Delhi High Court reverses ban on combination drugs


Quashing the ban on 344 fixed dose combination (FDC) drugs, Justice Rajiv Sahai Endlaw of the Delhi High Court said on Thursday 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?
  • An FDC is one that contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form.

“To say the least, the Central Government, though acting in public interest, seems to have gone about it in a haphazard manner..,” the court said in its 82-page judgment.

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 Bench said the Centre first claimed that licences for manufacture of the FDCs between September 1988 and October 2012 were wrongly granted by the State licensing authorities and had no approval of the Drug Controller. Instead of cancelling those licences, the manufactures were asked to apply for licences. Rather than the Drug Controller, 10 committees were constituted to consider the applications and when these committees failed to do their job, the Kokate committee was constituted. The Kokate committee, instead of considering the applications for approval, went into the aspects of risk to consumers, leading to the notifications.

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.

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Printable version | Nov 29, 2020 10:52:05 AM |

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