NEW DELHI: In a blow to the Centre, its decision to ban 344 fixed-dose combination medicines (FDC), including well-known brands such as the Corex cough syrup and Vicks Action 500 Extra and several diabetes drugs, was on Thursday set aside by the Delhi High Court, which said the step was taken in a “haphazard manner” and that such bans were not justifiable unless when the medicines posed a risk to consumers.
Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharma and healthcare majors such as Pfizer, Glenmark, Proctor & Gamble and Cipla, challenging the government’s March 10 notification banning the FDC drugs, saying the decision was taken without following the procedure prescribed in the Drugs and Cosmetics Act.
The court, which on March 14 had stayed the operation of the Centre’s decision, said the powers under Section 26A of the Drugs and Cosmetics Act cannot be exercised in the public interest except when a drug posed a risk to consumers.
The drug companies also argued in the court that the ban order was passed without considering clinical data and had termed as “absurd” the government’s claim that it took the decision to ban FDC drugs on the ground that safer alternatives were available in the market.
The government had banned 344 FDC drugs saying that they involved a risk to human beings and that safer alternatives were available. As per the March 10 notification, “on the basis of recommendations of an expert committee, the Central government is satisfied that it is necessary and expedient in the public interest to regulate by way of prohibition of manufacture for the sale and distribution for the human use of said drugs in the country”.
Defending its stand, the Centre had argued that the FDC medicines were “new drugs” and thus required sale and manufacture licences from the Drugs Controller General of India.
The government had also said there the pharma companies had no valid licences for making the FDC drugs. However, it had also said that the lack of approval for these FDC drugs was a secondary issue and the primary focus was that they “lacked safety and efficacy” and thus, “the ban was the only answer”. It had also said that the banned FDC drugs had no “therapeutic justification”.
The fixed-dose combination medicines that were banned also include Glaxo’s Piriton expectorant and Crocin Cold, Reckitt’s D’Cold, Piramal’s Saridon, Glenmark’s Ascoril and Alex cough syrups, Abbott’s Phensedyl cough syrup and Alembic’s Glycodin cough syrup.