Indian Biotech News & Discussion

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George J

Re: Indian Biotech News & Discussion

Postby George J » 13 Jul 2004 09:20

Originally posted by Rudra Singha:
http://www.fool.com/News/mft/2004/mft04071244.htm
Anecdotal evidence of biotech's effect on medicine costs can be seen in Genentech's (NYSE: DNA) great success with its cancer treatments Avastin and Rituxan, both of which are fairly pricey. Off-shoring could help biotech firms slow price inflation, which may help stave off regulation, while keeping profit margins healthy.
While I am not totally up on Biotech Rx in India, I can tell you that that making Biotech drugs (read: proteins read: LARGE molecules) aint a piece of cake. Large molecules are rarely synthesised they are usually fermentation products and QC is a bitch. A perfect case study is J&J trying to make Amgen's Epo in Europe as Eprex, they followed the instructions to the T, the bacteria fermented something but it was not eprex and its was not funny.

There is a lot of infrastructure demands for biotech drugs, labor is cheep but not the infra so I am a bit circumspect about the cost advantage in mfg.

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Re: Indian Biotech News & Discussion

Postby Guha » 13 Jul 2004 19:17

Originally posted by George J:
While I am not totally up on Biotech Rx in India, I can tell you that that making Biotech drugs (read: proteins read: LARGE molecules) aint a piece of cake. Large molecules are rarely synthesised they are usually fermentation products and QC is a bitch...

There is a lot of infrastructure demands for biotech drugs, labor is cheep but not the infra so I am a bit circumspect about the cost advantage in mfg.
George, I beg to disagree to some extent. The infrastructure for fermentation to bio-processing exists in India:
- Expertise: From Hindustan Antibiotics (40? years ago) to today we do have a significant number of running fermentation and down-stream seperation/processing plants.
- Infra-structure: In process plant construction and process equipment fabrication we have a large number of vendors from L&T, Alpha Laval, Sulzer to smaller companies like Praj all of whom now do design and fabrication work for plants all over the world. All will be more than willing to design and fabricate you super-duper SS316 100 K-litre fermentation vessels (please remember to mention BR when placing your order :-))
- Education: IIT-D, IIT-B, UDCT all have running post-graduate programs in bio-processing.

Drawbacks:
- A lot of bio-safe fittings and consumables like valves,filters etc have no local manufacturers but I consider this a problem of scale only.
- Changing culture among shop-floor workers (who generally come from a regular process industry background) to work in a ultra-clean enviornment is a bit of a challenge. In my (limited) experience in such plants I think contamination rates tend to be higher in India leading to more failed batches.

I think the seeds are there. Just need to get the moolah flowing!

George J

Re: Indian Biotech News & Discussion

Postby George J » 14 Jul 2004 05:35

Originally posted by Guha:
George, I beg to disagree to some extent. The infrastructure for fermentation to bio-processing exists in India:
- Expertise: From Hindustan Antibiotics (40? years ago) to today we do have a significant number of running fermentation and down-stream seperation/processing plants.
- Infra-structure: In process plant construction and process equipment fabrication we have a large number of vendors
Education: .....
Drawbacks:... Changing culture ..to work in a ultra-clean enviornment is a bit of a challenge. In my (limited) experience in such plants I think contamination rates tend to be higher in India leading to more failed batches.
Umm while I agree with you on the human resources I have to disagree with you on a technical level. Based on my indirect info large scale mfg of large molecules (proteins) it does not translate directly from cooking up a batch of pencillin or cephalosporine using textbook bio-sythetic methods.

Remember you are finally getting a small molecule like Penicillin G and V which you process further.

You dont have to deal with viruses, cell debries and and other biological contaniments that require nanofileration and propreitiery Chromatographic techniques to get to your bulk. If it was 'as easy as it looks' Indians should be selling EPO and Mononclonal Antibodies to the rest of the world like was do with with cephalo and cyclosporines.

Also I have never seen the failure of parentral batches in the clean rooms that I have worked with. Clean room tech is very mature in India and there are many good companies that offer turnkey installs.

If USFDA production facilites are any metric then Indian has the largest number outside the US, so whatever is common between packing and commercial production between the small and large molecules are pretty much worldclass in India.

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Re: Indian Biotech News & Discussion

Postby Guha » 14 Jul 2004 19:52

Originally posted by George J:
Based on my indirect info large scale mfg of large molecules (proteins) it does not translate directly from cooking up a batch of pencillin or cephalosporine using textbook bio-sythetic methods.

...
I see your point, with penicillin you can adjust pH and precipitate chemically so seperation is very easy (relatively) which will not be true for complex proteins. I have no experience with large-scale chromatography so dont have any idea.

But anyway however complex it is, I do feel process development and plant design/fabrication are area's of strength in India. Probably the cost (and time) to commercialization can be significantly lower if you develop the process and set up the first plant in India.

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Postby Gerard » 05 Aug 2004 00:32

http://www.iht.com/articles/532521.html

Bloomberg Commentary: Outsourcing drug trials could benefit East and West

George J

Postby George J » 05 Aug 2004 04:08

gerard wrote:http://www.iht.com/articles/532521.html

Bloomberg Commentary: Outsourcing drug trials could benefit East and West



There are more holes in that artical than in swiss cheese. Studies in US are expensive coz it simply cost a lot more to do anything the US and time consuming coz everyone and their uncle needs to make sure the RULES and REGS are being FOLLOWED. Else its their pants and the pants of their next 7 generations.

GCP only lays down how good reserach SHOULD BE DONE, it is NOT supported by laws that guarantee speedy justice for those who mess with it.

Also this 'lack of data protection' is pure humbug. All trial data is proprietary NO ONE can use it for anything thats industrial espionage. Even if you get a hold of trail data you need to get a hold of the active ingredient to make it. And where do they get that from? Literature? Sure but what about IPR?

Also the reason why Generics are making hay is coz they have to SIMPLY PROVE bioequivalence. You dont need to steal data to do that. Its available from the FDA for all APPROVED DRUGS. So you just have to wait for the drug to be approved by the originator. You dont drills holes in your own thali. Everyone knows that.

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Postby Vivek_A » 11 Aug 2004 21:29

Drug Firms Move Biotech Work to India

BANGALORE, India (AP) -- Drug makers in the United States and Europe are increasingly moving clinical trials and research work to India, which helped Indian firms earn $54 million in revenue in the last fiscal year, a trade body said Wednesday.

``India is being taken seriously as a biotech outsourcing destination,'' said Kiran Mazumdar-Shaw, who heads the Association of Biotech Led Enterprises, a grouping of India's biotechnology firms.

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For years, American and European companies have farmed out software development, engineering design and back-office work to firms in India and other countries that have lower wages and plenty of skilled workers.

India earns about $12.5 billion annually from information technology outsourcing and revenues are growing at 30 percent per year. More than half of Fortune 500 firms outsource some part of their work to India.

The practice of passing on jobs in drug development research, analysis of research data and clinical trials to India is a new but growing trend, Shaw said.

Revenue from work outsourced by Western companies accounted for more than 13 percent of India's biotechnology exports of $395 million in the year that ended March 31.

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Postby Rudra » 11 Aug 2004 23:13

Business Standard:

Biotech to cross $1bn this fiscal

Press Trust of India / Kolkata August 11, 2004


The biotechnology industry is expected to grow over 40% this fiscal to touch $1 billion, and the sector would witness a five-fold growth to $5 billion by 2010.

This was announced by Kiran Mazumdar Shaw, president of Association of Biotech-Led Enterprises (ABLE), after releasing the second ABLE-biotech industry survey today.

The survey of 235 biotech firms estimated their revenues at Rs 3,265 crore ($705 million) in 2003-04, up from Rs 2,345 crore of 150 companies in 2002-03.

While exports during last fiscal stood at Rs 1,817 crore, domestic sales totalled Rs 1,448 crore.

Pune-based Serum Institute (Rs 555 crore) and Bangalore-headquartered Biocon (Rs 502 crore) surpassed the Rs 500-crore mark in revenues last fiscal.

Nearly 9,000 scientists and technologists are directly employed by the fledgling sector, up from 6,400 in the previous fiscal. "These are the people who are directly involved in this sector," Mazumdar, CMD of Biocon, said.

The biotech sector attracted investment of Rs 635 crore during 2003-04 with an additional investment of Rs 1,000 crore expected this fiscal, she said.

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Postby Gerard » 13 Aug 2004 02:27

http://www.atimes.com/atimes/South_Asia/FH13Df02.html
India sowing the seeds of success
BANGALORE - India's biotechnology industry is expected to grow by more than 40% this fiscal year to touch revenues of US$1 billion, and the sector will witness fivefold growth to $5 billion by 2010


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Postby Neshant » 15 Aug 2004 23:19

> Outsourcing drug trials could benefit East and West

In most cases, pharma companies will use contractors in India so if anything goes wrong, the contractor will take the heat and the pharma will disappear overnight.

Even in the case of Union Carbide, its chief fled to the US and the US won't hand him over for trial.

Drug trials will boom in India only because human life is cheap and there are many loopholes to exploit. If the govt had sense, it should regulate the entire practice of drug trials.

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Postby Vick » 18 Aug 2004 16:57

From FT.com

How India hopes to reshape the world drugs industry
By Geoff Dyer
Published: August 17 2004 21:21 | Last updated: August 17 2004 21:21

For the last two decades Nicholas Piramal, a drugs company based in Mumbai, has made a decent living by buying the rights to medicines developed in the US and Europe and selling them in India.

These days, however, the company has its sights set on much bigger targets. Swati Piramal, the director responsible for research, has given the company a challenge that - if met successfully - would rewrite the rules of the global drugs industry.

“The big pharmaceuticals companies say it costs them at least $800m to develop a new drug,” she says. “Well, we can do it for $50m.”

The obstacles facing the company are daunting, but Dr Piramal is brimming with confidence. “We are going to develop a cancer drug to prove it,” she says. “We are hoping to turn the industry upside down.”

With its combination of high-quality scientists and low costs, India has already become a significant player in the software and information technology industries. The streets of Bangalore, the country's IT hub, are lined with gleaming buildings built in the last few years to house companies such as Microsoft, General Electric and Dell.

Inspired by the revolution in IT, several Indian drugs companies have set out an ambitious game plan. By tapping the same low-cost pool of English-speaking scientists, they want pharmaceuticals to become the next phase in the shift of service industries to India.

Their fate over the next decade will be a fascinating experiment into how far globalisation can be pushed. If developing countries can genuinely compete in industries that depend on brainpower, such as pharmaceuticals, it will have profound implications for the corporate world.

The bold talk from India also comes at a time when many executives at large multinational drugs companies are in despair over the sector's future. Over the last decade, they have pumped ever greater sums into drug research, yet the number of medicines produced has not increased. Many admit that the industry faces a crisis in the productivity of its research. They are watching closely to see if India will emerge as a low-cost centre of medical research.

Indian success in pharmaceuticals would also raise political hackles in the US and could become more controversial than IT outsourcing has been. For many politicians in the US, it might be acceptable under the logic of globalisation that some manufacturing jobs shift to Asia. But by the same logic the invention of medicines such as cancer drugs - the ultimate value-added, capital-intensive economic activity - is supposed to take place in developed countries.

India has long boasted an army of talented chemists but for the last two decades they have been mostly focused on finding ways to copy other companies' drugs. Under a patent law dating from 1970 Indian companies have been allowed to sell versions of prescription drugs as long as they used a different manufacturing process.

That is all about to change, however. From the beginning of 2005, drug patents will apply in India as part of the World Trade Organisation's intellectual property rules. As a result Indian companies will no longer be able to rely on their lucrative domestic market. The search for new business models is being driven by necessity.

For a handful of Indian companies - including Nicholas Piramal, Ranbaxy and Dr Reddy's - the response has been to invest in innovation. They plan to harness skills in medicinal chemistry to shift from re-engineering other people's drugs to developing their own.

“India is moving centre-stage in the drugs industry,” says Brian Tempest, chief executive of Ranbaxy, the Delhi-based company, which aims to have 40 per cent of its revenues from innovative products by 2012. “It will be like the scampering mammals taking over from the dinosaurs.”

Cost is the key competitive advantage. Just as in the IT industry, India has huge numbers of trained scientists prepared to work at a fraction of European or US salaries. Indian companies estimate the cost of hiring a researcher is between one-third and one-fifth of the US rate.

Moreover, the Indians believe they can conduct clinical trials much more cheaply. Somesh Sharma, chief scientific officer at Nicholas Piramal, says that India's huge population makes it much easier to find patients to take part in trials. When the company participated in the trial of a cancer drug developed by a US group, it finished its part four years ahead of its partner.

“It was an important experiment that proved we could do it,” he says.

The drugs companies are also beginning to tap the huge diaspora of Indian scientists working in the US. By some estimates, 20 per cent of all the researchers working in the biotechnology industry in the San Francisco area are of Indian origin. The Indian companies cannot afford to lure back too many expatriates as they would soon lose their cost advantage. But by recruiting a few experienced executives they can transfer industry skills and standards to local scientists.

“There are lots of people who want to come back,” says Kasim Mookhtiar, vice-president of new drug discovery at Ranbaxy. “We are now in a position to provide them with a career of their choice.”

Dr Mookhtiar, who used to run a research department at Bristol-Myers Squibb in Pennsylvania, also believes that this brain-drain of Indians is the most effective argument against political criticism in the US. “When I graduated from the Indian Institute of Technology in Bombay, from my class of 160 people, 120 went to the US,” he says. “Indians have made a huge contribution to the US. It cuts both ways.”

Yet despite the verve and optimism, the obstacles facing the Indian companies are immense. Pharmaceuticals executives estimate that only one in 10 drugs that enters clinical trials actually makes it to market. Over the last two decades, hundreds of biotechnology companies have been set up in the US and Europe staffed by well-trained scientists. Only a handful have actually managed to develop a drug.

The large pharmaceuticals companies manage this risk by conducting trials in dozens of different drugs, which they hope increases their chances of a few successes. The odds, however, are stacked heavily against smaller companies.

Dr Reddy's is a good example. The Hyderabad-based company was the first in India to try to build its own research operation a decade ago. It did have one drug for diabetes in late-stage clinical trials, but that failed 18 months ago. No Indian company has more than three molecules in clinical trials.

Dr Reddy's has opened a laboratory in the US, prompting rivals to claim that it could not find the necessary skills in India. Meanwhile attempts by Ranbaxy to lure high-profile Indians from the US have not always gone smoothly. Rashmi Barbhaiya, a former Bristol-Myers Squibb scientist hired to run its research department, left earlier this year after falling out with the senior management.

While India has great strengths in chemistry, some executives say it is harder to find people trained in molecular biology. Researchers complain about the bureaucracy; until recently, they say, it was difficult to get regulatory approval for animal experiments.

Moreover, drug research does not depend solely on talented scientists. As more has been discovered about the links between genes and disease, research has come to rely heavily on expensive equipment such as gene sequencers. The big increase in the cost of research in the US and Europe has partly been the result of these investments.

Despite their big cost advantages, the Indian companies do not have huge resources to spend heavily on research. While western companies spend more than 15 per cent of their huge revenues on research and development, the top Indian companies spend around 5 per cent. Ranbaxy has a research budget of $60m, Dr Reddy's closer to $40m. The entire revenue of the Indian drugs industry is less than the $7bn a year Pfizer alone spends on research.

“Are you really trying to tell me that the entire global industry is putting down its money badly?” asks Ranjit Shahani, managing director of Novartis in India. “To go from copying straight to innovation is some leap.”

There is a chance that one of the Indian companies could make it with a successful drug. As Indian entrepreneurs are quick to point out, many of the big companies in the industry today were transformed by one drug - for instance Glaxo, with its ulcer pill Zantac. But it is a long shot. The likelihood is that they will not turn themselves into research-based companies in one swoop.

As a result, most have a “plan B”. Rather than try to jump straight up the value chain from selling generics to developing their own drugs, the Indian companies are developing less ambitious strategies. There is a number of ways the companies can move into more value-added areas and acquire skills without betting everything on one or two projects.

Generics are still part of that strategy. With prospects for the Indian market weak in the long term, a number of Indian companies are pushing into international generics markets, where they can take advantage of their low-cost manufacturing. They are attractive businesses in their own right, but also good ways of funding research.

Producing generic versions of biotechnology drugs, which regulators are expected to allow soon, could also be an interesting market. Indian companies such as Biocon in Bangalore, for instance, have developed the ability to manufacture these drugs, which are much more complicated than pills, and have lower labour and land costs than most potential rivals.

Indian companies are also focusing on lower-risk types of research that play to their strengths in chemistry, such as devising new ways of delivering established drugs. Ranbaxy is already receiving royalties from Bayer of Germany after developing a once-a-day version of Cipro, its antibiotic. Dr Reddy's tried to use these skills to challenge to Pfizer's Norvasc, a $4bn-a-year blood pressure treatment. The company developed a version of the same drug that used a different salt in the formulation, hoping that this would allow it to evade Pfizer's patents. An initial court ruling went in its favour, but Pfizer won the appeal.

The company is now taking a different tack, acquiring a portfolio of established dermatology products that it hopes it can improve using its chemistry skills. These approaches are less glamorous but lower-risk than innovating new molecules and can help build up expertise in the development process.

The other strategy being adopted by Indian companies is not to compete head-on with the US and European industry but to collaborate. By partnering with multinationals on research projects, Indian companies can devolve some of the heavy development costs as well as learn more about how to manage research projects.

GV Prasad, chief executive of Dr Reddy's, says the company will not conduct late-stage clinical trials itself because the costs are too high. Its diabetes molecule in phase II trials has been licensed to Novo Nordisk, the Danish company.

Ranbaxy has entered into a different type of alliance with GlaxoSmithKline, the UK-based multinational, which allows it to benefit from GSK's extensive research infrastructure. GSK has invested billions of dollars in an early-stage discovery process that produces hundreds of possible ideas for drugs every year. Ranbaxy will get access to some of those leads and, if they prove viable in smaller trials, GSK will conduct the late-stage trials. Ranbaxy would then get a royalty on sales.

The multinationals are not talking about considerable outsourcing of drug research to India in the near future, but such alliances give them a window to view India's progress.

For all the potential growth that they predict, however, India's pharmaceuticals entrepreneurs are in a hurry. Like many other industries in India, they feel the hot breath of Chinese competition on their necks.

“We have about 10 years to make this transition,” says Dr Sharma at Nicholas Piramal. “If we do not make it by then, we shall be overtaken by China.”

IT experience holds lessons for sector

Many in India believe the country's drugs companies stand at the cusp of rapid growth - but for reasons that differ from those that transformed its information-technology industry, writes Khozem Merchant.

The key difference will result from a robust patent regime that will be implemented next year. The law will apply intellectual property rules, protecting companies' drug discoveries, thereby encouraging domestic and foreign companies to invest in research. By contrast, the IT industry's explosive growth in India happened without regulation. If the law is effectively enforced, Indian - and foreign - drugs companies could be able to climb the “value chain” far earlier than had been the case for their IT cousins.

Another difference is the gap in human resources. India's pharmaceuticals sector needs, but appears to lack, the mature biomedical community that commercial research requires.

“The academic contribution is particularly crucial in drugs innovation because so much flowers from researchers who can nurture drug discovery. But India's university-based research departments are not market driven,” says Nermeen Varawalla, vice-president at PRA International, a US clinical trials company set to open a testing centre in Mumbai. Yet, Dr Varawalla says, the best pharma companies are still dependent on a global network of Indian scientists.

Nevertheless, Indian pharmaceuticals companies can learn much from the experience of their IT cousins. First, India's IT companies jumped into low-end and low-value services, while pharmaceuticals companies must “fight commoditisation of their services”, says Ferzaan Engineer, chief executive of the Indian arm of Quintiles, the US clinical trials group. “We've got abundant home-grown chemistry skills and a mature IT industry to offer data-mining services based on, say, cardiovascular monitoring.”

One sign of high value services in pharmaceuticals is the emergence of back-office clinical trials facilities. These offshore outsourcing services are far removed from the less complex tele-sales that have made their IT counterpart the fastest expanding segment in technology services.

Second, big Indian pharmaceuticals companies have responded to the patent law, not only by declaring their research and development ambitions, but also by installing the technology and plant that have met US regulatory requirements. That strengthens their hand in global competition, making them stronger than most of the early IT service companies.

Third, huge R&D costs have led Indian companies to collaborate, not only with global industry leaders, but also with other Indian companies and across sectors. Raghunath Anant Mashelkar, the government's chief scientific adviser, cites an alliance between 18 public-sector research bodies and Tata Consultancy Services - a private company - that yielded software for bioinformatics at a fraction of the usual cost.

Fourth, Sunil Mehta, vice-president of Nasscom, the Indian IT trade lobby group, says Indian pharmaceuticals companies “should follow our lead and speak in the language of global customers”. But perhaps IT's biggest lesson for pharmaceuticals is showing the necessity a to create network of advisers, investors and lobby groups. “That will position Indian pharma for the huge healthcare opportunity in US and Europe, where high costs are forcing suppliers to turn to India.”

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Postby Vivek_A » 19 Aug 2004 04:47

[url=http://www.newscientist.com/news/news.jsp?id=ns99996300&lpos=home1]Synthetic drug offers malaria hope
[/url]

Clinical trials of a synthetic malaria drug have begun in the UK. The newly developed drug, which has similar properties to the naturally occurring substance artemisinin, could replace expensive plant extracts. Its developers hope it will help counter the resurgence in drug-resistant forms of the disease.

Now, a synthetic drug, with apparently similar properties to artemisinin, has been produced by Jonathan Vennerstrom of the University of Nebraska Medical Center in Omaha, US, and his colleagues. It is cheap to make and is being developed by the pharmaceutical company Ranbaxy of New Delhi, India, and Malaria for Medicines Venture (MMV), a non-profit organisation based in Geneva, Switzerland. The drug is now being tested for safety in humans.

Update 1: India Company Develops New Malaria Drug

Update 1: India Company Develops New Malaria Drug
08.18.2004, 10:49 AM

India's Ranbaxy Laboratories announced Wednesday it has developed a new anti-malarial drug, which it claimed would be cheaper and as effective as the drugs now used to cure the disease that kills more than a million people worldwide every year.

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Postby Vasu » 23 Aug 2004 19:15

Three Indian biotech firms plan R&D labs in Frankfurt

Three Indian biotech firms, including two from the city, planned to set up research and development centres at the Frankfurt Innovation Centre for Biotechnology (FIZ), a top FIZ official said on Monday.

"We are in final stages of discussions with three Indian firms to set up base at FIZ. Two are from Bangalore and the other from Pune," FIZ managing director and CEO Christian Garbe told reporters.

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Postby Vasu » 24 Aug 2004 08:28


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Postby Vivek_A » 28 Sep 2004 02:42

Glenmark in record licensing deal

By Khozem Merchant in Mumbai
Published: September 27 2004 03:00 | Last updated: September 27 2004 03:00

Glenmark Pharmaceuticals will receive $190m over five years from Forest Laboratories of the US after signing the biggest ever licensing deal between an Indian drugs maker and a global pharmaceuticals giant.

The deal will see Forest develop Glenmark's asthma molecule, which if successful could yield additional sales royalties in a North American market estimated at $1.5bn-$2bn, according to one analyst. The drug is ready for early clinical trials.

The transaction strengthens India's status as a hub for biomedical innovation, which is being fuelled by new rules to guard intellectual property and the rising costs of R&D in western countries. It also bolsters India's $5bn drugs sector's international ambitions.

Drugs innovation has been the weakest link in an Indian pharmaceuticals sector that has focused on generic drugs because it requires large capital expenditure with no guarantee of a pay-off.

But big Indian companies such as Dr Reddy's in Hyderabad and Delhi-based Ranbaxy, the largest Indian drugs maker, have led the way in transforming their profile from copy-cat manufacturers to developing new chemical entities.

The experience has been mixed. Only six Indian companies have signed licensing pacts with global drugs companies with milestone payments totalling about $50m.

Glenmark's deal with Forest, which has a market capitalisation of $16bn, is seen as a landmark because the drug has emerged from a relatively small company. Glenmark's sales were Rs3.8bn ($83m) last year, of which 6.5 per cent went on R&D, above the industry average.

"We can only take innovation so far because the risk profile [of molecules] rises through clinical trials," said Glenn Saldanha, chief executive of Glenmark. "We needed a big partner with wider capabilities to share the cost."

According to analysts, Dr Reddy's, Ranbaxy and Orchid, a Mumbai company, are soon expected to announce licensing deals covering treatments in diabetes and asthma.

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Postby Sohum » 17 Oct 2004 20:39

http://sify.com/finance/fullstory.php?id=13591557
Drugs on watch list after Rofecoxib ban
Sunday, 17 October , 2004, 08:34

Following the Government's decision to ban Rofecoxib (an anti-arthritis drug), just weeks after Merck voluntarily withdrew its branded version Vioxx, the Health Ministry plans to review the status of drugs that were previously banned or withdrawn from the international market.

Highly placed sources in the Ministry said there are several drugs that have gone off the market in the US due to serious side effects but are still available in India. "We will monitor the level of usage of these drugs and side-effects they can cause," said sources.

They said that concerns have been voiced about 10 drugs that have either been banned globally or whose use is severely restricted or not approved, but are available in India.

These include cerivastatin (cholesterol-lowering drug), droperidol (to reduce nausea and vomiting), furazolidone (to treat infectious diarrhoea and enteritis caused by bacteria), lynestrenol (hormonal agent), nitrofurazone (anti-bacterial for burns), phenformin (for diabetes), phenylbutazone (anti-inflammatory drug), piperazine (treatment of worm infections) and quiniodochlor (anti-fungal).

"Also, the use of nimesulide, a non-steroidal anti-inflammatory drug, which has been reported as causing liver toxicity is something that is to be examined," said sources. In August 2003, the Government banned the anti-allergy drugs astemizole and terfenadine.

According to available data, more than 13 drugs have been withdrawn from the market. However, single-ingredient formulations of some medicines such as phenformin, lynestrenol, piperazine and analgin have been permitted after consultation with medical experts, subject to a cautionary statement and contraindications being given on the label or package insert.

But for now, the Government has recommended the cautious use of other selective cycloxygenase II (Cox II) inhibitory drugs, though there are no immediate plans to ban these drugs. However, the Health Ministry will watch how this class of drugs behaves.

Meanwhile, the National Pharmacovigilance Advisory Committee (NPAC), comprising experts from the medical fraternity, will meet next month to chalk out strategies for effective monitoring.

"The NPAC will conduct studies on various drugs available in the market and how different drugs in the same class behave. It will try to work in a co-ordinated fashion with clinicians in various universities and medical colleges," said sources.

Industry sources said the drugs that have been withdrawn in the international market are generally not available in the country.

"Indian companies in recent times have been swift to respond to such situations. The number of banned drugs in circulation has come down," said an industry source

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Postby Kakkaji » 18 Oct 2004 18:55

Shourie gives Rs 12 crore to IIT-Kanpur! 8)

http://us.rediff.com/money/2004/oct/18spec1.htm

But the former telecom minister also had a few more pre-conditions. Turning his eyes to the future, he wanted to put the money into an area of frontier research. He wanted to tie up with an 'institute of excellence' and he wanted the money handed over directly.

"I didn't want to be involved in the handling and distribution of the money. The institute had to be one which had such a clean reputation that it was above question," Shourie said.

Finally Shourie had one more condition -- he wanted the building to be modern state-of-the-art construction with energy saving features. "I was very clear that if a building was involved, then it should be an education by itself."

The result is the new Biological Sciences and Bioengineering (BSBE) department at the Indian Institute of Technology in Kanpur. The 16-lab department is housed in a 64,000 sq ft building equipped with the latest research tools needed for molecular biology and other types of bio-engineering.

Inside the BSBE's portals a faculty of eight and about 75 students are carrying out research in a range of cutting-edge fields like DNA sequencing, tissue restructuring (which involves creating artificial human skin), bioinformatics and computational biology.

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Postby Sohum » 20 Oct 2004 23:21

India has long boasted an army of talented chemists but for the last two decades they have been mostly focused on finding ways to copy other companies' drugs. Under a patent law dating from 1970 Indian companies have been allowed to sell versions of prescription drugs as long as they used a different manufacturing process.

That is all about to change, however. From the beginning of 2005, drug patents will apply in India as part of the World Trade Organisation's intellectual property rules. As a result Indian companies will no longer be able to rely on their lucrative domestic market. The search for new business models is being driven by necessity.


I think one other important point is that while many proprietary drugs are on the market, there are many other drugs on market whose patents have expired and continue to be manufactured. Indian pharma can focus R&D on process chemistry to remove inefficiencies in processing of these chemicals to further gain comparative advantage.

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Postby Sohum » 20 Oct 2004 23:30

Biocon, Nobex to develop oral insulin
http://us.rediff.com/money/2004/oct/20biocon1.htm
October 20, 2004 17:52 IST
Last Updated: October 20, 2004 18:03 IST

Bangalore-based Biocon Ltd and a US biotech firm Nobex Corporation will jointly develop an oral insulin product for the treatment of diabetes.

The collaboration combines the peptide production capabilities of Biocon, with the proprietary peptide oral-delivery technology of Nobex, Biocon said on Wendesday.

The two companies would focus on the development of an oral insulin product that can be used to treat the world diabetic population, which is estimated to increase to more than 20 crore (2 billion) by the year 2030, Biocon said.

The two companies indicated that the collaborative effort in developing the oral insulin product would require several years to reach the market.

Kiran Mazumdar-Shaw, chairman and managing director of Biocon and Nobex's president and CEO Christopher H Price said they expect to have significant clinical data and make firm progress towards manufacturing within two years.

Mazumdar-Shaw said the agreement provided for Biocon to invest in the equity of Nobex. Mazumdar-Shaw did not disclose other financial terms of the deal citing commercial sensitivity and confidentiality.

Nobex, a privately held drug development company based in North Carolina's Research Triangle Park and specialises in medicinal chemistry applied to optimising the delivery of therapeutic peptide drugs by oral and other non-injectable routes of administration.


Already India has become location for process chemistry. This is type of work that will be outsourced by pharma companies now.

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Postby Sohum » 22 Oct 2004 08:55

New business model for biotech soon
Friday, 22 October , 2004, 08:48
http://sify.com/finance/fullstory.php?id=13595869

The Centre is scripting a "win-win" business model for the fledgling biotechnology industry so that the fund-starved sector can enter into equity-based partnerships with Government agencies.

This will help biotech companies to avoid dependence on grants and financial support from the Government, while getting free access to technology.

The Union Minister for Science & Technology, Kapil Sibal, assured industry representatives that his Ministry was drafting such a plan in public-private partnership (PPP). With all its risks, a PPP, he said, was a viable way for enterprises to thrive. The Government through its agency would pick equity in the joint venture that the company would float. In turn, the enterprise would get technology transferred free of charge from a public lab. Profits from successful venture would be ploughed back into further research projects.

Sibal was briefing the media after an interaction with the members of the biotech industry. He said the industry mainly raised issues related to duty anomalies, funding, intellectual property and regulations.

All these would be addressed in the National Biotechnology Policy that the Department of Biotechnology was working on. The policy framework would be announced in January 2005. The policy would also draw suitable inputs from the report that the Swaminathan task force report on agri biotech has submitted and the Mashelkar report that is coming out shortly on DNA drugs.

The DBT Secretary, M.K.Bhan, had announced the plan for such a policy during the Bangalore Bio conference held in July.

The new WTO-compliant Patents Act would also be in place by January 2005 and would take care of the IP issues of the knowledge-based industry. "The Government will not violate its international commitments," he said.

At the same time, a Bioinformatics Policy, the first in the world, was also in the making and would be announced around May 2005. The first draft was ready and consultations were on among the IT, communications and S&T Ministries.

All these measures would attract huge amounts of FDI into the nearly $ 1-billion domestic biotech sector and make it a $ 10-billion global industry.

Sibal said his Ministry found it difficult to approve proposals like a biotech seed capital fund. He recalled that a well-meaning move for a drug development fund got whittled down from Rs 500 crore to just the interest on a corpus of Rs 25 crore. "The PPP model will be such that we do not have to go the Finance Ministry every day."

However, a good PPP calls for synergy among the activities of the four elements - academia, labs, government agencies and the entrepreneur.

The Ministry planned to tackle the long procedural and regulatory delays in approvals for biotech products through a single-window mechanism. It was also looking at a need to have "at least 20 more Indian Institutes of Science" to address the emerging HR needs of the industry.

The diagnostics sector raised the problem of import duty anomaly, where the indigenous kit manufacturer paid 16 per cent import duty for raw materials, while whole kit imports had no duty. Sibal said this would be taken up with the Finance Ministry. He hoped to get the biotech sector the same incentives that the IT industries enjoy.

The interaction was organised by ABLE - the Association of Biotechnology-Led Enterprises. ABLE represents some 90 companies across the country.

George J

Postby George J » 22 Oct 2004 18:38

Sohum Desai wrote:
India has long boasted an army of talented chemists but for the last two decades they have been mostly focused on finding ways to copy other companies' drugs.........

........ beginning of 2005, drug patents will apply in India as part of the World Trade Organisation's intellectual property rules. As a result Indian companies will no longer be able to rely on their lucrative domestic market. The search for new business models is being driven by necessity.


I think one other important point is that while many proprietary drugs are on the market, there are many other drugs on market whose patents have expired and continue to be manufactured. Indian pharma can focus R&D on process chemistry to remove inefficiencies in processing of these chemicals to further gain comparative advantage.


Actually India is doing quite well in the field of NDDS: Novel Drug Delivery Design System. These are creating new and better methods of introducing drugs into the body: works well for generics (metformin sust. release) and near generics (Ciproflox sust. release).

Also most of the cost of drug development (i.e. bring a molecule into the market post patent) is clinical. Preclinical is peanuts compared to the clinical stages. Thats why most of the phase II and III for molecules discovered in India are currently being done aborad. Outlicensing (or in-licensing from India) is very profitable (provided at least one of your molecules clicks...which is a 1:10,0000 shot).

George J

Postby George J » 28 Oct 2004 20:08

Novo terminates further clinical development of DRL's Balaglitazone

Novo Nordisk has decided to terminate further clinical development of balaglitazone, as the preclinical results did not suggest a sufficient competitive advantage for balaglitazone compared to similar, marketed products within this therapeutic category, explained the communique.

Balaglitazone (DRF 2593) is an insulin sensitizer, which acts as a partial PPAR gamma agonist for the oral treatment of patients with type 2 diabetes. Dr Reddy's licensed this molecule to Novo Nordisk in 1997, the communique added.



This is what I have been talking about all this while. Drug development is NEVER easy. I remember way back then this molecules was first out licensed, it was supposed to open the floodgates of Desi Made molecules. I believe this was a $10 million molecule with prospective royalties if it hit the market. I am amazed to see that it was sold at pre-clin and it flunked when the buyer performed further pre-clin. I hope DRL did not dupe them coz that would be a very bad precendent. But then again I have seen this happen on a $1.3 Billion scale too in the US.

Thats why i keep saying until a desi drug enters Phase III there is nothing to crow about. And there are none currently in India or abroad.

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Postby manju » 29 Oct 2004 23:44

Today's Wall Street Journal carries an article on Indian AIDS drug manufacturers ... the first page of market place section.

Some important numbers avaiale.. I just read it from hard copy

If any of you have online access please post it here.

Thanks

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Postby svinayak » 30 Oct 2004 00:58

Fair usage


U.S. Pays High Prices
For Global AIDS Drugs, Study Says

By SARAH LUECK
Staff Reporter of THE WALL STREET JOURNAL
October 29, 2004; Page B1

The U.S. government is paying twice as much for many of the drugs in its global AIDS program as other international aid organizations are, because the Bush administration won't buy cheaper versions made in India , congressional investigators found.

A draft report by the Government Accountability Office -- the first independent comparison of the AIDS-drug prices -- shows that the lowest price available to the U.S. for one common AIDS-drug regimen, stavudine, lamivudine and nevirapine, is $562 per person annually. That compares with $215 available to international AIDS groups not bound by U.S. restrictions.

The stark price differences mean that President Bush's five-year, $15 billion global AIDS fund won't go as far as it might have. The GAO data was provided by Senate Democrats, who have criticized the Bush administration for not buying Indian-made drugs that combine three AIDS medicines into one pill, but violate U.S. patent laws because they are copies of brand-name products.

Public release of the report, based on a survey of AIDS drugmakers, will come only after the administration submits formal comments to GAO. Mark Dybul, chief medical officer for the Office of the U.S. Global AIDS Coordinator, acknowledges that prices for Indian-made pills are lower than the drugs the U.S. is buying. But spending on medications, he says, is a relatively small part of U.S. spending for treatment. Training of staff, salaries, lab tests and infrastructure cost far more, he said.


Administration officials have said for months that they will buy the cheaper drugs once the Food and Drug Administration certifies their safety. The Bush administration says it regards the issue as one of drug safety rather than a fight over generic versus brand-name drugs. But a special FDA approval process, set up with great fanfare in May, hasn't produced a single approval of a three-in-one AIDS pill, partly because some companies haven't submitted applications.

AIDS advocates call the FDA review unnecessary and say the administration should treat the epidemic as an emergency, especially in sub-Saharan Africa, where an estimated 25 million people are living with HIV or AIDS. The combination pills, made by Indian companies Ranbaxy Laboratories Ltd. and Cipla Ltd., are cheaper and cut the number of pills patients must take daily from six to two.

Other international AIDS-treatment programs, such as those funded by the Global Fund to Fight AIDS, Tuberculosis and Malaria and the World Bank, are using the Indian-made drugs that have been "prequalified" by the World Health Organization.

According to the U.S. AIDS coordinator's office, a survey of selected grantees found the difference between buying the cheaper Indian drugs and more costly brand-name drugs adds about 16% to the cost, about $200 per patient per year -- or $13 million more for the 57,000 patients the grantees plan to serve this fiscal year. "It's not nothing," Dr. Dybul says, adding that the one-year additional cost is the price of "knowing the drugs are safe."

The WHO has removed a few of the Indian drugs from the "prequalified" list because there were problems found with the data.

The big U.S. drugmakers don't produce the AIDS combination drugs; separately they make the individual components that are patented in the U.S. Even if the Indian-made drug cocktail received FDA approval, they wouldn't be sold in the U.S. because of the patent restrictions.

The GAO's draft report shows that different manufacturers make each of the drugs in the cocktail -- with varying prices. The U.S. pays nearly $450 per patient annually for Boehringer Ingelheim's nevirapine; generics available to other treatment programs run $120 to $170. GlaxoSmithKline PLC's zidovudine costs the U.S. about $200 annually per patient, compared with $125 to $175. For others, including Bristol-Myers Squibb's stavudine and Glaxo's lamivudine, the U.S. pays about the same as international groups.

Nancy Pekarek, a spokeswoman for London-based GlaxoSmithKline, questions whether the makers of the copy drugs would provide a dependable supply of the medicines, which patients must continue to take for the rest of their lives. But Glaxo isn't fighting the use of the Indian-made versions, as long as they're limited to the developing world. The company has licensed some of its AIDS drugs to generic companies, including South Africa's Aspen Pharmacare Inc., she said. "In Africa, it's not about markets -- it's about access," Ms. Pekarek said. But it "would be a huge problem if generic companies were allowed to completely ignore patent rights and bring drugs into countries like the U.S," she added.

"We need to make sure drugs taken by people around the world are safe," says Mark Grayson, a spokesman for the Pharmaceutical Research and Manufacturers of America, the main industry trade group. Brand companies also are considering working together on making combination AIDS drugs, or at least co-packaging their products together, for global AIDS treatment, Mr. Grayson notes.

To win FDA approval for the foreign-made generics, the manufacturers must show their drugs are equivalent to brand-name products and provide detailed information about chemistry and production. They can't simply duplicate information already given to the WHO and must permit FDA inspection of their plants.

"It may take three weeks once you get to FDA, but what is required to take to FDA?" asks Bill Haddad, an advisor to Cipla Ltd. He says he is in talks with the FDA about what data Cipla will need to submit to win agency approval for the company's three-in-one AIDS drug. While the FDA has been helpful, he says, the process is cumbersome and Cipla is still debating whether it's worthwhile to apply.

Once a company completes an application with the FDA, the agency says it would be able to grant approval quickly, perhaps in less than six weeks. The approval is "tentative," meaning drugs are safe and effective but can't be marketed in the U.S. because of patent restrictions. The administration has said it will purchase the drugs for overseas use, however, as long as the FDA says they are safe.

Ranbaxy spokesman Chuck Caprariello says the company applied last week for FDA approval of one medication, and plans to submit applications for 12 other products, including its three-in-one combination drug, early next year. The company had to re-do studies showing its products are equivalent to the brand-name versions. Aspen of South Africa says it will apply for FDA approval. Dr. Dybul of the AIDS coordinator's office says he is "hopeful" that a three-in-one pill will win FDA approval early next year.

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Postby manju » 31 Oct 2004 21:20

DhanayadhegaLu Aacharya!

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Postby Manu » 30 Nov 2004 08:10

http://www.rediff.com/money/2004/nov/30spec.htm

Hyderabad: India's Genome Valley

George Iype | November 30, 2004


"If Bangalore is the Silicon Valley, Hyderabad is the Genome Valley. India's future is in biotechnology," Andhra Pradesh Chief Minister Dr Y S Rajasekhara Reddy is excited as he makes a presentation on the biotech boom that is taking place in Hyderabad.

Truly, Dr Reddy has made a point.

Hyderabad has fast emerged as the biotech hub of India. The government of Andhra Pradesh has christened the city 'Genome Valley.'

"Genome Valley is our answer to the Silicon Valley of Bangalore. It is making waves not just in India, but across the world," an official assisting Dr Reddy in the biotechnology sector points out.

The figures that the chief minister's office provides are impressive. A journey later to the biotech clusters in and around Hyderabad testifies to the credentials of Genome Valley.

Genome Valley is India's first state-of-the-art biotech hub that provides research, training, collaboration and manufacturing activities for biotech companies. It is spread over 600 square kilometers. More than 100 biotech companies are operating out of the Genome Valley today.

"Yes, Hyderabad has already become India's biotech hub. It is our Genome Valley as several leading scientific research organizations and biotech companies are functioning from here," says Deepanwita Chattopadhyaya, Chief Executive Officer, ICICI Knowledge Park in Hyderabad.

The Park is situated in an aesthetically landscaped lush green 200-acre campus in Turkapally, near Hyderabad. It offers plots of land -- of varying sizes -- to build research centres and pilot plants as per specific requirements of resident companies.

The Knowledge Park says India's future is in the Genome Valley. It provides the statistics to prove the point:

India has more than three million scientific and technical manpower; India has over 0.6 million science and technology post graduates.
India has some 700,000 graduate engineers; the country gives over 3,500 doctorates in sciences every year.
After the United States, India is home to the largest pool of English-speaking scientific manpower.
Nearly 40 per cent of the start-ups in Silicon Valley in the US were from Indians.
One out of every ten scientists in the US is an Indian.
But what did the Andhra Pradesh government do to identify that biotechnology was the engine of growth for the state to succeed?

First, some years ago, the government launched India's first biotech venture fund with a corpus of $30 million. It was a joint venture between the Andhra Pradesh Investment Development Corporation and Dynam Venture East of the US. The venture fund began to finance start-up biotech companies.

Soon, there was a rush from Indian and foreign companies to Hyderabad, making it Genome Vallaey. Some of these firms are:

Shapoorji Pallonji Biotech Park: The Rs 100 crore (Rs 1 billion) project is spread over 400 acres. It provides state-of-the art infrastructure with support facilities like instrumentation facilities, incinerator, secondary effluent treatment plant, distilled, deionised DM water, cold storage and water housing facility, and animal house.

It has a technology incubation centre. A belt of 25 kilometers around the park has been declared as a 'pollution free zone.' The Park runs a pilot plant for the validation of the commercial viability of technologies and products.

ICICI Knowledge Park: It is a world-class centre for leading-edge, business-driven research in the country. The Park is also India's first knowledge network for collaboration between research. It is a 200-acre campus with world-class infrastructure and support facilities. It is promoted by the ICICI Group.

It encourages research and development in all knowledge-intensive fields. The current focus of the Park is on the areas of biotechnology, pharmaceuticals technology, specialty chemicals, new materials, information technology and telecommunications.

Biotechnology Incubation Centre: It runs research and development laboratories, multi-utility plant, specialised pilot plant and an analytical and quality control center.

Agri -Business Incubator of ICRISAT: The Agri-Business Incubator provides business support to existing and new agri-business, developed and housed at ICRISAT. The incubator helps in reducing the risk in commercialization of agri-technologies.

It has built a network with R&D centers of excellence, universities, academic institutions and agricultural-related incubators and incubates globally.

Apart from these major parks, Genome Valley is home to the leading biotechnology institutions and private pharma companies.

The institutions include: Indian Institute of Chemical Technology, Centre for Cellular and Molecular Biology, National Institute for Nutrition, and Centre for DNA Fingerprinting and Diagnostics.

Top private biotech companies include: Avra Laboratories, Bharat Biotech International, Bijam Biosciences, Biological E. Ltd, Bioserve Biotechnologies, Dr Reddy's Laboratories, Genotex International, GVK Bio, Indian Immunologicals Ltd, Indigene Pharmaceuticals, Jupiter Biosciences, Krebs Biochemicals, Microbiomed Products, Nuziveedu Seeds, Prabhat Agri Biotech, Satyam Computer Services, Shantha Biotechnics, Tata Consultancy Services and Vimta Labs.

Chief Minister Reddy says Genome Valley is forging ahead. "We have a well-defined policy to forge a private-public partnership in the development of biotechnology in the state," says Reddy.

The government's target, the chief minister says, is the large number of scientists from Andhra Pradesh, who are at present engaged in research, academics or manufacturing in the field of biotechnology in the US.

Officials say Genome Valley will leapfrog into the big league in the days to come.

The signs are showing in the projects that are in the pipeline:

An international life science institute is being set up in Hyderabad.

Indian Council of Medical Research is setting up a National Animal Resource Facility for Biomedical Research in collaboration with the National Institutes of Health of the US.

An Umbilical Cord Stem Cell Bank, a bio-medical research centre and a state-of-the art maternity/ neo-natal hospital are being set up by the Pacific Health Care Holdings, Singapore.

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Postby Rakoi » 29 Dec 2004 04:32

UCLA-VA study names India dietary staple as potential Alzheimer's weapon
http://www.eurekalert.org/pub_releases/2004-12/potn-usn122804.php

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Postby Vasu » 31 Dec 2004 06:49

[url=http://www.financialexpress.com/latest_full_story.php?content_id=78341]New patent law to shake up drug industry
[/url]

The Indian drug industry enters a new era in 2005 when laws recognising foreign patents take effect, ending a copycat trade that has fostered local pharma firms for three decades and helped bring cheaper medicines to the poor.

By presidential decree this week, India met a World Trade Organisation commitment to recognise foreign patents from Jan 1, the culmination of a 10-year process. The change will become law if ratified by parliament at its next session in February.

India has allowed its pharmaceutical makers to copy drugs patented abroad since the early 1970s, as long as they used different manufacturing processes.

The new rules do not apply to drugs patented before 1995, so Cipla Ltd can continue selling its widely distributed version of the HIV treatment AZT. Even copies of drugs patented between 1995 and the introduction of the law are unlikely to be withdrawn.

Nor are foreign companies expected to introduce a flood of new products they have so far kept off the Indian market. Most are still grappling with the nitty-gritty of the proposed law and fear that questions about what is or isn't patentable will ultimately be answered in the courts.

To adapt, domestic firms such as Ranbaxy, Dr Reddy's Laboratories Ltd, Cipla, Wockhardt Ltd and Sun Pharmaceutical Industries Ltd have been seeking new revenue streams.

The larger companies are looking overseas as drugs worth billions of dollars go off patent, or aim to become suppliers of drug ingredients for pharmaceutical majors, besides doing contract research such as complex chemical synthesis.

India has more than 70 US-approved manufacturing plants -- the most in the world outside the United States -- and could become a production hub because of its cheap, skilled labour.


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Postby Katare » 31 Dec 2004 23:53

Vasu wrote:[url=http://www.financialexpress.com/latest_full_story.php?content_id=78341]New patent law to shake up drug industry
[/url]

The Indian drug industry enters a new era in 2005 when laws recognising foreign patents take effect, ending a copycat trade that has fostered local pharma firms for three decades and helped bring cheaper medicines to the poor.

By presidential decree this week, India met a World Trade Organisation commitment to recognise foreign patents from Jan 1, the culmination of a 10-year process. The change will become law if ratified by parliament at its next session in February.

India has allowed its pharmaceutical makers to copy drugs patented abroad since the early 1970s, as long as they used different manufacturing processes.

The new rules do not apply to drugs patented before 1995, so Cipla Ltd can continue selling its widely distributed version of the HIV treatment AZT. Even copies of drugs patented between 1995 and the introduction of the law are unlikely to be withdrawn.

Nor are foreign companies expected to introduce a flood of new products they have so far kept off the Indian market. Most are still grappling with the nitty-gritty of the proposed law and fear that questions about what is or isn't patentable will ultimately be answered in the courts.

To adapt, domestic firms such as Ranbaxy, Dr Reddy's Laboratories Ltd, Cipla, Wockhardt Ltd and Sun Pharmaceutical Industries Ltd have been seeking new revenue streams.

The larger companies are looking overseas as drugs worth billions of dollars go off patent, or aim to become suppliers of drug ingredients for pharmaceutical majors, besides doing contract research such as complex chemical synthesis.

India has more than 70 US-approved manufacturing plants -- the most in the world outside the United States -- and could become a production hub because of its cheap, skilled labour.



Ney psy-op for robust bear :eek: :D

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Postby Sohum » 08 Jan 2005 19:47


George J

Postby George J » 09 Jan 2005 00:12

Eeeh...there is nothing earth shattering about having 70 USFDA plants. Whats important are how many formulations per plant are USFDA approved. In 1997 I heard that Cipla's Patalganga plant had 13 products that were USFDA approved.

Also realistically speaking if you want to enter the generic (or branded) mkt in the US you HAVE TO get your formulation lines approved by the FDA, so its par for the course.

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Postby Sohum » 31 Jan 2005 22:28

Dr.Reddy's Q3 profit plunges on competition, costs

I remember reading in C&EN that this was a particularly terrible year for India pharma industry. Looks like a good buy :twisted:

The New York Stock Exchange-listed drug maker has not had a major generic launch since its exclusive marketing rights for a version of Eli Lilly & Co.'s anti-depressant Prozac ended in January 2002.


Dr. Reddy's bears big legal bills from challenging patents. Key battles are with Eli Lilly over its schizophrenia drug Zyprexa, Sanofi-Aventis for blood-thinner Plavix, and GlaxoSmithKline Plc for anti-nausea drug Zofran.

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Postby Vick » 22 Feb 2005 05:25



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