The Drugs Control Administration (DCA), Telangana, seized drugs worth Rs. 5.50 lakhs that were illegally manufactured by Aspen Biopharma Labs Pvt. Ltd. in Shameerpet. The company is said to have manufactured APIs against a previous order in which it was asked to stop all production.
On Monday, the DCA authority of Shameerpet raided Aspen Biopharma Labs at Biotech Park, Plot No. 10, Phase-ll, Lalgadi-Malakpet Village, Shameerpet Mandal, Medchal-Malkajgiri District.
However, the company belonged to Kadari Sateesh Reddy. He was the prime accused in the spurious anti-cancer drugs case at Machabollaram in December 2023. Kadari Sateesh Reddy was a key conspirator in the illicit manufacturing of APIs at Annarugudem Village, Tallada Mandal, Khammam District.
While performing the raid, DCA authorities seized two bulk drugs: 110 kg of Ciprofloxacin Hydrochloride and 8.4 kg of Gatifloxacin Hydrochloride, as the drugs were manufactured during the ‘Stop Production Order period’.
DCA issued a Stop Production Order in March 2023 to Aspen Biopharma Labs due to various non-conformities with respect to Good Manufacturing Practices (GMPs) and other provisions of the Drugs and Cosmetics Act, 1940, and Rules 1945. However, Aspen Biopharma continued manufacturing the drugs. Production of drugs during the 'Stop Production Order' period is chargeable under the Drugs and Cosmetics Act with imprisonment for up to five years.
In a separate operation, DCA officials raided a quack's clinic and seized drugs stocked for sale at Khila Warangal Village, Warangal District.
Upon receiving information, DCA authorities raided the premises of a quack, Madhavaraju Birudaraju, on Monday. Madhavaraju was practicing medicine without proper qualification, calling himself a rural medical practitioner at his clinic.
Here, DCA officials detected huge stocks of medicines on the premises without any drug license. Around 48 varieties of medicines, including antibiotics, analgesics, cough syrups, anti-ulcer drugs, anti-hypertensives, IV fluids, etc., were found stocked at the premises. DCA authorities seized the medicines, worth a total of Rs. 52,000.
DCA officials observed several higher-generation antibiotics at the clinic. Such indiscriminate sales of antibiotics by an unqualified person may have disastrous consequences for 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 and dealers supplying medicines to unqualified persons who are stocking and selling drugs without a drug license are also punishable under the Drugs and Cosmetics Act. They should mandatorily confirm that the recipient entities hold a valid drug license before supplying medicines to them.
(Input from various sources)
(Rehash/Komal Bhoi/MSM)