The fate of 162 global clinical trials hangs in the balance, as the top Indian court has asked the government to provide more details on their approval process before they can proceed.

The trials, most of which involve new chemical entities (NCEs), were approved by the drug controller general of India earlier this year. During the latest hearing on a petition filed in February last year by Indore-based health pressure group, Health Right Forum, the supreme court allotted the government two weeks to provide details on the mechanism adopted to approve the trials.

India is not a good place for Phase II and Phase III trials for such products because of the inadequacies in the system

Amulya Nidhi, coordinator of Health Right Forum, says: ‘Clinical trials of NCEs are being conducted without following proper protocol, and companies are taking advantage of poor people.’ New chemical entities are drugs that have not yet been approved for marketing and are in various phases of testing. Indian drug laws don’t allow Phase I trials of drugs developed outside of India, but they permit concomitant Phase II and Phase III trials of such products.

Trials of NCEs have fired controversy in India because of the high number of deaths that have occurred in the last few years. According to information from the health ministry, 1542 deaths were reported in clinical trials between 2010 and 2012. However, only 54 of these were attributed directly to the trials.

Who benefits?

Commenting on the latest court order, C M Gulhati, editor of Monthly Index of Medical Specialities, India, says: ‘It is a good interim order pending final disposal of the case. Testing of NCEs in India does not help the country. It only helps multinational corporations to cut costs and avoid payment of compensation.’

Chinu Srinivasan, of Gujarat-based Low Cost Standard Therapeutics, a non-profit, small-scale pharmaceutical maker and public health advocacy group, agrees. ‘India is not a good place for Phase II and Phase III trials for such products because of the inadequacies in the system,’ he says. ‘The ancillary health services are weak. This is not Australia. If a person in a clinical trial in a remote village gets a cardiac arrest, he can’t be immediately flown in to the nearest hospital.’ Srinivasan adds that India is an attractive market for companies because the regulatory framework is weaker.

Recent amendments to India’s clinical research laws have led to the US National Institutes of Health pulling out of clinical trials in the country. The amendments tighten rules on compensation and the registration of ethics committees.

Big business

According to market research firm Frost & Sullivan, the Indian clinical trial industry was worth $450 million (£282 million) in 2010–11. Presently it is growing at 12% a year and is predicted to pass the $1 billion mark in 2016. However, recent developments have derailed progress. R K Sanghavi, head of the medical subcommittee of the Indian Drug Manufacturers Association, says: ‘To be honest, the clinical trial industry in India is in shutdown mode.’

Suneela Thatte, president of the Indian Society for Clinical Research, says that clinical trials are essential for improving the nation’s health. ‘The disease burden of India is like a double-edged sword,’ she says. ‘On one hand, we have a huge burden of diseases common in the third world, such as tuberculosis and malaria. On the other hand, we are seeing a sharp rise in diseases of the developed countries, such as diabetes, hypertension and psychiatric illnesses.’ Nidhi says that the loss incurred by pharma companies is immaterial. ‘We are concerned about and committed to the interests of people,’ he says. But Thatte reckons there is more to clinical trials than just profit making. ‘Clinical trials are the only hope for seriously ill patients who have tried all treatments without avail. By stopping trials, we’re denying them access to new treatment opportunities,’ she laments.

Trials on trial

Recently, a committee headed by leading pharmacologist Ranjit Roy Chaudhury submitted a report recommending ironing out the process of approving and conducting clinical trials. The committee was set up by the government following the supreme court’s harsh criticism of the government’s lax approach to dealing with unethical trials.

The panel recommended that clinical trials only be conducted at centres that have been accredited. It also suggested that the principal investigator of the trial, as well as the ethics committee of the institute, must be accredited. Among other things, the committee noted that if a trial volunteer developed medical complications during a clinical trial ‘the sponsor investigator’ will be responsible for providing medical treatment and care.

Srinivasan believes that while it’s a step forward, the report seems to favour multinationals, particularly by making it easier for them to perform concomitant trials of NCEs discovered abroad. Gulhati points out another problem. ‘Ranjit Roy Chaudhury has a clear conflict of interest since he is the head of clinical trial unit of Apollo Hospital, which is one of the biggest private sector clinical site management organisations. It was wrong on the part of the government to appoint a person who will benefit from changes in the rules,’ he says.