CLINICAL TRIALS Clinical trials in India are regulated by the Central Drugs Standard Control Organization (CDSCO) and the Drugs and Cosmetics Act, 1940 respectively. Rule 122 DAA of Drugs & Cosmetics Rules, 1945 (“D&C Rules”) defines clinical trials as a “systematic study of new drugs in human subjects to generate data to discover and/or verify clinical outcomes, pharmacological (including pharmacodynamics and pharmacokinetics) and/or adverse effects with the aim of determining the safety and/or efficacy of the new drug”. 500 million dollars and is expected to reach 500 million dollars by 2016. This market is driven by the availability of a huge genetically diverse population with extremely lower costs than developed nations regulations in clinical trials are hurting the prospects of clinical trials in India. Delays and regulatory ambiguity have destroyed innovation and growth in the clinical trials industry. Since the January 2013 amendment, ineffective regulatory oversight, the need for protection of informed consent of vulnerable populations, and guidelines on patient compensation for study-related deaths have materialized as major concerns. Recently, Biocon was forced to move various Indian projects to the US and Europe. This situation only makes the process more cumbersome, but also leads to a 10-20 times increase in the cost of drug development. In the last two years, companies such as Piramal Enterprises and Lupine have also been forced to go abroad to conduct clinical trials, due to slow and uncertain approval processes in India, and the matter has been challenged in court. FDI POLICY If India must... .middle of paper……low compared to acute care but its growth has outperformed that of the market. With the right support from the government and favorable policies, the sector is expected to see good growth in the near future. Small and Medium Enterprises (SMEs) are expected to play a significant role in the growth story of the country's pharmaceutical sector as they contribute 35-40% to the sector in terms of production with a turnover of around Rs 35,000 crore (5, 70 billion dollars). But we have also seen slow growth in the last quarter and this can be attributed to some policy changes. To ensure that the sector continues to grow at a healthy pace, Indian and foreign companies in the sector need to come up with some innovative strategies such as: • Venturing into newer markets • Leveraging new and improved technologies • Portfolio expansion • Portfolio optimization