The authorities of Central Drugs Standard Control Organisation (CDSCO), West Zone, Mumbai, have unearthed an illegal import of bulk drug albendazole from an unregistered Chinese manufacturer without drug registration in Form 41 and drug import licence in Form 10 by one Sheetal Pharma at Borivali in Mumbai.

According to Deputy Drugs Controller (CDSCO, West Zone), Sheetal Pharma, Shantivilla, Shantivan Tower Compound, Devids Lane, Near Club Aqueria, Borivali (West), Mumbai-400 103 has been importing bulk drug albendazole at Chennai Port and clearing it from Chennai Customs as chemical/non drug item and the relevant Bills of entry are not routed through Assistant Drugs Controller India, Chennai Port and no clearances obtained from ADC, Chennai Port.

Acting on the orders of Deputy Drugs Controller (CDSCO, West Zone), a team of drug inspectors from CDSCO and FDA, Maharashtra made a surprise visit of Sheetal Pharma, at Borivali in Mumbai on November 13, 2009. The firm, owned by two partners namely Nailesh Shah and Kalpesh Shah, were not available at the time of inspection.

Pradeep Nanubhai Soni, the authorized signatory, was present at the time of inspection and statement obtained from him. He had also given the computer statement of purchase and sales of albendazole for the period 1.4.08 to 31.3.09. As per the statement , it is observed that they imported 21000 kg of albendazole from China during that period and sold to different traders and drug manufacturers. Soni also informed that they do not possess Drug Import License in Form 10 and Drug Registration in Form 41 under the Drugs and Cosmetics Rules 1945.

No stock of albendazole was available at the premises. As per Soni’s statement, they store their bulk drugs at Pawar Roadways, Bhivandi and also confirmed that the stock of albendazole is nil.

The details of observations made during the visit are recorded in Form 35 and further investigation is under progress.