DCA stops illegal manufacturing of drugs at Aspen Biopharma

Hyderabad: Telangana State Drugs Control Administration (DCA), Shameerpet zone conducted a raid at Aspen Biopharma Labs Private Ltd located at Biotech Park Lalgadi-Malakpet village of Shameerpet mandal under Medchal-Malkajgiri district. The officials seized drugs worth Rs 5.50 lakhs.

According to DCA, the lab belongs to Kadari Sateesh Reddy, the prime accused in the spurious anti-cancer drugs case detected at Machabollaram in December 2023, and also the key conspirator in the illicit manufacturing of Active Pharmaceutical Ingredients (API) at Annarugudem village, Tallada Mandal, Khammam district, detected in December 2023.

During the raid, DCA officials seized two drugs in bulk quantities. ‘Ciprofloxacin Hydrochloride’ at 110 kgs and ‘Gatifloxacin Hydrochloride’ at 8.4 kgs which were manufactured during the ‘Stop Production Order’ period. The total worth of drugs seized during the raid was Rs 5.50 lakhs.

Aspen Biopharma Labs was issued a Stop Production Order in March 2023 by the DCA, Telangana due to various non-conformities concerning Good Manufacturing Practices (GMPs) and other provisions of the Drugs and Cosmetics Act, as reported during inspection.

The firm was not permitted to carry out any manufacturing activity regarding drugs thereafter. However, Aspen Biopharma illegally manufactured the drugs ‘Ciprofloxacin Hydrochloride’ and ‘Gatifloxacin Hydrochloride’ during the Stop Production Order period, said DG DCA, V B Kamalasan Reddy.

Further investigation will be conducted, and appropriate action will be taken as per the law against all the offenders, DCA said.

In another case, DCA on credible information, raided the premises of a quack MadhavarajuBirudaraju in Khila Warangal village, Warangal district. Madhavaraju was medical practitioner without pre-requisite qualification, calling himself as a Rural Medical Practitioner (RMP) at his clinic. During the raid, DCA officials detected huge stocks of medicines at the premises without any drug license. Around 48 varieties of medicines, including antibiotics, analgesics, cough syrups, anti-ulcer drugs, antihypertensives, IV fluids, were found stocked at the premises. DCA officials seized the stock, worth a total of Rs 52,000 during the raid. DCA officials detected several higher-generation 'antibiotics at the clinic during the raid.

Officials said, indiscriminate sale of antibiotics by an unqualified person may have disastrous consequences on the health of the public, including the emergence of 'Antimicrobial Resistance.' DCA officers took samples for analysis and further investigation will be carried out. Wholesalers/Dealers who supply medicines to unqualified persons, who are stocking and selling drugs without a drug license, are also punishable under the Drugs and Cosmetics Act, and stringent action shall be taken against such retailers. Wholesalers/Dealers should mandatorily ensure that the recipient entities hold a valid drug license before supplying medicines to them.