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Maha FDA seizes illegally stocked IVD kits worth Rs. 12.4 lakh in Thane

Our Bureau, Mumbai
Friday, August 5, 2022, 09:15 Hrs  [IST]

The Maharashtra Food and Drugs Administration (FDA) has seized illegally stocked in-vitro diagnostic kits worth Rs. 12.4 lakh from the premises of Bharat Eco Vista, Shilphata area in Thane, neighboring district of Mumbai.

Acting on a tip-off on August 2, 2022, intelligence branch of FDA comprising two drug inspectors (headquarters) including VR Ravi, drug inspector- Thane Ajay Mahule raided the premises of Bharat Eco Vista and recovered stock of rapid in vitro diagnostic kits such as malaria clear, HCV, HBsAg test for hepatitis, typhoid Ab, syphilis test, HIV I & II, dengue combo etc. which were found to be stored for sale. The premises did not have the requisite license for sale as per Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017, stated a senior official at FDA.

The diagnostic kits were manufactured by Sidak Health Lifecare, Bahadurgarh in Haryana, he said.

“The representative samples of the kits were drawn for the test and analysis and remaining stock worth Rs. 12.40 lakh was seized for the violation of Section 18C of the Drugs and Cosmetics Act. Further investigation in this matter is in process,” the official stated.

In May this year Maharashtra FDA registered FIR against Apollo Pharmacy and Conceptreneur Ventures, Govandi for manufacturing blood pressure measuring equipment without license.

During investigation, FDA officials found that the device was imported from New Era Corporation, China without import licence. As per agreement between Conceptreneur Ventures & Apollo Pharmacy (a unit of Apollo Hospitals Enterprises Ltd), Conceptreneur Ventures started manufacturing fully automatic upper arm style blood pressure monitors which is a brand of Apollo Pharmacy. The firm manufactured and sold around 82,510 units.

In April this year state FDA issued show cause notices to 95 pharmaceutical companies for non-compliance of good manufacturing practices as prescribed under Schedule M of the Drugs and Cosmetics Rules.

 

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