A team of the Food and Drug Administration (FDA), Haryana, on Wednesday raided the premises of a manufacturing unit in Faridabad and sealed it as it was found violating various provisions of the Drugs and Cosmetics Act.
The unit of XL Orthomed (P) Ltd, Sarai Khawaja, Faridabad, was manufacturing sterile and non-sterile orthopaedic implants, which came under the definition of 'drug', which was unlicensed, a spokesperson for the FDA said.
The unit was inspected in 2011 by the FDA team along with FDA officials from the Central Drugs Standard Control Organisation during which many shortcomings of serious nature were observed. The state drugs controller, Haryana, had directed the firm to remove them but it didn't mend its ways.
The spokesperson said that during the raid, the firm was found manufacturing sterile orthopaedic implants without holding a drug manufacturing licence. The firm had manufactured sterile orthopaedic implants without maintaining the required clean room conditions either, which could be harmful to patients to whom these orthopaedic implants were to be implanted.
An orthopaedic implant is a medical device manufactured to replace a missing joint or bone or to support a damaged bone.