Posts In: Pharmaceuticals

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...

Continue Reading

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...

Continue Reading

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...

Continue Reading

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...

Continue Reading

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...

Continue Reading

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...

Continue Reading

‘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...

Continue Reading

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 &...

Continue Reading

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 /...

Continue Reading

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...

Continue Reading