Delhi high court sets aside Centre's decision to ban 344 fixed dose combination medicines
The Delhi high court on Thursday set aside
the Centre's decision to ban 344 fixed dose combination (FDC) medicines,
including well known brands like Corex cough syrup, Vicks Action 500 extra and D'Cold.
The court pronounced its order after hearing
arguments of companies like Pfizer, Glenmark, Procter and Gamble and Cipla, the
central government and some NGOs like All India Drug Action Network (AIDAN)
over a span of over two months, starting from March 14.
The court had on March 14 stayed the Centre's
March 10 ban on 344 FDC drugs and this interim order was passed in each and
every case filed before it thereafter.
During arguments, the drug companies had
contended that the government has not properly implemented the powers under
section 26A (power to prohibit manufacture of drugs and cosmetics in public
interest) of Drugs and Cosmetics Act, under which the ban was ordered.
They had also argued that the ban order was
passed without considering clinical data and had termed as "absurd" the government's
claim that it took the decision to ban FDCs on the ground that safer
alternatives were available.
The government had banned over 300 FDC drugs
on the ground that they involve "risk" to humans and safer
alternatives were available.
As per the March 10 notification, "On the basis of recommendations of an expert
committee, the central government is satisfied that it is necessary and
expedient in public interest to regulate by way of prohibition of manufacture
for sale, sale and distribution for human use of said drugs in the country."
Defending its stand, the Centre had argued
that the FDC medicines are "new drugs" and thus, require licence from
Drugs Controller General of India (DCGI) for sale and manufacture.
The government had also said there were no
valid licences for making any of the banned FDCs and added it was difficult to
implement any action at state level.
However, it had also said that the lack of
approval for these FDCs were a secondary issue and the primary focus was that
they "lacked safety and efficacy"
and thus, "ban was the only answer".
It had also said that the banned FDCs had no
"therapeutic justification".
AIDAN, which had intervened in the matter,
had argued that there were nearly 40,000 FDC drugs in Indian market and since
the regulatory control over such medicines was allegedly "illusory",
the Centre's decision to ban some of them "was the only move".
Even the Indian Medical Association (IMA) had
moved an application seeking intervention in the matter saying it has decided
to support the Centre's decision.
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