Indigenous diabetes testing kit to cost 90% less

NEW DELHI: India is set to introduce indigenous testing products for diabetes by the year-end, bringing down costs by 90 per cent. The Indian Council for Medical Research (ICMR) is in the final stages of testing products including strips and readers for diabetes.

Speaking on the need for India to have affordable indigenous technologies, health minister Ghulam Nabi Azad said on Friday, “I have given ICMR a deadline of the end of the year to bring indigenously developed testing strips for diabetes.”

ICMR director general Dr VM Katoch said the cost of a diabetes testing strip was between Rs 15-30 since the products were all patented. ICMR aims to bring down the cost to Rs 3-5.

Dr Katoch added, “A dozen projects have been initiated while four are in a very advanced stage. We are hopeful that we will be able to come out with some products by December.”

India is home to 62 million diabetics, second only to China which has 92.3 million diabetics. By 2030, India’s diabetes numbers are expected to cross the 100 million mark according to a 2012 report by International Diabetes Federation. More worryingly, WHO projects that in the next 10 years, deaths by diabetes will increase by 35%.

The economic burden due to diabetes in India is among the highest in the world. As per WHO estimates, mortality from diabetes, heart disease and stroke cost about $210 billion in India in 2005. Much of the heart disease and stroke in these estimates were linked to diabetes. Diabetes, heart disease and stroke together will cost about $333.6 billion over the next 10 years in India alone, estimates WHO.

Diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, or when the body cannot effectively use the insulin it produces. The disease exposes a person to heart attack, stroke, amputations, nerve damage, blindness and kidney disease.

Work on diagnostic tests for TB, dengue, kalazar, leptospirosis and other infections that are indigenously produced is also underway.

India has too few cardiac, diabetes specialists

BANGALORE: In the world’s second most populous country, diseases of the heart are the biggest killers. The bigger tragedy is that the number of cardiac specialists graduating every year in India is a meagre 250.

The concern among medicos today is not just the limited number of postgraduate seats available in the country’s 381 medical colleges, it’s also the skewed distribution of seats between subjects. The number of seats in clinical subjects that deal with patients directly is low, though they attract the most number of students. In the end, those who don’t make it to these seats make do with para-clinical seats.

It’s worse for diabetics. Even when the country is heading towards becoming the diabetes capital of the world, we have only 50 PG seats in endocrinology. Not to forget that uncontrolled diabetes leads to kidney failure, heart failure and stroke. The US, on the other hand, has 250 PG seats in this subject.

While the World Health Organization puts tuberculosis as the sixth highest contributor to the number of deaths in India, we have only 307 specialized doctors graduating in pulmonary medicine every year. If cancer is the most feared disease in recent times, India has set apart 48 seats for specialization. In contrast, the US has 508 seats.

While a mother dies every 10 minutes in India, we have only around 1,400 obstetrics and gynaecology seats. There are about 93 seats in gastroenterology, as against 433 in the US, even when diarrhoeal diseases are the second highest contributor to deaths in India.

On the other hand, there are 5,833 para-clinical PG seats in the country. Pathology tops with 1,201 MD seats, microbiology has 724 and community medicine 736, biochemistry has been allotted 481 seats and physiology 672.

“Non-clinical subjects don’t deal with patients directly,” says Dr Devi Shetty, former member, board of governors, Medical Council of India. “The younger generation is not attracted to these subjects unless they have a scientific bent of mind. Most doctors who graduate would want to treat patients. Thus, the market value of these non-clinical degrees remains very low. They are the least preferred and taken up only if students don’t have a choice. Sometimes, they remain vacant.”

Experts in the field also point out that when there’s an increase in the number of PG seats, it happens in the non-clinical subjects. The increase, thus, becomes pointless.

Doctors say every unit in a medical college in the country can accommodate up to five PG students, according to MCI norms. If that’s the case, the number of PG seats can go up to 38,390 in the current scenario.

Speciality seats

Discipline——————- India————Us

Cardiology——————- 250————- 781

Diabetology/Endocrinology—50————251

Gastroenterology————— 93————-433

Haematology——————– 13————– 523

Nephrology———————-84————– 416

Neurology———————–159———- 592

Oncology———————— 48————- 508

(Source: MCI India, National Resident Matching Program)

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.”

FDA Moves Against Alternative Diabetes Treatments

Article Excerpt

FDA Moves Against Alternative Diabetes Treatments

WASHINGTON—The Food and Drug Administration is acting to stop U.S. sales of nearly two dozen products marketed as diabetes treatments that the agency said are illegal and can be ineffective, counterfeit or in some cases dangerous.

The federal agency sent warning letters to the companies involved and said it could follow up by seizing the products, enjoining their sale and even criminally prosecuting firms whose officials fail to take corrective action.

The products include dietary supplements, self-styled “natural treatments,” and ayurvedic medicines, part of an alternative health system that evolved in India and includes herbs and special diets. The drugs …

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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.

Govt bans popular diabetes drug and analgin

MUMBAI: The government has banned three popular medicines—the widely prescribed anti-diabetes drug pioglitazone, painkiller analgin and anti-depressant deanxit—in the wake of health risks associated with them. While it’s believed that pioglitazone can cause heart failure and increases the risk of bladder cancer, analgin has been discarded the world over on grounds of patient safety. Deanxit, on the other hand is a harmful combination, which has been long banned even in Denmark, its country of origin.

This decision comes in the wake of a strong stand by the government on suspending marketing of all drugs prohibited for sale in other countries like the US, the UK, EU and Australia.

The ministry of health and family welfare has suspended the manufacture and sale of all three drugs under Section 26A of the Drugs and Cosmetics Act, 1940 with immediate effect, through a notification issued on June 18, informed sources told TOI. While the ministry has been dilly-dallying on withdrawing analgin and deanxit for years now, despite pressure from a parliamentary panel, the decision on the diabetes drug pioglitazone has taken the industry completely by surprise.

The decision to ban pioglitazone and its combinations will hit the Rs 700-crore market for such drugs and adversely impact a clutch of companies including Abbott, Sun Pharma, USV, Lupin, Ranbaxy and Wockhardt.

Pioglitazone combination is a bigger market than plain pioglitazone itself which is has posted a strong double-digit growth, with over 30 companies marketing the drug. The top-selling brands of posiglitazone include Pioz MF G and Pioz (USV), Gemer P (Sun Pharma), Tribet (Abbott), Tripride (Micro Labs) and Gluconorm PG (Lupin). (See chart)

Popular pain-reliever analgin is a relatively small market with brands like Baralgan and Novalgin (Sanofi Aventis), as most companies fearing a ban have already pulled out from the market, industry experts said. The third drug, a combination of Flupenthixol and Melitracen sold as Deanxit (Lundbeck), Placida (Mankind), Franxit (Intas) and Restfull (Lupin) is facing a ban because deanxit is prohibited for sale in Denmark, its country of origin, and also, the combination is not sold in major countries.

Under the Drugs and Cosmetic Rule 30-B, the import and marketing of any drug the use of which is prohibited in the country of origin, is banned in India. A parliamentary panel report on health earlier this year had rapped the government for dilly-dallying on withdrawing deanxit and analgin, which are not sold in markets globally.

The family of ‘glitazones’, used for blood glucose lowering properties, has been mired in controversy since the beginning, with many drugs under the class having already been banned globally, and in India. Three years back, another drug from this family, rosiglitazone, marketed by a host of companies including GSK India was banned, following a decision taken in Europe.

In the case of pioglitazone too, France has already taken it off the shelves, while in the US it is sold with a boxed warning. The warning emphasizes that it may cause or worsen heart failure, and its use for over a year may be associated with an increased risk of bladder cancer.

Doctors here in India had said in a study last year that more robust data on use of pioglitazone on Indian patients was needed. Till that time, the patient should be adequately informed about this adverse effect and the drug should be used in as small a dose as possible, with careful monitoring and follow up. Earlier this month, the ministry had suspended sale of dextropropoxyphene, sold as Wockhardt’s Proxyvon, a widely-used pain-killer.

Addiction, hypertension and diabetes- It all plagues Ahmedabad's cops

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No interim relief to Merck against Glenmark's diabetes generics

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Delhi High Court has refused to bar Glenmark from selling the generic versions of anti-diabetic drugs manufactured by Merck Sharp  Dohme.
Delhi High Court has refused to bar Glenmark from selling the generic versions of anti-diabetic drugs manufactured by Merck Sharp Dohme.

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MUMBAI/ NEW DELHI: The Delhi High Court has refused to bar Indian drugmakerGlenmark from selling the generic versions of two anti-diabetic drugs manufactured by US-based

Merck Sharp Dohme (MSD). While Mumbai-based Glenmark welcomed the order, MSD said it would consider all options, including an appeal against the decision.

The order, passed on Friday, is yet to be put up on the court’s website. “We are very happy with the outcome of the court case. We maintain that Glenmark’s Zita and Zita-Met do not infringe any of Merck’s patents in India,” a spokesperson for Glenmark said in an emailed response to ET’s query on the development. Last week Mumbai-based Glenmark had launched Zita and Zita-Met, the generic versions of MSD Pharma’s antidiabetic drugs Januvia and Janumet, respectively, prompting the American pharma giant to seek an interim injunction on sale of Glenmark’s versions, alleging patent infringement.

Zita and Zita-Met are versions of the class of drugs known as sitagliptin phosphate, for which Glenmark claims it has a marketing approval. These drugs are 20%-30% cheaper than MSD’s Januvia and Janumet, which are patented and enjoy IP protection of 20 years in India. A spokesperson for MSD said the company would consider all options, including an appeal against the decision. “MSD is extremely disappointed with the decision of denial of injunction by the Hon’ble Delhi High Court against Glenmark for patent violation of our drugs Januvia and Janumet,” the spokesperson said in response to ET’s emailed query on the development.

The court decision is likely to impact MSD’s share in the domestic anti-diabetes drug market, which is growing at an average rate of 20%.

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Merck unit sues Glenmark over diabetes drug


MUMBAI |
Tue Apr 2, 2013 8:54pm IST

MUMBAI (Reuters) – A unit of U.S. drugmaker Merck Co (MRK.N) sued Glenmark Pharmaceuticals (GLEN.NS) on Tuesday for infringing its patent on two diabetes drugs.

The action comes a day after Swiss drugmaker Novartis AG (NOVN.VX) lost a landmark court ruling over patent protection for its cancer treatment Glivec, a decision widely seen as boosting India’s generic pharmaceuticals business.

Merck’s Indian unit, MSD, holds an Indian patent on sitagliptin, a chemical compound sold under the Januvia and Janumet brands.

Although the patent is yet to expire, Mumbai-based Glenmark confirmed it had launched generic versions of the two drugs.

“Glenmark is a responsible company and has launched the products after due diligence and research,” it said in an emailed statement.

MSD filed its case with the Delhi High Court on Tuesday, saying it was disappointed with Glenmark’s decision to launch products that directly infringed its intellectual property.

There are about 65 million patients in India being treated for type 2 diabetes, MSD said.

“We believe our patents for Januvia and Janumet are valid and enforceable and will vigorously defend them,” MSD said in an email to Reuters.

Januvia costs nearly 1,300 rupees for a month’s dose while Glenmark has offered the drug at a discount of about 30 percent, an industry source said.

Neither company would comment on their prices.

(Reporting by Kaustubh Kulkarni; Editing by Tom Pfeiffer)