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CDSCO DCGI FDA

CDSCO to enhance testing capacity for Medical Devices

The Drugs Controller General of India (DCGI) is in the process of enhancing capacity for testing medical devices in the country in...
Govt of India

Govt to relax norms for Medical Devices to register with CDSCO

In a relief to the medical devices industry, especially the micro, Small and Medium Scale Enterprises (MSME), the Union ministry of health...
FAQs

FAQs by CDSCO on Pharma, Cosmetics, MDR, Clinical Trial

Download FAQs by CDSCO on Pharmaceuticals, Cosmetics, Medical Devices and Clinical Trial
CDSCO DCGI FDA

CDSCO issues alert on these insulin pumps: Medical Devices

The Central Drugs Standard Control Organisation (CDSCO) has issued medical device alert on a series of insulin pumps and pump kits of...

Bharat Biotech submits Clinical Trial data to CDSCO for Covaxin in children

HYDERABAD: Bharat Biotech, which completed the Phase 2/3 trials of C-19 vaccine Covaxin for use in children under 18 years of age, has submitted the...
CDSCO DCGI FDA

CDSCO to start BA/BE studies registration process online from Oct 15

The national drug regulator will be switching the applications for registration of centres for bioavailability / bioequivalence (BA/BE) studies from the industry,...
CDSCO DCGI FDA

CDSCO makes application process for BA/BE study through online

In line with its efforts to digitise and streamline the regulatory submission procedures, the Central Drugs Standard Control Organisation (CDSCO) is switching...
DCGI CDSCO

CDSCO issues Guidelines for registration of Medical Devices

Guidelines for registration of Medical Devices Download the guidance: Medical devices in the Class A and B will...
CDSCO DCGI FDA

Isopropyl alcohol: CDSCO to make IP mandatory in Pharma

The Central Drugs Standard Control Organization (CDSCO) is planning to make Indian Pharmacopoeia (IP) mandatory for all isopropyl alcohol used in pharma...
CDSCO DCGI FDA

CDSCO fixes timelines for clearance of consignments at Port Offices

Download DCGI notice: In a bid to promote ease of doing business, the Central Drugs Standard Control Organization (CDSCO) has fixed timelines...
CDSCO DCGI FDA

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...
CDSCO DCGI FDA

CDSCO classifies over 400 Medical Devices under MDR Rule 2017

Download the classifications: The Central Drugs Standard Control Organisation (CDSCO) has announced classification of over 400 medical devices in various therapeutic segments,...
CDSCO DCGI FDA

J&J submits application to CDSCO for study of Covid-19 vaccine on adolescents

Johnson & Johnson has submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of its vaccine...
CDSCO DCGI FDA

CDSCO extends deadline to submit details of 19 FDCs permitted before 1988

The Central Drugs Standard Control Organisation (CDSCO) has extended the deadline till September 25, 2021 for the stakeholders to submit details of...
CDSCO DCGI FDA

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...
CDSCO DCGI FDA

CDSCO approves 12 laboratories for BA/BE studies

The Central Drugs Standard Control Organisation (CDSCO) has issued approval to 12 laboratories in the first six months of the year 2021,...
CDSCO DCGI FDA

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...
CDSCO DCGI FDA

CDSCO classifies 208 Medical Devices in various categories

The Central Drugs Standard Control Organisation (CDSCO) has announced classification of medical devices pertaining to rehabilitation, physical support, dermatology and plastic surgery...
CDSCO DCGI FDA

CDSCO grants permission to these 3 private C-19 Vaccines

The Central Drugs Standard Control Organisation (CDSCO) has granted manufacturing permission to private manufacturers for three corona virus vaccines for restricted use...
CDSCO DCGI FDA

Abbott gets CDSCO nod for FDC of Dydrogesterone + Estradiol

Abbott, the global healthcare company, has received approval from the Subject Expert Committee (SEC) at Central Drugs Standard Control Organisation (CDSCO) for...
CDSCO DCGI FDA

SII gets CDSCO nod for Clinical Trial of reduced inactivated salk Polio vaccine

Serum Institute of India (SII) has received approval from the Subject Expert Committee (SEC) at Central Drugs Standard Control Organisation (CDSCO) to...
CDSCO DCGI FDA

Lupin gets CDSCO committee nod for marketing Ranibizumab

Lupin Ltd has received marketing approval from the Subject Expert Committee (SEC) at Central Drugs Standard Control Organisation (CDSCO) for Ranibizumab.
Sugam Portal

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...
CDSCO DCGI FDA

CDSCO asks Philips India to discontinue these Ventilators

The medical devices and diagnostics division of the Central Drugs Standard Control Organisation (CDSCO) has asked Philips India Limited to discontinue continuous...

Latest posts

Govt releases draft policy for R&D, Pharma and Medical Devices

The Department of Pharmaceuticals (DoP) has come out with a draft policy to catalyse research and development (R&D) and innovation in pharmaceutical...

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