News of the Industry

Dr Reddy’s Labs Plans to Re-enter Japanese Market

 

HYDERABAD: After shrugging off its proposed Joint Venture (JV) with Fujifilm Corp., which was a non-starter, Dr Reddy’s Laboratories Ltd. (DRL) is back on the drawing board and is keen to make a fresh foray into the Japanese market, which is the world’s second largest pharma market after the US. “We are exploring all options in the sense that we have a product profile. We have already gone through (with Fujifilm), which did not work. We have to be sure that we don’t make those mistakes again. The priority is to get into the right plan to enter into the (Japanese) market,” said K. Satish Reddy, Vice-Chairman and Managing Director, DRL.

 


The Indian drug-maker and Fujifilm last June decided to terminate the memorandum of understanding (MoU) to enter into an exclusive partnership in the generic drugs business for the Japanese market and to establish a JV in the island nation in East Asia. DRL and Fujifilm had signed the MoU on July 28, 2011 and the two companies had conducted detailed studies on establishment of a JV for developing and manufacturing generic drugs in Japan. The new company was expected to develop, manufacture and promote competitive and high quality generic drugs, DRL had earlier said.

 


“Japan has a lot of barriers in terms of what you can do in that market. I see at the top is quality standards. In terms of manufacturing, besides Japan, there are a lot of restrictions in the minds of patients and doctors and in the minds of regulators,” Reddy said when asked about entering the Japanese market. “Even Fujifilm...at that time, we looked at different options. It did not work. We are now back on the drawing board. We do not know. Options are open (for taking a local partner in Japan),” Reddy further informed.

 


According to IMS health, in Japan, the key variable driving different scenarios is the successful establishment of an effective generic market, driven by the Japanese Ministry of Health, Labour and Wealth’s goal of increasing generic volume as a percentage of generic and listed drugs to 60 per cent by 2018. “By taking on this challenge, Japan aims to achieve a more rapid increase in generic utilization levels than what has previously been achieved in any country,” the IMS report said. According to market reports, Japanese healthcare market is estimated to be $90-120 billion by 2017.

 


Orbit Designs Flexible Travel Package for Interpack 2014


MUMBAI: Orbit Corporate & Leisure Travels (India), a Mumbai-based premier trade fairs tour operator, has thoughtfully designed highly flexible travel packages for Indian exhibitors and visitors keen on attending “Interpack 2014”. The travel package include the following: choice of exhibitors & visitors package to choose from; options for independent travelers; flexibility to fly as per choice of airline from any chosen city; enjoy breakfast & Indian dinner in the comfort of the hotel; daily exhibition venue transfers; service of friendly & experienced tour managers; and opportunity to extend tour to breathtaking Switzerland, Amsterdam, Paris & East Europe after the trade fair.

 


Commented Orbit in a press release, “The company is bracing itself to meet the challenges of leading the largest Indian delegation to the most happening event for processes and packaging.” Added the statement, “Industry professionals and end-users in India ought to plan their business visit to Interpack 2014. They can gain maximum advantage from the event by availing the expertise of Orbit.”
Interpack, the ultimate destination for the world’s best processes and packaging technology, is staged every three years at the Düsseldorf fairgrounds in Germany. As the world’s no. 1 packaging event, more than 2,700 exhibitors from all over the world will present the latest in packaging systems and machinery along with accompanying services from May 8-14, 2014. Over 166,000 visitors from around the globe will find solutions in 19 exhibition halls covering an area of nearly 2 million net square feet. “Visitors will get an entire encyclopedia of innovative solutions to contemporary packaging challenges across diverse segments, and opportunities to forge new contacts in this sector – something that’s unmatched by any other event,” informed Orbit in the statement (for more information, contact Ms Laju Jariwala at +91-22-2410 2801 to 2803, Email: btmktg@orbit-star.com).

 


Ranbaxy Declares Research Awards for 2012


GURGAON: Ranbaxy Science Foundation (RSF), a non-profit organization set-up by Ranbaxy Laboratories, has announced Ranbaxy Research Awards for the year 2012 for excellence in original research work in medical and pharmaceutical sciences. The Foundation also announced the annual science scholar awards for the young and brilliant new generation of scientists. The awards were given to five scientists and five science scholars.

 


The Awards were presented by internationally acclaimed scientist, Prof Pierre Alain Clavien, Chairman, Department of Surgery, University Hospital, Zurich, Switzerland, at a function held on March 22, 2014, at the auditorium of National Institute of Immunology, New Delhi. Dr Tsutomu Une, Chairman of Ranbaxy Laboratories; and Padma Shri Dr Nityanand, Chairman of RSF also graced the occasion.

 


The five scientists’ awardees were as follows:

 

Medical Sciences – Basic Research: Prof Umesh Varshney, Department of Microbiology and Cell Biology, Indian Institute of Science (IISc), Bangalore, received the award for his pioneering discoveries in the areas of protein synthesis and DNA repair using Escherichia coli and mycobacteria as model organisms.

 

Medical Sciences – Medical Research: The award was jointly shared by Prof Kanjaksha Ghosh, Director, National Institute of Immunohaematology, Mumbai; and Prof Saumitra Das, Department of Microbiology & Cell Biology, IISc, Bangalore. Prof Ghosh received the award for his significant contribution in understanding and economic management of congenital bleeding disorders. Prof Das received the award for his outstanding contribution towards developing novel antiviral agents against Hepatitis-C virus.

 

Medical Sciences – Clinical Research: Parmjeet Randhawa, Professor of Pathology, Division of Transplant Pathology, University of Pittsburgh, USA for recognizing BK virus nephropathy masquerading as rejection in the era of modern immunosuppression. BK virus Polymerase Chain Reaction (PCR) initially developed for research is now a routine diagnostic and screening tool.

 

Pharmaceutical Sciences: Prof Sandeep Verma, Shri Deva Raj Chair Professor, Department of Chemistry, Indian Institute of Technology, Uttar Pradesh for outstanding contribution in creating novel, self-assembling peptide scaffolds to mimic aggregation of amyloidogenic proteins and for using them as screens to discover inhibitors of these processes.

 


The five science scholar awards were given as follows: In the field of Bio-Medical Sciences, the awards were given to Kumar Somyajit, Senior Research Fellow, Department of Biochemistry, IISc, Bangalore; Ms Priyanka P. Trivedi, Ph.D. Scholar, Facility for Risk Assessment & Intervention Studies, Department of Pharmacology and Toxicology, NIPER, Punjab; and Ms Pushpa Mishra, Senior Research Fellow, Department of Chemistry, Tata Institute of Fundamental Research, Mumbai. In the field of Pharmaceutical Sciences, the awards were given to Ms Priyanka Shreekrishna Gokhale, PhD Student, Department of Infectious Diseases Biology, National Institute for Research in Reproductive Health, Mumbai; and Chetan Prakash Yewale, Senior Research Fellow, Pharmacy Department, Faculty of Technology and Engineering, Maharaja Sayajirao University of Baroda, Vadodara, Gujarat.

 


Earlier during the day, RSF organized its 20th annual symposium on “Regenerative Medicine – Current and Future Perspectives” in association with the Institute of Liver and Biliary Sciences, New Delhi. The inaugural address was delivered by the chief guest, Dr R. Chidambaram, Principal Scientific Adviser to the Government of India; followed by Prof Pierre Alain Clavien’s keynote address. Eminent scientists from India and abroad participated in the symposium and deliberated on the recent advances in regenerative medicine & stem cell therapy and its recent applications in various disease areas such as kidney disorders, type II diabetes mellitus, neuronal disorder, ocular disorders, liver injury, cardiac disorders, etc.

 


RSF received an overwhelming response when the nominations for Ranbaxy Research Awards opened in May 2013. The nominations were then evaluated by a panel of jury comprising 11 distinguished scientists from all over India.
Symposium on Drug Discovery and Development Organized by Ranbaxy, DSIN and RSC


GURGAON: Daiichi Sankyo India Pharma Pvt. Ltd. (DSIN), Ranbaxy Laboratories and Royal Society of Chemistry (RSC), UK’s professional body for chemical scientists, organized a two-day symposium on “Overcoming the Bottlenecks in Drug Discovery & Development (DDD)” on March 20-21, 2014 at Gurgaon, Haryana. The symposium was attended by over 400 delegates from many countries including India, Japan, USA, UK and Singapore.

 


With an estimated cost of discovering a new molecular entity soaring past US $1 billion and the significant gaps in providing affordable medicines around the world, the conference took on the challenge of productivity improvement in pharmaceutical R&D. During the symposium, leading researchers delivered featured lectures on four key pharmaceutical R&D themes, viz. Biological hit identification, Chemical hit identification, Pharmaceutical research and Chemical hit to lead optimization.

 


The symposium highlighted the recent advances in computational tools for lead optimization and new methodologies for chemical hit / target identification and delivery of medicines. The exhilarating journey from lead optimization to successful commercialization of the Daiichi Sankyo’s recently-approved drug Edoxaban was shared as a case study. A poster session and student poster competition was also held during the symposium. The poster entries were judged by an international panel and selected posters were invited for flash oral presentations during the conference.

 


On the occasion, Dr Tsutomu Une, Chairman of Ranbaxy Laboratories said, “It is a wonderful experience to see academic, industry and government leaders from all over the world converge to share recent advances in DDD. It has further cemented India’s position as an R&D hub for the pharma industry; while more substantial collaboration among Government, academia and industry is required in India upon the global network.” Dr Takahide Nishi, CEO of DSIN commented, “It is a great joy for those of us who cooperated in convening this conference to provide so many people with insights into the challenges facing modern DDD." On the sidelines of the event, he stated, "The whole event was a stimulating experience and I believe everyone profited from the lively exchange of opinions and ideas.”

 


Dr Alejandra Palermo, Open Innovation Manager at RSC said, “This is the first such event that RSC has delivered with industry partners in India and demonstrates our commitment to supporting healthcare research and to developing even stronger & more successful international networks to help chemical scientists across the world to share best ideas.” He added, “As part of the conference, we are also hosting an Open Forum discussion to address how open science can spark innovation in the area of neglected diseases. This session will help shape how we expand our open science activities into other areas of healthcare research in collaboration with key partners.” Finally, he informed, “This follows two successful events that were run from Hyderabad in collaboration with Indian Institute of Chemical Technology (IICT) and a memorandum of understanding with Council for Scientific & Industrial Research (CSIR) Open Source Drug Discovery to work in the area of DDD.”

 


Among the leading speakers during the two day conference were Abdul Basit, University College London, UK; Ian Collins, The Institute of Cancer Research, UK; Ben Davis, Vernalis, UK; Gautam Desiraju, Indian Institute of Science, India; Ulrike Eggert, King’s College London, UK; Paul Gleeson, Kasetsart University, Thailand; Anne Hersey, EMBL-European Bioinformatics Institute, UK; Andrew Leach, Liverpool John Moores University / MedChemica Ltd, UK; Masatoshi Nagamochi, Daiichi Sankyo, Japan; William Pennie, Pfizer, US; Ashok Prasad, Delhi University, India; Kunal Roy, Jadavpur University, India; Narahari Sastry, CSIR-IICT, India; Ravi Shanker, Pfizer, US; and Fumiaki Yokokawa, Novartis Institute for Tropical Diseases, Singapore.

 


DSIN is working in the field of innovative pharma R&D in India since it was established in 2007. DSIN aims to create first-in-class and best-in-class drugs which meet medical needs of the patients around the world. RSC is the world’s leading chemistry community and advancing excellence in chemical sciences. With 49,000 members and a worldwide knowledge business that spans the globe, RSC is a not-for-profit organization with 170 years of history and an international vision for the future.


Ranbaxy and APICON Break the Guinness World Records Title for the Largest Vegetable Mosaic


LUDHIANA: Ranbaxy Laboratories along with APICON 2014, the 69th annual conference of Association of Physicians of India, have broken the ‘Guinness World Records’ title with more than 1,000 participants, comprising doctors and Ranbaxy employees, to create the “Largest Vegetable Mosaic”, made in the shape of a heart, beating the existing record set by Japan. The event was held on February 21, 2014 at APICON 2014 in Ludhiana, Punjab.

 


The seven layered vegetable-based heart sign, measuring 5,165 sq. ft., promoting food for healthy heart, was made using approximately 19,825 kg of vegetables comprising cabbage, brinjal, cauliflower, zucchini, carrot, cucumber, garlic, red capsicum and red chillies. Ranbaxy achieved the World Record title by clocking it in approximately 10 hours. The previous record for the largest vegetable mosaic measured 402 sq. m. (4,327 sq. ft. and 10 sq. in.) and was achieved in Japan. “By breaking this record, APICON and Ranbaxy have now brought this title to India,” said Ranbaxy in a press release.


On achieving the milestone, Jack Brockbank, Guinness World Records Adjudicator, said, “It’s always exciting to witness a successful attempt to break a Guinness World Records title, especially when it’s for a good cause. We are pleased to present APICON Ludhiana 2014 and Ranbaxy with the new title for the largest vegetable mosaic.” Adhering to Guinness World Records guidelines, the mosaic was made entirely of vegetables with their stalks and roots removed. Further, no dyes were used. After the event, the vegetables were distributed to charity homes and Gurudwaras, thereby contributing to a noble purpose.

 


Rajeev Sibal, Vice President & Head-India Region, Ranbaxy, on the occasion, remarked, “A healthy diet is a major factor in reducing the risk of heart disease. Vegetables are an essential part of a healthy diet. At Ranbaxy, we are committed to supporting and creating awareness on a healthy lifestyle. The underlying thought behind healthy heart mosaic is in tandem with that commitment.”

 


Receiving the award on behalf of APICON Ludhiana 2014, Prof (Dr) Gurpreet S. Wander, Secretary, Organizing Committee, APICON 2014 said, “The role of diet in increasing prevalence of non-communicable diseases like heart attack, diabetes and hypertension is well recognized. Inspite of this, the young population of our country is attracted more towards fast food, which is high in fat and salt content. The Indian diet consisting of vegetables protects us from these diseases.” He added, “The vegetable heart mosaic will create awareness among public emphasizing the health benefits of eating vegetables in plenty. These are low in calories, very low in fat content and if prepared with less oil are the best forms of diet. Various studies have shown that individuals consuming vegetables in plenty have fewer heart attacks. We need to adopt a healthy lifestyle since the prevalence of Coronary Artery Disease (CAD) is one of the highest among South Asians. The prevalence of CAD in urban population is 10-11 per cent while in rural population is 4-5 per cent.”


APICON 2014 was hosted in Punjab after a long gap of 50 years and was attended by around 6,500 doctors. The theme of the four day conference was ‘Generating Indian Evidence’ and the programme included 360 guest lectures, workshops, panel discussions, debates and orations by national and international faculty. Around 850 original research papers were presented orally / in poster presentation and the topics included non-communicable diseases like diabetes, hypertension, coronary heart disease, brain stroke and cancer.


USFDA Issues Import Alert on Sun and Warning Letter to Canton


NEW DELHI: The US Food and Drug Administration (FDA) has issued an import alert on Sun Pharmaceutical Industries plant at Karkhadi in Gujarat. The import alert was imposed after FDA’s inspection of the plant during their audit in November 2013, where they found some non-compliance of current Good Manufacturing Practice (cGMP) regulations. The report, which made 11 observations on deviations from US prescribed quality standards, mentioned multiple torn documents & partially destroyed raw data showing undesirable results and that the toilet for manufacturing operators at the Gujarat-based facility in “total disrepair” and lists concerns about poor housekeeping. The plant, which manufactures the antibiotic Cephalosporin bulk and formulations, accounts for less than 1 per cent of the company’s sales.

 


In a statement, Sun Pharma said, “We have sent our response to the FDA and given that the facility now has an import alert, it’s clear that the FDA does not agree with our view.” Added the statement, “The company remains fully committed to compliance and has already initiated several corrective steps to address the observations made by the FDA.”

 


Sun Pharma has 12 FDA facilities, with six in the US, three in India and one in Canada, Israel and Hungary, respectively. Thus, the company has a well diversified manufacturing infrastructure to cater to the US markets, which contributed around 54 per cent of its sales in 2012-13. Also, its subsidiaries of the likes of Taro, Caraco and the recent acquisitions contribute a major chunk of the sales and growth.

 


In another development, the FDA has issued a warning letter to Canton Laboratories, manufacturer of fine chemicals and bulk drugs, for violations of cGMP. The FDA, during its inspection of Canton’s manufacturing facility at Vadodara in Gujarat from April 1-9, 2013, identified significant deviations from cGMP for the manufacture of active pharmaceutical ingredients (APIs). Following this, the regulator issued a warning letter at the end of February 2014 to Canton Labs.

 

FDA raised questions ranging from issues identified in laboratory testing of APIs, inadequate maintenance of data from tests conducted, serious documentation practices, results for tests it never performed to measure micro-organisms in APIs and unsatisfactory cleanliness of equipment so as to prevent contamination. The regulator has now told the company to provide specific steps taken to correct and prevent the recurrence of deviations with supporting documentation.

 

 

 

 

 

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