AUTOCRATIC DECISION OF BANNING FDC IN INDIAN MARKET

Mohammad Shahbaz Alam

New Delhi: At a time of ease of business implementation and make in India initiative Joint
Drug Controller Dr.V.G.Somani, who is heading FDC division proved himself as an
autocratic regulator.
Lets understand first who is defaulter, drug manufacturing companies or drug controller.
Manufacturers have got license from respective state drug controller and manufacturing fixed
dose combination since more than 35 years. There is a fight of dominance between state and
central drug controller and punishment was given to manufacturers and the poor patients.
If you have cough and cold associated with fever then doctors generally prescribe medicine
separately for cough, cold and fever. To make it affordable, easy to prescribe and easy to
make available, manufacturer came up with fixed dose combination. Up till now, there is no
ADR (adverse drug reaction) report is with the drug controller from all nook and corner of
India.
To grab the attention of media one fine day given notice on cdsco website to all pharma
manufacturers to submit application for approval, already approved fixed dose combination.
In 2013 to 2014 they made restless to the industry and due to that few companies shut down
and many are in line to sale. cdsco made millions of rupees from application fee which was
illegal, unethical and against the land of the law. Manufacturers were running here and there
to prepare application and they submitted application to cdsco rather than concentration on
production.
In 2015 cdsco started issuing rejection, show cause notice, data fabrication letter and
submission of phase-4 clinical trial report. They banned few companies and consultants for
false data fabrication charges. Case filed against dcgi in Chennai and defamation suit filed
against dcgi in New Delhi. Industry people came forward on behalf of cdsco to resolve
defamation and it had been resolved. Hearing is continuing in Chennai. First time they trid to
ban 298 FDC but case is pending in court since more than a decade and this is the second
failure attempt to ban FDC apart from 298. Many big issues may be get resolved by meeting
and discussing with positive note but when you hurt respect of anybody then they knock the
door of judiciary. Now manufacturers and consultants are financially strong and qualified
enough to go legally.
Medicare news staff met with cdsco executive on submission counter to know more about
phase-4 clinical trial protocol writing but they were not trained enough to reply. If cdsco
people are not aware about how to write protocol for phase-4 clinical trial then how come
they demand from manufacturers. Protocol protype was not even available on cdsco site that
time. Most of the companies submitted PSUR (periodic safety update report) in place of
phase-4 clinical trial. Few companies who are financially strong conducted phase-4 clinical
tril and invested more than 4 million rupees and even then their product banned.

cdsco is so mismanaged and unplanned in approach that gives a big question mark. They
demanded application for FDC but there was no checklist as how to apply. There was no
checklist as how to write protocol for phase-4 clinical trial. They banned few companies and
few consultants without consultation them. cdsco made fool to the industry. You should
conduct workshop for stake holders and consultants so that industry can grow with updated
regulation.
Now they banned 350 fixed dose combinations without giving chance to get clarification
from the stake holders. Note worthy they have given many approvals without clinical trials.
They have doctors in new drug approval committee to decide whether approval should be
granted or not.
New drug approval committee should be dissolved immediately because doctors do not know
drug and cosmetic act, they are not aware about QA/QC/Product tools to check the quality of
medicine. According to golden standard text book of medicine Goodman & Gillman, Martin
Dale and Harrison a doctor must diagnose and a pharmacist must prescribe medicine. Hence
in drug approval committee doctors has nothing to do as an expert. In this committee
QA/QC/Production/Regulatory/Pharmacovigilance/RnD people should be there. The can
make worth decision and not the doctors. Why do you appoint B.Pharm for drug inspector
post because they know about the drug and why don,t you appoint doctors for the post of
drug inspector.
Drug consultation committee has parliamentary power to ban any formulation in consultation
with the representative of stake holders and not alone. cdsco has no right to make any
decision on the basis of perception and assumption. Medicine is a double edged sword either
kills life or saves life. You have included few single drugs in new drug list which are more
than 5 years old approved formulation. Who has given power to violate drug and cosmetic
act? You cannot cross the boundary of drug and cosmetic act to ease your control.
Globally there is no guideline for formation of fixed dose combination and so in cdsco. You
cannot ban any fixed dose combination unless and until you got ADR report from the market.
cdsco tried to ban 298 FDC few years back and still they can not ban because case is going
on with Madras Court.That time they were not having any ADR report against 298 FDC.
Severe financial impact is there into the market place based on the current MAT valuation for
the companies and the subgroups. The major market impact is respiratory with 16.9% of the
market coming under this effect followed by pain & analgesics market at 8.2% and
antidiabetic at 7.68%
Subgroup
IPM
Respiratory
Antidiabetic
Pain/Analgesics
Anti-infective
Gastro Intestinal

MAT Value in Crores

98042
7738
7930
6763
14963
11535

Impact in Crores
3838
1308
609
556
519
485

% Impact
3.91%
16.90%
7.68%
8.22%
3.47%
4.20%

Dermacare
Neuro/CNS
Gynoecological
Blood Related
Urology
Cardiac

5879
6040
4902
1154
1069
12250

Subgroup
IPM
ABBOT HEALTHCARE
MACLEODS PHARMA
PFIZER
MANKIND
ALKEM
IPCA
MEDLEY
GLENMARK
FRANCO
WOCKHARDT
ARISTO
MICRO
INTAS
SUN PHARMA
LUPIN

279
49
30
3
1
1

MAT Value in Crores

98042
3149
2829
2872
3656
3045
1260
384
2347
630
1325
2425
2771
1842
5426
3405

4.75%
0.80%
0.60%
0.27%
0.09%
0.00%
Impact in Crores
3838
485
370
368
253
161
130
116
110
104
102
102
96
96
78
72

% Impact
3.91%
15.39%
13.07%
12.80%
6.93%
5.28%
10.35%
30.21%
4.71%
16.54%
7.72%
4.22%
3.48%
5.19%
1.43%
2.10%

Most importantly cdsco should take PSUR for all approved formulation on regular basis at
least six monthly to cross check the safety pattern of medicine and it should be mandatory
whether it is new drug or old drug. Take back banning of 350 FDC and give a chance to stake
holder to meet you and let them share their clarification. Noteworthy,stop giving approvals on
paper, take sample of finished formulation and API for lab analysis and all approval should
be given on the basis of result of lab analysis. For safety of drug, introduce safety tools like
PSMF, DSUR, PSUR and end to end case processing of ADR. Industry is not money eyed;
they are ready to follow friendly and respectable regulation. You got the 7 th pay commission
but what about 50 lakh family those will suffer due to your autocratic decision. Industry is
ready to follow land of law and on the same time ready to go legally against the autocratic
approach
if
not
resolved
amicably,
industry
people
informed.
Email:medicarechief@gmail.com