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Imact of IPR on indian pharma industry

Imact of IPR on indian pharma industry

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Published by: divyenshah3 on Oct 30, 2009
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10/26/2010

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The Indian pharma industry is already on a strong position in word for production. Indiais the 4
th
largest producer by volume and 13
th
by cost in world in pharmaceutical industry.India is having highest USFDA approved plant (75 plants in 2008) for production after USA. The cost of production is very less in India (20
th
times compare to USA). But stillthere is a need of improvement.The policies to make India a strong pharma hub can include1.The quality for the export and domestic market are not kept same. Generally it isknown that the quality of domestic formulation is on a lower side than that of theexport formulation. It can be seen easily by packaging. Thus quality of the product should be equal to that of export.2.Improve the knowledge of IPR. It was well know that before 2005, India has tofight to protect for the ancient use of many medicinal plant as some foreigncountries were claiming the patent of it. Government organizations such as‘PETT” have done good remarks to file patent to individual by funding them for their innovations.The government needs to provide clear guidelines on IPR andresolve issues related to data exclusivity, incremental innovation, etc. This will boost the confidence of MNCs to launch their products in India.3.The investment for the R & D is kept very less. Government has taken good step by giving exception in tax for the companies which invest in R & D.India’s adoption of WTO’s TRIPS in 2005 has accelerated its role in global outsourcing.Many companies like Astra Zeneca have already started outsourcing from India. As big pharma companies like Pfizer, Astra Zeneca, GSK, Novartis, Sanofi-Aventis, J&J,Merck, Roche, etc have started cost reduction aggressively which has created new market potential.Due to India’s potential of producing high quality pharmaceutical product at a low lost,many companies have shifted their focus from pure generics to contract research andmanufacturing. Companies like Dishman pharma, Jubilant Organosys, PiramalHealthcare, Dr. Reddy’s Lab, Divi’s Lab, Shasun Pharma, Suven Life Sciences, Cadialhealth care, Hikal, etc are the key player for CRAMS (Contract Research AndManufacturing Services). Many Indian companies like Dishman (acquisition of carbogenamcisAG, Synprotec- UK), Jubilant (Hollister Stier-US, Clinsys Clinical-US, Cadista pahrma- US), Piramal healthcare (morpeth- UK, Avecia- UK, Torcan-Canada) havemade acquisition which is playing important role in CRAMS.Even process patent known as process re-engineering had played vital role in facilitatingIndian pharma to develop its own skills, due to which India is the cost effective drugmanufacturer.
 
India has a strong talent pool with expertise in chemistry and synthesis skills the mostimportant resource for drug discovery and research activity. Indian Contract researchorganization also adheres to international regulatory and quality standards like ICH, ISO,GLP, GCP, etc which provides confidence to India to emerge as a dominant provider of drug discovery service.India is now one of the best destination to carryout clinical trials because of its low costand accuracy. Many MNC’s set up their own research facility or make outsourcing tolocal Clinical Research organizations (CROs). Many molecules such as vegamox,meremen, lamictal etc’s clinical trial is done in India. India has good infrastructure andmedical set up for conducting these clinical trials at a low cost. India is havingadvantages compare to other countries which includes least expense, highest patientrecruitment rate, moderate industrial trial experience, highest regulatory environment.Revision of schedule Y of drug and cosmetics rule, 1945 in 2005 has provided India agreat depth to carry out clinical trials in phase II and III. India is having highesttransparency and accountability in Asia by creating Clinical Trial Registry- India (CTRI) by Indian council of medical research. India takes average of about 3.5 months for application review for conducting clinical trials which is less compare to China andBrazil. Gov. of India has taken good initiative by exemption of service tax to clinical trialof new drug.Even collaborative work is carried out between MNCs and Indian pharma companies for the generation of NCEs. Companies like Glenmack, Dr. Reddy’s Lab, PiramalHealthcare, Alembic, Suven etc have made collaborative deals for NCE with Forest Lab,Tejin Pharma, Eli Lilly, Merch & Co.Thus Indian pharma is expanding footprints innotonly NCE but also in New Biological Entity Research.India is currently rankedamong the top 12 biotech destinations in the world and is the third biggest in the AsiaPacific in terms of number of biotech companies.Due to high expenditure healthcare market globally, generics are promoted. India hasalready proven that it is top generic supplier. As patent expiry is increasing now days,regulated generic market in India is also increasing. India has achieved a dominant position in terms of ANDA approvals (24.2 % in 2007). Indian pharma industry hasshown good interest in domestic drug market.India giants are challenging patents by filing para IV to get huge benefits by getting 180days of generic market exclusivity. Companies like Lupin, Sun pharma, Ranbaxy and Dr.Reddy’s lab have made such profits by filing para IV.Even it was observed that MNC’s have acquired many Indian Pharma Industry. Itincludes Daiichi Sankyo company Limited (Ranbaxy), Mylan Laboratories Ltd.( Matrixlaboratories), Actavis group (Grandix pharmaceutics). New patent rule may impact on prices of formulation. The prices of formulation canincrease which will not come under DPCO.

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