Cipla's Wine, Old Mug New Flavour!!!

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.

No pharma application pending for compulsory licence: Govt

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.

Pharma Corruption Kills Doctors Ethics, Nexus Exposed!!!

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)

Saudi Arabia keen on Indian pharma products

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

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

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 3rd Annual India Leadership Conclave & Indianaffairs Business Leadership Awards 2012

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.