Dr Gopal Dabade

All India Drug Action Network

(AIDAN)

Drug Action Forum – Karnataka

(DAF-K)

* Irrational Medicines-

Why? & How?

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●More than Rs 10,000 cr are lost per year due to the loss of person hours and productivity due to anaemia.

●Anaemia is responsible for 40% of 100000 maternal deaths that occur per year due to complications of pregnancy and childbirth.

●Over 90% of adolescents in Delhi are

anaemic. (Delhi Gynecologists Forum)

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Dr S V Subramanium from the Harvard School of

Public Health said, "India is among the countries with highest anaemia figures. Anaemia cases may have worsened in some states."

Anaemia among children (6-59 months) was highest in Bihar (78%), Madhya Pradesh (74.1%), Uttar Pradesh (73.9%), Haryana (72.3%), Chhattisgarh (71.2%) and Jharkhand (70.3%).

http://www.indiasanitationportal.org/1056

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The lone survivor: Scrutiny of the 338 drugs to treat anaemia

listed in CIMS revealed that only one drug,

namely ferrous fumarate, 200 mg tablet

conforms to the WHO’s List of Essential Drugs

2005, National Essential Medicines List 2003

of India and Goodman & Gilman’s standard

text book of Pharmacology, in terms of its active

ingredients and their quantities.

It is also priced Rupees 0.13 or 13 paise per

tablet, the lowest price for any drug to treat

anaemia from the list. 8

VIRTUALLY THE CONSUMER IS LEFT

WITH NO CHOICE BUT TO CONSUME

DRUGS THAT ARE IRRATIONAL. As they do

not match with those recommended in

standard text books of medicine.

AND UNNECESSARILY COSTLY.

FEW OF THEM ARE EVEN HARMFUL.

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Every 15 ml Dexorange contains,

1. 160 Ferric Ammonium Citrate

2. Vitamin B - 12

3. 7.5 Folic acid

4. 95% Alcohol

This preparation in unscientific because it is in the

form capsule – hence cannot be absorbed from

first part of small intestine. Also making it costly! -

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The list of items that the

drug companies add goes on.

Even zinc, copper,

Vitamin B-6, alcohol and

haemoglobin are added.

Iron and folic acid (IFA) tablets, which form the backbone of

the anaemia-control programme, have been in short supply for

more than six months now in the State.

The irony is that what has hit this important programme is

confusion over colour of the tablets.

There are 2,353 primary health centres (PHCs) in the State and each PHC caters to nearly 1,000 women. Each PHC requires nearly a lakh tablets a year, according to an estimate by medical officials in charge of PHCs.

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* http://www.thehindu.com/news/national/karnataka/blue-or-pink-pill-

colour-hits-health-programme-to-tackle-anaemia/article6305404.ece

Blue or pink? Pill colour hits health programme to tackle anaemia AFSHAN YASMEEN, THE HINDU, 11TH AUGUST 2014

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* Blue or pink? Pill colour hits health programme to tackle anaemia

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PRICE COMPARISON & AVAILIBILITY OF MEDICINES BETWEEN

TNMSC & POPULAR BRAND

Sl No Name of medicine Price Per tablet

TNMSC#

Retail price of

popular brand Aug

2012*

1 Ferrous sulphate

100 mg with Folic

Acid 0.5 mcg

Rupees 0.08 NA

2 Theophylline

23mg and

Etofylline

77mg Tab.

Rupees

0.08

NA

#http://www.tnmsc.com/tnmsc/new/html/pdf/drug.pdf

*CIMS April – July 2012

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LIST OF TOP SELLING UNESSENTIAL/IRRATIONAL MEDICINES; ITS RANKING AMONG TOP 300 BRANDS & ITS MOVING ANNUAL TOTAL (Rupees crores).

BRAND

RANK IN TOP 300

BRANDS

MOVING ANNUAL

TOTAL (Rupees crores)

Becousles

2

79.74

Dexaorange

5

57.65

Revital

27

47.64

Polybion

42

40.85

Zincovit

60

32.26

Cobadex forte

88

26.10

Methycobal

116

21.87

Zincovit

118

21.65

Neogadine

119

21.52

Riconia

125

20.78

R.B Tone

129

20.21

A to Z

145

19.07

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LIST OF TOP SELLING UNESSENTIAL/IRRATIONAL MEDICINES; ITS RANKING AMONG TOP 300 BRANDS & ITS MOVING ANNUAL TOTAL (Rupees crores).

BRAND

RANK IN TOP 300

BRANDS

MOVING ANNUAL

TOTAL (Rupees crores)

M2tone

157

18.22

Supradyn

221

15.25

Becadexamin

229

14.63

Raricap

239

13.89

Becosules Z

295

12.03

Optineuron

297

11.97

Total

495.33

Ref:- A lay persons guide to medicines, LOCOST.

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The drug known by the name

‘sofosbuvir’ ensures almost complete cure

for hepatitis C, and it is here that it totally

differs from the treatment that is advocated

for HIV/AIDS, where patients need to be

under life-long medication.

The duration of treatment with this drug

varies from 12 to 24 weeks.

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* The manufacturer of the drug, Gilead,

a US-based company, is charging US

$1,000 (around sixty thousand

rupees) for each pill, meaning the

cost of a 12-week course of treatment

will amount to US $84,000 (around

fifty lakh rupees).

WORLD’S BEST EXAMPLE FOR

IRRATIONAL DRUG PRICING!

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*Ever since sofosbuvir has come into the market, Gilead is earning roughly US $200 million every week.

*Thus, the company totally fails to justify the cost either on research or manufacture.

Gilead’s justification is that sofosbuvir

offers value for money i.e. it is cheaper

than liver-transplant.

According to a study done by Andrew

Hill of Liverpool University, UK, the

predicted production cost of this drug

would be around US $68 to US $136

(around six to eight thousand rupees).

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Gilead in its pursuit of profits had patented

sofosbuvir in 17 countries including China,

Indonesia and Israel, thereby gaining

global monopoly.

Similarly, it had applied for grant of

patents in India as well and the same was

opposed by several groups under the Pre-

Grant Opposition.

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The Indian Patent office in Kolkata, January

2015, rejected the patent claim of Gilead under

section 3(d) of Indian Patent Act and opened

the door for more Indian drug companies to

produce the same.

More companies will start manufacturing the

drug which will set in greater competition and

thus the drug price of sofosbuvir will soon

come down.

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Gilead has announced that it

will approach the higher

Court.

And the battle continues…….

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1. Antibacterial +

Antiamoebic Combinations:

Ciprofloxacin +

Metronidazole, Norfloxacin +

Tinidazole and Ofloxacin +

Ornidazole are such

commonly available fixed

dose drug combinations.

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Medindia's database currently has 504 Brands of Generics

of Ciprofloxacin and Tinidazole listed manufactured by

396 companies. New generics are constantly being updated

(www.medindia.net)

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Fixed Dose Combination of

Ciprofloxacin + Tinidazole

Sl

No

Brand

Name

Manufacturer

1 Alcipro Alkem Laboratories

Ltd

2 Acipro Tin Acichem

Laboratories

3 Adcip TZ Admac Pharma Ltd

4 Aglowcin

TD

Egis Healthcare

5 Akcip TZ Scott Edil Pharmacia

Ltd

6 Alcin TZ Anvik Biotech

2. Expectorant + central cough suppressants

+ antihistaminics + bronchodilator +

mucolytic agent

Bromhexine Hydrochloride 8 mg + Terbutaline

sulphate 2.5 mg + Guaiphenesin 100 mg +

Menthol 5 mg, this combination of expectorants

is a costlier way of helping a condition which is

often self-resolving. Expectorant given in

effective doses are often not tolerated and

produce adverse drug reaction.

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http://www.thehindu.com/news/national/other-states/big-

consignment-of-bangladesh-bound-cough-syrup-

seized/article4627244.ece

Big consignment of Bangladesh

bound cough syrup seized

SYED SAJJAD ALI, 17TH APRIL 2013, THE

HINDU

BSF has seized another big consignment of

Phensedyl cough syrup before it could be

smuggled to Bangladesh.

PHENSEDYL COUGH SYRUP;-

Nicholas Piramal India Ltd,

Contains CODEINE & CPM

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3. Metformin + Glimepiride + Pioglitazone

Metformin is indicated drug in obese type -2 diabetes mellitus

whereas Sulfonylurea (Glimepiride) is indicated drug in non-

obese type-2 diabetes mellitus.

As per pharmacological principle, other drug should be added

only when monotherapy fails.

Metformin (biguanide) is to be administered after meal whereas

Glimepiride (sulfonylurea) drug is to be administered before

meal, therefore even when both the drugs are required, it would

be better to administer them separately.

Pioglitazone is indicated in suspected cases of insulin

resistance. So, the combination of all these drugs in one

formulation is an irrational drug combination.

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FDC of

glimepiride + metformin + pioglitazone

Sl

No

Trade name Manufacturer

1 Amaryl MP Sanofi Aventis

2 Formin PG Alkem

3 Gemer P2 Alkem

4 Glimsite MP Sanofi

5 Gluconorm PG1 Lupin

6 Glyree – MP1 IPCA

7 Triexer Cipla

8 Trimetaday Wockhardt

The side effects of pioglitazone alone may include the following: (1) Cardiovascular disorders, heart failure, (2) Liver & biliary disorders, abnormal SGPT/SGOT/CPK levels, (3) Visual disturbance, (4) Upper respiratory tract infection, (5) Weight gain, (6) Sinusitis, pharyngitis, (7) Myalgia, (8) Dyspnoea, (9) New or worsening of diabetic macular oedema and (10) Bladder cancer.

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When taken with metformin the

additional side effects may include

the following:

(1) Anaemia,

(2) Oedema,

(3) Weight gain,

(4) Headache,

(5) Haematuria (blood in urine),

(6) Visual disturbance,

(7) Joint pain (arthralgia) and

(8) Impotence.

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Thus if all the three medicines are taken then

side effects are more than its benefits.

Hence pioglitazone alone is given particularly in

obese patients only when metformin cannot be

given or is not tolerated.

Pioglitazone in combination with metformin is

given when metformin alone is not adequate to

control blood sugar.

Pioglitazone in combination with glimepiride is

given when the patient cannot tolerate

metformin.

However the three drugs i.e. glimepiride,

metformin and pioglitazone are never given

together.

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The five top-selling metformin FDCs

accounted for 87% of sales volume

and 75% of monetary value off all

metformin FDCs in India.

Regulation and Use of Metformin FDCs in India by McGettigan P

http://www.amasa-project.eu/storage/WHD2013.Patricia.pdf

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Definition of

rational use of medicines (RUM)

“Patients receive medications appropriate

to their clinical needs, in doses that meet

their own individual requirements, for an

adequate period of time, and at the lowest

cost to them and their community.”

(WHO, 1985).

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THE FIVE MAIN PLAYERS;-

1. The Drug Manufacturers

2. The Drug Dealers (Wholesale &

Retail)

3. The Medical Lobby (IMA etc)

4.The Drug Regulatory Authorities

5. The Consumer

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The Functioning of the Central Drugs Standard Control

Organisation” (CDSCO), which was laid in Parliament

on May 8, 2012.

“the drug regulatory system in the country (India)

suffers from several deficiencies and shortcomings, some

systemic and several manmade.”

“The Committee is of the firm opinion that most of the

ills besetting the system of drugs regulation in India are

mainly due to the skewed priorities and perceptions of

CDSCO.”

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Several hundreds of drugs

have been cleared without

proper clinical trials.

On an average, CDSCO is

approving one drug every

month without trials.

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THE IRRATIONAL & UNSCIENTIFIC COMBINATIONS ARE A

MANIFESTATION OF THE OVER ALL VALUE SYSTEM IN THE

MEDICAL PROFESSION;-

Increasing domination of health care by private sector & 5

star hospitals.

Mushrooming of private medical colleges with high

capitation fees.

Over all commercialization of all forms of health care.

Domination of private sector stack holders in planning

public health policies.

Kick backs, drug-doctor nexus etc

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http://www.kdlws.kar.nic.in/

Karnataka State Drugs

Logistics and Warehousing

Society (KSDL & WS)

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http://www.searo.who.int/entity/medicines/k

arnataka_july_2014.pdf

“Karnataka, India Pharmaceuticals in Health

Care Delivery”

By WHO, August 2013

“stock-out status of the

Karnataka Drug Logistics and

Warehousing Society (KDLWS)

revealed a significant number of

stock-outs on that day”.

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“Overall, 24% of items were out

of stock in 80% or more of the

warehouses and only 23% of items

were available in all warehouses”.

“A number of community

members and other stakeholders

stated that stock-outs were a

problem”.

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Make available FREE MEDICINES and ensure

that RATIONAL MEDICINES ONLY are there

at all PUBLIC HEALTH OUTLETS.

STRENGTHEN PUBLIC HEALTH SYSTEMS

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Doctors banned by MCI under district administration vigil http://timesofindia.indiatimes.com/city/indore/Doctors-banned-by-MCI-under-district-admnistration-vigil/articleshow/46350678.cms

THE TIMES OF INDIA 24th February 2015

INDORE: District administration will keep tabs on 15 neurologists of state to ensure they do not practice for the next six months following their registration suspension orders issued by Medical Council of India (MCI). The council had suspended their registration for taking up pharma company sponsored foreign visits.

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http://timesofindia.indiatimes.com/india/Doctors-with-conscience-speak-out/articleshow/46329061.cms

24th February 2015

Doctors with conscience speak out,

"Voices of Conscience from the Medical Profession: Revealing

testimonies by rational doctors about the reality of private

medical practice in India” has been put together by Dr Arun

Gadre, a doctor and writer with 20 years' experience of working

as a gynaecologist in rural Maharashtra, and Dr Abhay Shukla, convenor of SATHI who did his MBBS and MD from AIIMS.

These are just a few of the shocking revelations by 78 doctors from small towns to every one of the megacities who are critical of the growing commercialisation of medical care. The doctors range from general practitioners to super specialists in corporate hospitals. These interviews expose the corruption in private healthcare.

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