For over 30 years, India has been conducting global clinical trials. With over 500 sites and over a billion people, India was a key destination for clinical trials for its vast treatment naïve clinical population. However, the environment has fluctuated throughout recent years, as The Central Drugs Standard Control Organization (CDSCO), India’s regulatory agency for clinical research, introduced regulations that has shifted India away and now back again in alignment with global clinical research practices.

The shift away from global clinical research practices have led to an exodus of drug companies and research organisations within India. However, CDSCO’s recent introduction of policies and regulations to reverse this trend is evidently working, based on the stabilization in number of clinical trial applications in India.

India possess extensive experience in international clinical trials and has received strong interest in clinical trials from global pharmas in the recent past; a result of India’s low per-patient trial costs; a large number of well trained, qualified, English speaking professionals, large pool of patients many more. However, several years ago, there were doubts over quality and data authenticity, and raised concerns of regulations in private trials after a series of scandals involving alleged malpractices and patient deaths.

As a result, between 2010 and 2013, there was a significant decrease in number of clinical trials in India; both local and international. Figure 1 conveys a steady incline from 2007, peaking in 2010; followed by a dramatic plunge in the number of approved clinical trials. There were many shifts in India’s clinical trial environment at that time as India sought to address the situation. One of the biggest concern from global pharmaceuticals was the introduction of SAE compensation guidelines in January 2013. The guideline meant that sponsors were responsible for compensating a patient’s death in clinical trials, irrespective of whether the death was related to the trial; with the amount depending on factors such as gender and income.

In July 2014, this regulation was re-examined and amended so that patient’s death was compensated only when it related to the drug or trial intervention. The amount was based on subject age, risk factor of the disease and a base amount of 8 lakhs (approximately US $12,000). Furthermore, patients with an expected mortality rate of 90% or more within 30 days, will be provided a fixed amount of US $3000.

The CDSCO will also monitor and verify the credibility and integrity of data generated in clinical trials, and confirm that sites are in compliance with various other regulatory provisions. In November 2010, the CDSCO introduced a guidance on clinical trial inspections which includes verification of essential documents to compare practice and procedure followed by the CRO/Sponsor, to that committed in the clinical trial application and GCP guidelines.

In late 2012, Indian regulatory officers carried out over 300 unplanned on-the-spot inspections on clinical trials. This led to sites and ethics committees becoming more cautious – SOPs were introduced and facilities upgraded to help manage trials in a more secure, confidential and transparent manner. This guideline is in line with wider government efforts introduced by the CDSCO to tighten up the regulatory framework for clinical research in India – ensuring continued ethical, scientific and safety standards at all sites are kept to the highest standards.

In November 2013, the CDSCO also introduced a regulation that all clinical trials (local and international) must provide written informed consent, AV recording of each trial subject, providing trial information to the subject and the assuring the patient understands the consent/trial in a language and format suitable for them. Due to the diversity of languages and socioeconomic situation in India, this is to ensure the quality of conduct during the consent process and provides further transparency.

Conclusion

The implementation of the CDSCOs regulations will allow a fair protection mechanism for all participating subjects and also enable a cleaner, transparent and easier decision-making process for Indian and global clinical researchers. Moreover, it is vital that sites in India maintain the highest standards, as any compromise may jeopardize public confidence and participation within clinical trials, ultimately affecting the availability of safe and effective products. These recent changes in India will allow its clinical trial environment to transform and help increase confidence in the conduct of clinical research again.