The future of clinical research in India continues to be a matter of speculation. While on the one hand there are  predictions that India will be the next hotspot for clinical trials (e.g. Ficci, Ernst & Young Report 2009; Frost & Sullivan Study 2010; McKinsey Report 2007) , on the other , industry forums speak of ongoing challenges and stagnant growth for a variety of reasons, such as regulatory delays in approval, escalating costs, inconsistent quality, ethical irregularities etc. While several CROs have started operations in India basing their future on the rosy predictions, it is also true that existing players are struggling to grow or even sustain their current business.

Since registration of clinical trials in CTRI was made mandatory from mid-2009 onwards, close to 1800 trials have been registered in this database. Of these, about 69 per cent  are sponsored by the pharmaceutical industry (both multinational and Indian companies), the rest being funded by grants from various government and not-for-profit institutions (e.g. DBT, CSIR, AIIMS, ICMR, Ministry of Defence, WHO, NIH, etc.).

Multinational pharma companies, who conduct over 90 per cent  of the industry-sponsored studies, use Indian sites mostly as a part of their global studies, while Indian pharma companies primarily conduct studies here for local registration only. A large chunk (about 64 per cent) of the industry-sponsored trials is conducted by the pharma companies directly, while the remaining is outsourced to various global and local CROs in approximately equal proportions. Given that there are at least 40-50 Indian CROs who offer clinical trial services, this amounts to an average of only about five to six  studies per CRO over the last two years! Shocking, but this is indeed the reality of the contract clinical trial business in India today.

Now before we write- off  the local CROs, let us take a step back and look at the generic pharma industry in India. Over the last 15 years, Indian pharma companies together with Indian CROs specializing in BA/BE studies have grown steadily to make India a dominant player in the generic business today accounting for the second largest number of ANDA filings in the world. In fact, CROs who conduct both healthy volunteer studies (for generic research) and clinical or patient studies (for ethical research) have a significantly larger portion of their business coming from offering services to the generic industry.

So what could be the reason for this apparent inability of CROs to get a strong foothold in the clinical trial business while they flourish or even rule the BA/BE space? A host of them actually, ranging from the market size of patented drugs relative to generic drugs in the country, regulatory restrictions for conducting studies in Indian patients when the drug is not intended to be marketed in India, wider acceptability of Indian data by western regulators for ANDA or 505(b)(2) submissions than for NDA submissions, etc., thus leading to slower development of the clinical trial infrastructure and expertise in the country.  All of this makes it less attractive to conduct clinical trials here as compared to BA/BE studies. Coupled with this is the fact that today big pharma companies are also gradually entering the generic business due to impending patent expiration on blockbuster drugs, declining R&D productivity, pressure from governments to curb healthcare costs, etc. Many are doing so by forming strategic ties with Indian generic companies, further enhancing the business opportunity in generic drug development in the country.

This leads to the question: can Indian CROs look for opportunities to conduct clinical studies within the generic space? Fortunately, the answer is ‘yes’. For drugs that are not absorbed in the GI tract, plasma concentrations are not useful to determine delivery of the drug to the site of activity, and hence bioequivalence of the generic product to the innovator cannot be established by BA/BE studies.  In such cases, one needs to demonstrate therapeutic equivalence with clinical or pharmacodynamic studies. Drugs in dermatology, ophthalmology, respiratory diseases, immunosuppressive agents, vaccines and biological products fall under this category.

When drugs for conditions such as neurological and psychiatric disorders, cancers and auto-immune diseases are given to healthy volunteers, significant adverse events may occur at doses that are well-tolerated in patients. To demonstrate bioequivalence for such drugs, it is often required to conduct the PK studies in patients rather than healthy volunteers, for better tolerability and so that the bioavailability findings can provide direct relevance to therapeutic effect. Such studies need to be conducted in hospital settings and involve similar considerations and complexities as clinical trials.

These are just a couple of emerging opportunities that CROs in India could take advantage of to enhance their growth prospects. Several others exist, such as studies for special populations, fixed-dose combinations, new indications for old drugs, orphan indications for marketed drugs, biosimilars or biobetters, nutraceuticals etc. Thus while clinical research in India may continue to face hurdles, CROs building expertise in such niche areas will enjoy a brighter future.