In 2013, there was a slowdown in clinical trials due to clinical trial litigation. Afterward, India experienced an upward trend. Read more about the history of clinical trials and the risks in part I and part II of this series. 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. Amendments in regulations, new orders, and further guidance on existing ones addressed stakeholder concerns.

Growth Opportunities From Clinical Trials in India

There are a few reasons why we can expect to see growth in the Indian clinical research sector in the future.

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. This portal, established in March 2016, allows for the import and registration of drugs and medical devices. These online services include allowing pharma companies to submit and apply for clinical trials as well. Clinical trial guidelines were revised. Compensation is only required if the drug caused an adverse reaction in a patient participating in the trial. This is a significant change from the earlier rule. Previously, it mandated payment regardless of whether the drug caused a severe adverse event. Regulatory procedures also made it clear that an audio-visual recording of informed consent is not always mandatory.

The Indian government has taken proactive steps.

India wanted back on the global clinical research map. The DGCI may soon allow pharmaceutical companies that conduct clinical trials in India to process some documents online. If this change comes through, it will significantly reduce the time and effort required in the application process. The government also aims to speed up approvals, remove intermediaries, and bring about transparency with these new guidelines. A more straightforward approach and less bureaucratic nature of these changes may lead to more clinical studies in India. Also, to the industry’s relief, the DGCI no longer requires the ICMR for importing or exporting biological samples. Shipments can now be directly cleared at the entry or exit port if the applicant declares compliance with all applicable rules and regulations

The rise of local stakeholders in clinical research.

Initially, CDSCO did not allow investigators to conduct more than three clinical trials at any given time. But CDSCO removed this restriction when it released its new rules. Instead, it has put the onus on the Ethics Committee (EC). This committee must consider the complexity and nature of clinical trials and grant permission accordingly. As a result of this change, experienced investigators and key opinion leaders can leverage their expertise and drive industry growth in India. The Indian government has also revised the requirement that mandated clinical trials to sites with more than 50 hospital beds. The EC can use discretion to decide whether the clinical trial site is suitable for the test or not.

The Rise of the Clinical Trial Industry 

The Indian clinical trials industry has seen exciting developments in the past decade. Peaking in 2011-12, significantly losing out over the next two-to-three years. But now once again slowly showing signs of revival. The recent regulatory and policy changes announced by the government have brought back fundamental competitiveness to the industry. Rebuilding global and local stakeholders’ confidence will be a slow process. However, the inclusive approach adopted by the Indian regulators is encouraging. Also, regulators are actively seeking and acting upon stakeholder feedback.

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

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