Tuesday, June 11, 2013

BJP Bickering - Congress Snickering - Media Gloating - Over a storm in a tea cup!

It is amusing to see sanctimonious Congress-wallahs strutting all over TV studios commenting on the internal bickering in the BJP. It is even more amusing to hear them preface their remarks with, ‘it is an internal matter of the BJP; that said…’! The problem lies in what was said after the conjunction. Their carefully crafted homilies only serve to expose thinly disguised glee at the discomfiture of their principal political rival.

Notwithstanding the furore generated by a 24/7 media which has its own agendas in looking for cataclysmic conspiracies where there were none, what has been happening in the BJP cannot even be described as internal strife. It may at best be described as internal bickering, the proverbial storm in a tea cup. For in politics as in everyday life it is the comparison of consequences that determine the relative import of an event. The media would have loved to endlessly debate the consequences of Narendra Modi’s elevation (sic) as the Chairman of BJP’s national election campaign committee.

Though they were not specifically named Chairmen, first the late Pramod Mahajan and later Arun Jaitley strategized BJP’s election management in the past. Therefore naming Narendra Modi as Chairman of the campaign committee could hardly be called elevation. It could just be media spin to create noise in its competitive quest for TRPs at the best or to scare off BJP’s potential allies at the worst, a terribly uncomplimentary idea to be ascribed to a free media. What the BJP did was to take the first tentative step – to test the waters as it were – before ‘entrusting Modi with higher responsibility’, to use a phrase popular in the corporate world.

But an old man with unfulfilled ambitions has probably trumped both his party’s action plan and the media’s script. Advani was largely responsible for raising the party’s parliamentary strength from two to eighty-five within a decade of its inception. He set for himself a very high standard of morality when he resigned his membership of the Lok Sabha and did not return to public life till his name was cleared in the Jain Hawala case.

Advani’s was perhaps a higher standard of morality than what Lal Bhahadur Sastry set for himself, when he resigned as Railway Minister following a train accident in which 112 persons died. (Contrast this with the conduct of Lalu Prasad Yadav during whose reign a train accident in Andhra Pradesh killed 114 people, on Diwali eve in 2005. Yadav did not deign to visit the accident site, as he was busy with elections in his native Bihar.) Even great men have their vanities and moments of weaknesses. Mohandas Gandhi used to go into a sulk when he did not have his way and so did Advani on earlier occasions.

To return to the study of relative import of events, the internal strife within the Congress, in an endless succession of events, often had far graver consequences for the nation. Here are a few that would hopefully humble sanctimonious Congressmen:

GANDHI FORCED BOSE TO RESIGN Mohandas Gandhi forcing Subhas Chandra Bose to resign from the post of party president to which he was elected with an overwhelming majority was far and away the most significant example of an internal power struggle in the Congress party. Had Bose been allowed to continue as party president, the history of our nation would have been probably different.

NEHRU SCUTTLED KAMARAJ PLAN Following India’s humiliating defeat in the 1962 China war there were rumblings within the Congress calling for a change of leadership. In no other democratic nation could a leader or a government survive such a blow to the collective national psyche. It was against this backdrop the then Tamil Nadu Chief Minister, Kamaraj came up with his proposal that all senior Congress men should henceforth shun public office but confine themselves to party work. The proposal, which came to be known as the Kamaraj Plan was probably carefully mooted so as not to give the impression that it was aimed at Nehru. It did not go well with Nehru and his acolytes. Although six senior ministers including Lal Bahadur Sastry, Morarji Desai, Jagjivan Ram, Biju Patnaik and S. K. Patil resigned from the government, Nehru did not. Kamaraj was forced to suggest an amendment excluding Nehru from the plan. The plan was quietly buried later.

Kamaraj’s exclusion (of Nehru from his plan) had far more serious consequences than were apparent at the time. Firstly, India could never assess the role of various ministries and organs of the government that led to the 1962 debacle, for which Nehru was responsible in a large measure. Secondly, it probably led to dynastic succession later when Nehru’s daughter Indira was made the prime minister. She would not have had the chance had Nehru demitted office as a discredited leader.

INDIRA SABOTAGED PRESIDENTIAL NOMINEE SANJIVA REDDY In 1969 the Congress party nominated Neelam Sanjiva Reddy for the President of India. Opposed to the candidate proposed by the ‘old guard’, Indira sabotaged Sanjeeva Reddy’s election by calling the electorate to ‘vote according to their conscience’. She indirectly supported V. V. Giri who defeated the official Congress candidate, Neelam Sanjiva Reddy.

INDIRA HITENDRA TUSSLE RESULTED IN GUJARAT’S IN WORST COMMUNAL RIOTS The 1969 upheaval in the Congress party had even graver consequences. Simmering tensions between Indira’s faction and some senior leaders whom the press loved to call the old guard led to her breaking away. Her faction was called the Congress-I (with the ‘I’ for Indira), probably the first time a national political party was named after an individual in the democratic world. That would not have mattered but for the fact that some state units of the party were still under the control of the Congress-O as the rival faction came to be known. Gujarat was one such led by Hitendra Desai. As the two leaders went at each other to settle scores, communal riots erupted, the worst ever the state has witnessed. The riots lasted six months resulting in 5000 deaths in Ahmedabad alone and between 12000 and 15000 in the state.

PARANOID RAJIV’S ACOLYTES ENGINEERED RIOTS IN AP & KARNATAKA After Indira died a violent death, her son Rajiv ascended to the throne in 1984 with immense sympathy in a nation known for its maudlin sentimentalism, and a lot of promise. The promise evaporated soon and he was out of power by 1989. A result of Congress party’s internal power struggle was recounted in ‘A decade of secular lies’:

In 1990, Rajiv Gandhi was out of power thanks to the Machiavellian V P Singh. His party was in power in only three major states, Andhra Pradesh, Karnataka and Maharashtra, ruled by Marri Chenna Reddy, Veerendra Patil and Sharad Pawar respectively. The three Chief Ministers held a conclave in Tirupathi. We do not know what if anything of significance transpired in the conclave, but Rajiv Gandhi construed that it was held to undermine his authority as the party’s high command. He turned to his trusted acolytes, the secular Y. S. Rajasekhara Reddy (YSR), state party president in Andhra Pradesh and the secular Jaffar Sheriff, party president in Karnataka. Sharad Pawar was considered invincible and left alone for the nonce. YSR, with some help from the secular MIM party engineered riots in Andhra. Jaffar Sheriff simultaneously did the same in Karnataka. The riots continued for weeks and stopped – as if a switch was turned off – as soon as Chenna Reddy and Verendra Patil resigned, obviously with some persuasion from the high command. This after Marri Chenna Reddy regained power for Congress from N. T. Rama Rao, quite a significant political feat. Some four hundred people lost their lives in the Hyderabad riots alone. In Karnataka, the riots were diffused throughout the state – because of its diverse religious composition unlike Andhra Pradesh where the Muslim population is mainly concentrated in Hyderabad and some pockets of Rayalaseema.

The ignominious exits of P. V. Narasimha Rao and Sitaram Kesri (as party presidents) are two more examples of Congress’ internal shenanigans that deserve mention. With these skeletons (cited as examples and many more) it is amusing to see the Congress party snickering at the BJP’s discomfiture. 

Thursday, May 16, 2013

What is Salman Khurshid Up To?


The aphorism ‘No nation has friends, only interests’ and its variations were attributed to the former French President, Charles de Gaulle and the English Statesman Lord Palmerston. Some believe it predates even these politicians. An article in Time Magazine (May 9, 1955) obliquely attributes it to the English Statesman. For now the authorship of the aphorism is not the issue but whether Indian politicians were / are wise enough to pursue the course defined by it. Surprisingly, India’s foreign policy from the days of Jawaharlal Nehru has functioned at complete variance from the wisdom the aphorism advocates. Another interesting feature is that although Indian Prime Ministers in general seem to have a penchant for the foreign ministry, probably because it helps them to frequently fly abroad and rub shoulders with other world leaders, Nehru never let go of the foreign affairs portfolio. He was his Foreign Minister throughout his tenure as Prime Minster from September 2 1946. He relinquished both the posts only when he died on May 27 1964. The following article was originally published in South Asian Idea (SAISA), the official website of the South Asian Institute of Strategic Affairs as, ‘What is Foreign Office Up To?

Does the Indian government have a strategy to counter the latest Chinese incursion deep into Indian territory on April 15? If it does, it is shrouded in mystery and obfuscation. The first reports indicated that the Chinese penetrated ten kilometres inside from the Line of Actual Control (LAC) and pitched tents. The government finally admitted that they intruded nineteen kilometres. (Dr.!) Salman Khurshid, the dermatologist heading the Indian Ministry of External Affairs (MEA) described it as a spot of acne on the India-China relations! Such expressions appear colourful in sophomore essays or university debates. However Khurshid is neither a sophomore nor was he writing an essay for a college magazine.

The recent incursion is not the first (more than 200 Chinese incursions into Indian territory have been reported since 2008) but what made it disturbing was, this time around the Chinese did not indulge in a niggling in-and-out inroad but seemed to have come to stay put. Equally disturbing is the Indian response which seems to be following the disastrous course of the 1962 script.

One would like to forget what happened in 1962 but for the indelible scar that the humiliating defeat left on India’s collective psyche. There were varying versions of what went wrong. There was an extreme view projected by the then undivided Communist Party of India (CPI) which overtly functioned as the Chinese fifth column. The left wing Chinese sympathizers in the academia and their fellow travellers in the media did their bit to cloud the picture. Several generals of the defeated army added to the cacophony by offering self-serving apologias.

Then there are accounts of foreign journalists like Neville Maxwell (1970. India’s China War). An Australian national born in London and educated in Canada, Maxwell was The Times’ foreign correspondent in Washington for three years, before being posted to New Delhi as the paper’s South Asia correspondent. Though extensively researched, the book appears to have been written to absolve Britain of any responsibility for the mess it left behind. In an article he wrote for Rediff in 2002, Maxwell observed that ‘[t]hrough the early 1950’s Nehru’s covertly expansionist policy had been implemented by armed border police…’ (Remembering a War).

Even his worst enemies would not have credited Nehru with an expansionist mindset. Quite the reverse; he was hugely enamoured of China and its culture and wanted its friendship not enmity. (The CIA documents mentioned below confirm this.) He meekly acquiesced when the Chinese usurped Tibet, although Sardar Patel warned him years earlier, about Chinese ambitions over it. Patel foresaw that the disappearance of a buffer state between India and China would only fuel the latter’s expansionist ambitions further. The Chinese proved Patel right. In 1956-57 they quietly built a road to Aksai Chin and occupied it. It was a monumental failure of the Indian intelligence but the Indian government came to know of it only in 1958 according to secret CIA documents declassified in 2007.

Isn’t 2013 a poignant parallel? With all the technology and spy satellites that are available to them, the Indian intelligence agencies (again) failed to notice the Chinese creeping in till they pitched their tents nineteen kilometres inside India. That is not all. There are ground reports that the Chinese have been nibbling at Indian territories for years and altering the contours of the borders. 

Nehru first denied the Chinese incursions into Indian territories (as Khurshid now seeks to minimize it) and when it was no longer tenable to do so informed parliament that the Indian army was asked to ‘throw the Chinese out’. The Chinese fifth column in the Indian polity latched on to that phrase and claimed that it hurt the Chinese pride and in a way triggered the war. After the war, the Indians were left with only shame, not pride! There is no dearth of Chinese sympathizers even today. Academics of the JNU variety argue in television debates that the incursions occur because of differing perceptions about the border. They never pause to ponder why, because of similar differing perceptions Indian troops do not wander into China? Isn’t it precisely because, it is not a settled and demarcated border it is called the ‘Line of Actual Control’ and not an international border?

Maxwell had access to the ‘Henderson Brookes-Bhagat Report’, an Operations Review of the debacle, commissioned by Gen. J. N. Chaudhuri, who became the army Chief after the war. The report is still classified and not available to the Indian public. Nehru revealed more about the Indian army’s capabilities to the Chinese Premier, Zhou Enlai (trained in military and intelligence matters) by taking him on a conducted tour of Indian ordnance factories than the Henderson Brookes-Bhagat report conceals from the Indian public.   

Maxwell and others opine that the Indian army was forced to take on a more superior army in terms of training and equipment. But the war was probably lost in the minds of the generals much before it was on the ground. There is the old saying that ‘The Battle of Waterloo was won on the playing-fields of Eton!’ (It may be an uncorroborated version but a veteran of the war whom this writer met in a train journey said that the Chinese were not as well equipped as it was made out to be. They carried one rifle for four to six soldiers.) The generals hoped till the end that Nehru would somehow find a diplomatic solution to the vexed border problem. He failed them and they failed him.

Haven’t the Americans met their Waterloo in Vietnam and the Russians in Afghanistan in spite of their vastly superior arms and equipment? Therefore the inferior quality of arms and equipment was not a valid argument for the defeat in 1962. Similarly, China’s numerical superiority of arms and equipment is not a valid argument for inaction in 2013. The rule is to be able to stare the enemy in the face. As an emerging economy and aspiring world power, China has as much at stake as India. 

There was a view that Nehru’s overweening ambition to win a Nobel peace prize was at the back many of his political decisions which resulted in disastrous consequences. One hopes the present leadership would not consider trading off national interests for some elusive personal monument for itself! The nation will not approve it. Therefore Salman Khurshid should keep the nation informed about his game plan for securing the safety and integrity of the nation. More importantly the nation would like to have an assurance from the Defence Minister that his armed forces are fully capable of securing the nation’s safety, security and integrity. 

Thursday, May 09, 2013

Random Reflections On The Karnataka Election 2013


If one were to name a singular failure of the intelligentsia, the politicians, the sociologists and finally the sanctimonious, ‘know-all’ media that comprise the opinion-shaping organs of the world’s largest democracy, it is its failure to build a cohesive national spirit. For, sixty five years after becoming a democratic polity, we still vote as castes and communities; ethnic and religious groups.

Unlike the Americans, Brits, Chinese, French or Russians we do not think, act or behave as a nation, like Indians. We think as vokkaligas, and lingayats; forward castes and backward castes; Hindus and Muslims; Bengalese and Biharis; Kanndigas and Marathis but certainly not as Indians.

Compared to these considerations, probity in public life or its converse, corruption appears to be a non-issue in Indian elections. This was earlier observed in AP in 2009 when the then YSR government accused of corruption on a gigantic scale not only comfortably returned to power but contributed 33 MPs to his party to form a government at the centre.

The reason could probably be that corruption only affects the middle classes. The poor do not mind whether the government is corrupt or not as in any case their lot remains poor. If someone provides them their daily necessities and a few other freebies, that would be all they want. Throw the poor some crumbs. The late YSR understood this principle and deployed it with great success. His philosophy was ‘I and my cronies would loot the state and none can question me as long as the people vote me back to power.’ He warded off all accusations of corruption with the hide of a hippopotamus. If in the process the government bankrupts, so be it!

His bête noire CBN, left out of power for two terms learnt his predecessor’s lessons well! It is early days yet to predict if he would or could come back to power in 2014 but to service all the freebies he has been promising during his recent 3000-km padayatra the state budget may be woefully inadequate. The freebies he promised would consume the revenues of the entire nation. To be fair to CBN he did not face any corruption charges when in power.

For the rich it is a closed circuit. ‘I can, and pay for services; I recover my costs and some by swindling the public.’ They need corruption and it needs them. It is a self-reinforcing loop.

The BJP, which laid great store by probity in public life, floundered when its tallest leader in the state, B.S. Yeddyurappa blundered. In the 1990s, its leader L. K. Advani, an accused in the Jain Hawala case resigned his parliament membership and stayed out of public life till his name was cleared. Its Prime Minister, Atal Behari Vajpayee sacrificed his 13-day government in 1996, by losing a vote of confidence on the floor of the Lok Sabha by a solitary vote. If his floor managers did what the Manmohan Singh government did at the fag end of its first term in 2004, he would not have had to go to the people again. Atal Behari Vajpayee had sacked Buta Singh, a minister from a politically sensitive community when the Supreme Court indicted him in the JMM bribery case.

B.S. Yeddyurappa nullified about forty years’ of hard work and clean public life with greed for some small peanuts. When there was a demand for probing mining licences, in a fit of foolish or inverted bravado, he included his own tenure in the terms of reference he ordered. That was his undoing. He was one of the few Chief Ministers who had to resign on grounds of corruption and sent to jail based on a report filed by the state Lokayukta. The High Court later rubbished the report. For the record, the report of the former Karnataka Lokayukta, Justice Santosh Hegde, also indicted two of Yeddyurappa’s predecessors, S. M. Krishna and Dharam Singh both of the CongressWhat was Yeddyurappa charged of in the Lokayukta report? He was charged of allocating a paltry 10 acres of land to his family members. He did it, as many of his predecessors did, under the Chief Minister’s discretionary quota. An indiscretion perhaps, for a leader of a ‘party with a difference’ but it can hardly be termed corruption. His son was accused of accepting a paltry Rs 10 Cr as a donation to a trust he was running as quid pro quo for getting him some mining leases.

The BJP did act by replacing Yeddyurappa as Chief Minister but by the time the damage was done. The anti-BJP media selectively went to town with Yeddyurappa’s alleged corruption and the stigma stuck. The reason for qualifying the media as anti-BJP is because it spared the two former Congress CMs indicted by the same Lokayukta report. The BJP could not effectively counter the campaign. Here is a lesson for the BJP to ruminate on its media management or look for a media organisation of its own. 

The lesson: don’t under-estimate the power of media. There is a corollary to the lesson: don’t over-estimate the power of the social media. The social media may be able to discipline the mainstream media to a certain extent but it can’t be a substitute for hard work on the ground. 

The manner of his exit rather than the exit per se must have angered Yeddyurappa. A faction within the party which wanted the party to brazen out corruption charges (as the Congress does often) raised false hopes in him. But a more martinet faction within the party wanted him out at least till his name was cleared by due legal processes. A miffed Yeddyurappa walked out of the party, formed his own outfit and proved to be the BJP’s nemesis at the hustings. His exit split the party’s votes and reduced its tally in the Vidhan Sabha to a third of its former strength. In the process, he rendered himself irrelevant in the political scheme of things in the state. He might yet learn his lesson and yearn for a homecoming as many others before him have done both in the BJP and its arch-rival, the Congress. For the nonce, he has had his revenge for a real or imaginary slight he suffered in the party.

Saturday, April 13, 2013

Is 2002 a decoy for 1984?

How do you make a line smaller without touching it?’ is a question which kids use while playing games. It is a sort of a children’s equivalent of an IQ test. It would be more appropriate to rephrase it as ‘How do you make a line appear smaller without touching it?’ The answer would of course be ‘by drawing a larger line adjacent to it.’

Why would adults play a kids’ game? But they do. They do. Human rights activists do. Intellectuals do. Media analysts do. Politicians do. Social activists do. They do and have been doing it, in spite of the issue under discussion being, as macabre as the butchering of thousands of men, women and children in the national capital. They do although one unnatural death (death by wanton murder) is one too many.

The riots in Gujarat following the burning of a wagon-load of karsevaks in February 2002 could be discussed as a standalone riot. There is another strange aspect to it. It is as if India had no history before 1992 and no history after 2002. Therefore the demolition of the ‘Sri Rama Janma Bhumi – Babri Masjid’ in 1992 and the riots that followed the burning of a wagon-load of karsevaks in 2002 are discussed ad nauseum as standalone incidents as if they had no context. In the case of 2002, only the riots are discussed. The burning of a wagon-load of karsevaks that preceded them is airbrushed as if it never happened. If it was ever mentioned it was done so, as an after-thought. ‘Yes, it happened. Unfortunate.

When it comes to discussing the Sikh massacres of 1984 (an inconvenient issue that cannot always be avoided), the issue of 2002 had to be invariably invoked as if it was somehow it was the incident that triggered it. Stranger still, even in a discussion about the massacre of 1984, the riots of 2002 become the focal point and the massacre of 1984 an addendum. These are the ways of our secular polity and objective media!

This was the background for Vivek Kaul’s ‘1984 riots: The original ‘maut ka soudagars’ set tone for future’. The issue came back to limelight after the Delhi High Court ordered reopening the Jagdish Tytler case, which, CBI, India’s premier investigation agency sought to bury umpteen times in the last twenty-eight years. It was not due to its ineptitude that the premier investigation agency sought to bury the case but because the oft-quoted dictum ‘the law will take its course’ is applicable only to ordinary mortals but not to the high and mighty. There is a separate jurisprudence for them!

Kaul relies heavily on Ramachandra Guha's book (India After Gandhi –The History of World’s Largest Democracy) to put across his point of view. There are many inaccuracies - deliberate and mala fide - in both Kaul's and Guha's versions. Guha writes, “…The mobs were led by Hindus who lived in and around Delhi…” That the massacre had nothing to do with Hindus or Hinduism has been conveniently ignored. That it was the private revenge of the Congress party was intentionally ignored. That the Congress party’s most cynical, if not macabre game plan was to use the sad incident to derive political dividends by whipping up public hysteria was deliberately not highlighted.

Guha goes on to say, ‘…in Delhi alone more than a thousand Sikhs perished…’ A deliberate attempt, to use Nixon’s famous phrase, to economize with the truth! The fact was, in Delhi more than 3000 Sikhs were butchered and 5000-7000 more were killed in the other parts of the country.

It is at this point Kaul tries to draw his ‘Gujarat 2002 larger line’ to make ‘the 1984 Sikh massacre, the smaller line’. Kaul doubles the number of deaths in the Gujarat riots – off his own bat without any help from Guha! The number of Muslims killed in Gujarat in the 2002 riots was not 2000. It was 790, according to a reply given by a secular Congress Minister of State for Home (MoS, Home) in the Rajya Sabha. There is more to the inappropriate comparison. The 1984 anti-Sikh carnage was a totally one sided affair, truly a genocide, to use a word often inappropriately applied to the Gujarat 2002 riots. In the riots that followed the burning of a wagon-load of karsevaks, 254 Hindus were killed. The number of Hindus dead is a matter of no consequence for secular writers and hence no mention was ever made of them.

Guha’s specious argument about unnamed Karsevaks ‘getting into a fight with Muslim vendors at the Godhra railway station’ as a reason for burning down a whole compartment of Hindus, more than half of whom were women and children is another spin of sick secular minds. This mauling of facts often resorted to by the secular mob since 2002 is a deliberate insult to the common sense of – well, the common man. Do platform vendors routinely store hundreds of gallons of petrol anticipating altercations over a few rupees with their customers, and do they routinely burn customers to teach them a lesson?

While the central government in Delhi deliberately delayed the deployment of the army in 1984 till the blood-lust of the dynasty was satisfied, the army was called in Gujarat in 2002 within 48 hours. (There were no four days between February 27 and March 1 as some over-zealous, motivated commentators tried to make out!) While the accuracy of Rajiv Gandhi’s ‘the earth trembles when a big tree falls’ statement has been fairly well established, the Gujarat Chief Minister’s statement following the riots was deliberately distorted to paint him as a bloodthirsty tyrant.

Another detail which the article deliberately glosses over was that in the Delhi massacre, senior Congress leaders like H. K. L. Bhagat, Sajjan Kumar and Jagdish Tytler led the murderous mobs from the front. The fact that Congress workers were as much part of the Gujarat riots as members of the BJP is too inconvenient for the secular brigade to be bothered about.

Thursday, April 04, 2013

Novartis Vs. The People Of India

Ivan Illich opened his seminal work, Limits to Medicine with the observation that ‘the growth of the medical establishment is a major threat to health.’ A large part of Illich’s work dealt with iatrogenic (meaning physician-induced) diseases. But to Illich, the ‘medical establishment’, also includes the pharmaceutical industry.

The recent Supreme Court verdict in the Novartis’ Gleevec (Glivec) patent case has generated a lot of heat and uninformed debate in the media. Novartis challenged the order of the Intellectual Property Appellate Board (IPAB), for rejecting a patent for its ‘old wine in a new bottle’ first in the Madras High Court and then in the Supreme Court. Novartis filed world-wide patents for its active molecule imatinib in 1993. In India, the company filed patent in 2003 for imatinib mesylate a beta crystalline form of the active ingredient, under the ‘mailbox provision’.

NOVARTIS Vs. PEOPLE OF INDIA

Novartis’ application for a patent for its beta crystalline form was rejected by the IPAB in 2006 on the ground that Novartis’ original patent application covered all forms of imatinib. The Madras High Court decreed that IPAB’s rejection of the application under Sec. 3 (d) of the Indian Patents Act as amended in 2005 did not violate Article 14 of the Indian constitution. This is now upheld by the Supreme Court.

The Indian Patents Act of 1970 did not recognize product patents but only process patents. However India agreed to consider patent applications filed from January 1 1995 for granting product patents pending amendment of its laws in line with the requirements of the WTO. The process was known as the ‘mailbox’ provision. Eventually India amended its patents law in 1999, to grant product patents with effect from January 1, 2005. A patent is an intellectual property which has a life of 20 years from the date of filing and which gives its holder exclusive marketing rights. The actual period of exclusive marketing depends on the company’s ability to develop the product for commercialization.

R&D COSTS

In the pharmaceutical industry, Research and Development (R & D) is of course an expensive and risky process. A company begins with thousands of molecules and narrows down its search to a few (less than a dozen) for further experimentation. After initial animal experimentation to establish efficacy, safety and toxicity a candidate drug (known in the industry as New Chemical Entity or NCE) is selected for human clinical trials. A patent application is generally filed at this stage and approval sought for commencing human clinical trials. These are conducted in four phases before it is submitted for marketing approval by the regulators. It is called filing a New Drug Application (NDA). The process takes quite a few years. This means, although a patent is granted for 20 years a company gets to exclusively market it for the residual period after conducting clinical trials and obtaining marketing approval. Even after a drug is approved for marketing it is still tested in a process called, Post Marketing Surveillance (PMS) every year to find out if any hitherto unnoticed side effects come to light. The company has an obligation to market a product only to be used in conditions for which it is approved. However a physician may use it in other conditions if he finds it suitable. This is known as off-label usage.

There are varying estimates about the cost of research and development of drugs. Several years ago an article in the Readers’ Digest put it at between $ 100 and 200 million. Recent estimates vary from $ 500 million to 1 to 2 billion depending on the therapeutic category and method of calculation used, such as inclusion of capitalization and opportunity costs. This does not mean that the entire amount is spent by a company. There is public funding and tax write-offs on R & D spending, which is a not unlikely incentive for bolstering the figures.

Pharmaceutical companies quite naturally argue that they have to make profit out of successful candidate drugs because they have to incur huge expenditure on R & D, which is a long drawn and uncertain process. This is the reason they claim, new drugs cost so much.

MARKET RISKS

However pharmaceutical companies are aware there is an element of uncertainty in the business. For, even if a company is able to come up with a successful candidate drug, there is no guarantee that a rival company with a competing product might not upstage it. As an illustration, see the case of the first anti-ulcer drug cimetidine. It was introduced by the British multinational, Smith Kline & French (SK&F) in the mid-seventies when the only cure for peptic ulcers was surgery. The drug was indeed a boon for patients as it reduced the necessity for surgery in about 90% of cases. The drug marketed by SK&F as Tagamet entered the Guinness Book of World Records for maximum number of prescriptions received in a year. A few years later another British multinational Glaxo came up with an updated version of the drug ranitidine which it marketed as Zantac. It too entered the Guinness Book of World Records in the year of its introduction, and Tagamet lost 50% of its market share. As a result, many heads rolled in SK&F and its Chairman had to resign. The two companies merged in the mid-nineties to become what is now known as GlaxoSmithKline (GSK). (In its process of mergers and acquisitions, GSK has also absorbed several other companies like Beecham and Burrows Wellcome.)

The success of the first two molecules, in the class of drugs called H2 receptor antagonists, made other companies board the bandwagon and many variations of cimetidine were launched. These include famotidine, loxitidine, nizatidine and roxatidine. Of these molecular variations only ranitidine and famotidine could achieve significant commercial success, while the others remained small players. For the treatment of peptic ulcer, another class of more powerful drugs known as proton-pump inhibitors emerged with members like omeprazole, esomeprazole, lansoprazole, pantoprazole and rabiprazole, a few years later.

Wouldn’t it be unfair for a company marketing, for instance, roxatidine to claim the same pricing privilege as SK&F which has laid the groundwork for finding a drug for peptic ulcer? On the flip side could SK&F claim that, as there was every possibility of its market monopoly being upstaged, it should be permitted to recover its costs at the earliest? In view of this should the company be allowed to price a tablet of cimetidine @ $100?

R&D – WESTERN BIAS

It would be unfair to see the Indian Supreme Court verdict as a triumph of left-liberal altruism against Western capitalism for several reasons. Firstly, US courts too held that derivatives of known substances are not eligible for patent protection under the ‘doctrine of inherent anticipation’. Also in the US a patentee cannot claim rights for more than one substance with identical claims, under the ‘doctrine of double patenting’. The third principle governing US jurisprudence in relation to intellectual property rights is the ‘patent misuse doctrine’, which prevents pharmaceutical companies from extending their patent rights by obtaining multiple patents covering essentially the same invention. In her extensively researched paper, Trials And TRIPS-ulations: Indian Patent Law And Novartis AG v. Union Of India, (Berkeley Technology Law Journal, Vol: 23. Mar 21, 2008. 281-313), Lynda L. Lee opined that the stand of the Indian courts indicates that the objective of India’s Section 3 (d) is not a radical departure from international practices to regulate the patenting of derivatives and new uses. It must be noted that the article was based on the Madras High Court judgment and written much before the final verdict of the Supreme Court.

The reaction of Novartis to the Supreme Court judgement appeared a bit peevish. In a press statement, the company’s Vice Chairman warned that it will discourage R&D spending by multinational companies in India. This is a bit surprising as multinational companies may have been using India as low cost hub for manufacturing and conducting clinical trials but never seem to be bothered about diseases specific to India. For a long time the healthcare fraternity has been complaining that multinational companies focus on diseases prevalent in the western world for researching remedies. For example, we have not seen new drugs introduced to combat malaria and tuberculosis which are endemic to countries like India, in years. The incidence of both the diseases is seeing virulent, intractable forms. Today tuberculosis resistant to multiple drugs – multidrug resistant TB or MDRTB is quite prevalent. On the other hand new drugs for cancer, diabetes and hypertension and related diseases are introduced by the dozen every year.

R&D – ALTRUISM OR BUSINESS STRATEGY? THALIDOMIDE TO GATIFLOXACIN

Multinational companies which have been assuming moral high ground for their altruistic R&D efforts ‘to ameliorate pain and suffering of humanity’ have also been guilty of destroying the lives of millions of people for short term gains.

The introduction and withdrawal of thalidomide is a classic example. In the 1950s, Distillers & Co (the makers of Johnnie Walker whisky) purchased Grunenthal, a small German pharmaceutical company. Grunenthal developed a tranquiliser named thalidomide which was then believed to be so safe it could be prescribed to pregnant women to relieve them of morning sickness. It was introduced in several countries in Europe and freely prescribed for pregnant women. In the early sixties a causal link was established between the use of thalidomide and delivery of malformed babies. This property of a drug which causes foetal abnormalities known as teratogenicity, was unknown till then. By 1961 an estimated 10000 to 20000 thalidomide babies were born and the drug was withdrawn. 

The thalidomide story should have warned the managements of pharmaceutical companies to be extra careful in vetting and promoting their products. But alas no, drugs with serious adverse effects have been introduced by pharmaceutical companies with unceasing regularity. Here are a few examples, some of which may not be as lethal as thalidomide. Analgin (like penicillin) is known to cause anaphylactic reactions so severe a single tablet could kill a patient. Anti-inflammatory drugs like oxyphenbutazone and phenylbutazone have been known to cause blood disorders. However all these drugs were marketed by multinationals in India for a long time after they were banned in their home countries. The newer pain-relieving drug, nimesulide has been banned in several European countries but is still marketed in India (not by multinationals; by Indian pharmaceutical companies). Terfenedine, introduced as an advanced, non-sedating anti-allergic had to be withdrawn a few years later as it was found to cause heart-problems. The latest in the series of drugs to be withdrawn was the antibiotic gatifloxacin, which was found to cause cardiac problems. Illich mentioned in his book that the American innovator of chloramphenicol (trade name, Chloromycetin) marketed the drug for simple conditions like acne. Originally introduced for treating typhoid, the drug is known to cause bone-marrow depression. (The human body produces red-blood cells in the bone-marrow.)

PRICING DRUGS

An argument that was vociferously voiced in the television debates relates to pricing; especially that pharmaceutical companies which spend millions (billions?) should be allowed the freedom to price their products. And any regulation would be a disincentive for them to introduce newer products. This argument lacks substance because the pricing of drugs is not uniform even in the western world. For example the prices of drugs in Canada are far lower than the corresponding prices of drugs in neighbouring USA. In some cases the Canadian prices are about half of their American counterparts.

The marketing of anti-retroviral drugs (used to treat AIDS) in South Africa offers an object lesson for those who blindly take sides with the advocates of free-pricing. Indian companies like Cipla and Hetero Drugs offered to sell a combination of anti-retroviral drugs @ $350 for a year’s course. Four multinational companies challenged them in the South African Supreme Court, on the ground that these companies were infringing their patent rights. They were selling the drugs @ $10000 for a year’s course. They had to withdraw their suit following worldwide revulsion. For, more than a third of world’s AIDS population lives in Sub-Saharan Africa.

In the television debates, medical doctors representing Novartis claimed that the company has a scheme for providing the medicine free of cost to ‘below poverty line’ patients. This is not entirely true because the company stopped providing imatinib free after two Indian companies were permitted to introduce low cost alternatives in 2006. (See the research paper cited above.) Even if the company has been providing the medicine free to BPL patients, how does one define a BPL patient? Certainly a household with an income of Rs 50000 per month cannot be considered BPL? If the household has a patient who requires imatinib, can it expend Rs 1.20 L a month? Besides, many cancers require multiple regimens of treatment, which include chemotherapy (drugs), radiation and surgery. The latter two are even more expensive than the cost of medicines.

TAILPIECE: By the by, the promotional or marketing budgets of pharmaceutical companies exceed their R&D budgets by a long chalk.   

Saturday, March 23, 2013

Have political ploys made the law an ass?


Is the law an ass?’ asks a character in Charles Dickens’ famous novel, Oliver Twist. Several incidences over the last few days make ordinary folk wonder whether the law is really an ass?

ITALIAN MARINES CASE The first of these concerns the Italian marines’ case, which raises several questions. Why had the Indian Supreme Court exhibited unseemly generosity in permitting the Italian marines – undergoing trial for first degree murder - to return home first to celebrate Christmas and then to vote in an election?

The Italian marines were undoubtedly undergoing trial for first degree murder as they shot to kill. Their claim that they thought that a pirate ship was closing in and they shot in self-defence does not wash. For, as trained naval officers, could they not distinguish between a pirate ship and a fishing boat? Were the naval officers so scared of a small fishing boat, that they thought that it was closing in to hijack their vessel? If so why did they not fire warning shots to dissuade the boat even assuming that it was closing in, which appears far-fetched?

Could an Indian citizen undergoing trial for first degree murder expect the same treatment from the Indian courts? Had an Indian Court ever permitted a prisoner, undergoing trial for first degree murder, to go home to celebrate Diwali? It would never have occurred to an ordinary citizen in judicial custody, undergoing trial for first degree murder to even pray for such leave. Therefore an ordinary citizen should not be faulted if he wonders why, even for the Indian Supreme Court Italian citizens are more equal than Indian citizens’. On many occasions in the last thirty years, the Indian establishment has demonstrated that for it, Italian citizens are indeed more equal than Indian citizens. The reason for the establishment to bend backwards being the Italian connection of India’s ruling party is quite obvious. But does it matter to the Supreme Court, the highest judicial body and the last arbiter for the ordinary citizen without any clout?

Having blundered twice, the Indian Supreme Court sought to make amends by taking a tough stance in restricting the movements of the Italian ambassador. This put the Indian establishment – especially with its Italian connection – in a quandary. After days of huffing and hawing about Italian perfidy (by the primary and proxy protagonists of the government), the External Affairs Minister grandiosely announced (not without a hint of self-congratulatory glee) that diplomacy succeeded in making the Italians see reason. His tall claims notwithstanding, there are several questions that require answers: 

Why did the Indian government sign a treaty with the Italian government in a hurry while the murder trial was under way? Was it not to benefit the two marines? Do sovereign nations sign bilateral treaties to solve instant crises? 

How would the Italian government have reacted if two Indian naval officers killed two Italian fishermen and were undergoing trial in an Italian court? Would it have been as generous as the Indian government?   

Did the Indian government make a clandestine deal with the Italians to satisfy the Supreme Court and bring back the marines? If this is not so, how could Salman Khurshid assert that the marines ‘will not be awarded death penalty as theirs is not a rarest of rare cases’? If it does not fall in the ‘rarest of the rare cases’ category are Indian fishermen routinely fired at and killed by foreign marines? 

Who should decide which case falls under the ‘rarest of the rare cases’ category or not? Is it the judiciary or the External Affairs Ministry?

The upshot of the deal - which the Minister denies was done - is, the marines will not be taken into judicial custody during the course of the trial; they will stay in their embassy; they will not be awarded death penalty as their case is not in the ‘rarest of rare cases’ category; and if awarded a prison sentence, they will serve it in their own country.

SANJAY DUTT CASE The second case is even more bizarre. It is about the sentence the Supreme Court awarded to Sanjay Dutt, famous film personality, son of a famous film personality and former Congress MP and bother of a sitting Congress MP. The four qualifiers deserve to be stressed to put the case in perspective. The 1993 Bombay blasts (in eleven locations) killed 257 people and severely injured 700 people. According to some sources, the number of injured was 1400.

[Sharad Pawar, Chief Minister of Maharashtra (at the time) later confessed that he deliberately misled people by adding Muslim dominated Masjid Bunder to the list blast locations to pacify communal tensions. See: To keep the peace, I misled people on 1993 blasts: Pawar. This secular balancing of terror has been going on since 1993. Pawar’s confession puts the pronouncements of P. Chidambaram, Sushil Kumar Shinde et al., Rahul Gandhi’s whispering to the American ambassador about Hindu Terror and the NIA ‘investigations’ in certain cases, all in perspective. To grab and retain power, secular politicians would go to any extent to appease the minorities, principally the Muslims. The invention of a phantom Hindu terror is part of the game.]  

The Supreme Court verdict in the case confirms the role of the ISI and several underworld dons. Sanjay Dutt’s role in the blasts has been known almost since the beginning. He had been known to confer with the dons, converse with them over phone and collect and store arms for the attack. His pedigree and the power of his political connections helped in almost getting him off the hook. 

If the CBI could be used to discipline wayward coalition partners to fall in line, it could also be used to save loyal allies. In Sanjay Dutt’s case the CBI did all it could to help him evade the long arm of law. It did not matter to India’s premier investigation agency that it was indeed obstructing the course of justice. It delayed investigation to help Sanjay Dutt destroy evidence, did not pursue leads, presented a weak case in the trial court and did not appeal against the trial court verdict. The CBI did not work for the people, who are its paymasters. It worked against them, and for an individual who declared a clandestine war on the people. Just as in the marines’ case, in Sanjay Dutt’s case too, it has been kinship with the high and mighty that carried the day.

One can understand the clamour of the film fraternity to obtain state pardon for Sanjay Dutt. It has been known for long that the same forces that supplied Sanjay Dutt with prohibited arms and ammunition to wage a war on the Indian state also control the film industry. But why would a retired judge of the Supreme Court and Chairman of the Press Council want to interfere with the administration of justice? That is the sad part.

The highest court in the country has delivered its verdict unambiguously pronouncing Dutt guilty. The Supreme Court has also been magnanimous in awarding the least possible sentence according to law. If in spite of this, as the Law Minister averred, an appeal for pardon is favourably considered, it would amount to subverting the justice system.