Delhi HC quashed the ban on fix dose combination:
Quashing the ban on 344 fixed dose combination (FDC) drugs, Delhi High Court said that the Centre had acted in a haphazard manner and did not take the advice of the statutory bodies under the Drugs and Cosmetics Act before issuing the March 10 notification.
What is a fixed-dose combination?
Fixed dose combinations are drugs with two or more active ingredients in a single dosage, acceptable only when the drugs so combined have a therapeutic advantage.
Grounds of removing ban:
1. The Centre had imposed the ban under Section 26A of the Drugs and Cosmetics Act. The court said the section gave no carte blanche to impose a ban.
The Health Ministry had banned the sale and distribution of 344 of them — considered unsafe and with no therapeutic justification — based on the recommendations of the Kokate expert committee.
2. Noting that the power cannot be exercised in public interest for any reason other than the drug being risky or not having any therapeutic value, the Bench said the same had to be decided based on scientific technical reasons on the advice of the Drugs Technical Advisory Body (DTAB) and the Drugs Consultative Committee (DCC) constituted under the Drugs Act.
The court wondered why the Centre took advice of Kokate Committee and not the DTAB and DCC.