Do we need More compensation for Clinical Trials
or stop the growing CRO industry?
“The number of trials has
reduced considerably because of the Supreme Court’s intervention. Also there is
greater compensation,” according to me “Patients will now get at least four
times more than they would have got before.”
The health ministry is currently working on a clinical-trial
policy that will incorporate quicker approvals and balanced compensation
guidelines. “The baseline figure of 800,000 rupees (US$13,000) as per the
formula can result in actual compensation of 400,000 rupees (US$6,500) for
patients over 65 years old with a short period of expected survival and a
maximum of 7.29 million rupees (US$0.1m) for young volunteers in phase 1
trials. Earlier, the compensation was 50,000 rupees (US$800) with a maximum of
300,000 rupees (US$5,000),” he says.
However, determining the cause of death is
dependent on the integrity of the investigator: “There are over 30,000
investigators in India — how many are honest and how many are corrupt?” No
sponsor would like to publicise unfavourable results, according to me, and
there is a conflict of interest because investigators are employees of the
sponsor and would find it difficult to file an adverse report. “There is no
independent mechanism,” .
Pulling out
Given the uncertain regime, drug companies and CROs are cutting
back on clinical trials in India. The Indian Pharmaceutical Alliance (IPA),
which represents leading domestic pharmaceutical companies, says that the
increasing reluctance of India’s drugs and devices regulator to grant approvals
for new drugs, even if they are approved in developed countries, and to allow
clinical trials or biostudies for export purposes, has severely hampered the
industry.
The hub appears to
have shifted to China, where a lot of government support has come to the aid of
the industry, in terms of easier processes
Francis says that some trials have moved to other countries.
“The hub appears to have shifted to China, where a lot of government support
has come to the aid of the industry, in terms of easier processes. English has
also been made mandatory in China, which has given a fillip to most CROs to
take on work from multinationals.”
it is easier to conduct business outside India. “CROs in Turkey,
Indonesia and Malaysia are flourishing, since the regulatory norms are not so
strict and approvals are given faster,” adding that CROs in Eastern Europe have
made it cheaper to carry out clinical trials there.
“From 2010–2011, things have changed quite drastically for CROs.
These regions [Eastern Europe] used to charge heavily, so many of the
multinational companies moved to India, where it was 40% cheaper to conduct
trials and there was a ready demographic,” she explains. “Now, the margin has
come down considerably.”
The effects of the regulatory uncertainty are already being
felt. Max India, for example, has announced that it will sell its clinical
research business for US$1.5m to JSS Medical Research, a Canadian CRO. The
company says the regulatory challenges have made it difficult to scale up the
business.
Other Indian pharmaceutical companies, such as Biocon, Alembic,
Zydus Cadila, Torrent and Lupin, have already moved trials out of the country.
At Biocon, the research and development (R&D) spend is 134% higher in the
second quarter of 2015 compared with the same period in 2014. The company’s
chairman, Kiran Mazumdar-Shaw, said at an analyst briefing that the high
R&D spend is a result of ongoing global clinical trials that require large
investment. For example, Biocon’s global phase III trial for biosimilar
trastuzumab is being conducted in Europe.
Indian CROs, started moving out to other Asian countries, including
Malaysia and Thailand, Since there is a high degree of uncertainty in India has
discouraged clinical trials.
