Original Drugs (Antibiotics) Vs Generic Drugs (Antibiotics) What we need to know ?? Dr Ankur Gupta, MD (Pharmacology) Medical Advisor, MSD Pharmaceuticals.

Original Drugs (Antibiotics)

Vs Generic Drugs (Antibiotics)

What we need to know ??Dr Ankur Gupta, MD (Pharmacology)Medical Advisor, MSD Pharmaceuticals

India- The Home for generic Drugs

> 100 Ciprofloxacins > 125 Piperacillin-Tazobactams > 50 Meropenems

Do we need so many ?Do we know them all ?

What is a Branded (Original) Drug ?

The original drug for which

production and marketing

are made possible for the

innovator

WHO Drug Info

2000

What is a generic drug

A copy of an original drug for which

production and marketing are made

possible by the expiry of the patent

covering the innovator product

WHO drug Int 2000

Quality is the key……..

“ In the manufacture of generic drugs, the three

concepts of quality, safety and efficacy apply to

generic in the same way as they do to the innovator

product..”

“ It is a fallacy to believe that quality production and

assurance can be achieved at no great investment !!!”

WHO Drug Infor. 2000

Components of Branded Drug Cost

Brand vs. Generic

– Brand

High drug prices due

to Research &

Development costs

and Production &

Quality Assurance

Costs

Production,Quality Control

26%

Distribution,Other

2% Administration11%

R & D22%

Marketing39%

Sources of Brand Name Drug Costs

Original Drugs: Expensive to Develop, Easy to Copy

• An average of 14 years and 800 million dollars is spent on each discovery that reaches the public

• A copy can be produced in 1 year for less than $1 million

Tufts Center for the Study of Drug Development. 2001.

Potential difference between Generic and Branded Drugs

Quality of Raw material used (Raw materials

can be more than 50% of the industrial cost of a generic drug. Pricing pressure may cause manufacturer to target lower quality raw

material in order to offer competitive pricing. )

Method Of Synthesis (There is a risk of toxicity from

degradation products or impurities in the event that the method of synthesis has been changed)

Packaging , Stability, Evaluation ( Plastic in

packing may chemically interact with drug, especially under conditions of high humidity or heat (tropical countries) Toxic phenomena can result from the stability modifications of the product

WHO drug information 2000 14(2) 77- 81

GENERIC DRUGS

There are 4 main aspects to be considered

– Are generics safe?

– Is their quality as good as that of corresponding brand?

– Is doctor wise in switching branded to a generic drug?

– Are generics as effective as Innovator drugs?

Are generics safe?Is their quality as good as that branded drug?

The answer to this questions is Probably “YES”

…….”But only if you live in a country

with strict regulatory control of

medicines…”

Is doctor wise in switching from branded to a generic drug?

The answer to this question is less clear cut

Some doctors are reluctant to switch from a branded

drug,

However, doctors will be under pressure not to exceed

their budget for prescription drugs and pharmacist will

be under pressure to substitute a generic for a brand

Are generics as effective as newer, medically innovated, more costly

drugs? Most difficult question to answer but most important

from patient perspective

This is where there is a conflict between the best medicine and

saving money arises

Innovative drugs are not cheap

They are a result of costly research and development with high risks

of product failure before it can be proven to be safe and effective

Use a Generic, But Only If……

FDA requirements for generic drugs (www.fda.gov/cder/ogd)

Thus, a generic drugs must:

contain the same active ingredients as the innovator drug

be identical in strength, dosage form, and route of

administration

have the same use indications

be bio-equivalent

meet the same batch requirements for strength, purity

and quality

be manufactured under the same strict standards of GMP

required for innovator products.

Original Parenteral Antibiotics Vs Original Parenteral Antibiotics Vs

GenericsGenerics. . Possible implications in Possible implications in

critical care ?critical care ?

Particles, degradation products, residual Particles, degradation products, residual solvent and mineral contamination all solvent and mineral contamination all pose potential threats to patient safety.pose potential threats to patient safety.

Particulate Matter Particulate Matter Contamination Contamination (PMC)(PMC)

Where does the Where does the Contamination arise Contamination arise from?from? 1.Manufacturing process 2.Transport and storage 3. Filling process 4.Clinical dispensing process

- - microscopic glass particles when glass microscopic glass particles when glass ampoule is brokenampoule is broken

- particulate rubber or plastic from septum or - particulate rubber or plastic from septum or syringesyringe

Particulate Matter - Particulate Matter - Matters !!!Matters !!!

ARDSAdult Respiratory Distress Syndrome

MOFMultiple Organ

Failure

Particulate Contamination

Microcirculation

DysfunctionMicrocirculationDisturbances

MODSMultiple Organ

Dysfunction Syndrome

Particles < 2µm

•Glass•Latex•Polymers

Kidneys

Liver

PancreasLungs

DEATH

1 g cefotaxime sodium vials

Membrane Filter Method

Membrane Filter Method

1 g cefotaxime sodium vials

New InvestigationsNew Investigations

CARBAPENEMS

Study SummaryStudy Summary

StudyStudy designdesign: Double-blind: Double-blind

OriginalOriginal Zienam Zienam, India compared , India compared with 13 with 13 Imipenem/CilastatinImipenem/Cilastatin Products from China,Indien,Taiwan Products from China,Indien,Taiwan and Thailandand Thailand

7 Meropenem Products from 7 Meropenem Products from China,India and TaiwanChina,India and Taiwan

Filter 14 Filter 19

Filter 24 Filter 26

Filter 37 Filter 40

Filter 41 Filter 43

Link Between Number of Generics and antibiotic Resistance ???

Overuse of 3rd Gen cephalosprorind linked to ESBL production ( ESBL rate in India between 50-70%)

Overuse of Flouroquinolones and Carbapenems leads to MDR pseudomonas and acinetobacter infections ( MDR rate in India around 20-30%)

Overuse of Vancomycin leads to VRE and VRSA

RecommendationsRecommendations

More More Regulatory Control and Regulatory Control and TightenTighten the Guidelines the Guidelines

• Choice of brand should be with the prescriber and not with administration or pharmacist

• Original Research should be strongly driven.

• In critical care, for IV antibiotics, Original drugs should be preferred

• Over the counter sale of IV antibiotics should be restricted

Thankyou