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SC directs Union govt & respondents to submit list of FDCs in 3 categories in 2 weeks
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Our Bureau, Bengaluru
October 31 , 2017
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Supreme Court of India has directed Union government and the respondent
pharma companies to submit within two weeks the list of fixed dose
combinations (FDCs) in three categories. This would enable the Court to
take a final decision on the much debated FDCs. On December 1, 2016, the
government had banned the 344 FDCs stating that they are harmful for
patients in the country. However the Supreme Court reserved the order
which is expected to come up for hearing on November 15.
Leading
pharma majors including multinational companies like Pfizer among
others who are the respondents argued that all these 344 FDCs were in
the market and were successful going by its acceptance in the healthcare
stream as patients responded to positive treatment outcomes with the
same.
In order to take the final call, the Supreme Court has now
ordered that the Union government which is the petitioner should submit
the first list of containing three categories of FDCs. The first
category listing of FDCs are those marketed before 1988 and the second
list would be those sold post 1988.
The Court has also called for
a second list containing four categories. The first list is where
Kokate Committee found the FDCs as having risk to human life. The second
is where the FDCs were without any therapeutic value as claimed. The
third is where the FDCs had no therapeutic justification and the fourth
for other reasons.
The order stated, “Upon hearing the counsel
the Court ordered via Petition(s) for Special Leave to Appeal (C) No(s).
7061/2017. This was arising out of impugned final judgment and order
dated 01-12-2016 in WPC No. 2212/2016 passed by the High Court of Delhi
at New Delhi.”
“Having heard the learned counsel for the parties
for some time, we are of the view that in the event of the impugned
judgment is being set-aside, there would be two courses open to us
namely, either to send back all the matters on points that have not been
adjudicated or to refer only certain categories of cases to the Expert
Board set up under Section 5 of the Drugs and Cosmetics Act, 1940,”
stated the SC order.
“We, therefore, grant a period of two weeks
in which the petitioner and respondents will categorise 349 cases that
have been interdicted by notification under Section 26A all cases that
are pre-21.9. 1988 and those after September 21, 1988 for which no
approvals by the Drugs Controller General of India have been granted,”
stated the SC order.
Further the Court also called for the need for further categorisation to be made depending upon the Kokate Committee's report.
“Apart
from this, we are also informed that there are cases of apparent
perversity which may separately be categorised. Armed with this
information, ultimately necessary directions may have to be issued in
respect of some of the categories above-mentioned. During the course of
hearing of these petitions, we have been informed that a number of
SLPs/TPs. have not been listed before us because of non-removal of
defects. We order that all SLPs/T.Ps whether defective or otherwise be
listed on the next date of hearing on October 25, 2017, along with these
matters,” stated the order.
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