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