Page 43 - A&A Patents&Design Rewind-2016

advice the Central Government and the DTAB on though acting in public interest, seems to have gone
any matter tending to secure uniformity throughout
India in administration of the Act.
Merely because the powers vested in the
Central Government vide some other Sections
of the Act expressly provide for exercise
thereof on advice of or in consultation with the
DTAB and/or the DCC does not take away
from the wide language used in Sections 5 and
7, while prescribing the purpose of constitution
of the DTAB and the DCC, to advise the
Central Government on technical matters
arising out of administration of the Act and
to carry out other functions assigned to the
Central Government by the Act
The Court cited 6 judgments delivered by various
High Courts in support of the proposition that
the DTAB and the DCC play a central role in the
decision making process, envisaged by Section 26A.
On the basis of these judgments, it drew inference
that a decision made under Section 26A without
consulting these bodies would be legally untenable. http://lobis.nic.in/ddir/dhc/RSE/
The Court also held that the Central Government,
about it in a haphazard manner. It claims that the
licenses for manufacture of the FDCs were wrongly
issued by SLAs between September, 1988 and 1st
October, 2012 without the approval of the Drugs
Controller. However, instead of taking action for
cancellation of said licenses, the manufactures were
asked to apply for licenses before Drugs Controller,
while continuing to manufacture the drugs where,
according to the Central Government, license(s)
was wrongly granted. When such applications were
received, instead of the same being considered by
the Drugs Controller, who is vested with the power
of approval, ten committees were constituted for
considering the applications. After the committees
failed to examine all the applications, the Kokate
Committee was constituted which instead of
considering the applications for approval, went into
the aspects of risk to consumers and therapeutic
value and therapeutic justification and consequently
issued the impugned notifications.
The order can be accessed at:-
judgement/01-12-2016/RSE01122016CW22122016.
pdf
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