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Karnataka pharma hopeful of govt calling on industry to discuss the way forward with FDCs
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Nandita Vijay, Bengaluru
December 08 , 2016
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Following the reversal on the ban of 344 fixed dose combinations (FDCs)
by the Delhi High Court on December 1, 2016, the Karnataka pharma
companies are hoping that the government would call on the industry to
discuss the way forward.
The FDC ban in March this year was done
too quickly and there was no rational behind the move which led the
DCGI to issue an immediate embargo on sale of these drugs in March this
year, said Dr BR Jagashetty, former National Adviser (Drugs Control) to
MoHFW.
Quoting the PharmaLetter news report, which stated
“Though the government has already filed an appeal in the Supreme Court
against the decision, drug companies are now seeking a reconciliation
with the health ministry and are moving towards an out-of-court
settlement regarding the vexed issue,” Dr. Jagashetty said that the
decision on reversing the DCGI order by the Delhi High Court seems to be
mainly on purely administrative or non technical matters.
He
further stated that the Delhi High Court could have considered technical
and scientific material evidence, if any, produced by the government of
India since this ban is mainly because of the irrational combinations
which have no therapeutic value. All these 344 FDCs were in the market
and were successful in the market going by its acceptance in the
healthcare stream as patients responded to positive treatment outcomes
with the same. Therefore there are no questions for such a mass ban, he
added.
The DCGI decision to withdraw the drugs is based on
guidance of the Kokate Committee testimony. But there should have been
scientific backing on the possible health hazards given to the industry
before hastily withdrawing the FDCs, pointed out Dr. Jagashetty.
According
to Sunil Attavar, president, Karnataka Drugs and Pharmaceutical
Manufacturers Association (KDPMA), we are all for banning the grossly
irrational FDCs. Now that the order is reversed, the government should
get together with the industry to find a way forward on these and other
combinations that still exist and were not part of the 344 banned drugs
list.
Currently, most of the small and medium enterprises in
Karnataka have already changed their formulations to DCGI approved
combinations, said Attavar. “We are not opposed to weeding out
irrational products. But the issue could have been handled better by
sensitizing the industry and comprehensive dialogue with all
stakeholders. Nobody gains by selling irrational products and the
industry had time and again suggested voluntary withdrawal of FDCs,
pointed out Harish K Jain, secretary, KDPMA and director, Embiotic
Laboratories.
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