Karnataka's bulk drug unit, Lake Chemicals, a subsidiary of Bal Pharma, has gone in for an investment of $1 million to set up a new Schedule M compliant facility located next to its existing decade-old unit located at Attibele Industrial Area, in the outskirts of Bangalore.

The company is already in an advanced stage of discussion with two generic companies in the US for a tie-up initiative. It is also in the final stages of development of Drug Master Files which is a key requirement by customers in Europe where Lake Chemicals has already has received approval for marketing three products with four more awaiting clearance.

The company is also fulfilling another mandatory requirement for bulk drug production, as it is in the process of filing the Common Technical Dossier (CTD), stated Manoj C Palrecha, managing director, Lake Chemicals Pvt. Ltd.

Business generation is focussed on the regulatory market. With European Union representing several countries, there are many business opportunities opening up for Lake Chemicals. About Seventy five per cent of its earnings are from the international market. It has a major presence in 30 countries including Europe, Australia and New Zealand.

Ending March 2004, Lake Chemicals registered earnings to the tune of Rs 13.5 crore and clocked a growth rate of 20 per cent. Efforts are on to maintain a growth of 25 per cent for the next three years, he said.

The main attraction for Indian bulk drug companies to tap the US markets is the potential to generate over four times the revenues earnings compared to the other global destinations. The presence in the US market strengthens Lake Chemicals stand in the other regulated markets, he informed.

Apart from its existing product line that addresses specific disease segments like psychiatry, anxiolytic, epileptic, insomnia, central nervous system and cardiology, the company has increased its product range in anti diabetics and anti diarrhoea." We are looking at exclusive product diversification to keep away from stiff competition and severe price cutting market conditions", he stated.

The international market is lucrative for bulk drug manufacturers with quality products which gives them an edge over the pricing unlike the domestic market which is bogged down by price bargains and a poor concern over the quality of bulk drugs. Under the circumstances, Lake Chemicals strategy is to produce high-value and low volume niche products where the competition is mainly from global majors. The success of the company in the global market in attributed to its research and development efforts for new product development.

About the problems in bulk drug sector, Manoj Palrecha is of the opinion that there is an urgent need for a streamlined and faster procedural clearance from government agencies to enter the global market.