From a regulatory perspective, a large degree of liberalisation took place with the abolition of industrial licensing, 100 percent foreign direct investment, liberalisation of rules related to foreign technology agreements as well as of the import regime. At the same time, international commitments and standards were sought to be introduced into the regulatory regime through the introduction of product patents, the introduction of Schedule M and Schedule T of The Drugs and Cosmetics Act, 1940. Export promotion was sought to be encouraged by the creation of PHARMEXCIL as well as a draft National Pharmaceuticals Policy, 2006 with the objective of, among other things, positioning India as a preferred global destination for pharmaceutical R&D and manufacturing. The recent creation of a separate Department of Pharmaceuticals is only a manifestation of the importance government of India has accorded to the sector.
India ranks only next to USA with a share of 21 percent of patent challenges. Undeniably India is an emerging leader in pharmaceuticals.
Data for 596 Indian pharmaceuticals companies, whose sales and R&D investment figures are available with CMIE database ‘Prowess’, reveals that a total of 151 companies invested in R&D activities as at the end of June 2008 (Refer Table 12 & chart 12). The total investment in R&D stood at Rs.2,973.2 crores which is 9.9 percent of the sales ofthese 151 companies
The combined total investment (Gross Block) of 561 pharmaceutical companies listed on Bombay Stock Exchange as per the latest company filings available (as at the end of June 2008) stood at Rs.40,461.7 crores (net fixed assets stood atRs.29,325crores). Further, as per Centre for Monitoring Indian Economy (CMIE) database