Ahmedabad: A Vadodara-based telemedicine company has moved Gujarat High Court after Food and Drugs Control Administration (FDCA) cancelled its licence for selling obesity drug Mounjaro without an endocrinologist’s prescription.FDCA cancelled Medicament Solutions Pvt Ltd’s licence to sell medicines on April 2, following a show-cause notice issued in March. The company’s appeal was rejected on July 27 by the deputy secretary in the health and family welfare department, leading it to approach the high court alleging the procedure was not followed and its explanations were not considered, making the decision “arbitrary, irrational and passed in violation of principles of natural justice.”Authorities said inspection of records showed sales bills did not mention complete addresses of doctors and patients, affecting traceability. They also pointed to the product label for Mounjaro Kwikpen Inj stating it should be given only on the prescription of an endocrinologist or an internal medicine specialist, but alleged the company sold it on prescriptions issued by Dr Karishma Mataina (MD General medicine).FDCA also cited the drug’s subcutaneous administration, stating it requires a doctor’s presence, while the company allegedly sent the injections to patients via courier. Officials said about 2,600 such injections were sold in a year and alleged misuse of the retail licence, calling it harmful to public health.The appellate authority, while upholding the cancellation, noted guidelines exist for dispensing medicines through telemedicine but said there is no legal provision governing it. “It is the moral duty of the licensee and the authorities to ensure that public health is not harmed due to the grey area that has been created here,” the appellate authority mentioned in his order.In its petition through advocate Arjun Sheth, the company said it had detailed its sales, prescription and delivery procedure in its show-cause reply but the authorities did not consider it. It contended the cancellation was based on grounds not mentioned in the show-cause notice, denying it an opportunity to respond to the mandates later cited in the final order.The firm also argued the authorities’ position was self-contradictory in referring to telemedicine guidelines while insisting there is no legal provision. It further questioned the insistence on face-to-face consultation and the contention that an MD (general medicine) is ineligible to prescribe Mounjaro, citing National Medical Commission’s curriculum for the MD (general medicine) course.After hearing the company, Justice Aniruddha Mayee issued notice to the authorities, seeking a response on why it should not stay coercive action against the firm and allow it to resume operations. The matter will be heard next on Nov 23.
