delhi high court

Delhi High Court: In a case wherein the petitioners filed the present petition impugning recommendations dated 06-12-2022 issued by the Committee on Stem Cell Use in Autism Spectrum Disorder constituted by Ethics and Medical Registration Board (‘EMRB’) of the National Medical Commission (‘NMC’), the Division Bench of Satish Chandra Sharma, C.J., and Sanjeev Narula, J., held that an abrupt cessation of the stem cell treatment might not be in the best interests of the patients involved and while granting permission to the petitioners to continue the stem cell treatment, the Court opined that they must do so with full knowledge and at their own risk.

The Counsel for the petitioners submitted that the children of the petitioners, who had been diagnosed with Autism Spectrum Disorder (‘ASD’), showed marked improvement after they were administered stem cell treatment. However, on account of the impugned recommendations, their treatment had been discontinued as their doctors were unwilling to continue the treatment on account of the stipulation in the impugned recommendation that any doctor who administered stem cell therapy would be subjected to proceedings for committing professional misconduct.

The Court stated that till date neither the National Medical Commission nor the Government of India had issued a definitive order prohibiting stem cell therapy for ASD. Furthermore, there were no statutory provisions that explicitly forbid the use of stem cell therapy in cases of ASD.

The Court noted that Dr. Sandhya Gokavarapu (‘Dr. Gokavarapu’), a distinguished oncologist and the mother of a child currently undergoing stem cell treatment for ASD, impressed upon the remarkable progress her child had made due to the therapy. Specifically, she stated there was a significant four percentage point reduction in the Childhood Autism Rating Scale (‘CARS’) within merely two months of initiating the treatment. The Court noted that Dr. Gokavarapu believed that any disruption in the treatment now would result in irreparable damage to her child’s health. Since the NMC was yet to render a decision concerning the recommendations as set forth in Section 27(2) in conjunction with Section 10 of the National Medical Commission Act, 2019, Dr. Gokavarapu appealed for the continuation of the therapy.

The Court noted that the impugned report acknowledged that “adult stem cells, after obtaining clearance from Institutional Ethics Committees for adherence to ethical standards, had been utilized in clinical trials due to their established safety”. The Court further noted that the petitioners were willing to continue with the treatments, fully acknowledging and accepting any potential risks, at their own discretion and that they would undertake this therapy without any financial support from the State.

The Court, upon reviewing the evidence and testimony presented, observed that the anecdotal evidence underscores potential benefits of the stem cell treatment, especially when early discontinuation might result in detrimental setbacks. The Court opined that “we must acknowledge that medical advancements often encompass both known and unforeseen risks, and individual autonomy in making informed decisions about treatment options was the cornerstone of patient rights”. The Court further opined that “in the spirit of patient autonomy, the petitioners were not seeking financial assistance from the State and were fully aware of and willing to assume potential risks. Their choice underscores their conviction in the treatment’s benefits for their loved ones”.

Thus, the Court held that an abrupt cessation of the treatment might not be in the best interests of the patients involved and while granting permission to the petitioners to continue the stem cell treatment, the Court opined that they must do so with full knowledge and at their own risk. The Court directed the NMC to expedite its review process and come to a conclusive decision, bearing in mind the Committee’s recommendations.

The matter would next be listed on 03-10-2023.

[Dalip Kaur v. Union of India, 2023 SCC OnLine Del 5491, Order dated 31-08-2023]

Advocates who appeared in this case :

For the Petitioners: Sandeep Sethi, Senior Advocate; Akshay Sapre, Shruti Shivkumar, Sahel Sood, Advocates; Dr. Gokavarapu Sandhya

For the Respondents: Chetan Sharma, ASG; Ripu Daman Bhardwaj, CGSC; Amit Gupta, Kushagra Kumar, Ghanshyam Jha, Saurabh Tripathi, Vikramaditya Singh, Advocates; Vedansh Anand, GP; Satya Ranjan Swain, Advocate, Panel Counsel; Kautilya Birat, Advocate; T. Singhdev, Aabhaas Sukhramani, Abhijit Chakravarty, Bhanu Gulati, Anum Hussain, Tanishq Srivastava, Advocates

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