IDIA IS CAPABLE TO LEAD GLOBAL PHARMA INDUSTRY

Mohammad Shahbaz Alam

Objective of writing this article is to know more about factual information about fixed dose
combination available globally, create awareness to design guideline for FDC. India should
lead the world in formulation of FDC as there is no final guideline in place. India is capable
to lead the world in terms of guideline designing of FDC because India is global hub of FDC
till to date. It is noteworthy fixed dose combination in herbal is available here since more
than 5,000 years. Most importantly India has rationalised all FDC available coupled with
pharmacovigilance system to know the adverse events.
India, China, Malaysia, Indonesia, Korea, Russian countries and Middle East countries were
using fixed dose herbal combination since the early age of this world. Triphala and
Chaivanprash to name a few are globally established herbal FDC. Triphala is a combination
of
three
fruits
Amalaki (Emblica
officinalis), Bibhitaki (Terminalia
bellirica),
and Haritaki (Terminalia chebula). Triphala is used for constipation, indigestion, hyperacidity
and cleansing our system. In this modern hitech world no one dare to challenge old aged
herbal fixed dose formulation till to date. We should salute to super doctor and innovator of
herbal formulation such as Shen Nung (2696 BC), Hakeem Luqman (1100 BC), Acharya
Charak (300 BC), Ibne Sina and others. Herbal doctors at that early age of the world were
technically and spiritually very sound and it was need of the hour to treat patient effectively
by innovating fixed dose combination.
The development of fixed-dose combination drugs is becoming increasingly important from a
public health perspective and they are commonly used to manage some of the world's most
infectious diseases. Benefits such as cost-effectiveness, simple distribution logistics and
improved patient adherence all add to their importance.
CDSCO has given approval approximately more than 2000 FDC and it would cross to 3000,
whereas America has given only 200 FDC approval till to date. India is developing
pharmacovigilance data on more than 1400 million populations where America has only 325
million populations followed by UK just 65 million populations.
India has emerged as global economic super power and global leader. India has given world
global Yoga day and global student day and in days to come India is going to give lots of gift
to the world. Mangalayan is the most economical satellite in the world developed
indigenously. India has launched 20 countries satellite including USA and UK. America has
denied giving super computer to India and India taken it positively, developed Param 1000
super computer and now giving back to most of the countries. India has developed its own
economic version of hepatitis B vaccine in collaboration with Oman. Nalanda University is
witness that India had developed cure for life threatening disease at time but all research
paper had been destroyed by invaders. India has taken a paradigm shift and placing back on
global leadership chair.
FDC is a good alternative not only for patient compliance but also to augment profitability of
pharmaceutical sector. Global pharma majors are in foray of FDC launch because it is a

multibillion dollar business tool. They have already launched FDC globally and among the
leading companies are Merck with 10, Novartis with 9, and GlaxoSmithKline with 8, Abbott
6, Pfizer 6, Bayer 5, Boehringer 5, AstraZeneca 4, BMS 4, Gilead 4, Takeda 4 FDC products
and others 66.

We should feel proud that we have immense number of FDC approval from CDSCO. Now
we should take process patent on priority. Pharmaceutical companies should innovate more
and more FDC. CDSCO generally give priority in approval for FDC those approved
anywhere in US or Europe. CDSCO should remove block barrier that even any FDC if not
approved in US or Europe can be approved first time in the world by CDSCO. Tapentadol &
paracetamol combination has been rejected whereas Tramadol & paracetamol is approved
with CDSCO. It is noteworthy tramdol is 100% opiod where as tapendaol is 50% opiod and
50% non-opiod. Tapentadol is safer than tramadol. Hence tapentadol & paracetamol is better
alternative and it should be approved in India.