Telangana DCA seizes illegally manufactured APIs worth Rupees one crore from Aspen Biopharma

The drug control officials in Telangana raided an unauthorized godown owned by Aspen Biopharma and seized stocks of illegally manufactured bulk drugs worth Rupees one crore kept inside it.

The officials informed Pharmabiz that the owner of the godown, Kadari Sateesh Reddy of Aspen Biopharma is a habitual offense and involved in several cases registered by the drug control administration (DCA). He was operating the godown without a valid license. He was the prime accused in the spurious anti-cancer drugs case detected at Machabollaram in December 2023 and also was the key conspirator in the illicit manufacturing of APIs at Annarugudem Village in Khammam District.

The raid operation was carried out by the department officials in association with the prohibition and excise department. The illegal stocks of APIs included anticancer, antiviral, antifungal, anticoagulants, antidepressants etc which were worth nearly one crore of rupees. All the products were seized in the raid. The godown was operating at Muduchintalpally Village in Medchal-Malkajgiri District.

A senior officer from the office of the director general Dr. VB Kamalasanan Reddy has shared the details of the seized active pharmaceutical ingredients. According to him, the officials detected the drugs such as sertraline hydrochloride (Qty: 350.0 Kg), misoprostol (Qty: 352.5 kg), darifenacin (Qty: 1.5 kg), heparin sodium (Qty: 1.3 kg), amisulpride (Qty: 9.0 kg ), pazopanib (Qty: 2.5 kg), palbociclib (Qty: 1.5 kg), nilotinib (Qty: 3.2 kg), losartan (Qty: 2.0 kg), Terazosin (Qty: 6.5 kg), sertaconazole (Qty: 4.5 kg), posoconazole (Qty: 1.4 kg), darunavir (Qty: 0.5 Kg), ropinirole (Qty: 0.6 kg), daptomycin (Qty: 0.8 kg), ibrutinib (Qty: 0.6 kg), tenofovir (Qty: 1.5 kg), abiraterone (Qty: 8.0 kg), docetaxel (Qty: 0.9 kg), gemcitabine (Qty: 0.9 kg), levetiracetam (Qty: 6.0 kg), ritonavir (Qty: 0.7 kg ) and rivastigmine tartrate (Qty: 8.92 kg).

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 manufacturers are not indicated on the API stocks found, indicating unlicensed manufacturing of the APIs. 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. DCA Telangana ensures the quality of drugs manufactured in the state by carefully monitoring drug manufacturers’ compliance with Good Manufacturing Practice (GMP) regulations. The licensing process for drug manufacturers includes a review of the manufacturer’s compliance with GMPs. Unlicensed entities do not follow GMPs and lack a formal system of controls which prevent instances of contamination, mix-ups, deviations, failures, and errors. Hence drugs manufactured and sold by unlicensed entities may not meet quality standards and such drugs may have serious implications on patient’s health, the officer added.

The raided team included Anjum Abida, assistant director, Shameerpet, B Praveen, drugs inspector, Shameerpet, Dr B Lakshmi Narayana, drugs inspector, Uppal, and P Ambedkar, drugs inspector, Medipally. Officers from Prohibition and Excise Department were Bharat Bhushan, excise inspector and Srinivas Reddy, excise sub-inspector and their staff.