Tuesday, November 27, 2007

 

Selling Medicines

Businessworld
Gina S Krishnan

A decade ago, when Subhiksha, the no-frills discount chain, opened its first store in Chennai, a 100-strong crowd gathered outside on its third day. Founder and poster boy for organised retail, Ramaswami Subramanian, had little cause to rejoice, though. His vociferous visitors were neighbourhood chemists protesting the sale of medicines at 8-10 per cent below the maximum retail price.

It took us two-and-a-half years to win our freedom to operate [the pharmacy business],” Subramanian was quoted as saying in an interview. It was a 1999 Supreme Court judgement that forced wholesalers to resume supply to Subhiksha, allowing it to sell medicines at a discount, which set a precedent that remains, regrettably, only that.

The Subhiksha experience is a reflection of the power wielded by the All India Organisation of Chemists and Druggists (AIOCD), the Mumbai-headquartered association of pharma wholesalers, stockists, distributors and retailers that decides who can be a part of the pharmaceutical supply chain in India. It issues discretionary no objection certificates (NOCs), creating, in the process, one of the toughest pharma retail markets in the world.

India tops the ranking in the Global Retail Development Index compiled by A.T. Kearney, ahead of Russia and China. The estimated $350-billion (Rs 14-lakh crore) market, pegged to nearly double by 2015, is full of internal pushes and pulls. Nowhere is this more obvious than in pharma retail, which has assiduously kept organised competition at bay so far.

More’s the pity. As elsewhere, the pharma sector can benefit from organised retail. Economies of scale will result in better prices for consumers. Bulk sourcing directly from manufacturers will also serve to neutralise the spurious drugs market, which is estimated to account for a whopping 25 per cent of all medicines sold in India.

Wrong Chemistry

India’s highly fragmented medical drugs market has close to 20,000 registered pharmaceutical companies with large manufacturing capabilities. And prescriptions are written according to the doctor’s preference, so pharmacies have to store a number of brands even if the molecule is the same.

Pharma companies appoint carrying and forwarding (C&F) agents for every state, sometimes more than one for large states such as Maharashtra and UP. They move products to at least one stockist or wholesaler in smaller cities, who then pass them on to neighbourhood medical shops, many of which are owned by wholesalers.

The government controls the price of 354 products and wants to increase that number. Retail margins are an assured 25 to 32 per cent. But the inefficient four-level supply chain and large number of pharmacies mean that revenue per pharmacy is really low.

Maximum Retail Problems

Zuellig Pharma, a Hong Kong-based pharma distribution company and logistics major in South Asia, started operations in India last year. It does not have a single order from a pharma company or retail firm till date.

A large player such as Zuellig can bring in economies of scale. But they have no idea when they will service the first order. “We have to be present in India”, says a senior official of Zuellig, who does not wish to be named. “It is an investment in the market. Right now, our expenses are only on meeting with companies and understanding how the market works. We are sure we will get orders. In any case, large players like us will also bring in efficiencies of scale.”

Even manufacturers are inhibited about dealing directly with bulk buyers such as Subhiksha, and logistics companies such as Zuellig. The AIOCD is a strong association and most feel that it’s best not to antagonise it. Moreover, drug companies neither have the time nor the inclination to go against existing relationships, which have been built over years, sometimes even decades. In any case, the volumes are not large enough for the pharma company to antagonise local AIOCD players.

Subhiksha has been able to procure supplies only from existing channels, for cash as against the 60-day credit enjoyed by other chemists. Its skirmishes with AIOCD continue. For instance, in March, the Chandigarh Chemists Association cut supplies of all medicines and pharma goods to Subhiksha. Distributors demurred delivery on grounds of depleted stocks.

Rajendra Pratap Gupta, formerly head of retail and supply chain at Reliance Health, which may yet prove to be a major player in the future, initiated the setting up of a parallel ‘Association of Professional Chemists and Distributors of India’. While agreeing to the idea in principle, many of its potential members believe that taking on AIOCD will be easier prescribed than achieved. With Gupta’s exit from Reliance Health, this alternative stands shelved as of now.

Growing, Growing...

Organised pharma retail has grown in three waves. In 1999-2000, chains such as Lifesprings, Subhiksha, Medicine Shoppe, and Health and Glow stirred the market. Some have grown, others closed, yet others stagnated. Dial for Health, CRS, 98.4, Guardian Life and Medplus led the second wave. This year, three large groups have heralded fresh hope: the Ranbaxy-promoted Fortis Healthworld, Manipal Cure and Care and, most recently, Reliance Wellness. None are members of AIOCD but accept whatever discount wholesalers and distributors give them for the volumes they lift.

In times to come, there will be Wal-Mart and Walgreens coming to India,” says Shinde. That’s the opportunity Zuellig is waiting for. In the US, almost 80 per cent of the market is controlled by three wholesalers, McKesson, Cardinal Health and AmerisourceBergen. They operate with warehouses in strategic locations and sell to hospitals and retail pharmacies.

The Apollo Group, which buys through its central procurement company Keimed and has 300 pharmacies besides 22 hospitals, currently, gets the highest discounts. Reliance Retail and Wal-Mart will also cut out intermediaries. An Ernst & Young study provides evidence of efficiencies derived by operating with big wholesalers.

They protest needlessly. With pharma as a small part of its retail outlets — often just one counter — Subhiksha does not sell the 30,000-odd products that the average pharmacy stocks. Only a list of generic medicines is put up. Customers cannot expect to meet all their prescription needs here.

Wednesday, November 21, 2007

 

Vegetable that lowers blood sugar

After the herb Gurmar, the well-known sugar killer, scientists have now discovered the diabetic-friendly properties of the common vegetable, Kundru.

TOI
Kounteya Sinha

This humble vegetable, so far met at the dining table with indifference, may now find new respect, even among picky palates. That's because new research shows that consuming 50 grams of kundru daily can help keep your blood sugar under check.

A three-month study conducted by doctors at the Institute of Population Health and Clinical Research, Bangalore, has found that the common kundru, which looks like a poorer cousin of the tasty gourd parwal and has no particular gastronomic appeal, can reduce blood sugar levels in patients with mild diabetes.

The team found that sugar levels in new diabetics, with fasting blood sugar counts below 200, can drop by 16% by simply slurping the curried vegetable, known to botanists as Coccinia indica. It also reduced post-prandial blood glucose (sugar count after a meal) by 18%.



The findings have been reported in the latest issue of the international journal Diabetes Care.

"We fed 30 early diabetics a daily capsule of one gram of frozen, dried powder of kundru, that is equivalent to 15 grams of the vegetable, for three months and found it to greatly reduce blood sugar. It also reduced glycosylated haemoglobin by 0.4% which is significant," said Dr Ganapathi Bantwal, associate professor of endocrinology at St John's Medical College Hospital, Bangalore.

However, doctors say when cooked and consumed, the dose has to be higher than that of the extract — typically about 50 grams.


Some other benefits of the Kundru vegetable:

Kundru is a local name of Ivy Gourd. It is under cultivation as vegetable crop in Chhattisgarh. Kundru Chana dal is a curry prepared by using Kundru fruits with Chana dal (Chickpea splitted seeds). Among the natives this preparation is popular for its delicious taste but the traditional healers are aware of its health benefits. According to them this preparation is specially useful for the patients having diabetes. It is also useful in biliousness and diseases of blood. During fever the use of this preparation with meals, helps in reducing the high temperature.



Other names for the Kundru vegetable:
Ivy Gourd, Gentleman’s Toes (English)
Dondakaya, Dondakai (Telugu)
Tondakayi (Kannada)
Vargoli (Hindi)
Tindora, Ghiloda (Gujarati)
Tondli, Tendli (Marathi)
Kovakkai (Malayalam)
Kovaikai (Tamil)
Goli (Rajasthani)
Kundru (Utter Pradesh)

Thursday, November 15, 2007

 

Medical devices in the human body


Businessworld
Gauri Kamath

India’s medical implants and devices industry is a poor cousin of the country’s biopharmaceuticals and technology sectors. According to Frost & Sullivan, the global medical devices industry, at $196 billion, is dwarfed by its $500-billion-plus pharmaceuticals counterpart. In India too, at $1.8 billion, the market is just about as large as Ranbaxy or Dr. Reddy’s Labs, the country’s largest drug makers. And while India’s pet sunrise industries have been richly rewarded with tax breaks and other incentives for putting the nation on the global map, makers of bone plates, pacemakers, intra-ocular lenses, heart valves and stents do not even have a law to govern them.

Without effective regulation, bonafide producers compete with barnyard operators and local traders who use scrap metal as raw material, and import goods of unproven quality. Also, Indian companies often fare poorly against premium global brands such as America’s Medtronic or Boston Scientific, which are approved by stringent western regulators and backed by huge amounts of clinical trials data. Imports account for most of the Indian market.

Intensive Care

But things are changing. The Ministry of Science and Technology is readying to table a breakthrough Bill in the Parliament’s winter session. The Medical Devices Regulation Bill, 2006 proposes to set up an autonomous regulator for the sector. Its primary aim will be to set standards on a par with the rest of the world. “Once a device is tested and approved in India, there should be no testing needed in any importing country,” says B. Hari Gopal, adviser to the ministry. The Bill will also regulate imports into the country.

However, another regulation is threatening to undo this promise. Since 2005, 10 categories of medical devices are subject to the Drugs & Cosmetics (D&C) Act of 1940. Companies allege the Act was not written for the devices industry and that it is endangering their survival. In Europe and the US, separate laws govern medical devices and implants.

The Trouble With The Law

Take the concept of sterility. A sterile drug, like an intravenous fluid, has to be manufactured in ‘clean room’ conditions. This requires a certain type of flooring, furniture, air flow and energy requirement to minimise impurities. But
a sterile medical device can even be one that is sterilised at the point of use
.

The Doctor Can’t Carry On

At the busy basement workshop of Pune’s Sancheti Hospital, artificial ‘Indus knees’ are being made, an innovation that took founder orthopaedic surgeon K.H. Sancheti and his team seven years to design. Indus knee allows patients with debilitating knee pain to not just walk but even squat. So far, the hospital says, more than 400 patients, including poor villagers from the states of Maharashtra, West Bengal and Madhya Pradesh, have received the Indus knee. At Rs 25,000-30,000, it costs a lot less than the Rs 60,000-1 lakh for an imported device.

But work will soon stop here. Dr Sancheti says he is unable to meet the requirements of the D&C Act. “Why, for instance, do I need an in-house biological testing laboratory?” he asks. The end-product is irradiated at the state-owned Bhabha Atomic Research Centre in Mumbai, after which the package is opened only in the operating theatre. Dr Sancheti, a 2003 Padma Bhushan awardee, says if he were to meet all the Act’s requirements, the cost of manufacturing would quintuple.

Serious Side-Effects

Ironically, imports are being approved on the basis of documentation, minus factory inspections. “We are getting implants even from China but there is no rule to inspect their factories,” says Dr Sancheti.

Exports may be hit too. Importing countries need evidence — called a free sale certificate — that a device is approved for use in the exporting country. Until the DCGI licenses a unit, a free sale certificate is out of the question.

Compounding matters is the fact that the industry has not banded together to influence policy. “They could achieve a lot more if they joined hands,” says Dilip Shah, secretary general of the Mumbai-based Indian Pharmaceutical Alliance, a grouping of top drug makers that has been successful in shaping policy. The way the medical devices industry is structured, that’s next to impossible. Products range from CT scanning machines, ECG and MRI apparatus on the one hand, to knee and heart implants on the other. Even sutures are medical devices.




Each market segment has addressed its own issues so far. Drug-coated stent producers are one example. It was illegal trials of an imported stent in a government hospital in Mumbai that led to a High Court order for regulation of medical devices in 2005.

Since then, stent producers such as Bangalore’s Vascular Concepts (which went to court), and Ahmedabad’s Sahajanand Medical Technologies (SMT), have got their licences. Dhirajlal Kotadia, SMT’s chairman, says the process took almost a year. “There may be some negative impact in the short term, but the move is positive.” Companies that make hydrocephalus shunts and pacemakers are not included in the regulated categories as yet. Indeed, they may prefer to work quietly.

Sustained Release

Everyone agrees that there is a need for a new law. “It will clear some of the backlog in the current system,” says Swaminathan Jayaraman, CEO of Vascular Concepts. Adds Atul Sethi, MD of Indore-based pacemaker Shri Pacetronix, “A device cannot be regulated as a drug.”

According to some, the only solution is to allow existing devices to continue in the market unequivocally, by government fiat, till the new Bill comes into force.


And in a related story on the testing and safety of drug-coated sttents:

Drug-coated stents - tiny wire-mesh tubes used to prop open clogged heart arteries - may not be as dangerous as earlier thought, Swedish researchers who had raised concerns over the devices said on Sunday.

Fears that patients might do worse on so-called drug-eluting stents than on older bare metal ones have led to a $1-billion (around R8-billion) slump in sales in the past year.

But according to new four-year data from a 35,000-patient Swedish database of stent procedures, the largest in the world, patients receiving drug-coated stents are not at higher risk of dying or having a heart attack.

While drug-coated stents do carry a small increased risk of blood clots after the first year - something known as late stent thrombosis - this was offset by better outcomes in the early months following implantation.

"The slightly increased risk of late events with DES (drug-eluting stents) seems counterbalanced by an early gain," James told reporters.

Tuesday, November 13, 2007

 

Saved by the scorpion!

TOI

Malathy Iyer



A deadly scorpion venom may well harbour what could turn out to be the healing touch for a particular heart ailment, says an article published in the world's prestigious medical journal Lancet on Friday. What makes this theory more special is its made-in-Maharashtra tag.

The Lancet piece, 'Can scorpions be useful?', has been contributed by Maharashtra's own 'rural doctor' Himmat Bawa-skar, who has been working in Mahad in Raigad district for over three decades. His proposal comes at a time when scientists across the world are busy developing cures from venom toxins. California's Sinai Medical Centre has even developed a man-made equivalent of the scorpion venom to fight brain tumours.


Bawaskar's contention is that the venom in western Maharashtra's infamous Red Scorpion's toxin holds a chemical that could stimulate the body's ion channels in such a manner as to reverse a particular heart condition. (Ion channels are proteins that regulate the movement of electrically charged ato-ms\molecules in and out of body cells. If chlorine channels in the stomach cells maintain acidity, sodium channels in the nerve cells control electrical stimuli.)

Says Bawaskar, "If scientists could isolate the sodium channel stimulator in the scorpion venom, patients suffering from Brugada Syndrome could be saved." Brugada Syndrome is an inherited disease which causes sudden andunexpected death in apparently healthy young people due to severe disturbances in the heart's rhythm. While the Brugada Syndrome is not much heard of in India, it's common in Japan, Saudi Arabia, Russia and many European nations. Patients need expensive intra-cardiac defribillators to survive. Scorpion venom could offer them a cheaper alternative, says the Lancet article.

Maharashtra doctor Himmat Bawaskar says the venom found in the Red Scorpion's toxin holds a chemical that could reverse a particular heart condition. Highlighting how he stumbled on the unlikely connection between one person's poison and another patient's cure, Dr Bawaskar talks of the unusual ECG report of a ten-year-old boy who was bitten by a Red Scorpion two years ago. "Thirty-six hours after his treatment at Mahad hospital, the boy's ECG report showed patterns characteristic of the Brugada Syndrome." The patterns were resolved within the next 72 hours and the boy has a normal ECG now.

"My deduction is that the scorpion venom stimulated the boy's sodium channel immediately after the sting, leading to bouts of vomiting. But 36 hours later, the channel was paralysed due to overactivity and showed up in the ECG as the Brugada Syndrome pattern," analyses the doctor. The Indian boy doesn't have Brugada Syndrome, but the venom stimulated his responses in a manner similar to the condition. The take-home lesson, according to Dr Bawaskar, is that the scorpion venom contains sodium channel stimulators that could help Brugada patients in whom this channel is disrupted, at times with fatal results.


Incidentally, this is not the only scorpion story Dr Bawaskar is associated with. Over two decades ago, he popularised the use of a common anti-hypertension drug, prazosin, as the first-line treatment for scorpion stings. "Although scorpion antivenom is available, it's only effective if administered within two hours after the sting.

Given the conditions in rural India, this is not always possible. Moreover, it's expensive at over Rs 350 for a vial. So, prazosin is a safer bet
," says the doctor, 20 years after he popularised the practice in rural India.

Saturday, November 10, 2007

 

Insulin plans

TOI
Rupali Mukherjee

The India plan of the world's first inhaled insulin — Pfizer's block-buster drug, Exubera, has been called off days before its proposed launch. This follows the parent's recent decision to stop manufacturing the drug due to sluggish sales worldwide.

"We will not bring the product to India now after the parent's decision. The launch, which was planned for this month, has been dropped as the drug has not met with a good response worldwide", a company executive told The Times of India.

Pfizer recently announced that it will be returning the worldwide rights for Exubera to Nektar, the company from which it licensed the inhaled insulin technology.

"We will not be launching the product in India or any other country where the product has not been launched as yet", a Pfizer India spokesperson added. Pfizer Inc has stopped manufacturing of the device at its plant in Indiana, in which it has already invested over $300m.

"This announcement is not a product recall, nor the result of any specific safety signal that would put patients at risk. While Exubera remains a safe and effective medicine, it simply has not met customer or financial expectations", the spokesperson added.




In India, a few patients have been prescribed Exubera by their treating physicians. Pfizer has said that it will support these patients for the next three months, and then help them to switch to other glucose-lowering therapies.

There is a huge segment of diabetics in India who need to take injectable insulin. About 30-35% of type II diabetics need some sort of insulin, and every diabetic will certainly receive insulin at some point of time, experts pointed out.

Type II diabetes is non insulin-dependent diabetes, obesity related and a metabolic disorder. According to the Diabetes Atlas 2007, there are approximately 40.8 million diagnosed patients with diabetes in India.

Industry experts pointed out that though inhalable insulin holds lot of promise, there are still questions on its long-term use. In Pfizer's case, the device to deliver insulin was also not too user-friendly.

Anoop Misra, director and head, Department of Diabetes and Metabolic Diseases, Fortis Hospital, says, "I still think inhaled insulin is very attractive concept especially for Indians who have sort of phobia for injections. Easy handling and dosage option of apparatus in future would make it more acceptable to patients".

Other Oral Insulin Plans

Thursday, November 08, 2007

 

Cheap new drugs in trial

Businessworld

Gina S Krishnan


Glen Saldanha, managing director of Glenmark Pharmaceuticals, is a relieved man these days. Eli Lilly has inlicensed its molecule GRC 6211 with an upfront payment of $45 million and $90 million in milestone payments. Further, if the molecule enters the market, Glenmark gets another $290 million. GRC 6211 is a next generation pain management molecule for osteoporosis and is undergoing late Phase II clinical trials in Europe. Phase II trials are carried out on a limited number of patients who have that particular disease and no other complication.

The good news comes on the heels of Merck KgAa’s announcement that it would get out of diabetes research. Glenmark had outlicensed its molecule GRC 8200 (for diabetes) to Merck KgAa early last year. Glenmark will now have to either undertake research on the molecule or find another company willing to take on its development.

October has largely been a good month for Indian pharmaceutical companies engaged in research. Of the seven promising molecules licensed hitherto (one each by Ranbaxy and Torrent, and three each by Dr. Reddy’s and Glenmark), two are moving into Phase II and Phase III clinical trials. Dr. Reddy’s Balaglitazone (DRF-2593) for diabetes has been given the green signal by the US Food and Drug Administration to move into Phase III clinical trials. Phase III is the last stage in clinical trials before the drug hits the market. It is administered to a larger group of patients that may have more than one disease. Glenmark’s GRC 3886, a molecule for asthma and chronic obstructure pulmonary disorder (COPD), outlicensed to US-based Forest Labs and Japan’s Teijin Pharma, will move into Phase II, almost a year later than scheduled.




The performance of Indian companies so far has been remarkable, with a hit rate of almost 50 per cent. According to studies carried out by the Tufts Center for the Study of Drug Development, a non-profit research group associated with the US-based Tufts University, one in 10,000 molecules screened manages to hit the market. As the molecules move forward into different stages of development and clinical trials — all of which come with huge expenses and expectations — their chances of falling by the wayside also increases. Only one in 10 molecules that enter Phase III is likely to succeed.

Indian companies’ success could be partly attributed to their ‘analogue approach’, which means that they look at ‘me-too’ drugs. However, sometimes these me-too drugs can turn blockbusters. Take, for example, Pfizer’s Lipitor. The $12-billion drug is a third-in-class molecule (a me-too drug), but has overtaken the first-in class (innovator) Merck’s Simvastatin (Mevacor) and second-in-class Pravachol of Bristol-Myers Squibb.

However, with three molecules returned till now and three others dropped, it is too early to say Indian R&D is maturing. Only Ranbaxy’s molecule for Malaria and Dr. Reddy’s Balaglitazone have the potential to reach the market. Since the first R&D laboratory dedicated to discovery opened at Dr. Reddy’s in Hyderabad in 1994-95, the Indian companies score is not outstanding, but it is not bad either.

Monday, November 05, 2007

 

Meat-eating and Cancer

How much red meat you eat, alcohol you drink and time you spend on a brisk walk could be what decides your chances of getting cancer. In a landmark study to pinpoint the possible links between diet, obesity and cancer, scientists have found convincing evidence to prove that over 40% of all cancers are a direct result of diet, physical build and exercise habits.

Headed by Sir Michael Marmot, professor of epidemiology at University College London, and professor Martin Wiseman from the World Cancer Research Fund, a 21-member elite panel analysed over 7,000 studies carried out in the last 40 years to access the actual links between lifestyle and cancer.

The panel's 571-page report — Food, Nutrition, Physical Activity and the Prevention of Cancer — prepared after five years of analysis, has made some crucial recommendations. The scientists confirmed that carrying extra weight, particularly around the waist, increased chances of cancer of the oesophagus, pancreas, colon, kidney and uterus drastically, as well as postmenopausal breast cancer.

Exercising for at least 30 minutes a day was vital. Physical activity in any form protected against colon and womb cancer. It strengthened immunity, helped keep the digestive system healthy and allowed for the consumption of more cancer-protective nutrients.

The researchers said men should limit their alcohol intake to two drinks a day and women one. According to them, alcohol causes cancer of the mouth, pharynx and larynx, oesophagus and breast. They also pointed to probable evidence that drinking was a cause of liver and bowel cancer in women.

Red meat, such as mutton, beef, pork and lamb, were found to have a direct link in causing colorectal cancer. It's consumption should be limited to 500 gm a week and should be replaced with poultry, fish and eggs.

Processed meats like bacon, ham and sausages should also be avoided, the researchers said. A minimum of 400 gm of fruits and vegetables should be consumed every day while salt consumption should not exceed 6 gm daily.

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