Monday, June 17, 2019
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CDSCO issues alert on Medtronic’s pacemakers, company says no product recall

The CDSCO has advised patients with specific pacemakers from Medtronic to seek immediate medical assistance if they feel dizzy, light-headed, severe short breath or loss of consciousness. Meanwhile, the company has said it is in talks with the regulator............

Govt notifies new rules for clinical trials, ISCR hails the move

Aimed at reducing the market entry of drugs in India, the ones approved for use in European countries and the United States will be allowed in the country if the Indian patients are included in the earlier trials held abroad...................

In a first, DCGI approves clinical trials for plastic surgery and...

The government for the first time has given approval to a chain of dermatology and plastic surgery centres for conducting clinical trials and drug development for skin, hair and other plastic surgery medications, cosmetology and cosmetic surgery devices in India...…………...

DCGI approves Brintellix in India for major depressive disorder

Lundbeck India has announced the launch of Brintellix (Vortioxetine), a novel multimodal antidepressant, which has been specifically designed to inhibit serotonin reuptake and modulate serotonergic receptor activity of the neurons in the brain of affected patients...…………...

MTaI’s seminar educates MedTech professionals on new European medical device rules

While speakers from DuPont educated audience on new rules in Europe, the regulatory experts present at the seminar agreed that the medical device regulations are changing steadfastly around the world and many of these new guidelines will impact packaging...……..

DCGI to discuss drug tracking mechanism with pharma firms on 25th...

The Drug Controller General of India will be discussing the introduction of trace and track mechanism for top 300 drug brands that are sold in India with representatives of 66 pharmaceutical companies..............

DCGI’s proposal for introducing unique code to drug packs gets nod...

The Drug Controller General India (DCGI) has proposed to introduce a unique code on drug packs whether it is a bottle, strip or vial to ensure the authenticity of the medicine.............

International Clinical Trials Day Special: Can Indian clinical research industry regain...

There was a time when India was set to be the biggest market for CRO business but then few incidents, bad press and tight regulations made it almost irrelevant. However, looks like there is still a hope for the industry. An analysis............

“Clinical research environment is improving at a decent pace”

Mentioned Dr Renu Razdan, Senior Vice President, JSS Research in her exclusive interaction with the BioVoice News, where she expressed her views on the clinical research scenario in India besides sharing few updates on her company's latest operations.................

No need to fear the regulator: DCGI

Calling upon the industry members to approach the Central Drugs Standard Control Organization (CDSCO) for any complaint or resolving of issues, the Drug Controller General of India, Dr S Eswara Reddy has informed that a special cell has been created to take care of it..............