Bharat Rakshak

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/

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

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.

Check this out. Very Impressive

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

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.

A successful stem-cell transplant in Pune

http://timesofindia.indiatimes.com/cms.dll/html/uncomp/articleshow?msid=172634

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

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

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.

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

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.

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

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.

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.

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.

Policy on bio-fuel in offing

http://www.thehindubusinessline.com/2003/10/29/stories/2003102901330400.htm

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.

Nice article on GangaGen

The virus that heals

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

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

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.

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/

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

-Ananth

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.

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.

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

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....

Biotech fever grips north (1/8/01)

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.

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

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

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

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

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.

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.

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.

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.

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.

That was ICRISAT based US scientists were doing during the 70s.

If you are referring to the statutory one line in all RCT articles......
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.

Apollo, DRDO to work on stem cell research

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