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India's regulatory reforms for clinical trials

Jun. 22, 2017

Due to low costs and a large patient population, India was previously considered a top-tier location for clinical trials. However, India's limited infrastructure and less-efficient regulations have resulted in many unfortunate accidents involving clinical trials.

The Indian government has testified to the deaths of 2,644 people during clinical trials for new drugs between 2005 and 2012 – with 80 of these deaths directly attributed to the drugs tested.

These official figures are believed to be underestimated. According to scholarly sources, around 2,500 people died because of adverse drug reactions during trials conducted between 2010 and 2012 alone.

The Indian government's response

Due to the escalating number of deaths and harmful side effects of clinical trials, the Supreme Court of India has dictated that the government must improve the situation.

In 2013, the Indian government framed new regulations and guidelines for clinical trial processes. These new regulations include:

  • Compensation for injuries related to clinical trials
  • Registration of Ethics Committees
  • Limiting the number of clinical trials to ensure investigators can retain their oversight
  • Mandatory audiovisual recordings of the informed consent process
  • Reporting deadlines for serious adverse events

Due to the excessive time, cost, and effort required to adhere to these regulations, many research institutions and investigators have discontinued clinical trials in India.

Reforms in 2015 and 2016

India implemented reforms in 2015 to reverse this situation.

Regulations in 2013 stipulated that compensation for trial injuries would have to be paid regardless of whether drugs used in the trial were the cause of injuries.

Reforms dictated that compensation would be paid only to the point that the drugs did damage. Another change eliminated the mandatory audiovisual recording of informed consent.

In August 2016, India relaxed two more restrictions in an effort to empower investigators to leverage their expertise and drive industry growth in India.

A new circular released by the Central Drugs Standard Control Organization (CDSCO) allows investigators to conduct more than three clinical trials simultaneously. The mandatory requirement that clinical trials could only be conducted at sites with more than 50 beds has also been revised.

India continues to advance

In an effort to put India back on the global clinical research map, the Indian government has taken great steps forward to speed up approvals, remove middlemen and provide more transparency.

In March 2016, the CDSCO set up SUGAM, an online licensing portal for the import and registration of drugs and medical devices. As India seeks to advance and continue driving industry growth, SUGAM’s online services are also open to pharma companies.

The DGCI is also considering providing online no objection certificates (NOCs) so pharma companies can conduct clinical trials in India. Online NOCs will allow documents to be submitted online, considerably reducing the effort required to make submissions in person. The status of an application can also be monitored via the online portal.

India set up for growth and further development

Despite past challenges, India has now positioned itself for advancement. The Indian clinical research industry has very strong fundamentals.

A genetically diverse patient pool, a vast population in need of medical treatment, qualified medical professionals, clinicians and data specialists and strong regulatory policies position India for further positive clinical trial outcomes.

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