Indian Biotech News & Discussion

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Vivek_A
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Re: Indian Biotech News & Discussion

Postby Vivek_A » 06 May 2004 18:14

I don't mean to sound cynical but this biotech boom has a lot to do with the fact that there are more people in India who will offer themsemselves as test subjects for drug trials without the drug company having to worry about being sued. Life in India, unlike in the US, is cheap(and plentiful).

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Re: Indian Biotech News & Discussion

Postby AjaySharma » 06 May 2004 18:40

CVS: Legalize prescription drug imports
Wednesday, May 5, 2004 · Last updated 3:01 p.m. PT

By MARK SHERMAN
ASSOCIATED PRESS WRITER

WASHINGTON -- Breaking with others in his industry, the chief executive of CVS Pharmacy called Wednesday for legalizing imports of prescription drugs. The statement by the nation's largest wholesale purchaser of prescription medicines came a day after the Bush administration's health secretary said legalizing imports appears inevitable.

Support is also growing in Congress, even among Republicans who previously opposed importation but now say constituents are clamoring for relief from soaring prescription prices.

"While many in our industry believe that the importation issue is a fundamentally flawed concept and oppose it without exception, I come with a slightly different view," Thomas Ryan, CVS chairman and chief executive officer, told a government task force on drug importation.

Ryan is the first executive of a large drug store chain to support importing drugs from countries where prices are controlled by governments so that people can fill prescriptions more cheaply than they can at U.S. pharmacies. Ryan said such a move would be a recognition of reality - a growing, somewhat shadowy business enterprise that he said is valued at $2.5 billion to $3 billion a year, far more than other estimates of the cross-border drug trade.

"Millions of Americans have already opted to import drugs because they can't afford not to. We owe it to them to face this issue head on and not look the other way," he said.

The government panel is considering whether and how drugs could be safely imported from Canada and elsewhere.

The Bush administration and Republican leaders in Congress, as well as the pharmaceutical industry, have opposed legalizing drug imports, citing safety concerns.

Among rank-and-file lawmakers, however, momentum for import legislation apparently is growing. Lawmakers who are talking up the new Medicare drug discount card are encountering complaints from constituents who say it will not do enough to lower prices.

"I just sense the buzz," Rep. Sherwood Boehlert, R-N.Y., said. "A lot of members are in their districts talking about this drug discount card. ... I have no doubt that many seniors are bringing this issue to their attention."

Boehlert voted against importation last year, but now supports drug imports from Canada.

On Tuesday, Health and Human Services Secretary Tommy Thompson said he believes Congress will pass a bill this year and he would advise President Bush not to stand in its way.

Ira Loss, a health care expert at Washington Analysis, a financial research company, said Thompson's comments send a signal that the "White House is prepared to bail on importation for political purposes if they need it near the end" of the presidential campaign.

White House aides have said they are awaiting the task force's report, which could come as early as this summer.

Ryan and three Republican governors who also testified Wednesday said the federal government can no longer avoid the issue because of rising drug costs and Americans' growing use of international pharmacies.

They also said the safety issue has been overblown, especially since they are proposing dealing only with licensed foreign pharmacies, not Internet operations of unknown origin.

"The safety concerns largely, if not entirely, melt away," said Minnesota Gov. Tim Pawlenty, who wants to permit Americans to fill prescriptions through licensed Canadian pharmacies. Govs. James Douglas of Vermont and John Hoeven of North Dakota also testified.

Twenty state attorneys general also expressed their support and suggested individual states, which already buy drugs in large quantities for their employees and retirees, could be responsible for safety certifications.

Ryan said prescription drugs can be imported safely by licensing foreign companies, using established distributors of pharmaceuticals in this country and selling the drugs through CVS and other pharmacies.

Even CVS, which Ryan said buys $16 billion worth of drugs a year at wholesale prices, pays 14 percent to 40 percent more than consumers in other countries. Such a difference, he said, tells him that consumers would see savings from imported drugs, even if they are passing through several entities before prescriptions are filled.

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Re: Indian Biotech News & Discussion

Postby Rudra » 06 May 2004 19:23

I dont know the exact reason but a guy I have heard of makes about $1 mil/annum managing clinical trials (he is a statistics phd) for big pharma cos. for some reason they are usually done in japan :confused:

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Re: Indian Biotech News & Discussion

Postby Rudra » 07 May 2004 00:32

dr reddys buys a american firm trigenesis for $11m
http://us.rediff.com/money/2004/may/06drl.htm

George J

Re: Indian Biotech News & Discussion

Postby George J » 07 May 2004 03:52

Originally posted by Rudra Singha:
I dont know the exact reason but a guy I have heard of makes about $1 mil/annum managing clinical trials (he is a statistics phd) for big pharma cos. for some reason they are usually done in [b] japan :confused: [/b]
Errr........

A statistician/biostatistican can NEVER be a Prin. Investigator on a RCT. No disrespect but you need an MD with an advanced degree to be the PI. Your statman can be Co-PI or Co-I or must be managing the design of the trial and the data mgmt./analysis but they never manage the whole trial they are not qualified to do so.

But biostatistics is a great field lots of jobs in trial data analysis and design, very well paid. Dont think you can pull a $1 million salary but you can have a major contract per say. But its possible if you are a Director/VP in the Clinical affairs dept and your Base salary is like 250-300K and your company is doing well (100% bonus) and you options are doing very better etc to pull to a million but there are too many ifs and buts.

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Re: Indian Biotech News & Discussion

Postby Rudra » 07 May 2004 06:48

he is a independent consultant not a employee. must have friends in a few places who send work his way. used to develop statistical models for financial industry before moving into this trade.

George J

Re: Indian Biotech News & Discussion

Postby George J » 07 May 2004 08:23

A million bucks for ONE trail? that just does not compute. He can make a million by working on several trails (like one of them $2000/hr consultants) in a year.

What kinda statistic does a statistican with a finance backgroud do to make that kinda money?? In trials statisitics is an essential tool to prove your hypothesis in an appropriate manner. If the drug is good, design is good you dont need to 'fudge' your stat or need consultant to 'explain' your numbers.

Are you sure its not a Million Yen? ;)

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Re: Indian Biotech News & Discussion

Postby AjaySharma » 07 May 2004 18:52

Wockhardt buys German firm`s business
Source: IRIS (07 May 2004)

Wockhardt, (Q, N,C,F)* the pharmaceutical major, announced the acquisition of the German pharmaceutical company, esparma. The deal, made at a consideration of $11 million (Rs. 49 crores), has been uniquely structured with Wockhardt having acquired esparma`s business and the sales and marketing organisation. Wockhardt, however, has not acquired the production facilities of the company and will have access to esparma`s production facilities. The production facilities will subsequently be moved to the U.K. and India.

Wockhardt has incorporated a new company, Wockhardt Germany, GmbH, to facilitate the acquisition and the new company will have 70 employees; most of them in sales, marketing and regulatory functions. This is Wockhardt`s third international acquisition with the earlier two being in the U.K. — Wallis Laboratory in 1998 and CP Pharmaceuticals in 2003.

esparma has a strong presence in urology, neurology and diabetology is in line with Wockhardt`s therapeutic strengths. The acquisition will drive Wockhardt`s further growth in the European Union besides boosting its international brand equity.


[URL=http://www.myiris.com/newsCentre/storyShow.php?fileR=20040507102038019&secID=fromnewsroom&secTitle=FromtheNewsRoom&dir=2004/05/07&headline=Wockhardt~buys~German~firm`s~busines s~]url hereURL]

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Re: Indian Biotech News & Discussion

Postby AjaySharma » 07 May 2004 18:53

Genentech's Generic Battle
Ashlea Ebeling, 05.05.04, 12:14 PM ET

As the U.S. Food and Drug Administration nears release of a plan for approving generic biological drugs, drug giant Genentech is taking preemptive action to protect its interests.

The FDA guidance, expected this summer, will describe how a generic drug manufacturer might show that a new biological drug is similar enough to an existing one to be safe and effective. The FDA has already said that it believes it has the authority to approve generic versions of some biological drugs originally approved under a special statute, 505(b)(2).

But in a petition filed last month, Genentech (nyse: DNA - news - people ) asks the agency to refrain from publishing the guidance, or approving generics of any Genentech drugs, because the company claims it would be impossible for the FDA to do so without infringing on Genentech's trade secrets. "We draw the line at agency reference to or reliance on Genentech trade secret and confidential commercial data and information to approve a competitor's product," the petition states.

The Genentech petition is just the latest front in a long battle over making cheaper generic versions of biological drugs available to the public. Biological drugs, which have a complex structure, are far more complicated to produce than regular chemical drugs, which have a single molecular structure. Genentech is attempting to safeguard its processes and laying the groundwork for a potential battle in the courts.

The stakes couldn't be higher for Genentech, which says it has poured $6.4 billion into research and development of such big-moneymaking biological drugs as the human growth hormone Protropin and the breast cancer drug Herceptin. A unit of Novartis (nyse: NVS - news - people ) has applied to the FDA for approval of a generic version of human growth hormone under 505(b)(2).

The pioneer drug companies like Genentech and Amgen (nasdaq: AMGN - news - people ), which makes the anti-anemia biological drug Epogen, argue that biological drugs are too complicated to copy. Therefore, they argue, relying on the original drugmaker's safety and efficacy testing data is unsafe. Drug companies that make generics, like Teva Pharmaceuticals (nasdaq: TEVA - news - people ) and Mylan Laboratories (nyse: MYL - news - people ), insist they can reproduce biological drugs safely. They're understandably eager to tap the biologics market, estimated at $22 billion in the U.S. alone in 2003.

As of now, there is no legal or regulatory framework to approve most generic biological drugs. Generic versions of chemical drugs have been available since 1984, when the Hatch-Waxman Act allowed them. But that law didn't contemplate the rise of the biotech industry, so it doesn't cover biological drugs.

Yet the issue of generic biologics has been brewing as pioneers' patents are starting to expire, and competitors are getting sophisticated enough to make generics a possibility. At the same time, there has been tremendous pressure to cut drug costs, and that makes more generics a good idea politically, says Chris Brown, a food and drug lawyer with Sonnenschein, Nath & Rosenthal in Washington, D.C., who represents Teva.

"It's going to happen," he says. "It's a matter of how and when."

If the FDA guidance says it will go forward in approving biological generics, expect the pioneer companies to continue their fight to block the approval process in court. It's likely Congress will have to step in, Brown says, to clarify the FDA's legal authority to approve biological generics. One player will surely be U.S. Sen. Orrin Hatch (R-Utah), who has already shown an interest in creating a fast-track approval system for the drugs.

The FDA has 180 days to respond to the Genentech petition. In the meantime, the guidance should come out, although the FDA is mum on the exact release date.

http://www.forbes.com/business/2004/05/05/cz_ae_0505beltway.html?headline=Genentech's~Generic~Battle

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Re: Indian Biotech News & Discussion

Postby Rudra » 07 May 2004 19:16

GJ, obviously he would be managing multiple trials in parallel. and million is a approx
figure his brother was claiming, could be 600K for all I know. this is the kind of job ?
http://lib.stat.cmu.edu/modules.php?op=modload&name=DB_phpBB2&file=viewtopic&p=64

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Re: Indian Biotech News & Discussion

Postby svinayak » 11 May 2004 02:02

Reliance Clinical services for global markets

By Our Staff Correspondent

MUMBAI, MAY 10. Reliance Clinical Research Services (RCRS), a part of the Reliance Group of companies, is mandated to emerge as an India-based contract clinical research services organisation. RCRS is a component of the life sciences initiative of Reliance and is now addressing the clinical research services market in the U.S. and Europe.

RCRS performs, assists and manages pharmaceutical, biotechnology product and medical device development through preclinical and clinical (Phase I to Phase IV) studies. The vision of the company is to become a worldclass full-service contract clinical research service provider. "RCRS initiative is one aspect of Reliance's transformation from a manufacturing organisation to a knowledge and services driven enterprise,'' said Mukesh Ambani, Chairman and Managing Director, Reliance Industries.

The company is now conducting several studies for clients based in the U.S., the U.K. and Middle East. RCRS is working for indications in oncology, burn wounds, cardiovascular, endocrinology, nephrology, gastroenterology, infectious diseases and vaccines.

According to the company, costs of clinical trials in the U.S. and Europe have skyrocketed and completing clinical drug trials and product development in India could be up to 75 per cent faster. As per Rabo India Finance, although the average costs of doing Phase I/II/III drug trials in the U.S. are $20 million, $50 million and $100 million respectively, in India they are 50-60 per cent of the same.

India is seeing a rapid growth of clinical trials. The setting of a large, diverse, and therapy-naive population, low cost for technical services and use of English as the primary business and medical language is ideal for completing trials rapidly and cost effectively.


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Re: Indian Biotech News & Discussion

Postby Neshant » 04 Jun 2004 11:21

> India is seeing a rapid growth of clinical
> trials.

In other words, Indians are being used as gunie pigs for experimental drugs.

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Re: Indian Biotech News & Discussion

Postby VikramS » 04 Jun 2004 11:25

Originally posted by Vivek A:
Originally posted by Rudra Singha:
[b]http://www.atimes.com/atimes/South_Asia/FE07Df02.html
I don't mean to sound cynical but this biotech boom has a lot to do with the fact that there are more people in India who will offer themsemselves as test subjects for drug trials without the drug company having to worry about being sued. Life in India, unlike in the US, is cheap(and plentiful).[/b]
I think there is a misunderstanding about how drug trials are conducted and lawsuits emerging from them. People who participate in a drug trial essentially forgo their right to sue unless there is some gross negligence involved. The company may provide some form of relief in the case of serious side-effects. In cases like cancer-drugs where something is better than nothing, it is not difficult to find subjects. In more benign situations, it may take a lot of effort to recruit subjects.

This is where India's vast pool of people can be helpful. What we need to ensure that the standards which are used to determine whether a drug is ready for human trial remain the same. Our government agencies need to develop expertise in judging which drug is ready for trial and which is not. However, any system is open to manipulation.

We will have to count on the conscience of folks conducting the trials to make sure that they do not have double standards. A rights group which has the power to sue and seek damages will go a long way in making sure that these folks act right. This group should have the power to sue the company in courts in the home country. Once we put enough checks and balances into the system, it should benefit India and the rest of the world too.

George J

Re: Indian Biotech News & Discussion

Postby George J » 04 Jun 2004 17:41

Originally posted by VikramS:
Originally posted by Vivek A:
I think there is a misunderstanding about how drug trials are conducted and lawsuits emerging from them. People who participate in a drug trial essentially forgo their right to sue unless there is some gross negligence involved. ..........We will have to count on the conscience of folks conducting the trials to make sure that they do not have double standards. A rights group which has the power to sue and seek damages will go a long way in making sure that these folks act right. This group should have the power to sue the company in courts in the home country. Once we put enough checks and balances into the system, it should benefit India and the rest of the world too.
Err is this a figment of your imagination or you have something to back this up. In phase I-Tox studies you are suppose to establish the toxicity of the drug and you need to monitor your patients closely. The drug DOES NOT goto Phase II and III if its too toxic in the healthy volunteers. So any harm done to the patient cannot be justified as par for the course, you can sue the crap out of them.

Unfortunately our judicial system coupled with the availablity of gullible, lower SES, uninformed volunteers makes for an excellent breeding ground for unethical studies. There are tons of unathorized CT's going haywire in India. The nuances of informed consent is simply glossed over.

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Re: Indian Biotech News & Discussion

Postby VikramS » 05 Jun 2004 23:30

In response to my statement that:
People who participate in a drug trial essentially forgo their right to sue unless there is some gross negligence involved.
posted by George J:
Err is this a figment of your imagination or you have something to back this up. In phase I-Tox studies you are suppose to establish the toxicity of the drug and you need to monitor your patients closely. The drug DOES NOT goto Phase II and III if its too toxic in the healthy volunteers. So any harm done to the patient cannot be justified as par for the course, you can sue the crap out of them..
Not monitoring patients closely in Phase-I Tox studies would qualify as "gross negligence". Wouldn't it?

Further there are guidelines for determining which drug can enter Phase-I Tox human studies; I presume they have to be tested on animals before they can enter human trials, aren't they?

So if a company does not due its due dillegence in animal trials and in Phase-I Tox trials, it is guilt of "gross negligence" and liable to damages.

What is the point you are trying to make?


Unfortunately our judicial system coupled with the availablity of gullible, lower SES, uninformed volunteers makes for an excellent breeding ground for unethical studies. There are tons of unathorized CT's going haywire in India. The nuances of informed consent is simply glossed over.
That is exactly the issue which an independent CT Patients' Rights Commission would do. There charter should be to:

1. Scrutinize each application for CT to make sure that all revelent US/European standards have been met before Human CTs start. In fact in cases where they have a doubt, they may require the company to obtain permission to do the human CT in their home country before starting them in India.

2. Become a liason between the home country's FDA (or equivalent) to certify the results of the trial. This is going to be important if the drug maker intends to use the results of the Indian trial.

3. Sue and fine drug companies which do not follow the same guidelines as they would in their home country.

4. Establish training programs to certify medical professionals who conduct the trials.

5. Generate educational material in local language which would inform the human subject of the process, their rights, and also their duties. A trial in which the patient just dump the pills does not serve any purpose.

This agency should be quasi-government; its charter, standards and guidleines should come under the purview of the Central Govt. However, they should be allowed to run independently. Like the FDA, they should be required to respond in a fixed amount of time to any application. The executive members of this agency should have 3 year terms, and be selected from public/private sector.

Its primary source of funding will be applications for drug trials. However, it should have an initial govt. funded corpus to make sure that they are not entirely dependent on the drug companies.

Finally, any employee of the organization will have to be held to the highest standard of the law. If needed special Central courts could be autorized to fast-track the persecution of a member of this agency. For any offence which would have endangered the life of a trial subject, jail time should be manatory.

On a personal note George: I feel that you may be associated with the health care industry. I also tend to get a feeling that you have been around the block a few times in your life; been there, seen that. Perhaps that is what drives the element of cynism in your posts. It would be great if you could lend a more optimistic tone with a more "can do" attitude. A person who knows why a system can fail, can be a lot more effective in suggesting a way in fixing, than a less informed, wordly unwise optimist like me.

George J

Re: Indian Biotech News & Discussion

Postby George J » 08 Jun 2004 00:54

Vikram:
its not as easy as coming up with a bright spark solution on BRF one find sunny afternoon. Trials are very complex business and while I am confident that India is very advanced in drug discovery research and development we are absolute newbies in the area of trial ethics, law and management.

To be very succint we will have our 'Tuskeegee experiments' before folks realize the importance of ethics and law.

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Re: Indian Biotech News & Discussion

Postby Rudra » 09 Jun 2004 00:10

newkerala.com

Business News > India's biotech market to generate $5 bn revenues: study

New Delhi, June 8 (IANS) :

India's nascent biotechnology industry is expected to generate a whopping $5 billion in revenues and create over one million jobs in the next five years, said an Ernst and Young study Tuesday.

"This growth is expected to come on the back of increased partnering activity, transition to a product driven model, growth in the bio-generics market and government initiatives to encourage investment and expansion," it said.

The Ernst and Young 2004 Global Biotechnology Report, released in San Francisco on the sidelines of a convention, has identified India as one of the five emerging biotech leaders in Asia Pacific.

Other countries selected in the category are Singapore, Taiwan, Japan and South Korea. The report said China too was catching up quickly.

"India is ranked third in the region based on the number of biotech companies (96), trailing behind Australia (228), and China including Hong Kong (136)," said the study.

"India's position as a biotech player is assuming greater eminence as we continue to build critical mass in terms of skills and capabilities," said Rajiv Memani, chief executive officer of Ernst and Young India.

"An analysis of the year's events clearly indicates that Indian biotech companies are getting their fundamentals firmly in place, business models are maturing and product commercialisation capabilities are improving," he noted.

The report said the "dramatic overall recovery" in the global biotech sector in 2003 over the previous year had been driven largely by product successes.

"The industry has evolved from touting technology potential to creating new, first-in-class drugs, vaccines and diagnostics, with more than 190 biotech products now approved for marketing," it said.

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Re: Indian Biotech News & Discussion

Postby Rudra » 09 Jun 2004 00:11

pharma offshoring to india

http://www.businessworldindia.com/june1404/indepth01.asp

the charts are worth a look...

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Re: Indian Biotech News & Discussion

Postby Rudra » 09 Jun 2004 00:14

imo the indian biotech sector is climbing to a
higher level faster than the IT sector did. maybe its because they already knew plenty from
servicing the domestic economy after 1947, in IT we started from ground zero around 1980.

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Re: Indian Biotech News & Discussion

Postby Umrao » 09 Jun 2004 00:21

having near and dear work for Pharma. George garu is right on dot. It is one this reasons the prescription drugs are so expensive. Recall the case of 'Resulin' Pfizer/Parke-Davis diabetic drug recall.

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Re: Indian Biotech News & Discussion

Postby svinayak » 09 Jun 2004 06:18

Business

Biotechnology: India emerging as a partner of choice

By K. T. Jagannathan

CHENNAI, JUNE 8. India is among the five emerging biotech leaders in the Asia-Pacific region, according to the regional edition of the Global Biotech Report titled "On The Threshold" released by Ernst and Young, a well-known professional services company.

The Asia-Pacific perspective provides insights into the current state of the biotechnology industry in the region.

The report has selected India as one of the five emerging biotech leaders in Asia Pacific. The others are Singapore, Taiwan, Japan, Korea and Mainland China. India is currently ranked third in the region based on the number of biotech companies (96), trailing behind Australia (228) and China, including Hong Kong, (136).

The report said that the events of the past year "clearly indicate that Indian biotech companies are getting their fundamentals firmly in place. Business models are maturing and product commercialisation capabilities are improving." While noting several policy changes and fresh sources of capital, the report pointed out that "India's position as a biotech player in Asia-Pacific is assuming greater eminence as it continues to build critical mass in terms of skills and capabilities."

The decision of IRDA (Insurance Regulatory Development Authority of India) to let insurance firms invest in biotech ventures, the move to allow, on a case-by-case basis, increased foreign direct investment by venture funds to $50 million and the move to let Phase I and II multi-centre trials in India by multi-national firms had all gone down positively in promoting biotech ventures, the report pointed out. Besides budget-induced incentives, the federal governments, too, competed with each other in promoting biotech ventures, it said. All these had resulted in the emergence of "regional bio-clusters," it said.

The report said "the biotechnology has now the potential to replace information technology as the engine of economic development in the 21st century." In this context, it pointed to the success of Biocon India's public offering.

Bio-partnering between industry and academia was a highly evolved model globally, it said. Yet, in India, these linkages were weak or missing. Nonetheless, the report noted that these linkages had received a major boost in recent years. According to the report, India's growth would come on the back of increased partnering activity, transition to a product-driven model, growth in the bio-generics market and government initiatives to encourage investment and expansion.

With its abundant high quality low cost technical manpower, India was emerging as a partner of choice. Though intellectual property protection in the country continued to be a bugbear, several Indian companies had managed to cross IPR hurdles to work with international partners through confidentiality and non-disclosure agreements, the report said.

Partnering, it said, was equally an imperative for Indian companies as they were increasingly pursuing a resource-intensive, product-driven model for sustainable growth in the wake of the new IPR regime. Indian biotech companies had initially emulated the information technology sector's service based model to earn early revenues. "India's major biopharmaceutical companies are now accelerating efforts to get bio-equivalent versions of patented, well-characterised recombinant proteins onto the market before the window closes in 2005. The small biotech companies are focusing on innovative research, and are picking niches where there is little competition," the report said.

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Re: Indian Biotech News & Discussion

Postby Rak » 16 Jun 2004 07:56


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Re: Indian Biotech News & Discussion

Postby Rak » 18 Jun 2004 23:31


VikramS
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Re: Indian Biotech News & Discussion

Postby VikramS » 19 Jun 2004 07:12

Originally posted by George J:
Vikram:
its not as easy as coming up with a bright spark solution on BRF one find sunny afternoon. Trials are very complex business and while I am confident that India is very advanced in drug discovery research and development we are absolute newbies in the area of trial ethics, law and management.

To be very succint we will have our 'Tuskeegee experiments' before folks realize the importance of ethics and law.
George: There has to be a start. People can and will be exploited. Trials will happen, whether they are approved or not.

Since trials are a relatively new area in India, it would be better if we have an organization which can regulate them than have nothing at all. This does not mean that there will not be any "Tuskeegee experiments". What we need to reduce the chance that they happen. Having a proper agency to regulate them will certainly be better than nothing.

George J

Re: Indian Biotech News & Discussion

Postby George J » 19 Jun 2004 07:40

There is a proper agency to frame policy thats the Indian FDA but 'Taali do haaton se bajti hai' i.e you cant have regulation without adequate punishment to ensure compliance with regulations.

What happens if a trial is not approved by the FDA even though its mandated? Well the punishment is light.

What happens if someone dies as a result of this negligent homicide? The same standard punishment applied.

What happend if proper documentations are not maintained or purposed hidden from the FDA? Does that fall under regular purgery or is it a more henious form of purgery tantamounting to mass murder.

Talking about mass murder one of the best legistations I have heard about in a long time is the one for 'counterfiet drugs' and how they wanted to equate that to mass murder and hence should be punishable by IPC 302 or the death penalty. On many levels that would be an excellent presendence. It was approved by the previous cabinet on 12/21/03 but has not been tabled for approval before the parliament. Donno how long that will take.

Also trials are NOT relatively new in India they are infrequent. Big difference. Reason we dont have too many phase III is a side effect of the 'generic pharma' industry. I think the only real phase III's are for studies where India is a site: AIDS vaccine, RU486 etc.

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Re: Indian Biotech News & Discussion

Postby VikramS » 19 Jun 2004 12:31

George:
What I am suggesting is a revamping of the 'no-name' agency. This is an area which, if properly executed, will benefit folks all over the world.

We need proper guidelines about the conduct of trials, which are up to date with the times.

We need laws which allow the parent company which is developing the drug to be held responsible if their agents screw up.

We need laws which allow the parent companies to be sued in their home country.

And above all, we need a sharp-toothed agency to bite if the need be.

The more I think of it, the more I feel the need of an effective Desi FDA. I suspect that we may have already have had our own Tuskugee but no one knows about it. Human life is too cheap in India; somebody or the other will exploit it.

When it comes to big-Pharma, I feel that if the bark of the Desi FDA is frightening enough, the bite will not be needed. They have too much at stake to screw up. The Desi-FDA needs to start marking its territory aggressively.

The sooner we have a high profile agency in place, the better it will be. The fact that we do not even know the name of the Desi FDA points to the fact that this agency needs a complete overhaul.

George J

Re: Indian Biotech News & Discussion

Postby George J » 19 Jun 2004 23:04

Well there are enuf and more people setting guidelines from ICMR, MCI to FDA. Trails are very complex business and have a Principal investigator (PI), Co-PI, Co-I (site I), site coordinator and down that heirarchy. You can havce govt. or pvt (pharma) funding these investigators. These investigators could be in academia, contract research orgs or 100% employees of the funding agencies and could be 100% intra agency or inter-agency hybred trials with part academia and part for profit.

There are very few drugs in clinical phases (I, II and definitely not in III) from pharma in India. Since we usually have a 'reactive' policy on everything there will be a few 'Tuskeegee' before anything will change. Also from a policy makers POV how can you set policy for something thats not happened yet. That would involve 'foresight', there is no such thing in politics and bureaucracy :D .

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Re: Indian Biotech News & Discussion

Postby abhejit » 05 Jul 2004 20:42

Sibal Spearheads Biotech’s Cause

Minister for science and technology and ocean development Kapil Sibal plans to see the biotechnology sector mirror the success of the Indian IT industry. Mr Sibal has sought concessions for the biotech industry - like the ones given to the IT industry - from the finance minister in the upcoming budget. He is planning a Rs 150-crore drug development fund to boost R&D (research and development) activities besides setting up a scientific advisory committee (SAC) to help the ministry in forming a national biotech policy.

According to department of science and technology (DST) secretary Professor VS Ramamurthy, additional funds are being sought to make substantial investment in emerging areas like nanosciences and nanotechnology. There is a proposal to set up laboratories which will focus on R&D in these two areas. Besides this, a climate research observation station will be set up at the UP State Observatory for Astronomy, that will be brought under the ambit of DST, he said.

Two biotech parks are proposed to be set up while the one in Lucknow will come up by the year end.

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Re: Indian Biotech News & Discussion

Postby Ashok_shetty » 05 Jul 2004 22:38

THE REAL HOT DUDE
Two specimens have also found their way into the Microbiology Department of the Bhabha Atomic Research Centre. Vouching for its efficacy, head of the department Dr Sharad Kale says: ‘‘The bin is ideal for disposal of solid waste at home and most importantly, there are no drawbacks.’’
‘‘I realised that bacteria were converting the garbage into compost. So why not in a bin, I wondered,’’ explains Pawgi. What followed was a year’s research till he perfected the bio-culture, which takes 45 days to prepare and looks like granular soil.

Sion resident Dr Lata Katdare, who has been using the bin for a year, says she has not emptied her bin even once. ‘‘Earlier, the house would stink when the garbage was not picked up for a day. Now I don’t have to worry,’’ she beams.

abhejit
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Re: Indian Biotech News & Discussion

Postby abhejit » 06 Jul 2004 03:11

Spurious drug legislation not on UPA's agenda

Of the many casualties of regime change, is the strident measure to regulate the sprawling fake drugs market. A legislation to curb the menace, which was introduced by the previous Government, has quietly slipped away from the priority list of the United Progressive Alliance.

The Government will not re-introduce the amendment Bill to modify the Drugs and Cosmetics Act, 1940, in the marathon Budget session, sources said. The previous Bill lapsed when Lok Sabha was dissolved.

The Mashelkar committee advocated harsh punishment for manufacturers of fake drug, including capital punishment for those convicted of the crime. Former health and parliamentary affairs minister Sushma Swaraj was in favour of such strong action. But the Bill is proving to be a hot potato for the new incumbent.

The present mechanism fails to keep pace with the thieves of the industry, and hence an overhaul of the regulatory mechanism was sought. But these plans have met with luke response from the new dispensation.

The delay in bringing about changes could prove costly to treatment. Besides, fake drugs incur serious loss of revenue to the Government. Industry estimates a loss of Rs 4,000 crore for itself. There is a corresponding loss of revenue to the public exchequer.

The counterfeit market also gives the country a bad name at a time when several developing countries are looking up to India for its pharma success. The United States keeps India under watch list special 301.

The World Health Organisation estimates 35 per cent fake drugs produced in the world come from India. According to the same report, two-third of drugs do not contain active ingredients. Less than 20 per cent contain the wrong ingredient, while 16 per cent have harmful and inappropriate ingredients.

I bet thats how you ensure jobs to the people who work in the fake drugs industry. :mad:

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Re: Indian Biotech News & Discussion

Postby Div » 06 Jul 2004 05:46

Counterfeiting medicines has to be one of the worse crimes imaginable. It must take a sick individual to do it and an equally sick government to allow it.

Neshant
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Re: Indian Biotech News & Discussion

Postby Neshant » 06 Jul 2004 11:26

What is the reason for not proceeding with tough justice against counterfeiters? The article does not explain it and it really makes no sense.

George J

Re: Indian Biotech News & Discussion

Postby George J » 06 Jul 2004 23:21

I think the sticking point is 'death penality or not'. And who gets the noose. If my reading is right there is a potential to misuse the law unless not framed properly.

E.G: What would happen if there is a repeat of the Boheringer IngleHeim Case? Would this cover Industrial mistakes that kills a lot of people? How do you qualified malicious intent? Too many legal issues. And if its too narrow it just might not have any teeth.

Will need to exercise my sources to find out what the real story is.

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Re: Indian Biotech News & Discussion

Postby Katare » 07 Jul 2004 00:20

What we need is better enforcement of existing laws instead of more stringent laws. Death penalty will make it harder to convict these pricks, I don’t see no need for capital punishment.

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Re: Indian Biotech News & Discussion

Postby abhejit » 07 Jul 2004 00:40

if not the threat of capital punishment, the punishment can be that all the property and financial assets used by the counterfeiters will automatically be taken over by the state, and there is no legal way those assets will be returned under any circumstances.

George J

Re: Indian Biotech News & Discussion

Postby George J » 07 Jul 2004 04:26

Our jingo-armchair-judges have already 'who is to take the fall'. If a reputed pharma company accidentally uses a white powder thought to be starch in making its tablet and then it turns out that its NOT starch but an active anti diabetic agent and folks die from it. Who is to blame? The CEO in India, the entire top mgmt, should they all get the death penalty. Its a mistake no doubt a people died from it but who SHOULD get the death penalty due to this accidental murder.

Thats the sort of issues that need to be clarfied. Sure there are some seedy folks out there who puunch out tablets using nothing more than calcium carbonate and other spurious stuff. But the law should discriminate between a genuine mistake from a malicious intent.

Thats gonna take some work.


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Re: Indian Biotech News & Discussion

Postby abhejit » 12 Jul 2004 06:12

`New biotech policy in 6 months'

THE Centre is expected to frame a new biotech policy within six months while a regulator for the sector will be in place within two years.

Dr M.K. Bhan, Secretary, Department of Biotechnology told a conference on biotechnology on the occasion of Bio-2004, that a regulator will be in place within two years and the Centre will start enforcing the intellectual property rights (IPR) next year.

Earlier, at the inaugural event, the chairperson of the Vision Group on Biotechnology, Ms Kiran Mazumdar Shaw, said nearly one million jobs are expected to be created by 2010 and around Rs 1,000 crore worth investments will be poured into the biotechnology sector in Karnataka within two years. Around 100 exhibitors from 15 countries are participating in the three-day event.

The Karnataka Chief Minister, Mr Dharam Singh, said the State had decided to grant Rs 10 crore this year for setting up the Rs 100-crore Bangalore Helix, the proposed Biotech park in Bangalore which is expected to be completed in the next two years. Mr Singh said the State had sought around Rs 50 crore from the Centre for setting up the park and the rest of the investments will be through partnerships. He said the State had allotted 100 acre of land for this purpose which is worth Rs 25 crore.

Ms Shaw said during the last financial year, 25 new biotechnology companies were set up in India of which 17 were in Karnataka.



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