Tuesday March 26, 2019

FDA indicts Snapdeal for selling prescription drugs; Amazon, Flipkart also ‘under’ scanner

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Rx-Drugs

By NewsGram Staff Writer

In a major crackdown on the sale of prescription drugs online, The Maharashtra Food & Drugs Administration (FDA) has come down heavily upon e-commerce website Snapdeal.

As per FDA Commissioner Harshadeep Kamble the FDA sleuths raided Snapdeal’s office in Goregaon, north-west Mumbai, after a specific tip-off was received that prescription drugs like Ascoril cough syrup, Viagra tablets, and other medicines were being sold online.

The official said that Snapdeal.com has been asked to provide details of the people involved, medical stores, companies, their respective documents including agreements, challans, invoices, payment details etc.

The FDA directive mandates Snapdeal to immediately withdraw offers for sale and exhibition of such drugs from its e-commerce sites and delist them, which the company has agreed to comply with.

The FDA has also ordered a search of Snapdeal’s offices and godowns in this connection.

Responding to the allegations, Snapdeal denied findings of any such restricted products at their fulfillment centre by the FDA team. Snapdeal, however, assured help to the FDA sleuths in their investigations.

An official spokesperson of Snapdeal said, “Though we periodically educate sellers on engaging in fair and safe sales on the platform and consequences of selling inappropriate products, at times sellers end up listing such products.”

“Upon being notified of any such products, we delist the products and take appropriate action against such seller. In this case, upon receiving the notice, we have delisted the products and provided all information to the FDA team”, he further added.

The FDA Commissioner also said that Flipkart and Amazon offices will also be investigated to ascertain whether they are also indulging in such activities, for which details are being sought.

Next Story

FDA Approves Device to Treat Heart Failure Patients

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics

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The US Food and Drug Administration has given approval for a new device that would help treat patients with life-threatening heart failure, and address an unmet need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

The Optimizer Smart system is comprised of several components, including an implantable pulse generator, battery charger, programmer and software. The pulse generator is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart.

After the device is implanted, a physician tests and programmes the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability.

The device would be beneficial for patients not suited to treatment with other heart failure devices such as cardiac resynchronisation therapy to restore a normal timing pattern of the heartbeat, the US FDA noted in a statement.

“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” said Bram Zuckerman, Director at FDA’s Centre for Devices and Radiological Health.

Photo Credit: www.medscape.com

“The FDA recognised the unmet need for these patients and worked with the manufacturer…to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Zuckerman added.

For the study, the US FDA evaluated data from two clinical trials with a total of 389 patients with moderate-to-severe heart failure.

All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant.

Also Read- Microsoft to Notify Users About End of Windows 7

The Optimizer Smart system improves quality of life and functional status of certain heart failure patients.

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics. (IANS)