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.
“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.
