This is the last of a three-part series on regulatory requirements for clinical trials in India.


 After the slowdown in clinical trials experienced in 2013—in part due to litigation of clinical trials —India is seeing an upward trend. There are several reasons behind the positive growth in clinical phase 1 and phase 2 trials, not the least of which is the proactive and business-friendly approach of the Indian government.

In 2014 and 2015, Indian regulators took steps to mitigate the challenges posed by regulatory uncertainty. Concerns of stakeholders were addressed through amendments in regulations, new orders and further guidance on existing ones.

Here are a few reasons why we can expect to see growth in the Indian clinical research sector in the near future:

  1. Simplification of regulatory procedures:

New updates have made the approval process quicker, predictable and in line with global practices. The Central Drugs Standard Control Organization (“CDSCO”) set up an online licensing portal known as SUGAM in March 2016, for the import and registration of drugs and medical devices. These online services have been extended to pharma companies to submit and apply for clinical trials as well.

In addition, clinical trial guidelines have been revised so that compensation can be paid only if the drug caused an adverse reaction in a patient participating in the trial. This is a significant change from the earlier rule which stated that compensation had to be paid regardless of whether or not the serious adverse event was caused by the drug. Regulatory procedures have also made it clear that audio-visual recording of informed consent is not mandatory in all cases.

  1. Proactive steps taken by the Indian government

In order to put India back on the global clinical research map, the DGCI may soon allow pharmaceutical companies who wish to conduct clinical trials in India to process some documents online. If this change comes through, it will greatly reduce the time and effort required in the application process. The government also aims to speed up approvals, remove middlemen and bring about transparency with these new guidelines. The simpler process and less bureaucratic nature of these changes may lead to more clinical studies in India.

Also to the relief of the industry, the approval of the ICMR for importing or exporting biological samples is no longer required. All shipments can now be directly cleared at the port of entry or exit if the applicant declares that all applicable rules and regulations will be complied with.

  1. The rise of local stakeholders in clinical research

Originally, investigators were not allowed to conduct more than three clinical trials at any given period of time. But CDSCO removed this restriction when it released its new rules. Instead, it has put the onus on the Ethics Committee to take into consideration the complexity and nature of clinical trials and grant permission accordingly. As a result of this change, experienced investigators and key opinion leaders are poised to leverage their expertise and drive industry growth in India. The Indian government has also revised the mandatory requirement that clinical trials can only be carried out at sites that have more than 50 hospital beds. The EC can use discretion to decide whether the clinical trial site is suitable for the trial or not.

The bottom line

The Indian clinical trials industry has seen interesting developments in the past decade, peaking in 2011-12, significantly losing out over the next two-to-three years and now once again slowly showing signs of revival. The recent regulatory and policy changes announced by the government have brought back basic competitiveness to the industry. While rebuilding confidence of global and local stakeholders will be a slow process, it’s encouraging to note the inclusive approach adopted by the Indian regulators, as stakeholder feedback has been actively sought and acted upon in many cases.

The clinical research industry in India took some time to regroup after the introduction of new regulatory practices. However, it appears to be headed in the right direction and the country is set for growth again.