EXTRANCHECK: PRE-LICENSE CHECK: SERUM INSTITUTE OF INDIA

UNCLAS NEW DELHI 002742 SIPDIS SIPDIS USDOC FOR 532/OEA/M. NICKSON-D/JAY HATFIELD USDOC FOR 3131/USFCS/OIO/ANESA/KREISSL USDOC FOR 4530/MAC/ANESA/OSA ICE HQ FOR STRATEGIC INVESTIGATIONS STATE FOR EB/ESP E.O. 12958: N/A TAGS: ETTC ETRD BEXP IN SUBJECT: EXTRANCHECK: PRE-LICENSE CHECK: SERUM INSTITUTE OF INDIA LTD., PUNE, LICENSE NO. D373940 REF: USDOC 04313 ¶1. Unauthorized disclosure of the information provided below is prohibited by Section 12(c) of the Export Administration Act. ¶2. Export Control Officer (ECO) Paul Cushman and BIS FSN Prem Narayan conducted a Pre-license Check (PLC) at Serum Institute of India Ltd. (SIIL),Pune, on June 4, 2007. ¶3. BIS requested a PLC at SIIL, a private sector company, located at: Serum Institute of India Ltd., 212/2 Hadapsar, Pune 411028, Tel: 91-20-2660-2386, Fax: 91-20-2699-3921, email:rakesh.kumar@seruminstitute.com, website: www.seruminstitute.com. SIIL was listed as the ultimate consignee for 5 Model SK2P484EO membrane-based separation device in prostak tangential filter systems controlled under ECCN 2B352. The license applicant was Millipore Corporation (Millipore),Burlington, MA. ¶4. ECO along with FSN Narayan met with Dr. S.D. Ravetkar (Ravetkar), Senior Director and Dr. Rakesh Kumar (Kumar),Director-Production, SIIL. ¶5. SIIL representatives were not aware of the BIS regulations. This was the first visit by BIS or USG officials to SIIL. Kumar provided a copy of the SIIL corporate brochure, Millipore quotation, SIIL purchase order, and SIIL's end-use statement. ¶6. Kumar stated that they have been purchasing and using Millipore filters of various sizes for approximately ten years. He did not know if Millipore had obtained BIS export licenses for the previous transactions. In addition, Kumar was unaware of any export license conditions. However, SIIL, on Millipore's request, does submit an end-use certificate for every filter order. The filters on order will be used for producing the Diphtheria-Pertussis-Tetanus group of human vaccines. The filters will be connected to fermentors. Bacteria are grown in the fermentor and subsequently, the fermented bacterial mask is separated by the filter. The separated formulation is further processed to make human vaccines. ¶7. After the meeting, ECO and Narayan were given a tour of one of several fermentors operating at SIIL. The BIS Team witnessed a filtration system being used to separate bacterial mask. Kumar stated that the life of a filter is approximately one year and they always maintain an adequate supply of filters. The BIS Team was shown a packaged Millipore filter of the same model they have ordered. This filter is kept as a spare. The SIIL complex is guarded 24 hours a day. Entry to the SIIL manufacturing laboratories is highly restricted and access is accomplished via an electronic card reader system. ¶8. Established in 1966, SIIL is a large, family-owned company. It manufactures the DPT (Diphtheria, Tetanus and Pertussis) and MMR (Measles, Mumps and Rubella) groups of human vaccines. In addition, SIIL manufactures rabies vaccine, hepatitis-B vaccine, anti-venom serum, anti-cancer products, serono products, hormonal products, and several life-saving biologicals. Per SIIL's brochure, it is estimated that 2 out 3 children immunized in 2004, received one manufactured by SIIL. SIIL manufacturing laboratories conform to CGMP (Current Good Manufacturing Practices) and is approved by World Health Organization (WHO),Pan American Health Organization (PAHO) and UNICEF. SIIL sells its vaccines to WHO and UNICEF and exports its products to approximately 140 countries. It also caters to the Expanded Program of Immunization (EPI) of the Government of India's Ministry of Health. Under this program, the Government of India immunizes children free of cost. SIIL has marketing offices in all major Indian cities including Mumbai, Delhi, Hyderabad, Kolkata, Chennai and Pune. The SIIL Group of companies' sales turnover for FY-06 was approximately $487 million including $212 million by SIIL. SIIL employs approximately 1,000 personnel. ¶9. Recommendation: Post recommends Serum Institute of India Ltd. as a reliable recipient of the controlled U.S.-origin commodities. All indications are that the listed commodities will be used in accordance with U.S. Export Control Regulations. (PSCUSHMAN/PNARAYAN) Mulford