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 

We asked them and here's the verdict: Scotch is one of the #GiftsMenLove

A handy guide to buying a gift for a guy.

Valentine’s day is around the corner so men and women everywhere are racking their brains for the perfect present. Buying a gift for men though can be a stressful experience. Be it a birthday, celebration or personal milestone, many men and women find it difficult to figure out what their male friends or significant others want. That’s why TVF decided to perform a public service and ask the guys directly what they loved. So, the next time you’re running around to buy a gift for a man, just pick something from the list below and thank us later.

Watches: A watch can complete a man’s ensemble and quickly become a talking (or bragging) point at a party. If your man loves classics, a vintage HMT (if you can find one) with a metal strap should be your brand of choice. For fun-loving guys, try a Swatch watch with a pop-coloured leather strap or even a watch with Swarovski crystal studded dials from a variety of watchmakers. Fossil’s unconventional dials will delight a creative or artistic soul. Alternatively, the G-shock collection by Casio is reasonably priced, waterproof and perfect for those who love adventure sports. If your man is a fitness enthusiast, surprise him with an excellent fitness band from GoQii.

Image Credits: Pexels
Image Credits: Pexels

Whisky: A well stocked bar is every man’s pride and joy. Whisky, especially scotch is an extremely popular gift with men. It is a gift that can be displayed with pride and shared on occasions with friends and family. Scotch is any whisky (single malt or blended) that comes from Scotland, is usually aged for at least three years (often more) and distilled twice. Each region in Scotland produces whisky with a distinct flavor. Spirits from Islay, like Laphroaig, tend to have a strong peat flavor while single malts from Speyside tend to be lighter and sweeter. Connoisseurs will sing praises of the golden colour of blends like Johnny Walker or Black and White, and the smoky taste of Scotch whiskies like Black Dog. If your partner is truly mad about malts, go the whole hog and surprise him with a malt tour in Scotland - the ultimate whisky experience.

Image Credit: Pexels
Image Credit: Pexels

Jackets: For a more personal touch, a jacket can be quite an apt gift. A romantic-at-heart will love a traditional bandhgala while bike enthusiasts swear by their weather-worn leather jackets. Blazers are great day-to-night apparel, looking perfectly at home in the office or in a bar. You’ll be spoilt for choice when it comes to brands and designers: high street labels like Blackberry’s and Zara offer trendy outerwear at affordable prices. Custom made jackets like the ones from Raymond’s Made-To-Measure collection or the Bombay Shirt Company are also a great option, if you really want to get creative with the design.

Sunglasses: If your friend is a globetrotter, a smart pair of shades will delight him like nothing else. Whether he is sunbathing in the Maldives, chasing zebras in Tanzania or skiing in Courchevel, this travel accessory adds an instant glam quotient to almost every type of holiday. Recent sunglass trends have been a major throwback to retro shapes inspired from Hollywood films like Tom Cruise’s aviators from Top Gun, Steve McQueen’s Persols from The Thomas Crown Affair or the wayfarers sported by the lead actors in The Blues Brothers. You’ll find many variations at high street brands like H&M and Diesel but if you can stretch the budget, pick up a good quality pair from Burberry or Louis Vuitton. Better yet, buy a unisex design that you can borrow when your heart desires!

Image Credits: Pexels
Image Credits: Pexels

Headphones: Most guys love their music, whether their choice of genre is soft rock, hard metal or folk fusion. So, it makes sense that headphones are on the list of the most popular gifts loved by men. Make sure you know what you’re looking for when it comes to buying headphones. For style combined with comfort, Skull Candy headphones come in a fun palette of colours. For amazing sound quality and pumping bass, you can opt for Shure or Sennheiser; they may look basic but deliver on their audio capabilities. Audio-Technica headphones are also gaining a cult following among audiophiles for their excellent sound clarity. If your man listens to music while working out, get the Jabra Sports in-ear headphones which are made for the gym. Though it feels pragmatic, this gift will be treasured by all music lovers.

So, take a pick from this list and the guy you gift will be indebted to you for life! For more great gifting ideas, see here.

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