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 

When did we start parenting our parents?

As our parents grow older, our ‘adulting’ skills are tested like never before.

From answering every homework question to killing every monster under the bed, from soothing every wound with care to crushing anxiety by just the sound of their voice - parents understandably seemed like invincible, know-it-all superheroes all our childhood. It’s no wonder then that reality hits all of a sudden, the first time a parent falls and suffers a slip disc, or wears a thick pair of spectacles to read a restaurant menu - our parents are growing old, and older. It’s a slow process as our parents turn from superheroes to...human.

And just as slow to evolve are the dynamics of our relationship with them. Once upon a time, a peck on the cheek was a frequent ritual. As were handmade birthday cards every year from the artistically inclined, or declaring parents as ‘My Hero’ in school essays. Every parent-child duo could boast of an affectionate ritual - movie nights, cooking Sundays, reading favourite books together etc. The changed dynamic is indeed the most visible in the way we express our affection.

The affection is now expressed in more mature, more subtle ways - ways that mimics that of our own parents’ a lot. When did we start parenting our parents? Was it the first time we offered to foot the electricity bill, or drove them to the doctor, or dragged them along on a much-needed morning walk? Little did we know those innocent acts were but a start of a gradual role reversal.

In adulthood, children’s affection for their parents takes on a sense of responsibility. It includes everything from teaching them how to use smartphones effectively and contributing to family finances to tracking doctor’s appointments and ensuring medicine compliance. Worry and concern, though evidence of love, tend to largely replace old-fashioned patterns of affection between parents and children as the latter grow up.

It’s something that can be easily rectified, though. Start at the simplest - the old-fashioned peck on the cheek. When was the last time you gave your mom or dad a peck on the cheek like a spontaneous five-year-old - for no reason at all? Young parents can take their own children’s behaviour available as inspiration.

As young parents come to understand the responsibilities associated with caring for their parents, they also come to realise that they wouldn’t want their children to go through the same challenges. Creating a safe and secure environment for your family can help you strike a balance between the loving child in you and the caring, responsible adult that you are. A good life insurance plan can help families deal with unforeseen health crises by providing protection against financial loss. Having assurance of a measure of financial security for family can help ease financial tensions considerably, leaving you to focus on being a caring, affectionate child. Moreover,you can eliminate some of the worry for your children when they grow up – as the video below shows.

Play

To learn more about life insurance plans available for your family, see here.

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