The Gujarat High Court has sought a response from authorities after a Vadodara-based telemedicine company challenged the cancellation of its licence to sell Mounjaro, an obesity drug, allegedly without prescriptions from an endocrinologist or internal medicine specialist.
Food and Drugs Control Administration (FDCA) cancelled the licence of Medicament Solutions Pvt Ltd on April 2, after issuing a show-cause notice in March. The company’s appeal was rejected by the deputy secretary in the health and family welfare department on July 27, prompting the firm to approach the high court.
The company has alleged that the cancellation was arbitrary, irrational and contrary to principles of natural justice. Through its advocate Arjun Sheth, it told the court that its detailed explanation of its sales, prescription and delivery process had not been properly considered. It also contended that the final order relied on grounds that were not included in the show-cause notice, leaving it without an opportunity to respond to those issues.
According to the authorities, an inspection of the company’s records found that sales bills did not contain the complete addresses of doctors and patients, affecting the traceability of the medicines. FDCA also referred to the product label for Mounjaro Kwikpen Inj, which states that it should be administered only on the prescription of an endocrinologist or an internal medicine specialist.
Officials alleged that the company sold the injections on prescriptions issued by Dr Karishma Mataina, identified in the report as an MD in general medicine. They also raised concerns about the drug’s subcutaneous administration, stating that it requires a doctor’s presence, while the company allegedly sent the injections to patients through courier. Authorities said around 2,600 such injections were sold in one year and described the alleged use of the retail licence as harmful to public health.
The company has disputed the authorities’ position on prescriptions and face-to-face consultations. It has questioned the claim that an MD in general medicine is ineligible to prescribe Mounjaro, citing the National Medical Commission’s curriculum for the course. It has also argued that the authorities’ reference to telemedicine guidelines was inconsistent with their simultaneous assertion that there was no legal provision governing the dispensing of medicines through telemedicine.
The appellate authority, while upholding the licence cancellation, noted that guidelines exist for dispensing medicines through telemedicine but said there is no legal provision specifically governing the practice. The order said it was the moral duty of both licensees and authorities to ensure that public health was not harmed by the resulting grey area.
After hearing the company, Justice Aniruddha Mayee issued notice to the authorities and sought a response on why coercive action against the firm should not be stayed and why it should not be allowed to resume operations. The matter is scheduled for its next hearing on November 23.
