Cipla's wholetime director Amar Lulla told The Financial Express that the company's CFC-free inhaler, branded Asthalin HFA, will be ready for a domestic launch shortly, even as the company is working concurrently on export registrations in major markets, including Europe and South Africa.

The Montreal treaty, drawn up in 1987 and signed by over 150 nations, aims to ban a number of ozone-depleting substances including CFCs, halons and carbon tetrachloride. Consequently, the production of CFCs was banned in the developed world from January 1996, except for a small amount required foressential uses like in metered-dose inhalers (MDI).

MDIs are used to prevent and relieve the symptoms and progression of asthma, chronic obstructive pulmonary disease, cystic fibrosis, and bronchiectosis.The Rs 616-crore Cipla's entry into the non-CFC inhalers segment is expected to pump up competition, given that Asthalin HFA will be priced at a discount of over 200 per cent that of international prices, which are ruling at roughly Rs 270 per inhaler. Cipla officials, however, say even this price level could be lowered "substantially" if the existing import duty levy of approximately 42 per cent is eased. Anti-asthmatic drugs account for about 20 per cent of Cipla's turnover and analysts see a quantum leap in this figure if Asthalin HFA is a success internationally. Cipla's product took roughly four years at the R&D stage, at an investment of around Rs 6 crore.

The aerosols market in Europe is estimated to be worth one billion pounds (230 million units) and Lulla said Cipla was looking at a share ofaround 3-6 per cent in the first year, post-launch. However, export sales of Cipla's CFC-free inhaler will not be reflected in the current fiscal, given that overseas registrations take at least six months to materialise.

The key players in the international aerosol market include Glaxo, Norton Healthcare, 3M Pharmaceuticals, Rhone-Poulenc, and Schering-Plough, all part of the International Pharmaceutical Aerosol Consortium. The UK Patents court had in 1997 revoked a 3M Pharmaceuticals patent on the use of CFC replacements in MDIs and invalidated the company's patents on non-CFC propellents for use in MDIs, which was challenged by Norton Healthcare.

Currently, MDIs account for 77 per cent of global inhalation therapy and over 70 million patients the world over use MDIs (the number of asthmatics is growing at 7 per cent), as per statistics culled from various international publications on the subject.

Cipla's successful development of its CFC-free inhaler comes even as the company has sought patentprotection for its new dry powder asthma inhalation device, Rotahaler (a novel inhalation device used with rotacap formulations), in Australia, Europe and South Africa. The company has also applied for patents for another asthma device, a zero stat spacer, in India, South Africa and other PCT (Patent Co-operation Treaty) countries.

Insight

Firm proves its subremacy

By developing a non-chloroflourocarbon salbutamol inhaler, Cipla has once again proved its supremacy in the anti-asthamatic drug segment. An important point worth noting is that in spite of the four-year period involved in developing the product, Cipla has managed to do it at a cost as low as $1.4 million. It is because of the low cost of development that the company is able to price the product at a discount.