Is stem cell treatment legal in India?

 

A Delhi High Court judgement (Raghubir Singh v. Union of India May 28, 2019), allowed a clinic in New Delhi to continue embryonic stem cell therapy for some of their patients even in the absence of an approval under the New Drugs and Clinical Rules, 2019.

Two patients undergoing the embryonic stem cell therapy were suffering from cerebral palsy. The clinic began treating these patients in October 2018; and when the New Drugs and Clinical Rules, 2019 came in, the clinic discontinued its treatment. 

The medicine provided to the patients under such treatment were new drugs, as defined under the New Drugs and Clinical Rules 2019 being a stem cell derived product. 

The Rules state that to manufacture new drugs for the purpose of sale, permission from the Central Licencing Authority is required. After obtaining permission the company or person must get a licence under the Drugs and Cosmetics Act, 1940. 

The patients pleaded that the treatment provided to them was necessary for their daily sustenance of life and basic activities. If the treatment were discontinued, it would lead to a serious impact on their health, and in the time that would lapse until the clinic obtained the marketing license, serious prejudice would be caused to their health.  The patients asked the court to allow the clinic to provide the treatment until the clinic obtained the necessary licences.

The court allowed the treatment to be continued, provided the clinic submits all the information related to the treatment to the Central Drugs Standard Control Organisation.

The National Guidelines for Stem Cell Research 2017 by the Indian Council of Medical Research (ICMR) provide that any stem cell use in patients, other than for hematopoietic stem cell (cells usually found in bone marrow, peripheral blood or umbilical cord blood) reconstitution for approved indications, is investigational. So, stem cell use in patients can only be as part of an approved and monitored clinical trial, and not therapy. Every use of stem cells in patients outside an approved clinical trial is deemed unethical and considered as malpractice.

But the guidelines are not legally enforceable so many clinics provide stem cell treatments without putting the stem cell related products through clinical trials. The Ministry of Health and the ICMR have argued for several years over rules on stem cells that could be exploited as a loophole and allow doctors to offer unproven and unregulated stem cell therapies.

The New Drugs and Clinical Rules, 2019 include stem cell derived products without creating any exemptions for minimally manipulated stem cells, so it does not define stem cell derived products. So, several clinics offer stem cell based treatments that should be only allowed if they have the licences to continue their operations. Despite the law, some clinics continue as before with no licence.

The judgement allows a clinic to provide treatment that hasn't been approved through trials or received a licence. The court has chosen a humanitarian course by permitting such treatment to continue only until the clinic obtains the necessary licence. It is not a generic rule but offers other clinics legal loopholes.

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