‘Decision to ban FDC drugs, a legislative action’, ASG Sanjay Jain tells Delhi High Court

In a hearing that has spanned nearly two weeks now, the Centre today told the Delhi High Court that the Health Ministry’s decision to ban 344 FDC drugs was a legislative action..Hence, it was not incumbent upon the Government to seek advice from any Committee in this regard..ASG Sanjay Jain, appearing before Justice RS Endlaw, argued that Section 26A of the Drugs & Cosmetics Act gave powers to the Government for regulating drugs to its ‘satisfaction’ and by way of prohibition, if it came to light that a particular drug posed ‘significant risk’ to human health and had no therapeutic justification..Jain also submitted that the affirmation of unsafe drugs might come through the recommendations of a technical committee, a Government appointed Committee or through any other relevant material available with the Government..The law officer was responding to arguments made by the pharmaceutical companies earlier when they had submitted that the government had not followed due process but exercised its own discretion..The companies had also argued that the Kokate Expert Committee, on whose recommendations the government had banned the drugs, was not a statutory body; the Drug Technical Advisory Board (DTAB) being the competent authority in this regard..While the Bench will continue hearing the case on April 4, the interim stay on the ban will continue. Yesterday, Senior Advocate Kapil Sibal had completed his arguments on behalf of Pfizer Ltd, with the Bench had directing the other petitioners to frame issues that were yet to be argued.