India’s drug trial industry: regulation and challenges

India is the world’s most favoured destination for pharmaceutical R&D and clinical research. The key reasons are a 100 million-plus English-speaking population, over 2 million science postgraduates, a large pool of treatment-naïve patients from multi-ethnic and multiracial backgrounds, easy patient recruitment, robust IT Industry, 30 million patients with cardiovascular disease, 25 million with type 2 diabetes, 10 million with psychiatric disorders, 2 million cases of cancer with 500,000 cases detected every year, 600,000 practising physicians, 17,000 medical graduates per year, 14,000 hospitals and 700,000 specialty beds.

PricewaterhouseCoopers expects the total market value to rise to about US$50 billion by 2020, and R&D costs are 50% to 75% lower than in the US and EU.

Regulation

The onus is on regulatory bodies to ensure well regulated clinical trials and a healthy supply of quality drugs. Regulations for drug trials in India are being transformed to ensure more transparent and ethical clinical trials conforming to international standards. This is evidenced by the new regulations on compulsory registration of all clinical trials with the Clinical Trials Registry of India and by guidelines for calculating compensation for adverse drug events based on age, income, severity of the disease the person was suffering prior to participation in the trial and the percentage of permanent disability. Also, persons with adverse drug reactions will be treated for as long as required.

Dr Rachna Bharadwaj is an associate at Krishna & Saurastri Associates and an advocate registered with the Bar Council of India.