The full version of this outsourcing feature can be read in the September issue of our digital magazine: http://www.pharmtech.com/ptedigital0910
Marcel Velterop
|
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 (TRIPS). 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 have 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. 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.
The breadth of outsourced services offered in India has 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.
Impact of the shift in global trends
Digital bites
|
Moving forward we expect the wider pharmaceutical market to continue to be faced with pricing pressures, the need for enhanced
innovation and also adapting to the requirements of the emerging markets. These factors will require relationships to develop
and business models to shift from being transactional and more toward strategic partnerships. Global pharmaceutical companies
will identify outsourcing partners that provide integrated supply solutions across the pharmaceutical development cycle and
also the value chain. These developing strategic partnerships will also force the Indian based CMOs and CROs to develop their
their EH&S and cGMP credentials to ensure sustainably, and it will be those companies with the highest standards in these
areas that will succeed.
The rapid growth in the number of CMOs and CROs seen over the last 10 years is, however, unlikely to be sustained in the future.
Pharmaceutical companies are already rationalising their supply bases and reducing the number of companies they partner with.
This trend will continue and make market entry all the more difficult as the sector in India matures.
It is highly likely with the developing infrastructure that India will also see further expansion as a centre for discovery
services to include clinical trials. This could ultimately lead to the development of India as a region for pharmaceutical
innovation. These trends would also be supported with its increasing relevance as an emerging market.
Global expansion
There are a number of reasons why it is desirable to have a global presence. One of the main drivers is recognition that in
order to become a strategic outsourcing partner a company must have capabilities fully aligned with customers' needs.
Although Dr Reddy's origins are in India, it was recognised that there were R&D, technical and engineering capabilities that
could be best accessed by expanding the global reach of the company. Furthermore by having a significant presence in Europe
and North America we can be closer to our customers, both for daytoday communications, but also should there be a specific
need for our customers to have outsourced manufacturing capacity available locally.
Ultimately it is all to do with customer alignment and ambition. Niche players can probably operate effectively being exclusively
based in India; however, for providers to global organisations with complex needs, this type of relationship does not lend
itself well to a very regionalised business and I believe a global presence is necessary to effectively meet global customer
requirements.
