The Department of biotechnology (DBT) and the Council Scientific and Industrial Research (CSIR) have accredited the research and development lab of Bhat Biotech, one of the leading diagnostic kit manufacturers in Karnataka. Further, the company is investing Rs 15 lakhs to improve its storage and production facilities.

Last year, the company received ISO 13485: 1996 certificate from UL India Private Limited, an affiliate of Underwriters Laboratories Inc. (UL Inc., USA). The ISO 13485 is the certificate for medical devices and is a prerequisite for receiving the CE marking and US FDA approvals.

“The accreditation from the DBT and CSIR is a boost to our business which will help us to get more orders, both in the domestic and global market,” Dr. Shama Bhat, chairman and managing director, Bhat Biotech India Pvt., Ltd. told Pharmabiz.

The company has also added three potential products to its basket, which are for malaria, cancer markers and cardio markers. In order to meet the demand, it has made an investment of Rs 15 lakh to expand its storage and production area. The facility located in the Veerasandra Industrial Area in the outskirts of Bangalore is a WHO-GMP compliant unit. Bhat Biotech has been investing between Rs 20 and Rs 40 lakh annually to upgrade its research facility.

The company, which commenced operations in 1996, has registered Rs 6- crore turn over for FY ending March 2005. Among its range of products, HIV dry line, which is a rapid lateral flow type test kit, has been a revenue generator. The product has sales of Rs 2 crore alone from South Africa.

In the domestic market, HIV and Hepatitis B kits are major volume builders. Among the other kits for pregnancy, haematology, immunology, clinical chemistry, biochemistry and other ELISA instruments along with OEMs for thyroid, fertility, Torch and Elisa kits are directly imported from USA. Competition from China and Korea pose a serious threat to Indian manufacturers in terms of pricing, informed Dr. Bhat.

Although the diagnostic kit manufacturing business is growing with a steady flow of orders, issues like customs duty on HIV and Hepatitis B kits, is a serious problem apart from the duty drawback issue. Companies are forced to shell out 15 per cent for customs duty, 16 per cent as excise duty and 2 per cent on educational cess, added Dr. Bhat.