Relief to Abbott, MacLeods as Delhi High Court stays FDC drug ban

After Pfizer, the Delhi High Court today granted a breather to Abbott Healthcare Pvt Ltd and MacLeods Pharma when it stayed the Central Government’s Notification banning manufacture, distribution and sale of 344 Fixed Dose Combination (FDC) drugs..A Single Bench of Justice RS Endlaw, while noting that there was ‘no reason to not extend the stay granted to Pfizer Ltd to the other Petitioners’, also directed the Union to not take any co-ercive steps against the Petitioners and their stockists, retailers & distributors..The Bench also sought a reply from the government over the issue..“List the petitions on March 21. Till then, the effect of the notification qua the Petitioners will be stayed.”.Close on the heels of Pfizer that was granted the same relief yesterday by the same Bench, pharmaceutical giants Abbott Healthcare and MacLeods Pharma had moved the High Court and challenged the notification..As per Abbott’s petition, a copy of which is with Bar & Bench, the ban affected the company’s products Trustyl, Tossex and Phensedyl [cough syrups] which are FDC of codeine and chlorpheniramine..The petition states that,.“The ban on FDC on the basis that the same has no therapeutic justification is completely without application of mind inasmuch as the FDC which is in use for the last several decades would not have been in the market all over the world if the same would not have established and proven therapeutic justification…..….the fact that several established manufacturers of pharmaceutical preparations sell FDC in question establishes that there was no requirement to ban the FDC in India. The ban is per se illegal, unlawful and is liable to quashed immediately.” .The plea also states that the said Notification was issued without any ‘mandatory consultation with the Expert Committee’ and nor had the Respondents invited any suggestions/representations from the largest stake-holders for consideration..ASG Sanjay Jain appeared for the Union and argued that under Section 26A of the Drugs & Cosmetics Act of 1940, the government had the power to issue the said Notification. Opposing the grant of any interim order, he further submitted that there was a wrong impression being created that the decision to ban FDCs was against any specific company/brand, when it was not so..“A decision has been taken under detailed deliberation of an Expert Committee that does not agree that these drugs have any therapeutic value. .It is also not a case where the general public is suffering because the consumer of this country is not deprived of individual medicines that are combined to created FDCs. .The individual drugs making up the composition are freely available in the market.” .Senior Advocates AS Chandiok, CS Vaidyanathan and Sandeep Sethi appeared for Abbott, briefed by JSA. Pratibha M Singh appeared for MacLeods Pharma, briefed by Singh & Singh..Both the cases were taken up together and the ban was stayed qua both Petitioners till the next hearing on March 21.