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