Post on 01-Jan-2017
RAJASTHAN MEDICAL SERVICES CORPORATION
Availability and Efficacy of Generic Medicines in India – Making Medicines Affordable through
Free Medicine Scheme in Rajasthan
Naveen Jain, IAS
Managing Director, RMSC
Declaration of Alma-Ata, 1978(Conf. on Primary Health Care)
Good quality healthcare is a basic fundamental right of
people and should be made available to all.
Major Stakeholders in the Field
•Sale of non
essential
drugs.
•Over the
counter sale
of useless
drugs
•Nexus with
doctors
Chemist
•Keeps profit
before
peoples
health
•Unethical
promotion
•misleading
claims
Industry
• lack of updated objective drug information
•Succumb to promotion
•Failure of ethics regulatory body
•pressure to prescribe
•misleading beliefs about efficacy
Prescribers
• vulnerable
•Medically illiterate
• inability to choose
Patients
•overpricing
•availability of
irrational
drugs
Drug Regulation
“Pharmacy of the developing world”
3rd in (10% in global sales) terms of volume and 14th (1.5%) in
terms of value.
It is among the top Five producers of bulk drugs in the world
After USA (169), India has the highest number of AFDA approved
(132) plants.
Total Sale Rs 73,000 cr within India (Mar 2013 IMS)
Exports Rs 80,000 cr
Nominal rate of growth in 2012: 11%.
The total number of brands in the Pharma market in India in 2012
was 62345
Patented drugs make up approximately 8% of total market sales
in India: Rs 6000 cr
92 percent of Indian drugs mkt is out of patent
INDIA’S PHARMA INDUSTRY
• As per WHO 65% of the Indian population lacks regular access
to essential medicines.
• The expenditure on health is the second most common cause
for rural indebtedness.
• Over 23% of the sick don’t seek treatment because they are not
having enough money to spend.
•Over 40% of hospitalized patients have to borrow money or sell
their assets to get themselves treated.
Problem : 1 Medicines are beyond the reach of our people.
Where does the money for health expenditure (in India) come from?
Private out of pocket expenditure 79%
State govt. 14%
Central govt. 4%
Private investment 3%
Private insurance 0 – 1%
Problem : 2 Expenditure on medicines make people poor.
•Expenditure on drug constitutes about 50-80% of the health care cost.
•Expenditure on health is responsible for 3% shift from APL to BPL every year .
•A study by World Bank shows that as a result of single hospitalization 24% of
people fall below poverty line in India.
(COMPARATIVE PRICES OF GENERIC AND BRANDED DRUGS)
Problem: 3 Medicines are overpriced and beyond the reach of the majority
Use Name of Drug Pack size
RMSC Tender
price (In Rs.)
Equivalent
Popular
Brand
MRP
(Rs.)
ANALGESIC
DICLOFENAC
SODIUM TABLET
IP 50 MG
10 TAB
STRIP0.9
DICLORAN
10 Tab 20.47
CHOLESTEROL
LOWERING
ATORVASTATIN
TABLET IP 10 MG
10
TAB
STRIP
2.6
ATROVA
(ZYDUS)
10 Tab
65.94
DIABETESGLIMEPIRIDE
TABLET IP 2 MG
10
TAB
STRIP
1.3
AMARYL
(AVENTIS)
10 Tab
138.6
BLOOD
THINNING
DRUG
CLOPIDOGREL
TABLET IP 75 MG
10 TAB
STRIP5.54
PLAVIX
(SANOFI
AVENTIS)
10 Tab
105.3
Rs. 19.01
Manufactureris
Ciplafor all the
three brands
One branded&
Two generic
Rs. 20.19 Rs. 19.01MRP for 10 tabs
Purchase price for 10 tabsRs. 2.36 Rs. 15.80
Rs. 2.36
4. DIFFERENTIAL DRUG PRICING (After DPCO 2013)
Adapting drug prices to the purchasing power of consumers in different geographical or socio-economic segments is a very effective way to improve access to medicines .
RMSC tender price 6.75/-
Prescription by brand name
Manufacturing
company
(Brand
Name) (GenericName)
(Stockistprice)
One Injection
(Printed
MRP)
Cadila Amistar 500Amikacin
500 mg8.00/- 70/-
German
RemediesAmee 500
Amikacin
500 mg8.00/- 70/-
Wockhardt Zekacin 500Amikacin
500 mg9.90/- 70/-
Alembic Amikanex 500Amikacin
500 mg9.90/- 69.50/-
Intas Kami 500Amikacin
500 mg8.13/- 60/-
Unichem Unimika 500Amikacin
500 mg7.80/- 72/-
Ranbaxy Alfakim 500Amikacin
500 mg8.50/- 70/-
Cipla Amicip 500Amikacin
500 mg7.42/- 72/-
Problem : 5 Promotion of Non essential drugs
DRUGS PRODUCED ARE NOT IN ALIGNMENT WITH THE DISEASE PATTERN
Drugs in Essential Medicines List Adequate to take care of the majority of the health
needs of the population.
Sales of top 300 brands Only 38% of brands are of the drugs mentioned in the
NLEM.
The other 62% brands comprise drugs that are higher priced alternatives without a clear therapeutic advantage and many are unnecessary, irrational and even hazardous.
Promotion of Non essential drugs
Addressing
”Availability of Generic Medicines in Rajasthan through MNDY”
Enhancing
ACCESS TO MEDICINES IN RAJASTHANthrough
Policy entitlement
Essential medicines
free of cost to all patients
visiting public healthcare institutions
Universal in nature
• Entitles the entire 7 Crore population of the state.
• No BPL card, Ration card, ID proof required.
So that there is no barrier to access to treatment.
Current Scenario
•Free Medicine Scheme was launched on 2nd October, 2011
across the state.
•Under the aegis of the scheme commonly used essential
generic medicines are being made available free of cost
at all levels of healthcare to all patients visiting OPD/IPD
through Drug Distribution Centers.
•Annual demand is submitted by Dept of M&H and ME
Dept as per flow chart decided, to State Level Demand
Finalization Committee (SDFC) , wherein after rationalization
and verification it is submitted to RMSC.
• No. of Beneficiaries:
January – July 2014: 3,28,56,313 (excluding SMS Hospital)
January – July 2014: 6,36,646 (SMS Hospital)
COMPONENTS OF FREE MEDICINES SCHEME
A. TO MAKE DRUGS AVAILABLE IN
GOVT. HOSPITALS.
B. TO CHANGE PRESCRIPTION
BEHAVIOUR OF DOCTORS.
1. Establishment of autonomous centralized
procurement agency :
Rajasthan medical services corporation.
1. Sensitization and orientation about
rational use of drugs (RUD).
2. Identification of drugs for free essential
drug list (EDL)
2. Write prescription on self carbonated
prescription slips
3. Procurement through a two-bid
transparent e-tendering process
3. Diagnosis must be written
4. Drug Warehouse at every district 4. Write Generic / Salt names
5. Empanelled laboratories for quality testing 5. Use out of Essential Drug List
6. System for transportation of drugs 6. Follow Standard Treatment Guidelines
7. System for storage and distribution of
drugs in all hospitals
7. Constitution of Drug and Therapeutics
Committee (DTC).
8. e-Aushadhi Software for Inventory
management
8. Prescription Audit.
9. Transparent and prompt payment system 9. Computerized drug dispensing upto PHCs.
10. Sufficient funds. 10. Patient counselling
1. Autonomous centralized procurement agency.ESTABLISHMENT OF
RAJASTHAN MEDICAL SERVICES CORPORATION
Procurement Cell
Finance Cell
Logistic Cell
QC Cell
Supply Cell
ITCell
e-Tender Purchase
Order
Storage &
Transport
Testing &
Issue
Inventory
Management
Payments
2. Identification of free drugs for essential drug
list (EDL)
Technical Advisory Committee
has developed the procurement
list of RMSC (EDL).
Drugs : 607
Surgical : 73
Sutures : 77
Criteria for inclusion
• Efficacy
• Safety
• Suitability
• Cost effectiveness
Major Drug Categories
Sr. Category Total
drugs
1 Anesthetics. 14
2 Analgesic, Antipyretic and Anti-
Inflammatory.
27
3 Anti-allergics 21
4 Antidotes for poisoning 4
6 Anti Bacterial 72
7 Anti Fungal 6
8 Anti Malarials 10
9 Anti Viral 5
10 Anti Cancer 39
11 Drugs used in Haemophilia 3
12 Drugs used in Thalassaemia 5
13 Anti Arrhythmic (Heart) 6
14 Anti Anginal (Heart) 4
15 Drugs used in Heart Failure 5
16 Anti Hypertensive 29
17 Lipid lowering 3
18 Dermatological drugs 23
19 Antacid 2
20 Anti Ulcer 8
21 Anti Diabetics 17
22 Thyroid & Anti Thyroid 4
23 Anti Rabies 4
24 Anti Snake Venum 1
25 Ophthalmological preparations 25
26 Drugs acting on Uterus 7
27 Anti psychotics 13
28 Anti depressants 7
29 Anti Asthmatic 16
Surgicals & Sutures
Blood Transfusion Set
Surgical Gloves
Suction Catheter
Foley Balloon Catheter
Infant Feeding Tube
IV Infusion set
Insulin syringe
Micro drip Perfusion Set
Nasal Oxygen Set
Paper Adhesive Plaster
Plaster of Paris Bandages
Ryle's Tube / Nasogastric Tube
Scalp Vein Set
Disposable Syringe with Needle
Surgical Blade
Suture Needles
Disposable Spinal Needle
Urine Collecting Bag
Endotracheal Tube
Tracheostomy Tube
Abdominal Drain Kit
Synthetic Surgical Mesh
Bone Wax
Temporary Cardiac Pacing Wire
Skin Graft Knife Blade
K Wire
Face Mask
Surgical Cap
Foldable Intra Ocular lens
Standard PAMA Intra Ocular Lenses
T-tube
Bone Cement
Sanitary Napkins
•Absorbable surgical suture (sterile catgut)
•Non absorbable surgical suture
A two-bid open transparent tendering
process. Only manufacturer / Importer can participate.
Annual turnover more than Rs 20 Cr.
GMP Certificate.
3 years market standing for the product.
Firm or product should not be blacklisted/debarred/convicted.
e-procurement is mandatory.
Information of rate
contract (RC), tender
conditions, supplier
contact details are
available on website
www.rmsc.nic.in for all
visitors.
Display of rate contract (RC) information on
website.
S.N
o.
Name of manufacturer participated in tender Price quoted
(Rs)
1 Biogenetic Drugs Pvt Ltd. 9.15
2 Zim Laboratories Ltd 9.91
3 Medicamen Biotech Ltd 12
4 Wings Pharmaceuticals Pvt Ltd. 12.38
5 West Coast Pharmaceutical Works Ltd 13.12
6 Rhydburg Pharmaceuticals Ltd. 16.1
7 Moraceae Pharmaceuticals Pvt Ltd. 21.57
Prices (MRP) of Brands in the Market: Dicloran Rs 204.7, Reactin 205
Diclofenac Sodium Tablets 50 mg: for 10x10 Tabs
RMSC Price Rs 9.15DPCO Ceiling Price: Rs 207
Amlodipine 5 mg Tablets: for 10x10 Tab
Name of manufacturer participated in tender Price quoted (Rs)
UNICURE (INDIA) PVT. LTD. 8.23
IND-SWIFT LTD 9.99
Innova Captab 10.15
Acme Formulation Pvt. Ltd. 11.67
Rhydburg Pharmaceuticals Ltd 11.94
MICRON PHARMACEUTICALS 14.69
Morepen Laboratories Limited 15.1
Zee Laboratories 15.59
R H LABORATORIES 17.17
Norris Medicines Limited 17.39
BRAWN LABORATORIES LTD 17.87
PULSE PHARMACEUTICALS PVT LTD 19.8
MORACEAE PHARMACEUTICALS (P) LTD 22.63
WINGS PHARMACEUTICALS PVT. LTD. 16.15
MICRON PHARMACEUTICALS 18.36
M/s USV Limited 21.1
FDC LIMITED 24.36
RMSC Rs 8.23
DPCO Ceiling Price: Rs 301
Prices (MRP) of Brands available in the Market:
Amlogard Rs 297, Amtas Rs 312.9, Stamlo Rs
297, Amlopress Rs 315.6, Amlopin Rs 297.2
S.no. Bidders Participation Price Quoted
1 Zim Laboratories Ltd 26.1
2 Preet Remedies 28.34
3 UNICURE (INDIA) PVT. LTD. 28.43
4 Zee Laboratories 29.17
5 Innova Captab 29.33
6 BHARAT PARENTERALS LTD 29.74
7 Arion healthcare 34
8 ARBRO PHARMACEUTICALS LTD 34.44
9 Synokem Pharmaceuticals Ltd. 35.35
10 PULSE PHARMACEUTICALS PVT LTD 36.2
11 Medicamen Biotech Limited 37
12 WINGS PHARMACEUTICALS PVT. LTD. 37.57
13 Stallion Laboratories P. Ltd. 43.77
14 MORACEAE PHARMACEUTICALS (P) LTD 53.34
15 M/s USV Limited 63.9
16 FDC LIMITED 71.02
17 Panacea Biotec Limited 88.9
Atorvastatin Tablets 10 mg: for 10x10 Tablets
RMSC Price: Rs 26.1
DPCO Price: 628
Price of Brands: (MRP) Atorva Rs 659.4, Tor
Rs 659.6, Atorec Rs 620.5, Tonact 650.6
S.
No.
Bidders Participation Price Quoted for
10x10 Tablets
1 UNITED BIOTECH PRIVATE
LIMITED
1,911.48
2 Reliance Life Sciences Pvt. Ltd. 3,927.00
3 NATCO PHARMA LIMITED 6,171.00
4 Cipla Limited 8,968.00
Imatinib Tablets 400 mg: RMSC Rates received in recent
tender (Fin bid opened in Aug 2014):
DPCO Price: Rs 28529 for 10x10 Tab MRP of Brands in market:
Imatib (Cipla) Rs 29935.6
Veenat (Natco) Rs 26550 ,
Zealata (Ranbaxy) Rs 28170
4. Warehouse at every district.
GSK
Three Tier System for supply of drugs
CIPLA BAXTER GERANBAXY BIOCON
Sub
stores of
MCH,
DH, CHC
PHCs
OPD DDCs
Indoor DDCs
OT, Wards
Injection room
Warehouse at every district.
Walk in Cooler
DEEP FREEZER
I L R
Cold Storage
Addressing
”Efficacy of Generic Medicines under Free Medicine Scheme”
5. Three Step quality checking system
1. Check at procurement level – Strict parameters for
selection of reputed supplier companies.
2. Check at supply level – Acceptance of drugs only with QC
passed batch release certificate (COA)
-QC passed test report of each batch supplied along with the
invoices, without which goods not accepted in warehouses.
3. Check at issue level – Pre-release quality assurance
• Stock quarantined
• Samples sent to QC cell
• Retesting of all batches of drugs in
Govt. approved empanelled labs.
33
Drug receipt at DDW
Drugs quarantined at DDW
Sampling Samples Sent To RMSC Hqtrs
Reassurance of Quality prior to Release..
Sampling Processes
SortingPooling of common batches
Concealing identity
CodingSending to empanelled
Labs
To empanelled Lab
Coded samples
Reassurance of Quality prior to Release..
Govt. approved & NABL accredited
independent empanelled laboratories
Amol pharmaceutical
(p) Ltd.
Oasis Test House
Ltd. Jaipur
Oasis Test House
Ltd. Ahmadabad
National Institute of
Biological, NoidaCentral Research
Institute, Kasauli
ITL Labs (p) Ltd.
Delhi
Auriga Research Ltd.
Solan, H.P
Quality Parameters
As prescribed under provisions of Drugs and
Cosmetics Act, 1940 & Rules there under the
drugs are retested for quality parameters of:-
1. Identity
2. Purity
3. Strength
and other specified tests whichever is applicable as per pharmacopoeias.
36
HPLC GC AAS and ICP
Dissolution UV and KF IR
Modern & Sophisticated Instruments
Retesting in Empanelled Labs
Test are carried out as per Pharmacopeias
TestReport
39
Decoding of tested samples.
Reports are decoded through labels indicating
manufacture name, address, and license number
which is duly signed and stamped by ADC (QC)
Ensuring release of only & onlyQUALITY PASSED
batches of drugs in distribution
channel
6. System for transportation of drugs
• Own Vehicles.
• Hired Vehicles.
Cold chain maintains using:-
• Cold box
• Ice packs
7. System for storage and distribution of
drugs in all hospitals
•Each DDC created @ Rs
2.25 lacs
Shelves/Racks
Refrigerator
Computer with printer.
Stationary.
• Pharmacist
• Informatics assistant
•Total Number: 15169
• Complete Supply Chain Management Solution for drugs,surgical items and sutures• Provides inventory management at all DDWs and at substores / DDCs of Medical college hospitals, District Hospitals,CHCs and PHCs• Implemented across 5139 locations spread across the state.• Provides detailed information from the stage of procurementof the drug to its consumption by the end users.
Key Features of e-Aushadhi• Facilitates online annual demand submission• Online purchase order generation to suppliers• Provision to maintain expiry date/shelf life• Provides details of Quality control• Ability to track drug inventory online• Ability to generate customized reports• Facilitates inter ware house transfer of drugs• Alert generation in different colours for expired drugs, re-order level• Maintains daily stock ledger of drugs
8. e-Aushadhi Software for Inventory management
9. Transparent and prompt payment system.
e-Payment
• Payment of all stake holders through NEFT/RTGS, internet banking in
instant manner.
• Supplier payment especially against Drugs supplied through
e-Aushadhi Software.
•Deposit by any stake holder through CBS of PNB & through e-deposit.
10. Funds –Received and Utilized(In Crores)As on 20.7.2014
F.Y Budget Received Budget Utilized
2011-12 • State Plan: 189.99• NRHM-MNDY Drugs: 0.00• NRHM-JSSY/Other Drugs:5.06• Others:0.00
Total Received: 195.05
174.710.004.460.00
179.17
2012-13 • State Plan:292.31• NRHM-MNDY Drugs:0.00• NRHM-JSSY/Other Drugs:38.10• Others(Police, RAC, Jail, Sambhar salts, KTPS, RSMML etc.) :0.54
Total Received:330.95
222.880.00
29.960.23
253.07
2013-14 • State Plan:140.00• NRHM-MNDY Drugs: 61.00• NRHM-JSSY/Other Drugs:57.12• Others:2.46
Total Received:260.58
174.4761.0048.510.59
284.57
2014-15 • State Plan:73.75 (for 3 months)• NRHM-MNDY Drugs: 0.00• NRHM-JSSY/Other Drugs:17.80Others:0.34
Total Received:91.89
94.640.00
11.650.47
106.76
1. Sensitization about the poor and orientation
of Doctors about rational use of drugs (RUD).
Seminars,
Conferences
&
Review meetings
COMPONENT-2 : STEPS TO CHANGE PRESCRIPTION BEHAVIOUR OF DOCTORS.
2. Write prescription on self carbonated
double prescription slip.
3. Diagnosis must be
written
4. Write Generic / Salt names.
5. Use out of
Essential Drug
List.
6. Follow Standard
Treatment
Guidelines.
7.
Constitution of Drug
and Therapeutics
Committee.
8.
Prescription Audit.
DTCs can – facilitate tremendously in curtailing inappropriate drug use; reduce drug expenditures and increase availability and accessibility
to essential medicines thus optimizing the value of government funds.
One of the very vital roles of DTCs is supervision in form of "Prescription audit" and feedback which consists of -
(1) analyzing prescription appropriateness and then(2) giving feedback, prescribers may be informed of their prescribing compared with accepted guidelines or with that of
their peers.
The DTCs are required to undertake audit of 1 % of all prescriptions (OPD and
IPD) on a monthly basis. After auditing the prescriptions are to be kept for a
period of 6 months and may then be disposed off.
The defaulters may be dealt with as follows –
Step 1 - Counselling by Unit head & DTC membersStep 2 - Written advice by Supdt./ PMO/MOIc/CM&HO with copy to the
departmentStep 3 - Case may be referred to Principal Secretary M&H / M.E Dept.
for disciplinary action
9. Computerized
drug dispensing up
to PHCs
10. Patient counselling
Provision of Drugs/Surgical and Sutures -EDL
Category of Healthcare Institutions
DrugsSurgicalItems Sutures
Medical College Hospitals
607 73 77
District / Sub-dist / Satellite Hospitals
526 69 37
CHCs 457 51 11
PHCs/Dispensaries 234 34 2
Sub Centers 30 8 0
Along with 71 National Program Drugs supplied by GoI
Institutions Covered (Medical & Health/Medical Education Department)
S.No. Type of Institutions No. of Institutions
1 Medical College Hospitals 28
2 District hospitals 36
3 Satellite Hospitals 8
4 Sub-Divisional Hospitals 16
5 CHCs 567
6 PHCs 2133
7 Dispensaries 194
8 Sub Centers 14407
9 Aid Posts 13
10 MCWC 118
11 Mobile surgical units 7
Continue…
NRHM
S.No. Programs
NRHM
1 ASHA Kit
2 Deworming Programme (Albendazole)
3 Anemia control program
4 JSSY
5 RTI / STI
6 108 Emergency Services
7 MMU (Mobile medical unit)
8 IFA (WIFS)
Continue…
Institutions (Others)
S.No. Type of Institutions
Law enforcement agencies
1 Jail Dispensary
2 RAC battalion (Rajasthan Armed Constabulary)
3 Police dispensaries
Others
1 ICDS - Anganwadi
2 School Education Department
3 NVBDCP
4 Rajasthan State Mines & Minerals Ltd.
5 Rajasthan University
6 Sambhar Salts
7 NREGA
Continue…
Institutions (NGOs/Trusts)
S.No. Type of Institutions
Private Hospital
1 Mahesh Hospital Jaipur
NGOs/Trusts
1 Social Work & Research Centre, Tilonia
2 Tabbar
3 Kuhad trust, Jaipur
4 Ma Madhuri Brij Waris Seva Sadan, Apna ghar, Bharatpur
5 Khejri, Jaipur
6 Kota Super Thermal Power Station
7 Social welfare charitable trust, Jaipur
8 Indian Asthma Care Society, Jaipur
1. INCREASE IN NUMBER OF PATIENTS IN GOVT. INSTITUTES
Before After MNDY
44 lacpatients
per month
About 80lac
patients per
month(>2.5
lac/day)
IMPACT
2. DECREASE IN OUT OF POCKET EXPENDITURE
•Everyday we are giving drugs to more than 2.5
Lac patients
•The average cost per patient is around Rs.12 - 30
• Otherwise the cost of drugs purchased from the
market use to cost around Rs.300 - 500.
IMPACT
3. OUT OF POCKET EXPENDITURE SAVINGS
(1st Two years of MNDY)
RMSC cost Rs. 507 crore
Market cost Rs. Over 3000 crore
Savings to the Public Approx Rs. 2500 crore
Due to procurement by generic name
IMPACT
4. SMILING PATIENTS & THOUSANDS OF LIVES SAVED
IMPACT
IMPACT
SIDE EFFECT
SIDE EFFECT
Challenges of the Journey so far
Geographical spread of the state 342,239 Sq.Km. and large distances - PHC up to 150 kmfrom district HQ(DDW)
Population- 70 million population - longerwaiting times (Increase in both OPD IPDpatients after MNDY/MNJY schemes)
Cold chain maintenance (in summer temp risesupto 510c)
High patient load in tertiary care centers &shortage of Doctors/Pharmacists.
A common myth amongst public that “generic”drugs are less effective.
Poor confidence of doctors on generic drugs dueto lack of scientific evidence of their quality andefficacy.
Issues related to pilferage, breakage,deterioration, drugs becoming obsolete etc.
Lack of checks and control of quality at variouslevels of supply chain.
Failure to generate realistic annual demand andnon submission of timely indent.
Unforeseen epidemics of swine flu, malaria,dengue, Chickengunia, scrub typhus etc
Sub optimal storage conditions of drugs atinstitutions and space constraint at DDWs inearlier days.
To maintain un-interrupted supplies at all levelsdue to delays by Pharmaceutical manufacturers,fluctuation in dollar rupee value and alternatesupplier for each drug are often not available.
Challenges …………… cont’d
NHM is providing funding to States/UTs toprovide free essential drugs and freeessential diagnostics in public healthfacilities.
Health minister plans to provide 50essential generic medicines, free of cost, toall Indians across the nation.
Budget 2014: Hon’ble Finance MinisterSh. Arun Jaitley mentioned that for"Health for All", two key initiatives - FreeDrug Service and Free Diagnosis Service -would be taken up on priority.
RECENT DEVELOPMENTS
RMSC motto
All essential medicines
At all public health institutions
◦At all timesso that
No human being dies for want of treatment
THANK YOU