FDA lodged FIR for manufacturing BP monitoring machines without license

The BP apparatus is a medical device and is required to be manufactured under requisite manufacturing licence as per Medical Devices Rules, 2017.

Blood Pressure BP
Picture: Pixabay

Last Updated on May 23, 2022 by The Health Master

The Maharashtra Food and Drugs Administration has registered FIR against Apollo Pharmacy and Conceptreneur Ventures, Govandi for manufacturing blood pressure measuring equipment without license.

Acting on a tip-off that Conceptreneur Ventures Pvt Ltd, Govandi was manufacturing BP apparatus without requisite manufacturing licence, FDA sleuths raided the company at Shah Industrial Estate, Deonar, Govandi and conducted verification.

During verification it was observed that the firm was manufacturing the blood pressure monitor in absence of licence.

The BP apparatus is a medical device and is required to be manufactured under requisite manufacturing licence as per Medical Devices Rules, 2017.

The Central government extended the timeline till June, 2021 for obtaining the licence. The firm has not obtained the licence and continued to manufacture the BP apparatus.

Hence the available stock worth Rs. 10.35 lakh was seized for violation of Section 18 (c) of Drugs and Cosmetic Act, 1940. FDA issued instructions for the recall of the sold stock to Apollo Pharmacy, said a senior FDA official.

In further investigation it was revealed 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, the official said.

It has been observed that during the Covid-19 pandemic, a large number of these BP monitors were manufactured and sold without any quality test by this firm.

If the blood pressure measuring instrument is faulty, it may affect the patient’s treatment and may pose a risk to the patient’s health due to wrong diagnosis, he stated.

Since the firms manufactured the medical devices without licence and sold them without quality check, FDA filed a FIR against Conceptreneur Ventures & Apollo Pharmacy at Govandi Police Station under Sections 420 and 34 of Indian Penal Code 1860 read with Section 18 (C) of Drugs & Cosmetics Act, 1940. Further investigation is going on in the matter, he added.

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