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On Generic Drugs

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On Generic Drugs. Presentation at Raipur, CIPH August 5, 2013-S.Srinivasan. Email: chinusrinivasan.x_at_gmail.com – PowerPoint PPT presentation

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Title: On Generic Drugs


1
On Generic Drugs
  • Presentation at Raipur, CIPH August 5, 2013
  • -S.Srinivasan
  • Email chinusrinivasan.x_at_gmail.com

2
Definitions
  • Patented Drug Exclusive monopoly of drug
  • Generic Drug out of Patent
  • Generic Generics Unbranded Generics sold as
    aspirin, paracetamol, etc.
  • Branded Generics Out of patent drugs sold under
    brand names, eg. Dispirin, Calpol, etc.

3
Indias Pharma Industry
  • Total Sale Rs 72,000 cr within India (Mar 2013
    IMS)
  • Exports Rs 65,000 cr
  • Unbranded generics Rs 7000 cr
  • 3rd largest by volume, 13th by value
  • Pharmacy of the developing world

4
India Poverty Amidst Plenty?
  • Medicines are overpriced and unaffordable in
    India..
  • Medicines constitute 50 to 80 percent of health
    care
  • costs in India
  • Health care is the second-most leading cause of
    rural indebtedness, after dowry.
  • No universal health insurance in India
  • Crumbling public health system,
  • the first choice of patients is a private
    practitioner which means more out of pocket
    expenditures apart for loss of wages etc

5
FDCs and Irrational Medicines
  • Nowhere in the world there are 100,000 brands
    (of generics)
  • A study by LOCOST (2012) says 50 of the
    top-selling 300 medicines (IMS 2009) are not in
    the National List of Essential Medicines, 2011.
  • Many unnecessary drugs including medicines of
    uncertain efficacy, safety, such as ginseng,
    liver extract, Vitamin E, and nimesulide
    irrational combinations of antibiotics, which
    lack therapeutic justification
  • Many irrational FDCs - only 65 of the top
    selling 300 are rational (LOCOST 2012)
  • Need for clear criteria for weeding out
    irrational and useless medicines

6
Some other reasons for poor access to the right
medicine at affordable prices
  • Aggressive Drug Promotion by drug companies
  • Inducements to doctors
  • Over/under prescribing by doctors
  • Cut Practice

7
Pricing Anomalies of Indias Drugs
  •  
  • Overpricing
  • Profit margins can be up to 4000 percent
  • Different brands of same drug sell at vastly
    different prices
  • Most drugs out of Govt price regulation

8
Profitability of Pharmaceutical Industry
(Profit Before Tax as of Sales)
9
Governments Response
  • Put all 348 drugs in NLEM 2011 under price
    regulation
  • But has left loopholes me toos, combinations
    and irrational FDCs out of price control
  • Many rational Drugs outside NLEM outside price
    control
  • Market Based Mechanism for price ceiling
  • Only 14 of the total sales are under price
    control

10
Markets Do not Work in Pharma Sector
  • Pharma markets do not work generally in favour
    of the consumer
  • Because of asymmetry, no real decision making
    power of buyer, etc.
  • Because buyers and sellers have different
    bargaining strengths (info asymmetry)
  • Sellers and doctors decide
  • Buyers (patients) have little or no choice
  • Buyers have to make decision usually under
    distress

11
Market Profile of Anti diabetics
Name of Drug/Subject In NLEM? Under Price Regulation? In Rs crores Percent
Total Antidiabetics mkt 70 out 70 percent out 4502 100
Glibenclamide Yes Yes 16.51 0.37
Metformin Yes Yes 267 5.93
Metformin and combinations 90 out 90 Out 2278 50.59
Insulins Yes Yes 1176.67 26.14
Glimipiride and combinations No No 1448 32.16
Glucagon Yes Yes 2.62 0.06
Source of data Pharma Trac, Oct 2012
12
Paracetamol Market
  MAT Oct 12 No. of Formulations
Single Ingredient 527.73 20.52 358 11.65
Combinations 2043.49 79.48 2714 88.35
Total 2571.22   3072  
13
Why market cannot decide medicine prices in
India?
  • Because buyers and sellers have different
    bargaining strengths (info asymmetry)
  • Sellers and doctors decide
  • Buyers (patients) have little or no choice
  • Buyers have to make decision usually under
    distress

14
Competition does not reduce prices!
  • Same drug is sold at different prices by the
    SAME company too!
  • Brand Leader often also the Price Leader
    (costliest drug is most sold).
  • Therefore competition does not automatically
    bring down the prices.
  • In fact more players seems to result in a range
    of prices.

15
Brand Leaders are Indeed Price Leaders
THERAPEUTIC CATEGORY/ MOLECULES Top Three Market Leader Brands (in Value) PRICE PER STRIP Top Three Price Leader Brands/Most Expensive (in Prices) PRICE PER STRIP
ATORVASTATIN (10 MG x 10) STORVAS (RANBAXY) 74.61 CAAT (ABBOTT) 75.49
ATORVASTATIN (10 MG x 10) 2. ATORVA (ZYDUS CADILA) 72.81 2. LESSKAA (TROIKAA PHARMA) 75.21
ATORVASTATIN (10 MG x 10) 3. AZTOR (SUN) 64.29 3. STORVAS (RANBAXY) 74.61
ATENOLOL (50 MG x 14) ATEN (ZYDUS) 32.8 TENORMIN (ABBOTT) 39.0
ATENOLOL (50 MG x 14) 2. TENORMIN (ABBOTT) 39.0 2. ATEN (ZYDUS) 32.8
ATENOLOL (50 MG x 14) 3. TENOLOL (IPCA) 30.5 3. TENOLOL (IPCA) 30.5
16
Brand Leaders are Indeed Price Leaders
THERAPEUTIC CATEGORY/ MOLECULES Top Three Market Leader Brands (in Value) PRICE PER STRIP Top Three Price Leader Brands/Most Expensive (in Prices) PRICE PER STRIP
GLIMEPIRIDE (UNCOATED 2 MG x 10) AMARYL (SANOFI) 96.3 AMARYL (SANOFI) 96.3
GLIMEPIRIDE (UNCOATED 2 MG x 10) 2. ZORYL (INTAS) 44.2 2. GLIMER (ABBOTT) 93.2
GLIMEPIRIDE (UNCOATED 2 MG x 10) 3. GLIMER (ABBOTT) 93.2 3. GLIMSITE (SANOFI) 76.8
CIPRO- FLOXACIN 500 mg x 10 CIFRAN (RANBAXY) 76.5 CIFRAN (RANBAXY) 76.5
CIPRO- FLOXACIN 500 mg x 10 2. CIPLOX (CIPLA) 70.5 2. CIPLOX (CIPLA) 70.5
CIPRO- FLOXACIN 500 mg x 10 3. CIPROBID (ZYDUS) 51.6 3. CIPDAC (LABORATE PHARMA) 64.7
17
What it costs to a poor person?
  • Prevention of Hepatitis A 30 days of wage labor
  • Iron deficiency anemia (using Dexorange) Rs.
    3,744 for 6 months.
  • Coronary artery disease Rs.12,541 per year
    (using the expensive brands).
  • Diabetes using oral glimepiride 2 mg Rs. 3660
    per year.
  • Multi-drug resistant TB gt Rs.100,000 for 2
    years.

18
If drugs are made available free in public health
services?
  • People seeking tt in public health facilities
    will increase
  • Decrease in patients going to pvt practitioners
    and retail drug shops
  • And get less exploited
  • Decrease in related indebtedness, impoverishment

19
DPCO 2013
  • All 348 drugs in NLEM 2011 under price control
  • Ceiling price simple avg price of prices of
    brands with more than 1 mkt share
  • Touches 12-15 of the mkt of Rs 72000 crores.
  • Leaves most FDCS and other formulations untouched
  • Escape hatches combinations, non-standard
    dosages
  • Most ceiling prices are still in the range of 200
    to 4700 margin

20
Generic Drugs Problems
  • Quality
  • Bioequivalence/bioavailability issues
  • At present Bioequivalence of generics is only a
    problem of some 40 medicines like warfarin,
    digoxin, carbamezipine.
  • In general in vitro BA tests (like dissolution)
    plus compliance with IP parameters is considered
    good enough.

21
Case Studies
  • Public Health System
  • Govts of Tamil Nadu, Kerala, Rajasthan
  • Jan Aushadhi, Jeevandhara Scheme
  • Not for profit sector
  • LOCOST, Vadodara
  • CMSI, Chennai

22
Some features of TNMSC Tamil Nadu Medical
Services Corporation
  • 260 drugs in its EDL (2011-12)
  • Surgicals 75 items, sutures 113 items
  • 21 fast moving drugs account for 80 of
    procurement budget
  • Speciality drugs 292 (2010-11) - 10 drugs
    account for 85.6
  • One drug Temozolamide caps - 52
  • CAT scan and X Ray centres
  • 21 of popln utilization in 2001-02 (currently
    40 )
  • Services top to bottom level of care
  • Drugs are free
  • (Source partly Maulin R.Chokshi. TN Drug
    Procurement Model, Nov 2008, WHO-SEARO)

23
TNMSC Scan Centers
  • At present 45 nos. of single slice CT scan
    centers in the Government Hospitals all over the
    State (min. 1 CT scanner in each dist.) and 4
    slice CT scanners one each at Govt. General
    Hospital, Chennai, ICH Govt. Hospital for
    Children, Chennai are in operation.
  • 45 scan centers
  • Category Plain With Contrast
  • Inpatients Rs. 350/- Rs. 550/-
  • Outpatients Rs. 500/- Rs. 700/-

24
TNMSC Other Supportive Services
  • MRI scan centers in 9 govt hospitals Rs 2500
    (plain) Contrast Rs 1500 extra
  • Lithotripsy
  • Regional diagnostic centers
  • Sale counter at Chennai for Cyclosporin Cap. USP
    2. Cyclosporin Oral Solution USP 3. Anti Snake
    Venom Serum IP 4. Human Insulin (Short acting) 5.
    Human Insulin (Intermediate acting)
  • Lab Services

25
25 warehouses
26
Inside Warehouse at Sivagangai
27
(No Transcript)
28
A positive side effect! Generics advertised by
pvt pharmacists!
29
Some Comparisons

1. SrNo. 2. Name of Drug and Use 3. Market leader price (2012 price) 4. Simple Avg Ceiling price (2008 IMS figures) 5. TNMSC price 2012-13 6. Market leader price/ TNMSC price 7. Simp. avg ceiling price/ TNMSC price 8. Price as per DPCO norms with 100 mar-gin 9. Simple Avg Price/ Price as per DPCO norms (Col 4/Col 8) x 100
Diclofenac 50 mg tablets 45.00 (Voveran) 12.20 1.20 37.50 10.16 2.81 434
Atorva-statin 10 mg tabs 104.00 (Atorva) 42.40 2.10 49.52 20.19 5.60 757
Atenolol 50 mg, (14 tabs) 51.40 (Aten) 17.50 1.50 34.26 11.66 3.50 500
30
Necessities For MAKING MEDICINES AFFORDABLE
  • Generic prescribing
  • Adoption of essential drugs list
  • Standard Treatment Guidelines
  • Centralized drug procurement open tender system
  • Distribution of Low cost drugs through Govt. drug
    counters
  • Public awareness and demand generation

31
How much does medicines for all cost?
  • Rs 200 crores TNMSC medicine budget per year
    approx
  • Under assumptions of about 40 percent of those
    ill using public health services
  • It costs around Rs 6000 cr
  • Eventually this figure will go to Rs 12,000 cr
    per year for full utilization
  • Assumption is that these are at TNMSC prices
    which are very low 3 to 40 times cheaper than
    market prices

32
What are the Barriers to Access to Medicines in
Public Health Systems
  • None except in the mind
  • Failure of imagination
  • In this case it does not even take much
    imagination
  • As the homework has already been done in 2-3
    states of India
  • Resistance from pharma and medical lobbies need
    to be negotiated

33
Systemic Changes Required in the Run Up to
Medicines for all (say by 2020)
  • Right to medicine and health needs to be
    legislated as a fundamental human right.
  • All essential drugs shld be under price control
  • All irrational medicines should be removed
  • Only rational drugs shld be marketed/approved in
    India
  • Govt use CL on essential drugs under patent
  • Easy takeover of Indian Pharma companies should
    be stopped

34
What can be done about providing medicines to
patients in a public system?
  • Provide it
  • Provide it free
  • It does not cost the government much

35
What is LOCOST?
  • LOCOST is an alternative not for profit
    pharmaceutical venture based on ethical business
    practices
  • Located at Baroda, India
  • LOCOST founded in 1983
  • LOCOST is/was a response to the therapeutic
    anarchy and regulatory chaos in India

36
LOCOST Since 1983
Providing essential medicines for those working
with urban and rural poor in India. Since
1983. At Vadodara, Gujarat, India
37
WHO Recommendations
  • Studies by WHO (2011) and many others show that a
    limited, prioritised list of drugs numbering not
    more than 360 are enough to take care of 99
    percent of the disease conditions occurring in
    our country.
  • Out of these 360 drugs, only 252 are combinations
    (like ORS, co-trimoxazole, etc.).

38
LOCOST Experiment what does it
show?
  • Good quality medicines can be made at viable,
  • low prices.
  • There is a market for low priced drugs.
  • Demystification of Drug Production is necessary
    and possible

39
LOCOST Other Concerns
  • Public Advocacy for a people-oriented drug
    policy, patent policy and health policy
  • Medicines are for people, not people for
    medicines
  • Fighting against other irrationalities in health
    care sex selection, caesarian sections,
    unnecessary investigations

40
LOCOST Meeting The
Needs
LOCOST makes more than 100 formulations
(liquids, capsules, tablets). Own production
unit helps in producing not so easily available
drugs (like hydrochlorthiazide, etc.)
41
LOCOST DRUGS HOW MUCH LESS COSTLY?
  • Many of LOCOSTs drugs are anything between 200
    to 4000 percent cheaper than similar
  • products in the market.
  • (See table below)

42
Price Difference
Reasons?
  • No fancy marketing
  • Generics
  • No irrational combinations
  • Modest salaries
  • Price about 30 percent gt cost of production

43
Name/Strength 1. Bulk Drug Price per Kg 2. Cost of Active ingredients per 1000 Tabs 3.Total RM Cost per 1000 Tabs 4. Mfg Cost 5. Total Cost per 10 in Rs 6. Price of Market Leaders per 10 In Rs 7. Market Leaders Price/ Total Cost per Unit (as percent)
Albendazole Tabs 400 mg 1260 504 564.17 282.38 8.50 170 (Glaxo) 2000
Amlodipine Tabs 5mg 2982 21 34.98 58.27 1.00 24.50 (Cipla) 2450
Atenolol Tabs 50 mg 1173 59 67.64 79.59 1.50 28.50 (Nicholas Piramal) 1900
Cetrizine Tablets 10 mg 3510 35 44.65 68.45 1.20 31.00 (Cipla) 2583
44
OUR
STRENGTHS
  • Generic, essential drugs
  • Quality consciousness
  • No bribes, no underhand dealings
  • No shortcuts in production
  • Social accountability
  • Education and advocacy of rational
  • therapy and a people-oriented drug policy.

45
Lessons from the India story
  • Need for favourable patent regime
  • Preferably no patents for essential medicines
  • Licence only essential medicines (for mfr and
    mktng)
  • No brand names
  • Public Health System plus rational prescription
    safeguards
  • Free medicines for all
  • Price regulation
  • Trading Formulations APIs
  • Choice of Appropriate Technology
  • Set achievable/realistic quality standards and
    do not move goal post because of international
    pharma pressure

46
For more information, contact us at
email locost_at_sify.com website www.locostindia.c
om Ph 91 265 2830009 91 999 877 1064
(Srinivasan) 91 917 300 0787 (Krishna)
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