Even India is slowing down!!!

Biotech growth slows for first time in 5 years

Bangalore: After five straight years of rapid expansion, India’s biotechnology industry slowed to 20% growth in the year to March, down from more than 30% in the previous years, largely due to a rising rupee and price pressures in the global market.

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F.D.A. Plans to Post Inspectors Overseas

Guess you won't need to buy a house in Virginia if you work for the FDA...

WASHINGTON — The Food and Drug Administration intends to post inspectors to embassies and consulates throughout the developing world in hopes of improving the quality of the food and medicines increasingly flowing to the United States, a top official said Thursday.
The agency’s commissioner, Dr. Andrew C. von Eschenbach, said that he wanted to have “boots on the ground” in nations like India and China and regions like Central and South America and the Middle East.
The agency already sends inspectors to dozens of countries each year to inspect pharmaceutical plants and clinical trial sites. But Dr. von Eschenbach said in a briefing with reporters that he wanted the agency’s presence abroad to be on an “ongoing and continuous basis rather than episodic and periodic.”
“Right now, we come, we leave,” he said.
The inspectors would primarily “build capacity and bring others in to do inspections that are certified,” Dr. von Eschenbach said.

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JNJ Blog and the Corporate Membrane...

There have been some posts recently about various companies and the moves to set up shop in India...see previous posts here and here...and even the FDA...see post here...

Quite frankly, some of these moves seem to be born from panic, or more likely the corporate smokescreen executives put out to demonstrate "our new strategic direction" when all they really have is a desperate attempt at cost-cutting, which, in all likelihood, will wind up costing the corporation more...but that won't stop them from flailing away, or collecting the bonus they so richly deserve...

So what does this have to do with corporate blogging?

Recent articles regarding JNJ activity in India can lead you to their blog, JNJBTW...there you might find some recent posts regarding their history in India... not bragging, just giving out interesting tidbits... like the fact that JNJ has had interests in India since 1947...

Other links take you to the backstory of worldwide travel by the Johnsons to develop global strategies for corporate growth...interesting, but does this have anything to do with what JNJ is currently thinking?

It turns out it might, if you read about the latest efforts to develop growth strategies for the next 40 years...

the blog posts, the articles, the backstory...it all adds up to a coherent story about what JNJ is doing and why...available to anyone who wants to spend a few minutes on the web...which you were doing anyway, by the way...

the corporate membrane can be porous...

absent this infromation, you would be forced to draw your own conclusions about whether a company moving overseas was part of a coherent strategy, or just an act of desperation...JNJ does a pretty good job of making their case...I don't think the same can be said for all those other companies in such a rush to get to India...

FDA considering establishing Indian presence

Can this even be considered out-sourcing???...

The US Food and Drug Administration (FDA) is considering establishing a presence in India, amidst the country's growing ties with the US pharma industry.

FDA commissioner Andrew Von Eschenbach and US Health and Human Service (HHS) secretary Michael Leavitt have been visiting India to assess the manufacturing practices at some of the facilities there. The visit was largely initiated in response to mounting apprehension over the quality of both food and drugs and related ingredients being imported into the US. The current import protection system was described by Leavitt as "inadequate."

Some Indian media reports have also claimed that the visit was made because the FDA is planning on setting up an office in the country. On the flip side, other media reports have said that the FDA is not planning such a move. Outsourcing-Pharma.com confirmed with an FDA spokesperson that at this point the agency is just offering advice and guidance to the Indian authorities who are looking at setting up a regulatory body that is comparable to that of the FDA.

During his trip to India last week, Leavitt stated: "Basically, we would be glad to try to provide technical assistance to the Indian government as it further develops its new regulatory agency/ies."

He also said that "we are considering trying to establish an FDA presence/office in India," although no decision has been made as yet, the spokesperson advised.

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Teva earmarks $1bn for India plans

Teva continues to set the pace...it seems a lot of companies stand the possibility of being out-maneurvered...

The world's generics titan, Teva, has reportedly earmarked over $1bn to fuel an ambitious plan to broaden its presence in India.

Over the next two years the firm is intending to use $250m-$300m to build new generic ingredients manufacturing facilities in the country.The first of these planned constructions is imminent, with company preparing to build a large active pharmaceutical ingredient (API) manufacturing facility, on over 100 acres of land near Gwalior, Madhya Pradesh. Production capacity will be in line with Teva's large Indian competitors.Meanwhile, the remainder of the money will be used by Teva to fund the hopeful takeover of some Indian pharma businesses. The Israeli company's plans were revealed by Indian newspaper Business Standard, who reported that Teva has been eyeing major acquisition opportunities in India for the past three years, so far to no avail. Teva already has a presence in India through its Indian subsidiary, Teva India, in addition to a two year old R&D centre in New Delhi, however, a company spokesperson reportedly told Business Standard that: "Teva considers India an interesting geographical region and is looking to broaden its activities in the country".

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Indian firm takes over German biologics plant

India just keeps coming...

An Indian firm has taken over the contract biologics manufacturing business of German corporation Siegfried.

The deal is a further sign of the ambition of Indian firms to break into the burgeoning biopharmaceuticals market, which was identified as a key target growth area for India at the recent Interphex show in Mumbai, and is tipped to generate $5bn (€3.5bn) in revenue in the country by 2010, up from its current figure of $1.5bn.

India's Avesta Biotherapeutics and Research is now the new owner of Berlin-based Siegfried Biologics and its 50 employees, gaining a capability in developing biologics, from cell line generation, upstream process development, through to manufacturing.

Avesta plans to use the facility to make an entry into the world of making good manufacturing practice (GMP)-compliant biopharmaceuticals for the regulated US and European markets.

However, the Bangalore-based firm said it will initially concentrate on manufacturing biologics for the semi-regulated markets of Brazil, Russia, India and China, where small molecule drugs prevail in the market.

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Global biotech firms on India quest

more on India...

Indian shores turn attractive for clinical trials.

Close on the heels of global pharmaceutical giants, international biotechnology companies are also finding India an irresistible attraction, though for different reasons.

If the low-cost availability of raw materials was the major reason for global generic pharmaceutical majors such as Teva, Mylan and Actavis to have an Indian base, the emerging opportunities in clinical trials is driving the biotech majors towards the country.

Of the top-10 global biotech companies, the biggest two — Amgen and Biogen — have already set up wholly owned subsidiaries in the country.

Others, such as Genentech, Serono, Chiron, Gilead, among others already have their presence in India through marketing partners and are in the process of exploring business opportunities in a big way.

For instance, Biogen Idec, the oldest biotech company in the US, announced the setting up of its wholly owned domestic subsidiary Biogen Idec Biotech India last month. Biogen, which had a sales of $2.7 million in 2006, also indicated its commitment of significant investments in the Indian R&D segment.

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Industry events in India- Interphex

I had a recent posting regarding the ISPE meeting in India...

ISPE and Bio Pharm Industry in India

I didn't find much feedback on the event on the web...

but check out Interphex India

and, even better, some coverage of the event by Outsourcing-Pharma.com...covering the keynote speech by Satish Reddy, managing director and chief operating officer of Dr Reddys

Innovation 'key' to India's pharma future

India had it going on!!!

but, apparently, some people have gotten their noses out of joint based on the outcome of some recent court cases regarding patent protection for drug discovery...

PhRMA meet OPPI, OPPI meet PhRMA...

Big Pharma hits back at Indian patent laws

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More on India and Asia...

I particularly like the name of the PWC report...Gearing up for a global gravity shift

Asian countries push big pharma boom

Industry grows at more than 35 percent, aims for $40 billion by 2015

The center of gravity for the pharm industry has always been the Delaware Valley...but you can drive up Route 1 and see the formar pharma facilities all up for rent...I guess the rent/ labor costs finally got to be too much, even for Big Pharma...

Bio is harder to determine the real center...

but nothing stays the same but the changes...

Increasing Indian Influence...

and that's not neccesarily a bad thing...

for one, I'll bet we won't have the same type of quality issues we see with other countries...perhaps the Chinese need to take a look at their neighbor for some quality lessons...

Indian law on generic drugs is upheld

NEW DELHI: Indian pharmaceutical companies can continue making low-cost generic drugs, ensuring their flow to patients in the developing world, after a seminal challenge to patent laws in India was rejected Monday.

Aid organizations declared the ruling a victory for the "rights of patients over patents," but the Swiss drug company Novartis, which filed the case, warned that the judgment would "discourage investments in innovation" and would undermine efforts by drug companies to improve their products.

Despite disagreeing, Novartis said that it was unlikely to appeal.

The test case mounted by Novartis last year asked the High Court in Madras to clarify a significant element of India's 2005 patent legislation, arguing that it breached the Indian Constitution. At issue was the question of granting patents for incremental developments.

The full text of the judgment was not immediately released, but Reuters reported that the judge said the court had no jurisdiction over whether Indian patent laws complied with the World Trade Organization guidelines on intellectual property law.

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ISPE and Bio Pharm Industry in India

Check out the India Affliate of the ISPE...over 50 new members in the past couple of months...

and they just had their big industry event...

ISPE India’s Annual Conference on Aseptic Manufacturing and Contamination Controls-Current Issues and Trends

Anybody out there have any news, infromation or feedback from this event to post???

Send me a link...

India's biotech queen goes for global crown

BANGALORE, India (AFP) - When Kiran Mazumdar-Shaw founded Biocon India in 1978 with 10,000 rupees (225 dollars) and an office in a rented car garage, no banker was willing to give her a loan.

Back then, no one had heard of biotechnology, which uses micro-organisms such as bacteria or biological substances like enzymes to make drugs and synthetic hormones.

Women entrepreneurs were also rare and finding recruits willing to work under a female boss was difficult.

Mazumdar-Shaw, hailed in 2004 as India's richest woman with a personal fortune of 21 billion rupees, and Biocon, India's biggest biotech firm with 3,000 employees, have come a long way from the garage.

The businesswoman, who will turn 54 on Friday, is now setting her sights beyond the domestic market, despite the company's 29 percent annual growth rate, estimated to touch five billion dollars by 2010.

"I see myself and Biocon as being a biotech company in a leadership position on the global stage," Mazumdar-Shaw told AFP in an interview in Bangalore.

"We are on the right track to getting there," added the entrepreneur, who plans to double research spending every year to discover new drugs and enter the league of giants such as Amgen and Genentech.

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