Cipla Limited, which is banking on a slew of anti-asthma products that it plans to launch in Europe and especially in Germany to give a much-needed fillip to its exports, has received a major set back as the Pharmaceutical Inspection Convention (PIC), Germany, asked the company to re-conduct clinical trials of its CFC- free inhalers in the country for granting marketing approval.

The company had in fact submitted the DMF for the products and also the trial results to the German drug regulatory body a couple of years ago and was awaiting the approval since then. The new directive from the PIC has, however, showed the authority's lack of confidence on the clinical research data submitted by the company for the CFC-free inhalers to be imported and marketed into the country.

According to industry sources, following the PIC's requirement to prove the safety and efficacy of the products through a retrial, the company is already in the process of organizing another round of clinical trials in the country to secure the approval.

However, reacting to Pharmabiz query on this, Amar Lulla, chief executive, Cipla Limited, said that the products are in different stages of approval procedures in the German market and it is too difficult to say now when would the clearance be granted. Though admitted that long delay occurred in the PIC approval for the products, he could not give reasons to the same while commenting. However, he denied the information of the repeated clinical trials of CFC-free inhalers in Germany.

According to a pharma analyst, Cipla has a variety of asthma drugs such as Salbutamol, Fluticasone, Ipratropium and Budesonide. It has entered into a tie-up with three German drug companies for distribution in Europe. However, the $3.5-billion asthma marketing Germany is getting very competitive with an Italian company, Chiesi Farmaceutici, launching CFC-free Budesonide Modulite in the market. Moreover, Ivax Corporation has entered into a licensing agreement with Novartis Pharma to utilise the former's patented Airmax multi-dose dry powder inhalers for Novartis' trademarked medicines Foradil (formoterol) and Miflonide (budesonide) in the European Union and certain other countries.

The analyst added that "there has been a delay in obtaining product registrations for Cipla's CFC-free inhalers in German markets though the company is now targeting a basket of 8-9 products for simultaneous launch in Germany.

Cipla currently exports budesonide-based inhalers, which do not use ozone-depleting chlorofluorocarbons (CFCs) as propellants, to South Africa. Earlier, the company's inhaler (aerosol) manufacturing facility at Goa underwent an inspection by MCA and subsequently, was granted approval by the UK-based certifier. The marketing or regulatory nods for five inhaler products in the UK/Germany markets were expected soon. These include CFC-free Salbutamol, CFC-free Beclamethasone, CFC and CFC-free Budesonide inhalers.

However, the industry sources quoting senior Cipla officials said that the company would be able to export CFC-free inhalers to Germany only in second half of the year 2004 as it is redoing certain clinical trails for the products for the German market as asked by the local regulators. "We believe that this would delay the approval process by another 5-6 months. This would potentially reduce sales and profit for the company," said the industry sources.

As per the earlier projections of the company, it was to generate US$10mn sales in FY 2004 from this opportunity. However, the export growth of the company is likely to slow down in the year without CFC-free inhalers.