Press Release – #India – 5 activists accused by Tata Steel in fabricated cases acquitted #goodnews


Noamundi activist released
from Ieft are: Mosa Mundi, Rajaram Das, Xd, Indu Iaguri, John Barjo
 — atOut side Chaibasa District Court Singhbhum Jharkhand India
Xavier Dias
The Noamundi five have been acquittedon 29th June 2013 by the Chaibasa Court In 1991 eighteen of us were accused by TATA ST EEL in multiple fabricated criminal cases this particular case the Company got the Railways to fiIe an additional criminal case for damage to railway property too for which in NOvember Iast year 6 of us went to jaiI
The sixth Basu Deogam died in May from malnutrition and TB, I wish to remember the children and widows of the 13 of our comrades aII of who died early from curable diseases aII before the age of 45, yes we are now acquitted after 22 yrs of one of the countries biggest mining companies TATA STEEL failed strategy to harass Intimidate and defeat the resistance movement,
The struggle and resistance against Mining in the Saranda forest within which TATA STEEL and Noamundi comes continues and is now Ied by some of the children of our former comrades On 22 June a Pubic Hearing for a new mine could not be held as over 500 women men and children under the Leadership of Omon MahiIIIa Sanghatan drove them away This picture was taken out of the Court ,

.

 

#India -Bhopal gas victims take out rally and demand “no Justice, no Vote”


29th June 2013

By TCN News,

Bhopal: In an attempt to awake political parties from there stupor, today several hundred gas victims staged a rally from Ganesh Mandir, Chhola to Bhopal Bus Stand for their long standing demands of compensation, punishment of guilty individuals and corporations. In the upcoming elections of state and central government, Bhopal gas victims have resolved that they will only vote for those political parties who will ensure their compensation and end the continuing injustices against them. Residents from J.P. Nagar, Shakti Nagar, Kainchi Chhola, Risaldar Colony and Rajgarh participated in this rally and shouted slogans “No compensation to Gas Victims, then No Vote of Gas Victims”, “No Justice, No Vote”.

Several residents of J.P. Nagar, Kainchi Chhola and Rajgarh have painted slogans “Compensation First, Second Vote” on their houses. “This time we will tell representatives of political parties visiting our communities that first secure our compensation and then ask for vote”, says Anees Qureshi from J.P. Nagar who lives right across from the Union Carbide factory.

Several gas victims believe that this is the right time to get answers from political parties towards resolving the lingering issues of compensation, punishment of guilty, medical and social rehabilitation. “This time we will only vote for that political party which ensures compensation and justice for Bhopal gas victims and we want to see result before the elections not after,” says Premlata Chowdhary of Kainchi Chhola,

In March 2013, five organization working among the survivors of the December 1984 Union Carbide gas disaster had written a letter to dozen political parties seeking their response and support to their 8 demands on additional compensation for the gas disaster, correction of figures of injury and death caused by the disaster, cleanup of contaminated soil and ground water, compensation for injuries and birth defects caused by toxic contamination, setting up empowered commission for rehabilitation and stopping Dow Chemical from doing business in India till it presents Union Carbide in the ongoing criminal case on the disaster. Except Aam Aadmi party, none of the parties have bothered to respond to the demands of gas victims.

Gas victims participating in this rally appealed to gas victims living in 36 wards to make judicious and strategic use of their power to elect candidates so that that the lingering issues of the disaster are resolved in their favor. They also said that similar rallies should be taken out by all gas victims in their own communities, Paint slogans on houses and shops, and question all the political representatives that come in their community on what steps they have taken in ensuring there compensation from the state and central governments.

Photo Credit: Sanjay ‘KunKun’ Verma

Bhopal gas victims take out rally and demand "no Justice, no Vote"

By TCN News,

Bhopal: In an attempt to awake political parties from there stupor, today several hundred gas victims staged a rally from Ganesh Mandir, Chhola to Bhopal Bus Stand for their long standing demands of compensation, punishment of guilty individuals and corporations. In the upcoming elections of state and central government, Bhopal gas victims have resolved that they will only vote for those political parties who will ensure their compensation and end the continuing injustices against them. Residents from J.P. Nagar, Shakti Nagar, Kainchi Chhola, Risaldar Colony and Rajgarh participated in this rally and shouted slogans “No compensation to Gas Victims, then No Vote of Gas Victims”, “No Justice, No Vote”.

Several residents of J.P. Nagar, Kainchi Chhola and Rajgarh have painted slogans “Compensation First, Second Vote” on their houses. “This time we will tell representatives of political parties visiting our communities that first secure our compensation and then ask for vote”, says Anees Qureshi from J.P. Nagar who lives right across from the Union Carbide factory.

Several gas victims believe that this is the right time to get answers from political parties towards resolving the lingering issues of compensation, punishment of guilty, medical and social rehabilitation. “This time we will only vote for that political party which ensures compensation and justice for Bhopal gas victims and we want to see result before the elections not after,” says Premlata Chowdhary of Kainchi Chhola,

In March 2013, five organization working among the survivors of the December 1984 Union Carbide gas disaster had written a letter to dozen political parties seeking their response and support to their 8 demands on additional compensation for the gas disaster, correction of figures of injury and death caused by the disaster, cleanup of contaminated soil and ground water, compensation for injuries and birth defects caused by toxic contamination, setting up empowered commission for rehabilitation and stopping Dow Chemical from doing business in India till it presents Union Carbide in the ongoing criminal case on the disaster. Except Aam Aadmi party, none of the parties have bothered to respond to the demands of gas victims.

Gas victims participating in this rally appealed to gas victims living in 36 wards to make judicious and strategic use of their power to elect candidates so that that the lingering issues of the disaster are resolved in their favor. They also said that similar rallies should be taken out by all gas victims in their own communities, Paint slogans on houses and shops, and question all the political representatives that come in their community on what steps they have taken in ensuring there compensation from the state and central governments.Photo Credit: Sanjay 'KunKun' Verma

 

#India – Mental Health Care Bill cleared by Cabinet


Music and Mental Health

The Union Cabinet  cleared the Mental Health Care Bill, 2013 that makes access to mental health care a right of all persons

Submitted on Fri, 06/14/2013 – 16:55

The Union Cabinet on Thursday cleared the Mental Health Care Bill, 2013 that makes access to mental health care a right of all persons. Such services should be affordable, of good quality and available without discrimination, it said. The proposed law decriminalises suicide.

The Bill, in consonance with international laws, has the provision of Advance Directives — described as a progressive and far-sighted step. No person who has recorded an Advance Directive to State that he or she should not be admitted to a facility without consent can be so admitted.

A rights-based Bill also has a provision wherein a person with mental illness can appoint a nominated representative to take decisions for him or her. Under the provisions of the Bill, government has an obligation to provide half way homes, community caring centres and other shelters for mentally ill people. This has been planned under the District Mental Health Programme in the 12th Plan.

In 2005, the National Commission on Macroeconomics and Health reported that 10-12 million or one to two per cent of the population suffered from severe mental disorders such as schizophrenia and bipolar disorder, and nearly 50 million or five per cent from common mental disorders such as depression and anxiety, yielding an overall estimate of 6.5 per cent of the population. The prevalence of mental disorders was higher among women, those who were homeless, poor and living in urban areas, Union Health and Family Welfare Minister Ghulam Nabi Azad told The Hindu.

The new Bill, once approved by Parliament, will repeal the Mental Health Act, 1987, which had vested extraordinary power in the hands of the treating psychiatrists. There was enough evidence of misuse and unscrupulous families collaborating with psychiatrists in addition to badly functional or non-functional Central and Mental Health Authorities primarily because of lack of funds.

Under the proposed new law, there is provision for voluntary admission with supported admission limited to specific circumstances; appeals can be made to the Mental Health Review Commission, which will also review all admission beyond 30 days and free care for all homeless, destitute and poor people suffering from mental disorder. The Bill provides right to confidentiality and protection from cruel, inhuman and degrading treatment, in addition to right to live in a community and legal aid. It bans the electric-convulsive therapy without anesthesia and restricts psychosurgery, Mr. Azad said.

He said the Bill tries to address the needs of the families and caregivers, and the needs of the homeless mentally ill. It provides for setting up Central and State Mental Health Authorities, which would act as administrative bodies, while the Mental Health Review Commission would be a quasi-judicial body to oversee the functioning of mental health facilities and protect the rights of persons with mental illness in mental health facilities.

Credit and Source: The Hindu

 

Men, Women and Other People: Understanding Sexualities #Sundayreading


breaking1

From left to right  ( Nine members of the research team ) – Hasina Khan , Kranti  ,  Shruti, Shalini Mahajan, Smriti Nevatia , Raj, Sabla , Meenu pandey, and Chayanika shah

Kamayani Bali Mahabal, Women Feature Service 

The concept of gender needs to be transformed. That was the central thrust of a recent study entitled, ‘Breaking The Binary’, released by the queer feminist collective, Labia, at an event organised in Mumbai’s well–known SNDT University.

Questioning the male–female binary, the study concluded that there can be no uniformity within these identities. Even when people use the same term like ‘man’, ‘woman’, ’transgender’ to define themselves, their lived realities may differ greatly. Such categories, therefore, should necessarily be less rigid because when the boundaries between them get blurred, individuals are enabled to exert greater agency and choice in moving across them. According to the study, gender needs to be consensual; it needs to get transformed from a hierarchical discrete, binary system to a porous, multiple–gender one.

‘Breaking The Binary’ was based on 50 life history narratives that explored the circumstances and situations of queer PAGFB (Persons Assigned Gender Female at Birth), who were made to, or were expected to, conform to existing social norms pertaining to gender and sexuality.

The research team for the study comprised 11 members, with Chayanika, Raj, Shalini and Smriti from Labia anchoring the work. Explained Chayanika, “Through this study, we looked at the experiences of our subjects within their natal families and while at school. We charted their journeys through intimate relationships and we attempted to understand what happened to them in public spaces, how they were treated by various state agencies, what were their sources of support and refuge when they came under the threat of violence or faced discrimination.”

The people interviewed came from a wide cross–section of society in terms of location, age, caste, class, and religion. These variations were critical, according to Chayanika, as the intention was to reach those living at the intersections of many marginalised identities. But achieving this was difficult, even impossible. As she put it, “The silence and invisibility around individuals who continually transgress gender norms meant that we were able to approach only those individuals who have some contact with queer groups.”

The 50 respondents were spread across north, east, west and south India – living in cities such as Bangalore, Mumbai, Kolkata, Chennai, Delhi, Pune and Thrissur. The representation of individuals living in rural areas was low, but two persons – one from rural Maharashtra and the other from rural Jharkhand – were interviewed, and 11 of the respondents had grown up in rural settings. Of the 50 individuals who participated in the study, 30 were from the dominant castes, 11 people were from the Scheduled Castes/Scheduled Tribes/Special Backward Classes, three were from Other Backward Classes (OBC) and six identified themselves as Others.

‘Woman’ as a biological category was one of the subjects that figured in the interviews. Persons whose biological sex did not correspond with their psychological sex, were branded as gender “variants”, even though women do not constitute a homogenous category and could belong to many different categories – including a category as unfamiliar as ‘working class lesbian’ or ‘dalit lesbian’.

According to Raj, a member of Labia, “We found that being from an upper class background was no guarantee of privilege. There was a 20–year–old from a business family. Because of family dynamics, she was unable to get the education she had wanted and was forced to support herself by earning small sums of money playing cricket. Another respondent, identified as upper class, was also deprived of a meaningful education.” Clearly, a privileged, upper class background does not protect queer persons, especially if they happen to challenge gender and/or sexuality norms.

The study identified three levels of violence the respondents had faced. The first is at the individual level, where harmful acts are perpetrated against people and property. This can range from taunts to forced marriage and even murder. The second is at the institutional level, where damaging consequences are perpetrated by social institutions with the idea of obstructing the spontaneous expression of human potential – as, for example, when an office denies promotion to an employee on account of sexual orientation. The third is at the structural – cultural – level as, for instance, when religious or political beliefs rule that homosexuality is immoral or illegal.

A woman’s sexual orientation can, among other things, determine her access to resources as well as her social status, according to the study. Women suffer severe material loss when their families desert them and many experience emotional and psychological trauma in their struggle against discrimination and ostracism. Mis–recognition and non–recognition can become a very perverse form of violence as it seeks to naturalise the power enjoyed by dominant groups over non–dominant ones.

For instance, families, friends and teachers could refuse to recognise the need of lesbians to be acknowledged as they are and treated with dignity, leading them to experience a severe loss of self–esteem. This constitutes a form of violence imposed by the majority on a minority. As Shalini, one of study team members, put it, “Every society has its own notion of what is normal and what is assumed to be normal. Going beyond that construct could invite violence on the individual. Many of the respondents felt that the gay rights movement was crucial precisely because people cannot hide behind identities that are not their own. Therefore, just as women defied patriarchy through the women’s rights movement, queer persons defy heteronormativity through the queer rights movement.”

This study, the first of its kind, has helped shed light on how queer persons have addressed the challenges of life and how they continue to search, negotiate, and challenge multiple boundaries. It has attempted to answer some important questions. Where, for instance, are the points at which gender binaries rupture? How are the normative gender lines being reinforced? What situations help to create varied gender identities? Most important of all, the study has helped to capture the experiences of Persons Assigned Gender Female at Birth and their negotiations with families, friends, communities, social structures, as well as the health and legal systems.

The team hopes to take the study forward to highlight areas of concern and conceptualise effective interventions. As one of the team members put it, “We are aiming to convey its insights to the more general category of people, at least those who are interested in taking proactive steps in addressing violence against any human being in any form and also for those who would like to understand the root causes of homophobia. We also want to take it to educational and governmental institutions, so that they can also help usher in change.”

The study was released not just in Mumbai, but in Kolkata, Delhi, Bangalore, Thrissur and Chennai as well. A Hindi translation of it is also on the cards. (WFS)

 

#India -an Appeal From Tribal Activist Himanshu Kumar: On Atrocities, Self Reflection


An Appeal From Tribal Activist Himanshu Kumar: On Atrocities, Self Reflection And More

Posted on: June 2, 2013
-Youth ki Awaaz

Translated from Hindi by Akhil Kumar

Self-Reflection Fast: How should India Behave With Its Tribal Population

Dear friends,

A large number of army troops are being sent to the tribal areas to establish peace.

Whereas past experience tells us that the entry of the army troops in tribal territory has never decreased unrest but escalated it instead.

For a long time now, the tribal people have faced oppression from the government. And if any one of them asks for justice against this oppression, they are branded as Naxalites and tortured again. The government has thus closed all doors of Justice for them.

Soni Sori, Linga Kodopi and Binayak Sen were a victim of government tyranny because they raised their voice against this injustice. We know that the educated and prosperous urban class of India does not see anything wrong with sending the army in large numbers to tribal areas in order to occupy the resources of the indigenous people.

Also, there are talks of using force to suppress the dissatisfaction caused by displacement due to this plunder of resources. But if India keeps killing its citizens like this, it will result in the moral degradation of the Indian community that holds power.

India will have to think, as a nation, on how should it behave with its native inhabitants.

Do we approve of occupying the lands of the tribal community on gun point? Do we believe that we can bring peace to the country after burning their villages, driving them out of their homes and occupying their land?

If once we get habituated to doing injustice to our own citizen, wouldn’t it make way for us to do it to everyone else tomorrow? Today, we will attack the tribals, then we’ll kill Dalits and go on to kill our villagers and then, one day, we will find ourselves surrounded by enemies that we created ourselves.

Hence, we need to review our behavior towards the tribal people as soon as possible.

It is my humble effort that we use this opportunity to ponder on this issue that how should the tribal people of this country be treated. To self introspect on this issue, I am sitting on an indefinite hunger strike from 1st June and I hope that you, wherever you are, will also introspect on it.

This is not just a question of the tribals but a question for all those who want to build a better society, where everyone gets justice because it is impossible to even think of peace without justice.

Please do visit Jantar Mantar if possible, we will be pleased.

Yours
Himanshu kumar
Jantar Mantar, New Delhi

09013893955
vcadantewada@gmail.com

 

#India – Anti-nuke activists urge PM not to sign Nuclear Agreement with Japan


By Newzfirst Bureau5/27/13

New Delhi – In the wake of Indian Prime Minister Manmohan Singh’s visit to Japan, hundreds of people from across the globe have appealed him not to sign the IndiaJapan Nuclear Agreement.

Singh will be visiting Tokyo on Monday, 27th May in a trip that was scrapped last year after a general election was called in Japan.

With an aim to expand the partnership by discussing a wide range of issues including politics and the economy, it is expected to include the signing of infrastructure projects deals worth $15 billion, say reports.

“We stand in complete opposition to the India-Japan nuclear cooperation agreement that is currently under intense negotiation. The governments of both countries must refrain from promoting nuclear commerce, jeopardizing the health and safety of their people and environments.” reads the petition addressed to the both Indian and Japanese authorities.

Referring the Fukushima accident and post-accident impacts, the petition further reads thatIndia must behave responsibly and should rethink its use of nuclear energy.

Nuclear energy currently provides less than 3% of its total electricity and can be easily replaced, freeing the country to embrace renewable and sustainable alternatives, it adds.

Petitioners have also appealed the Government of Japan to desist the Nuclear Export Policy, through which it exports nuclear technology to other countries.

“The current policy option of exporting nuclear energy to countries like India, Vietnam, Jordan etc… are totally unjust while Japan is reeling under the huge financial losses posed by the Fukushima accident and its citizens are observing massive protests to demand a nuclear-free future and the victims of the triple meltdowns remain uncompensated.” the petition says.

(IANS)

 

Chhatisgarh PUCL condemns the abduction and killings of Congress men in Bastar


CHHATTISGARH LOK SWATANTRYA SANGATHAN

(PEOPLES UNON FOR CIVIL LIBERTIES, CHHATTISGARH)

___________________________________________________________________________

Chhatisgarh PUCL condemns the abduction and killings of Congress Party men in Darbha Ghati in Bastar area of the State

Calls for urgent intervention by democratic forces

to end the spiral of violence in the Region

Raipur,

25th May, 2013

The Chhattisgarh PUCL strongly condemns the attack by suspected Maoists on the convoy of Congress Party leaders in the course of their election campaign in the forested Darbha Ghati in Sukma area in which, according to news reports till the present time, Congress leader Mahendra Karma and Uday Mudaliar have been killed and the President of the Congress Party Nand Lal Patel is suspected to have been abducted. More than 20 people have been reportedly killed with several seriously injured and the numbers of missing, injured and fatalities are on the increase.

The PUCL has always had a principled stand opposed to violence and the politics of killings and abduction. The spiraling violence in the Bastar region in which the present killings and abduction have occurred, and only a week ago on 17th May, 8 villagers including 3 children and a jawan were killed in an operation of security forces in Village Edesmeta, district Bijapur. For the first time, the police actually admitted that those who were attacked were innocent and instituted an enquiry. This situation requires the urgent intervention of all democratic forces in the country as also expressed in the recent strong and anguished letter issued by the Union Minister for Tribal Affairs Shri K Chandra Deo to the Governors regarding the situation in the Scheduled Areas.

Sudha Bharadwaj

General Secretary

(Chhattisgarh PUCL)

 

UN calls for strengthened protection of more than 260 million victims of caste-based discrimination


United Nations Human Rights Council logo.

 

 

 

 

Continued plight of the ‘untouchables’

UN experts call for strengthened protection of more than 260 million victims of caste-based discrimination

GENEVA (24 May 2013) – They occupy the lowest levels of strict, hierarchical caste systems founded on notions of purity, pollution and inequality. They face marginalization, social and economic exclusion, segregation in housing, limited access to basic services including water and sanitation and employment, enforcement of certain types of menial jobs, and working conditions similar to slavery.

They are the Dalits of South Asia, who constitute the majority of victims of entrenched caste-based discrimination systems which affect some 260 million stigmatized people worldwide, people considered ‘untouchable’.

Caste-based discrimination remains widespread and deeply rooted, its victims face structural discrimination, marginalization and systematic exclusion, and the level of impunity is very high,” a group of United Nations human rights experts warned today, while urging world Governments to strengthen protection of the hundreds of millions of people across the globe who suffer from discrimination based on work and descent.

“This form of discrimination entails gross and wide-ranging human rights abuses – including brutal forms of violence,” they said. “Dalit women and girls are particularly vulnerable and are exposed to multiple forms of discrimination and violence, including sexual violence, on the basis of gender and caste. Children victims of caste-based discrimination are more at risk to be victims of sale and sexual exploitation.”

On this day, two years ago, the experts recalled, Nepal adopted the ‘Caste-based Discrimination and Untouchability Bill’, a landmark legislative piece for the defense and protection of the rights of Dalits. A recent decision by the British Government in April 2013 to cover caste discrimination by the Equality Act serves as a good practice to protect Dalits in diaspora communities.

“We urge other caste-affected States to adopt legislation to prevent caste-based discrimination and violence and punish perpetrators of such crimes, and call on world Governments to endorse and implement the UN Draft Principles and Guidelines for the Effective Elimination of Discrimination Based on Work and Descent.”*

The UN experts expressed concern about a serious lack of implementation in countries where legislation exists, and called for effective application of laws, policies and programmes to protect and promote the rights of those affected by caste-based discrimination. “Political leadership, targeted action and adequate resources should be devoted to resolving the long-standing problems, discrimination and exclusion faced by Dalits and similarly affected communities in the world,” they stressed.

“Caste-based discrimination needs to be addressed as a major structural factor underlying poverty,” the expert said, while welcoming the acknowledgment of caste-based discrimination as a source of inequality by the global consultation on the post-2015 development agenda.

However, they expressed hope that the agenda will also include specific goals for the advancement of Dalits and particularly affected groups. “Their specific needs require tailored action to lift them out of poverty and close the inequality gap between them and the rest of society,” they underlined.

“We will pay specific attention to the particularly vulnerable situation of people affected by caste-based discrimination and advocate for their integration and inclusion so that they can fully enjoy their human rights in accordance with international human rights law and national legislation”, the UN independent experts said.

“No one should be stigmatized; no one should be considered ‘untouchable’”.

The experts: Rita IZSÁK, Independent Expert on minority issues; Rashida MANJOO, Special Rapporteur on violence against women, its causes and consequences; Gulnara SHAHINIAN, Special Rapporteur on contemporary forms of slavery, including its causes and its consequences; Najat Maalla M’JID, Special Rapporteur on the sale of children, child prostitution and child pornography; Mutuma RUTEERE, Special Rapporteur on contemporary forms of racism, racial discrimination, xenophobia and related intolerance; Catarina de ALBUQUERQUE, Special Rapporteur on the human right to safe drinking water and sanitation; Magdalena SEPÚLVEDA, Special Rapporteur on extreme poverty and human rights.

(*) UN Draft Principles and Guidelines for the Effective Elimination of Discrimination Based on Work and Descent:
http://www.ohchr.org/Documents/HRBodies/HRCouncil/RegularSession/Session11/A-HRC-11-CRP3.pdf

For further information on the experts mandates and activities, log on to: http://www.ohchr.org/EN/HRBodies/SP/Pages/Welcomepage.aspx

For further information and media requests, please contact Marta Franco (+41 22 917 9268 / mfranco@ohchr.org) or write to minorityissues@ohchr.org

For media inquiries related to other UN independent experts:
Xabier Celaya, UN Human Rights – Media Unit (+ 41 22 917 9383 / xcelaya@ohchr.org)

 

 

 

 

Indian pharma under the microscope


US FDA issues import alert on Wockhardt plant; drug makers fear being smeared by the transgressions of a few
Vidya Krishnan Mail Me |  C.H. Unnikrishnan
A file photo of the Ranbaxy headquarters in Gurgaon. Photo: Ramesh Pathania/Mint
A file photo of the Ranbaxy headquarters in Gurgaon. Photo: Ramesh Pathania/Mint
Mumbai/New Delhi: Malvinder Singh put forth a robust defence of his record at Ranbaxy Laboratories Ltd, which has come under a cloud after revelations of dodgy practices that had to be settled with the US Food and Drug Administration (FDA) through a $500 million payment.
While the company’s former chief executive officer (CEO) could be at the receiving end of a suit filed by Japan’s Daiichi Sankyo Ltd, which took control of Ranbaxy from Singh’s family in a $4.6 billion deal in June 2008, the contagion could spread to other Indian generics manufacturers as they come under increased scrutiny as more skeletons come tumbling out of the closet.
Indian manufacturers are afraid they may all get smeared because of the transgressions of a few, handing ammunition to companies in developed markets that would like to see more stringent controls on cheaper generic imports.
“They cannot pass the blame on to previous shareholders and management,” Singh said in an interview on Thursday. “I don’t think they (Daiichi Sankyo) have a case. There was absolutely no concealment on our part… They should be held accountable for destroying an Indian brand.”
The stock market is palpably nervous—shares of some Indian generics companies have fallen in the past few days, most particularly after a 15 May Fortune story that detailed the extent of possible wrongdoing at Ranbaxy.
Wockhardt Ltd is the first Indian company that’s said it faces FDA strictures since Ranbaxy made details of its case public on 13 May, when it said it had agreed to pay $500 million to settle civil and criminal charges of making fraudulent statements to the FDA and selling adulterated drugs.
The Wockhardt stock plunged 20% on Thursday after the FDA issued an import alert banning the import of products made at one of its plants at Aurangabad in Maharashtra. Chairman Habil Khorakiwalaconfirmed the development and said, “The company expects a financial impact of $100 million in this financial year due to the import ban of products from this plant.”
The plant manufactures sterile injectables as well as solid oral drugs. Wockhardt called off a media conference on Monday (27 May) to announce its fourth-quarter results, citing no specific reasons.
Wockhardt shares have declined 24.83% since the 15 May Fortune story, while the Ranbaxy stock has declined 11.11% in the same period.
Malvinder Singh refuted all allegations against his family and said the current owners of the company were responsible for the troubles they were facing.
“They are the owners and they have to be accountable for what they do. They spent money and did their diligence. They were keen to buy and they ran it to the ground,” he said. “I am not here to discuss whether Ranbaxy is doing well or not. I am here because of the allegations against my family. For the last many years, after I moved out of that space, I have not spoken on anything related to Ranbaxy or the industry.”
India’s pharmaceutical industry regulator meanwhile elaborated on the action it is considering against Ranbaxy. Drug controller general of India G.N. Singh said in an interview that all drug applications and dossiers filed by Ranbaxy as well as court documents presented in the US will be scrutinized to see if there have been any breaches of the Drugs and Cosmetics (D&C) Act.
“No one and no company is above rules,” Singh said. “We want companies operating in India to follow established procedures and will initiate necessary steps to ensure that.”
He said the regulator’s duty wasn’t to companies but to patients and to ensuring that they have access to safe drugs. “I want to assure people that the drugs currently allowed in the domestic market are of good quality and as per the D&C Act,” he said. “We have no reason to believe that the company has violated Indian laws. The matter, however, is currently being looked at.”
The drug regulator pointed out that India’s rules vary from those in other countries.
However, he said, “We export drugs to 218 countries and we are conscious of our responsibility towards health of all those who use Indian drugs. From time to time, we have put companies on alert and taken appropriate action against then when violations have been established.”
India’s image as a low-cost generic drugs manufacturer of high quality could get a beating in the wake of recent developments, said Tapan Ray, director general of the Organisation of Pharmaceutical Producers of India, the industry lobby that largely represents foreign drug makers operating in India.
“In the backdrop of such high decibel quality concerns raised by USFDA, the level of apprehension regarding effectiveness of generic drugs made in India may increase, unless some tangible remedial measures are taken forthwith,” he said. “These issues are company specific; it will not be appropriate to comment even remotely that all generic drugs manufactured in India are of dubious quality.”
The Ranbaxy episode won’t taint all domestic manufacturers of generics as the development is specific to one company, said Dilip G. Shah, secretary general, Indian Pharmaceutical Alliance, which represents the top Indian companies.
“We should admit that it was crude if Ranbaxy hasn’t shown the documents regarding the non-compliance issues and the related investigation to Daiichi during the due diligence process,” he said. “If it is so, Daiichi has all the rights to raise legal remedies to recover the damage that it has caused the company post deal.”
Any impact on the overall industry will be short-lived, he said.
“I don’t think quality is a concern as far as Indian generics are concerned as the country has several manufacturing plants which have been approved by many regulatory agencies including USFDA, and those are products are there in the market for so long.”
Singh added that Ranbaxy was built on professional principles.
“This company was built over generations based on talent and capability. It was one of the few companies that ran professionally which went global because it was forward looking with an international perspective. These aspects speak about the management capability amply,” he said.
Cases such as the Ranbaxy one will persuade deal makers and potential buyers to dig deeper during the due diligence phase, said Avinash Gupta, head, financial advisory, at corporate consultancy and audit firm Deloitte Touche Tohmatsu India Pvt. Ltd.
“Many deals have gone wrong in the past not only in India but globally too, as exuberant buyers or deal makers tend to discount the impact of certain issues or factor them lightly,” he added.
India exports generic drugs worth about Rs.60,000 crore to least 200 key markets in the US, Europe, Africa and Asia. Of this, about 40% is to the US, the largest drugs pharmaceutical market in the world in terms of value.
India, the country which has the largest number of USFDA-approved manufacturing plants outside the US, has been the largest generic drug exporter to the US and Europe. Top Indian drug makers includingSun Pharmaceutiucal Industries LtdDr Reddy’s Laboratories LtdLupin Ltd and Cadila Healthcare Ltd, besides Wockhardt and Ranbaxy, also operate several manufacturing plants abroad, including the US, to cater to markets there.
The local industry has faced several US regulatory issues in the past. Besides the import ban imposed on Ranbaxy’s manufacturing plants in Himachal Pradesh and Madhya Pradesh, other key instances include a 2009 ban on one of the sterile plants of Hyderabad-based Aurobindo Pharma Ltd, an import ban on Claris Lifesciences Ltd’s plant in 2008 and a four-year ban on the manufacturing plant of Sun Pharma’s US subsidiary Caraco Pharma.
The local drug industry also faced intellectual property related issues while exporting drugs. In recent years, several export consignments from companies such as Cipla Ltd and Dr Reddy’s were seized at European ports on charges of patent infringements, though many of them were released later after they were proved to be legal consignments to either Europe or other markets.

 

Kudankulam N-plant: Safety norms gains primacy over commissioning deadline


, TNN | May 16, 2013

Kudankulam N-plant: Safety norms gains primacy over commissioning deadline
Last week, the Supreme Court cleared the power plant, paving the way for early commissioning. Originally, the plant was scheduled to be commissioned in 2007.
NEW DELHI: Regardless of the recent promise made by Prime Minister Manmohan Singh to his Russian counterpart Vladimir Putin on the sidelines of the BRICS summit in Durban about the early commissioning of the Kudankulam nuclear power plant (KKNPP), the government has instructed theAtomic Energy Regulatory Board (AERB) that safety reviews of KKNPP should be run with a “fine-toothed comb” without being pressured by commissioning deadline. In fact, the government had recently invited the Operational Safety Review Team of the IAEA to do an independent safety assessment of other Indian reactors, particularly RAPS (in Rajasthan).Last week, the Supreme Court cleared the power plant, paving the way for early commissioning. Originally, the plant was scheduled to be commissioned in 2007.A whole new set of safety checks were conducted by the AERB after four valves that came from a Russian supplier were found to be “deficient”.Stung by a series of popular protests about safety issues in Kudankulam, which has inspired protests by a large number of NGOs, the government is keen that no stone is left unturned. If this means the Russians are less than pleased, sources said, so be it. They added that some of the supplies from Russian companies have been found to be below par.

NPCIL has that the commissioning of KKNPP would now happen only in June, after another set of checks are carried out. The company said the physical progress of the plant was 99.6% complete.

This week a group of 60 leading scientists wrote a letter to the PM, and chief ministers of Tamil Nadu and Kerala asking for more stringent safety checks of the KKNPP. They have sought “renewed study” of safety issues by an independent panel of experts. The scientists — most of them serving in state-run institutions — have expressed doubts, “particularly with reference to possible sub-standard components” used in the plant.

These are not scientists advocating against nuclear energy, but concerned about safety issues. “These safety concerns are compounded by the fact that Russian authorities arrested Sergei Shutov, procurement director of Zio-Podolsk, on corruption charges for having sourced cheaper sub-standard steel for manufacturing components that were used in Russian nuclear installations in Bulgaria, Iran, China and India,” they wrote in the letter, The arrest of Shutov, they cited, led to several complaints of sub-standard components and follow-up investigations in both Bulgaria and China.

While the AERB gave an in-principle clearance for fuel loading of the plant in April, hopes that it would be commissioned by May were dashed after faulty valves made news. In an effort to quell the protests and spiralling negative perception about the power plant, the government has been on an information overdrive to educate and be transparent. This week, minister of state V Narayanasamy said, “All nuclear power projects undergo an elaborate in-depth safety review during the consenting stages, like siting, construction, commissioning, etc. After satisfactory review during project stage, AERB issues operating licence to an NPP for a period of up to five years.”

Last week, responding to a question in Parliament, government assured that components supplied to KKNPP are “tested in an integrated manner during commissioning to verify their performance in accordance to design performance criteria. Any shortfall noticed in performance is addressed/corrected as a part of the commissioning programme”

 

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