The Gujarat Food and Drug Control Administration (FDCA) recently filed a first information report (FIR) and issued a show cause notice to a Baroda based orthopaedic implants manufacturer Orbit and its sister concern B J Patel Surgicals. The action was jointly undertaken by the state regulatory authority and the police after a raid revealed that the company has been indulging in manufacturing orthopaedic implants without any valid license under the Drugs & Cosmetics Act (D&C Act).


The drug authorities recovered raw-materials, finished products and in-process materials worth around Rs.1 lakh from Orbit's manufacturing facility situated in GIDC Makarpura in Baroda district. The company has been actively manufacturing, storing and distributing orthopaedic implants without any license which is an offence under the D&C Act.


Dr H G Koshia, commissioner, Gujarat FDCA informed that ever since orthopaedic implants have been included as a drug under the D&C Act in 2005, it has been mandatory for the manufacturers to have a license to manufacture it.


“Gujarat contributes a lions share in the orthopaedic implants market in the country, thus it is necessary for us to keep a tab on the manufacturing activities that are being conducted within the state. This raid was a part of the inspection drive that we are currently conducting across the state to monitor the activities of the orthopaedic implants manufacturers,” Dr Koshia said.


He added that this drive is aimed at checking whether the manufacturers have a valid license to do the business and to confirm whether they are complying to the standards as needed under D&C Act.


“It had come to our notice that there were some manufacturers who are indulging in the manufacturing these implants without any license which is punishable under the law. We have asked these facilities to stop its operations immediately and have ordered them to resume it only after getting a requisite license and have issued them show cause notice for the same,” informed Dr Koshia.


The FDCA has already completed the first phase of the inspection drive by flagging it off from Ahmedabad. Dr Koshia informed that in Ahmedabad the team issued show cause notices along with telegraph to stop production to nearly 15 manufacturers due to lack of licence and non compliance. Whereas in the second leg of their inspection drive in Baroda they have issued one show cause notice along with a police complaint against the company for disrupting the work of the drug authorities in doing their duties.


He informed that this drive will be conducted in all the major districts in the state and may last about a month.