Indian Biotech News & Discussion

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Rudra
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Indian Biotech News & Discussion

Postby Rudra » 02 Sep 2003 22:39

The age of biotech is upon us. one has to adapt to
changing trends, hence time to start a thread specific to biotech,pharma and related areas.
better rice, designer branded kids, potions of owls
testicles to see better in dark, fierce squirrels
genetically enhanced to gorilla strong and bred to sniff out jihadis, croco-cats, lion-dogs and the more ho-hum world of "conventional"
medicines.theres a lot of fun to be had in bio.

AP Govt gets 3 NRI firms to start centers
http://www.rediff.com/money/2003/sep/02biotech.htm

Portal with links to bangalore bio firms and news
http://www.bangalorebio.com/

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Re: Indian Biotech News & Discussion

Postby venkat_r » 03 Sep 2003 00:19

This might have some hype and presentation skills of Naidu.. but none the less impressive

http://www.aponline.gov.in/Quick%20Links/Industrial%20Policy/biotechnologypolicy.pdf

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Re: Indian Biotech News & Discussion

Postby AJay » 03 Sep 2003 01:57

Originally posted by Rudra Singha:
AP Govt gets 3 NRI firms to start centers
http://www.rediff.com/money/2003/sep/02biotech.htm
[/QB]
I gave a quick scan of the contents here. The AP guys are giving VC funding to the tune $0.5 Millon each to these three companies for a stake of 15%-25% in each of these. One of the companies is supposed to be doing drug discovery and molecular modeling and the founder is Chandra Singh who the article says is credited with developing AMBER, GAUSSIAN and GIBBS. I looked up the development team of AMBER and Chandra Singh is one of a long list of 25 poeple. The main players are people from Scripps, UCSD, UCSF etc. What I wonder is whether $500K is a steep price for 25% - erring on the positive side here and assuming that AP govt. is getting on the higher side of the stated range - of a company that is basically going to use some publicly available open source software package to service their clients.

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Re: Indian Biotech News & Discussion

Postby GGanesh » 03 Sep 2003 02:19

Check this out. Very Impressive

http://www.srlranbaxy.com/index.htm

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Re: Indian Biotech News & Discussion

Postby Kakkaji » 03 Sep 2003 23:23

Scientists are BARC-ing up the banana tree

http://www.indianexpress.com/full_story.php?content_id=30839

I hope these BARC-developed technologies can be commercialized fast.

I saw samples of low-level-irradiated potatoes and onions at BARC almost 25 years ago. This technology has not yet reached the market in India where it could save thousands of tons of produce from going to waste. :( Even the ultra-safety-conscious markets of the West have been using this technology for some time now.

Our labs do some great work on the agro-tech front, but the farmers and consumers have not yet benefited. I hope it changes soon in the agro-tech front as it has lately in other fields.

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Re: Indian Biotech News & Discussion

Postby Kakkaji » 08 Sep 2003 23:16


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Re: Indian Biotech News & Discussion

Postby Kakkaji » 20 Sep 2003 01:09

NDDB arm to develop rabies vaccine — To set up plant, R&D centre

http://www.thehindubusinessline.com/2003/09/20/stories/2003092001450200.htm

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Re: Indian Biotech News & Discussion

Postby Arun A » 03 Oct 2003 22:09

Protein database unveiled

An international team of scientists this week unveiled the Human Protein Reference Database, an online database that currently contains entries for the 3000 most-studied human proteins. Information on a total of 10,000 proteins is expected to be in the database by year's end, freely accessible to noncommercial researchers.

Dozens of researchers at the Institute of Bioinformatics in Bangalore, India, created the database with colleagues in the United States, Belgium, Denmark, and Spain. They critically reviewed hundreds of thousands of scientific papers, drawing connections between papers and resolving inconsistencies. Each researcher read an average of at least 10 to 20 papers each every day, with every protein reviewed twice.

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Re: Indian Biotech News & Discussion

Postby svinayak » 18 Oct 2003 06:08

India a `rich' market for clinical trials?
Amit Mitra

Pharma industry analysts say that the present trend reflects global CRO majors joining forces with the Indian CROs for undertaking a range of clinical trials.

Mumbai , Oct. 17

THE fact that India has a huge population, especially in the rural areas, that has had no access to modern medical services may be spreading ripples of concern amongst the country's medical fraternity, as it mirrors the poor penetration of drugs in India. But for global pharma majors, this represents a potential market for clinical trials of a wide range of untested drugs.

The reason - certain protocols for clinical trials require certain drugs to be tested on such `uncontaminated' patients, or people who have not been subjected to any drugs.

This, coupled with the existence of a spreading pool of patients with urban lifestyle diseases and tropical diseases, who can be roped in relatively easily for clinical trials and the lower costs involved, is increasingly attracting global clinical research organisations (CROs) to India.

Statistics compiled by the Organisation of Pharmaceutical Producers of India (OPPI) indicate that the clinical trial sector in India has burgeoned into a $70 million market, which is growing at a brisk pace.

Pharma industry analysts say that the present trend reflects global CRO majors joining forces with the Indian CROs for undertaking a range of clinical trials.

The recent alliance between SIRO, a domestic player, and global CRO major, Covance, may well accelerate the trend in the coming months, as MNCs are increasingly turning to India for clinical trials.

Market sources say that some of the Indian CROs, especially Lotus Labs, are looking out for such alliances with global majors for undertaking clinical trials in India.

Says Mr Alok Gupta, Director-Head of Rabo India's Life Sciences and Biotechnology division: "I foresee a few more such alliances in the coming months. Indian CROs have conducted clinical trials for big MNCs and the products are in the process of being registered in Europe and US. Already MNCs like Novartis, Pfizer, Eli-Lilly have established data management and statistical data analysis centres in India."

What makes India actually a potential laboratory for clinical trials? Firstly, India has a direct cost advantage in the realm of contract research and clinical trials.

For example, a study by Rabo India recently has pointed out that the cost of trials in India is 50 per cent lower than the $20 million required in the US for the phase I study and 60 per cent lower than the $50 million required for the phase II study. Also, India has a lower cost of hiring investigators, nurses, computer operators and recruiting patients.

Further, industry experts indicate that cost of patient recruitment in the US could range from $4,000 to $10,000 per patient while in India these costs are estimated to be lower by 50 per cent.

Secondly, India's advantage lies in the huge population of `uncontaminated' or naïve patients, who are required for testing of certain drugs.

This is because of the low penetration of drugs in India, which is reflected by the fact that India has one of the lowest per capita expenditure on drugs. Recent studies have shown that India's per capita spend on drugs is at a measly level of $3, compared with $97 in UK and $412 in Japan.

Another advantage India has is its biodiversity of population, involving a wide and varied gene pool that can provide a wealth of information for target identification. Said Mr Gupta: "It has been calculated that all of the currently known drugs act against only 500 different molecular targets in the body. It has however been estimated that between 5,000 and 10,000 targets actually exist. I think that genomics will play a greater role in increasing the identification of newer targets."
lk

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Re: Indian Biotech News & Discussion

Postby putnanja » 18 Oct 2003 06:44

India a `rich' market for clinical trials?
Amit Mitra

Is there a regulatory authority in India which monitors the clinical trials? Though the article has a feel good feeling around it, I am a bit worried about these companies treating the patients as mere guinea pigs!! As the law enforcement in these areas are not very good, companies might try to get away with trials/procedures which might not be permitted in the western countries, taking the naive people for a ride.

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Re: Indian Biotech News & Discussion

Postby VinodTK » 27 Oct 2003 05:59

From Sify Finance: Pharma exports to touch Rs25000cr
http://headlines.sify.com/newheadlines/2207wnews4.html

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Re: Indian Biotech News & Discussion

Postby Rudra » 27 Oct 2003 06:11

there have been constant efforts to steal valuable plant, animal and human biodata from India. you are right that certain things not allowed in the West could be attempted in india because there is almost zero supervision of who does what once they get into the cage.

Govt oversight is essential and these cos should be held accountable via lawsuits in the US/EU if need be.

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Re: Indian Biotech News & Discussion

Postby svinayak » 27 Oct 2003 06:35

It can be safely assumed that a major portion of the genetic bio diversity of India has been collected by the west in the last 30 years under the eys of the GOI.

Guest

Re: Indian Biotech News & Discussion

Postby Guest » 27 Oct 2003 07:24

CRO, or Contract Research Outsourcing, offers a lot of potential and risks. Accenture recently bagged a CRO deal from AZ (Astra Zeneca). Though its unclear if they are doing the actual trials or just the paperwork.

Naturally its a big risk for the host nation, therefore we need to strengthen our own laws to protect our citizens.

One of the new "offshoring" thing is CRO, and I have been asked by my firm to look into the same to steal Accentures lead in this space. All I can say is that Pharma cos are rich, with 80% margins, because of the system that allows for it. That same system is slow to change, and naturally they don't want to ruin a good thing - so its pretty tough to change the mind set. Its changing though.... ;) wish I could tell you more.

Rudra S, if you are in Phili, lets try to meetup this week.

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Re: Indian Biotech News & Discussion

Postby Kakkaji » 29 Oct 2003 05:48


Rudra
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Re: Indian Biotech News & Discussion

Postby Rudra » 29 Oct 2003 07:24

DP, I in boston unfortunately. you sound like a guy I could have interesting talks with. drop me a line at robust_bear at yahoo dot com sometime.

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Re: Indian Biotech News & Discussion

Postby wasu » 09 Nov 2003 08:39

Nice article on GangaGen

The virus that heals

http://www.businessworldindia.com/Nov1703/invogue.asp

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Re: Indian Biotech News & Discussion

Postby chaitanya » 09 Nov 2003 22:35

The phage therapy is a wonderful technology! Good going for GangaGen.

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Re: Indian Biotech News & Discussion

Postby Rudra » 22 Nov 2003 21:58

from FinancialExpress.com

Overseas Scientists Flock To Ranbaxy

AJAY JAIN

NEW DELHI, NOV 21: Ranbaxy Laboratories has started globalising its scientific talent pool in a serious way. About 25 scientists from overseas have joined Ranbaxy R&D team in India over the last one year, with a similar number expected to also join in the coming months. While all of these have been of Indian origin, those of other nationalities have started showing interest in working in India with Ranbaxy too.


This has been a gradual process that is picking up steam now. Key personnel to have joined include Rashmi H Barbhaiya who joined just over a year ago as president (R&D) and new drug discovery research vice president Kasim A Mookhtiar who joined six months ago.

The company’s general manager (human resources) Udbhav Ganjoo told FE that Ranbaxy, the only Indian company to do so, recently attended the recruitment fair of the American Association of Pharmaceutical Scientists. “Of the 500 people who registered, 200 applied to meet us. Of these, 60 per cent were of Indian origin,” he said.

Mr Mookhtiar told FE that they are looking for good people to join Ranbaxy, and were colour blind in their choice. “While all recruits so far have been of Indian origin, there is a growing interest from other nationalities too. We can expect them to join once they feel the infrastructure and nature of work is good for them. But then, Delhi is now an international city in many respects,” he said.

“In the coming months, Ranbaxy has a need for 200 scientists of which 20-25 are expected to join from from overseas. We interviewed 96 candidates during our visit to USA recently. About 5-6 would be at the senior level which includes directors and vice presidents,” said Mr Ganjoo.

He added that not only are recruits coming from American universities but renowned pharma companies like Glaxo Smithkline, Pfizer and Wyeth. Mr Mookhtiar himself joined from Bristol Myers-Squibb.

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Re: Indian Biotech News & Discussion

Postby Div » 22 Nov 2003 22:22

I was going through my bookmarks and found this company that I had checked out a few years ago. Not sure what they've done in the last few years, but their website sure looks a lot better. :)

Back then I was told to keep an eye on them...so I'm gonna check them out now.

http://www.strandgenomics.com/

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Re: Indian Biotech News & Discussion

Postby Ananth » 23 Nov 2003 16:17

It is led by the people from the Simputer Team. IISc CAS faculty.

-Ananth
Originally posted by Div:
I was going through my bookmarks and found this company that I had checked out a few years ago. Not sure what they've done in the last few years, but their website sure looks a lot better. :)

Back then I was told to keep an eye on them...so I'm gonna check them out now.

http://www.strandgenomics.com/

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Re: Indian Biotech News & Discussion

Postby Arthur » 21 Dec 2003 08:25

What is the regulatory environment like in India?
Can I start up the 'Kwiki Clone Shop' or the 'Customized Transgenic Pet Centre' ?
Where does India stand compared to other countries in terms of research and capabilities in these areas?

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Re: Indian Biotech News & Discussion

Postby arun » 21 Dec 2003 09:36

Originally posted by Arthur Dent:
What is the regulatory environment like in India?
Can I start up the 'Kwiki Clone Shop' or the 'Customized Transgenic Pet Centre' ?
Where does India stand compared to other countries in terms of research and capabilities in these areas?
Now if you were planning to clone the “ Ravenous Bugblatter Beast of Traal “ you have a client for both your shop and centre (Free towel to go with puchase, I insist on that!).

On a more serious note for the regulatory environment check out if you get anything on this site.

For a broad overview on the Biotech industry read this.

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Re: Indian Biotech News & Discussion

Postby Kumar » 21 Dec 2003 10:14

AFAIK as of now there are no laws on cloning or transgenic pets in India. That may change in future though. Courts can of course be made to interfere if some arguments like "danger to public safety" can be provided convincingly.

The recent case of some Indians developing a red glowing fish by genetic manipulation and trying to sell it around the world as a new pet fish comes to mind. Also pest resistant genetically modified crops (GM) have been tesetd in India.

It seems at the moment genetic manipulation in animals is regarded at the same level as in plants. And India of course has huge agricultural research activity that also deals with developing newer vrieties of crops by genetic manipulation.

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Re: Indian Biotech News & Discussion

Postby Sidd » 22 Dec 2003 17:15

Temporary link so posting in full.
Indian firms killing cost of AIDS cure
Indian firms killing cost of AIDS cure

Yoga Rangatia/ New Delhi

Indian IT companies are not the only ones rewriting the rules of the game worldwide. Four Indian pharmaceutical companies are now making HIV/AIDS treatment accessible to a million poor in sub-Saharan Africa and Asia, and are leagues ahead of multinational competition.




While MNCs talked about ways to reduce the cost of HIV/AIDS treatment, the Indian companies walked the talk. The result: Cost of treatment has crashed from $15,000 per year to $140 per year in the past two years.



The fall in drug prices prompted the Governments of Brazil, South Africa, China and India to announce free HIV/AIDS treatment to whoever needs it. Already, there are 40 million people living with HIV/AIDS worldwide, over six per cent of whom are children.



Cipla, the Mumbai-based pharma company which took the lead in 2000 to bring prices down, insists the change was borne out of a sense of corporate social responsibility. "The enormity of the problem (of treating several million people living with HIV/AIDS) has been evident for years now. But nothing could be done because of the humongous cost of treatment. We provided drugs at cost price, which in turn made treatment accessible. At that time, there was no money to be made from such low prices," said Mr Amar Lulla, managing director of the company. Cipla supplies about half of the anti-retrovirals, for HIV/AIDS treatment, worldwide.



Now, three more Indian pharma companies - Delhi-based Ranbaxy Laboratories, Hyderabad-based Matrix Laboratories and Bangalore-based Hetero - are further pushing prices down. According to industry estimates, together the four companies are expected to drive volume sales worth $2 million in the next five years. The Clinton Foundation, one of the major providers of free HIV/AIDS treatment, has already said it will buy drugs from them to treat one million poor.



And there is still the talk of cost reduction at such large volumes of drug sale. "The treatment has to be provided for lifetime. As volumes further go up, we will reduce the price. The Clinton Foundation rebuild the entire supply chain for this industry and took assurance from the Chinese industry to provide raw material at cost," said Mr C Ramakrishna, executive vice-president of Matrix Laboratories, which supplies active ingredient to the drug manufacturer.



The reason the Indian companies are able to provide low cost drugs is due to the process of patent regime applicable in India so far. These generic drug manufacturers could make the same product by reforming the process of an already existing, and probably patented, drug. This way they got away without paying huge royalty to the innovator. And passing on the price benefit to the customer.



But public health experts and the drug companies are now apprehensive that this could change once the product patent regime is put in place in the country in early-2005. Will the new patent regime, which India agreed upon under the Trade Related matters of Intellectual Property Rights (TRIPS) agreement, hike drug prices in the developing world? This is a question everybody is asking, and nobody has the answers.



The pharma companies are worried, too. "We will evaluate the scenario then. But we will still remain cost-effective in the world," said Mr Ramakrishna. Mr Lulla said: "We should be concerned. Prices will go up. We are buckling under US pressure." They want the Government to safeguard consumer interest before taking a decision.



The World Health Organisation (WHO) is hoping to treat three million people by 2005, and will be shopping for cheap drugs. Indian companies are still the favourites. The availability of cheap treatment could be the turning point in dealing with a disease that has assumed menacing proportions in the past decade, it is felt.


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Re: Indian Biotech News & Discussion

Postby abhejit » 23 Dec 2003 01:04

Website of the Biotech City created in Lucknow.
Biotechnology City - Lucknow

From their website, the project aims to be a..
Network of :

Four CSIR laboratories
Three ICAR laboratories
National level medical research colleges
Major universities on science and agricultural technology
Low cost R&D facilities of 26 scientific institutions for outsourcing research
Trained manpower : Over 400 scientists, 700 technicians and 500 research students
______________________________________________

From an old Project Monitor report....

The proposed biotechnology park at Lucknow will be networked with all research institutes in the city and in its vicinity. These institutes are the National Botanical Research Institute, the National Bureau of Fish Genetic Resources, the Industrial Toxicology Research Centre, the Indian Institute of Sugarcane Research, the Central Institute for Sub-Tropical Horticulture, the Central Institute for Medicinal and Aromatic Plants and the Central Drug Research Institute.
Biotech fever grips north (1/8/01)

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Re: Indian Biotech News & Discussion

Postby Rak » 23 Dec 2003 01:33

Originally posted by Arthur Dent:
What is the regulatory environment like in India?
Can I start up the 'Kwiki Clone Shop' or the 'Customized Transgenic Pet Centre' ? Where does India stand compared to other countries in terms of research and capabilities in these areas?
While I am not sure about these grey-areas of frankenstein technology and their regulatory body in India, I can say with confidence that any "Kwiki Pharmaceutical" deal will earn you a death penalty. One of the latest addition to the law.

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Re: Indian Biotech News & Discussion

Postby Vivek_A » 03 Jan 2004 22:25

Business Week again..

India: Big Pharma's New Promised Land?
Drugmakers are heeding the siren call of its well-trained, cheap chemists


For years, software companies have known that they can slash costs by hiring eager, smart, and inexpensive programmers and engineers in India. Following in software's footsteps, corporations providing telephone support and back-office services soon saw the virtues of India's well-trained workforce as well. Now, Big Pharma is discovering the same benefits, as multinationals such as Pfizer (PFE ), GlaxoSmithKline (GSK ), Bristol-Myers Squibb (BMY ), and Novartis (NVS ) tap India's research and manufacturing prowess to cut costs and speed development of new pharmaceuticals.

That's a big change for India. Foreign drugmakers have long shunned the country because of its lack of patent protection and blatant copying of drugs. But on Dec. 22, the Indian government introduced a bill in Parliament that would bring India's intellectual-property protections in line with international norms. "India's changing regulatory environment is coinciding with the pharma majors' increasing need to trim costs and boost productivity," says Gautam Kumra, a partner at McKinsey & Co. in New Delhi.

The trend is still nascent. So far, India's drug-outsourcing market amounts to just $470 million. But it's expected to grow 30% a year, hitting $800 million by 2005, according to Bombay brokerage Kotak Institutional Equities. The growth will come from the efforts of companies such as Bombay's Nicholas Piramal India. On Dec. 9, Advanced Micro Optics, a Santa Ana (Calif.) maker of eye-care products, hired Nicholas to produce eye drops and tablets for contact lenses. The pact is proof of the company's "ability to meet stringent quality and time requirements for the export market," says Chairman Ajay Piramal. Now, Nicholas has a dozen similar deals in the pipeline.

A host of players are entering the outsourcing game. Hyderabad-based Divi's Laboratories does custom chemical synthesis for Merck, Abbott Laboratories, and Glaxo and makes generic anti-inflammatory and anti-arthritic formulas for other firms. Bulk drugmaker Matrix Laboratories has seen its outsourcing business grow fivefold, to $10 million, in one year. In Bangalore, Biocon has 300 scientists doing contract research, up from just 25 in 2000, after sealing deals with Pfizer, AstraZeneca, and Bristol-Myers Squibb.

"STRONG COLLABORATIONS"
It makes sense for pharma companies to look to India. Indian scientists are well-trained yet earn about a third of what their Western counterparts make. India has more pharmaceutical facilities approved by the U.S. Food & Drug Administration than any foreign country. And many of the 122,000 chemists and chemical engineers that India graduates every year have traditionally found jobs reverse-engineering patented drugs. Now, as India tightens its patent laws, its pharma companies will be looking for ways to keep both researchers and manufacturing plants busy.

In their eagerness to cut costs, some multinationals are even willing to set aside old grievances. Although New Delhi-based Ranbaxy Laboratories in March successfully challenged Glaxo's patent on the antibiotic Ceftin, in October Glaxo hired Ranbaxy to research molecules that may become the building blocks for drugs. The deal "fits naturally with our other collaborations around the world to complement our own resources in drug discovery," says Mencef Slaoui, a Glaxo senior vice-president.

Similarly, Novartis has hired Hyderabad-based Dr. Reddy's to research a diabetes molecule despite an ongoing lawsuit over a generic version of Novartis' antifungal cream Lamisil. AstraZeneca, meanwhile, has established a $10 million R&D facility in Bangalore that will focus on developing cures for tuber- culosis. While expansion in India represents just a fraction of these companies' global business, the share is growing fast as India becomes competitive in yet another knowledge industry.

By Manjeet Kripalani in Bombay

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Re: Indian Biotech News & Discussion

Postby Kumar » 07 Jan 2004 04:02

Originally posted by Arthur Dent:
What is the regulatory environment like in India?
Can I start up the 'Kwiki Clone Shop' or the 'Customized Transgenic Pet Centre' ?
Where does India stand compared to other countries in terms of research and capabilities in these areas?
The following article talks about the regulatory agency GEAC (Genetic Engineering Approval Committee) under the Ministry of Environment and Forests. So I was wrong when I stated that there don't seem to be any regulations.

How to kill the Biotech industry

GEAC was constituted in the mid-1990s to look into the environmental safety of genetically-engineered products. The committee took seven years to clear for commercial use Mahyco-Monsanto's insect-resistant cotton, and that too only because illegal varieties prospered. Does that mean that the regulatory agencies have the power to stop someone from selling lawful varieties of genetically-engineered crops but are helpless when people use it illegally?

The entrepreneur has no interest in agriculture, but he begins to get the drift. And the more he learns about the GEAC, the more nervous he becomes. He finds out that the GEAC had always been headed by a non-scientist. It has 18 members, but they meet only once in a while, sometimes as infrequently as once in six months. He needs quick approvals to beat competition.
...
Several questions run through his mind. Isn't the GEAC exceeding its brief? It has to see that genetically-modified products do not disturb the environment during manufacture, but why should it be concerned about clinical trials?

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Re: Indian Biotech News & Discussion

Postby Vivek_A » 10 Jan 2004 04:45

Business Week

India's Next Outsourcing Coup: Drugs

For years, software companies have slashed costs by hiring inexpensive programmers and engineers in India. Now Big Pharma is discovering the same benefits. Pfizer (PFE ), GlaxoSmith-Kline (GSK ), and Novartis (NVS ) are tapping into India's research and manufacturing prowess to cut costs and speed development of new drugs.

That's a big change for India. Foreign drugmakers have long shunned the country because of its lack of patent protection. But on Dec. 22, the Indian government introduced a bill that would toughen intellectual-property rules. If passed, it could help double the drug-outsourcing business, to $800 million, by 2005, says Bombay brokerage Kotak Institutional Equities.

A host of Indian players already are in the outsourcing game. Hyderabad-based Divi does chemical synthesis for Merck (MRK ), Abbott (ABT ), and Glaxo. In Bangalore, Biocon has 300 scientists doing contract research, up from just 25 in 2000, after sealing deals with Pfizer, AstraZeneca (AZN ), and Bristol-Myers Squibb (BMY ). While these contracts are just a fraction of the global pharmaceutical business, expect many more such deals as India becomes competitive in yet another knowledge industry.
By Manjeet Kripalani

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Re: Indian Biotech News & Discussion

Postby putnanja » 18 Jan 2004 00:37

Originally posted by Ravi:
[b]India a `rich' market for clinical trials?
Amit Mitra
Is there a regulatory authority in India which monitors the clinical trials? Though the article has a feel good feeling around it, I am a bit worried about these companies treating the patients as mere guinea pigs!! As the law enforcement in these areas are not very good, companies might try to get away with trials/procedures which might not be permitted in the western countries, taking the naive people for a ride.[/b]
India should set up independent regulator to regulate clinical trials, which can strictly oversee the entire process in the country, otherwise these things are bound to happen!!

Illegal tests done on 790 Indian women

Indian women have once again been used as guinea pigs. Between August 1999 and October 2002, as many as 790 healthy women in West Bengal were illegally administered the antibiotic erythromycin to test whether it would work as a contraceptive. The tests were backed by a US outfit

George J

Re: Indian Biotech News & Discussion

Postby George J » 18 Jan 2004 20:25

Originally posted by Ravi:
India should set up independent regulator to regulate clinical trials, which can strictly oversee the entire process in the country, otherwise these things are bound to happen!!
Thats why we have the Food and Drug Administration. Besides this article does not provide much details of the Erythromycin case it talks more about the quinacrine. In in quinacrine case there was an 'informed consent' form but the reporter claims that it was 'forced' the fact that there was one means that some protocol was being followed. It also appears that the quincrine case was published in some journal too.

Too many loopholes and too shoddy a reporting to construe anything.

George J

Re: Indian Biotech News & Discussion

Postby George J » 18 Jan 2004 22:16

Here is a reference to whats being done/revised in terms of protecting human subjects.

http://www.expresspharmapulse.com/20040115/patents03.shtml

FYI: Ethics Committee in India is whats knowns as Institutional Review Boards (IRB) in the US.

Whats gonna separate the wheat from the chaffe will be the powers endowed on the Ethics committee in reviewing study protocols and the legal provisions to deal with offenders.

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Re: Indian Biotech News & Discussion

Postby Kumar » 18 Jan 2004 22:30

I think journals in USA do require evidence of adequate protection for human subjects before they publish a paper from other countries. Otherwise say 'Idi Amin labs for research on human pain' ;) could get unfair advantage over other researchers performing research on humans.

So if a research group wishes to publish in US journals, they would claim that they followed the norms of human subject protection in research.

US IRB (Institutional Review Board) and now HIPAA (human subject privacy protection) are good mechanisms. Although HIPAA seems to be too broadly defined for now and in the Indian context could be open for abuse.

George J

Re: Indian Biotech News & Discussion

Postby George J » 19 Jan 2004 03:38

No journal is going to ask you if you have adequate human subjects protection it is ASSUMED that you have met the highest standards for it since you have already reached the publication stage. No self respecting academic/research/private institution (in the US) will try to publish something that has not undergone the most stringent IRB screen and approval. IRB's in the US are very powerful and will make or break your study, design, analysis etc.

HIPAA is the Health Insurance Portability and Accountablity act it has nothing to do with human subjects safety per se. It has everything to do with the data collection and subsequent use of human subject data (hence the term portability and accountablity). It affects folks who use ANY TYPE of secondary healthcare data for research. The collection of such data i.e primary data is under the purview of the investigator, the institution and the IRB.

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Re: Indian Biotech News & Discussion

Postby Kumar » 19 Jan 2004 04:47

Each journal article in a medical field in US in its methodologies section, does put in a claim to have followed the guidelines for human subject protection. IRB approvals are needed even before the research can be performed, publication of course comes much later.

I think articles submitted from other countries for publication in US medical journals, would have to convincingly show in their methodologies section that they followed the norms of human subject protection. This is especially important as they can't assume beforehand that an IRB type of strict regulation was followed in other countries or not. Otherwise reviewers axe is sure to fall on them.

Regarding HIPAA, it does provide protection of a sort, protection of the privacy of the human subject. And now each human subject study has a HIPAA consent form along with the usual informed consent form approved by IRB.

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Re: Indian Biotech News & Discussion

Postby Umrao » 19 Jan 2004 06:43

Originally posted by acharya:
It can be safely assumed that a major portion of the genetic bio diversity of India has been collected by the west in the last 30 years under the eys of the GOI.
That was ICRISAT based US scientists were doing during the 70s.

George J

Re: Indian Biotech News & Discussion

Postby George J » 19 Jan 2004 06:50

If you are referring to the statutory one line in all RCT articles......
Prior to enrolling patients, each study center obtained institutional review board/institutional ethics committee approval and obtained written informed consent from all patients.
then yes..but as far as i know no first tier journal requires you to furnish proof supporting the abovementioned statement its assumed that all the requisite proof has been reviewed and approved by the IRB, after all thats what they are for. Even in the abovementioned article they claim to have informed consent. But there is no way to cross check.

Most journals however require explicit proof/disclosure about the author(s) conflict of interest and financial commitments. Which is kinda ironic. You can claim to have gotten IRB and no one will cross check you but you better be killing all those patients with full financial disclosure.

Again filling out a HIPAA form does not in anyway increase the security for the patient/subject. It is merely an administrative hurdle for the end user of the data: the researcher. You can do away with the HIPAA requirements and still do ethical research by having a powerful IRB process, but you cant protect patient with merely HIPAA.

Trust me I do this for a living. ;)

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Re: Indian Biotech News & Discussion

Postby abhejit » 19 Jan 2004 23:10

Apollo, DRDO to work on stem cell research

President A P J Abdul Kalam today formally launched the Apollo DRDO Technology Partnership at the Apollo DRDO Hospital. The Apollo-DRDO partnership is a joint venture of Apollo group of hospitals and Defence Research and Development Organisation (DRDO).

Prathap C Reddy, the chairman of Apollo Hospitals group, said Apollo-DRDO Technology Partnership would focus on stem cell research in neurology, neuro surgery and cardiology.

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Re: Indian Biotech News & Discussion

Postby svinayak » 25 Jan 2004 03:40

Is India becoming a country of guinea pigs?
Rema Nagarajan
New Delhi, January 24

Is India becoming a country of guinea pigs? Even as reports surface
of illegal tests being done on Indians — last week HT reported how
illegal tests were conducted on 790 Indian women — the pharma
fraternity is excited about the boom in outsourcing of clinical
trials to India.

The same low-cost, high-skills advantage that is driving IT jobs to
India is helping the medical tests outsourcing market. A vast gene
pool helps too. Statistics compiled by the Organisation of
Pharmaceutical Producers of India indicate that the clinical trials
sector in India has burgeoned into a $70 million market, and is
growing at a brisk pace.

This would be welcome, but the illegal tests have cast a shadow.
Patients had not consented to being guinea pigs, and did not know
they were being given medicines of unknown efficacy. Will this happen
to more people?

Pharma giants such as Pfizer that invest millions of dollars a year
on clinical trials in India dismiss such a possibility.

"The outsourcing of clinical trials could mean a huge source of
foreign exchange for India. Just a few isolated incidents of
controversy over drug trials should not be allowed to deprive the
country of such a major opportunity. It is the smaller companies and
fly-by-night operators that try shortcuts," says A. Krishna of Pfizer.

Analysts believe the clinical studies market could increase to $300-
500 million by 2010. Another market forecast places the value in 2008
at $200 million and an eye-popping $1 billion if further incentives
are introduced.

Dr S.K. Gupta, head of the pharmacology department at AIIMS say that
there has been a sharp increase in the number of proposals for
clinical trials.

The office of the Drug Controller General of India estimates that
over 250 clinical trials are going on in the country. Pfizer alone
has doubled its clinical research investment in India over six to
seven years. Its total cumulative investment in India is around $13
million.

Health secretary J.V.R. Prasada Rao says new laws are being
framed. "Today what we have are guidelines for clinical trials. Now
these will be converted into legislation and once that is in place
there will be specific offences and penalty for violations," he says.

The question mark hangs over implementation. "We have a legislation
to regulate organ transplant too, and yet the poor are being
exploited. So how far can legislation protect poor patients?" asks a
doctor.

Testing territory

Lower costs: Development of new drug costs up to $1 billion in West.
In India, half that

Patient bank: With a billion plus people, no dearth of patients with
various diseases

Vast gene pool: Testing drugs on various ethnic groups can determine
how drugs work

Hindustan Times


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