irrational medicines- why? & how? · * irrational medicines- why? & how? 1 ... according to...
TRANSCRIPT
Dr Gopal Dabade
All India Drug Action Network
(AIDAN)
Drug Action Forum – Karnataka
(DAF-K)
* Irrational Medicines-
Why? & How?
1
●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)
*
2
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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*
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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! -
12
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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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.
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).
29
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.
30
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.
31
1. Antibacterial +
Antiamoebic Combinations:
Ciprofloxacin +
Metronidazole, Norfloxacin +
Tinidazole and Ofloxacin +
Ornidazole are such
commonly available fixed
dose drug combinations.
33
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)
34
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.
35
36
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.
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.
40
41
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.
42
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.
43
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.
44
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
45
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).
46
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
47
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.”
48
Several hundreds of drugs
have been cleared without
proper clinical trials.
On an average, CDSCO is
approving one drug every
month without trials.
49
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
50
*
http://www.kdlws.kar.nic.in/
Karnataka State Drugs
Logistics and Warehousing
Society (KSDL & WS)
52
*
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”.
53
“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”.
54
Make available FREE MEDICINES and ensure
that RATIONAL MEDICINES ONLY are there
at all PUBLIC HEALTH OUTLETS.
STRENGTHEN PUBLIC HEALTH SYSTEMS
55
*
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.
56
*
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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