Pharmaceutical Technology Europe - September 2010 - (Page 10)

The Indian perspective The turning point for India as a centre for outsourcing came in 2005 with the Patents (Amendment) Act, which brought India into compliance with the WTO agreement on Trade Related Aspects of Intellectual Property Rights. With this new legislation in place, Western pharmaceutical companies were assured that patents on their innovative products would be recognised and this fully opened up the capabilities and capacities of the region for outsourced pharmaceutical services. The following 5 years has seen India evolve from being perceived as predominantly a low cost region to becoming an area with extensive technical capability and high standards of quality and compliance. The breadth of outsourced services offered in India has also increased dramatically, from its origins in raw materials there are now CROs supporting drug discovery, and CMOs scaling up processes and producing materials for clinical trials and intermediates for launched products. More recently large pharmaceutical companies have also begun fully outsourcing API and formulated products for their commercial needs. This expansion of services has been aided by the general economic growth of India, enabled by its welleducated and highly motivated workforce and with English as the business language. Overall, the sector in India has gone from strength to strength and it is now the country with the highest number of FDA approved facilities outside of the USA. It is highly likely with the developing infrastructure that India will see further expansion as a centre for discovery services to include clinical trials and this could ultimately lead to the development of India as a region for pharmaceutical innovation. These trends would also be supported US. So, some of our main challenges today result from our customers’ own restructuring activities and lower overall levels of demand coupled with their low internal asset utilisation. This is frequently driving short-term make-versus-buy decisions, which can present interesting economic challenges to the contract services provider. PTE Marcel Velterop with its increasing relevance as an emerging market. At our company, we no longer consider there to be huge disparities in the geographic-based challenges to outsource partners working for Western and Japanese pharmaceuticals companies. The issues we face today will largely be identical to those of a service provider historically based in Europe or the Based on a contribution by Marcel Velterop, Vice President at Dr Reddy’s Custom Pharmaceutical Services. To read the full version of this article, go to www.pharmtech.com/velterop www.drreddys.com X CONTENTS 1 XXX X THE RIGHT ASIAN PARTNER 9 XXX X XXX CLIMB BACK 3 SLOW 10 XXX X INDIAN PERSPECTIVE X XXX 6 FINANCIAL CRISIS 14 XXX X SUCCESSFUL RELATIONSHIPS X XXX TO COMPETE 7 HOW 16 XXX MORE… X READ http://www.pharmtech.com/velterop http://www.drreddys.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - September 2010

Parmaceutical Technology Europe: September 2010
Contents
Pharmaceutical Technology Europe Poll
Slow Climb Back
The effect of teh Financial Crisis on Outsourcing
How a CMO Can Compete In An Increasingly Competitive Market
How Responsible Should the Sponsor Be For The Outsourcing Provider's Success?
How to Identify the Right Partner in Asia-Pacific
The Indian Perspective
The Challenges of Outsourcing Early Development
The Benefits of Outsourcing Highly Potent API Manufacture
Managing an Outsourced Biologics Project
Successfully Managing CMO - Client Relationships
Making a CRO Project Run Smoothly

Pharmaceutical Technology Europe - September 2010