Pharma companies consider leaving India over clinical trial ban

Angered by the Supreme Court’s decision to stop 157 clinical trials, pharma companies are considering moving them out of India. It’s believed that this uncertain scenario will in the long run harm

By: Admin | | Updated: October 23, 2013 3:16 pm

Angered by the Supreme Court’s decision to stop 157 clinical trials, pharma companies are considering moving them out of India. It’s believed that this uncertain scenario will in the long run harm India’s image as a diverse location for clinical trials and also impact the availability of drugs in India.

Dhananjay Bakhle, Executive Vice-President (Medical Research), Novel Drug Discovery & Development, Lupin Limited told The Indian Express, ‘The regulatory environment and volatility therein, the uncertainty over the last two years was already discouraging and we started conducting clinical trials in other geographies such as Europe. If granted approvals are also being cancelled, there is no sanctity of governance. One has already noticed a sizeable decline in the number of trials and applications over the last 2 years.’

Not everyone was sad about the recent move though. Anjali Nayaar, senior VP of NGO Global Health Strategies, said: ‘Appreciate the SC decision. All clinical trials should be conducted as per ICMR ethical guidelines and human lives should not be jeopardised. India has always provided cheaper and quality solutions, be it drugs or vaccines. For a country with such a large burden of disease, especially affecting the poor and disadvantaged, we have to acknowledge the cost of delay in research and development.’

The bulk of the trials stopped were for diabetes and anti-cancer drugs, diseases that are a major concern in India.

The story so far…

On October 21, the Supreme Court said that it won’t allow any clinical trials until proper guidelines were put in place. ‘It is not possible to pass any order in respect of the clinical trials of 157 new chemical entities. We are not passing any order. You will tell us the findings of the apex committee and the technical committee,’ the bench told Additional Solicitor General Siddarth Luthra who had appeared for the government.

In an earlier hearing, the bench asked the Centre to consider suggestions from various stakeholders in putting in place the mechanism to avoid any serious and adverse impact. The court had earlier said that clinical trials of untested drugs on humans require certain mandatory standards to be followed and had also directed the government to put in place a mechanism to monitor them.

Centre failed to stop the ‘rackets’ which caused deaths

The SC had directed the Centre to convene a meeting of Chief Secretaries or Health Secretaries of all the states to frame a law for regulation of clinical trials of drugs by multi-national pharma companies. Earlier, the apex court had said that uncontrolled clinical trial of drugs by multinational companies was creating ‘havoc’ and slammed the Centre for failing to stop the ‘rackets’ which caused deaths.

Observing that the government has slipped into ‘a deep slumber in addressing this menace’, the court had ordered that all drug trials will be done under the supervision of the Union Health Secretary.

New guidelines already drafted

Earlier, the National Human Rights Commission had also written to the Union Health Ministryto seek their view on guidelines prepared by the NHRC on clinical trials. The NHRC’s expert committee also suggested that standard operating procedures (SOPs) should be written down and followed in all clinical trials based on prevailing good clinical practices (GCP) guidelines for biomedical research on human participants and there should be an effective mechanism for monitoring the implementation of the SOPs.

Participants of the clinical trial should be provided medical care from the time of enrolment in the study, for the duration of study and for the period of follow up as specified in the protocol, the guidelines on clinical trials suggested. The Commission in a statement said that it has also decided to file an affidavit before the Supreme Court and intervene in the pending matter related to clinical drug trials.

The PATH of darkness

The can of worms was opened when reports revealed that phase IV clinical trial for an HPV vaccine was carried out on unsuspecting tribal girls. ‘There were also reports of deaths of seven girls in the same trial which led to suspension of the whole process a year later (April 7, 2010) and a committee was constituted to enquire into the alleged irregularities,’ said a senior health ministry official. There were also indications that on several counts where the US-based called PATH NGO which was conducting the aforementioned trials behaved irregularly. In some cases the consent forms actually read ‘You will not be charged for your daughter to receive the vaccine’.

‘However, the NGO conducting the trials was let off with a warning letter only asking them to be careful in future,’ the official said. (Read: India’s drug control body’s hall of shame)

India – the testing ground for Big Pharma?

Various sources also suggested that major global pharmaceutical companies were using India as their testing ground for different drugs for cancer and antibiotics. The SC had also pointed out the government’s failure to halt unethical clinical trials by multinational drug companies on Indian patients who were used as ‘guinea pigs’. Referring to a May 2012 report of the Parliamentary Standing Committee on health and family welfare, Judges R.M. Lodha and Anil R. Dave said ‘it really pains us that illiterate people and children of India are being used as guinea pigs by the multinational drug companies’. The health ministry data shows the number of trials being approved has also gone down: from 529 permissions granted in 2010 to 283 in 2011 and 253 in 2012. What is even more shocking is the fact that the vaccines were provided by Merck and GlaxoSmithKline and was in collaboration with the Indian Council of Medical Research (ICMR) – the country’s apex body for the formulation of biomedical research and was reportedly funded by the Bill and Melinda Gates Foundation!

A silent spectatorial regulatory body

A parliamentary panel report took note of these violations around a month ago and even lashed out at the Drug Controller General of India (DCGI), the head of the CDSCO who it claimed ‘remained a silent spectator even as its own regulations were being violated’ while there were also irregularities in the approval of the clinical trials, the import licenses and even the marketing approvals. While the issue was reported in 2010, the new report points to a horrendous amount of irregularities. It’s almost as if than rather than acting as a regulatory body, the ICMR was acting actively to promote the interest of the HPV vaccine manufacturers.

The report also pointed out that the cases of serious adverse events (SAE) weren’t monitored during the studies. Shockingly, the vaccines were given to children irrespective of age. The panel has demanded further tightening of regulations and stricter action against the wrongdoers and strict monitoring of SAEs.

With inputs from agencies

Published : October 23, 2013 3:14 pm | Updated:October 23, 2013 3:16 pm

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