Tuesday, June 25, 2019
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Cost raising exercise via QCO won’t cover all aspects of patient...

Bureau of Indian Standards (BIS) through the Department of pharmaceuticals (DoP) is in the process of finalizing a quality control mechanism for medical devices...............

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............

Exclusive vertical in CDSCO will check ‘garage manufacturing’, says MTaI

The Drugs Technical Advisory Board (DTAB) has proposed the creation of a vertical in CDSCO specifically for medical devices to enable the latter to regulate all medical devices sold in the country in phases....................

Top govt bodies hold workshop on regulatory compliance to accelerate innovations

The National workshop on regulatory compliance for accelerating innovations held on 9th April, at the Centre for Cellular And Molecular Platforms (C-CAMP), Bengaluru, was one of the six national programs planned across the nation.................

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...................

CDSCO’s notification on medtech regulations not as per industry’s aspirations: AIMED

Baffled to see the notification same evening in conflict with our discussion at the first meeting held by the Central Drugs Standard Control Organization regarding the “road map” for regulating the sale and manufacture of all medical devices, said Rajiv Nath...…...

MTaI supports CDSCO proposal on surgical gowns & drapes

Medical Technology Association of India says it is ready to work with CDSCO, member companies to ensure compliance................

Taking steps to strengthen drug regulatory system, says govt

Speaking in the Parliament recently, the Minister of State for Chemicals and Fertilizers, Mr Mansukh L. Mandaviya explained the various steps taken by the government during 2017 and 2018 so far to ensure effective regulation over quality of drugs...…..

DCGI amends rules, state drug controllers can now issue NOCs for...

Earlier any such order had to go through the scrutiny by the Central Drugs Standard Control Organization which now has been abolished to grant a sort of independent powers to state drug controllers...………….

AiMeD welcomes CDSCO’s proposed move to regulate high-end medtech equipment

While the Association of Indian Medical Device Industry has welcomed the Central Drug Standard Control Organisation's latest notification on inclusion of high-end medical equipment into Drugs and Cosmetics Act, 1940, the association has raised few demands......