Bangalore based Bhat Bio-Tech India (P) Ltd., has bagged the CE Certification from the Institute of Testing and Certification Limited, Czech Republic for its products to test HIV, malaria, Hepatitis B, pregnancy and Urine Chemistry.

The certification was issued in compliance with the Council Directive 98/79 EC (IVD), which is implemented by the Czech Government via Order No. 453/2004(Collection of Laws) certifying in-vitro diagnostic medical devices according to Annex II, List A of the IVD Directive. The certified products are Hepa-Scan HBsAg card, Pareekshak HIV-1/2Spot Test, Pareekshak HIV1/2 Trilline Card Test, Maleriscan-Malaria-P-f/P.v3 line Antigen Test, Pregny-Scan hCG Card Test, Pregny-Scan hCG Dipstick Test, Urine Reagent Strips Glucose-Ketobe-Specific Gravity pH-Protein Test.

The company was awarded the certification because it qualified the norms under Annex IV, Section 3.2 of the Directive 98/78/EC. The notified body No 1023 performed an audit of the product's quality system which was assessed and approved after it was subject to continuous surveillance according to Annex IV, Sections 3.3 and 5 of the Directives 98/79/EC.

The company will now affix the CE marking stamp to each in-vitro medical device proving its conformity to global standards.

The CE certification is a major achievement for the company. Although 50 per cent of the company sales are from the international market, it could not enter the regulated markets for want of a CE certification. "Now with the distinguished stamp of quality, we can enter the markets of Europe and Gulf," Dr. Shama Bhat, chairman and managing director, Bhat Bio-Tech India (P) Ltd., told Pharmabiz.

The company already has the quality certification like GMP, ISO9001:2000 and ISO 13485:2003. It already exports to UK, South Africa, Nigeria and other countries. In South Africa, the company kits have clocked a three fold growth over last year with the HIV and malaria kits. The company is also scouting for marketing tie-ups to increase the reach of its products in the international arena.

For the FY 2007-8, the company registered a turnover of 8 crore and is 30 percent growth rate.

The company is also setting up a research and development centre which will be commissioned by Q3 this year. Present head count of the company is 120 which includes 12 scientists. Bhat Biotech also received a Rs. 25 lakh grant from the Union government's Department of Biotechnology for a three-year kit improvement research programme. It has tied up with the Malaria Research Centre in Bangalore, located in the premises of the Isolation Hospital, to work on advancing the technology of the kits.

The company is also working on nano-tech based products, micro-fluid based applications and has teamed up with IIT-Mumbai for development of the lab-on-a-chip product.

Recognizing the capability of the company in the international arena, Dr Bhat was invited to make a presentation of the company's growth and development for a global conference titled 'Mobilizing the Private Sector for Global Health' at Toronto, Canada last month.