Breaking:”Govt acted in a haphazard manner”Del HC quashes FDC ban [Read Judgment]

Rajiv Sahai Endlaw, J. of the Delhi High Court, today, quashed 344 notifications issued in March this year by the Ministry of Health and Family Welfare banning Fixed Dose Combination (FDC) drugs. The judgment was reserved on June 2 this year..A Fixed Dose Combination drug is one that contains two or more drugs combined in a fixed ratio of doses into a single dosage form. Millions of unapproved formulations of FDC drugs are available in India, although an approval from the Central Drugs Standard Control Organisation (CDSCO) is mandatory for FDCs since 1961..Top-players like Pfizer, Glenmark, Procter & Gamble, Sun Pharmaceuticals, Sanofi, Cipla and Dr. Reddy’s had approached the Court, with their lawyers arguing that the government had not properly implemented their powers to prohibit manufacture of drugs and cosmetics in public interest under the Drugs and Cosmetics Act. In this regard, Justice Endlaw held in his 82-page judgment,.“Section 26A does not vest the Central Government with a carte blanche to regulate, restrict or prohibit the manufacture, sale or distribution of a drug. The Central Government can exercise power thereunder only when satisfied that the drug involves risk to the consumers thereof or does not have any therapeutic value or contains ingredients of which there is no therapeutic justification ‘and’ that in public interest it is necessary or expedient to regulate, restrict or prohibit that drug. .Thus, the power of regulation, restriction or prohibition under Section 26A cannot be exercised in public interest, for any reason other than the drug posing a risk to consumers thereof or having no therapeutic value or no therapeutic justification.”.The Government had defended its action and said that the ban was imposed because popular drug brands like Corex cough syrup, Phensedyl, D’Cold and Vicks Action 500 Extra were ‘unsafe’ and not efficacious. Dealing with this issue, Justice Endlaw opined,.“I have already held above that this Court in exercise of power of judicial review cannot adjudicate whether these FDCs are risky to the consumers or lack therapeutic value or therapeutic justification. The statute requires the said aspects to be considered by DTAB and DCC and to report thereon. That has admittedly not been done.”.ASG Sanjay Jain had appeared for the government and submitted that most licenses given to the pharma companies for manufacturing the drugs were given by State Governments and when these Governments did not take any action against the said ‘harmful’ drugs, the Parliamentary Committee had to intervene and conduct a proper drug trial..The bench criticized the manner in which the government acted stating,.“To say the least, the Central Government, though acting in public interest, seems to have gone about it in a haphazard manner. It claims that the FDCs for manufacture of which licences were issued by SLAs between September, 1988 and 1st October, 2012 without the same having approval of the Drugs Controller were wrongly granted such licences. However instead of taking action for cancellation of said licences, the manufactures were asked to apply for licences to be Drugs Controller, while continuing to manufacture the drugs for which according to the Central Government licence was wrongly given.”.The stay order on the Government’s notification that was initially granted to Pfizer Ltd, triggered a slew of pharmaceutical companies to come knocking on the doors of the High Court and demand a similar relief. Mumbai-based law firm Veritas Legal advised Pfizer with a team led by Partners Abhijit Joshi and Rahul Dwarkadas along with Yuvraj Choksy and Rebha Dakshini. Aggarwal & Associates also assisted Veritas on this matter..Even as pharma companies rejoice, an appeal to a division bench seems imminent..Read the judgment: