Kolkata: Calcutta High Court on Thursday directed the additional solicitor-general to take instructions from the Centre about ways to import a particular drug for muscular dystrophy—a rare disease—for patients in India.
Givinostat, an oral non-steroid drug manufactured in the US, has received approval from the Federal Drug Administration (FDA) US in March 2024, but it is yet to be approved by the Central Drugs Standard Control Organization (CDSCO) in India.
The counsel for the petitioner submitted prescriptions, in which doctors of AIIMS, Kalyani, and two other hospitals had recommended the drug for patients suffering from the rare disease, Duchenne Muscular Dystrophy (DMD).
Additional solicitor-general Asoke Kumar Chakraborty submitted to the division bench of Chief Justice T S Sivagnanam and Justice Hiranmay Bhattacharyya that the directorate of health services, India, was not in the process of approving the drug. The petitioner submitted that an NGO was importing the drug for patients willing to take the medicine at their own risk. The petitioner’s counsel submitted that the drug cost Rs 70,000 a bottle.
The petitioner’s counsel also submitted to the division bench an order of the Delhi High Court, in which it was stated that 14 patients, including those suffering from DMD, were being treated at AIIMS, Delhi and the drug manufacturer, Sarepta, had been providing the medicine to AIIMS at concessional rates. The Delhi HC directed the health ministry to release Rs 10 crore to AIIMS, Delhi, for it.
The counsel prayed to the division bench for an appropriate order so that the AIIMS model could be replicated for treating DMD patients at IPGMER.
The division bench directed Chakraborty to take instructions from the GOI, ascertaining the process of importing the drug through proper channels. The bench told the ASG to take instructions from the health ministry if the AIIMS model could be followed at IPGMER.