Though the Indian clinical trial industry was passing through a wringer in the recent past, it hopes to overcome setbacks and retrieve the lost ground soon. The slow but steady increase in approvals by the Drugs Control General of India (DCGI) office is a pointer to the signs of revival in the clinical trials business. The formation of expert committees on oncology and cardiology to scrutinize fatality reports arising from serious adverse events (SAEs) during trials is also proving to be a source of solace for the industry.

For the last 18 months, clinical trial industry has been forced to survive in a volatile regulatory environment which had led to a drastic decline in the number of human studies, rue the industry.

From pharma to biotech and herbal companies, all are dependent on human studies because most of their products are ethically promoted and require safety-efficacy data for clearances from the regulatory authority which help medical experts to prescribe drugs.

By insisting that approval of clinical trials from the DCGI office should be within six months, the Union Government has now extended its support to the clinical trial companies. The government has also levied a dialogue fee to be paid to the DCGI by companies if they need to ascertain the status of submissions before the stipulated time of six months.

Since earlier the approval process took a minimum two years, the latest effort by the government can be considered as the biggest support for Indian and global clinical research companies as there is a timeframe for approval and an opportunity to discuss with DCGI, said Prof. Ranjit Roy Chaudhury, Chairman of the Expert Committee on Clinical Trials constituted by the Ministry of Health and Family Welfare.

Further, the government is also mulling a panel of experts to review and assess the New Drug Applications. The pool of scientific experts would be selected randomly from across India to prevent any bias during the evaluation of drug applications.

These two endeavours by the Union government would increase the confidence level of both the Indian and global clinical trial industry. A few more norms are likely to be announced by the government before the month-end,” said Prof. Chaudhury.

Referring to the approval of clinical trials by the DCGI office, he said pharma companies and clinical research organizations (CROs) were facing uncertainty after they submitted drug applications seeking permission to conduct a clinical trial. Now the companies could also approach the DCGI office to ascertain the details of the trial which is put before the regulatory authority for clearance. However, they will need to pay a dialogue fee to find out the status of their submissions related to the human study. In turn the DCGI or the concerned officials in his office could explain to the pharma, biotech and CRO on the exact stage of the approval process, he said.

The centre’s strategic efforts have now helped to create some momentum in the clinical trial space where human studies have come to an absolute standstill. In the last few months, the approvals of applications to conduct human studies are at a faster pace and trials are also taking place, said Prof. Chaudhury.

The sector has been reeling under uncertainty since January 3, 2013, after the Supreme Court slammed the government for its failure to stop illegal clinical trials companies and also for the rise in fatality from human studies. However, with the government gearing up to support the sector, this has given a reprieve for both India and global pharma and CROs. The unpredictability of the duration for approval or response from the regulatory authority was seen to hamper progress of drug research, pointed out Prof. Chaudhury.

On July 22, 2014, Kiran Mazumdar-Shaw, chairman and managing director Biocon Ltd in her capacity as the chairperson CII-Biotechnology had sought the intervention of Prime Minister Narendra Modi to drive the industry at a faster pace.

If India has to claim leadership in the pharmaceutical industry, it is imperative to focus on drug innovation. The current moratorium on clinical trials is hampering the drug development and instead strengthening external competition which is highly undesirable, said Shaw in her letter to Prime Minister Modi.

The medical profession can only be strengthened if it pursues clinical research along with clinical practice. Only when these run in tandem can there be better health innovation and better health outcomes, she had pointed out.

“The concerns of ethics and safety pertained to a few trials should have been investigated and dealt by the regulators. Unfortunately, the entire sector was forced to pay the price because of a few errant trials. Hence there is an urgent need to resume clinical trials ,” said Shaw in her note to the Prime Minister .

Hurdles impacting industry
Despite the fact that it has become essential for the clinical trial companies to have a dialogue with the government to sort out the problems impacting the industry and bring back the fervour of conducting human studies, there is no such move by the industry at present. This is because CROs are not strong and are not united on this move, said Prof. Choudhury.

The Finance Minister Arun Jaitley in his Union Budget 2014-2015 chose to withdraw the service tax exemption on technical testing of new drugs, including vaccines and herbal remedies. Withdrawing the exemption on service tax and enforcing 12.3 per cent levy was viewed by the Indian Society for Clinical Research (ISCR) as a disincentive to undertake human studies in India.

“This has sent a wrong signal to the global community on the government’s commitment to promote research for better healthcare,” said Suneela Thatte, President, ISCR.

According to Philipe Haydon, CEO, The Himalaya Drug Company, India is proving to be a difficult place to conduct clinical trials. Now herbal companies including ours are at the receiving end. We are facing a serious crunch of investigators for human studies which are mandatory since all our pharma products are prescription-driven and require clinical research data to back the effectiveness and wellbeing. On an average, we conduct 10 clinical trials annually which span over four months. The service tax of 12.3 per cent will definitely hit the company’s net earnings.

“It is puzzling and disappointing to see the withdrawal of service tax exemption on drug testing. This is another blow for the clinical trials industry that is already reeling from the ongoing moratorium and regulatory uncertainty,” said Shaw.