Patients turn litigants as new rules stall therapy

Several critically ill patients have been forced to line up at the Delhi High Court after they suddenly stopped getting their medication following the implementation of the Centre’s ‘New Drugs and Clinical Trials Rule 2019’.

The March 19 notification, issued by the Ministry of Health and Family Welfare, marked “stem cell derived products” under the definition of “new drug”. It also mandated that such formulations are approved by the Central Drugs Standard Control Organisation. The new rules require clinics engaged in such ‘new drug’ therapy to acquire a marketing licence. But there is no provision for an interim arrangement for the period between an application being made to the Drug Controller and a decision being taken on the application.

While this process is likely to take few months, four patients with different ailments, have moved the High Court as their treatments has been discontinued.

One of the appellants, Krishna Tokas, in his plea filed through advocate Ajay Kohli, said he was suffering from a spinal injury and the notification of the new rules had resulted in stoppage of his Human Embryonic Stem Cell Therapy, which was required for his day-to-day sustenance of life and basic activities.

Mr Tokas said the clinic administering the treatment was now unable to function until it obtained a licence.

Another petition was filed by Ms Rita Devi suffering from Dilated Cardiomyopathy, who had also stopped receiving Human Embryonic Stem Cell Therapy.

Interim order

Taking note of the issue at hand, a Bench of Justice G.S. Sistani and Justice Jyoti Singh said the treatment being provided to the four patients should not be hindered. As an interim measure, and till such time as the clinics’ application for a licence is processed, the Bench allowed patients to continue receiving therapy from their clinics.

It also said the clinics in question should submit all information on the treatment being afforded to the patients to the Central Drugs Standard Control Organisation (CDSO).


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