Dissertation Report on Banned FDC drugs in India on 10th March

Overnight ban on Fixed Dose Combination Drugs by Government
of India: Impacts & Analysis on Indian Pharmaceutical Industry
Dissertation Report
March-April, 2016
Submitted By:
Akshay Saxena
MBA (Pharmaceutical Management)
Faculty of Management & Information Technology
Jamia Hamdard
Session: 2014-2016
Submitted to:
College Mentor:
Dr. Shibu John
Head of Department
Jamia Hamdard

DissertationReport 2
Declaration
I, Akshay Saxena hereby declare that the project entitled “Overnight ban on Fixed Dose
Combination Drugs by Government of India: Impacts & Analysis on Indian
Pharmaceutical Industry” is my original and exclusively my own work. I further declare
that the work is my own authentic piece of work and has not been submitted at my
organization/institute/university for personal/academics gains and benefits or award of any
degree/diploma/certificate.
Akshay Saxena
MBA (Pharma Management)
Enrolment No.: 2014-542-001
Jamia Hamdard
New Delhi

Acknowledgement
I wish to express my gratitude to the almighty God for giving me the strength to perform my
responsibilities as an intern and complete the report within the stipulated time.
I was given the opportunity to prepare a report for my dissertation work under supervision of
our honourable supervisor of internship. It was great opportunity for me to augment my
knowledge about analysing critical data and information. This report would have been
incomplete without the help of certain people. The purpose this part of the report is to pay a
tribute to all of those cooperative people who gave their precious time to help me and without
whose assistance it would have been impossible to finish the report.
I would also like to thank and express my gratitude to Dr. Shibu John, Head of Department,
Jamia Hamdard for his invaluable feedback and support.
I am also grateful to my parents, Harsh Shah and my other friends without their valuable
input, this report and research could not have been successful.
In the end, it is necessary to mention that this report is the result of days of hard work. I am
thankful to the people who have contributed greatly behind the completion of the report.
Without their help, this report would have not been even completed within the deadline.

Executive Summary
On 10 March 2016, the Union Health Ministry banned 344 fixed drug combinations by
issuing a gazette notification. Fixed dose combination (FDC) drugs including painkillers,
anti-diabetic, respiratory and gastro-intestinal medicines will have an impact of 3.1 per cent
or Rs. 3,049 crore of the country's pharma retail market currently valued at 98,042 crores,
according to a market based study.
The list is inclusive of a number of commonly used cough syrup solutions, as well as
antibiotic combinations and analgesics. Majority of the combinations banned are sold over
the counter. The government had recently constituted an expert committee in order to gauge
how effective were the various drug combinations found in India. It was on the basis of the
recommendations made by the said committee that the ban was imposed. However, it is
expected that the industry will not take this lying down; in fact, some of the companies
affected by the ruling may even seek judicial redress.
A lot of these medicines, thus developed, happen to have antibiotics in their make. They are
also sold in an over-the-counter manner, thus, making it hard for authorities to carry out drug
resistance measures properly. Recently, the Health Ministry had started a programme to
reduce the casual and irresponsible manner in which antibiotics are consumed in India. As a
result of that initiative, the government has now come up with a special schedule that requires
chemists to check prescriptions before they sell medicines and also have records of the same.
If they don’t observe these measures, they may face actions initiated by the government
against them.
Even as the Union health ministry's ban on 344 fixed dose combination (FDC) drugs
including painkillers, anti-diabetic, respiratory and gastro-intestinal medicines has made a
sales impact of over Rs.10,000 crore, category of FDCs most impacted includes antibiotics,
antihistaminic, caffeine and codeine combinations and NSAID.
Government has banned common household medicines Crocin Cold and Flu, D-Cold Total,
Sumo, Oflox, Gastrogyl, Chericof, Nimulid, Kofnil, Dolo Cold, Decoff, O2, paediatric syrup
T-98 and TedyKoff, as part of its decision to stop the manufacture and sale of FDCs.
Delhi High Court extends stay on ban of some drugs till 28 March
The Delhi High Court put on hold a ban that has been imposed on the sale and manufacture
of more than 300 fixed dose combinations (FDC) medicines like D’Cold, Vicks Action 500
Extra and Benadryl. After resuming a hearing on pleas by 30+ pharmaceutical companies, the
court decided to hold the ban till 28 March 2016. Previously, Delhi High Court had offered
an interim relief on 14 March to Pfizer’s cough syrup ‘Corex’.

Content
1.0 Introduction
1.1 The Indian pharmaceutical industry 7
1.2 The Ban 9
1.3 List of banned FDC drugs 11
2.0 Literature Review 20
3.0 Justification/Rational 25
4.0 Objectives 26
5.0 ResearchMethodology 27
4.1 Research Design
4.2 Research Tools
4.3 Data Collection
6.0 Study Findings
6.1 Reason for the ban of FDC drugs 29
6.2 Financial loss endured by the pharmaceutical companies 35
6.3 Measures taken by the pharma companies after the ban 42
6.4 Impact on consumers 44
7.0 Conclusion 45
8.0 Bibliography 50

1.0 Introduction

The Indian PharmaceuticalIndustry
The Indian Pharmaceutical Industry has witnessed a robust growth over the past few years
moving on from a turnover of approx. US $1 billion in 1990 to over US $30 billion in 2015
of which the export turnover is approximately US $ 15 billion. The country now ranks 3rd
world wide by volume of production and 14th by value, thereby accounting for around 10%
of world’s production by volume and 1.5% by value. Globally, it ranks 4th in terms of
generic production and 17th in terms of export value of bulk actives and dosage forms. Indian
exports are destined to more than 200 countries around the globe including highly regulated
markets of US, West Europe, Japan and Australia. It has shown tremendous progress in terms
of infrastructure development, technology base creation and a wide range of products. It has
established its presence and determination to flourish in the changing environment. The
industry now produces bulk drugs belonging to all major therapeutic groups requiring
complicated manufacturing technologies. Formulations in various dosage forms are being
produced in GMP (Good Manufacturing Practices) compliant facilities. Strong scientific and
technical manpower and pioneering work done in process development have made this
possible.
The Indian pharmaceutical industry currently tops the chart amongst India's science-based
industries with wide ranging capabilities in the complex field of drug manufacture and
technology. A highly organized sector, the Indian pharmaceuticals market is expected to
expand at a CAGR of 23.9 percent to reach US$ 55 billion by 2020. It ranks very high
amongst all the third world countries, in terms of technology, quality and the vast range of
medicines that are manufactured. It ranges from simple headache pills to sophisticated
antibiotics and complex cardiac compounds; almost every type of medicine is now made in
the Indian pharmaceutical industry.
The Indian pharmaceutical industry is estimated to grow at 20 per cent compound annual
growth rate (CAGR) over the next five years. India is now among the top five pharmaceutical
emerging markets. There will be new drug launches, new drug filings, and Phase II clinic
trials throughout the year. On back of increasing sales of generic medicines, continued
growth in chronic therapies and a greater penetration in rural markets, the domestic pharma
market to grow at 10-12 per cent in FY15 as compared to 9 per cent in FY14.
Recognizing the potential for growth, the Government of India took up the initiative of
developing the Indian Pharmaceuticals sector by creating a separate Department in July 2008.
The Department is entrusted with the responsibility of policy, planning, development and
regulation of Pharmaceutical Industries. An assessment of the Indian Pharmaceutical
Industry's strength reveals the following key features:
 Strong export market- India exported drugs worth US$ 15 billion to more than 200
countries including highly regulated markets in the US, Europe, Japan and Australia.
Large Indian pharma companies have emerged as among the most competitive in the
evolving generic space in North America and have created an unmatched platform in
this space. Indian companies are also making their presence felt in the emerging
markets around the world, particularly with a strong portfolio in anti-infective and
antiretroviral.
 Large domestic pharma companies have continued to grow, assuming leadership
position in many therapies and segments in the Indian market as well as creating a
strong international exports back-bone.

 Competitive market with the emergence of a number of second tier Indian companies
with new and innovative business modules.
 Indian players have also developed expertise in significant biologics capabilities.
 Biologic portfolios while still nascent in India are being built with an eye on the
future.
 Multinational companies have continued to invest significantly in India and are
making their presence felt across most segments of the Indian pharma market.
Companies have also begun to invest in increasing their presence in tier II cities and
rural areas and making medical care more accessible to a large section of the Indian
population.
 Low cost of production.
 Low R&D costs.
 Innovative Scientific manpower.
 Excellent and world-class national laboratories specializing in process development
and development of cost effective technologies.
 Increasing balance of trade in Pharma sector.
 An efficient and cost effective source for procuring generic drugs, especially the drugs
going off patent in the next few years.
 An excellent centre for clinical trials in view of the diversity in population.
Indian pharmaceuticalmarket segments by value
Anti-infective drugs command the largest share (16%) in the Indian pharma market.

THE BAN
Since 1961, India’s drug controller has approved more than 1,200 combination drugs or
FDCs (Fixed Dose Combinations), according to a list published on the website of the Health
Ministry’s Central Drugs Standard Control Organization (CDSCO), the national drug
regulatory body. But many have also been licensed on the state level without the approval of
the central government.
It wasn’t until 1988 that the definition of a “new drug” under Indian law was amended to
expressly include the combination of two or more already approved drugs.
What is a fixed-dose combination?
The term fixed-dose combination product is synonymous with fixed-ratio combination
product. Both terms refer to a product that contains two or more active ingredients. Because
the product is of a defined composition, the two (or more) ingredients are present in a fixed
ratio. Hence the term “fixed dose” or “fixed ratio” combination.
Such a product may be available in more than one strength, each of which may itself be a
fixed dose combination and may contain different ratios of active ingredients. For example,
Augmentin Duo Forte® tablets contain 850 mg of amoxicillin and 125 mg of clavulanic acid
(a ratio of 6.8:1) whereas Augmentin Forte® tablets contain 500 mg of amoxicillin and 125
mg of clavulanic acid (a ratio of 4:1). Different ratios can be rational in particular
circumstances.
Advantages of fixed-dose combinations
The presumed advantages of FDCs include:
• Drugs that are normally given in combination are more conveniently prescribed and
consumed as an FDC.
• Better patient compliance is claimed.
• It is cheaper to purchase an FDC product than to purchase the products separately.
• The logistics of procurement and distribution are simpler (which can be especially
important in remote areas).
Disadvantages of fixed-dose combinations
Critics of FDCs suggest that:
• FDCs discourage separate titration of each active ingredient. This is a particular
problem when both of the active ingredients require dose titration. Indeed, it can be
argued that the very existence of an FDC discourages adjustment of doses to the
patient’s needs (if that is appropriate for the combination in question).
• When the active ingredients in question have different pharmacokinetics and/or
pharmacodynamics, an FDC may not be appropriate.
• Unless both of the active ingredients are available as separate entities, FDCs
encourage polypharmacy irrespective of whether it is appropriate for a particular
patient.

In 2007, the government tried and failed to get close to 300 state-licensed combination drugs
withdrawn. In 2012, the government undertook another attempt to exert control over the FDC
market. That followed a parliamentary report critical of the functioning of the CDSCO. The
report also underlined the health risks posed by unapproved combinations.
For a long time in India, patients have been consuming drugs which are banned in various
countries like the USA, Canada, Europe, Australia etc. The most common are like
Nimesulide, Furazolidone, Phenylpropanolamine and other over the counter preparation are
banned by USFDA due to their side effect on kidney, liver and nervous system.
Unfortunately analgesic, antidiarrheal and cough preparations which are banned in other
countries and are blindly used in India as over the counter drugs because of unawareness,
lack of law enforcement and corruption.
All the formulations are meant for prevention or treatment of ailments and diseases, out of
which only a few drugs are lifesaving and essential, rest of the drugs are substitutes of each
other.
Banned drugs are drugs which are prohibited to intake as they artificially improve the
performance but show various adverse effects more than therapeutic effects. Their production
or use is prohibited or strictly controlled via prescription.
“Drug Controller general of India” is the highest authority in India to expand the approval of
any drug or to ban a drug. Some of the dangerous drugs have been globally discarded but are
available in India. The most common are like Nimesulide, Furazolidone and
Phenylpropanolamine
On 10 March 2016, an expert committee, CDSCO (Central Drugs Standard Control
Organization) found about over 300 of medicinal products to be irrational in nature which
means that they could potentially harm patients who consumed them. Commentators pegged
fixed dose combination or FDCs to constitute nearly 50% of the $15 billion domestic Indian
pharma market. It is impossible to believe that such a large market exists without consumer
demand to match.
Fixed-dose combination drugs are when a pharmaceutical combines two or more active drugs
in a fixed ratio into a single dosage.
The full impact of the ban would be Rs. 3,800 crore a year on the Indian pharmaceutical
industry. The government had constituted a panel under Professor Chandrakant Kokate to
review the fixed combination drugs. The panel, which had examined 5,518 drug
combinations, had recommended in January 2015 that 963 drug combinations are irrational.
These medicines have been available for years – in some cases, over 30 years. To be sure,
this doesn’t make it legitimate. If FDCs have been deemed to be unsafe for patients by
experts, then we must accept the verdict. What is wrong is wrong and one should not defend
it.
The move is aimed at curbing the misuse of such medicines in India, where nearly half the
drugs sold in 2014 were so called “fixed dose combinations.”
Following is the list of FDCs that are now banned:

S. No. Banned FDCs (Fixed Dose Combinations)
1 Aceclofenac (SR) + Paracetamol
2 Aceclofenac + Paracetamol + Famotidine
3 Aceclofenac + Paracetamol + Rabeprazole
4 Aceclofenac + Zinc Carnosine
5 Acetaminophen + Guaifenesin + Dextromethorphan + Chlorpheniramine
6 Acetaminophen + Loratadine + Ambroxol + Phenylephrine
7 Acriflavine + Thymol + Cetrimide
8 Acrivastine + Paracetamol + Caffeine + Phenylephrine
9 Albuterol + Bromhexine + Theophylline
10 Albuterol + Etofylline + Bromhexine + Menthol
11 Alginic Acid + Sodium Bicarbonate + Dried Aluminium Hydroxide + Magnesium
Hydroxide
12 Allantoin + Dimethieone + Urea + Propylene + Glycerin + Liquid Paraffin
13 Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine
14 Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine +
Chlorpheniramine Maleate + Menthol
15 Ambroxol + Salbutamol + Choline Theophyllinate + Menthol
16 Ambroxol + Salbutamol + Theophylline
17 Ambroxol + Terbutaline + Dextromethorphan
18 Ammomium Chloride + Bromhexine + Dextromethorphan
19 Ammonium Chloride + Dextromethorphan + Cetirizine + Menthol
20 Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol
21 Ammonium Citrate + Vitamin B 12 + Folic Acid + Zinc Sulphate
22 Amoxicillin + Bromhexine
23 Amoxicillin + Cefixime + Potassium Clavulanic Acid
24 Amoxicillin + Dicloxacillin
25 Amoxicillin 250 mg + Potassium Clavulanate Diluted 62.5 mg
26 Amoxycillin + Dicloxacillin + Serratiopeptidase
27 Amoxycillin + Tinidazole
28 Ascorbic Acid + Manadione Sodium Bisulphate + Rutin + Dibasic Calcium
Phosphate + Adrenochrome mono Semicarbazone
29 Atorvastatin + Vitamin D3 + Folic Acid + Vitamin B12 + Pyridoxine
30 Azithromycin + Acebrophylline
31 Azithromycin + Ambroxol
32 Azithromycin + Cefixime
33 Azithromycin + Cefpodoxime
34 Azithromycin + Levofloxacin
35 Azithromycin + Ofloxacin
36 Azithromycin, Secnidazole and Fluconazole
37 Beclomethasone + Clotrimazole + Chloramphenicol + Gentamycin + Lignocaine
Ear drops
38 Beclomethasone + Clotimazole + Neomycin + lodochlorohydroxyquinone
39 Beclomethasone + Clotrimazole + Gentamicin + lodochlorhydroxyquinoline
40 Beclomethasone Diproprionate + Neomycin + Tolnaftate +
lodochlorhydroxyquinoline + Chlorocresol
41 Benfotiamine + Metformin

42 Benzoxonium Chloride + Lidocaine
43 Betahistine + Ginkgo Biloba Extract + Vinpocetine + Piracetam
44 Betamethasone + Fusidic Acid + Gentamycin + Tolnaftate +
lodochlorhydroxyquinoline (ICHQ)
45 Betamethasone + Gentamicin + Tolnaftate + lodochlorhydroxyquinoline
46 Betamethasone + Gentamycin + Zinc Sulphate + Clotrimoazole + Chlorocresol
47 Betamethasone + Neomycin + Tolnaftate + lodochlorohydroxyquinoline +
Cholorocresol
48 Borax + Boric Acid + Naphazoline + Menthol + Camphor + Methyl Hydroxy
Benzoate
49 Bromhenxine + Phenylephrine + Chlorpheniramine + Paracetamol
50 Bromhexine + Cetrizine + Phenylephrine IP+Guaifenesin + Menthol
51 Bromhexine + Dextromethorphan
52 Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
53 Bromhexine + Dextromethorphan + Phenylephrine + Menthol
54 Bromhexine + Phenylephrine + Chlorepheniramine Maleate
55 Caffeine + Paracetamol + Chlorpheniramine
56 Caffeine + Paracetamol + Phenylephrine + Cetirizine
57 Caffeine + Paracetamol + Phenylephrine + Chlorpheniramine
58 Calcium Gluconate + Chlorpheniramine + Vitamin C
59 Calcium Gluconate + Levocetirizine
60 Cefixime + Levofloxacin
61 Cefixime + Linezolid
62 Cefpodoxime Proxetil + Levofloxacin
63 Cefuroxime + Linezolid
64 Cephalexin + Neomycin + Prednisolone
65 Certirizine + Phenylephrine + Paracetamol + Caffeine + Nimesulide
66 Cetirizine + Acetaminophen + Dextromethorphan + Phenyephrine + Zinc
Gluconate
67 Cetirizine + Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine +
Menthol
68 Cetirizine + Dextromethorphan + Ambroxol
69 Cetirizine + Dextromethorphan + Bromhexine + Guaifenesin
70 Cetirizine + Dextromethorphan + Phenylephrine + Tulsi
71 Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol +
Menthol
72 Cetirizine + Dextromethorphan + Zinc Gluconate + Menthol
73 Cetirizine + Diethyl Carbamazine
74 Cetirizine + Phenylephrine + Dextromethorphan + Menthol
75 Cetirizine + Phenylephrine + Paracetamol + Ambroxol + Caffeine
76 Cetirizine + Phenylephrine + Paracetamol + Zinc Gluconate
77 Cetirizine + Nimesulide + Phenylephrine
78 Chlopheniramine Maleate + Codeine Syrup
79 Chloramphenicol + Beclomethasone + Clomitrimazole + Lignocaine
80 Chloramphenicol + Lignocaine + Betamethasone + Clotrimazole + Ofloxacin +
Antipyrine
81 Chlorpheniramine + Ammonium Chloride + Sodium Chloride

82 Chlorpheniramine + Ammonium Chloride + Chloroform + Menthol
83 Chlorpheniramine + Ammonium Chloride + Noscapine + Sodium Citrate
84 Chlorpheniramine + Codeine + Sodium Citrate + Menthol Syrup
85 Chlorpheniramine + Codeine Phosphate + Menthol Syrup
86 Chlorpheniramine + Dextromethorphan + Phenylephrine + Paracetamol
87 Chlorpheniramine + Paracetamol + Pseudoephedrine + Caffeine
88 Chlorpheniramine + Phenylephrine + Caffeine
89 Chlorpheniramine + Phenylephrine + Dextromethophan + Menthol
90 Chlorpheniramine + Phenylephrine + Paracetamol + Zink Gluconate
91 Chlorpheniramine + Terpin + Antimony Potassium Tartrate + Ammonium Chloride
+ Sodium Citrate + Menthol
92 Chlorpheniramine + Vasaka + Tolubalsm + Ammonium Chloride + Sodium Citrate
+ Menthol
93 Chlorpheniramine + Vitamin C
94 Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate
95 Chlorpheniramine Maleate + Dextromethorphan + Dextromethophan +
Guaiphenesin + Ammonium Chloride + Menthol
96 Chlorpheniramine+Ammonium Chloride + Menthol
97 Chlorpromazine + Trihexyphenidyl
98 Chromium Polynicotinate + Metformin
99 Cilnidipine + Metoprolol Succinate + Metoprolol Tartrate
100 Ciprofloxacin + Fluocinolone + Clotrimazole + Neomycin + Chlorocresol
101 Ciprofloxacin + Fluticasone + Clotrimazole + Neomycin
102 Ciprofloxacin + Phenazopyridine
103 Clidinium + Paracetamol + Dicyclomine + Activated Dimethicone
104 Clindamycin + Clotrimazole + Lactic Acid Bacillus
105 Clindamycin + Telmisartan
106 Clobetasol + Gentamicin + Tolnaftate + lodochlorhydroxyquinone + Ketoconazole
107 Clobetasol + Neomycin + Miconazole + Clotrimazole
108 Clobetasol + Neomycin + Miconazole + Zinc Sulphate
109 Clobetasol + Ofloxacin + Ketoconazol + Zinc Sulphate
110 Clobetasol + Ofloxacin + Miconazole + Zinc Sulphate
111 Clobetasol Propionate + Ofloxacin + Ornidazole + Terbinafine
112 Clobetasole + Gentamicin + Miconazole + Zinc Sulphate
113 Clomifene Citrate + Ubidecarenone + Zinc + Folic Acid + Methylcobalamin +
Pyridoxine + Lycopene + Selenium + Levocarnitine Tartrate + L-Arginine
114 Clotrimazole + Beclomethasone + Lignocaine + Ofloxacin + Acetic Acid + Sodium
Methyl Paraben + Propyl Paraben
115 Clotrimazole + Beclomethasone + Ofloxacin + Lignocaine
116 Clotrimazole + Ofloxacin + Lignocaine + Glycerine and Propylene Glycol
117 Codeine + Chlorpheniramine + Alcohol Syrup
118 Codeine + Levocetirizine + Menthol
119 Cyproheptadine + Thiamine
120 Dextromethorphan + Chlopheniramine + Ammonium + Sodium Citrate + Menthol
121 Dextromethophan + Chlopheniramine + Bromhexine
122 Dextromethophan + Chlorpheniramine + Guaifenesin + Ammonium Chloride
123 Dextromethorphan + Ambroxol + Ammonium Chloride + Chlorpheniramine +

Menthol
124 Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine +
Chlorpheniramine
125 Dextromethorphan + Bromhexine + Guaiphenesin
126 Dextromethorphan + Bromhexine + Guaiphenesin + Menthol
127 Dextromethorphan + Cetirizine
128 Dextromethorphan + Cetirizine + Guaifenesin + Ammonium Chloride
129 Dextromethorphan + Chlorpheniramine + Chlorpheniramine Maleate
130 Dextromethorphan + Chlorpheniramine + Guaiphenesin
131 Dextromethorphan + Levocetirizine + Phenylephrine + Zinc
132 Dextromethorphan + Paracetamol + Cetirizine + Phenylephrine
133 Dextromethorphan + Phenylephrine + Ammonium Chloride + Menthol
134 Dextromethorphan + Phenylephrine + Bromhexine + Guaifenesin +
Chlorpheniramine
135 Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + Caffeine
136 Dextromethorphan + Phenylephrine + Cetirizine + Zinc + Menthol
137 Dextromethorphan + Phenylephrine + Guaifenesin + Certirizine + Acetaminophen
138 Dextromethorphan + Phenylephrine + Guaifenesin + Triprolidine
139 Dextromethorphan + Phenylephrine + Triprolidine + Menthol
140 Dextromethorphan + Phenylephrine + Zinc Gluconate + Menthol
141 Dextromethorphan + Triprolidine + Phenylephrine
142 Dextromethorphan + Triprolidine + Phenylephrine
143 Dextromethorphan + Bromhexine + Chlorpheniramine Maleate + Guaiphenesin
144 Dextromethorphan + Promethazine
145 Diclofenac + Paracetamol + Chlorpheniramine Maleate + Magnesium Trisillicate
146 Diclofenac + Paracetamol + Chlorzoxazone+Famotidine
147 Diclofenac + Paracetamol + Magnesium Trisilicate
148 Diclofenac + Paracetamol injection
149 Diclofenac + Tramadol + Chlorzoxazone
150 Diclofenac + Tramadol + Paracetamol
151 Diclofenac + Zinc Carnosine
152 Dicyclomine + Paracetamol + Domperidone
153 Diethyl Carbamazine + Chlorpheniramine + Guaifenesin
154 Diethylcarbamazine Citrate + Cetirizine + Guaiphenesin
155 Diethylcarbamazine + Cetirizine + Ambroxol
156 Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + Menthol
157 Diphenhydramine + Guaiphenesin + Ammonium Chloride + Bromhexine
158 Diphenhydramine + Terpin + Ammonium Chloride + Sodium Chloride + Menthol
159 Diphenoxylate + Atropine + Furazolidone
160 Disodium Hydrogen Citrate + Paracetamol
161 Doxycycline + Serratiopeptidase
162 Doxylamine + Pyridoxine + Mefenamic Acid + Paracetamol
163 Dried Aluminium Hydroxy Gel + Prophantheline + Diazepam
164 Dried Aluminium Hydroxy Gel + Prophantheline + Diazepam
165 Drotaverine + Clidinium + Chlordiazepoxide
166 Enrofloxacin + Bromhexine

167 Ergotamine Tartrate + Belladonna Dry Extract + Caffeine + Paracetamol
168 Ethylmorphine + Noscapine + Chlorpheniramine
169 Famotidine + Oxytacaine + Magaldrate
170 Fluconazole Tablet, Azithromycin Tablet and Ornidazole Tablets
171 Flunarizine + Paracetamol + Domperidone
172 Flupentixol + Escitalopram
173 Furazolidone + Metronidazole + Loperamide
174 Gabapentin + Mecobalamin + Pyridoxine + Thiamine
175 Gentamicin Sulphate + Clotrimazole + Betamethasone + Lignocaine
176 Gentamycin + Dexamethasone + Chloramphenicol + Tobramycin + Ofloxacin
177 Glibenclamide + Metformin (SR)+ Pioglitazone
178 Gliclazide 40mg + Metformin 400mg
179 Gliclazide 80 mg + Metformin 325 mg
180 Glimepiride + Pioglitazone + Metformin
181 Glimepiride 1mg/2mg/3mg + Pioglitazone 15mg/15mg/15mg + Metformin
1000mg/1000mg/1000mg
182 Glimepiride 1mg/2mg+ Pioglitazone 15mg/15mg + Metformin 850mg/850mg
183 Glipizide 2.5mg + Metformin 400 mg
184 Glucosamine + Methyl Sulfonyl Methane + Vitamin D3 + Manganese + Boron +
Copper + Zinc
185 Guaifenesin + Bromhexine + Chlorpheniramine + Paracetamol
186 Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol +
Serratiopeptidase (as enteric coated granules) 10000 SP Units
187 Guaifenesin + Dextromethorphan
188 Guaifenesin + Diphenhydramine + Bromhexine + Phenylephrine
189 Heparin + Diclofenac
190 Imipramine + Chlordiazepoxide + Trifluoperazine + Trihexyphenidyl
191 Imipramine + Diazepam
192 Ketoconazole + Tea Tree oil + Allantoin + Zinc Oxide + Aloe Vera + Jojoba oil +
Lavender oil + Soa noodles
193 Ketotifen + Cetirizine
194 Ketotifen + Levocetirizine
195 Ketotifen + Theophylline
196 L-5-Methyltetrahydrofolate Calcium + Escitalopram
197 L-Arginine + Sildenafil
198 Levocetirizine + Ambroxol + Phenylephrine + Guaiphenesin
199 Levocetirizine + Ambroxol + Phenylephrine + Paracetamol
200 Levocetirizine + Dextromethorphan + Zinc
201 Levocetirizine + Montelukast + Acebrophylline
202 Levocetirizine + Paracetamol + Phenylephrine + Caffeine
203 Levocetirizine + Phenylephrine + Ambroxol + Guaiphenesin + Paracetamol
204 Levocetirizine + Ranitidine
205 Levofloxacin + Bromhexine
206 Levofloxacin + Ornidazole + Alpha Tocopherol Acetate
207 Levothyroxine + Pyridoxine + Nicotinamide
208 Levothyroxine + Pyridoxine + Nicotinamide

209 Lignocaine + Clotrimazole + Ofloxacin + Beclomethasone
210 Lornoxicam + Paracetamol + Serratiopeptidase
211 Lornoxicam + Paracetamol + Tramadol
212 Lornoxicam + Paracetamol + Trypsin
213 Magaldrate + Famotidine + Simethicone
214 Magaldrate + Papain + Fungal Diastase + Simethicone
215 Magaldrate + Ranitidine + Pancreatin + Domperidone
216 Mebeverine & Inner HPMC capsule (Streptococcus Faecalis + Clostridium
butyricum + Bacillus mesentricus + Lactic Acid Bacillus)
217 Menthol + Anaesthetic Ether
218 Metformin (SR) 500mg + Pioglitazone 5mg
219 Metformin (Sustained Release) 500mg + Pioglitazone 15 mg + Glimepiride 3mg
220 Metformin + Atorvastatin
221 Metformin + Bromocriptine
222 Metformin + Gliclazide + Chromium Polynicotinate
223 Metformin + Gliclazide + Pioglitazone + Chromium Polynicotinate
224 Metformin + Glimepiride + Methylcobalamin
225 Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride
1/2/1/2mg
226 Metformin 500mg/500mg+Gliclazide SR 30mg/60mg + Pioglitazone 7.5mg/7.5mg
227 Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 1mg
228 Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 2mg
229 Metformin ER + Gliclazide MR + Voglibose
230 Metronidazole + Norfloxacin
231 Metronidazole + Tetracycline
232 N-Acetyl Cysteine + Ambroxol + Phenylephrine + Levocetirizine
233 Naphazoline + Carboxy Methyl Cellulose + Menthol + Camphor + Phenylephrine
234 Naphazoline + Chlorpheniramine + Zinc Sulphate + Boric Acid + Sodium Chloride
+ Chlorobutol
235 Naproxen + Paracetamol
236 Neomycin + Doxycycline
237 Nimesulide + Certirizine + Phenylephrine
238 Nimesulide + Cetirizine + Caffeine
239 Nimesulide + Diclofenac
240 Nimesulide + Dicyclomine
241 Nimesulide + Loratadine + Phenylephrine + Ambroxol
242 Nimesulide + Paracetamol + Cetirizine + Phenylephrine
243 Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine
244 Nimesulide + Paracetamol dispersible tablets
245 Nimesulide + Paracetamol injection
246 Nimesulide + Paracetamol Suspension
247 Nimesulide + Phenylephrine + Caffeine + Levocetirizine
248 Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol
249 Nimesulide + Serratiopeptidase
250 Nimesulide + Tizanidine
251 Nimorazole + Ofloxacin

252 Norfloxacin+ Metronidazole + Zinc Acetate
253 Ofloxacin + Ornidazole Suspension
254 Ofloxacin + Clotrimazole + Betamethasone + Lignocaine
255 Ofloxacin + Metronidazole + Zinc Acetate
256 Ofloxacin + Nitazoxanide
257 Ofloxacin + Ornidazole + Zinc Bisglycinate
258 Olmesartan + Hydrochlorothiazide + Chlorthalidone
259 Omeprazole + Paracetamol + Diclofenac
260 Oxytacaine + Magaldrate + Famotidine
261 Pantoprazole (as Enteric Coated Tablet) + Zinc Carnosine (as Film Coated Tablets)
262 Paracetamol + Ambroxol + Phenylephrine + Chlorpheniramine
263 Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaifenesin
264 Paracetamol + Caffeine + Codeine
265 Paracetamol + Cetirizine + Caffeine
266 Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + Phenylephrine
267 Paracetamol + Codeine + Chlorpheniramine
268 Paracetamol + Dextromethorphan + Bromhexine + Phenylephrine +
Diphenhydramine
269 Paracetamol + Dextromethorphan + Chlorpheniramine
270 Paracetamol + Diclofenac + Famotidine
271 Paracetamol + Disodium Hydrogen Citrate + Caffeine
272 Paracetamol + DL Methionine
273 Paracetamol + Domperidone + Caffeine
274 Paracetamol + Levocetirizine + Phenylephrine + Zink Gluconate
275 Paracetamol + Levocetirizine + Pseudoephedrine
276 Paracetamol + Loratadine + Dextromethophan + Pseudoephedrine + Caffeine
277 Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + Caffeine
278 Paracetamol + Mefenamic Acid + Ranitidine + Dicyclomine
279 Paracetamol + Pheniramine
280 Paracetamol + Phenylephrine + Caffeine
281 Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + Caffeine
282 Paracetamol + Phenylephrine + Chlorpheniramine + Zinc Gluconate
283 Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + Ambroxol
284 Paracetamol + Phenylephrine + Levocetirizine + Caffeine
285 Paracetamol + Phenylephrine + Triprolidine
286 Paracetamol + Phenylephrine + Triprolidine + Caffeine
287 Paracetamol + Prochlorperazine
288 Paracetamol + Prochlorperazine Maleate
289 Paracetamol + Promethazine
290 Paracetamol + Propyphenazone + Caffeine
291 Paracetamol + Pseudoephedrine + Cetrizine
292 Paracetamol + Pseudoephedrine + Dextromethorphan + Cetirizine
293 Paracetamol + Tapentadol
294 Paracetamol + Phenylephrine + Levocetirizine + Sodium Citrate
295 Paracetamol + Pseudoephedrine + Certirizine + Caffeine
296 Permethrin + Cetrimide + Menthol

297 Phenylbutazone + Sodium Salicylate
298 Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + Caffeine
299 Phenytoin + Phenobarbitone
300 Pholcodine + Phenylephrine + Promethazine
301 Pholcodine + Promethazine
302 Pioglitazone 15mg + Metformin 850 mg
303 Pioglitazone 30 mg + Metformin 500 mg
304 Pioglitazone 7.5/7.5mg + Metformin 500/1000mg
305 Pseudoephedrine + Bromhexine
306 Pseudoephedrine + Dextromethorphan + Cetirizine
307 Rabeprazole + Diclofenac + Paracetamol
308 Rabeprazole + Zinc + Domperidone
309 Rabeprazole + Zinc Carnosine
310 Ranitidine + Domperidone + Simethicone
311 Ranitidine + Magaldrate
312 Ranitidine + Magaldrate + Simethicone
313 Roxithromycin + Serratiopeptidase
314 Salbutamol + Bromhexine
315 Salbutamol + Bromhexine + Guaiphenesin + Menthol
316 Salbutamol + Certirizine + Ambroxol
317 Salbutamol + Choline Theophyllinate + Ambroxol
318 Salbutamol + Choline Theophyllinate + Carbocisteine
319 Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
320 Serratiopeptidase (enteric coated 20000 units) + Diclofenac Potassium & 2 tablets
of Doxycycline
321 Sildenafil + Estradiol Valerate
322 Tamsulosin + Diclofenac
323 Telmisartan + Metformin
324 Terbutaline + Ambroxol + Guaiphenesin + Zinc + Menthol
325 Terbutaline + Bromhexine + Etofylline
326 Terbutaline + Bromhexine + Guaiphenesin + Dextromethorphan
327 Terbutaline + Etofylline + Ambroxol
328 Terbutaline + N-Acetyl L-Cysteine + Guaifenesin
329 Terpinhydrate + Dextromethorphan + Menthol
330 Thyroid + Thiamine + Riboflavin + Pyridoxine + Calcium Pantothenate +
Tocopherol Acetate + Nicotinamide
331 Thyroxine + Pyridoxine + Folic Acid
332 Tranexamic Acid + Proanthocyanidin
333 Ursodeoxycholic Acid + Silymarin
334 Voglibose + Pioglitazone + Metformin
335 Voglibose+ Metformin + Chromium Picolinate
336 Zinc Carnosine + Magnesium Hydroxide + Dried Aluminium Hydroxide +
Simethicone
337 Zinc Carnosine + Oxytacaine
338 Zinc Carnosine + Sucralfate

Large sales volumes of FDCs in India, in comparison to Britain and United States of
America, have been deliberated upon by expert committees since the 1980s and bans on
various combinations have periodically been issued.
In 2015, a study of FDCs in four therapeutic areas demonstrated that there were multiple
formulations available on the Indian market that had been banned, restricted or never
approved internationally. Ideally, then, CDSCO ought to be able to make out a strong case
upholding its ban. Case law on similar bans would appear to bear this out.
The Central government imposes such bans by exercising its powers under Section 26A of
the Drugs and Cosmetics Act, 1940. This provision allows the government to prohibit the
manufacture, sale or distribution of drugs that are likely to pose a risk to human beings or
animals, or that do not have the therapeutic value that they claim, or contain ingredients in
quantities for which there is no therapeutic justification. The Central government must also
be satisfied that it is necessary or expedient in the public interest to impose such prohibition.

2.0 Literature Review
.

Drugs undergo rigorous testing before they are introduced into the market. The efficacy as
well as safety profiles of the drug are tested. In spite of this, some adverse effects of drugs
appear only after the drug is released called Pharmacovigilance.
Pharmacovigilance is the Pharmacological science relating to the detection, assessment
understanding and prevention of adverse effects, particularly, long-term and short-term side-
effects of medicines.
DCGI (Drug Controller general of India) is the highest authority in India to expand the
approval of any drug or to ban a drug. If any is to have harmful side-effects, the government
issues the ban order and all manufacturer and wholesaler are asked not to manufacture and
sell the particular medicine.
If doctors stop prescribing drugs that are harmful to patient’s health, chemists will
automatically stop selling since there are no patients asking for it, and hence, manufacturers
do not produce it. Certainly, much of the problem can be solved like that the manufacturers
have every reason to sell their products if there are buyers.
Here is the list of companies and their products that are affected
S. No. Company Brand Name of Medicine
1. Abbott Phensedyl, Tossex, Tribet
2. Alkem Sumo, Taxim AZ
3. Cipla Triexer & Oflox
4. Glenmark Ascoril
5. GSK Crocin Cold & FLU Max
6. Ipca Zerodol P
7. Lupin Gluconorm
8. Macleods Panderum Plus
9. Mankind Paediatric syrup T-98 TedyKoff
10. Medley Pharmaceuticals O2
11. Micro Labs Dolo Cold
12. Panacea Biotech Nimulid
13. Paras Lab D Cold-Total
14. Pfizer Corex
15. Procter and Gamble Vicks Action 500 Extra
16. Sun Pharma Gemer P, Chericof, Decoff
17. Torque Pharma Kofnil

18. Wockhardt Zedex, Ace Proxyvan
FDC Drugs in Indian Law
FDCs should always be based on convincing therapeutic justification. Each FDC should be
carefully justified and clinically relevant (e.g., in cases when each component of the FDC has
several possible dosages, dosages that have shown benefit on clinical outcomes may be
preferable).
Appendix VI of Schedule Y (Drugs and Cosmetics Rules 1945) specifies the requirements for
approval for marketing of various types of FDCs. The same is further elaborated to provide a
detailed guidance for industry.
Drug control issues in India
The Indian drug control authority has issued notifications banning many FDCs. The principal
notification under Section 26-A of the Drugs and Cosmetics Act, 1940, (prohibiting
manufacture, sale and distribution of certain FDCs, which do not have any therapeutic
justification or are likely to involve risk to the human being) banned 79-drug formulations
from the year 1983 till date. Some examples are FDCs of vitamins with anti-inflammatory
agents and tranquillizers, of anti-histamines with anti-diarrheal etc. It is an accepted fact that
an FDC be treated as a new drug, because by combining two or more drugs, the safety,
efficacy, and bioavailability of the individual active pharmaceutical ingredient (API) may
change. As per the Drugs and Cosmetic Act, 1940, any new drug and the permission to
market a drug is to be given by the Drugs Controller General of India (DCGI). As per rule
122 (E) of the Drugs and Cosmetic Rules, 1945, the same criteria holds good for US markets
as well.
FDCs in India
More than one-third of all the new drug products introduced worldwide during the last decade
were FDC preparations. The trend varied from country to country. In Japan, only 10% of the
new products were fixed ration combinations, whereas, in European countries like Spain, it
was up to 56%. However, such statistical data are lacking for the developing countries,
although, the trend seems to be the production and prescription of FDCs. The World Health
Organization (WHO) lists nearly 325 essential drugs, including only 19 of such drug
combinations. Whereas, the national list of essential medicines has 354 essential drugs,
including 14 drug combinations. FDCs available for the treatment of various ailments range
from nutritional deficiency to cardiovascular diseases. Maximum FDC preparations comprise
vitamins, cough suppressants, anti-diarrheal, iron preparations, antacids, analgesics, and
tonics [18].
There are many popular FDCs in the Indian pharmaceutical market, which have flourished in
the last few years. Medical experts world over have been expressing serious concerns over
the marketing of increasing number of drug combinations by pharmaceutical companies,
particularly in the developing countries. Some FDCs can impose unnecessary financial
burden, increased adverse effects, as well as hospitalization, and decreased quality of life.
The Indian drug control authority has issued notifications banning many FDCs. The principal
notification under Section 26-A of the Drugs and Cosmetics Act, 1940, (prohibiting
manufacture, sale and distribution of certain FDCs, which do not have any therapeutic
justification or are likely to involve risk to the human being) banned 79 drug formulations
from the year 1983 till date. Some examples are FDCs of vitamins with anti-inflammatory
agents and tranquillizers, of anti-histamines with anti-diarrheal etc.

The DCGI had given marketing approvals for 40 FDCs in January 2002. It is an accepted fact
that an FDC be treated as a new drug, because by combining two or more drugs, the safety,
efficacy, and bioavailability of the individual API may change. As per the Drugs and
Cosmetic Act, 1940, any new drug and the permission to market a drug is to be given by the
DCGI. As per rule 122 (E) of the Drugs and Cosmetic Rules, 1945, the same criteria holds
good for US markets as well. WHO has made the following observations regarding the FDCs,
as new fixed ratio combination products are regarded as new drugs in their own right [18].
FDCs are highly popular in the Indian pharmaceutical market and have been particularly
flourishing in the last few years. The rationality of FDCs should be based on certain aspects
such as:
• The drugs in the combination should act by different mechanisms
• The pharmacokinetics must not be widely different
• The combination should not have supra-additive toxicity of the ingredients.
Most FDCs have the following demerits:
• Dosage alteration of one drug is not possible without alteration of the other drug
• Differing pharmacokinetics of constituent drugs pose the problem of frequency of
administration of the formulation
• By simple logic, there are increased chances of adverse drug effects and drug
interactions compared with both drugs given individually.
The “combined” pills are marketed with slogans like “ibuprofen for pain and paracetamol for
fever” and “ibuprofen for peripheral action and paracetamol for the central action.” It is
indeed very unfortunate that the medical fraternity in India has fallen prey to such gimmicks.
The gullible patient then has to pay for the doctor’s complacence in terms of extra cost and
extra adverse effects. There is no synergism when two drugs acting on the same enzyme are
combined. Thus combining two NSAIDs does not and cannot improve the efficacy of
treatment. It only adds to the cost of therapy and more importantly, to the adverse effects and
the ‘muscle relaxants’ in some of these combinations are of questionable efficacy.
Combinations of NSAIDs/analgesics with antispasmodic agents are also available in India.
They are not only irrational but also could be dangerous. The antipyretic drug promotes
sweating and thereby helps in heat dissipation. On the other hand, the anticholinergic
antispasmodic drug inhibits sweating. Combining these two can result in dangerous elevation
of the body temperature. Some such fixed drug combinations are now banned in India.
Medical fraternity in India has fallen prey to such gimmicks. The gullible patient then has to
pay for the doctor’s complacence in terms of extra cost and extra adverse effects. There is no
synergism when two drugs acting on the same enzyme are combined. Thus combining two
NSAIDs does not and cannot improve the efficacy of treatment. It only adds to the cost of
therapy and more importantly, to the adverse effects and the ‘muscle relaxants’ in some of
these combinations are of questionable efficacy.
Combinations of NSAIDs/analgesics with antispasmodic agents are also available in India.
They are not only irrational but also could be dangerous. The antipyretic drug promotes
sweating and thereby helps in heat dissipation. On the other hand, the anticholinergic
antispasmodic drug inhibits sweating. Combining these two can result in dangerous elevation
of the body temperature. Some such fixed drug combinations are now banned in India.

Fixed-dose combination drugs like Zimnic AZ aren’t unique to India. They are used
worldwide to improve patients’ compliance in complicated courses of treatment for such
conditions as HIV, tuberculosis and malaria. It’s easier to get patients to take one drug than a
number of different pills.
A study published in the journal of Public Library of Science (PLOS) in May found that over
70% of non-steroidal anti-inflammatory drug (NSAID) combinations, which are used
as painkillers, were being marketed in India without central government approval. The
authors recommended that unapproved drug combinations be banned immediately.
Combination drugs are also useful in increasing compliance among the many Indian patients
who can’t read, said Sanjay Sikaria, director of drugmaker Suncare Formulations Private Ltd
in Uttarakhand state. “FDCs are not bad,” he said. “Rampant misuse of these drugs is bad.”
That’s the problem in India, where there has been an explosion of combination drugs. They
have become a way to boost sales and increase market share: More and more companies have
tacked on ingredients to existing drugs so they can peddle a new product to doctors and
chemists, say people in the country’s highly competitive pharmaceutical sector.
Combination drugs are profitable because of high demand from doctors, who see them as a
way to ensure patient compliance, say people in the pharmaceutical industry. Many doctors
also see them as providing “quick-fix solutions” that cover multiple possible symptoms with
a single pill, said a physician employed by a pharmaceutical company. “The market needs it
and demands it,” he said.
Between 2011 and 2014, India’s fixed-dose combination market grew more than 40% in
Rupee terms, according to IMS Health.

3.0 Justification
The Central Drugs Standard Control Organization (CDSCO) in India has banned the
manufacture and sale of more than 300 fixed dose drug combination to prevent the misuse of
drugs and to prevent drug resistance.
A gazette notification by Ministry of Health and Family Welfare was issued on 10th March
2016 to ban these fixed drug combinations. The list includes common cough syrup solutions,
analgesics and antibiotic combinations. Some of these drugs are sold over the counter. In
2014 a committee was set up to review over 6000 drug combinations that had entered the
market based only on state regulator’s approval.
This ban is likely to affect many leading pharmaceutical drug manufacturers such as Pfizer,
Abbott, Macleods Pharma and Glenmark Pharmaceuticals. Some of these companies have
already appealed to the court and received interim injunctions.
This could be a ‘Maggie moment’ for the big pharma companies as the Govt. has ordered
stay on the ban of FDC drugs for several companies.
Due to this ban pharma companies are suffering huge financial losses. The BSE Healthcare
index dropped, all the stock that was already manufactured and stored is now is valued zero.
The study is important in the aspect of pharmaceutical market value, the reasons given by the
CDSCO and the measures taken by the pharma companies.

4.0 Objectives
1.0 Reason for ban on FDC drugs
2.0 Financial loss endured by the pharma companies
3.0 Measures taken by the pharma companies
4.0 Impact on consumers

5.0 Research Methodology
Research Design
An observational study was done on the recent ban on over 300 drugs to study its
implications on the pharmaceutical market in India.
A cross sectional study was performed in which secondary data was studied, followed by its
depth analysis.
Research Tools
A checklist was prepared keeping in view of the objectives. The data was collected from the
secondary sources. A few published articles were also referred.
Primary data was also collected, studied, analysed and consolidated to form the dissertation
report.
Data Collection
The data was collected from few published journals, newspaper articles, websites, case
studies and online organizational records.
Primary data was collected by interviewing five chemists in West Delhi. Questions were
asked regarding the effect on daily sale of drugs after the ban, change in inventory
management, change in prescription pattern and customer reviews.

6.0 Study Findings

Reason for the ban of FDC drugs
On March 10, the Central Drugs Standard Control Organisation (CDSCO)—an Indian drug
regulator—banned 344 drugs in the country. The notification said that these drugs can’t be
made, sold or distributed in the country. These medicines are fixed dose combinations, which
mean they are made by mixing two or more drugs.
The CDSCO gave two main reasons for the ban: the drugs were “likely to involve risk to
human beings” while safer alternatives were available, and they were “found to have no
therapeutic justification.” The list of the banned drugs included some widely used products
such as the Vicks Action 500 tablet, made by Procter & Gamble, and Pfizer’s Corex cough
syrup.
The Ministry, while banning over 300 drug combinations also said that “there are safer
alternatives available in the market.” The Department said that it had the best of scientists
on board to study the effects of these drugs. "We have tried to bring objectivity to the issue
by roping in the best of scientists to study the effects," the Ministry said.
The order hasn't come out of the blue. The government says that the companies were first
issued show cause notices and even given a chance to present their case, but some companies
hadn't even bothered to respond to the notice.
After a thorough examination by the expert committee, the Central government said that it
was satisfied with the recommendations of the expert committee.
According to doctors and health experts across the globe, the increasing use of combination
drugs is dangerous since they cause antibiotic resistance in patients. Also, since most FDCs
are common to many active ingredients, there's an alarming risk of difficulties to identify
which medicine is responsible for the adverse effects, if any.
In 2014, India set up a committee to review more than 6,000 combinations that had entered
the market based only on state regulators’ approval. Policymakers gave pharmaceutical
companies a chance to retroactively prove the safety and efficacy of these drugs by
submitting data on their drugs.
Uncertainties regarding the quality of FDC formulations and their registration, and barriers to
effective implementation in national programs, have limited the widespread use of FDCs.
Bioavailability of individual components may change when put into combination with other
components. For example, variable bioavailability of the tuberculosis drug rifampicin from
solid oral dosage forms has been reported, whereas bioavailability problems with the
isoniazid, pyrazinamide and ethambutol components of FDCs have not been encountered,
presumably because of the much greater water solubility and more rapid rates of absorption
of these latter drugs. Hence, using FDC tablets with poor rifampicin bioavailability could
lead directly to treatment failure and may encourage drug resistance. Other FDC components
may have similar issues.
Now many of the combinations which are recently banned in India, they were already banned
in many countries like USA, Canada, Europe. FDA has clearly mentioned various side effects
of drugs in FDCs which are very harmful and can be fatal.

There are more than 300 FDCs which were banned; 338 to be precise. I have categorized
them into their purpose of usage/type. The following is the Chart 1 which depicts the same:
1
4
1
1
1
1
35
1
1
1
1
2
59
2
1
5
1
2
1
1
3
2
13
4
26
4
1
3
1
19
24
20
4
8
70
11
1
0 10 20 30 40 50 60 70 80
Zinc Supplement
Supplement
Stomach ache
Skin infection
Sedative/Hypnotics
Probiotic
NSAIDs
Multivitamin
Melasma treatment
Liver Function
Joint Pain
Gout Treatment
Expectorant
Erectile Dysfunction
Burn Treatment
Antiulcer
Antithyroid
Antiseptic
Antimigraine
Antihypertensive+Antidiabetic
Antihypertensive
Antihelmentic
Antifungal
Antiemetic
Antidiabetic
Antidepressant
Anticoagulant+Analgesic
Antibiotic+Antiprotozoal
Antibiotic+Antihypertensive
Antibiotic+Antifungal
Antibiotic
Antiasthametic
Antianxiety
Antiallergic+Analgesic
Antiallergic
Antacid
Anaesthetic
Type of FDCs banned

Out of 338 FDCs banned, there are 70 antiallergic drugs, 59 expectorants, 33
analgesics/antipyretics, 26 antidiabetics, 24 antibiotics and 20 antiasthametics. Also there was
one multivitamin and probiotic each which were strangely included in banned FDCs.
For further clarity, the following Chart 2 categorises or type of FDCs according to their usage
in percentage of grand total:
0.30%
1.19%
0.30%
0.30%
0.30%
0.30%
10.42%
0.30%
0.30%
0.30%
0.30%
0.60%
17.56%
0.60%
0.30%
1.49%
0.30%
0.60%
0.30%
0.30%
0.89%
0.60%
3.87%
1.19%
7.74%
1.19%
0.30%
0.89%
0.30%
5.65%
7.14%
5.95%
1.19%
2.38%
20.83%
3.27%
0.30%
0.00% 5.00% 10.00% 15.00% 20.00% 25.00%
Zinc Supplement
Supplement
Stomach ache
Skin infection
Sedative/Hypnotics
Probiotic
NSAIDs
Multivitamin
Melasma treatment
Liver Function
Joint Pain
Gout Treatment
Expectorant
Erectile Dysfunction
Burn Treatment
Antiulcer
Antithyroid
Antiseptic
Antimigraine
Antihypertensive+Antidiabetic
Antihypertensive
Antihelmentic
Antifungal
Antiemetic
Antidiabetic
Antidepressant
Anticoagulant+Analgesic
Antibiotic+Antiprotozoal
Antibiotic+Antihypertensive
Antibiotic+Antifungal
Antibiotic
Antiasthametic
Antianxiety
Antiallergic+Analgesic
Antiallergic
Antacid
Anaesthetic
Type of FDCs banned

Out of 338 banned FDCs, 20% are antiallergic, 17% are expectorants, about 10% are
analgesics/antipyretics, 8% are antidiabetics and these all contribute more than 50% of
banned FDCs.
Following graph represents various side effects of the FDCs which are mostly encountered by
the patients:
2
4
13
9
2
2
1
1
3
1
1
2
8
12
3
10
5
1
3
8
4
16
1
42
7
6
1
130
1
2
2
3
26
4
0 20 40 60 80 100 120 140
Stomach upset
Ototoxicity+Allergic reaction
Ototoxicity
Other
Nephrotoxicity+CNS Problems
Nausea/Vomiting
Kindney problem+Gastric…
Joint pain+Headache
Hypoglycemia
Hepatotoxicty+Nephrotoxicity
Hepatotoxicty
Gastric problem+Muscular Pain
Gastric Problem+Hepatotoxicty
Gastric problem+CNS Problems
Gastric problem+Allergic…
Gastric Problem
CVS+Muscular Pain
CNS Problems+Rheumatoid…
CNS Problems+Renal Calculi
CNS Problems+Ototoxicity
CNS Problems+Nephrotoxicity
CNS Problems+Muscular Pain
CNS Problems+Hypersensitivit
CNS Problems+Hepatotoxicity
CNS Problems+Gastric problem
CNS Problems+Cardiovascular…
CNS Problems+Blurry Vision
CNS Problems
Cardiovascular…
Cardiovascular…
Allergic Reactions+Gastric…
Allergic Reactions+CNS…
Allergic Reactions+CNS Problems
Allergic reactions

As you can see from the graph 1, maximum FDCs cause CNS (Central Nervous System)
problems, severe allergic reactions and hepatotoxicity. The term “(blank)” represents the
possible side effects of supplements and
For more clarity, the following chart 2 represents the percentage of side effects of various
FDCs:

From the above chart, we can interpret that out of 338 FDCs banned, more than 50% of the
dugs causes CNS problems and hepatotoxicity. CNS problems include dizziness, vertigo
and/or nausea/vomiting. This clearly shows that these FDCs should have been banned a long
time ago.
0.31%
0.31%
0.31%
0.31%
0.31%
0.31%
0.31%
0.31%
0.61%
0.61%
0.61%
0.61%
0.61%
0.61%
0.92%
0.92%
0.92%
0.92%
1.22%
1.22%
1.22%
1.53%
1.83%
2.14%
2.45%
2.45%
3.06%
3.67%
3.98%
4.89%
7.95%
12.84%
39.76%
0.00% 5.00% 10.00% 15.00% 20.00% 25.00% 30.00% 35.00% 40.00% 45.00%
CNS Problems+Blurry Vision
CNS Problems+Hypersensitivit
Hepatotoxicty+Nephrotoxicity
CNS Problems+Rheumatoid Arthritis
Joint pain+Headache
Hepatotoxicty
Kindney problem+Gastric Problem
Cardiovascular Disease+Muscular Pain
Nephrotoxicity+CNS Problems
Gastric problem+Muscular Pain
Stomach upset
Allergic Reactions+Gastric problem
Nausea/Vomiting
Cardiovascular Disease+Hepatotoxicty
Gastric problem+Allergic Reactions
Allergic Reactions+CNS Problems+Gastric problem
Hypoglycemia
CNS Problems+Renal Calculi
Allergic reactions
CNS Problems+Nephrotoxicity
Ototoxicity+Allergic reaction
CVS+Muscular Pain
CNS Problems+Cardiovascular Disease
CNS Problems+Gastric problem
CNS Problems+Ototoxicity
Gastric Problem+Hepatotoxicty
Gastric Problem
Gastric problem+CNS Problems
Ototoxicity
CNS Problems+Muscular Pain
Allergic Reactions+CNS Problems
CNS Problems+Hepatotoxicity
CNS Problems
% of Grand Total Side effects

Zimnic AZ (manufactured by Abbott) has been promoted for a wide array of indications such
as fevers, colds, urinary tract infections and even sexually transmitted diseases. The drug is
also said to be used by patients to prevent post-surgery infections and lung problems. Medical
experts, however, said that this antibiotic combination is very risky and some indications,
particularly that of colds, is not sound.
Clinicians and other health professionals say improper administration of antibiotic
combinations may be adding up to the burden of antibiotic resistance in the country. In fact,
superbugs or strains of pathogens that have grown resistant to antibiotics have been
discovered among individuals who have travelled from India to nations such as Britain and
the U.S.
India has banned the production and marketing of more than 300 fixed dose combinations
(FDCs) drugs, including cough syrups like Phensedyl and Corex widely consumed by addicts
in Bangladesh.
Bangladesh has long been urging India to stop the smuggling of Phensedyl and some of its
officials had even suggested that production of these drugs be stopped.
The cough syrup is already banned in Bangladesh as its Codeine content is unusually high
and attracts addicts, who cough up to three times the rate in India to buy these cough syrup
bottles.
The Phensedyl smuggling volume ran into nearly 1.5 billion Indian rupees, according to most
conservative estimates.
Financial Loss Endured by the Pharmaceutical Companies
The government notification issued March 10 by Union Health Ministry Joint Secretary KL
Sharma said various combination drugs, after examination by an expert committee, were
found to be risking the lives of humans. The committee had submitted its recommendations
to the Central government on the prohibition of manufacture, sale and distribution of such
drugs.
The Centre has ordered a ban on the manufacture, sale and distribution of such drugs under
Section 26(A) of the Drugs and Cosmetics Act, 1940, the notification said.
In 2014, the government appointed an expert committee to review over 6,000 combination
drugs which entered the market based only on state regulators' approval. The committee was
supposed to classify the drugs into rational, irrational, and those that need further studies,
Sharma was quoted by the Reuters as saying.
He said based on the responses from the committee and assessment of products, more than
300 drugs have been banned.
The annual impact of the ban, according to AIOCD (All Indian Origin Chemists &
Distributors) Pharmasofttech AWACS (Airborne Warning And Control System) — a
pharmaceutical market research firm, is estimated to be Rs 3,049 crore, affecting 3% of the
retail pharma market.

The drug companies have recalled the banned products from stockists, retailers after the
government in a notification dated March 10, directed a ban on various FDCs.
Stocks of impacted brands will need to be recalled and destroyed, and companies like Cipla,
Emcure, Mankind and Zuventus on Tuesday started informing stockists and retailers about
the banned drugs, asking them to stop selling them with immediate effect.
The sudden move has created confusion among stockists, retailers and patients, forcing
certain companies like Abbott, Glenmark and Macleods to join Pfizer in challenging the ban
in courts, even as the drug industry body, IDMA, said that it is weighing all options. They
have been granted interim injunction suspending the implementation of the notification till
the next date of hearing on March 21.
Taking the drug industry by surprise, the health ministry, in a notification issued on March
12, prohibited the manufacture, sale and distribution of 344 fixed-dose combinations (FDCs)
with immediate effect. The drug industry along with stockists feel that sufficient time should
have been given so that losses could have been reduced. In the past, the government issued
similar notifications from a prospective date, giving the industry sufficient time to prepare,
particularly for drugs which are not life-threatening
The drop in domestic revenue will only add to the woes of Indian drug-makers. Experts have
already warned of a bleak export growth for the 2017 fiscal year. For instance, a Feb. 1 report
by India Ratings and Research, a credit ratings agency, said export growth in the 2017 fiscal
will be about 5%. The slow growth is due to regulatory challenges and competition in foreign
markets. The agency expects the domestic market growth around 13-15%. Investors are
worried as this ban means loss in revenue for pharma companies.
“As for the revenue, most Indian companies are dependent on combination drugs because
they drive sales. So a drop in revenue could be possible for companies who are heavily
dependent on combination drugs,” Surajit Pal, a pharma research analyst at Prabhudas
Lilladhar, a brokerage, told Quartz.
Pal believes this ban was long due.
“Typically, around 60-70% of combination drugs in the industry do not hold any logic. Many
of them are produced for purely commercial purposes, irrespective of what their health
impacts are. These practices should be stopped,” he said.
The BSE Healthcare Index is down 9% so far this year.

Earlier this month, Dinesh Thakur, a whistle-blower and activist, had filed public interest
litigation against the CDSCO, questioning regulatory standards in India’s pharma industry.
The Supreme Court dismissed the petition.
The government ban on fixed dose combination (FDC) drugs has taken a toll on
pharmaceuticals stocks, which saw a fall in the range of 20-50% year-to-date. Marksans
Pharma Ltd has fallen 47% in 2016 so far, while Wockhardt Ltd posted a decline of 38% in
its share price. Pfizer Ltd, another company which got affected with the FDC ban, saw its
shares fall 29% year-to-date. .
According to the latest data released by pharmaceutical research company AIOCD
Pharmasofttech AWACS, Abbott Healthcare is likely to suffer a loss of Rs.485 crore,
MacLeods Pharma of around Rs.370 crore and Pfizer to the tune of Rs.368 crore.
“This is a significant financial impact to companies. Some of the well-known brands have
been included in the mix along with some truly irrational brands. The intention is good but
the government will have to find a way to segregate the bad from the good,” said Sujay
Shetty, leader - pharma life sciences, PWC India.
Pfizer India said that the prohibition of the Corex drug is likely to adversely impact the
company’s revenue and profitability. Corex recorded sales of Rs.176 crore for the first nine
months of the fiscal year ended on 31 December 2015. Pfizer said it was suspending the
manufacturing and sale of its popular Corex cough syrup which contains a combination of
Chlopheniramine Maleate and Codeine syrup. However, after moving the Delhi High Court
over the order, the HC has provided interim relief to the company until the next hearing date
which hasn't been announced yet. The company said the ban is likely to have an adverse

impact on its revenue and profitability, and that it is exploring all the available options in this
issue.
"A government of India notification, dated March 10, 2016, has prohibited the manufacture,
sale and distribution of a fixed-dose combination of Chlopheniramine Maleate + Codeine
Syrup with immediate effect. In view of this, the company has discontinued the manufacture
and sale of its drug 'Corex' with immediate effect." the company said in a filing to the
Bombay Stock Exchange (BSE).
Macleods Pharma's much sought skin cream Panderm+ has also been banned. This cream
itself was bringing Rs 228.2 crore (Rs 2.28 billion) to the company in annual sales.
Mankind Pharma's 32 brands have been banned which had annual sales of Rs 234 crore (Rs
2.34 billion).
Abbott saw 36 of its brands banned which had annual sales of Rs 400 crore (Rs 4 billion) in
the same period. Similarly, 30 brands by Macleods Pharma, with annual sales of Rs 400
crore, have been banned.
Abbott's three major cough syrups - Phensedyl, Tixylix and Tossex - which had annual sales
of Rs 290 crore (Rs 2.9 billion), were also banned by the government.
Phensedyl (cough syrup), marketed by Abbott, takes up approximately one-third of the entire
Indian cough syrup market. The sales of this medicine is said to contribute to more than 3
percent of the entire company revenue of $1 billion in India. The

Health Ministry also included antibiotic combinations in the list of banned drugs. One
product affected by the ban is Abbott's Zimnic AZ, which is a combination of cefixime and
azithromycin. The shares of Abbott India Ltd fell by 21.4% year-to-date.
Abbott is not the only firm to manufacture such drug combination in India as about 15 more
companies also produce this drug.
"Our concern is patients may not have access to some medicines which have been approved
by the DCGI (Drug Controller General of India) and are being used safely and effectively in
India for years," an Abbott official was quoted by the Economic Times as saying.
Market research agency PharmaTrac meanwhile was quoted as saying by ET that Abbott may
take a hit of Rs 485 crore and Pfizer Limited a hit of Rs 368 crore as a result of the
government move.
Sun Pharma - India's largest pharmaceutical company - has got its 28 brands banned which
had total annual sales of just Rs 95.7 crore (Rs 957 million).
Lupin's anti-diabetic drug Gluconorm -PG, which had sales of Rs 46.5 crore (Rs 465 million),
has also been banned.
This brand's FDC name is Glimepiride + Pioglitazone + Metformin. This FDC - which is sold
by more than 85 companies under different brand names - had total sales of Rs 525 crore
annually.
Chlopheniramine Maleate + Codeine, which had annual sales of Rs 700 crore (Rs 7 billion)
and is sold by almost 60 companies in the country, has also been banned.
GlaxoSmithKline's four brands which have been banned are - Crocin Cold and Flu, Piriton-
CS, Dilo-DX and Piriton Expect. These four drugs had annual sales of Rs 58 crore (Rs 580
million).
Following is a list of companies and there percentage of shares dropped after the ban:
S. No. Company % of Shares dropped after the ban
1. Abbott 21.4
2. Alembic 28
3. Anuh Pharma 35
4. Aurobindo Pharma 17
5. Biocon 10
6. Cipla Ltd 19
7. Claris Lifesciences 36
8. Divi’s Laboratories Ltd 14

9. Glenmark Pharmaceuticals 13
10. Ipca Laboratories 29
11. Lupin 10
12. Marksans Pharma Ltd 47
13. Merck Ltd 17
14. Nacto Pharma 19
15. Nector Lifesciences 28
16. Novartis India 19
17. Orchid Pharma 35
18. Pfizer India 29
19. Sequent Scientific 33
20. Sharon Bio Medicine Ltd 54
21. SMS Pharmaceuticals 31
22. Strides Shasun 20
23. Syncom Formulations India 50
24. Torrent Pharmaceuticals 10
25. Unichem Laboratories 18
26. Vimta Labs 35
27. Wockhardt Ltd 38
[Source: http://www.livemint.com/Money/HZJ4tIfRbWd8cyCfUouKtO/Pharma-stocks-dive-
2055-this-year-after-ban-on-combination.html]
The same has been presented in form of a bar chart for more clarity:

Procter & Gamble has stopped the manufacturing and sale of Vicks Action 500 Extra which
contains a combination of paracetamol, phenylephrine and caffeine.
"Our product 'Vicks Action 500 Extra' has the same fixed dose combination and gets covered
under notification. We have discontinued the manufacture and sale of all SKUs of 'Vicks
Action 500 Extra with immediate effect," the company said.
38
35
18
10
50
20
31
54
33
29
35
19
28
19
17
47
10
29
13
14
36
19
10
17
35
28
21.4
0 10 20 30 40 50 60
Wockhardt Ltd
Vimta Labs
Unichem Laboratories
Torrent Pharmaceuticals
Syncom Formulations India
Strides Shasun
SMS Pharmaceuticals
Sharon Bio Medicine Ltd
Sequent Scientific
Pfizer India
Orchid Pharma
Novartis India
Nector Lifesciences
Nacto Pharma
Merck Ltd
Marksans Pharma Ltd
Lupin
Ipca Laboratories
Glenmark Pharmaceuticals
Divi’s Laboratories Ltd
Claris Lifesciences
Cipla Ltd
Biocon
Aurobindo Pharma
Anuh Pharma
Alembic
Abbott
% of Shares dropped after the ban

He said some of the formulations in the combination drugs have been the treatment of choice
in certain medical conditions.
The Indian Pharmaceutical market in FY12 stood at Rs. 63,000 cr - more than double than in
FY07. This market is estimated to grow at 15% CAGR up to 2020 driven by lifestyle diseases
such as cardiovascular, diabetics and Oncology as has been the case in the past. FDC has
grown its domestic revenues by 60% over FY07-FY12 while the market has doubled due to
lack of strong brands in these fast growing segments. Market share is down to 1.2% from
almost 1.5% in FY07. We expect FDC’s domestic business to grow at higher single digits
given stiff competition from MNC and leading domestic players.
Measures Taken by Pharma Industries
The Drugs Controller General of India (DCGI) Dr G N. Singh’s recent act of banning of
more than 300 FDCs under Rule 26-A of Drugs and Cosmetics Act (D&C Act) with
immediate effect, without allowing the pharma companies any chance to sell the already
manufactured products which are in the market, is injudicious, imprudent and unfair as far as
the Indian pharma industry and the country’s patient society are concerned, said the Indian
Drug Manufacturers Association (IDMA).
Some of the common household medicines, including Crocin Cold and Flu, D-Cold Total,
Nasivion, Sumo, Oflox, Gastrogyl, Chericof, Nimulid, Kofnil, Dolo, Decoff, O2, paediatric
syrup T-98 and TedyKoff, have been banned by the Indian government as part of its decision
to halt the manufacture and sale of fixed dose combinations (FDCs).
Many of these drugs are cleared or licensed officially by the state licensing authorities under
the Drugs and Cosmetics Act and also by the office of the DCGI. Further, these medicines are
prescribed to the patients by thousands of qualified doctors, and no adverse reaction has been
reported either of efficacy or of safety.
According to him, Dr G N Singh has not only given any opportunity to the industry for
personal hearing, but also not responded to the many issues raised by manufacturers in their
reply to his show-cause notices. He said in the past government had withdrawn 94 products,
and the whole exercise was carried out in a systematic, careful and judicious manner so as to
avoid hardship to all concerned.
The drug companies said the ban has taken them by surprise as they were not informed and
consulted by the government before issuing the notification March 10.
The government notification issued on March 10 by Union Health Ministry Joint Secretary
KL Sharma said various combination drugs, after examination by an expert committee, were
found to be risking the lives of humans. The committee had submitted its recommendations
to the central government on the prohibition of manufacture, sale and distribution of such
drugs.
The drugs that have been banned in India are likely to be diverted to African countries or
even SAARC countries except Pakistan and Afghanistan, as the Central government has not
banned their exports.
A source in the drug control department said, “The products are not to be consumed in India,
but if the importing country has no objections then the drug controllers cannot stop it.”

Drug controllers say that they don’t have a say in what the manufacturers do with the recalled
drugs. While the makers of cough syrups Corex and Phensedyl have approached the court
and got a stay order, the others are still contemplating legal action. The problem is that this
time the government has listed each combination and banned them instead of issuing a bulk
order. This means that each pharma company will have to separately go to court for each
combination. The Delhi High Court has scheduled a hearing for March 21.
Meanwhile, the government gazette gives minimum information about the reason for the ban.
A senior pharma official on condition of anonymity said, “These combination drugs have
gone through proper regulatory approvals. They have been in the market for a long time.
Even the new combinations are approved and only then released in the market. How come
they have become ineffective now?” The Central government has been asked to submit the
details for ineffectiveness of Corex and Phensedyl to the court as the report is not in public
domain.
A senior officer said, “There is very little information in public domain except that it is not
viable for human consumption. The expert committee was set up in 2014 and the task was to
classify the drugs into rational, irrational and those that needed further studies. Based on the
responses and assessment of the products, the drugs have been banned.”
But a case to point is the combination of metformin+gliclazide+pioglitazone, which is used
by diabetic patients and which was approved by the Drug Controller General of India. But the
combination is now in the list of banned drugs. A senior doctor said, “This drug is very useful
for diabetics. The government had approved it earlier, how can it be banned now? There are
80 combinations of pioglitazone which are effective for diabetic patients and their ban is
going to affect the patients.”
The WHO had approved only 350 formulations of fixed dose combinations to treat prevalent
diseases but the pharma companies got too ambitious and made more than 6,000
combinations.
Dr Hari Krishna, a senior physician said, “With 50 per cent of the market containing FDCs it
had become a concern for prescribing medicines. For example if a person came with
headache and high fever, the combination drugs prescribed mostly were medicines for
headache, fever, body pain and cold. For the other two symptoms that did not exist (body
pain and cold), the medicine was not required and it caused side-effects.”
Abbott India, along with another pharma company Macleods Pharma, moved the Delhi High
Court Tuesday, against the government ban on combination drugs. The court meanwhile
granted a stay on the ban on the drugs of the two companies.
The court, while granting a temporary stay on the ban, observed the interim relief to the
pharma companies is justified. It also questioned the government on the sudden imposition of
ban on combination drugs that have been in the market for the last 20 years, according to the
daily.
U.S- based consumer healthcare company Procter & Gamble, whose product Vicks Action
500 Extra was banned, also approached the Delhi High Court for a stay on the ban.
Karnataka-based pharma companies like Embiotic Laboratories, Juggat Pharma and Anglo
French have been granted interim relief by Karnataka High Court for the ban imposed by the

Centre on sale of some of their fixed dose combination (FDC) drugs.
Another manufacturer Ce Chem has confirmed that it has also got a stay through the Indian
Drug Manufacturers Association which filed a plea in the High Court for its members. Micro
Labs too said it got a respite for the FDC ban from the Delhi High Court.
Pfizer Limited, whose popular cough syrup Corex was banned by the government, also
managed to get a stay on the ban. The court hearing on the ban has been scheduled for March
21.
Market agency PharmaTrac said that Abbott and Pfizer may be the worst hit pharma
companies due to the ban. Abbott may take a hit of Rs 485 crore and Pfizer Limited of
Rs. 368 crore as a result of the government move, the Economic Times reported.
Impact of ban on consumers
Corex, Vicks Action 500, D Cold-Total, FLU Max, Phensedyl and a lot more OTCs (Over
The Counter) drugs are now banned by the CDSCO. These are the drugs which are very
commonly known to us mostly because of the brand name and their easy availability.
I interviewed five chemists in West Delhi to know the actual status of the banned drugs.
I was bit shocked about the information they gave me. First of all let me remind you once
again that the Indian Gazette said that these drugs will not be manufactured and sold in India.
But surprisingly these all drugs were available in those chemist shops.
They told me that the banned FDC drugs are available but will sell only if the doctor
prescribes. This means that one can still buy these medicines by showing the prescription to
chemist. So now one cannot just go and buy Vicks Action 500 without prescription.
Now this is strange because almost all of these banned FDC drugs come under schedule H.
Now a Schedule H drug comes under the purview of Narcotic Drugs and Psychotropic
Substances Act, 1985, it must carry the texts "NRx" and "Schedule H drug. Warning: To be
sold by retail on the prescription of a Registered Medical Practitioner only." on the label
prominently.
Now the question arises how were these drugs sold by the chemists without prescription for
about 10-25 years before the ban? Not only this but now the chemist will give u these banned
drugs with a bill.
Previously these drugs were easily available without any prescription and that too without
bill. This is actually one of the reason for exponentially increase in the antibiotic resistance in
us. People consume antibiotics even for cough and cold.
In a nut shell, Government says all the drugs are banned but they are available but can only
be bought with a prescription of a registered medical practitioner with bill.

7.0 Conclusion

The Indian pharmaceutical sector is highly fragmented with more than 20,000 registered
units. It has expanded drastically in the last two decades. The Pharmaceutical and Chemical
industry in India is an extremely fragmented market with severe price competition and
government price control. The Pharmaceutical industry in India meets around 70% of the
country's demand for bulk drugs, drug intermediates, pharmaceutical formulations,
chemicals, tablets, capsules, orals, and injectable. There are approximately 250 large units
and about 8000 Small Scale Units, which form the core of the pharmaceutical industry in
India (including 5 Central Public Sector Units).
The Indian Pharmaceutical Industry, particularly, has been the front runner in a wide range of
specialties involving complex drugs' manufacture, development, and technology. With the
advantage of being a highly organized sector, the pharmaceutical companies in India are
growing at the rate of $ 4.5 billion, registering further growth of 8 - 9 % annually.
More than 20,000 registered units are fragmented across the country and reports say that 250
leading Indian pharmaceutical companies control 70% of the market share with stark price
competition and government price regulations.
Today, when we read diabetes guidelines recommending early use of combination therapy,
we tend to forget that Indian diabetologists have been using this form of treatment for over 40
years. Today, when the pharmaceutical industry celebrates the approval, by the FDA, of a
FDC for diabetes, we do not realize that these combinations were the norm in India nearly
half a century ago. The development and needs of FDCs plays a pivotal role in public health
sector because of potential lower cost comparing to separate products. Simpler logistics and
reduced development of resistance in case of antimicrobials. FDC therapy reduces poly
pharmacy and pill burden, which improves patient compliance. Identifiable population group
epidemiologically favours FDC. The rationality and therapeutic justification of all FDC’s are
the most controversial issue in current clinical practice. The knowledge about FDC’s were
lacking in resident doctors, which leads irrational prescription.
On March 10, 2016, the Central Drugs Standard Control Organisation, – or CDSCO, as it
commonly known – issued a notification prohibiting the manufacture, sale and distribution of
more than 300 FDCs drugs.
The ban on FDCs over safety and efficacy concerns will adversely affect MNCs like Abbott,
Pfizer and domestic companies including Alkem, Ipca and MacLeods, according to market
sources. Top brands which will face a ban include popular analgesics Zerodol and Sumo,
dermatology drug Panderm Plus, anti-diabetic medicine Tripride, and gastro-intestinal drug
Zenflox, besides cough syrups Phensedyl and Corex.
As per the notification gazette, a panel appointed by the government has found these
medicines likely to involve risk to human beings and where safer alternatives are available.
Besides this, these drugs are found to have “no therapeutic justification”, the notification
gazette says.
There have long been safety and efficacy concerns over FDCs in general and action against
them had long been awaited. However, the manner in which CDSCO acted underlined
serious problems with the working of the drug regulatory system in India. These include the
unclear division of functions between Central and State licensing authorities and inadequate
guidelines for taking action against violations.

These problems were exhaustively documented in a public interest petition filed against
CDSCO by the Ranbaxy whistle blower, Dinesh Thakur, but dismissed by the Supreme Court
only a day after the CDSCO notification.
But almost immediately, Pfizer dragged CDSCO to Delhi High Court, challenging the ban of
one of the 338 FDCs, the popular cough syrup known as Corex.
The Delhi High Court granted an interim stay on the ban until March 21 to Pfizer, a similar
injunction against the ban on Phensedyl (another cough syrup) and Vicks Action 500. The
interim stay has been granted on the grounds that the drug has been marketed for 25 years
and that the notification banning it does not disclose any “grave urgency”. The court’s order
also records the alleged objection of the manufacturers that they had been denied a hearing
before the ban was imposed.
There is no mention in the provision of the “grave urgency” that the Delhi High Court order
mentioned while granting an interim stay on the ban. In any case, in previous instances
involving Section 26-A bans, courts have been unsympathetic to the argument that the drugs
in question have been available on the market for several years and therefore, there is no
danger to public health.
This is because Section 26-A does not restrict the government’s power to life threatening
situations. Bans may be imposed even when there is no therapeutic justification for the drug
in question, even though the drug might not pose a risk to human health. In any case, courts
have stayed away from reviewing the technical merits of bans, restricting their enquiry to
whether the regulator had sufficient material on which to base its decision.
The contention of the manufacturers that they were entitled to a hearing before the ban was
imposed has no basis in Section 26-A either. Courts have held that the Drugs and Cosmetics
Act constitutes a complete code in itself and that principles of natural justice have no role to
play in the exercise of a power that is primarily legislative in nature, like the power under
Section 26-A.
What this means is that the manufacturers affected in this case might not be able to argue for
the lifting of the ban solely on the ground that they were not offered the opportunity to make
a representation. Even the fact that other manufacturers, unlike them, might have been given
such an opportunity, is not sufficient to create an entitlement to a hearing.
Although there might be enough technical material and legal precedent to support CDSCO’s
orders, it is very worrying that a situation such as this was allowed to arise, that is more than
300 drugs without any therapeutic justification were allowed to enter the market. Apart from
concerns about safety and efficacy, many FDCs were also allowed to enter the market
illegally. State Drug Authorities issued manufacturing licences for such FDCs without
obtaining Central approval from CDSCO. This contravenes Rules 122B (3) and 122D, read
with Rule 122E of the Drugs and Cosmetics Rules, 1945.
These provisions explicitly include FDCs within the definition of a “new drug”. When
applying for approval to a State licensing authority to manufacture a new drug, the applicant
must also provide evidence that the Central licensing authority, CDSCO, has approved the
drug.

These regulatory violations first came to the notice of CDSCO in early 2013, when it issued
directions to State Drug Authorities to ask the manufacturers of such unapproved FDCs to
demonstrate their safety and efficacy, failing which the drugs would be considered for
prohibition. When very few manufacturers submitted such evidence to CDSCO, it directed
them to make an application in Form 44 which would be considered in consultation with an
expert committee.
Form 44 is used by applicants seeking permission to import or manufacture a new drug.
Through its March 10-2016 notification, what CDSCO has done in effect is to refuse
approval for the manufacture of new combinations, rather than prohibit the manufacture of
drugs that were legally on the market. However, the use of Section 26-A to ban these drugs
ignores this important legal distinction.
CDSCO and State Drug Authorities were caught sleeping on the job. The government must
recognise that the weakness of the legal and regulatory framework contributed to this. One of
the prayers in Dinesh Thakur’s petition asked for a reference to the Law Commission of India
to consider the need for a new law on pharmaceutical regulation. Despite the dismissal of the
petition by the Supreme Court, the government ought to initiate this process of its own
accord.
“The pharmaceutical industry is so much frustrated and angered over the government
decision. We are not against ban, but we stand against the way it was handled,” said D.G.
Shah, secretary general, Indian Pharmaceutical Association (IPA). Codex, marketed by
Pfizer, has been sold across the globe including highly regulated markets and there’s no
justification for a ban in India, Shah said.
Companies like Abbott India, Macleods Pharmaceuticals, Pfizer India, Procter and Gamble
Hygiene and Health Care (P&G), Glenmark Pharmaceuticals, RB India, Piramal Enterprises
and Alembic Pharma got interim stay on the ban from the Delhi high court. The next hearing
of the case is on 21 March.
Later, Wockhardt Ltd and Laborate Pharmaceuticals also won a stay order from the Delhi
high court against the government ban
Included in the list of banned drugs are Abbott's Phensedyl and Pfizer's Corex. Both are
widely used cough syrups made up of codeine and chlorpheniramine maleate.
These medicines along with 336 more are said to have no therapeutic justifications.
Pfizer India has already announced that it had stopped selling Corex, while Abbott is yet to
give a statement about Phensedyl.
But the pharmaceutical industry too has a point. Out of the 6,220 samples that were taken up
by the committee 963 have been found irrational after a year of study, but the government
decided to ban only 338. If all the 963 drugs are banned the industry would have to take a hit
of Rs 10,000 crore, which is nearly 10% of the pharmaceutical market.
The industry has reason to feel betrayed given the opacity with which the entire process has
been carried out. Though no one doubts the credibility of Professor Kokate or his group of
scientists in the expert committee, the fact that the findings have not been made public is a

valid reason for grievance. Banning a drug overnight would not only mean stopping
production but also taking back the products that are in the supply chain pipeline. The 338
drugs that have been banned will result in a hit of around Rs 3,000 crore to the sector.
But money is not an issue when it comes to public health and safety. If the poorest of poor
patient can find money to pay for the medicine, the least the industry can do without griping
is give him value for his money. The industry and the authorities who cleared the drugs need
to be taken to task for allowing drugs that are banned abroad to be sold in India.
Asking more time to clear up their inventories of products which should not be in the market
in the first place does not make sense.
Pharmaceutical companies willingly shell out millions of dollars to settle cases in the US for
not following proper process let alone poor quality products. It is sheer hypocrisy when they
cry foul for being pulled up in India for selling products which are no longer effective.

8.0 Appendix

References
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Dissertation Report on Banned FDC drugs in India on 10th March