Jaipur: Rajasthan Food Safety and Drug Control Commissionerate has launched a manufacturer-level investigation after five medicine samples seized during a raid on an unlicensed drug warehouse in Bhiwadi on Sept 1 were found substandard.
Drug Control Wing had collected 18 samples of medicines belonging to various manufacturers and marketers for quality testing. Reports for 16 samples have been received so far, with 11 found to be of standard quality and five declared substandard by govt analyst at Drug Testing Laboratory, Jaipur. Reports for two samples are awaited.
The substandard medicines include Ciprofloxacin Tablets BP 500mg, Tapentadol Tablets 225mg, two batches of Chakapen Extra containing Diclofenac 50mg and Caffeine 50mg, and Medicb-55 containing Diclofenac Sodium 50mg.
Principal secretary (health and medical education) Gayatri Rathore said the manufacturers linked to the medicines include Candor Healthcare, Lalru in Punjab; Opal Healthcare, Karnal in Haryana; Alexa Pharmaceuticals, Baddi in Himachal Pradesh; and Unisharp Organics Pvt Ltd, Lalru in Punjab.
The investigation follows a raid on a warehouse operating without a valid licence in Bhiwadi, Khairthal-Tijara district, based on confidential information.
Around 1,500 cartons of medicines and related material, valued at nearly Rs 4 crore, were seized during the operation. The seized stock has been kept in the custody of Drug Control Officer as per court orders.
Investigation teams have been sent to the concerned manufacturing units. They will examine batch manufacturing records, raw materials, quality control documents, manufacturing records, and distribution and supply chain documents.
The inquiry will determine whether the medicines were manufactured, tested, stored and distributed in accordance with prescribed standards and legal requirements.
Rathore said active pharmaceutical ingredients, including Tapentadol, Pregabalin and Cotrimoxazole, along with packaging material, punches, dyes and expired Sildenafil tablets, were also seized during the raid.
The department said action would be taken under the Drugs and Cosmetics Act based on the findings. Officials said negligence related to medicine quality and unlicensed drug trade would not be tolerated and action would be taken against persons, institutions and other parties found responsible.
