CDSCO shall process the application for manufacturing/import of new drugs within 7 working days

The Central Drugs Standard Control Organization(CDSCO) vide its notification dated 20th February 2020 has directed all state drug controllers to give bioavailability-bioequivalence (BA/BE) study approvals for export and also approvals for manufacturing, import of new …

CDSCO issues clarification on applicability on New Drugs and Clinical Trial Rules, 2019

CDSCO has issued clarification regarding applicability and the processing of application for grant of permission to manufactures under New Drugs and Clinical Trial Rules, 2019.

Medical devices which are notified as drugs to be mandatorily registered under The Medical Devices Amendment Rules, 2020

Medical devices which has been notified as “Drug “ shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organization.

DGFT Prohibits the export of personal protective equipment.

The Directorate General of Foreign Trade in its Notification dated 31st January, 2020, has banned the export of all varieties of personal protection effective from date of publication of the order.

MOHFW notifies import of oxytocin reference standards exclusively for test and analysis.

The Ministry of Health and Family Welfare vide notification dated 27th January, 2020, issued amendment to the Drugs and Cosmetics Act, 1940 by which the Oxytocin reference standards is permitted to be imported exclusively for …

The High Court of Judicature at Patna (HC) orders the closure of all illegal laboratories, Diagnostic centers, Clinics & Nursing homes in the State

The High Court of Judicature at Patna (HC) has passed Judgement on 09-12-2019, ordering the closure of all pathological laboratories, Diagnostic centers, Clinics and Nursing homes which has developed illegally in the State of Bihar. …

CDSCO Issues notification on processing of application for product approved as medical device

The Central Drugs Standard Control Organization in its Notification dated 15th November 2019 has issued an Office Memorandum directing that the processing of application for product approved as medical device in the country of origin …

Haryana government mandates hospitals to notify the health department about the cases of Influenza A H1N1

The State Government of Haryana in its Notification dated 19th November 2019 has published the Haryana Epidemic Diseases, Influenza A H1N1 Regulation, 2019, under which all hospitals are obligated to report to health department about, …

Digital thermometer, BP monitoring devices to come under regulation from January 1, 2020

The Central Drugs Standard Control Organisation In its notification dated 13th November 2019, has brought in devices that are used to monitor temperature or blood pressure under new medical device Rules, 2019 effective from 1st …

The Central Drugs Standard Control Organization soon to exempt sale license on import of high tech equipment’s

The Drugs Controller General of India (DCGI) is planning to recommend Drug Technical Advisory Board (DTAB) to exempt drug sale license for import of high tech equipment like X-Ray, MRI, PET, Ultrasound and CT Scan …

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