UPDATE 4-Novartis loses landmark India cancer drug patent case

* Court verdict seen setting precedent in drug patent cases

* Novartis India shares fall before recovering; Natco, Cipla gain

* India intellectual property system "not very encouraging"- exec

* Activists see verdict as win for patients in poor countries

MUMBAI/NEW DELHI, April 1 (Reuters) - India's top court dismissed Swiss drugmaker Novartis AG's attempt to win patent protection for its cancer drug Glivec, a blow to Western pharmaceutical firms targeting India to drive sales and a victory for local makers of cheap generics.

The decision sets a benchmark for intellectual property cases in India, where many patented drugs are unaffordable for most of its 1.2 billion people, and does not bode well for foreign firms engaged in ongoing disputes in India, including Pfizer Inc and Roche Holding AG, analysts said.

It cements the role of local companies as big suppliers of inexpensive generics to India's rapidly growing $13 billion-a-year drugs market and also across the developing world.

Among the chief beneficiaries of Monday's Supreme Court ruling will be India's Cipla Ltd and Natco Pharma Ltd , which already sell generic Glivec in India at around one-tenth of the price of the branded drug.

"The multinational companies will have to find new ways of doing business in India," said Deepak Malik, healthcare analyst at brokerage Emkay Global, suggesting they may consider licensing agreements with local firms to offer cheap versions of branded drugs like Glivec.

Ranjit Shahani, managing director of Novartis India Ltd , the firm's locally listed unit, said it will be cautious about investing in India, especially over introducing new drugs, and seek patent protection before launching any new products. It will continue to refrain from research and development activities there.

"The intellectual property ecosystem in India is not very encouraging," Shahani told reporters in Mumbai after the ruling.

Healthcare activists have called on the government to make medicines cheaper in a country where many patented drugs are too costly for most people, 40 percent of whom earn less than $1.25 a day, and where patented drugs account for under 10 percent of total drug sales.

"This appears to be the best outcome for patients in developing countries as fewer patents will be granted on existing medicines," said Leena Menghaney, Medecins Sans Frontieres' Access Campaign manager for India.

Over 16,000 patients in India use Glivec and the vast majority of those get it free of charge, Novartis says. By contrast, generic Glivec is used by more than 300,000 patients, according to industry reports.

The Supreme Court's decision comes after a legal battle that began when Novartis was denied a patent for Glivec in 2006.

EXTRA WORK

Novartis had argued it was entitled to a patent for the amended version of Glivec because the original patented compound was never suitable for making into a pill. Developing the final chemically stable form took years of extra work and it was this effort that marked the real breakthrough in developing Glivec as a life-saving cancer medicine, the Swiss company said.

Glivec is used to treat certain forms of leukaemia and gastrointestinal cancer, as well as some other rare tumours.

Shares in Novartis' Indian unit ended 1.8 percent lower after falling as much as 6.8 percent after the verdict. Natco Pharma stock ended 5.4 percent higher after earlier gaining nearly 11 percent and Cipla gained 1.3 percent, beating the benchmark index which ticked up 0.15 percent.

India's domestic drugs market is the 14th-largest globally, but with annual growth of 13-14 percent and the world's second-biggest population, international pharmaceutical firms say India has massive potential at a time when traditional developed markets have slowed down.

The ruling may dampen enthusiasm from foreign pharmaceutical firms in the short term, said S. Majumdar, head of law firm S. Majumdar & Co based in the eastern city of Kolkata.

"They will have to get used to it and learn to live with the law," he said.

NOT SO EVERGREEN

Pfizer's cancer drug Sutent and Roche's hepatitis C treatment Pegasys lost their patented status in India last year, decisions the companies are fighting to have reversed. The Supreme Court's latest ruling will make it tougher for them to win back patent protection.

"Henceforth, multinational pharma companies are likely to want that their patents are first recognised in India before launch of a patented product," said Ameet Hariani, managing partner at Mumbai-based law firm Hariani & Co.

India has refused protection for Glivec on the grounds that it is not a new medicine, but an amended version of a known compound. By contrast, the newer form of Glivec has been patented in nearly 40 countries including the United States, Russia and China.

Indian law bans firms from extending patents on their products by making slight changes to a compound, a practice known as "evergreening". The Supreme Court said Glivec does not satisfy a patent's "novelty" requirement, Pravin Anand, lawyer for Novartis, told reporters.

Novartis can file a review petition within 90 days.

Indian Trade Minister Anand Sharma called the ruling "a historic judgment" that reaffirmed legal provisions mandating the need for substantial innovation before new patents are issued on medicines.

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India hails "historic" Supreme Court drug patent ruling against Novartis

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Big Pharma in nervous wait for India verdict on Glivec patent

MUMBAI, March 27 (Reuters) - Global drugmakers, battered by recent intellectual property decisions in India, are girding for a landmark court ruling next week that could have broad consequences for their ability to sell lucrative patented medicines in the country.

India's Supreme Court is due to decide on April 1 whether or not an amended form of Swiss giant Novartis AG's cancer treatment Glivec deserves a patent in the country.

"Big Pharma is nervous because nothing has gone in their favour in the recent past," said Ajay Kumar Sharma, associate director of the pharmaceutical and biotech practice at business consultancy Frost & Sullivan.

"With this verdict, at least, things will get clearer about what is the definition of patented medicines."

Novartis has been fighting since 2006 to win a patent for an amended form of Glivec, which many oncologists view as a major advance in treating chronic myeloid leukaemia, which kills 80-90 percent of sufferers, and some gastrointestinal cancers.

India has refused protection for Glivec on the grounds that it is not a new medicine but an amended version of a known compound - a decision consistent with domestic patent law which sets tight restrictions on multiple patents for a drug.

By contrast, in the United States, amended versions can be patented.

Novartis is seeking to overturn a clause in Indian Patents Law that restricts patent protection for newer forms of existing molecules, and next week's ruling could set a precedent for how other similar patent claims are treated.

"India is a formidable world power with international rights and obligations," Ranjit Shahani, vice chairman and managing director of Novartis India Ltd, the firm's India unit, said in an email to Reuters.

"Novartis understands and recognizes the contribution of generics once drug patents expire; our concern is with the non-recognition of intellectual property rights that ultimately help sustain and advance pharmaceutical research and development."

PROMISE AND PERIL

While Western firms see huge potential in India's rapidly growing $13 billion drugs market, 90 percent of which is made up of generics, they worry that India is failing to recognise valuable medical innovation.

Among Big Pharma's setbacks in the country, India last year allowed local drugmaker Natco Pharma to sell cheaper copies of Bayer AG's cancer drug Nexavar through the controversial mechanism of "compulsory licensing".

A global agreement, known as Trade-Related Aspects of Intellectual Property Rights or TRIPS, allows countries to issue compulsory licences for certain drugs that are deemed unaffordable to large sections of their populations.

Also last year, India revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's hepatitis C drug Pegasys, and Merck & Co's asthma treatment aerosol suspension formulation. They were all revoked on grounds that included lack of innovation.

In another potential hit, Mumbai-based BDR Pharmaceutical International this month applied for a compulsory licence on a blood cancer drug, dasatinib, sold as Sprycel by U.S.-based Bristol-Myers Squibb Co.

Last month, an Indian government panel proposed that prices of patented medicines be based on the country's per capita income, a move that would substantially reduce prices of costly drugs made by global pharmaceutical firms.

"In the minds of global drugmakers, the recent developments will definitely hamper India's image," said lawyer Dominic Alvares, of S. Majumdar & Co which represents Indian drugmakers.

But he said social justice and the public interest should come ahead of India's reputation as a future drugs market. "The developments would impact reputation but for the sake of reputation, do you sacrifice on public interest?"

PATENTS VS AFFORDABILITY

In almost every patent dispute, India has held affordability as a key reason to allow generic drugmakers to launch copycat versions of patented medicines in a country where nearly 40 percent of the population lives on less than $1.25 a day.

For example, Natco Pharma was told by the patents office in its compulsory licence ruling to offer generic Nexavar at 8,800 rupees ($162) for a month's dose - a fraction of Bayer's price of 280,000 rupees. Natco must pay a 7 percent royalty to Bayer.

BDR Pharma, in its application, has offered generic Sprycel at 8,100 rupees for a month's dose compared with Bristol-Myers' price of 165,000 rupees.

Generic versions of Glivec, which won its first patent in 1993, cost about $2,500 for a year's dosage in India, compared with nearly $70,000 in the United States where only the branded version is sold.

Discount programmes mean the branded version is available for much less in poor countries. In India, more than 95 percent of patients using branded Glivec receive it free under a company donation scheme, Novartis has said.

U.S. industry groups this month demanded that the United States increase pressure on India to reform high-tech, agricultural and pharmaceutical policies they said blocked export access and damaged patent rights.

"India has essentially created a protectionist regime that harms U.S. job creators" in favour of India's generic drug manufacturers, Roy Waldron, chief intellectual property counsel for Pfizer, said in testimony to a U.S. House panel.

India's $25 billion drugs industry, a major exporter of generics, is growing at 16 to 17 percent a year.

"You can expect more muscle-flexing from the respective countries of the big pharmaceutical companies in the future," Frost & Sullivan's Sharma said.

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Big Pharma in nervous wait for India verdict on Glivec patent

MUMBAI, March 27 (Reuters) - Global drugmakers, battered by recent intellectual property decisions in India, are girding for a landmark court ruling next week that could have broad consequences for their ability to sell lucrative patented medicines in the country.

India's Supreme Court is due to decide on April 1 whether or not an amended form of Swiss giant Novartis AG's cancer treatment Glivec deserves a patent in the country.

"Big Pharma is nervous because nothing has gone in their favour in the recent past," said Ajay Kumar Sharma, associate director of the pharmaceutical and biotech practice at business consultancy Frost & Sullivan.

"With this verdict, at least, things will get clearer about what is the definition of patented medicines."

Novartis has been fighting since 2006 to win a patent for an amended form of Glivec, which many oncologists view as a major advance in treating chronic myeloid leukaemia, which kills 80-90 percent of sufferers, and some gastrointestinal cancers.

India has refused protection for Glivec on the grounds that it is not a new medicine but an amended version of a known compound - a decision consistent with domestic patent law which sets tight restrictions on multiple patents for a drug.

By contrast, in the United States, amended versions can be patented.

Novartis is seeking to overturn a clause in Indian Patents Law that restricts patent protection for newer forms of existing molecules, and next week's ruling could set a precedent for how other similar patent claims are treated.

"India is a formidable world power with international rights and obligations," Ranjit Shahani, vice chairman and managing director of Novartis India Ltd, the firm's India unit, said in an email to Reuters.

"Novartis understands and recognizes the contribution of generics once drug patents expire; our concern is with the non-recognition of intellectual property rights that ultimately help sustain and advance pharmaceutical research and development."

PROMISE AND PERIL

While Western firms see huge potential in India's rapidly growing $13 billion drugs market, 90 percent of which is made up of generics, they worry that India is failing to recognise valuable medical innovation.

Among Big Pharma's setbacks in the country, India last year allowed local drugmaker Natco Pharma to sell cheaper copies of Bayer AG's cancer drug Nexavar through the controversial mechanism of "compulsory licensing".

A global agreement, known as Trade-Related Aspects of Intellectual Property Rights or TRIPS, allows countries to issue compulsory licences for certain drugs that are deemed unaffordable to large sections of their populations.

Also last year, India revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's hepatitis C drug Pegasys, and Merck & Co's asthma treatment aerosol suspension formulation. They were all revoked on grounds that included lack of innovation.

In another potential hit, Mumbai-based BDR Pharmaceutical International this month applied for a compulsory licence on a blood cancer drug, dasatinib, sold as Sprycel by U.S.-based Bristol-Myers Squibb Co.

Last month, an Indian government panel proposed that prices of patented medicines be based on the country's per capita income, a move that would substantially reduce prices of costly drugs made by global pharmaceutical firms.

"In the minds of global drugmakers, the recent developments will definitely hamper India's image," said lawyer Dominic Alvares, of S. Majumdar & Co which represents Indian drugmakers.

But he said social justice and the public interest should come ahead of India's reputation as a future drugs market. "The developments would impact reputation but for the sake of reputation, do you sacrifice on public interest?"

PATENTS VS AFFORDABILITY

In almost every patent dispute, India has held affordability as a key reason to allow generic drugmakers to launch copycat versions of patented medicines in a country where nearly 40 percent of the population lives on less than $1.25 a day.

For example, Natco Pharma was told by the patents office in its compulsory licence ruling to offer generic Nexavar at 8,800 rupees ($162) for a month's dose - a fraction of Bayer's price of 280,000 rupees. Natco must pay a 7 percent royalty to Bayer.

BDR Pharma, in its application, has offered generic Sprycel at 8,100 rupees for a month's dose compared with Bristol-Myers' price of 165,000 rupees.

Generic versions of Glivec, which won its first patent in 1993, cost about $2,500 for a year's dosage in India, compared with nearly $70,000 in the United States where only the branded version is sold.

Discount programmes mean the branded version is available for much less in poor countries. In India, more than 95 percent of patients using branded Glivec receive it free under a company donation scheme, Novartis has said.

U.S. industry groups this month demanded that the United States increase pressure on India to reform high-tech, agricultural and pharmaceutical policies they said blocked export access and damaged patent rights.

"India has essentially created a protectionist regime that harms U.S. job creators" in favour of India's generic drug manufacturers, Roy Waldron, chief intellectual property counsel for Pfizer, said in testimony to a U.S. House panel.

India's $25 billion drugs industry, a major exporter of generics, is growing at 16 to 17 percent a year.

"You can expect more muscle-flexing from the respective countries of the big pharmaceutical companies in the future," Frost & Sullivan's Sharma said.

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As Sexual Violence Intensifies, India Considers Strengthening Its Penalties For Rape

Protester at Dec. 18 rally in New Dehli

A new law strengthening the penalty for rape passed the lower house of India’s Parliament recently, a bright point in India’s still troubled relationship with sexual assault and violence.

Should the legislation pass India’s upper house, it would provide an increase of the minimum prison sentence for gang-rape to twenty years, that can be extended to life in jail. It also adds the opportunity for prosecutors to seek the death penalty in cases of rape that result in death or leave the victim in a coma. Most promising of all, the revised law would make other sex-based crimes such voyeurism, stalking, acid attacks and the trafficking of women punishable under criminal law. “This is just a first step in a journey of 1,000 miles,” MP Harsimrat Kaur Badal, a woman MP a regional party, said before the vote.

The revised law originally was developed in response to the brutal gang rape of a young Indian woman — identified as Jyoti Signh Pandi — in December, which sparked mass protests throughout the country. Pandi later died from the massive injuries obtained, leading to her alleged assailants being charged with murder, rape, and kidnapping.

Recent actions taken to strengthen the punishment of these crimes does not lessen the long way that India still has to go when it comes to combating sexual violence. According to a recent report from a United Nations panel, in India “every 60 minutes two women are raped, and every six hours a young married woman is found beaten to death, burnt or driven to suicide.” The stigma that surrounds these crimes, however, leads to a severe underreporting of rape, particularly in the case of women in lower castes.

Tourists are also becoming more frequent targets of attacks, as evidenced in the case of a British woman on the same day the new rape law moved forward in Parliament. The woman was forced to leap through an open window in her hotel room to escape the advances of the hotel owner, fracturing both of her legs:

Police arrested the hotel owner in connection with the incident in Agra, the site of the Taj Mahal, one of India’s most cherished tourist attractions, [police officer Sushaunt] Gaur said. No charges have been filed.

The woman told the police that the hotel owner kept knocking on her door persistently and even tried to unlock the door after she refused his offer of a free massage.

A Swiss tourist was the vicitim of gang-rape just weeks ago in the Indian state Madhya Pradur while cycling with her husband. In that instance, the state’s Home Minister suggested that the tourist herself was at fault for not alerting the police of her travel plans. Another incident of gang rape was reported in the same state on Tuesday, in which two minors were assaulted at gunpoint in their family’s home.

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UPDATE 2-BDR Pharma seeks India licence for Bristol-Myers drug

* BDR Pharma seeks compulsory licence on cancer drug dasatinib

* Company offers to sell drug at 8,100 rupees/month

(Recasts, adds Bristol comment)

By Kaustubh Kulkarni

MUMBAI, March 18 (Reuters) - BDR Pharmaceuticals said on Monday it has applied to India's patent office for a compulsory licence to sell a generic version of Bristol-Myers Squibb Co's

cancer drug dasatinib, after unsuccessfully seeking a voluntary licence from Bristol-Myers.

Under a global Trade-Related Aspects of Intellectual Property Rights agreement, countries can issue compulsory licences for certain drugs that are deemed unaffordable to a large section of their populations.

If approved, a compulsory licence for dasatinib, a blood cancer drug, would be another setback for global drugmakers in India. German company Bayer AG lost an appeal earlier this month challenging the first such Indian license, which was granted to Natco Pharma for cancer drug Nexavar.

Dasatinib is sold as Sprycel by U.S.-based Bristol-Myers Squibb and costs about 165,000 rupees ($3,050) for a month's treatment in India.

BDR Pharma filed its application seeking a compulsory licence on March 4 and has offered to sell the drug at 8,100 rupees for a month's dose, Aravind Badiger, technical director at BDR, an Indian pharmaceuticals company, said.

"We expect the patent office to respond at the earliest," he said in an email response to a Reuters query.

BDR had unsuccessfully sought a voluntary licence from Bristol-Myers to sell a copycat version of the drug, Badiger said.

Bristol-Myers Squibb said in a statement that it does not comment on ongoing proceedings. The company said it "has and will continue to pursue all appropriate avenues to protect its intellectual property rights in India."

It said Sprycel is protected by a composition of matter patent from the Indian Patent Office.

Natco Pharma already sells a generic version of dasatinib in India, which is the subject of a legal battle with Bristol-Myers Squibb.

Generic drugs account for about 90 percent of India's $13 billion drug market. While India holds promise for global drugmakers facing slower growth in developed markets, big pharmaceutical companies have lost several rulings on intellectual property rights in recent years.

Among those setbacks, India revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's

hepatitis C drug Pegasys, and Merck & Co's asthma treatment aerosol suspension formulation. ($1 = 54.17 Indian rupees)

(Additional reporting by Caroline Humer in New York; Editing by Tony Munroe, Charlotte Cooper and Leslie Adler)

((kaustubh.kulkarni@thomsonreuters.com)(+91 22 61807399)(Reuters Messaging: kaustubh.kulkarni.thomsonreuters.com@reuters.net))

Keywords: INDIA BDRPHARMA/DRUG

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UPDATE 1-BDR Pharma seeks India licence for Bristol-Myers drug

* India's BDR Pharma seeks compulsory licence on cancer drug dasatinib

* BDR Pharma offers to sell generic dasatinib at 8,100 rupees/month

(Adds details, quote) By Kaustubh Kulkarni

MUMBAI, March 18 (Reuters) - BDR Pharmaceuticals has applied to India's patent office for a compulsory licence to sell a generic version of Bristol-Myers Squibb Co's cancer drug dasatinib, a BDR executive said on Monday.

Under a global Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, countries can issue compulsory licences for certain drugs that are deemed unaffordable to a large section of their populations.

If approved, the compulsory licence would be another setback for global drugmakers in India. German firm Bayer AG lost an appeal earlier this month challenging the first such Indian licence, which was granted to Natco Pharma on cancer drug Nexavar.

Dasatinib is a blood cancer drug sold as Sprycel by Bristol-Myers Squibb and costs about 165,000 rupees ($3,050) for a month's treatment in India.

India's BDR Pharmaceuticals had unsuccessfully sought a voluntary licence from Bristol-Myers Squibb to sell a copycat version, Aravind Badiger, technical director at the Indian firm,

said in an emailed response to a Reuters' query.

Officials at U.S.-based Bristol-Myers Squibb could not immediately be reached by Reuters for comment.

BDR Pharma filed its application seeking a compulsory licence on March 4 and has offered to sell the drug at 8,100 rupees for a month's dose, Badiger said.

"We expect the patent office to respond at the earliest," he said in the email.

Natco Pharma already sells a generic version of dasatinib in India, which is the subject of a legal battle with Bristol-Myers Squibb.

Generic drugs account for about 90 percent of India's $13 billion drug market. While India holds promise for global drugmakers facing slower growth in developed markets, big pharmaceutical firms have lost several rulings on intellectual property rights in recent years.

Among those setbacks, India revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's

hepatitis C drug Pegasys and Merck & Co's asthma treatment aerosol suspension formulation. ($1 = 54.17 Indian rupees)

(Editing by Tony Munroe and Charlotte Cooper)

((kaustubh.kulkarni@thomsonreuters.com)(+91 22 61807399)(Reuters Messaging: kaustubh.kulkarni.thomsonreuters.com@reuters.net))

Keywords: INDIA BDRPHARMA/DRUG

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India rules against Bayer in cancer drug patent case

CHENNAI, March 4 (Reuters) - An Indian patent appeals board dismissed on Monday Bayer AG's petition against a government decision to allow a domestic company to sell cheap copycat versions of cancer drug Nexavar, delivering a blow to global drugmakers' monopolies on high-priced medicines.

Last year, the Indian patents office, under a mechanism called "compulsory licence", allowed Natco Pharma to sell generic Nexavar at 8,800 rupees ($160) for a month's dose -- a fraction of Bayer's price of 280,000 rupees.

Bayer challenged this decision with the Intellectual Property Appellate Board (IPAB) in the southern city of Chennai.

Although dismissing the petition, the board did order Natco Pharma to pay a royalty of 7 percent on sales of generic Nexavar to Bayer, an increase from the 6 percent royalty that had earlier been set.

($1 = 54.90 rupees)

(Reporting by Anupama Chandrasekaran; Editing by Alex Richardson)

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Keywords: INDIA BAYER/

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India rules against Bayer in cancer drug patent case

CHENNAI, March 4 (Reuters) - An Indian patent appeals board dismissed on Monday Bayer AG's petition against a government decision to allow a domestic company to sell cheap copycat versions of cancer drug Nexavar, delivering a blow to global drugmakers' monopolies on high-priced medicines.

Last year, the Indian patents office, under a mechanism called "compulsory licence", allowed Natco Pharma to sell generic Nexavar at 8,800 rupees ($160) for a month's dose -- a fraction of Bayer's price of 280,000 rupees.

Bayer challenged this decision with the Intellectual Property Appellate Board (IPAB) in the southern city of Chennai.

Although dismissing the petition, the board did order Natco Pharma to pay a royalty of 7 percent on sales of generic Nexavar to Bayer, an increase from the 6 percent royalty that had earlier been set.

($1 = 54.90 rupees)

(Reporting by Anupama Chandrasekaran; Editing by Alex Richardson)

((kaustubh.kulkarni@thomsonreuters.com)(+91 22 61807399)(Reuters Messaging: kaustubh.kulkarni.thomsonreuters.com@reuters.net))

Keywords: INDIA BAYER/

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India panel proposes to regulate prices of patented medicines

By Kaustubh Kulkarni

MUMBAI, Feb 26 (Reuters) - An Indian government panel has proposed that prices of patented medicines be based on the country's per capita income, a move that would substantially reduce prices of costly drugs made by global pharmaceutical firms.

The proposal, which seeks the input of other government agencies as well as industry groups, could provoke the ire of Big Pharma, which has clashed with India over protection of intellectual property, price regulations for generic drugs, and compulsory licenses for costly medicines.

A panel formed under the ministry of chemicals and fertilizers has recommended setting up a committee to negotiate with drugmakers to fix prices of costly drugs used to treat deadly diseases such as cancer, HIV and hepatitis.

The proposal is the latest in a series of measures taken by India to make medicines more affordable for the country's 1.2 billion population.

"If we compare the per-capita income with the prices of patented medicines in countries like Australia or France, prices in India are comparatively high and hence, they need to be regulated," a senior ministry official told Reuters, declining to be identified because he was not authorised to speak with media.

Generic medicines account for more than 90 percent of India's $13 billion pharmaceuticals market. U.S.-based Abbott Laboratories has the largest share of the overall Indian drug market followed by India's Cipla .

The proposal, posted late on Monday on the ministry website, cites as an example the lung-cancer drug erlotinib HCL, sold by Roche Holding AG as Tarceva. In India, it costs 35,450 rupees ($660) for one month of 100 mg tablets, equivalent to 121,085 rupees in France and 121,650 rupees in Australia.

Based on per-capita gross national incomes, if the drug costs 35,450 rupees in India, its respective cost would be just 11,643 rupees in France and 10,309 rupees in Australia based on per capita income in the respective countries, the report said.

The Organization of Pharmaceutical Producers of India, which represents foreign drugmakers in India, did not reply to questions from Reuters.

"If stringent price regulations are enforced then latest drugs will not be made available in India," said Ameet Hariani, managing partner at Hariani & Co, a Mumbai-based law firm that advises drugmakers and other companies.

($1 = 53.89 rupees)

(Editing by Tony Munroe and Louise Heavens)

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Keywords: INDIA PHARMA/PRICES

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REPORT: Rape Often Targeted, Underreported In India

Protester at Dec. 18 rally in New Dehli

A report from a UN-affiliated working group on human rights in India exposes the constant struggle that women face, as sexual violence is used by security forces to implement their whims and targeted against lower castes.

Drafted by the Working Group on Human Rights in India and the UN (WGHR), “Human Rights in India: Status Report 2012” covers the gamut of human rights failures that take place within the state. Several sections deal with sexual assault and violence towards women in both conflict zones and during peacetime, highlighting the neglect that many of these cases face from the legal system and authorities. Among other statistics the WGHR uncovered, one of the most staggering is that “every 60 minutes two women are raped, and every six hours a young married woman is found beaten to death, burnt or driven to suicide.”

Security forces within India are frequent perpetrators of violence against women, according to the report, though the stigma associated with victimhood results in cases of rape being under reported. At one point, the report accused the armed forces of thwarting investigations where “circumstantial evidence strongly indicates the involvement of armed forces.” Prosecution of those in the armed forces discharged for committing rape is particularly difficult as well, thanks to provisions in India’s legal system that require a waiver from the state or central government to allow charges to go forward.

Women of the Dalit group — the lowest place in the Indian caste system — face a particular stigma and are the subject of a disproportionate amount of violence:

Violence against Dalit women is targeted, 361 and atrocities committed against them include: verbal abuse and sexual epithets, naked parading, pulling out of teeth, tongue and nails, and violence, including murder. Dalit women are also threatened by rape as part of collective violence by higher castes. The National Crime Record Bureau (NCRB) reported a total of 1,349 rape cases of Dalit women for 2010, with the state of Madhya Pradesh reporting 316 cases, followed by Uttar Pradesh with 311 cases. There are cases of kidnapping and abduction of women, with Uttar Pradesh alone accounting nearly 48.5% of the 511 cases for 2010. Notably, there is no disaggregated data collected on atrocities against Dalit women.

The report comes at a time when violence against women is in the spotlight in India, following the horrific rape and death of a young woman in the capital city New Dehli. Mass protests broke out throughout the country in the aftermath of the vicious attack on the victim — identified as Jyoti Signh Pandi — with the potential for a change in India’s laws beginning to take shape.

Meanwhile, the trial against the accused attackers has already been closed to the media due to the interest the case has generated. The trial is sure to be contentious as defense lawyers have already both engaged in blaming the victim for the attack and claiming that police tortured a confession out of one of the defendants.

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