The in-vitro diagnostic kits for health ailments such as malaria, dengue, HIV, hepatitis, and typhoid were stored in the unit which did not have the requisite license for sale as per Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017
Seized rapid test kits by FDA Maharashtra. Pic/FDA
Maharashtra’s Food and Drugs Administration (FDA) officials seized in-vitro diagnostic kits (rapid test kits) which were being sold without licence in the Thane region. The stock of diagnostic kits worth Rs 12.40 lakh was seized during a raid at a unit in Shilphata area, Thane.
The in-vitro diagnostic kits for health ailments such as malaria, dengue, HIV, hepatitis, and typhoid were stored in the unit which did not have the requisite licence for sale as per Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017, the FDA officials said.
“Based on the information received at Intelligence branch of FDA Maharashtra, a team comprising of drugs inspectors raided premises located at Bharat Eco Vista, Shilphata, Thane on Tuesday. During the investigation, it was observed that the stock of rapid in-vitro diagnostic kits for malaria, hepatitis C virus, typhoid, syphilis test, HIV 1 and 2, and dengue manufactured by M/s Sidak Health Lifecare Bahadurgad, Haryana was found to be stored for sale,” said Ganesh Rokde, FDA Assistant Commissioner, Drugs department.
“There was no need to arrest anybody in the case. We have taken all records and a few representative samples of the kits are taken for further testing and analysis, the remaining stock of the rapid kits worth Rs 12.40 lakh was seized for the violation of Section 18c of the Drugs and Cosmetics Act. After the analysis results are out, we will be prosecuting the matter further,” added FDA official Rokde.