Currently, India is one of the top countries where clinical research companies are planning to invest over the next 5-6 years. The Indian government had also proposed a 10-year Tax Holiday on R&D investments – a move to attract more Global Sponsors from the Clinical Research Industry. India has also become the favoured destination ahead of other competing countries like Israel, Philippines, Canada, China, Ireland & Russia in terms of Overall Climate (Gartner Report, January 2003). The Indian sub-continent is also a powerhouse in research and development boasting of over 80 experienced CROs offering services from Phase I to IV trials. With 4,216 hospitals and rapidly increasing stand-alone investigators serving at sites for clinical trials, India is emerging as one of the fastest recruiters of subjects across the world. The large patient pool is also a significant contributor towards achieving these milestones. A new set of rules in place since 2019 is beginning to make India the favourite among the big pharma giants to conduct clinical trials in India. India ranks among top five destinations for clinical trial sites and numerous big global studies are now being carried out in India – especially post the Covid pandemic. In 2021, India approved over 100 global clinical trials, this being the highest number since 2013. India has also enacted the New Drugs and Clinical Trials (NDCT) rules in March 2019 wherein a lot of accommodation is being provided to enrich the clinical research activities in the country. One of the prime reasons for global attraction is quality services at reduced costs. India is still 60% cheaper than the U.S. when it comes to conducting end-to-end clinical trials. India also has numerous world class hospitals as trial sites: 1,762 sites and counting. Also, it is equipped with about 4000+ ICH-GCP trained investigators. Being the second largest populated country in the world, India boasts of a large pool of treatment naïve patients from multi-ethnic and multiracial backgrounds – something unique to our country. Participants generally benefit (as the trials conducted in India, mostly in phase II – IV, provide improved care and cost savings as procedures and drugs are provided free of cost to the patients). This also helps in better patient recruitment, patient retention and patient compliance to the Protocol. Hence the highlights of the Indian scenario can be summarized as per the below sections:

• Cost effective operations – India offers significant cost savings which is a prime determining factor that attracts Sponsors from the leading countries.
• Higher GMP / GLP / GCP Compliance. India has the most number of approved GMP-plants outside the USA. India is getting better by the day!
• Excellent Quality Management, Technology and Infrastructure. Global standards are being set as working standards.
• Increasing presence of all Pharma majors, CROs & also in-house CROs set up by leading Pharma companies. India is the growing hub.
• Strong IT industry availability of IT skilled manpower. This is another key factor that attracts global sponsors to consider India as their best bet.
• Positive Regulatory Environment – Protocols Approved by DCGI / Schedule Y in reasonable time frame and is getting better.

The Indian Government is also making registration of CROs mandatory along with registration of clinical trials. This is a smart-move to bring in greater compliance and quality standards. The CDSCO (Central Drugs Standard Control Organization) regulates the Clinical Research industry in greater detail to ensure compliance with guidelines and regulations. There has been further strengthening of the clinical research environment by setting up the National Drug Authority that has an effective management module. Another vital factor is the current intellectual property protection rights – India recognizes both the process and the product patents. This is very encouraging towards innovations and improved healthcare. The government is also mulling complete duty-free import of clinical trial supplies. The Drug Importation Procedure has been simplified as a way to encourage clinical trials. The ICMR (Indian Council of Medical Research) – Guidelines on the Safety of Human Subjects ensures that the IECs approving the study at the site-level is comprised of an equal distribution of medical/scientific and non-medical people from the lay-community so that all aspects of safety are considered prior to granting approval. This is just the beginning. India is climbing the ladder of being a global leader in the Clinical Research Industry rather swiftly. The Covid-pandemic has only elevated its position and has also led to multiple innovators doing their bit in making healthcare more effective, affordable and tech-savvy to cater to the huge patient population of India.