Posts In: Pharmaceuticals

‘Marketer’ of Drugs will soon be responsible for the quality of drugs as well as other regulatory compliances followed by manufacturer/s; Amendment proposed to the Drugs and Cosmetics Rules

June 26, 2019 OPS, Pharmaceuticals, states 0

In a Notification dated 24th June, 2019, the Ministry of Health and Family Welfare (“Ministry”) has published the Draft Drugs and Cosmetics (…. Amendment) Rules, 2019...

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BIS rolls out new IS standard for Medical Devices; Implementing new IS standards are expected to make Organizations more compliant with the essential principles of Safety and Performance / Quality Management System requirements

The Bureau of Indian Standards (“BIS”) has published a new standard IS 23485 Medical Devices – Quality Management System requirements and Essential Principles of safety &...

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CDSCO releases Form for reporting Medical Devices Adverse Event ; designed to be used voluntarily by Manufacturer / Importer / Distributor of Medical Devices, Healthcare Professionals having knowledge of such adverse events

The Central Drugs Standard Control Organization has, recently released a Form for reporting Medical Devices Adverse Event (“MDAE”) designed to be used voluntarily by Manufacturer /...

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CDSCO issues a list of spurious, adulterated, misbranded, or not of standard quality drugs and devices for the month of April, 2019

May 16, 2019 OPS, Pharmaceuticals, states 0

The Central Drugs Standard Control Organization (“CDSCO”) in their official website has published a list of drugs, medical devices and cosmetics that have been declared as spurious...

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CDSCO directs applicants to upload applications through SUGAM Portal as per the New Drugs and Clinical Trial Rules, 2019

April 13, 2019 OPS, Pharmaceuticals, states 0

The Central Drugs Standard Control Organization, 2019 has released a circular dated 10th April, 2019, with regard to uploading of applications through SUGAM Portal in...

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Ministry of Health and Family Welfare has added ‘organ preservative solution’ as a drug under Drugs and Cosmetics Act, 1940

April 4, 2019 OPS, Pharmaceuticals, states 0

The Ministry of Health and Family Welfare, in a recent notification dated 2nd April, 2019 has added “Organ preservative solution” as a drug for external or internal use...

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Ministry of Health and Family Welfare notifies New Drugs and Clinical Trials Rules, 2019; effective 19th March, 2019

March 28, 2019 Pharmaceuticals 0

This is a quick update to let you all know that the Ministry of Health and Family Welfare, has notified the New Drugs and Clinical Trials...

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Department of Biotechnology proposes the first ever ‘Guidelines for Evaluating Nanopharmaceuticals’; it is expected to ensure quality / safety / efficacy of use nanotechnology in the pharmaceuticals industry

March 25, 2019 OPS, Pharmaceuticals, states 0

Department of Biotechnology, Government of India and Indian Society of Nanomedicine have jointly prepared the Guidelines for Evaluation of Nanopharmaceuticals in India. This is to...

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Amendments likely to the Drugs and Cosmetics Rules; Labelling requirements to change in Form on ‘Conditions for Grant of Approval ’ and ‘Permission to import Finished Formulation & manufacture of new drug’

March 20, 2019 OPS, Pharmaceuticals, states 0

The Ministry of Health and Family Welfare has on 6th March, 2019 proposed changes in Drugs and Cosmetics Rules, 1945 which will impact Form 45 and 46 of...

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CDSCO has listed Drugs, Medical Devices and Cosmetics declared as not of standard /quality /spurious/ adulterated /misbranded for February, 2019

March 15, 2019 OPS, Pharmaceuticals, states 0

The Central Drugs Standard Control Organization (“CDSCO”) has recently released, on their website, a list of drugs, medical devices and cosmetics declared as not of standard /quality...

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