India's Future as a Biologics Manufacturing Hub - Collaborations between Western and Indian companies may provide the best path for offshoring successfully and for developing India's readiness. - BioP

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India's Future as a Biologics Manufacturing Hub
Collaborations between Western and Indian companies may provide the best path for offshoring successfully and for developing India's readiness.


BioPharm International
Volume 23, Issue 3

INDIA'S BIOTECH FUTURE

Despite the success of some of these international collaborations, however, India's biotech sector has not yet reached its potential, and Indian CMOs have not yet acquired significant quantities of foreign biologics manufacturing contracts. Collaborations have been limited by the concerns of Western companies regarding both quality and IP protection, as mentioned above.

Therefore, India's continued success in competing with other emerging countries, such as China, will depend on the country's ability to address the concerns of Western biopharmaceutical companies. The Indian government must better ensure that regulations to improve quality control and regulatory oversight are enforced, and that training programs for both biologics regulatory approval and manufacturing practices are improved.

Western companies who choose to work in India, meanwhile, must make a conscious effort to address India's regional cultural and linguistic differences by incorporating professional translation and interpreting services into their business strategies, and help to provide specific training in the areas in which India is lacking.

Greater collaboration between Western and Indian companies means fostering an unprecedented level of partnership between the two. However, the result—new quality products that are available to more people for less—may be worth the effort.

Karen Politis Virk is the director of biopharmaceutical and pharmaceutical research at Language Connections, Brighton, MA, 617.731.3510,

REFERENCES

1. Harachand S. Strategic Boost for CMOs. Contract Pharma. 2009 Sept. Available from: http://www.contractpharma.com/articles/2009/09/india-report

2. Pickup Z, Whitworth A. Biogenerics: A move towards regulation of the unknown. Bio-science Law Rev. 2003/2004; 6(4):139–41.

3. Martino M. Lonza invests 150M in Hyberabad. Fierce Biotech. 2009 May 22. Available from: http://www.fiercebiotech.com/story/lonza-invests-150m-hyderabad/2009-05-22#ixzz0RO7qwLHH

4. Van Arnum P. Kemwell to Build Biologics Manufacturing Facility with Boehringer Ingelheim in India. Pharm Technol. 2009 June 11. Available from: http://pharmtech.findpharma.com/pharmtech/News/Kemwell-To-Build-Biologics-Manufacturing-Facility-/ArticleStandard/Article/detail/602702

5. Boswell C. Asian contractors aim for growth in biologics. An emerging opportunity. http://ICIS.com/ 2009 Jan 20. Available from: http://www.icis.com/Articles/2009/01/20/9185770/asian-contractors-aim-for-growth-in-biologics.html

6. Frew SE, Rezaie R, Sammut SM, Ray M, Abdallah S, Daar AS, Singer PA. India's health biotech sector at a crossroads. Nature Biotechnol. 2007;25(4):403–17.

7. Dhatta J. India turning capital for counterfeit drugs. The Hindu Business Line. 2 Aug 2003. Available from: http://www.blonnet.com/bline/2003/08/03/stories/2003080301260500.htm


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