The global pharmaceutical industry has continued to evolve over the last few years into different permutations aimed at maximizing research and development (RD) capabilities while minimizing the overall costs associated with the discovery, development, and launching of new drugs.
The environment that has grown from this process has lead to the emergence of an innovative new approach to sustaining product development by integrating a global clinical research framework into the traditional RD landscape with the aim of keeping the industry’s momentum toward continued important pharmaceutical developments.
During this period, the pharmaceutical industry in India has devoted a great deal of focused attention on bringing the subcontinent’s RD infrastructure up to the standards expected by the world’s major enterprises. These efforts have led to over 70 FDA approved US pharmaceutical firms establishing facilities in India, where they now conduct ongoing RD toward finding unique investigational new drugs (IND).
The Evolution of Pharmaceuticals in India
While thepharmaceutical industry in Indiahas advanced in response to this new focus to become the world’s third largest, the fact remains that there are actually a fairly low number of Indian-owned pharmaceutical companies. The lion’s share of these enterprises in India areoperated and controlled as subsidiaries for a wide sampling of the world’s leading foreign companies.
India has developed astrategy to further develop a home grown industry that rests largely on its efforts to build state-of-the-art facilities and infrastructure, while simultaneously working with global bio-tech educators to revised the university curriculum in order to raise the professional level of pharmaceutical researchers in India.
Added to this is the adoption of attractive direct foreign investment regulations in India, which make it both easy — and potentially lucrative — for companies interested in global clinical research options to seriously include India in their calculations.
The Professional Level
The overwhelming majority of employees involved in the global clinical research aspects of these companies are Indians, freeing foreign enterprises from having to relocate staff to these facilities. The level of committed professionalism instilled by parent enterprises is consistently maintained. As early as 2005, the FDA was already receiving 20% of all submitted ANDAs from Indian based RD.
Foreign firms are able to take advantage of innovative local sourcing ideas derived from knowledge of traditional medicinal systems, as well as associations with local universities, bio-tech institutes, with a wide array of pharmaceutical expertise.
Integrating India as a global clinical research component into your pharmaceutical company’s strategic growth plan offers the opportunity to provide a quality solution that can meet any expectation of a clinical research process — from initial planning all the way through to clinical RD. And each element of this process can be achieved at considerably reduced costs. Our experiences on the ground in India can provide you with valuable guidance.
The bottom line is that incorporating a presence in India into a systematic expansion of global clinical research presents a forward thinking pharmaceutical enterprise with a real opportunity to reap a considerablereturn on their investment.
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com
Claire WyntersThu, 15 Nov 2012 15:46:00 GMT