Sealing the FDC Drugs Fate
T
his is one inevitable news which obviously the
Indian pharmaceutical industry would not
like to hear as it would bring a big blow to the
industry. Over 6000 medicine brands of different
pharma companies and nearly Rs 2500 crore to Rs
3,000 crore market is at the stake for just one order
from the health ministry that is expected any time.
The decks for the health ministry order to ban
the Fixed Dose Combination (FDCs) Drugs are
cleared now with a sub-committee of the ministry’s
Drug Technical Advisory Board recommending
such a ban. The sub-committee headed by Dr
Nilima Kshirsagar, chair in Clinical Pharmacology
at Indian Council of Medical Research, has
recommended to ban 343 of the 349 “irrational”
FDCs that are potentially harmful to patients. It
has been stated that FDCs should be banned as
their safety was not established by the respective
drug producers. The remaining six drugs, the sub-
committee has recommended, should be restricted
and regulated.
This issue had been pending since over the last
two years when the government banned these drugs
first following a declaration made by a committee
headed by Prof C K Kokate, vice chancellor of
KLE University, Belagavi. Kokate committee was
constituted following concerns of experts about the
safety of FDCs which had been flooding the market.
They posed more danger since patients were self-
medicating many of those drugs.
However the entire matter took a legal turn
when the industry challenged the government ban
order in different high courts. Delhi Court quashed
the order on the grounds that before issuing the ban
order the government did not consult the statutory
bodies established under the Drugs & Cosmetics
Act 1940. The health ministry challenged the Delhi
High Court order in the apex court. Dr Kshirsagar
committee was appointed following the Supreme
Court order asking the ministry to re-examine the
issue through another expert committee.
The recently submitted report of the Kshirsagar
committee has now come as a bombshell for the
industry as it reconfirmed the ban with seriousobservations against FDCs. The committee said the
FDCs expose patients to overuse risks and could
result into adverse effects on human organs. It has
also pointed out that most of the FDCs producing
companies challenging the ban failed to generate
safety and efficacy data. Now that two subsequent
expert sub committees have given the similar
recommendation the industry may not have any
other choice but to accept it.
The pharma experts are raising more
fundamental and valid points in this issue. They
have pointed out that the FDCs have flourished
in India as companies used them to escape
government price control. Drug price control
orders capped the prices of drugs having only one
active pharmaceutical ingredient (API). Companies
combined different drugs into one FDC, thus
making a new product, bypassing the price control.
Mixing of drugs into one does not necessarily
enhances efficacy of the new FDC, but the mixing of
two APIs could lead to a possible toxic combination
affecting the human body. Hence it is essential to
test the new FDCs produced by combining two or
more drugs.
Thus, the more serious issue according to the
experts is how these drugs got approved in the
first place without clinical trials. It appears that
the central government regulator is blaming the
state regulators for giving approvals overstepping
their jurisdiction as only the central government
regulator can approve a new drug. If this is the
reality, as claimed by some media then it is a very
serious issue which needs a thorough investigation.
It is important that besides punishing the
pharma producers by banning their FDCs, the
governments should also enquire into its internal
systems and take action against the insiders if they
too are violating any rules. The internal systems
need to be free of systemic errors and people
bypassing the rules to prevent recurrences of such
incidences having potential to harm the patients.
Milind Kokje
Chief Editor
[email protected](^6) BIO EDIT BIOSPECTRUM | SEPTEMBER 2018 | http://www.biospectrumindia.com