04:07 pm BY VISHNU MAKHIJANI New Delhi, American investigative journalist Katherine Eban pored over roughly 20,000 internal documents from the US FDA, including emails, memorandums, minutes of meetings and thousands of internal government records, as also replies under the Freedom of Information Act, to piece together a riveting and definitive account of how once storied Indian pharma major Ranbaxy blatantly cut corners - to improve its bottom line. "I discovered that a cloud hovered over the company. American regulators were investigating whether Ranbaxy had fabricated quality data in order to gain approval to market its drugs. The allegations had first been made by a company whistleblower who had contacted the agency (FDA)," Eban, who travelled halfway across the globe as part of her investigations, writes in "Bottle of Lies - Ranbaxy and the Dark Side of Indian Pharma" (Juggernaut/pp 482/Rs 699). The whistleblower in question, says Eban, is Dinesh Thakur, then Ranbaxy's Director and Global Head of Research, Information and Portfolio Management, who, in 2004, put together a team to study a deadly secret he had come across: that the company was fudging data. "Little by little, as the team members stitched together small bits of information, they stumbled into Ranbaxy's secret: the company manupulated almost every aspect of its manufacturing process to quickly produce impressive looking data that would bolster its bottom line," Eban writes. "Each member of Thakur's team came back with similar examples. At the behest of managers, the company's scientists substituted lower-purity ingredients for higher ones to reduce costs. They altered test parameters so that formulations with higher impurities could be approved. They faked dissolution studies. To generate optimal results, they crushed up brand-name drugs into capsules so that they could be tested in lieu of the company's own drugs. They superimposed brand-name test results onto their own in applications," the book says. Noting that document forgery "was pervasive", the book says: "The company even forged its own standard operating procedures, which FDA investigators rely on to assess whether a company is following its own policies. In one instance, employees backdated documents and then artificially aged them in a steamy room overnight in an attempt to fool regulators during inspections", the book says. Essentially, Ranbaxy's manufacturing standards "boiled down to whatever the company could get away with", the book says. Thakur worked 14-hour days and after weeks of exhaustive research, brought his team's preliminary findings to his boss, Raj Kumar. "Once Kumar heard from each member of Thakur's team, it finally sank in. The company was committing fraud and potentially harming patients on a global scale. He distilled the information into a four-page report for the CEO, Brian Tempest," that "laid bare systematic fraud in Ranbaxy's worldwide regulatory filings", the book says. Predictably, there was no action as the findings "were not news to Ranbaxy's top executives", Eban writes in the book , and when Thakur pressed the issue, the company fought back in a rather unusual manner: It accused him of downloading pornography on his office computer. Thakur realised he had to go but agonised on what to do next. He made his first move, masking his identity, on the morning of August 15, 2005 but when there was no action for two weeks, he sent a message directly to FDA Commissioner Lester Crawford, the book says. The result was immediate and set in motion a chain of events that culminated in May 2013 with Ranbaxy pleading guilty to felony charges in the manufacture and distribution of certain adulterated drugs made at two of its facilities in India, and misrepresenting clinical generic drug data. "In the largest drug safety settlement to date with a generic drug manufacturer... Ranbaxy also agreed to pay a criminal fine and forfeiture totaling $150 million and to settle civil claims under the False Claims Act and related State laws for $350 million," the Justice Department said in a statement on May 13, 2013. Ranbaxy also pleaded guilty to three felony FDCA (Food Drug and Cosmetic Act) counts, and four felony counts of knowingly making material false statements to the FDA. Among the adulterated products were antiretroviral (ARV) drugs destined for treatment of HIV/AIDS in Africa. In this context, the book notes that the endorsement in November 2013 of Ranbaxy and other Indian pharma companies by former US President Bill Clinton for their efforts at producing low-cost generics had set the sales of the ARV drugs zooming. In the midst of all this, Ranbaxy initially passed into the hands of Japan's Daiichi-Sankyo in November 2008 and was bought over in April 2014 by India's Sun Pharmaceutical. In February, the Supreme Court asked the company's former owners, Malvinder Mohan Singh and his brother Shivinder to cough up the Rs 35 billion they owe to Daiichi Sankyo in compensation post its exit from the company - warning they could be jailed if they failed to do so.
12:07 pm New Delhi: Literary publisher HarperCollins India on Friday announced the acquisition of a three-book series titled, "The Gopi Diaries" penned by noted English and Kannada author Sudha Murthy. In a statement, the publisher said that the series is told from a dog's perspective. They are Murthy's first books with HarperCollins, and draw inspiration from her own dog, Gopi. "Told in Gopi's voice, the first book begins with Gopi coming home, and tells the story of how he settles down with his loving, human family. How Gopi sees the world around him and what he thinks of the people in his life give the story a truly unique flavour," it revealed. The books will be in told in Murty's inimitable style, and are simple stories that talk of basic values even when told from a dog's perspective. "It is my first book for youngsters, particularly those kids who love animals. It is about my dog Gopi who is the joy of my life," Murthy, 69, who also chairs the Infosys Foundation, said. Childrens' publisher Tina Narang said that the 2006 Padma Shri recipient writes from her heart, and when the subject is as close to her heart as Gopi is, the "stories are bound to be as charming as it gets". Murthy, who married Indian industrialist N.R. Narayana Murthy in 1978, is the recipient of the R.K. Narayan Award for Literature (2006), the Attimabbe Award from the Karnataka government (2011) and the Lifetime Achievement Award at the 2018 Crossword Book Awards. The first book of the trilogy is expected to towards the end of this year.
03:07 pm New Delhi: On the occasion of International Yoga Day on Friday, yoga guru Baba Ramdev announced his first official autobiography, titled "My Life, My Mission". It will release in August, the publisher Penguin said. Sharing the news on Twitter, Ramdev said that although a lot has been written on him by other people, he will now share his life's story in his words. The volume, co-authored by senior journalist Uday Mahurkar, is touted as an one of a kind personal narrative of the life and times of the globally renowned yoga teacher. "This autobiographical account uncovers the trials, tribulations and triumphs of his life and provides insights into his childhood, his passion for yoga and good health, his friends and foes and the Swadeshi campaign he spearheaded," the leading publishing house said in a Friday statement. The upcoming book will also show the journey of Ramdev's venture, Patanjali Group of Institutions and how it became a multi-billion corporation and is considered one of the fastest growing companies in Fast-Moving Consumer Goods (FMCG) in India with a turnover of about Rs 12,000 crore. "I hope readers, fans and followers from across the world will read it and be a part of my journey," the 53-year-old Ramdev said about the gripping 'tell-all'. Ramdev's first autobiography, that spells his journey from a small village in Haryana to the international stage, is available for pre-order on e-commerce sites.
03:07 pm New Delhi: Best-selling author Chetan Bhagat says he likes to use his writing not just to tell stories but also to bring attention to some of the issues within the country. Bhagat's latest non-fiction book "India Positive" comprises essays examining a gamut of subjects such as education, employment, Goods and Services Tax (GST), corruption and casteism. It also consists of tweets that highlight and touch upon the current issues that need focus today. "These are important issues for our country. I like to use my writing not just to tell stories but also to bring attention to some of the issues within the country," Bhagat told IANS via a recorded response. "There is a space for something positive. People on social media are so negative these days.. So I think, there is a space to have a positive view on what needs to be done," he said, adding that he has no intention of joining politics. "But I think people need to be aware of issues," added the author, who had curated a special line-up of movies based on his favourite books for Sony PIX and AXN. Talking about the importance of books, the author said: "Books will always have a place. Books are a basic building block of a story. Reading is the best way to widen your imagination… Reading is still the best way of learning and imagining things." The "2 States" author also expressed his desire to work on a "a big epic film". "Something I have never done, like ‘Baahubali'... A grand thing."
03:07 pm New Delhi/Kathmandu: Even as Indian publishers are grappling with a budget proposal of 5 per cent customs duty on imported books, in close neighbour Nepal, a 10 per cent duty on imported titles has left publishers and booksellers reeling, with students hit badly as Kathmandu imports over 80 per cent of its books from India. A few days after the Nepal government on May 29 announced a 10 per cent duty on imported books, publishers stopped picking up books at the Nepal customs point in protest and have demanded roll back of the move. With no text books coming in to Nepal, the student community has been affected the most, say publishers. "Around 80-90 per cent of books in Nepal are imported, and most of it from India. Now the students, including those in Classes 10 and 11, are not getting text books on time. The National Booksellers' and Publishers' Association of Nepal (NBPAN) has decided not to import any books in protest. We import 90-95 per cent of academic and text books from India," a noted book seller in Kathmandu told IANS on phone, declining to be named. According to Madhab Maharjan, Advisor NBPAN and owner of Mandala Book Point in Kathmandu, the 10 per cent customs duty will attract other taxes, like the cost, insurance and freight tax and other charges, further pushing up the price of imported books. "Books all over the world are sold at the printed price. With the customs duty and the added charges, it is going to be difficult to sell imported books to academic institutions, libraries and students," Maharjan told IANS over phone from Kathmandu. He said they have requested the KP Sharma Oli government to remove the tax. "We have a long tradition of importing books from India. Religious books were imported from Benaras in the 20th century. Now the import of books is restricted to New Delhi," said Maharjan, adding that scholars, academics and experts are raising their voices in protest against the move through the print and social media. The 10 per cent tax will hamper the free flow of books and also affect the reading habit of students, says Maharjan. According to him, a Nepali journalist in an article in a local daily asked Finance Minister Yuba Raj Khatiwada, who is a PhD in economics, whether it was a theory of economics to impose the customs duty on books when the need was to improve the reading habits and culture of the people. The reason for stopping the books at the customs point was because "as soon as we import we will have to increase the price, and secondly the old stocks have to be sold at the old price". "Thus there will be two prices of the book in one book store. This will create misunderstanding with students, readers, scholars, researchers and academics at large with whom we have to deal with everyday," Maharjan said. He added: "We do not want any one taking undue advantage of the situation, including politically motivating the students. Thus we have opted for this move not to import books till we come to a final decision." According to him, the onset of the digital era has hit book sellers and publishers. "There are not many book shops left, and with moves like this book sellers may not survive for long." Many Nepali publishers print their books in India and earlier would have to pay 15 per cent tax. "Now they are asked to pay 10 per cent duty on total imports. The earlier system was better to protect the local industry," Maharjan said. The number of students pursuing higher education in Nepal under Management, Humanities, Science and Education stands at around 400,000, and they would be directly hit by the duty on books imported from India. According to Maharjan if India revokes the 5% duty on imported books the move "may help to revoke 10 per cent duty in Nepal too". K.P.R. Nair, Managing Director Konark Publishers in Delhi, said Indian publishers are aware of the situation in Nepal and are trying to help. "They have asked for our help, and we are going to help them," Nair, a veteran in the publishing industry, told IANS.
03:07 pm Gurugram: The second edition of Gurgaon Literature Festival (GLF), to be held on November 16-17 at the DLF Cyber Hub, will be themed around mental health and fitness. It will feature around 80 speakers, including authors, politicians and psychiatrists. "The festival will also donate 10 per cent of its proceeds to the Sanjay Chugh Clinic to be used for the treatment of the mentally ill," festival director Ajay Setia said in a statement on Monday. "Mental health expert and author Shabri Prasad Singh is one of the directors of the festival, which aims to glorify and celebrate culture," said the organisers. "These health issues are often brushed under the carpet. Sitting at a desk and working for hours in front of a computer is a norm for Gurugram millennials. But we want them to escape to a world where there is a cohesive culture for reading which helps to release stress and fight any mental disorder one may not be aware of," Singh added.
03:07 pm London: The British library has acquired the archives of the prestigious Granta magazine, covering 40 years since the literary journal was relaunched, and spanning the work of Nobel Laureates to debut novelists. Now permanently housed in the British Library, the archives are hailed as a significant source for understanding the landscape of contemporary British writing and publishing. It comprises around 300 boxes of material. The archives includes marked-up proofs, back issues, original correspondence to authors, agents and literary organisations and documents on readership, marketing, design, financials and other administrative concerns, the Library said. It features letters and papers from well-known authors such as Kazuo Ishiguro (2017 Nobel Prize winner), Margaret Atwood, J.G. Ballard, Angela Carter, Iris Murdoch, Ben Okri, Fay Weldon, Martin Amis, John Berger, Raymond Carver, Doris Lessing and Martha Gellhorn. Granta magazine was founded by Cambridge university students in 1889 before being re-launched in 1979 by editor Bill Buford, who transformed it into one of the world's most important literary periodicals. "The material generated from 40 years of publishing Granta does so much more than simply showcase the history of our beloved literary quarterly: it also reveals how a plucky American, determined to shake things up by bringing new, edgy American writing to British readers, accidently ended up championing some of Britain's - and indeed the world's - most exciting writers," Sigrid Rausing, Editor of Granta, said. Granta initially relaunched in 1979 to promote American writing in Britain. It has launched the careers of some of Britain's most significant contemporary writers, the British Library said.
07:07 am Bhubaneswar: (IANS) With "Gandhis Idea of India: Truth, Harmony, Non-Violence" as its central theme, the three-day Kalinga Literary Festival (KLF) here later this month will pay tribute to the Father of the Nation through contemporary reflections on his ideas and is set to trigger global and national discussions on his work and ideas through literature; lived experience, politics, art, film, business, media and sports. Around 250 speakers, poets, musicians, artists and performers will feature in the fourth edition of the festival during innovative sessions on radio, poetry recitation, short story, lyrics and cinema. Concurrently, the Kalinga Art Festival will showcase works of 60 artists from Odisha and India. Four prestigious awards will be conferred and more than 30 national and international books/publications will be released during the July 19-21 event. "KLF is well-known for its socially relevant themes and in a way compels all creative people to think and articulate 'the contemporary'. The festival will cover several dimensions of the interconnection between literature, Gandhian ideology, truth, harmony and non-violence," the organisers said in a statement. KLF founder director Rashmi Ranjan Parida said that as Gandhi's 150th birth anniversary is being celebrated this year, "it is only fitting to pay tribute to him, his ideas and reflect upon them in contemporary times". The key sessions will be on topics such cultural nationalism, Gandhigiri, Generation Y, Odisha, Media Children, Women, Transgenders, Kamasutra, Citizen's Engagement, Cinema, Sports, Ethics, Discrimination, Revolutions, Peace-building, Conflict Resolution and Harmony. "The delegates will have a unique opportunity to participate in the Ekamra Heritage Walk and participate in plantation and seed ball making. To expand the opportunity for the delegates, KLF team has partnered with local cycle clubs to provide cycles for speakers to roam around the temple town and experience the blend of ancient heritage and modern urban planning," the statement said. The writers, poets, speakers and performers at the Festival will include Bhawana Somaaya, Bhavani B Iyer, Christopher C. Doyle, Namita Gokhale, Nalini Mehta, Nambi Narayanan, Pavan K. Verma, Priya Somaiya, Pushpesh Pant, Rakhshanda Jalil, Sathya Saran, Saira Shah Halim, Tamal Bandopadhya and Yashwant Sinha, among others. There will be cultural programmes to showcase Odisha's art, culture and literature on each day of the event. Among other highlights will be the story-telling session "Dastan-E-Mantoiyat" by Syed Shadab Hussain and Meera Rizvi and the screening of Oscar-nominated director Ashvin Kumar's "No Fathers In Kashmir". The Kalinga Literary Award (for a distinguished writer in Odia), the Kalinga International Literary Award (for a writer in any global language), the Kalinga Karubaki Literary Award (for women writers) and the Kalinga Literary Youth Award (for a young writer in any global language) will be conferred on the occassion.