Medchal-Malkajgiri: DCA, Excise bust illegal manufacturing drugs godown, seize stock worth Rs 96 lakh

Hyderabad: The Drugs Control Administration (DCA), Telangana, in a joint operation with the Prohibition & Excise Department, busted a godown storing illegally manufactured and stocked bulk drugs worth Rs 96 lakh at Muduchintal Pally Village, Medchal-Malkajgiri District.

Case details

DCA director V B Kamalasan Reddy said that the godown, operating illegally without any drug licence, belongs to Kadari Sateesh Reddy of Aspen Biopharma, who is the prime accused in the spurious anti-cancer drugs case detected at Machabollaram in December 2023. He is also the key conspirator in the illicit manufacturing of APIs at Annarugudem Village, Tallada Mandal, Khammam District, which was detected in the same month.

During the raid, large stocks of bulk drugs (Active Pharmaceutical Ingredients) of various categories, including anticancer, antiviral, antifungal, anticoagulants, antidepressants, etc., which were illegally manufactured, were found stocked at the godown belonging to Aspen Biopharma Pvt. Ltd. All drugs worth Rs. 96 lakh were seized by the officials, he added.

The DCA director said that the stocks of Bulk Drugs/APIs present in the godown are in LDPE bags and only bear the name of the bulk drug. Certain stocks bear only code names of the APIs. The batch details and the details of the manufacturer are not indicated on the API stocks found, indicating unlicensed manufacturing of the APIs, he said.

“Drugs manufactured by unlicensed entities pose a severe threat to public health. They do not adhere to any 'Good Manufacturing Practices' (GMP). According to the Drugs and Cosmetics Act, drugs must be manufactured in ISO-8 Clean Rooms while adhering to GMP. GMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug. GMP ensures that a drug is safe for use by patients,” Kamalasan Reddy said.

Details of the stocks of Bulk Drugs (APIs) detected

Sertraline Hydrochloride ( 350 kg), Misoprostol (352.5 kg), Darifenacin (1.5 kg), Heparin sodium (1.3 kg) Amisulpride (9 kg), Pazopanib (2.5 kg) Palbociclib (1.5 kg), Nilotinib (3.2 kg), Losartan ( 2.0 kg), Terazosin (6.5 kg), Sertaconazole (4.5 kg), Posaconazole (1.4 kg), Darunavir ( 0.5 kg), Ropinirole (0.6 kg) Daptomycin (0.8 kg), Ibrutinib (Qty: 0.6 Kg) Tenofovir (1.5 kg), Abiraterone (8.0 kg), Docetaxel (0.9 kg), Gemcitabine (0.9 kg), Levetiracetam (6.0 kg), Ritonavir (0.7 kg)and Rivastigmine Tartrate (8.92 kg).