medical regulation

Medical research council objects to the health ministry easing up on stem cell therapy regulation

The health ministry says that use of “minimally manipulated” stem cells need not be regulated. ICMR says this can lead to doctors offering unproven therapies.

The Indian Council of Medical Research has objected to amendments proposed by the Ministry of Health and Family Welfare to the Drugs and Cosmetics Rules, 1945 on the regulation of stem cells procedures. The amendments seek to exclude certain kinds of processed stem cells, called minimally manipulated stem cells, from being defined as new drugs. Such an exclusion will man that these cells will not have to be tested in clinical trials for efficacy and safety before they receive market approval. If passed, these amendments may legitimise the use of unproven stem cell therapies in India.

The proposed amendments were notified on April 4, with 45 days until May 20 given for objections and comments. The Indian Council of Medical Research submitted its objections on April 29.

Stem cells are cells that are derived from parts of the body like the embryo and umbilical cord that can grow into different kinds of specialised cells in the body, like nerve cells or blood cells. Stem cells derived from bone marrow have been successfully used for treating blood cancers including leukemia. Donation may be autologous, in which a patient is treated with his or her own stem cells, or allogenic, in which a patient gets stem cells from another donor. Many other stem cell therapies are still in clinical trials and their efficacy and safety are yet to be proven.

In India, there is no law to regulate the use of stem cells. The Indian Council of Medical Research has issued guidelines that recognise stem cell therapies only for certain treatments and say that other types of treatments are unproven and should not be offered as therapy.

The health ministry seeks to change this by amending the rules of the Drugs and Cosmetics Act, which regulates the approval and use of drugs in India. At present, stem cells are not classified as drugs. If the amendments are accepted, stem cells will be classified as drugs and will come under the jurisdiction of the Drugs Controller General of India. Crucially, however, the proposed amendment excludes stem cells that are “minimally manipulated” from the definition of a new drug.

Stem cells are described as being minimally manipulated when they are retrieved from an individual, subjected to minor procedures like rinsing, cleaning and resizing and do not undergo any other processing steps that may alter their function before being re-implanted into the same individual.

The amendment contradicts the guidelines issued by the ICMR. On April 29, ICMR submitted its objections, suggesting that minimally manipulated stem cells should also fall under the definition of a drug. By excluding “minimally manipulated” stem cells, the proposed amendment may allow doctors to offer many unproven and unregulated stem cell therapies.

“Even if minimally manipulated stem cells are to be used for clinical application, our guidelines mandate that necessary permissions from the Central Drugs Standard Control Organisation and the Institutional Committee for Stem Cell Research need to be taken,” said Dr Geeta Jotwani, deputy director general, Indian Council of Medical Research.

The ICMR guidelines say that any stem cell use in patients, apart from those already approved, must only be done as an approved and monitored clinical trial with the intent to advance science and medicine, and should not be offered as therapy.

Several Indian doctors offer stem cell procedures for to treat conditions like autism, muscular dystrophy, spinal cord injuries, cerebral palsy without having adequate clinical data to show that the therapy has benefits in improving the condition of patients.

The Drugs Controller General of India Dr S Eswara Reddy defended the proposed amendments, which he said his office had been mulling over for more than a year. “The amendments are proposed to bring uniformity and clarity on stem cell products in India,” he said.

However, suspicion is being raised on why the DCGI did not wait for the report of the sub-committee formed by its advisory body, the Drug Technical Advisory Board. The sub-committee was formed to deliberate on regulating stem cell on January 31, 2017. But a member of the sub-committee told Scroll.in that they never met. “Even we didn’t know about this draft notification,” said the member.

Valid distinction?

In 2001, at around that time at United States President George W Bush restricted federal funding for stem cells obtained from human embryos, the Indian government started looking into regulating the growing stem cell industry in India. The health ministry asked the ICMR and the DCGI to to draw up guidelines. The latest edition of stem cell research guidelines by the ICMR were issued in 2017.

Neurons (green) that have been developed from human induced pluripotent stem cells; the cell nucleus is depicted in blue. (Photo: The Scripps Research Institute)
Neurons (green) that have been developed from human induced pluripotent stem cells; the cell nucleus is depicted in blue. (Photo: The Scripps Research Institute)

A senior official from the office of the DCGI said that guidelines are “not mandatory”. The same official added that the guidelines were not being followed. “The only way we can regulate the industry is by having a legislation which clarifies what is and what is not allowed,” added the official who did not want to be named.

However, a senior ICMR official told Scroll.in that the proposed amendments are only a cover for doctors to offer unproven stem cell therapies for exorbitant fees.

In its comments on the health ministry’s proposed amendments, the ICMR has objected the exclusion of minimally manipulated stem cells from being called drugs.

The health ministry notification says that only those stem cells that undergo “substantial or more than minimal” manipulation need to be regulated. But the ICMR wants the use of minimally manipulated stem cells also to require approval before they are offered as clinical therapy.

Last year, the ICMR had asked doctors offering stem cell procedures to submit clinical data demonstrating the efficacy of these therapies but the research body did not receive any submissions of importance. “Some doctors submitted us hypothesis on stem cells,” said an official from ICMR. “No one had any scientific data to show us [that the therapies were effective].”

Capacity of the regulator

Health activists and researchers said that the regulatory difficulties cannot be an excuse to not regulate the industry. Dr Anant Bhan, a researcher of bioethics and global health and policy, pointed out that patients will be more vulnerable to exploitation in the absence of a regulatory authority. “We have already seen cases where families have paid heavy sums to get these so called magical stem cell therapies and haven’t been benefited,” he said. “There are concerns about the safety and utility of stem cell therapies and [having] no regulation would only bring bad name to the industry and increase distrust.”

Not surprisingly, doctors working on stem cell therapies have welcomed the proposed amendments.

“It is an extremely proactive step from the regulator,” said Dr Abhjit Bopardikar, director of Reelabs, a company dealing in stem cell banking and therapies.

Speaking to Economic Times, Stem Cell Society of India president Dr Alok Sharma called the changes progressive and in line with developments in countries like Japan, Korea and the US.

“This amendment will facilitate growth of cell therapies in India and will also make these therapies available to lakhs of patients who are currently suffering with incurable diseases,” he said.

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Swara Bhasker: Sharp objects has to be on the radar of every woman who is tired of being “nice”

The actress weighs in on what she loves about the show.

This article has been written by award-winning actor Swara Bhasker.

All women growing up in India, South Asia, or anywhere in the world frankly; will remember in some form or the other that gentle girlhood admonishing, “Nice girls don’t do that.” I kept recalling that gently reasoned reproach as I watched Sharp Objects (you can catch it on Hotstar Premium). Adapted from the author of Gone Girl, Gillian Flynn’s debut novel Sharp Objects has been directed by Jean-Marc Vallée, who has my heart since he gave us Big Little Lies. It stars the multiple-Oscar nominee Amy Adams, who delivers a searing performance as Camille Preaker; and Patricia Clarkson, who is magnetic as the dominating and dark Adora Crellin. As an actress myself, it felt great to watch a show driven by its female performers.

The series is woven around a troubled, alcohol-dependent, self-harming, female journalist Camille (single and in her thirties incidentally) who returns to the small town of her birth and childhood, Wind Gap, Missouri, to report on two similarly gruesome murders of teenage girls. While the series is a murder mystery, it equally delves into the psychology, not just of the principal characters, but also of the town, and thus a culture as a whole.

There is a lot that impresses in Sharp Objects — the manner in which the storytelling gently unwraps a plot that is dark, disturbing and shocking, the stellar and crafty control that Jean-Marc Vallée exercises on his narrative, the cinematography that is fluid and still manages to suggest that something sinister lurks within Wind Gap, the editing which keeps this narrative languid yet sharp and consistently evokes a haunting sensation.

Sharp Objects is also liberating (apart from its positive performance on Bechdel parameters) as content — for female actors and for audiences in giving us female centric and female driven shows that do not bear the burden of providing either role-models or even uplifting messages. 

Instead, it presents a world where women are dangerous and dysfunctional but very real — a world where women are neither pure victims, nor pure aggressors. A world where they occupy the grey areas, complex and contradictory as agents in a power play, in which they control some reigns too.

But to me personally, and perhaps to many young women viewers across the world, what makes Sharp Objects particularly impactful, perhaps almost poignant, is the manner in which it unravels the whole idea, the culture, the entire psychology of that childhood admonishment “Nice girls don’t do that.” Sharp Objects explores the sinister and dark possibilities of what the corollary of that thinking could be.

“Nice girls don’t do that.”

“Who does?”

“Bad girls.”

“So I’m a bad girl.”

“You shouldn’t be a bad girl.”

“Why not?”

“Bad girls get in trouble.”

“What trouble? What happens to bad girls?”

“Bad things.”

“What bad things?”

“Very bad things.”

“How bad?”

“Terrible!!!”

“Like what?”

“Like….”

A point the show makes early on is that both the victims of the introductory brutal murders were not your typically nice girly-girls. Camille, the traumatised protagonist carrying a burden from her past was herself not a nice girl. Amma, her deceptive half-sister manipulates the nice girl act to defy her controlling mother. But perhaps the most incisive critique on the whole ‘Be a nice girl’ culture, in fact the whole ‘nice’ culture — nice folks, nice manners, nice homes, nice towns — comes in the form of Adora’s character and the manner in which beneath the whole veneer of nice, a whole town is complicit in damning secrets and not-so-nice acts. At one point early on in the show, Adora tells her firstborn Camille, with whom she has a strained relationship (to put it mildly), “I just want things to be nice with us but maybe I don’t know how..” Interestingly it is this very notion of ‘nice’ that becomes the most oppressive and deceptive experience of young Camille, and later Amma’s growing years.

This ‘Culture of Nice’ is in fact the pervasive ‘Culture of Silence’ that women all over the world, particularly in India, are all too familiar with. 

It takes different forms, but always towards the same goal — to silence the not-so-nice details of what the experiences; sometimes intimate experiences of women might be. This Culture of Silence is propagated from the child’s earliest experience of being parented by society in general. Amongst the values that girls receive in our early years — apart from those of being obedient, dutiful, respectful, homely — we also receive the twin headed Chimera in the form of shame and guilt.

“Have some shame!”

“Oh for shame!”

“Shameless!”

“Shameful!”

“Ashamed.”

“Do not bring shame upon…”

Different phrases in different languages, but always with the same implication. Shameful things happen to girls who are not nice and that brings ‘shame’ on the family or everyone associated with the girl. And nice folks do not talk about these things. Nice folks go on as if nothing has happened.

It is this culture of silence that women across the world today, are calling out in many different ways. Whether it is the #MeToo movement or a show like Sharp Objects; or on a lighter and happier note, even a film like Veere Di Wedding punctures this culture of silence, quite simply by refusing to be silenced and saying the not-nice things, or depicting the so called ‘unspeakable’ things that could happen to girls. By talking about the unspeakable, you rob it of the power to shame you; you disallow the ‘Culture of Nice’ to erase your experience. You stand up for yourself and you build your own identity.

And this to me is the most liberating aspect of being an actor, and even just a girl at a time when shows like Sharp Objects and Big Little Lies (another great show on Hotstar Premium), and films like Veere Di Wedding and Anaarkali Of Aarah are being made.

The next time I hear someone say, “Nice girls don’t do that!”, I know what I’m going to say — I don’t give a shit about nice. I’m just a girl! And that’s okay!

Swara is a an award winning actor of the Hindi film industry. Her last few films, including Veere Di Wedding, Anaarkali of Aaraah and Nil Battey Sannata have earned her both critical and commercial success. Swara is an occasional writer of articles and opinion pieces. The occasions are frequent :).

Watch the trailer of Sharp Objects here:

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This article was published by the Scroll marketing team with Swara Bhasker on behalf of Hotstar Premium and not by the Scroll editorial team.