The news that Sanofi pasteur was acquiring control of Shantha Biotechnics, one of India?s largest vaccine manufacturers, shows that Indian companies continue to be increasingly attractive ?value buys? for global majors. Post the deal, Sanofi pasteur gets to strengthen its position in the global vaccines sweepstakes, just as Abbott?s recent acquisition of Wockhardt?s nutrition business, with brands like Farex?, Dexolac? and Nusobee? infant formulas in the paediatric category and adult protein supplement Protinex?, will add substantially to Abbott?s standing in the nutrition segment. Considering these are market leading and award winning brands, the Wockhardt management felt that the time was right to cash in on these heritage brands. No doubt the $130 million it got in exchange for these brands will help it clear off some of its many debts and take it one step closer to refocusing on its core human pharmaceutical business.

Industry observers say that all signs point to an impending ?clearance sale? in Indian pharma. Singapore-based Fresenius Kabi had acquired Delhi-based oncology Dabur Pharma for over Rs 1,000 crore last year and the Ranbaxy-Daichii Sankyo deal last year was a game-changer. With the increasing number of regulatory raps for charges ranging from non-compliance in manufacturing standards to poor documentation and governments of developing nations succumbing to pressure to change their IP laws and restrict import of medicines from India, many promoters of pharma companies are merely waiting for the right price.

Meanwhile, they are trying to get their positioning right, either by adding an R&D flavour with their pipeline prospects or announcing drug development deals with MNC pharma. The pessimists point out these ?leads? from MNC pharma are ?back burner? leads and will result in a loss of precious time and money, since most of these deals are based on milestone payments. So, if the results are not good enough, the service provider (the Indian pharma company doing all the grunt work till the molecule shows promise) doesn?t get paid.

Some would argue that any research activity is better than none at all, as it builds capacity towards developing in-house leads, but how much of this talk is hope and how much merely hype is difficult to guess. Is the industry a victim of its own ambitions? Can it ride the tiger or is this an illusion? When will we see a ?Discovered in India? molecule rather than ?Made in India? clones?

Pessimists blame years of the process patent regime for blunting our innate intellect. The process patent mindset has no doubt given us manufacturing prowess and met our country?s healthcare needs at the time, but at what cost? Today, there has been a shift in India?s disease profile from a pre-Independence infectious disease profile to a mix of both infectious as well as chronic ?lifestyle? diseases like diabetes and cancer, which require expensive drugs.

Optimists in the industry insist Indian pharma has one of the most promising futures and pipelines need time to develop. The pessimists retort, why develop a pipeline only to sell it? If there are no long term plans to stay the course, should Indian pharma promoters simply give up and move on to more lucrative and less technical domains?

Realists say Indian pharma should choose its path carefully and stick to the areas where India truly has an edge. For instance, traditional medicine can be a source of many leads as can India?s biodiversity.

Validating ancient ?eastern? cures using modern ?western? techniques should be our forte.

There are already many early bird companies on this path. Some savvy ones prefer to hedge their bets and have a foot in both camps. In the end, necessity is the mother of invention and healthcare needs will force a mindset change. Post the deal with Shantha, Sanofi Pasteur says it will use Shantha as ?a platform for high quality affordable vaccination.? Affordable for whom is the niggling doubt plaguing pessimists who insist that MNC takeovers will lead to monopolies and increased costs of medicines. And this is where the country?s regulators need to step in.

Indian regulatory agencies are responding faster, both to facilitate and to crack the whip. For instance, India?s Drugs Controller General (DGCI) recently fast tracked permission to three of India?s top biotechnology firms, (Serum Institute, Bharat Biotech and Panacea Biotech) to start developing a vaccine for the swine flu/H1N1 virus infection sweeping the country and indeed the world.

Regulatory intervention will be key if the H1N1 infection continues because even if these vaccines do hit the market, there will be no time for long term safety studies. Thus while the World Health Organisation advocates mass vaccinations globally, against swine flu infection, its own Web site stresses: ?Since new technologies are involved in the production of some pandemic vaccines, which have not yet been extensively evaluated for their safety in certain population groups, it is very important to implement post-marketing surveillance of the highest possible quality. In addition, rapid sharing of the results of immunogenicity and post-marketing safety and effectiveness studies among the international community will be essential for allowing countries to make necessary adjustments to their vaccination policies.? In this scenario, it is in the interests of community members to become more vigilant at spotting flu symptoms and drug/vaccine reactions as well as pressing for action from the relevant authorities.

Researchers have warned that this H1N1 infection could reach the same proportions as the 1918 flu pandemic that resulted in the deaths of at least 40 million people globally. This swine flu strain is particularly virulent as it is able to embed and replicate in lung tissue, unlike the seasonal flu strains.

The DCGI?s role as a facilitator of a ?Made in India and Made for India? vaccine couldn?t have come sooner. Such a venture best highlights India?s capabilities to meet future healthcare needs of our country as well as of other needy nations. That we actually have the infrastructure to do this is reason enough for the optimists to continue to hope.

The author is editor, Express Pharma