Unpleasant Monsoon in
Politics & Unstable Economic Scenario Grapple India’s Growth Story
LK Advani Fumes at
Nitin Gadakari, Naveen Patnaik feels uncomfortable, The GDP data at a staggering
5.3 percent cripple Political-Economic Growth
Satya Brahma
BJP patriarch L K Advani today is
a lonely man & feels ignored by ambitious second generation maverick politicians
& surely missing his long-time colleague Atal Bihari Vajpaye who is ill
& bede-ridden. Many see the recent
remarks by Advani in his blog slamming the RSS influenced BJP President Nitin
Gadkari as the reincarnation of his image in an desparate attempt to exercise
his monopoly in the faction-ridden Parivar who termed the present feel in the
party is NOT UPBEAT.
In politics, we all know ambition
rules over values & BJP has adapted the present state of affairs as the
most unfortunate given Modi’s status in post Gordha, Yeddurappa’s political
ambitions, Raje Scindhi’s revolt in Rajasthan are ample indications to prove
that all is not well in the party.
Meanwhile the Nifty is trading
above the 4,900. However, market sentiment continues to remain weak after the
latest GDP data showed India’s growth slipping to 5.3 percent, lowest since a
decade.
The improvement in the markets
could be attributed to the European stocks which opened higher as the markets
were looking to stabilize after a tumultuous trading session the prior day,
amid concerns about Spain.
Surely BJP’s uneasiness will
never be an asset for Congress who is targeted by Anna & the original
reformer of Indian Economy Dr Singh is not spared.
Issues are complex, situations
are worse, the road ahead looks dim if not black.
The Author is Editor-In-Chief of Indian Affairs & a passionate
advocate of free Press.
If one is to know truly one must see truly. The power and importance of observation cannot be overstated. The stock market is not an environment that allows the application of the scientific method. We cannot subject a control group to a certain stimuli and draw conclusions from the findings. It is more analogous to astronomy where orbitals and complex vector space is quantified by understanding position and momentum and attributing values to each.
An inherent problem with observation is that we tend to perceive what we expect to perceive and our perceptions resist change even in the face of new and better data. In addition, conclusions drawn from a small body of consistent data engenders more confidence than those drawn from a larger body of less consistent data. It is a critical junction where judgment becomes more important than knowledge. Once you evaluate your observations you must orientate your exposure to the long and/or short side of the market and then decisively act.
Based on the foregoing, these are my views and observations:
The Trade - I suspect that (LLY) is a short at $41.50. I would only establish ¼ of the position at $41.50 and the remaining ¾ at $44.00 with a stop out at $46.25. I would never post my stop loss. It is too easy for the Designated Market Maker to cash investors out by raising the price above the stop out and move the price right back down again. Remember the "Flash Crash"? This is a short-term trade and nothing more. I would be looking to cover at $38.00. This is based on the facts that we know at the present time.
I believe Insiders have been distributing and selling short. It is in the process of forming a double top. In addition, it is currently at the higher levels of a trading range and this is occurring to the accompaniment of an increase in big block activity and heavy aggregate volume (300% greater than the 3-month average). When you witness this type of activity you can be fairly certain (but not positive) that insiders are liquidating positions and selling short.
I believe that the Designated Market Maker in this issue has depleted his inventory and will drop the price in order to cover his short positions, replenish his inventory and accumulate from the selling which ensues.
(click to enlarge)
Although the blocks below are controlling the pattern they are not large enough to expect a long-term trend reversal. They are more indicative of a reversal in a trading range. In this case a sideways channel pattern. They also have occurred at clearly obvious support/resistance levels, which make them all the more significant.
Blocks, which evidence themselves at the reversal of a long-term trend in this issue, should be about 20,000,000 shares or greater or a series of blocks aggregating a position of that magnitude. A pullback to $38.00 to $39.00 is most likely. I might just split the difference for the cover.
Recent discoveries have placed Eli Lilly (LLY) in the spotlight forcolluding with India's drug regulators.
Eli Lilly, along with other Big Pharma names such as GlaxoSmithKline (GSK) and Novartis (NVS), has been colluding with Indian drug regulators to speed up approval procedures and put drugs on the Indian market that are not yet available or even legal in other countries. Thirteen of the drugs being investigated are not allowed to be sold in United States, Canada, Britain, European Union and Australia. The question of course arises how exactly the companies involved can justify selling such drugs in India. Several other major drug companies and firms have also been implicated. It took an 18-month investigation to reach this conclusion, but it does appear to be true.
What I gather from this information is that there is a lack of adequate supervision in emerging markets in India, where drug companies and other major industries are starting to focus their attention more intensively. The reason for this strong focus is that drug companies like Eli Lilly are feeling the pressure that comes from patent expirations. The only way for the company to maintain a good profit is by focusing on these emerging markets. Because of this sudden "dash" into new markets, the U.S. government has grown suspicious of the activities of drug companies. This led to the investigation under the Foreign Corrupt Practices Act and consequently resulted in the report regarding the activities of Eli Lilly and others.
The report references collusion between drug companies such as Eli Lilly, the Central Drugs Standard Control Organization (CDSCO), and independent medical experts. It is interesting to note that the CDSCO is not accused of wrongdoing outright. None of the officials of the firm have been named. To me, it seems that the blame will rest mostly with the pharmaceutical companies involved, which would threaten Eli Lilly's future. The report focuses instead on the series of procedural failures that have led to the various companies involved being accused of marketing drugs that are not, strictly speaking, safe.
If Eli Lilly is found guilty in this regard, it will mean that its stock should decline significantly. Perhaps the worst effect it will have is that investors will lose faith in the company and its ability to provide them with a reliable stock to back.
Novartis announced its intention to look into the allegations that it colluded with Indian drug regulators. A number of drugs were randomly assessed and in 11 cases, including Novartis' everolimus and aliskiren, it was found that "mandatory" Phase III clinical trials had not been conducted as required. In its defense, Novartis claims that it conducted trials as per one global standard. It stands by the safety and efficacy of its drugs. Regardless of the final outcome, it is clear that companies such as Novartis and Eli Lilly are going to be painted in a very bad light for the next few months.
In other news, Eli Lilly has won a small victory in court. Recently, courts sided with the company in rejecting the idea that companies must pay overtime to their sales force. The plaintiff argued that, as she did not close any sales and as she does not fall under the same heading as administrative exemption, that she should be entitled to overtime. This is at least something positive for the company. If it had lost the suit, it would have become instantly vulnerable to multiple class action cases leveled by sales employees demanding back pay for the many years that they did not receive overtime benefits. Longstanding federal labor law exempts salespeople from overtime requirements. However, this is not the only case of its kind that has recently been made against pharmaceutical companies. If the high court rules against pharmaceutical companies in another case, Eli Lilly -- along with many other players in the market such as Abbott (ABT) and Johnson & Johnson (JNJ) -- will still be significantly affected.
Eli Lilly competitor Pfizer (PFE) has finally decided to give up once and for all on Lipitor. Following an aggressive marketing campaign to make as much money as possible following the expiration of the Lipitor patent, Pfizer has now ceased all marketing efforts related to the drug. The company is now focusing more intensively on the other medications in its pipeline, such as tofacitinib, which the company hopes will soon beapproved by the FDA. At this stage, new drugs are the only way for Pfizer to get back in the game.
Sanofi (SNY) appears to be downsizing as well, although in this case it may be against the company's will. Recently, it announced its intention to close a plant in Newcastle that is likely to leave 450 employees, some of whom have been working at the plant for decades, without jobs. In addition another plant will also be closed, which means that even more employees will lose their jobs. Clearly, the company is in some sort of trouble if so many plants are being shutdown at once.
Last but not least, GlaxoSmithKline made a bid to take over the drug manufacturer Human Genome Sciences (HGSI). The two companies have a long history of cooperation and so it is hoped by GSK at least that the deal can be closed on friendly terms. Glaxo is offering $13 cash per share for the company, a very good deal that Human Genome is unlikely to beat. In fact, no other buyers have stepped forward and it seems that Human Genome, which thus far attempted to hold on Glaxo, may just have to give in and merge with its stronger partner.
Eli Lilly just gotten caught red-handed in this collusion fiasco. Look for it to make some play that will help it avoid long-term consequences from it. Anything less, I'm afraid, could drive the company further down than you'd want it to be.
It's a no-brainer that buying from a Chinese supplier is cheaper than from a Japanese one, right? Pravin Herlekar, Chairman of Omkar Speciality Chemicals, a Rs 100-crore bulk drug maker based in Badlapur, near Mumbai, learned the hard way that it is not always true. His company dumped its Japanese supplier of selenium when it found a cheaper source in China. But, Herlekar says, the Chinese suppliers resisted inspection of shipments before delivery. Within a few months, the intermediates that Omkar made using Chinese selenium began to suffer from quality issues. The company went back to sourcing selenium from Japan.
"Chinese suppliers often don't agree to third party inspections which help keep a check on quality," says Herlekar. Selenium derivatives are used to make an active pharmaceutical ingredient (API) or bulk drug. Bulk drugs are used to make medicines. For instance, intermediate compounds such as isobutyl benzene, aluminium chloride and sodium dichromate are used to make ibuprofen, the principal ingredient in formulation brands such as Combiflam.
SPECIAL: Ranbaxy sets the trend for more indigenous drugs
With strong advantages such as economies of scale and government funding, Chinese companies have been fl exing their muscles by resisting inspections, neglecting quality issues and raising prices. Many Indian companies are fi nding or creating alternatives to Chinese suppliers"
Lower prices offered by Chinese companies have caught the attention of many Indian drug makers. "In the last five years, API imports by Indian companies have doubled. In 2010/11, imports crossed $7 billion, of which China has a 60 per cent share," says O.R.S. Rao, Director, Cygnus Business Consulting and Research. "In the same period, India's bulk drug production has fallen to 35 per cent of its consumption, from about 70 per cent." The Hyderabad-based research firm releases a study on the Indian bulk drug industry every two years; the last edition was published in 2011. The Indian bulk drug market is valued at $13.5 billion, and its Chinese counterpart at $30 billion.
China and India are the leading players in bulk drugs, accounting for more than 40 per cent of global bulk drug production. China is the largest bulk drug supplier, and India is second. Part of China's competitive advantage comes from the operating environment (lower interest rates, access to power and other infrastructure) and government aid (cheaper land, government funding). This has enabled Chinese manufacturers to benefit from economies of scale. China is also better endowed with raw materials such as phosphorous, potassium and sulphur. So it can produce bulk drugs at 10 per cent of the cost in developed countries.
In 2010/11, bulk drug imports by Indian companies crossed dollar 7 billion, of which China has a 60 per cent share: O.R.S. Rao
Given their strong advantages, Chinese companies have been flexing their muscles by not allowing inspections, neglecting quality issues and raising prices. And Indian pharma seems to have finally decided that it needs to stop depending on China. Some Indian companies are integrating their operations backward to increase control over bulk drugs and intermediates. And, as price increases by Chinese manufacturers squeeze margins, Indian companies are trying to move up the value chain into the high-margin formulations business. Dependence on China has generated enough concerns for the Indian Drug Manufacturers' Association (IDMA) to call for anti-dumping duties on some bulk drugs and intermediates from China. IDMA also wants the government to set up a $700-million fund for bulk drug manufacturers. "Low-priced Chinese APIs are attractive, but this phenomenon can only be temporary," says Manish Doshi, President, IDMA.
"Nothing can stop them from raising prices once they know that Indian API manufacturers have closed down due to cut-throat competition. It is the government's duty to protect the industry from such dumping tactics by China." Doshi is also Managing Director at Amoli Organics and Umedica Laboratories, companies which were set up by his father and which make intermediates, bulk drugs and finished drugs. Naresh Gupta, who heads Lupin Laboratories's bulk drug unit, also argues that the government should try to level the playing field for Indian manufacturers. Incidentally, Lupin is the only Indian pharma major that exports bulk drugs to China.
Omkar Speciality Chemicals isn't waiting for the government act, however. Its strategy is to meet international standards. Its Badlapur factory has good manufacturing practices (GMP) status from the US Food and Drugs Administration. Regulatory authorities in many countries grant GMP status, but the most important for Indian companies are the US and British authorities, besides Indian regulators. Omkar will also seek GMP status for its factory coming up in Chiplun, Maharashtra. Herlekar says his advantage will be quality. "Indian formulations majors are increasingly sourcing from India, as they don't have to maintain large stocks and quality can be controlled," he says. "Most Indian API and intermediates manufacturers get their facilities audited by their customers, so quality isn't much of an issue."
Another strategy is backward integration. Shasun Chemicals and Drugs, a Chennai-based Rs 1,000-crore company, has decided to manufacture some intermediates at its Andhra Pradesh plant, rather than importing them from China. Managing Director S. Abhaya Kumar says: "We have earmarked Rs 70 crore to move production of some of our key intermediates to India. The shift should be complete by December." He adds that intermediate prices in China have increased by 10 per cent in the last three months, because of rising petroleum prices and pressure on China to adhere to environmental norms. Shasun is the largest producer of ibuprofen in the world. It is developing 13 APIs for a few billion-dollar drugs whose patents expire in the next five years.
Another way to integrate backward is to acquire a bulk drug maker. For example, Mumbai-based Aanjaneya Lifecare bought intermediates manufacturer Apex Drugs in February for Rs 250 crore. The aim is to reduce dependence on third parties and reduce its vulnerability to fluctuations in price and supply. Similarly, Indoco Remedies, also based in Mumbai, acquired bulk drug maker La Nova Chem in 2006. The contribution of bulk drugs to overall revenues is negligible, but Indoco plans capital expenditure of Rs 55 crore over the next couple of years in its bulk drug factory at Patalganga, near Mumbai.
To counter the Chinese, big Indian drug makers such as Dr. Reddy's, Ranbaxy and Lupin have been moving up the value chain, from intermediates and bulk drugs to generics. But not everyone finds it easy to walk away from China.
"Only intermediates that have an impact on the quality of the finished product are manufactured in India or inhouse," says Sanjay Bhanushali, Head of International Business at Cipla. Procurement from China has increased five to eight per cent every year for the last three years." Cipla is looking at stronger alliances with other Indian or overseas companies to avoid sudden shocks. It is also open to dealing with companies in other markets, such as Brazil, Argentina, and Vietnam.
Lupin's Gupta says his company's Japanese operations are looking to shift all bulk drug manufacturing to India. "Despite price volatility in some inputs, the company was able to insulate itself due to hedging," he adds. Quality and research differentiate India from China. India has more than 175 plants approved by the US FDA - the highest number outside the US. Focus on quality has helped Indian companies increase their presence in developed markets. According to a report published in April by HSBC Global Research, half the Drug Master Files (DMF) in the first three months of this year are from Indian companies, compared to China's share of 14 per cent. DMF documents contain complete information about a drug's chemistry and manufacturing process, among other things, and enable a company to protect its intellectual property.
Many medium-sized bulk drug manufacturers have, with investments in research and development, shifted focus to late-stage intermediates and complex synthetic APIs. Chandigarh-based Parabolic Drugs , a Rs 900-crore company, recently commissioned a facility to manufacture bulk drugs in new therapy areas such as oncology and lifestyle ailments such as diabetes. The facility is likely to generate revenues of Rs 50 crore to Rs 75 crore in the current financial year and when fully operational, can generate up to Rs 300 crore.
But in the near future, it looks as if Chinese companies will continue to bleed Indian bulk drug makers. The capital-intensive nature of operations and extended working capital cycles have suppressed their return on capital. "Many bulk drug manufacturers are struggling financially," says Ajit Mahadevan, Partner - Life Sciences, Ernst & Young. "A lot of them are looking for funds and finding it difficult to manage them in these times." It may be a while before they are strong enough to fend off the dragon
Sunday, May 13, 2012
The much-awaited leadership event, The 3rd Annual India Leadership Conclave & Indian Affairs Business Leadership Awards 2012 successfully concluded with the participation of more than 250 business heads, social entrepreneurs, celebrities and industry veterans.
The event was organised by the country’s most analytical news magazine Indian affairs in Bengaluru. Brand India: The Emerging Superpower, Limitless Leadership & Limitless Possibilities, the theme of the 3rd annual conclave saw the leading voices of India debating on issues of tremendous significance.
IIPM won India’s most valuable B-School award at the ceremony beating IIMs, XLRI and SP Jain in a nationwide voting. Commenting the mechanism and process of judging, Satya Brahma said the nominees had to undergo a three-tier process where they were tested by the public through smses, emails and physical interactions with a sample size of 11,200 in 17 states.
Satya Brahma, chairman of the 3rd Annual India Leadership Conclave & Indian Affairs Business Leadership Awards & editor-in-chief of Indian Affairs addressed the gathering emphasising the need for a stronger government policies for the growth of the India Inc. Noted economist and management guru Prof Arindam Chaudhuri addressed the conclave with a speech that left the audience delighted as he said, “Brand India is not a mere abstract but a reality and India can truly become a superpower if it addresses issues like independence of judiciary and host of path-breaking reforms.
Drug major Ranbaxy Laboratories on Friday said its consolidated net profit surged over four-fold to Rs 1,246.76 crore during the first quarter ended March 31, 2012, over the same period of previous year.
The company had posted a profit of Rs 304.38 crore during the quarter ended March 31, 2011, Ranbaxy Laboratories said in a filing to the BSE.Net sales of the company rose to Rs 3,695.40 crore for the quarter ended March 31, 2012, as against Rs 2,141.49 crore during the same period of previous year.On a standalone basis, the company posted a net profit of Rs 827.23 crore for the first quarter, while it had a net loss of Rs 52.9 crore in the corresponding period of last year.
The company's net sales on standalone basis rose to Rs 1,810.22 crore during the first quarter, as against Rs 1,054.92 crore in the same period of last year.Commenting on results, Ranbaxy CEO and Managing Director Arun Sawhney said: "The focus on key products and markets, while maintaining emphasis on further strengthening quality and compliance standards, has had a positive impact on the performance of Ranbaxy during the quarter".
In his trademark audacious style Cipla Chairman Yusuf Hamied is back at doing what he is best known for -- making life-saving medicines affordable. In business language that reads; PRICE WARS. The difference is -- a decade ago Hamied -- a Ph.D in chemistry from Cambridge -- took on global companies GSK, Boehringer Ingelheim and Bristol-Myers Squibb by slashing prices of leading anti-HIV therapies from USD 12000 per patient, per year to USD 370 per patient, per year. This time he has sought to breech the lowest price set by Natco Pharma -- a fellow Indian rival.
In March, Natco was granted India's first Compulsory License and has since been preparing to launch its cut-price versions of Bayer's kidney cancer treatment sorafenib (branded Nexavar) at a pre-set price of Rs. 8,800 for a month's treatment (Nexavar costs Rs 2.8 lakhs). But before Natco could hit the market Cipla took the controversial price debate to a new level -- offering to slash prices of not just its sorafenib brand Soranib but two more anti-cancer drugs by as much as 75%.
As things stands now, Cipla's brand will be available to patients at below Rs 7000 and if market dynamics are anything to go by, the stage looks set for an intense price war. For cancer patients it's a life and death situation -- from the time Bayer gained product patents for its Nexavar back in 2007 and introduced it at approximately Rs. 2,80,000 to now -- as these price moves bring anti-cancer drugs within the reach of many more of India's billion plus population.
The new market situation can perhaps be traced back to a few years ago. In 2010, a defiant Cipla ignored Bayer's product patents and took sorafenib to the market at an astounding one-tenth price on grounds that it had obtained a market authorization from India's Drug Controller General of India. Some said it was a legitimate launch that must be viewed from the patient affordability angle whereas others argued that India had shown scant regard for the international patenting system and had violated multi-lateral WTO rules.
What followed were many rounds of a legal battle between Cipla and Bayer before it culminated at the Supreme Court, whose refusal to grant Bayer an injunction was seen as a tacit backing of Cipla's position. Separately, a 2009 judgement by the Delhi High Court overlooked Bayer's product patents and instead directed the German company to pay Rs. 6.70 lakh to Cipla and the Indian government in legal charges. Unfazed by the decision, Bayer appealed to a divisional bench at the same court calling for the drug approval process to be linked to patents, in line with the prevalent practice in the United States, so as to prevent the launch of generic versions of drugs that have been granted product patents.
On the policy side, Bayer noted that India, being a signatory to the WTO, was obliged to protect IPR. That argument is often countered by those who believe that, within the framework of multi-lateral trade agreements, every country must have the freedom to design policy safeguards in order to serve the health needs of its population.
On its end Cipla also challenged the validity of Nexavar patent. It found support from lawyers representing public health activists who contended that the high prices of patented drugs are a big hurdle to an effective healthcare system, especially in a country like India where citizens foot the bill.
Cipla's aggression ran the risk of being challenged as patent violation and a loss would have entailed a hefty penalty. Natco on the other hand followed a more subtle but sure approach. The Hyderabad-based company fired its first salvo at Bayer by applying for a voluntary license for sorafenib. As was expected, Bayer saw no valid grounds to award a license and in turn argued that global research companies needed to recoup their R&D spending via successful launches.
By driving Bayer to that defence, Natco opened a new frontier for a compulsory license. It became more certain that if the Controller General of Patents (India) denied Natco a license, it would be accused of acting against the needs of patients in India.
No matter how steadfastly the proponents of world intellectual property rights (IPR) may call for an overhaul and demand more certainty in India's patent regime, the clear fact remains that prices of drugs are moving lower, despite the arrival of product patents in India. Natco's compulsory license has acted as an indirect price control mechanism, not just for global companies but, going by Cipla's latest action, for Indian firms too.
Where does one find the balance between patients and patents? Maybe this time, patent holders will have to reconcile to the realities of the changing world. No drug launch can be relevant without an affordable pricing strategy to make it accessible to those who most need it.
Roche's latest alliance with India's Emcure Pharma to introduce second brands bears testimony that global companies are tweaking their basic strategies to be relevant to emerging markets. That sounds to be a more robust option than engaging in endless legal battles and needlessly earned ire. Global companies acknowledge they ended up in a veritable PR disaster about a decade ago - that folly can be avoided now.
Amid concerns that more domestic pharma companies could seek compulsory licences to replicate patented drugs, the government today said no such application was pending for approval. In March, the government had allowed Hyderabad-based Natco Pharma to manufacture and sell a generic version of cancer-treatment drug Nexavar at a price, over 30 times lower than charged by its patent-holder Bayer Corporation. d Sharma said: "No application for compulsory licence is pending at present".
The Minister said only one such licence has been granted in India since the amendment of the Patents Act in 2005. The only compulsory licence has been granted to Natco Pharma for Sorafenib Toylate, a drug used for treatment of liver and kidney cancer, he said. As per WTO agreement, a compulsory license can be invoked by a national government allowing someone else to produce a patented product or process without the consent of the patent owner in public interest. The compulsory licence was granted to Natco by India Patents Office under Section 84 of the Indian Patent Act, which is in compliance with the TRIPS agreement of the World Trade Organisation. Natco was allowed to sell the drug at a price not exceeding Rs 8,880 for a pack of 120 tablets required for a month's treatment as compared to a staggering Rs 2.80 lakh per month charged by Bayer for its patented Nexavar drug.
Probe finds collusion between drug regulator, pharma firms
Officials of India’s drug regulator have been colluding with pharmaceutical firms to speed up approval procedures, allowing some drugs that are not permitted in other countries to go on sale, according to an 18-month investigation by MPs.
The parliamentary panel’s 78-page report names a number of major international drug companies and Indian firms.
The report may fuel concerns over lax supervision of the global industry in emerging markets, where Western drug manufacturers are increasingly focusing their sales effort.
The report talks generally of collusion between officials in the Central Drugs Standard Control Organisation (CDSCO), independent medical experts and pharmaceutical companies but does not directly accuse the firms of wrongdoing or name any of the CDSCO officials.
Instead, the panel catalogued a series of procedural failures that it said raised questions about how some of the drugs, including those made by pharmaceutical giants, were allowed to be sold in India.
Thirteen drugs scrutinised by the panel are not allowed to be sold in the United States, Canada, Britain, European Union and Australia, it said.
The Indian pharmaceutical market is the fourth largest in the world in terms of volume, according to the Organisation of Pharmaceutical Producers of India (OPPI). It generates $12 billion in sales every year.
International drug companies whose profits are being squeezed by patent expiries in the developed world are investing heavily in emerging markets, which are expected to account for 29 percent of global pharmaceuticals sales by 2015, up from just 12 percent in 2005, according to IMS Health.
The dash into new markets has brought with it greater scrutiny from U.S. regulators, which are investigating a number of drug companies under the Foreign Corrupt Practices Act.
The union government has come under intense pressure over the past two years over its failure to stem graft that has undermined investor confidence.
“COLLUSIVE NEXUS”
The report by the health committee of the Rajya Sabha painted a chaotic picture of the CDSCO, which oversees the licensing, marketing and trials of drugs in India.
“There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts,” it said.
The report underlines the difficult relations between international drug companies and India, a country with a long history of making cheap off-patent medicines. Western firms were alarmed by New Delhi’s decision in March to effectively end Bayer’s (BAYGn.DE) monopoly on cancer drug Nexavar by issuing the country’s first-ever compulsory licence.
The panel recommended the government re-examine certain drugs that had been approved, investigate the “gross violation” of Indian laws it had uncovered, and take action against officials alleged to have colluded with the drug companies.
“What we have found is very alarming,” Brajesh Pathak, chairman of the Standing Committee on Health and Family Welfare told Reuters. “The Health Ministry should investigate the matter and take urgent action on the report.”
The Health Ministry said it was studying the report and would take “appropriate action” if required.
The newly appointed Drug Controller General of India, G.N. Singh, who is head of the CDSCO, said he had not seen the report but that his team was dedicated to making sure “there are no violations”.
The OPPI, the main lobby group for foreign drug-makers, said some of the committee’s “observations” raised serious concerns.
“We sincerely hope that necessary remedial measures will be taken by the concerned authorities to set the system right, sooner,” said Tapan J. Ray, OPPI’s director general.
“So far as clinical trials are concerned, OPPI members remain committed to sponsoring clinical trials that fully comply with all legal and regulatory requirements in India,” he said.
A spokesman for Danish drugmaker Lundbeck (LUN.CO), whose anti-anxiety drug Deanxit the report described as “unlawfully approved”, said the medicine had been approved after undergoing mandatory clinical trials in India.
OPINIONS WRITTEN BY “INVISIBLE HANDS”
The parliamentary report found numerous shortcomings in the CDSCO.
The regulatory body suffered chronic staff shortages and was overwhelmed by its responsibilities in a country where more than 10,500 drug manufacturers were operating and the pharmaceutical industry was growing at a rate of about 10 percent a year.
The report also said the body had for decades neglected the “poor and hapless patient” in favour of the drugs industry.
“The regulatory procedures are not at all stringent in India and there is a general apathy towards human life. We are sitting on a time bomb and it will soon explode if corrective measures are not taken,” said Siddhant Khandekar, a healthcare analyst at ICICI Direct in Mumbai.
The parliamentary committee reviewed 39 randomly selected drugs approved by the CDSCO and found that in the case of 11, “mandatory” Phase III trials – the final stage of testing before a drug is approved – had not been conducted as required.
“The basic purpose of Phase III trials is to determine if there are any ethnic differences that can alter the metabolism, efficacy and safety of the drug when administered to patients of different ethnicities living in India,” the report said.
These included Novartis’ (NOVN.VX) everolimus and aliskiren, and Eli Lilly’s (LLY.N) pemetrexed. In the cases of everolimus and pemetrexed, the opinion of independent experts was not sought by the CDSCO, which relied on the judgment of non-medical staff, it said.
Eli Lilly said pemetrexed’s approval for lung cancer in multiple markets was based on trials with thousands of patients from diverse ethnic backgrounds – including patients from India.
“Lilly followed all appropriate regulatory processes required by the regulatory agency in India,” the company said.
There was no immediate comment from Novartis.
The Health Ministry told the panel that the head of the CDSCO had the power to approve drugs without clinical trials in the “public interest”, but the lawmakers were sceptical, saying that the waivers saved the companies the costs of the trials.
“How can approvals given to foreign drugs without testing on Indians be in public interest?” the committee said.
It found that the files of three drugs it wanted to scrutinise had mysteriously disappeared and that the recommendations of independent medical experts promoting certain drugs were similarly worded, to the point of including the same misspellings.
Three opinions from experts on rivaroxaban, a drug for prevention of blood clotting made by Bayer (BAYGn.DE), were copies of each other. Bayer said it had no immediate comment.
The report said in another instance, letters from medical experts recommended approval of the drug Pirfenidone, marketed by pharmaceutical company Cipla (CIPL.NS), which has the second-largest share of the country’s domestic drug market. Despite being dated weeks apart, they were all received by the regulator on the same day.
“No company breaks the law,” Cipla chairman, Y.K. Hamied, told Reuters, without elaborating.
“There is adequate documentary evidence to come to the conclusion that many opinions were actually written by invisible hands of drug manufacturers and experts merely obliged by putting their signatures,” the parliamentary report said.
(Writing by Ross Colvin, additional reporting by Annie Banerji in New Delhi, Kaustubh Kulkarni in Mumbai and Ben Hirschler in London; Editing by Jeremy Laurence and Elaine Hardcastle)
Evincing interest in the Indian pharmaceutical and medical technology sector, Saudi Arabia today said it was keen to extend incentives to Indian pharma industry to set up base in their country for producing affordable medicines.
These views were expressed by a Parliamentary delegation led by Abdullah Bin Mohammed bin Ibrahim Al Al-Sheikh, Speaker of Majlis Ash Shura (Consultative Council) of the Kingdom of Saudi Arabia that called on Health and Family Welfare Minister Ghulam Nabi Azad here today.
The delegation, which is on a three-day visit to India, welcomed help from India for transfer of medical technology and help it with medical education as India possessed the technical capacity.
Abdullah said bilateral visits not only help enhance understanding between the two countries but also help highlight areas of possible cooperation. The delegation informed that currently Kingdom of Saudi Arabia imports about five billion dollar worth of pharmaceuticals.
Azad recalled the close relations reflecting old economic and socio-cultural ties India shared with Saudi Arabia and shared the Indian experience in areas of innovations in health care service delivery, interventions in making health care accessible and equitable and the country's strength in producing good quality generic drugs at affordable prices.
The Minister suggested that India could help Saudi Arabia with knowhow of setting up medical colleges as also with medicine supplies. He said India is the 4th largest producer of pharmaceuticals in the world in terms of volume and 13th largest in terms of value and its products are exported to 211 countries which are acknowledged at many a UN forum for their good quality, safety and efficacy.
Azad noted that about two million Indians in Saudi Arabia account for a big expatriate community in the country.
Emerging markets will drive 70 per cent of growth in the pharma industry and India will require supportive policies to leverage the BioPharma opportunity to become an innovation hub for the sector, says a BCG report. Noting that for India to become an innovation hub, supportive policies is required, the position paper on India¿s BioPharma sector has sought to leverage the country's unique capabilities in genomic databases, translational research and nanotechnology.
A supportive environment is vital for India in particular as the commercial landscape in the country does not create enough pull to drive these opportunities by themselves, it argued. "The Indian government has declared 2010 through 2020 as the 'Decade of Innovation'. Innovation in life sciences will be essential to make this happen," said Karun Rishi, president of USA-India Chamber of Commerce, giving a preview of the report to be released later this week during the US-India BioPharma and Healthcare Summit in... Boston.
The findings of the position paper, prepared by Boston Consulting Group for the chamber, are part of interviews conducted with over 50 global thought leaders drawn from the industry, academia and policy makers. Rishi said achieving the promise of spending two per cent of GDP on R&D by 2017 will require a considerable jump from the current spend of approximately one per cent.
"From in-depth interviews in oncology, three areas emerge where India can be leveraged: capturing economic advantage through building and maintaining unique assets such as a genetic information database; creating process efficiencies, such as translational research hubs; and capitalising on technological advantage to drive more applied research in emerging areas like nano-technology centres of excellence," Rishi said.
The report has noted that all of this is not possible without a supportive environment, as it learnt from its clinical research deep dive. We believe that an advocacy platform to co-ordinate efforts across stakeholders... must be established and that policymakers need to focus on setting guidelines, streamlining processes, building capacity in the administration, and finally encouraging infrastructure investments," it said. According to the report, emerging markets will drive 70 per cent of the growth in the pharma industry. While there is a significant commercial opportunity, the link to R&D investments will need to be tailor-made for each country based on local capabilities present, it said....
Emerging markets will drive 70 per cent of growth in the pharma industry and India will require supportive policies to leverage the BioPharma opportunity to become an innovation hub for the sector, says a BCG report. Noting that for India to become an innovation hub, supportive policies is required, the position paper on India¿s BioPharma sector has sought to leverage the country's unique capabilities in genomic databases, translational research and nanotechnology.
A supportive environment is vital for India in particular as the commercial landscape in the country does not create enough pull to drive these opportunities by themselves, it argued. "The Indian government has declared 2010 through 2020 as the 'Decade of Innovation'. Innovation in life sciences will be essential to make this happen," said Karun Rishi, president of USA-India Chamber of Commerce, giving a preview of the report to be released later this week during the US-India BioPharma and Healthcare Summit in... Boston.
The findings of the position paper, prepared by Boston Consulting Group for the chamber, are part of interviews conducted with over 50 global thought leaders drawn from the industry, academia and policy makers. Rishi said achieving the promise of spending two per cent of GDP on R&D by 2017 will require a considerable jump from the current spend of approximately one per cent.
"From in-depth interviews in oncology, three areas emerge where India can be leveraged: capturing economic advantage through building and maintaining unique assets such as a genetic information database; creating process efficiencies, such as translational research hubs; and capitalising on technological advantage to drive more applied research in emerging areas like nano-technology centres of excellence," Rishi said.
The report has noted that all of this is not possible without a supportive environment, as it learnt from its clinical research deep dive. We believe that an advocacy platform to co-ordinate efforts across stakeholders... must be established and that policymakers need to focus on setting guidelines, streamlining processes, building capacity in the administration, and finally encouraging infrastructure investments," it said. According to the report, emerging markets will drive 70 per cent of the growth in the pharma industry. While there is a significant commercial opportunity, the link to R&D investments will need to be tailor-made for each country based on local capabilities present, it said....
The much awaited Leadership Event “The 3rd Annual India
Leadership Conclave & Indianaffairs Business Leadership Awards 2012 (
www.indialeadershipconclave.net )” was successfully concluded with the
participation of more than 250 business heads, social entrepreneurs,
celebrities & industry veterans organized by India’s Most Analytical News
Magazine Indian Affairs ( www.indianaffairs.in ) at the IT capital of india,
Bengaluru. Brand india : The Emerging Superpower, Limitless Leadership &
Limitless possibilities” , the theme of the 3rd Annual Conclave saw the leading
voices of india debating on issues of tremendous significance.
IIPM won India’s Most Valuable B-School Award at the
ceremony beating the IIMs, XLRI and SP Jain in a nationwide voting.
Commenting the mechanism & process of judging, Satya
Brahma said the nominees had to undergo a three tier process where they were
tested by the public through sms & emails & physical interactions with
a sample size of 11,200 public in 17 States, Indian Affairs salute these
leaders who made india proud through their innovations & breakthrough
technologies.
Satya Brahma, chairman of 3rd Annual India Leadership
Conclave Indian Affairs Business
Leadership Awards & Editor-In-Chief of Indian Affairs addressed the
gathering emphasizing the need for a stronger government policies for the
growth of the Indian inc. Noted economist & management guru Professor
Arindam Chaudhuri addressed the conclave with a fiery speech that made audience
completely delighted as he said “ Brand India is not a mere abstract but a
reality & india can truly become a super-power if it addressed the issues
like independence of judiciary & host of path-breaking reforms. Among
others who addressed at the high profile event were the luminaries that
included Globalization of Indian Brands by Dr Mukesh Batra , Founder Chairman
& MD, Dr Batra’s, Mr Vijay K Rekhi. Chairman, Executive Committee, United
Spirits ( UB Group), Mr. Sushil Karwa, CEO & MD, Krishidhan Group , The
Road Ahead, Dr B.R. Jaga Shetty, Drugs Controller, Government of Karnataka and
Mr Nishanth Chandran, Co-Founder & CEO, EBS India.
The much awaited prestigious Asia’s Biggest Leadership
Event “The 3rd Annual India Leadership Conclave & Indianaffairs Business
Leadership Awards 2012 ( www.indialeadershipconclave.net )” was successfully
concluded with the largest participation of more than 250 business tycoons, social
entrepreneurs, celebrities & industry veterans organized by India’s Most
Analytical News Magazine Indian Affairs ( www.indianaffairs.in ) yesterday, the
6th of April 2012 at the IT capital of india, Bengaluru in a star-studded gala
award night. Brand india : The Emerging Superpower, Limitless Leadership &
Limitless possibilities” , the theme of the 3rd Annual Conclave saw the leading
voices of india debating on issues of tremendous significance. Among those who
addressed at the high profile event were the luminaries that included
Globalization of Indian Brands by Dr Mukesh Batra , Founder Chairman & MD,
Dr Batra’s, Mr Vijay K Rekhi. Chairman, Executive Committee, United Spirits (
UB Group) on Challenges & Opportunities of Indian alcobevindustry, Mr.
Naveen Surya, Managing Director, Itz Cash Card Ltd on Ecommerce and Digital
Payments Challenges and Opportunities, Mr. Sushil Karwa, CEO & MD,
Krishidhan Group on Agriculture - New Directions & New Paradigms, The Road
Ahead, Dr B.R. Jaga Shetty, Drugs Controller, Government of Karnataka, on
Strong Legislations for Indian Healthcare Industry” : The Way Forward Strong
Legislations for Indian Healthcare Industry” : The Way Forward, Mr Nishanth
Chandran, Co-Founder & CEO, EBS India on “A peep Into Indian E-Commerce
Business ” : The Emergence of Asean Power.
Satya Brahma, chairman of 3rd Annual India Leadership
Conclave Indian Affairs Business
Leadership Awards & Editor-In-Chief of Indian Affairs addressed an
inspiring opening Address to the strong 250 industry veterans who had assembled
to witness the debate on Brand India. In his Opening Address, Satya emphasized
the need for a stronger government policies for the growth of the Indian inc.
Lambasting the politicians & Ministers at the helm of affairs in policy making,
Satya said “ Due to the political infighting & coalition compulsions, the
administrators failed to live up to expectations of the aam admi & urged
the leaders to be responsible in policy making so that india can become a great
nation with the claim to the world as a super-power” Satya added. The real
problems in india are not population but the corruption & warned the policy
makers to mend their ways to pave the road for india’s Global ambitions. Noted
economist & management guru Professor Arindam Chaudhuri addressed the
conclave with a fiery speech that made audience completely delighted as he said
“ Brand India is not a mere abstract but a reality & india can truly become
a super-power if it addressed the issues like independence of judiciary & host
of path-breaking reforms.
Noted Singer & Composer Lucky Ali were present to
confer the coveted Awards in 30 categories along with Satya Brahma, Chairman of
network 7 Media group. Ending the 60 days of votings, the suspense for
nominations were announced & declared at the coveted Indian Affairs
Business Leadership Awards 2012. Among those who were felicitated &
recognized for their outstanding contributions & services were the
following.
Business Leader of The Year
Dr Kannan Vishwanath, MD, Aanjaneya Lifecare
Businesswoman of the Year
Vinita Bali, Managing Director, Britannia Industries
India’s Most Valuable 4 Wheeler Brand
Renault Pulse
India’s Most Valuable Private Bank
Yes Bank Ltd
India’s Most Valuable Public Bank
Bank of Baroda Ltd
India’s Most Valuable IT Software Company
Infosys Technologies Ltd
India’s Most Valuable Agricultural Biotech Company
Krishidhan Seeds Pvt. Ltd
India’s Most Valuable IT & Web Solution Provider
Company
General Data Pvt Ltd.
India’s Dynamic Entrepreneur of The Year
Mr. Sushil Karwa, MD, Krishidhan Seeds
India’s Most Valuable English Broadcast Electronic Media.
Times Now
CEO of the year
Mohit Anand, MD - Indian Sub Continent, Belkin
Dr Kannan Vishwanath, MD, Aanjaneya Lifecare
First Generation Entrepreneur of the year
Ashish Agarwal, Managing Director, ONCO Life Sciences
Pvt. Ltd.
Healthcare Professional of The Year
Dr B R Jagga Shetty, Drug Controller of Karnataka. ( No
Nomination)
Global Indian Of The Year (Media)
Mr. Rakesh Gupta, Chairman, Sadhna Group
India’s Most Valuable Pharmaceutical Company
Micro labs Ltd
India’s Most Valuable E-Commerce Company of the year
E-Billing Solutions Pvt Ltd.
Deal Maker of The Year 2012
Paritosh Joshi , Chief Executive Officer at STAR CJ
Network India Pvt Ltd
India’s Most Promising & Valuable Infrastructure
Company
Digi Ports Limited
India's Most Valuable Brand of the Year 2012
Percept
Emerging Company of the Year 2012
Adroit Biomed Limited.
India's Most Valuable Financial Advisory & Stock
Brokerage Company 2012
Bonanza Portfolio Ltd
Social Enterprise of The Year
Rural Healthcare Foundation
India’s Most Valuable B-School of the Year 2012
The Indian Institute of Planning and Management
India’s Most Valuable Legal Firm
Hemanth & Associates
Healthcare Professional of the Decade
Dr. Mukesh Batra, Founder Chairman & MD, Dr Batra’s
Clinic
Lifetime Achievement Awards
Mr Vijay K. Rekhi , Chairman – Executive Committee
Mr. Kashi Vishwanath, Chairman, Aanjaneya Lifecare
Limited.
Commenting the mechanism & process of judging, Satya
Brahma said the nominees had to undergo a three tier process where they were
tested by the public through sms & emails & physical interactions with
a sample size of 11,200 public in 17 States, Indian Affairs salute these
leaders who made india proud through their innovations & breakthrough
technologies.
