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Govt to rectify Form CT-03 under the New Drugs and Clinical...

The Union health ministry will soon rectify Form CT-03 under the New Drugs and Clinical Trials (NDCT) Rules, 2019 to include Department...

CDSCO to remove 8 redundant compliances related to D&C Rules, MD...

To reduce and rationalize compliance burden for improving cost and ease of doing business, the Central Drugs Standard Control Organisation (CDSCO) will...

Govt to amend Rule 87 of Medical Devices Rule 2017

The Union health ministry will soon amend provisions of sale of notified medical devices as per Medical Device Rules (MDR)-2017 to effectively...

E-Pharmacies & OTC Drugs: High time for regulation

It is not an uncommon trend in India to self-medicate for minor bodily discomforts. The C-19 pandemic has in all probability only...

Appeal to DCGI to implement DCC guidelines on NSQ drugs: Pharma...

In a bid to protect drug makers from enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008, the small and medium...

DCC emphasizes need to regulate sale of Medical Devices

The Drugs Consultative Committee (DCC) has underlined the need to regulate sale and distribution of medical devices mandating registration of retail and...

Guidelines on post-approval changes in drugs: Sub-committee DCGI

The sub-committee, constituted by the Drugs Controller General of India (DCGI), has submitted the guidelines on post-approval changes in drugs to the...

Govt to amend Rule 123 w.r.t. Schedule K: D&C Rules 1945

The Union health ministry will soon amend Rule 123 of the Drugs & Cosmetics Rules 1945, and will add and delete certain...

Haryana asks govt to ban Aceclofenac for veterinary use

The Vulture Conservation Breeding Centre (VCBC), Haryana has recommended to the Union health ministry to ban non-steroidal anti-inflammatory drug (NSAID) aceclofenac for...

Oseltamivir & Zanamivir to be included in Sch-H1

The Union health ministry may revoke notification dated February 17, 2017 to allow export of drugs oseltamivir phosphate and zanamivir and these...

Govt to amend Sch V of D&C Rules regarding Vitamins

The Union health ministry is planning to amend provisions of Schedule V of the Drugs and Cosmetics (D&C) Rules, 1945 to ensure...

Urgent need to define OTC drugs regulation in India

Industry stakeholders express that there is an urgent need to define over the counter (OTC) drugs regulation in India and implement it...

OTC drugs regulations: Webinar

OPPI, IPA and FICCI organized a webinar on proposed over the counter (OTC) drugs regulations. KG Ananthkrishnan, Director General of OPPI and...

Mfrs to submit applications for CoPP as per DCC recommendation

In order to streamline the process of issuance of WHO-GMP Certificate of Pharmaceutical Products (CoPP) through a uniform procedure of review and...

Draft guidelines finalized on post-approval changes in drugs

Draft guidelines finalized on post-approval changes in drugs The Dr Venkateswarlu headed sub-committee, constituted by the Drugs Controller...

Sub-committee on post approval changes to pharmaceutical products: DCGI

The Drugs Controller General of India (DCGI) has constituted a sub-committee to frame guidelines on post approval changes to pharmaceutical products in...

Health Ministry directs SDCs to use common software to process grant...

Union Health Ministry has directed all the state drugs control authorities to start utilising common software platform (statedrugs.gov.in) to process application for...

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