In an unprecedented move, the Ministry of Health and Family
Welfare proceeded to prohibit "the manufacture for sale,
sale and distribution for human use" of 344 (three
hundred and forty four) drugs constituting fixed dose combinations,
vide notifications bearing S.O. 705(E) through S.O. 1048(E) dated
March 10, 2016 ("Notifications"). These
Notifications were swiftly followed by a circular dated March 12,
2016, whereby Drugs Controller General of India
("DCGI"), reiterating the prohibition
and instructing the Drug Controllers of all states and union
territories to take necessary action in this regard.
The scale and magnitude of the ban has surely left
pharmaceutical sector shell-shocked. The genesis of the move can be
traced to the amendment made to the Drugs and Cosmetics Rules,
1945, in December 2001, whereby fixed dose combinations of two or
more approved drugs required permissions from the Licensing
Authority before its import or manufacture. The Notifications have
relied on the recommendations of an Expert Committee which has
found that these drugs have "no therapeutic
justification". The details of the Expert Committee are
not mentioned in the Notifications, however, it is likely, that the
Expert Committee refers to committee under the Chairmanship of
Prof. C. K. Kokate which had given its recommendations in July
2013. It is pertinent to mention here that the committee report
available on the website of the CDSCO does not contain the specific
recommendations of irrationality of any of the drugs prohibited
under the foregoing Notifications.
Subsequently, the Delhi High Court has granted an interim
injunction suspending the operation of notification bearing no.
S.O. 909(E) vis-à-vis the fixed dose combination of
Chlopheniramine Maleate + Codeine Syrup marketed by Pfizer under
the brand name "Corex" on March 14, 2016. On behalf of
Pfizer, it had been argued that the decision of Government
prohibiting Corex has been undertaken arbitrarily without due
process on its part. It is further being contended that the drug
has been marketed in India for over 25 (twenty five) years as well
as globally without any restrictions. The matter would come up
before the court again next week.
Prima facie there seem to be multiple irregularities in
the notification, especially, in light of the allegations made by
Pfizer that such steps have been taken without due process,
including an opportunity to show cause. However, its remains to be
seen whether that is actually the case, with the DCGI likely to
contend that ample opportunity has been afforded to the
stakeholders to represent against these coercive measures.
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