Medical ethics

New government regulations water down clinical trial safety norms

Two circulars empower ethics panels to remove requirements on the size of trials facilities and the number of trials principal investigators can work on.

Crucial changes made in the regulation of clinical trials in India recently seem to have been made to align the industry to the favourite mantra of the Narendra Modi government – ease of doing business.

Experts say that two circulars that the government issued on August 2 has reversed advances for better regulation of such trials made previously through the intervention of the Supreme Court.

The circulars – issued by the Central Drugs Standard Control Organisation, the apex body of the Government of India to regulate clinical trials and quality of drugs – put immense powers in hands of ethics committees, which have been at the centre of controversies for not regulating clinical trials adequately.

The first circular has taken away the requirement that any hospital conducting clinical trials must have a minimum of 50 beds. Instead, an ethics committee can decide the trial site.

The second circular has removed a restriction on the number of trials a principal investigator can work on at any given time. The cap was set at three. The final authority for this decision will also be the ethics committee.

Role of the ethics committee

Ethics committees are supposed to be formed by qualified individuals – a medical speciality being a minimum qualification – who have been approached by scientists and companies seeking approval for trials of their medicines. These are private bodies which can operate within a health facility or independently.

Critics of this new policy say that for ethics committees to decide on principal investigators and clinical trial sites – the two most important components of trials apart from human subjects – they need capacity building. For instance, ethics committee members should be able to judge scientific standards of a trial site, an indicator of which is the number of beds at the facility.

“Number of beds signify how complex an organisation is with various facilities,” said Amar Jesani, editor of the Indian Journal of Medical Ethics. “It gives an idea about the number of departments, intensive care, blood bank, etc. These are important in case of an emergency.”

S Srinivasan, co-founder of Vadodara-based organisation Low Cost Standard Therapeutics said that it was a bad idea to allow one principal investigator to monitor several trials.

“Ideal is one trial at a time," he said. "But in some exceptional cases, where that person might be the only one with required expertise, more trials can be considered. But leaving it completely in the hands of the ethics committee is not good.”

Trials that went wrong

A widespread debate on clinical trials in India started in 2009 when seven girls between the ages of 10 and 14 from tribal belts in Gujarat and Andhra Pradesh died during clinical trials of the Human Papilloma Virus vaccine for cervical cancer. The Bill and Melinda Gates Foundation-funded Programme for Appropriate Technology in Health was conducting the vaccination trials. The HPV vaccines tried were products of companies GlaxoSmithKline and Merck Sharp & Dohme.

In 2013, a Parliamentary Standing Committee report indicted government officials for colluding with other stakeholders to conduct unethical clinical trials.

They were conducted on young girls before being tried on adults, a major violation of rules in India. The Programme for Appropriate Technology in Health described the project as an observational study rather than a clinical trial. The Parliamentary committee concluded that this was done to avoid lengthy procedures and hit the vaccination market at the earliest.

In 2014, the Supreme Court of India had asked the government to put proper regulation in place before permitting any pharmaceutical company to proceed with clinical trials. This was in response to a public interest litigation filed by the NGO Swasthya Adhikar Manch.

Citing government data, the NGO showed that there had been 3,458 deaths and 14,320 cases of serious side effects related to clinical trials in India between 2005 and 2012. The Supreme Court has been taking a tough stand against unethical practices in various other cases.

"The circulars go against the spirit of the Supreme Court orders," said Amulya Nidhi, of Swasthya Adhikar Manch. "SC has said that the problem lies with the existing law which has to be completely changed. Any new rules have to be within SC's framework."

Any new rule or circular has to abide by the three principles laid down by the court – that is testing for commercial benefit analysis, that the trial is for a new molecules and ones that have an established history, and the medical need of the country.

The loopholes

"Many trials are conducted in India for diseases which are not prevalent here," said Nidhi. "Thus, the country and patients do not benefit from them. SC has said such trials should not be conducted."

Nidhi also points out that the new circulars do not specify penalties on principal investigators who don't meet these Supreme Court mandated paremeters.

Just last month, the Indian Council of Medical Research came up with draft guidelines to conduct such trials in an ethical and fair manner so that poor patients don’t end up being guinea pigs for medicines that won’t even treat them.

“The recent circulars are a reversal of all this progress that has been made to regulate clinical trials in the country,” said Jesani. “So much power in the hands of the ethics committee, where we have more than 600 of them in India, goes against the principle of strict regulation.”

Ethics committees have come under fire by health experts and activists for not working independently and instead playing into the hands of organisations interested in conducting clinical trials. This results in slips in supervision and in the enforcement of rules and regulations.

After a hue and cry over the past few years, the government made it mandatory to register an ethics committee with the Central Drugs Standard Control Organisation before taking approval for the trials.

“There is a lot of paper work,” said Jesani. “But before putting so much power in the hands of the committee, the government should have generated evidence of substantial improvement in their functioning. There is no such evidence.”

Clinical researchers, however, have welcomed the circulars. “The earlier restrictions impacted a sponsor’s ability to choose the best qualified investigators and sites for a study,” said Suneeta Thatte, president of the Indian Society for Clinical Research. “The new announcements vest this decision with ethics committees who are best positioned to deliberate on this and take a well calculated decision.”

Srinivasan of Low Cost Standard Therapeutics disagreed. “This is a clear cut case of inviting pharmaceutical companies to conduct clinical trials in India and signal them for ‘ease of doing business’,” he said. “The decisions seem to have been taken under pressure from the pharma lobby to make it convenient to test their drugs in India.”

We welcome your comments at letters@scroll.in.
Sponsored Content  BY 

As India turns 70, London School of Economics asks some provocative questions

Is India ready to become a global superpower?

Meaningful changes have always been driven by the right, but inconvenient questions. As India completes 70 years of its sovereign journey, we could do two things – celebrate, pay our token tributes and move on, or take the time to reflect and assess if our course needs correction. The ‘India @ 70: LSE India Summit’, the annual flagship summit of the LSE (London School of Economics) South Asia Centre, is posing some fundamental but complex questions that define our future direction as a nation. Through an honest debate – built on new research, applied knowledge and ground realities – with an eclectic mix of thought leaders and industry stalwarts, this summit hopes to create a thought-provoking discourse.

From how relevant (or irrelevant) is our constitutional framework, to how we can beat the global one-upmanship games, from how sincere are business houses in their social responsibility endeavours to why water is so crucial to our very existence as a strong nation, these are some crucial questions that the event will throw up and face head-on, even as it commemorates the 70th anniversary of India’s independence.

Is it time to re-look at constitution and citizenship in India?

The Constitution of India is fundamental to the country’s identity as a democratic power. But notwithstanding its historical authority, is it perhaps time to examine its relevance? The Constitution was drafted at a time when independent India was still a young entity. So granting overwhelming powers to the government may have helped during the early years. But in the current times, they may prove to be more discriminatory than egalitarian. Our constitution borrowed laws from other countries and continues to retain them, while the origin countries have updated them since then. So, do we need a complete overhaul of the constitution? An expert panel led by Dr Mukulika Banerjee of LSE, including political and economic commentator S Gurumurthy, Madhav Khosla of Columbia University, Niraja Gopal Jayal of JNU, Chintan Chandrachud the author of the book Balanced Constitutionalism and sociologist, legal researcher and Director of Council for Social Development Kalpana Kannabiran will seek answers to this.

Is CSR simply forced philanthropy?

While India pioneered the mandatory minimum CSR spend, has it succeeded in driving impact? Corporate social responsibility has many dynamics at play. Are CSR initiatives mere tokenism for compliance? Despite government guidelines and directives, are CSR activities well-thought out initiatives, which are monitored and measured for impact? The CSR stipulations have also spawned the proliferation of ambiguous NGOs. The session, ‘Does forced philanthropy work – CSR in India?” will raise these questions of intent, ethics and integrity. It will be moderated by Professor Harry Barkema and have industry veterans such as Mukund Rajan (Chairman, Tata Council for Community Initiatives), Onkar S Kanwar (Chairman and CEO, Apollo Tyres), Anu Aga (former Chairman, Thermax) and Rahul Bajaj (Chairman, Bajaj Group) on the panel.

Can India punch above its weight to be considered on par with other super-powers?

At 70, can India mobilize its strengths and galvanize into the role of a serious power player on the global stage? The question is related to the whole new perception of India as a dominant power in South Asia rather than as a Third World country, enabled by our foreign policies, defense strategies and a buoyant economy. The country’s status abroad is key in its emergence as a heavyweight but the foreign service officers’ cadre no longer draws top talent. Is India equipped right for its aspirations? The ‘India Abroad: From Third World to Regional Power’ panel will explore India’s foreign policy with Ashley Tellis, Meera Shankar (Former Foreign Secretary), Kanwal Sibal (Former Foreign Secretary), Jayant Prasad and Rakesh Sood.

Are we under-estimating how critical water is in India’s race ahead?

At no other time has water as a natural resource assumed such a big significance. Studies estimate that by 2025 the country will become ‘water–stressed’. While water has been the bone of contention between states and controlling access to water, a source for political power, has water security received the due attention in economic policies and development plans? Relevant to the central issue of water security is also the issue of ‘virtual water’. Virtual water corresponds to the water content (used) in goods and services, bulk of which is in food grains. Through food grain exports, India is a large virtual net exporter of water. In 2014-15, just through export of rice, India exported 10 trillion litres of virtual water. With India’s water security looking grim, are we making the right economic choices? Acclaimed author and academic from the Institute of Economic Growth, Delhi, Amita Bavisar will moderate the session ‘Does India need virtual water?’

Delve into this rich confluence of ideas and more at the ‘India @ 70: LSE India Summit’, presented by Apollo Tyres in association with the British Council and organized by Teamworks Arts during March 29-31, 2017 at the India Habitat Centre, New Delhi. To catch ‘India @ 70’ live online, register here.

At the venue, you could also visit the Partition Museum. Dedicated to the memory of one of the most conflict-ridden chapters in our country’s history, the museum will exhibit a unique archive of rare photographs, letters, press reports and audio recordings from The Partition Museum, Amritsar.

This article was produced by the Scroll marketing team on behalf of Teamwork Arts and not by the Scroll editorial team.