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Indian Society for Clinical Research to host 13th annual conference in...

The conference will be focused on ‘Beyond New Regulations- Increasing Participation and Enhancing Patient Safety’. While Dr V G Somani, Drug Controller General India, CDSCO, to be the Chief Guest, Dr Gagandeep Kang, Executive Director, THSTI will deliver late Prof Ranjit Roy Chaudhury Oration........................

CDSCO approves CoSara Diagnostics’ five test kits for TB, Hepatitis B...

CDSCO approval was granted following the completion of the CoSara manufacturing facility and a comprehensive inspection of the location, presentation of the technology, quality system, procedures, product validation data and performance evaluation by an independent NABL & CAP accredited laboratory..........

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...…..