The Cost of Cheap Medicines: Antibiotic Pollution in Patancheru

(Note: The following story is the result of a series of interviews done with affected villagers, environmental activists, lawyers and other stakeholders along with visits to the affected areas by Anil Cherukupalli and Tushar Dhara in June 2009 as a follow up to news reports referring to a Swedish study that found extremely high concentrations of many drugs in local water sources in the Patancheru area of Hyderabad.)

The mantra that drives India today is development through industrialisation. Having missed the first wave of industrialisation India latched on to the emerging industries of the new millennium: Information Technology and Biotechnology. The precursor to biotechnology was the pharmaceutical industry which took root in Hyderabad from the late 1970s onwards. The succeeding decades saw Hyderabad emerge as one of the world’s largest centres for bulk drug production. The drugs were exported to major markets around the world including Europe and the USA and in lesser developed markets in Africa.

The rise of the Indian generics industry was made possible by a host of institutional and non-institutional factors: availability of a large pool of scientists; the Patents Act of 1970 that made a distinction between product and process patents which removed the legal constraints for manufacturing generics. In particular, the establishment of Indian Drugs and Pharmaceuticals Limited (IDPL) in 1961 by the government in Hyderabad led to the concentration of the generics drug industry in the southern Indian city.

The pharmaceutical manufacturing units are concentrated in the Patancheru industrial area, which lies 25 kilometres to the northwest of the city. Although a separate municipality before 2007 Patancheru became part of the newly constituted Greater Hyderabad Municipal Corporation that year. The newly constituted GHMC made it possible for the erstwhile suburban municipalities to access more funds for civic amenities and provided an integrated development plan for the Greater Hyderabad conurbation.

Though Hyderabad has become an important node in the global pharma industry, the environmental, human, economic and social costs have been overlooked. Although the benefits of providing cheap generic drugs are not in question the environmental cost is being borne by communities located in the vicinity of the drug manufacturing units in Patancheru. Since the early 1980s, when the pharma industry took off, these communities have had their water and soil polluted by the untreated industrial effluents. This has affected their livelihoods in the form of decreased agricultural yields. On the health front, although the evidence is anecdotal, abortion rates have increased; stunted growth has been reported in children, and increased incidence of skin diseases. The communities lack of the means to make their voice heard and along with willful disregard of existing environment laws and their monitoring by the regulatory authorities makes Patancheru a typical case of environmental neglect in a developing country.

A Swedish research team led by Joakim Larsson from the University of Gothenburg conducted a study on the levels of pharmaceutical drugs in the water discharged from a common effluent treatment plant in the Patancheru area of Hyderabad. The shocking results of the study, which was published in January and April 2009 in peer reviewed scientific journals, revealed the presence of very high levels of antibiotics such as Ciprofloxacin (up to 6.5 mg/L) and the anti-histamine drug Cetirizine (up to 1.2 mg/L). In one place, the levels were found to exceed human therapeutic blood plasma concentrations!

Moreover, it was not just Ciprofloxacin or Cetirizine that were found in the treated effluent. According to an Associated Press report, the supposedly cleaned water contained 21 different active pharmaceutical ingredients, used in generics for treatment of hypertension, heart disease, chronic liver ailments, depression, gonorrhea, ulcers and other ailments. Half of the drugs measured at the highest levels of pharmaceuticals ever detected in the environment!

From The Earth To The Moon

With the successful launch of Chandrayaan-1 ISRO has joined a select league of nations that have launched missions to the moon. While the spacecraft will take a few more days to attain lunar orbit the successful launch is in itself a great first step for ISRO in space exploration.

Inevitably, amidst the euphoria, there have been voices of dissent. There are some who argue that India cannot afford to waste precious money on what they see as a grandiloquent gesture to catch up with China’s far more advanced space program. They also argue that enough is known about the moon and this mission will not advance our scientific knowledge about our nearest neighbor enough to justify the mission.

Let us look at the ‘price tag’ first. Before the USA embarked on their Apollo missions they launched a series of lunar probes to do lunar imaging and impact studies. Total expense: a neat $1 billion. Japan’s Kayuga moon mission cost a whopping $480m! Even China’s lunar probe cost them a cool $180m. Compare these sums to what the cost is for India’s moon mission: $76m! An unmanned moon mission at that price can easily be termed dirt cheap. In terms of expenditure, the Indian mission is obviously the cheapest of all known global moon missions 1 2.

Coming to the scientific ‘worth’, Chandrayaan-1 is no slouch in this regard as well. The main mission objectives are to create a 3-D atlas of the Moon, study its chemical and mineral composition, look for Helium-3 (a potential future energy source) and search for the presence of water-ice. Towards fulfilling these objectives the moon craft carries a total of 11 scientific instruments of which 5 are Indian, 2 American (NASA), 3 European (ESA) and one Bulgarian (BAS).

Using these instruments ISRO will undertake a high resolution remote sensing of the moon in visible, near infrared, low-energy and high-energy X-ray spectra. This will help create a high resolution 3-dimensional map of the near and far side regions of the moon. In addition, questions about the origins of the moon (whether it was created by a collision with earth of another heavenly body or was an alien body captured by earth’s gravity) might be answered through this mission. On top of this a chemical and mineralogical mapping of the moon’s surface will reveal the distribution of various elements (such as Titanium, Magnesium, Aluminum for example) on the lunar surface and help in determining the nature of the lunar crust. These data will lead to greater understanding of the moon’s evolutionary origin, mineral composition (for potential energy sources) as well as potential sites for a human moon base if water-ice is found on the moon 3 4.

After reading all this you might wonder how does this benefit the common man? How will these questions help anyone apart from satisfying the curiosity of a few scientists? These are valid questions especially from an Indian point of view where $76m might be used for schemes that benefit the common man more directly. But as I’ve argued in a post before when ISRO began taking tentative steps in starting a modest space program in the early 80s many termed it as a waste of valuable money. Now, the many satellites developed and launched by ISRO over the years have helped an average Indian in many ways, from early cyclone warning to something as mundane as satellite TV. With ISRO also becoming a small but important player in the lucrative global satellite launch business and high quality remote sensing it is earning valuable foreign exchange for the country.

When you look at the history of science it can be observed that the potential benefits from basic science research were not always immediately apparent. Bacteria were initially considered curious but useless creatures, flying a heavier than air object was considered a fool’s fancy while DNA was thought to be scaffold for the more important proteins. It is only when the fundamentals of basic science were properly understood and tested out did they result in applications that later helped humanity.

ISRO’s moon mission while not having immediate benefits for the common man might lead to many such ancillary benefits. Even now, the building of the Deep Space Network (necessary for monitoring the moon missions) is generating local employment. There will be an increased demand for science graduates to work for future missions. ISRO plans to launch another mission to the moon in the near future, Chandrayaan-2, which intends to land a rover on the moon to collect and test lunar samples. And ultimately, experience from these missions will benefit future planned missions such the project to put an Indian in space in the next decade as well as send a probe to Mars.

It is a pity that the enthusiasm there was for space exploration in the 60s has diminished over time. From looking out towards the universe and wanting to explore different worlds we have turned insular and limited ourselves to this planet. I hope the recent revival in interest for space exploration, in which Chandrayaan is playing its part, will spark a new space era with humans finally establishing a bridge head on the moon to serve as a base for an eventual manned mission to Mars.

The Indo-US Nuclear Deal – Pre-marital Discord?

The nuclear deal refuses to go off the news. Just when India thought that two of the three key hurdles – defense of the deal in the Indian Parliament, a clean waiver from NSG, and ratification of the deal by the US congress – had been accomplished, came word about the White house letter to a Congressional committee in Jan 2008, and Bush’s covering letter referring the deal for ratification to the Congress. The Bush letter shows, irrespective of its content, the extent to which the US government has gone to get the deal approved, as did the Indian government on its end. Why such hardsell? because the nuclear deal isnt about nuclear fuel supply etc anyways. Given that nuclear non-proliferation has been the biggest irritant in Indo-US ties since the 1990s, this deal was about removing the roadblock to building a strategic partnership with US. The Indian communists were right in what they say the deal entailed. They were wrong in opposing it. Because it’s time india moved out of shadows of the Cold War and took an interests-based approach to foreign policy rather than an ideology-based one.

Having said that, we cannot ignore the Bush letter’s content altogether. After the letter was revealed, people wondered if India had been naive in expecting the US to honor the 123 agreement’s guarantee of uninterrupted supply of nuclear fuel. Under the cover of “interpretation” of the agreement, was the Bush administration trying to have its cake and eating it too?

Actually, both India and the US have displayed some naivete in estimating the other side in this deal. India thought it could get a clean waiver with no strings attached. The US thought India could both be made an ally and a confirmant to non-proliferation laws through the deal. Neither side has achieved much in terms of these expectations.
Trust has always been a difficult element in Indo-US ties. American critics think India’s self-righteous posturing cannot be effaced by strategic benefits from the US and that therefore, India will remain a pain. Witness India’s duplicitous dealings with Iran despite American protests. American diplomats believe in reciprocity – willing to give as long as there is something being given. Indian skeptics on the other hand, say that reciprocity difficult when the odds are so heavily in the Americans’ favor. They also feel that the US will never shed its one-sided, self-centered way of dealing and will walk away from any deal it feels uncomfortable with. Witness the US’ unilateral withdrawal from the ABM treaty with Russia. In other words, Americans sees Indians as Machiavellis while Indians see Americans as Vito Corleones.These perception defects would have to change if the real aim of the 123 agreement viz. strategic relationship, is to be fulfilled. And that can only happen through relentless dialog at all levels between the India and the US. But whether the relationship triumphs is something that only time can tell.

As one of the architects of India’s strategic doctrine put it to me recently, “We’ll have to wait and watch if the relationship works. The US has never had partners, only allies. And India’s never had neither partners nor allies”. In some ways, this deal is like a marriage between a male chauvinist and a feminist. Let’s hope it lasts.

Thoughts on the Gleevec Controversy

We have borne in mind the object which the Amending Act wanted to achieve, namely…to provide easy access to the citizens of this country to live saving drugs and to discharge their constitutional obligation of providing good health care to its citizens.

With these words a Division Bench of the Madras High Court dismissed the petitions filed by multinational drug company Novartis against a key provision of the Indian Patents Act, 1970. The provision in question, called section 3(d) seeks to promote public access to affordable drugs by restricting the granting of frivolous patents on medicines.

Before I dive into the fascinating story of the politics behind public health let me briefly give a backgrounder to the ‘Gleevec issue’.

Gleevec is a drug used to treat a form of cancer called chronic myeloid leukemia. The drug was invented by the Swiss multinational drug company Novartis which has a patent for it. However, the Indian Patents Act of 1970 has provisions that grant ‘process patents’ and not ‘product patents’ (I shall explain the legalese later in this text). What this basically means is that companies could only obtain a patent for the process of manufacture and not on the final product itself. This enabled Indian pharmaceutical companies to reverse engineer the final products and discover new processes to manufacture them, thus giving rise to the generic industry. What this meant in practical terms is that India – thanks to domestic pharma companies that made generic versions of many of the multinational companies’ drugs – went from a net importer of drugs to a net exporter. By the same token, drugs which were overall expensive post-independence became cheap by the 1980s. In fact, global NGO’s working in the field of public health procure affordable drugs from India to use them in Africa, Asia and Latin America.

However, as a member of the WTO and a co-signatory of the TRIPS agreement India had to bring her domestic laws in compliance with international laws. It is in this context that the Gleevec controversy has to be examined.

It is an indictment of our media and society that important issues are given short shrift in favour of fluff and floss. The gleevec issue barely got a passing mention in the mainstream media.

And now we dive headlong into the chemical sludge…

In May 2006 Novartis AG and its Indian subsidiary, Novartis India (henceforth Novartis) filed a bunch of writ petitions before the Madras High Court claiming that section 3(d) of the Indian Patents Act was contrary to the requirements of the TRIPS agreement and article 14 of the Indian constitution as it is vague and ambiguous. But what is section 3(d) about?

In a nutshell, 3(d) aims to prevent the practice called ‘evergreening’ by which drug companies seek to extend monopoly on their drugs by patenting minor variations of that chemical entity. Suppose a drug company has a patent on a chemical entity that is about to expire. What they will do is tweak the drug slightly and patent the new product(s). This guarantees that generics cannot be manufactured and that the patent is extended by another 20 years.

Section 3(d) was introduced into the 1970 Patents Act (the bedrock of Indian patents law and a progressive piece of legislation) via the Patents Amendment Act of 2005. This was done to meet India’s WTO obligations to grant product patents. Now, the 1970s Act granted only ‘process patents’ to agricultural and pharmaceutical products. Only the manufacturing process could be patented for 7 years and not the end product.

De-fencing Procurement Policy

The Indian government is revising its Defense procurement policy yet again. The new policy is more complicated but more vendor-friendly. Earlier, vendors had to prove that 30 % of their order should come from India. The new rules would mean that if a contractor like Lockheed Martin has been sourcing parts for his civilian jets from India, then he can be waived off this 30 %. Similarly, if a contractor proves that in some other way, he has been doing technology transfer to India, he can be waived this requirement. On the face of it, this rule seems rational. But in reality, this is symbolic of the woes that have beset our procurement policy forever. We do not have sufficient transparency in defense procurement. Unless something turns up during a CAG audit, there is no way of finding what went on in a defence deal. The other extreme of such opaqueness is over-sensitivity to scrutiny.

For e.g. the Government is now relaunching the bid for artillery guns, since the contender who seemed ready to win on technical grounds, was the Swedish firm, Bofors. Unwilling to let itself be associated with the name, the government wants to relaunch the bid. This does not augur well for India. Defense procurements should be made on the basis of technical and to an extent financial considerations. (for e.g. with a 70-30 ration being given to technical and financial proposals). Politics should not be allowed to intervene. Though to the credit of our folks in Ministry of Defense, we have a comfortable hybrid of Russian, French, German, Czech, Israeli and now American weapons and our military capabilities are rated even par with the chinese by some experts, the procurement process is all too often doubted by any and every politician. for instance, some years ago, HD Devegowda who was in the opposition, raised a stink saying the T90S battle tanks from Russia were inferior in quality. Exactly how much does HDD know about battle tanks and who were his advisors. This kind of political mudslinging kills any room for bold and timely purchases. As a result, most of our hardware gets outdated before it is even procured.

Yet another problem is that due to the rules of the Indian civil services, no bureaucrat is allowed to spend more than 5 years with the Defence ministry. This is problematic in an area like defense procurement where it takes at least a few years to understand the dynamics of the international arms trade and the country’s requirements. Just when the bureaucrat gets a hang of the job, he is posted out. Since defense tender bidding processes can take up to 3 years, this means that often a bureaucrat in charge of a deal maybe posted out before the deal is signed thus killing continuity. Doesn’t altogether lend us a lot of confidence, right?

It’s time India’s defense ministry and the procurement policy underwent a major overhaul. What we need possibly is a separate service for the defense ministry, an IDS, and greater transparency through ombudsmen etc. Transparency without politicisation. A difficult balance but a necessary measure.


In India, we believe in reincarnation. So it seems that the nuclear deal has found new life again after being throttled to death. This deal was supposed to be a triumph of Indian diplomacy and of lobbying by the Non-Resident Indian community. It would mean the symbolic acceptance of India as a member of the Nuclear Powers club – a rather parochial institution.

The deal assures that the US provides India nuclear fuel and allow for similar supplies from other nuclear suppliers to further India’s civilian nuclear program as long as IAEA safeguards are respected by India. Ok, all this is known. We also know how this has been opposed by Leftists in India, who threatened to bring down the UPA government and almost scuttled the deal. Now, perhaps due to the public fury generated by the Nandigram incidents, the Left has given its green signal to the deal albeit with silly caveats.

India’s Department of Atomic Energy is now negotiating with the IAEA for India-specific safeguards. Now the Left wants that post the negotiations, a report on the the list of IAEA safeguards agreed upon by India be submitted to a parliamentary committee led by them after which they will give the green signal. Since when have members of our polity become experts on nuclear security? Exactly what is accomplished by this roadblock except face-saving for the Left.

I recently spoke to a key US negotiator for the 123 agreement and I found him a worried man. Will the deal go ahead, he asked me given the political pressures in India? After all, he had spent months cobbling the agreement together along with India’s top diplomats such as Indian ambassador to US, Ronen Sen and Indian ambassador to Singapore, S.Jaishankar apart from officials of the US’ AEC and India’s Department of Atomic Energy. I told the Negotiator that the deal will go ahead, all the while hoping the Indian political system proves me right.

(Indian) Man on the Moon

The Indian Space Research Organization (ISRO) recently held a meeting of major Indian scientists in Bangalore to discuss the feasibility and economics of sending an Indian astronaut into space and then later landing him/her on the moon. This has given rise to the usual arguments both in favor of and against such a venture. There are those who argue that India, with her many social and economic problems, should not waste money on something that has already been done before and will yield nothing new. That instead, the money should be used to help the poor and the downtrodden. Simply put, India should not dare to dream that big and be constantly aware of her limits.

I firmly disagree. I think India should seriously plan on putting a man into space and then later on the moon. Yes, it will be expensive. However, what no one realizes is how much of a kick start it will give to the science and technology fields in India and ultimately benefit society. The space race between the erstwhile U.S.S.R. and the U.S. in the 1950s and 60s led to the development of many new technologies that later found widespread applications in many different areas, ranging from health to housing.

Now, a Ban on Orkut?

A petition has been filed in the Bombay High Court for banning the social networking site, Orkut, which is owned by Google, according to this report. Apparently, the petitioner, a certain Subodh Balsaraf of Thane, found that ‘Orkut’ used “slang, rude and vulgar language” about the Maratha king Shivaji. Disturbingly, Orkut has already been banned in Pune by the police after the occurrence of a few violent incidents there.

I’m surprised. Does Mr. Balsaraf or for the matter the police even know how Orkut works? Orkut by itself does not post any inflammatory remarks. It is some people who are bent on stirring things up that start these ‘hate’ communities. I even know of a few ‘Hate India’ communities started by some Pakistanis on Orkut.

There is a feature on Orkut to report about such communities to the people who run Orkut. Apparently, if enough complaints are received, steps are taken to remove that community. Now, I’m not very sure how effective this report back feature is but if you have a problem about certain people posting defamatory remarks about your idol you should first write to the people who run the site. Banning the complete site won’t help. It will only cause inconvenience to thousands of others. Orkut is actually very popular among Indians and is used by many, including myself, to keep in touch with friends and people sharing similar interests from around the world.

Doing Business With Bush

India is rapidly growing and needs loads of energy soon to fuel that growth. We cannot (and should not) depend on the unstable Middle-East for our oil, not just because they are repressive and thus unstable regimes but also because of the spiraling cost and long-term environmental problems. Wind, solar and tidal energies are still at a nascent stage and need more time before they can be widespread. And there is stiff resistance in India to large scale hydro electric plants. So the only reliable alternative left is nuclear power. The Indian nuclear establishment for all its talent of working under adverse conditions is still using unstable cold-war era technologies. Added to this is the fact that India has very low reserves of Uranium. We do have huge reserves of Thorium but lack the technology to use it as a nuclear fuel as of yet. So we urgently need access to safe and reliable nuclear technologies and fuel. And who controls this? The US (and other Western powers) of course. So if not today tomorrow we would need this deal. And that I think is the raison d’etre for this agreement. Remember, this deal was asked for by the Indians and not the Americans.

Now with this little setting of context out of the way let us come to Mr. Bush. I do not like him and I think he is perhaps the worst US president in history. He is a war mongerer and I seriously think he is in the pocket of big business. But I do give him certain credit. He has had the courage to change decades of anti-India policies by the US. I know he is not doing this out of love for India, he is doing it from a purely strategic and business point of view but he did something which even Clinton was not willing to do.

So it is a purely pragmatic decision on India’s part to deal with him. When we can directly deal with war mongerers and repressive dictators like Musharraf of Pakistan and Wen Jiabao of China what is wrong in dealing with Bush? Musharraf is even worse than Bush I think. He was directly responsible for the killing of hundreds of Indian soldiers during the Kargil episode and indirectly responsible for the thousands of deaths due to terrorism in Kashmir and beyond. For god’s sake, he blatantly ignores terrorists acting from his own soil! And I doubt if even you will support a totalitarian state like China and the immense human rights abuses it’s ruling government has been party to. So why didn’t anyone (apart from perhaps the far right parties) protest their visit to India? Why didn’t the Left come out in full force and protest the Chinese leadership’s visit sometime back or Musharraf’s continuing support for terrorism? Do you really believe that the Indian left cares for the issues on hand? They are making such a noise only because they have elections coming up in key states where they hold power or have influence. So I don’t see anything really wrong in India doing business with Bush.

Finally, that brings us to the question, what is it that the Indian left wants? Do they even have a vision for India’s future or does it change every time they taste power? Do they want to turn India into a totalitarian communist regime like China? I mean these were the very people who apparently opposed nuclear weapons of any kind when India embarked on a such a program first. Now, it is hilarious to see them getting concerned for the military nuclear program!

Even though my politics lie left of center I’ve never been in favor of the Indian Left parties. They have never done anything that has benefited the poor and have only bothered themselves about staying in power as long as possible.

Let not the above words give you the impression that I support nuclear weapons. Far from it, I wish they had never been invented in the first place. But they exist and will continue to do so. I was disappointed to see India soften its long held stand for the complete eradication of nuclear weapons in the world. However, that is a also a shift based on current reality. India is surrounded by hostile and unstable regimes. From Pakistan to Burma, from China to Bangladesh, we have neighbors who refuse to see reason and are willing to continue on the path of violence and/or brutal suppression of human rights. So we do need a credible deterrent, something that will make them think twice before threatening our national and territorial integrity. In spite of this obvious security fear, India is perhaps the only nuclear power in the world who has imposed on herself a no first-strike policy. Did any of the other other nuclear powers follow India’s example? The answer is a resounding no. And this is where India’s need for nuclear weapons comes from.

(A post that was in response to Tushar’s argument that Bush is a war criminal and therefore it was an insult for him to offer respects at Mahatma Gandhi’s samadhi and that India should not do business with him.)

Indian Life Sciences

In its latest issue, the science journal Nature has produced a special Outlook section on the current state of science, and in particular life science research in India. The articles are uniformly well-written and objective with very little of the usual condescension shown by Western scientific establishments towards Indian science. Together, they give us an insight into how research is done in India and the many problems plaguing it. From a scientific culture which frowns upon independent thinking and instead rewards conformity and obedience to the lack of accountability and appropriate funding, from the lack of proper regulatory frameworks for critical areas like stem cell research and human clinical trials to the heart-warming stories of a handful of research institutes leading the way in life sciences the issues are many.

To name a few; India is still way behind in research spending as a percentage of GDP even when compared to other developing countries like China, Brazil or South Korea. Ayurveda is another crucial area where India is sitting on a goldmine of traditional medicine that could be a potential source for new drugs if only the traditional knowledge is subjected to rigorous scientific analysis. The education system also needs to be upgraded and revamped. The present emphasis on only the theoretical aspects of science should be changed and equal emphasis needs to be placed on the experimental aspects, which are what makes a good scientist in the long run. This is one crucial area, I feel, where science graduates from India in general are behind their Western counterparts. I am a product of the Indian scientific education and have experienced first-hand the deficiencies of the existing system. Most of the crucial experiments in Genetics and Molecular Biology were either demonstrated to us or worse only described. We rarely had hands-on experience over techniques which would be considered standard laboratory work elsewhere and this was in a central university where the standard is much much higher compared to state universities!

But do not despair yet. Things are slowly but surely moving ahead in the right direction. The success of independent research institutes like National Centre for Biological Sciences, Bangalore, Centre for Cellular and Molecular Biology, Hyderabad, National Centre for Cell Science, Pune and few others is reason enough to hope for more change. Scientists from these institutes regularly publish in high-impact, peer-reviewed international journals and their numbers are steadily increasing from year to year. Start-up biotech companies like Biocon, Avesthagen and established pharma companies like Dr. Reddy’s, and Ranbaxy are also growing in strength and stature. All that India needs now is good support and direction from the government in terms of funding, less bureaucratic hurdles, and last but not the least, for a critical mass of life-scientists to develop to give research the right push. This could usher in the next revolution, for after IT it might just be the turn of BT!