EXTRANCHECK: POST-SHIPMENT VERIFICATION: GLAND PHARMA

UNCLAS NEW DELHI 001961 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: BEXP ETRD ETTC IN SUBJECT: EXTRANCHECK: POST-SHIPMENT VERIFICATION: GLAND PHARMA LIMITED, HYDERABAD, INDIA REF: USDOC 02992 ¶1. Unauthorized disclosure of the information provided below is prohibited by Section 12(c) of the Export Administration Act. ¶2. On June 11, 2008, Export Control Officer (ECO) Paul Cushman and FSN Shailendra Srivastava conducted a Post-Shipment Verification (PSV) at Gland Pharma Limited (GPL) in Hyderabad. ¶3. BIS requested a PSV at GPL, a private sector company located on Narsapur Road, approximately 25 kilometers outside of Hyderabad. GPL was listed as the ultimate consignee for three absolute pressure transducers (1,000 torr range) manufactured by MKS Instruments Inc. of Andover, Massachusetts. Export License: D361166. ECCN: 2B230. ¶4. ECO and FSN Srivastava met with Mr. Srinivas Sadu, Director, Mr. K.V.G.K. Raju, Director-Technical, Mr. Ravinder Varma, Manager-Engineering and Mr. N. Prabhakar Rao, Manager-Commercial, GPL. ¶5. GPL representatives were not aware of BIS regulations and this was the first visit by BIS officials to their facility. Rao provided copies of the following documents relating to this transaction: MKS Invoice, GPL Purchase Order, Air Waybill, a receipt for import duties paid to the Indian Customs Authority, and the Delivery Challan. Rao stated that MKS did not provide the license conditions to GPL. ECO provided Rao with a copy of the license conditions. He reviewed the license conditions, confirmed that GPL had complied with them and would continue to do so. ¶6. Raju confirmed the stated end-use. He explained that the pressure transducers are used to monitor vacuum pressure in their lyophilization chamber which is used to suspend and freeze-dry aqueous solutions in the pharmaceutical manufacturing process. He stated that one of the three transducers is used as a master gauge to calibrate the remaining two transducers. Annually, the master gauge is sent to the National Physical Laboratory in New Delhi for recalibration. ¶7. After the meeting, the BIS team was given a tour of the GPL plant. ECO physically verified the pressure transducer serial numbers as 09XX06-014717600, 09XX06-014695778, and 09XX06-014702684. At the time of this visit, only one pressure transducer was installed. The remaining two transducers were secured in a locking cabinet in GPL's quality control department. ¶8. Established in 1978, GPL is a research-oriented company focused on developing niche products for the Indian and global pharmaceutical markets. GPL has 1,000 employees. The plant operates around the clock. A roving security force is on-duty 24/365. ¶9. Recommendation: At the time of this visit, Gland Pharma Limited appeared to be a suitable recipient of this controlled technology. The items on check were physically verified and were being used in a manner consistent with the Export Administration Regulations. WHITE