Supreme Court cures headache for Saridon, two other banned FDC drugs (for now)

The Supreme Court today temporarily allowed the sale of Saridon and two other drugs after the Central government imposed a ban on the sale of 328 Fixed Dose Combination (FDC) drugs via a notification last week..The Bench of Justices Rohiton Nariman and Indu Malhotra issued notice to the Centre, seeking its response in the petition filed by drug manufacturers..The Union Health Ministry had banned the sale of 328 FDC drugs via a notification dated September 7. After it was moved by drug manufacturers, the Supreme Court allowed the sale of Saridon and two other drugs today. However, as regards other drugs in the list, no relief has been granted by the Supreme Court..Pharma company Piramal Healthcare’s Saridon was represented by Senior Counsel Mukul Rohatgi and Advocate Siddharth Bhatnagar, along with Karanjawala and Co.’s Samarjit Pattnaik, Debmalya Banerjee, Arjun Mahajan, Puneet Relan, Aman Singh and Aviral Kapoor. ASG Pinky Anand appeared for the Centre..Earlier, pharma giant Wockhardt had approached the Delhi High Court against the Health Ministry’s notification banning 328 FDC drugs, claiming that it had been producing its FDC tablet for over eleven years. It also contended that the ban was imposed without providing Wockhardt with a Drug Technical Advisory Board (DTAB) report..The petitioners before the Delhi High Court represented by Senior Counsel Parag Tripathi also contended that the report stated that the drug “may involve health risk”, but there was no Adverse Drug Report (ADR) for the tablet in question..Based on the technical ground, the Single Judge Bench of the Delhi High Court of Justice Vibhu Bakhru had set the next date of hearing for September 18 after issuing notice to the Centre. In its order dated September 14, the Court held that the petitioners shall not be stopped from producing the drug. Further, it was directed that the petitioners would not be proceeded against in respect of the medicines that are already in distribution channels..The High Court had also directed the respondents to furnish relevant extracts from the DTAB report that relate to the FDC in question, to the petitioners..In a similar move, the Health Ministry had banned the distribution, sale and manufacture of as many as 346 FDCs back in March 2016..The notification was challenged before the Delhi High Court and the Supreme Court, with the latter subsequently referring the matter to the DTAB for re-assessment and re-examination..The DTAB report stated that 328 out of the 349 FDC drugs may involve health risks to people and did not contain “therapeutic justification” for the ingredients. Therefore, the notification on September 7 this year banned the sale of FDCs like Saridon..Read Delhi High Court’s Order: