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INTRODUCTION

Fritz Hoffmann was the founder of F. Hoffmann-La Roche & Co. on 1st October 1896 in Switzerland. Shortly, after the foundation of the Company, offices and manufacturing sites of Roche were opened in several other countries. Headquartered in Basel, Switzerland, Roche is one of the world's leading research - oriented healthcare groups in the fields of pharmaceuticals and diagnostics. Roche's innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people's well being and quality of life. Since then Roche has grown into one of the leading healthcare companies in the world.

ROCHE PRESENCE IN INDIA

In November 1957, F. Hoffmann-La Roche Ltd. (FHLR), Basle, finalised negotiations with the Government of India for the local manufacture of synthetic Vitamin A and pharmaceutical specialties in line with the Indian Government's policy of industrialisation.

The activities of Roche in India commenced with the import of finished pharmaceutical products and bulk vitamins by Volkart Brothers and subsequently by Voltas Ltd. Later the manufacture of two pharmaceutical specialties -SARIDON® and SIROLIN® commenced after an Indian Roche entity was incorporated on 1st April, 1958.

After its presence in India for more than three decades, in November 1993, FHLR entered into Agreements with Nicholas Piramal India Ltd. (NPIL) after which some products of Roche were to be distributed in India by NPIL for a specified period of time and certain brands of Roche like SARIDON®, BACTRIM®, SUPRADYN® LIBRAX®, LIBRIUM®, PROSTIGMIN®, VALIUM®, AROVIT®, BECOZYM®, BENADON®, EPYHNAL® (under toll manufacture), REDOXON® (Qsolv.Tab Chew), ROVIGON® (Chew Drag), VITAMINETS® (Forte Drag) and AIROL® Cream (under toll manufacture) were licensed to NPIL for manufacturing. In addition to these drugs certain other products like ROCALTROL®, RIVOTRIL®, SYNTARIS®, LARIAM® and MADECASSOL® were also licensed to NPIL for manufacturing for a specified period of time.

In 1997, consequent to Roche acquiring Bohereinger Manheim (BM) the following products have been deemed to be licensed in perpetuity by Roche to NPIL in India viz. BEZALIP®, CALCILUVIN®, DISPEPTAL®, EUGLUCON®, ISMO, MITTAVIN®, PARAXIN®, and SEMBRINA®.

After a contractual relationship of 10 years with NPIL, it was decided by FHLR to end the Frame Co-operation Agreement with NPIL in November 2003. This means that NPIL does not have access to any new ROCHE Pharma products for distribution post November 2003. But, if any locally formulated product is to be launched by Roche after November, 2003, NPIL is to be given the first opportunity subject to Roche requirements of technical standards being met by NPIL and also if NPIL has no product which competes with the Roche product offered. However, pre-1993 Roche products licensed to NPIL may continue to remain with NPIL for a specified period of time.

In November 2003, the distribution rights of NPIL ceased in respect of Roche's strong biotech range- CellCept®, Zenapax®, Cymevene®, Mabthera®, Xeloda®, Herceptin®.

Effective 4th November, 2003, FHLR has appointed a new distributor in India viz. Taksal Pharma Pvt. Ltd. (Taksal) for distribution of FHLR products in India. Taksal presently has distribution rights in India for products such as CellCept®, Zenapax®, Cymevene®, Mabthera®, Xeloda®, Herceptin®, Pegasys®, Fortovase®. In addition, Taksal currently has distribution rights for Recormon®, Neupogen®, Roferon®, Vesanoid®.



ROCHE SCIENTIFIC COMPANY (INDIA) PVT. LTD.

On 5th April, 1994, ROCHE SCIENTIFIC COMPANY (INDIA) PVT. LTD. (RSCIPL) was incorporated in India as a wholly owned subsidiary of Roche Group mainly to :-

  • ensure registrations of new products and obtain amendments to registrations.

  • initiate and monitor clinical trials with new chemical entities for generation of data for international use and for registration with Drug Controller General of India.

  • monitor and ensure adherence of International Federation of Pharmaceutical Manufacturers' Association (IFPMA) guidelines in respect of F. Hoffmann - La Roche products.

  • sponsor R & D projects for process developments for new bulk drugs in India.

  • provide support in conducting programmes for continuous Medical Education, assist in protocol studies, hands on experience with new therapies in new therapy management and dissemination of updated scientific and technical information in fields of Oncology, Virology, and Nephrology.

Roche in Transplantation

Roche is strongly committed to improving a long – term outcome of transplantation and enhancing the quality of life of transplant recipients. Roche has developed three innovative therapies that improve graft and post – transplant health; Cellcept is the cornerstone of low toxicity immunosuppressant therapies. Cellcept is the largest selling branded immunosuppressive in North America, offers both physicians and patients the possibility of an effective long term immunosuppressive regimen with low toxicity, Zenapax prevents the acute rejection of the newly transplanted organ, and Cymevene/Cytovene/Valcyte has been developed for the prevention and treatment of cytomegalovirus, a dangerous viral infection associated with transplantation. Recently, Roche have announced a co-development agreement with Isotechnika for their new medicine, ISA TX  247, a potentially more potent and less toxic calcineurin inhibitor.

For further information please visit our website at:-
www.rochetransplantation.com

 

Roche in Oncology

Roche has developed and introduced a number of targeted novel medicines to treat different forms of cancer, providing longer survival and new treatment options for cancer patients worldwide.

Roche is at the forefront of oncology research with major advances in early diagnosis and better - targeted drugs.

With their advanced mechanisms of action, these drugs represent much needed progress in fighting cancer.

 

Non-Hodgkin's Lymphoma

Please visit the www.lymphoma-net.org

 

Breast cancer and its treatment

Please visit the www.xeloda.com

www.oralchemo.org

 

Roche in Hepatitis

Chronic forms of viral hepatitis which result in inflammation of the liver occur throughout the world.
The main pathogens are hepatitis B and C viruses. Every year the number of people newly infected with hepatitis C increases by 3-4 million worldwide adding to the 170 million people already infected.
In India alone, it is estimated that 18.5 million people have chronic hepatitis C.
As there is no vaccine against the chronically progressing hepatitis C which leads to cirrhosis (scarring) of the liver, liver failure or liver cancer, it is very important that drugs are available to treat the disease. The first interferon introduced by Roche to treat hepatitis C was
Roferon ®-A (Interferon alfa-2a) which in combination with Ribavirin has been shown to increase the response rate to therapy. One of the newest advances in this disease area is Pegasys ® (Pegylated Interferon-alfa 2a) which shows an excellent response to therapy especially when combined with
Ribavirin . Due to the commitment of Roche to the treatment of Hepatitis C, there has been a strong collaboration between the pharmaceutical and diagnostics divisions resulting in new diagnostic tests using PCR technology for detecting and monitoring the disease. This helps to facilitate targeted drug treatment and optimal monitoring of the patient's progress.

With regard to hepatitis B, more than 2 billion people worldwide have been infected by this virus and approximately 350 million people have chronic hepatitis B. In India , approximately 4 million people are infected.
Trials with Pegasys ® (Pegylated Interferon alfa-2a) have confirmed that this molecule is superior to the standard medicines currently prescribed for this disease.

 

Roche in HIV

Roche is at the foremost of efforts to combat HIV infection and AIDS, committed since 1986 to groundbreaking research and development of innovative new drugs and diagnostic technology. Saquinavir with ritonavir (1000/100 mg twice daily) has shown encouraging results in the MaxCmin 1 trial with high efficacy and an excellent safety and tolerability profile. Saquinavir/r was approved in the EU in August 2002. Viracept (nelfinavir), another PI is supplied by Roche outside the US and Canada. In first- line HIV therapy, Viracept delivers consistent long-term efficacy and safety. When used first line, Viracept also allows the subsequent use of both NNRTIs and other PIs for most patients due to its unique resistance pattern.

The viral load measurements in the clinical trials for Fuzeon were performed using the AMPLICOR HIV-1 MONITOR version 1.5 assay. This test from Roche Diagnostics is considered to be a highly sensitive measurement of the amount of HIV circulating in a patients blood ("viral load"). With a limited number of treatment regimens available, the accurate monitoring of viral load levels is essential to establish and monitor the effectiveness of therapeutic regimens and assess the potential onset of drug resistance. Roche is a committed partner of the Accelerating Access Initiative to increase to HIV care in sub-Saharan Africa and the world's Least Developed Countries. For more information on Roche Policy and pricing of HIV therapies- including a paediatric formulation- for these regions and research in HIV, 

Please visit the Roche HIV website.