(^30) OPINION BIOSPECTRUM | SEPTEMBER 2018 | http://www.biospectrumindia.com
Regulatory gaps that led to the
problem continue to remain unplugged
Although Appendix VI of Schedule Y (Drugs &
Cosmetics Rules 1945, India) provides details about
the requirements for manufacture/import approval
and marketing of various types of FDCs which in
general, seeks justification and therapeutic rationale for
combination of active substances, level of requirement
to generate new data is unclear. There is also no specific
pathway for approval of OTC drugs. In the absence of
regulatory clarity, some of the drugs currently banned
were approved by State Licensing Authority with no
approval from the CDSCO and the others have approval
from no regulator in India. The problem was trigged
by a combination of regulatory ambiguity as well as
the tendency of some companies to take advantage of
regulatory gaps to launch unapproved combinations.
The regulatory gaps are emphatically evident when
compared to a more evolved global context such as
the US where there are separate regulatory pathways
for various drug categories including New Drug
Applications for NCES, reformulated or repurposed
drugs through the 505(b)(2) pathway and the OTC
pathway with Product Monograph for OTCs. While the
505(b)(2) pathway allows referencing of data from the
previously approved drugs, the OTC pathway allows
drugs to be launched without any additional approval
from USFDA if active ingredients (and dosage) being
used are as stated in the OTC monograph. The missing
OTC regulatory pathway particularly represents a
glaring gap in the current landscape.
Emphatic example of stretching too far
- globally sold OTC products are now
banned in India
While the ban against 343 drugs and is justifiable in
part of the list, merit of enforcing the axe in several
cases is questionable. Most poignant examples of this
regulatory action being more extreme than needed are
the long suite of OTC drugs that are banned. Several
OTC combinations have been globally driven by clinician
or consumer preference, ease of use and clinical/
non-clinical benefit. Even the WHO and FDA indicate
‘Ease of use’ for patients and prescribers as a potential
advantage of FDCs. It is alarming to note that many of
the OTC combinations drugs banned are popular off the
shelf products across several highly regulated markets
such as UK, US et al. In these regulated markets,
similar OTC formulations are sold and are found to be
in compliance with formulations permissible per the
OTC monographs. As illustrated below, Vicks Action
500 now banned in India has the same combination as
Theraflu sold in USA, UK. The only addition ingredient
in Vicks Action 500 is caffeine with levels comparable to
a can of coke or one third cup of coffee.
Vicks Action 500 Extra sold in India vs.
Theraflu sold in US and UK as OTC drugA final mixed outcome – patient benefit
in some cases but erosion of consumer
choice and markets in others
The ban is estimated to shave off close to Rs 7000 crore
of erstwhile peak revenues from the Pharma Industry.
It is a significant blow to the industry that has found
itself in the midst of a perfect storm – two quarters
impacted by demonization and GST in India, the FDC
axe, API supply constraints and pervasive pricing
pressure across global markets.
From a consumer perspective, it is encouraging to
see proactive regulatory action in the interest of patient
safety and benefit. However, with blanket decisions
underlined by redundancy in action, patients could
be denied access to convenient choices that citizens in
several other countries continue to have. If OTC drugs
available in several other countries are banned in India
and no clear regulatory pathway is created for OTC
drugs in India, both industry and consumers stand to
lose. Most importantly, a regulatory environment that
is not industry friendly could threaten domestic self-
sufficiency in the longer term, and the Indian patients
should be most insecure about this implication. To
ensure such casualties don’t repeat in the future, it is
also important that we urgently bridge regulatory gaps
and points of ambiguity – especially with creation of a
globally comparable OTC pathway. The patient should
continue to be at the heart of every regulatory decision- but with greater understanding of implications for
today, tomorrow and the longer term.
(Note: The opinions discussed here are based on the
assumption that the DTAB sub-committee report has
recommended ban of all 343 drugs reviewed.)
Ingredients
(Vicks Action
500 Extra)
● Paracetamol
500 mg
● Phenylephrine
HCl 10 mg
● Caffeine
Anhydrous 32 mgIngredients (Theraflu)
● Paracetamol 650 mg
(Pain reliever)
● Phenylephrine HCl 10 mg
(Nasal decongestant)
● Diphenhydramine HCl 25 mg
(Cough suppressant)