For Western companies and CROs, India is an increasingly attractive destination for conducting clinical trials. Costs are low, clinical infrastructure in urban areas is becoming more advanced, and many local project managers are trained in international GCP standards. Moreover, the rise of the Indian middle class and changes in lifestyle mean conditions such as diabetes and cardiovascular disease are more common.
In the past, weak intellectual property protection and lack of regulatory clarity complicated the clinical trial process in India. However, in the past few years, India’s Central Drugs Standard Control Organization (CDSCO) has taken steps to address these issues.
For example, CDSCO has tried to harmonize India’s clinical trial regulatory process with international clinical trial standards, formalized clinical trial inspection procedures, established a national clinical trial registry, and introduced a separate regulatory pathway for imports of small quantities of drugs for clinical trial use.
These changes show CDSCO’s commitment to improving clarity and streamlining the clinical trial regulatory process.