Regulatory uncertainty concerning stem cell treatment in India has been a polarizing issue. In a recent Delhi High Court judgement (Mr. Raghubir Singh and Another v. Union of India and Another dated May 28, 2019), the court passed a ruling allowing 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.
In the instant case, two patients undergoing the embryonic stem cell therapy were suffering from cerebral palsy. The clinic in question was treating these patients since October, 2018; since the notification of the New Drugs and Clinical Rules, 2019, the clinic discontinued its treatment. The medicine provided to the patients under such treatment fell within the ambit of 'new drugs' as defined in Rule 2(1)(w)(v) of the New Drugs and Clinical Rules, 2019 being a stem cell derived product. As per the New Drugs and Clinical Rules, 2019 in order to manufacture new drugs for the purpose of sale, permission from the Central Licencing Authority is required. After obtaining permission under the New Drugs and Clinical Rules, 2019, the person intending to manufacture a new drug for sale shall make an application for grant of licence in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and its related rules. The petitioners, being the patients, pleaded that the treatment provided to them was necessary for their day to day sustenance of life and basic activities. If the treatment was discontinued, it would lead to a serious impact on their health. It was emphasised that in the time period which would lapse till the clinic obtained the marketing license, serious prejudice would be caused to the health of the petitioners. The petitioners sought directions from the court to allow the clinic to provide the treatment to the petitioners till such time the clinic obtained the necessary licences.
The court passed a judgement in favour of the petitioners allowing the treatment to be continued, provided the concerned clinic submits all the information related to the treatment being afforded to the petitioners to the Central Drugs Standard Control Organisation within a period of one week from the date of the order. As an interim measure and till such time as the said clinic or at least some other clinic applied for a licence and the licence was processed, the concerned clinic was allowed to provide treatment to the petitioners.
The National Guidelines for Stem Cell Research 2017 ("2017 Guidelines") drafted 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. Accordingly, any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offer the same as therapy. In accordance with this stringent definition, every use of stem cells in patients outside an approved clinical trial would be unethical and be considered as malpractice.
The directory nature of these guidelines, lack of enforcement or presence of any other specific law on the subject has led to the mushrooming of many clinics that provide stem cell treatments without putting the stem cell related products through clinical trials.
The Ministry of Health and Family Welfare on April 04, 2018 had proposed a draft to amend the Drug and Cosmetics Rules, 1945 which included stem cells in the definition of 'new drugs' however it excluded 'minimally manipulated stem cells' from the definition of a 'drug' and exempted it from the purview of the Drugs and Cosmetics Rules, 1945. This drew the ire of the ICMR that viewed the proposed amendment as a contradiction to the 2017 Guidelines as the exclusion of 'minimally manipulated' stem cells, would be exploited as a loophole and allow doctors to offer unproven and unregulated stem cell therapies.
Before the proposed amendment came into force, the New Drugs and Clinical Rules, 2019 were notified which included 'stem cell derived products' without creating any exemptions for 'minimally manipulated stem cells'. The New Drugs and Clinical Rules, 2019, in fact, do not define stem cell derived products at all. Accordingly, several clinics that have been providing stem cell based treatments would have to discontinue such therapies as they are now required to obtain relevant licences to continue their operations.
The judgement in this instance, even though, an apparent boon for the petitioners concerned, allows a clinic to provide treatment which hasn't been approved through trials or received a licence. The court has chosen a humanitarian course by permitting such treatment to continue however, only till the time the concerned clinic or any other clinic obtains the necessary licence. Further, the language of the judgement makes it clear that such a treatment can only be administered to the petitioners (who are parties to the writ petition) and not to any other existing or new patients who require stem cell therapy. It nevertheless lays down a precedent for other clinics and their patients to follow suit and plead for such favourable orders. In the bargain to protect patient health, courts must duly consider the intent of regulatory teeth being given by way of the New Drugs and Clinical Rules, 2019 to monitor the stem cell therapy process, lest it becomes a get-out-of-trial card for profiteering clinics.
 Under Section 2(1)(w) "new drug" means- (i) a drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labelling thereof and has not been approved as safe and efficacious by the Central Licencing Authority with respect to its claims; or (ii) a drug approved by the Central Licencing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or (iii) a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or (iv) a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licencing Authority; or (v) a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug.
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