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INDIAN INDUSTRY PERSPECTIVE ON ALTERNATIVES TO HYDROFLUOROCARBONS (HFCs)

FORMetered Dose Inhalers (MDIs)

Presentation by

MDI manufacturers in India

INDO-US WORKSHOP 18th February 2011

NEW DELHI

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Growth of Consumption of HFCs as Propellant

CFC HFC

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Achievements in Phase out of CFC India has transformed majority of CFC MDI’s to HFC

in domestic as well as export market. Also, In addition of transforming old CFC products

to HFA, some of the new molecules / combinations / new Breathe Actuated Inhalers were developed & introduced using HFC .

India, being one of the large generic market, has introduced around 25+ products including various strengths in HFC formulations over the period of 15 years.

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Current status of Alternatives to HFCs as Propellant Globally HFCs are used as propellants for MDIs. There are still some concerns in acceptance of HFC

based MDIs in some parts of the world. No technically proven alternatives to HFC for MDIs. MDIs are used as life saving drugs hence due care

has to be taken in selection of suitable HFC alternatives.

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HFC alternatives - ConcernsPharmacological concerns:1. Safety: Toxicological screening: The most important

property of a medical propellant is impeccable toxicology. Everything else is secondary.

Reasons :A. Significant quantity of propellant gas is taken by the

user on a daily basis for many years, often a lifetime.B. Gas is taken into an organ which is already weakened

by a disease.C. An organ in which the gas inhaled is quickly available

to the bloodstream.

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Compatibility

Filling machines(Seals ,Pumps)

API(Timelines 1-3 years)

Can

Rubber gasket Plastic Components

Valve (Investments & Resources)

Device

Surfactant

• Timelines• Investments• Resources

Technical concerns:1. Compatibility of new alternative with active ingredients and

different components of MDI’s.

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Technical concerns (cond.):2. Re-designing of formulation as per the physico-

chemical properties of the new alternative.

Formulation Re-designing

Suspension stability

Particle Size Engineering Choice of Surfactant

Optimization of devices

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Regulatory concerns:

Toxicology

Safety & Efficacy

Regulatory approval timelines (3 – 8 years)

IP Strategy

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Patient concerns:

1. Cost is the key factor

2. Patient – physician interface

3. Patient acceptability Change in taste & odour Cold freon effect

4. Lack of confidence in new product

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Way Forward:

1. We had 5 decades of CFC’s for Medical Aerosols and over a decade of development replacing CFC’s to HFC’s. Therefore Changing to a new HFC alternative raises concerns as any change to the alternative propellants will have a significant impact on product development, timelines and cost.

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Way Forward:

2. we therefore need to make a very informed judgment on the introduction of new HFA alternative for Medicinal Aerosols based on commercial viability, development & regulatory challenges expected ahead.

3. Inspite of that, Pharma industry is definitely open for a dialogue.

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