugs linked to valvular heart disease, such as cabergoline (Dostinex)

    • People taking certain medicines for depression; migraine; the common cold; or mood, anxiety, psychotic, or thought disorders
    • Men with conditions that predispose them to erections lasting more than four hours. These conditions include sickle cell anemia, multiple myeloma, and leukemia
    • Men with a deformed penis

When Can I Get Them?

Qsymia will be available sometime after September 2012, while Belviq won’t be available until early-to-mid 2013.

As with any medication, talk to your doctor to see if this medication may be right for you. Tell your doctor if you are on any other medications, nutritional supplements (including vitamins), pregnant, nursing, or have any other health condition.


 

John Grohol, PsyDDr. John Grohol is the founder CEO of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues — as well as the intersection of technology and human behavior — since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.

Scientifically Reviewed
    Last reviewed: By John M. Grohol, Psy.D. on 30 Jan 2013
    Published on PsychCentral.com. All rights reserved.

 

After ban on diabetes drug, patients rush to doctors with questions

City doctors are receiving anxious calls from diabetic patients worried about ban on anti-diabetic drug pioglitazone.

“Pioglitazone is a good drug. The only issue is that it should be used with certain restrictions,” said Dr KP Singh, senior consultant, endocrinology, Fortis Hospital, SAS Nagar.He said, “It is an affordable drug, which is at least 10 times cheaper as compared to other medicines of similar nature. So we were prescribing it quite commonly.”

Following the ban, now Dr Singh is getting 30-40 queries every day from his patients regarding the medicine.

The medicine, Dr Singh said, should not be used for patients suffering from urinary bladder cancer, heart problems, kidney failure.  “The patients are now left with the option to either switch to insulin or opt for costlier yet less effective drugs,” Dr Singh said.According to experts, Pioglitazone is the second and third line of treatment for Type 2 diabetes and is one of the commonly prescribed medicines for the treatment.

According to the data available, over 30-lakh diabetes patients across the country were on pioglitazone drug banned last week. The union health ministry had issued a notification announcing the ban on June 18.

Along with pioglitazone, two other drugs – analgin (painkiller) and deanxit (anti-depressant) – were also banned due to alleged health risks associated with the drugs.Doctors complained that the Indian government relied on foreign data which links urinary bladder cancer with the intake of pioglitazone.

Some doctors allege that scientific evidence was ignored before banning the drug and that its benefits outweigh the risk factors.

However, Dr RJ Dash, considered a pioneer in endocrinology in the country, believes that it was a right decision to ban the medicine. “When it is established that there are serious side effects of the medicine then there is no question of continuing the sale of medicine,” Dr Dash said.

He said some general physicians were using this medicine mindlessly without knowing its side effects, so it was right to stop the sale of this medicine.

 

Diabetes drug ban to help some companies

MUMBAI: In the wake of a government ban on top-selling diabetes drug, pioglitazone, the volumes are expected to shift to other classes such as first-generation drugs (combination of glimepiride and metformin) and newer class of drugs, ‘gliptins’, as well as insulins, even as domestic companies are protesting the ban and examining all options, including legal recourse.

With the shift to other treatments, companies like Sun Pharma, USV, Glenmark, Sanofi-Aventis and Lupin will benefit from the move, analysts say. The combination of glimepiride and metformin is the largest selling product in the anti-diabetic segment, valued at Rs 823 crore (MAT May 2013, AIOCD AWACS). The oral anti-diabetic market is estimated at Rs 3,550 crore, while insulins are around Rs 1,100 crore. Pioglitazone, sold by USV, Sun Pharma, Abbott Healthcare, Micro Labs and Lupin, corners around 20%, or over Rs 700 crore of the market.

The biggest beneficiary will be the combination of glimepiride and metformin drugs marketed by USV, Sun Pharma and Lupin. USV clocks nearly Rs 160 crore through this combination drug, while Sun Pharma mopped up Rs 90 crore and Lupin Rs 70 crore.

The relatively new class of diabetes drugs, gliptins, manufactured by Sun Pharma and Glenmark, will also benefit from the volume switch while Lupin will benefit from its brand presence in insulin, an analyst from Nomura said.

In terms of costs for patients prescribed glimepiride plus metformin, there will be some savings as the combination drug (Rs 4-5) is slightly lower than the combination of pioglitazone with glimepiride plus metformin (Rs 5.3).

Technically, a shift to gliptins makes sense but there are supply constraints as the product is patented, as well as expensive, with costs at three to six times those of pioglitazone combination therapy, he added.

Surprised by the government’s move to ban pioglitazone, the industry is protesting the move. Indian Pharmaceutical Alliance secretary-general DG Shah told TOI: “We are examining all options as the process has not been complied with the established norms and the decision to suspend production and marketing with immediate effect has put lakhs of diabetic patients to risk.”

Suspension of anti-diabetes drug takes industry by surprise

The move by the Ministry of Health and Family Welfare to ‘suspend’ a diabetes treatment drug, pioglitazone, and its combinations has perplexed the pharmaceutical industry. The move follows reports of its suspected links to increased risk of cancer and heart failure.

While the drug is banned for sale in France, it sells in the U.S. and Europe with a cautionary note in the packing. The product has been sold in the U.S. since 2000, and in India since 2001.

Thiazolidinediones are referred to as glitazones, and are insulin-sensitizer drugs. The only Thiazolidinedione available is pioglitazone. Glitazones target insulin resistance, a core physiologic defect in those with Type 2 diabetes, and this improves glucose control for the patient.

“It is very perplexing,” said D.G. Shah, secretary-general, Indian Pharmaceutical Alliance (IPA), an industry body representing larger Indian pharmaceutical companies. “The decision has been taken to suspend the manufacture and sale of pioglitazone unilaterally without any consultation with industry and manufacturers. Industry should be given a chance and time to explain. What happens to patients?”

Based on volume sales compiled by IMS for May 2013, the number of patients in India using pioglitazone and its combinations was around 30 lakh, Mr. Shah said.

The market for this drug was around Rs. 700 crore, he added.

In India, it is made by several companies, including Lupin, USV and Sun Pharmaceuticals. A spokesperson from a leading manufacturer of the drug said, “most of the manufacturers have several anti-diabetes drugs in their portfolio. Manufacturers will comply but patients will be affected.”

A new family of anti-diabetes drugs known as gliptins are currently available with a unique action to decrease hepatic glucose output. They are DPP-4 inhibitors and available gliptins include sitagliptin, vildagliptin, saxagliptin and linagliptin. Gliptins were a relatively new, and were effective but cost five to six times more than pioglitazone, Mr. Shah said, adding that such unilateral action by the authorities put unnecessary pressure on the industry and patients.