Posts In: Pharmaceuticals

CDSCO notifies that unit monitoring devices like digital thermometer and blood pressure monitor will fall under the purview of Drugs and Cosmetics Act, 1940; effective 01.01.2020

November 16, 2019 OPS, Pharmaceuticals, states 0

In a Notification dated 13th November, 2019 the Central Drugs Standard Control Organisation (“CDSCO”) has stated that, in addition to the devices specified in notification dated 3rd December,...

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Sale license for import of X-ray, MRI, PET, Ultrasound, CT Scan equipments will soon be exempted, says CDSCO

November 14, 2019 OPS, Pharmaceuticals, states 0

The Central Drugs Standard Control Organization (Medical Devices Division) (“CDSCO”) has by a notice dated 8th November, 2019 stated the requirement of an exemption from Drugs...

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MOHFW proposes to exempt drugs supplied to Health Functionaries like Community Health Officers, Nurses etc. attached to Primary Health Centres/ Health & Wellness Centres from certain provisions of the Drugs & Cosmetics Act

November 11, 2019 OPS, Pharmaceuticals, states 0

In a notification dated 6th November 2019 the Ministry of Health and Family Welfare has issued a draft amendment to the Drugs and Cosmetics Rules, 1945...

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All medical devices under the Drugs and Cosmetics Act and Medical Devices Rules to soon be covered under the ambit of “Drugs”; MOHFW issues a draft notification and invites comments and suggestions by 18th November, 2019

October 30, 2019 OPS, Pharmaceuticals 0

The Ministry of Health and Family Welfare (“Department”), through a draft notification dated 18th October 2019, has proposed to notify all the medical devices under Drugs...

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Effective 1st November, 2020, ultrasound equipment intended for external or internal use in human beings will be considered as a ‘drug’

October 23, 2019 OPS, Pharmaceuticals, states 0

The Department of Health and Family Welfare, through a notification dated 16th October, 2019, has specified Ultrasound equipment which is intended for external or internal use in human...

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Amendments underway to the Medical Device Rules, 2017; Department invites comments and suggestions within 18th November, 2019

October 23, 2019 OPS, Pharmaceuticals, states 0

This is a quick update to let you know that the Department of Health and Family Welfare, through a notification dated 18th October, 2019, has introduced...

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Ministry of Health and Family Welfare amends the Medical Devices Rules, 2017 ; confirms Central Licensing Authority to be the signatory for Form MD-10 ; effective 13.09.19

September 19, 2019 OPS, Pharmaceuticals, states 0

The Ministry of Health and Family Welfare (“Ministry”) through a Notification No. G.S.R. 652(E), dated 13th September 2019 has amended the Medical Devices Rules, 2017 (“Parent Rules”) by bringing...

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CDSCO advises all pharmaceutical Industry associations to request their members having the Pharmaceuticals and Bio-pharmaceutical manufacturing units to follow the Apprentices Act, 1961

September 11, 2019 OPS, Pharmaceuticals, states 0

The Central Drugs Standard Control Organization (“CDSCO”), has issued an advisory dated 24th August, 2019 advising all pharmaceutical Industry associations to request their members having the...

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NPPA clarifies that the Hospitals / Nursing Homes / Clinics are allowed to add trade margins on orthopaedic knee implants as per the prescribed rates

September 6, 2019 OPS, Pharmaceuticals, states 0

In a recent notification dated 13th August 2019 the National Pharmaceutical Pricing Authority (“NPPA”) has once again extended the timeline of ceiling price fixed for orthopaedic knee implants...

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CDSCO issues advisory on labelling requirements for Combi Kit of Misoprostol and Mifepristone tablets for Medical Termination of Pregnancy

August 23, 2019 Healthcare, OPS, Pharmaceuticals, states 0

The Central Drugs Standard Control Organisation (“CDSCO”) has, in a letter dated 9th August, 2019, instructed that the Combi kit of Misoprostol and Mifepristone tablets...

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