BIOSPECTRUM | SEPTEMBER 2018 | http://www.biospectrumindia.com OPINION^29
FDC Ban – a well-intended
but overdone development
Shree Divyya,
Senior Consultant,
Sathguru
Management
ConsultantsA
lthough the report of the Drug Testing Advisory
Board (DTAB) sub-committee constituted to
review 343 (plus 6) Fixed Dose Combinations
(FDCs) is not yet in public domain, it is akin to an
execution sentence for several companies and brands
they have toiled to create. While the coffin is still not
nailed, it has been an arduous and long drawn journey
so far for the 343 FDCs - On 10th March, 2016, based
on the Kokate Committee report, the health ministry
banned 344 FDC drugs. Given the sweeping business
implications of this decision, pharma companies moved
the Delhi High Court with 454 petitions challenging
the decision and claiming it was not done through a
statutory body consultation process. While this led to a
withdrawal of the ban, the government took this matter
to the Supreme Court which mandated the DTAB to
make final recommendations. The proposed ban and
the impending judgment is bound to have far reaching
implications for both, the Pharma industry and the
Indian patients:FDCs are not always harmful and are
clinically preferred in several cases
There is no denying that overuse or abuse of combinations
could result in unintended harm to patients. Specifically,
FDCs with pharmacodynamic mismatch between
the two components, chemical non-compatibility
and bizarre combinations of many ingredients with
or without rationality for their presence and in the
quantity combined are not acceptable. However, unlike
the popular inference from developments over the last
couple of years, FDCs are not always harmful. In fact,
FDCs are required for the treatment of infectious diseases
like HIV, hepatitis-C, malaria and tuberculosis, where
usage of multiple antimicrobial agents is necessary to
combat the disease. The clinical importance of FDCs is
evident from the fact that even WHO’s list of Essential
medicines includes about more than 30 FDCs as these
drugs are useful for chronic conditions, especially
when multiple disorders co-exist. Not just in infectious
diseases, there is also significant clinical justification for
use of FDCs in various chronic conditions. Globally,
they have gained popularity as a means of ensuring
ease of use and administration as well. Given that no
two FDCs are comparable on clinical rationale or harm
to patients, it is surprising that a blanket decision has
been made with a single lens for the 343 FDCs currently
under consideration.Pushpa
Vijayraghavan,
Director, Sathguru
Management
ConsultantsOn July 26, the sub-committee of Drugs
Technical Advisory Board (DTAB), the
highest drug advisory body on technical
matters in the country formed by the
Health Ministry, has recommended
prohibition of 343 fixed drug combinations
(FDCs) after reviewing 349 and called for
regulation and restriction of remaining
six. The 12 member DTAB, which was
reconstituted in May 2018 with Director
General of Health Services (DGHS) Dr
Promila Gupta as an ex-officio chairman
and Drugs Controller General of India Dr
S Eswara Reddy as an ex-officio Member
Secretary with 8 members (including
Pankaj Patel, Chairman and Managing
Director, Zydus Cadila Group) and 2 special
invitees. The expert sub-committee in its
reports suggested banning 343 FDCs,
three should be restricted for specific
indications or diseases and other three
FDCs should be restricted to specific
quantities of ingredients and for specific
indications. It stated that for most FDCs,
their use will lead to unnecessary overuse
and patients will be exposed to risk of
multiple ingredients when one will suffice.