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DCGI grants EUA to Hetero’s Biosimilar Version of Tocilizumab

India, Hyderabad: Hetero announced today that the Drug Controller General of India (DCGI) has issued for restricted use, Emergency Use Authorization (EUA)...

India has the best digital friendly regulatory system: DCGI

India is having one of the best, easiest, very digital friendly and most competent Good Regulatory Practices (GRP)-driven regulatory systems in place...

Granules India gets license from DRDO for Covid drug 2-DG

Granules India yesterday said it has received licence from Defence Research and Development Organisation (DRDO) to manufacture and market COVID-19 treatment drug,...

DCGI asks State FDAs to restrict Tolperisone FDC for these usage...

Download DCGI's letter dated 01-09-2021 The Drugs Controller General (India) has asked the State drug controllers to restrict the...

DCGI gives nod for Vaccine’s phase-II/III trials on kids aged between...

The Drugs Controller General of India (DCGI) yesterday granted permission to Hyderabad-based Biological E to conduct phase-II/III clinical trials of its ‘Made...

DCGI approves 3 FDCs containing Cefixime & Cefadroxil as rational

Download DCGI's latest Notices: The Drugs Controller General (India) has allowed three fixed dose combinations (FDCs) as rational with certain conditions.

CDSCO issues procedure for regulation of 19 FDCs out of 294

Download DCGI's latest Notices: The Central Drugs Standard Control Organisation (CDSCO) has issued a procedure for regulation of 19 fixed dose combinations...

India gets its 1st Vaccine for Children above 12

Indigenously developed Zydus Cadila C-19 vaccine ZyCoV-D has received approval for Emergency Use Authorisation from the Drug Controller General of India (DCGI)...

Nasal Vaccine gets DCGI nod for Phase II, III trials: Bharat...

The first nasal vaccine against C-19, developed by Bharat Biotech, has received the DCGI’s nod for conducting phase-II and -III clinical trials,...

Track and Trace mechanism for Pharmaceutical Products

Expressing its concern on the rising incidences of spurious and adulterated drugs in India, the Department related Parliamentary Standing Committee on Commerce...

CDSCO issues clarification on Regn Certificate issuance under Cosmetics Rules 2020

The Central Drugs Standard Control Organization (CDSCO) has clarified vide CDSCO Notice dated 06-08-2021 that those who want to apply for the...

DCGI classifies 135 Ophthalmology, 51 respiratory Medical Devices

The Drugs Controller General (India) has classified 135 medical devices related to ophthalmology under the provisions of Medical Devices Rules, 2017.

CDSCO to regulate Cosmetic products like skin patches

The Central Drugs Standard Control Organisation (CDSCO) may take steps to regulate the products like skin patches which are being used as...

Traders seeks removal of exemption for Doctors under Schedule K

The Uttar Pradesh Pharma Traders Association has urged the Union health ministry to remove exemption given to registered medical practitioners to stock...

DCGI: Already approved drugs is New Drug, if certain changes occur...

The Drugs Controller General (India) has said that certain changes in the active substance of an approved drug may lead to change...

Virtual workshops series to be organized on GMP

The Ministry of Health, along with the Ministry of Chemicals and Fertilizers, the World Health Organization (WHO), the Indian Pharmaceutical Alliance and...

Vaccine for Kids to be available soon: Govt

The Union government on Friday told the Delhi high court that C-19 vaccines for children below the age of 18 years will...

DCGI classifies 112 Anesthesiology Medical Devices

The Drug Controller General (India) has classified 112 medical devices related to anesthesiology, which is used in taking care of a patient...

Serum Institute to start Mfg Sputnik vaccine in September

Serum Institute of India (SII) will start production of Sputnik vaccine at the company’s facilities in September, Russian Direct Investment Fund (RDIF)...

Hetero seeks EU Authorisation from DCGI for Molnupiravir

HYDERABAD: The Hyderabad-based Hetero Drugs announced interim results from Phase III clinical trials of Molnupiravir in treatment of mild C-19 patients on Friday,...

Webinar held on Investigational skills for Drug regulators of India

With a view to empower the investigational skills of Drugs Regulatory Officers across India, DCO India-Drugs Control Forum organised a webinar on...

Mankind Pharma gets DRDO nod to make and market 2-DG

Mankind Pharma said it has received the licence from the Defence Research and Development Organisation (DRDO) to manufacture and market oral 2-deoxy-D-glucose...

CDSCO to API units: To file online applications on Sugam Portal

The Central Drugs Standard Control Organisation (CDSCO) has directed active pharmaceutical ingredient (API) manufacturers to file online applications for issuance of written...

NPPA fixes price of drug for the treatment of Black Fungus

The National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price of antifungal drug Amphotericin B (emulsion) injection 50mg at Rs. 3,136.81...

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