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 

“My body instantly craves chai and samosa”

German expats talk about adapting to India, and the surprising similarities between the two cultures.

The cultural similarities between Germany and India are well known, especially with regards to the language. Linguists believe that Sanskrit and German share the same Indo-Germanic heritage of languages. A quick comparison indeed holds up theory - ratha in Sanskrit (chariot) is rad in German, aksha (axle) in Sanskrit is achse in German and so on. Germans have long held a fascination for Indology and Sanskrit. While Max Müller is still admired for his translation of ancient Indian scriptures, other German intellectuals such as Goethe, Herder and Schlegel were deeply influenced by Kalidasa. His poetry is said to have informed Goethe’s plays, and inspired Schlegel to eventually introduce formal Indology in Germany. Beyond the arts and academia, Indian influences even found their way into German fast food! Indians would recognise the famous German curry powder as a modification of the Indian masala mix. It’s most popular application is the currywurst - fried sausage covered in curried ketchup.

It is no wonder then that German travellers in India find a quite a lot in common between the two cultures, even today. Some, especially those who’ve settled here, even confess to Indian culture growing on them with time. Isabelle, like most travellers, first came to India to explore the country’s rich heritage. She returned the following year as an exchange student, and a couple of years later found herself working for an Indian consultancy firm. When asked what prompted her to stay on, Isabelle said, “I love the market dynamics here, working here is so much fun. Anywhere else would seem boring compared to India.” Having cofounded a company, she eventually realised her entrepreneurial dream here and now resides in Goa with her husband.

Isabelle says there are several aspects of life in India that remind her of home. “How we interact with our everyday life is similar in both Germany and India. Separate house slippers to wear at home, the celebration of food and festivals, the importance of friendship…” She feels Germany and India share the same spirit especially in terms of festivities. “We love food and we love celebrating food. There is an entire countdown to Christmas. Every day there is some dinner or get-together,” much like how Indians excitedly countdown to Navratri or Diwali. Franziska, who was born in India to German parents, adds that both the countries exhibit the same kind of passion for their favourite sport. “In India, they support cricket like anything while in Germany it would be football.”

Having lived in India for almost a decade, Isabelle has also noticed some broad similarities in the way children are brought up in the two countries. “We have a saying in South Germany ‘Schaffe Schaffe Hausle baue’ that loosely translates to ‘work, work, work and build a house’. I found that parents here have a similar outlook…to teach their children to work hard. They feel that they’ve fulfilled their duty only once the children have moved out or gotten married. Also, my mother never let me leave the house without a big breakfast. It’s the same here.” The importance given to the care of the family is one similarity that came up again and again in conversations with all German expats.

While most people wouldn’t draw parallels between German and Indian discipline (or lack thereof), Germans married to Indians have found a way to bridge the gap. Take for example, Ilka, who thinks that the famed differences of discipline between the two cultures actually works to her marital advantage. She sees the difference as Germans being highly planning-oriented; while Indians are more flexible in their approach. Ilka and her husband balance each other out in several ways. She says, like most Germans, she too tends to get stressed when her plans don’t work out, but her husband calms her down.

Consequently, Ilka feels India is “so full of life. The social life here is more happening; people smile at you, bond over food and are much more relaxed.” Isabelle, too, can attest to Indians’ friendliness. When asked about an Indian characteristic that makes her feel most at home, she quickly answers “humour.” “Whether it’s a taxi driver or someone I’m meeting professionally, I’ve learnt that it’s easy to lighten the mood here by just cracking a few jokes. Indians love to laugh,” she adds.

Indeed, these Germans-who-never-left as just diehard Indophiles are more Indian than you’d guess at first, having even developed some classic Indian skills with time. Ilka assures us that her husband can’t bargain as well as she does, and that she can even drape a saree on her own.

Isabelle, meanwhile, feels some amount of Indianness has seeped into her because “whenever its raining, my body instantly craves chai and samosa”.

Like the long-settled German expats in India, the German airline, Lufthansa, too has incorporated some quintessential aspects of Indian culture in its service. Recognising the centuries-old cultural affinity between the two countries, Lufthansa now provides a rich experience of Indian hospitality to all flyers on board its flights to and from India. You can expect a greeting of Namaste by an all-Indian crew, Indian food, and popular Indian in-flight entertainment options. And as the video shows, India’s culture and hospitality have been internalized by Lufthansa to the extent that they are More Indian Than You Think. To experience Lufthansa’s hospitality on your next trip abroad, click here.

Play

This article was produced by the Scroll marketing team on behalf of Lufthansa as part of their More Indian Than You Think initiative and not by the Scroll editorial team.