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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...
Sugam Portal

Submit applications for Form 41 & Form 10 on Sugam Portal: CDSCO

In order to streamline the regulatory submission procedure, the Central Drugs Standard Control Organisation (CDSCO) has directed all State Licensing Authorities (SLAs)...
Sugam Portal

Maha FDA to sensitise mask mfrs for Regn on Sugam portal

In order to raise compliance to medical device norms, the Maharashtra Food and Drug Administration (FDA) is planning to sensitise mask manufacturers...
Sugam Portal

Sugam portal Version II to launch to revamp Drugs Act: CDSCO

The Central Drugs Standard Control Organisation (CDSCO) is in the process of strengthening the functioning mechanism of...
Sugam Portal

Health ministry to sensitises manufacturers on SUGAM portal

The Union health ministry will be organizing various workshops this year to sensitise drug and medical device manufacturers to upload details on...
Stethoscope Doctor Medical Devices Doctor

Applications of non-notified Medical Devices through SUGAM Portal only: CDSCO

The Central Drugs Standard Control Organization (CDSCO) has directed manufacturers and state drug controllers (SDCs) to process applications of non-notified medical devices...
Sugam Portal

CDSCO Invites Suggestions To Improve Sugam Portal

In order to promote digital India and ease of doing business, the Central Drugs Standard Control Organisation (CDSCO) has asked for suggestions...
USFDA

USFDA gives tentative nod to Gland Pharma for generic muscle relaxant drug

Gland Pharma Limited, a generic injectable focused pharmaceutical company, received tentative approval from the United States Food and Drug Administration (USFDA) for...
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...
Job

Govt Job for M.Pharm, M.Sc as Project Coordinator at ICMR

The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical...
DCGI CDSCO

DCGI directs API manufacturers to submit applications online

The Drugs Controller General of India (DCGI) has directed bulk drugs manufacturers to submit applications online of already issued valid Written Confirmation...
Bp Apparatus, Medical Devices

Procedure to obtain license for manufacturing of Medical Devices

Medical devices - Manufacturing license In India, at present only notified medical devices are regulated as Drugs under...

A salute to women caregivers

India has over 4 million people living with dementia and more than 70% of caregiving responsibility falls on women caregivers. However, juggling between roles of...
USFDA

Unichem gets tentative USFDA nod for drug to treat Diabetes

Unichem Laboratories has received tentative approval for ANDA of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the United...
DCGI CDSCO

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,...

Rs 10 crore fine imposed on Pharma Company: NGT

The National Green Tribunal (NGT) has slapped a penalty of Rs 10 crore on a pharmaceutical manufacturing company in Amroha district of Uttar Pradesh...
CDSCO DCGI FDA

Latest Circulars, Notices & Guidelines: CDSCO, DCGI

Download latest Circulars – CDSCO, DCGI Download latest circulars: Govt of India, DCGI, Health Ministry, ICMR issues notices...
Cosmetics

DCGI extends deadline to submit documents for Import & Regn. of Cosmetics

As the situation arising out of the C-19 pandemic is worsening further in the country, the Drugs Controller General of India (DCGI)...
DCGI CDSCO

Online National Drug Licensing system from April 15: DCGI

To bring uniformity, traceability and accountability in evaluation and disposal of licenses, the Drugs Controller General of India (DCGI) has directed state...
CDSCO DCGI FDA

CDSCO gives this direction to stakeholders involved in Clinical Trial

The Central Drugs Standard Control Organization (CDSCO) has directed all stakeholders involved in clinical trials (CT) for online submission of serious adverse...
DCGI CDSCO

DCGI: Deadline extended – Import and Regn of cosmetics

The Drugs Controller General of India (DCGI) has further extended deadline by 4 months or till normalization of C-19 scenario to submit...
CDSCO DCGI FDA

Recall batches of rapid antigen IVD kits of these Cos: DCGI to SLAs

The Drugs Controller General of India (DCGI) has directed all state licensing authorities (SLAs) to recall batches of rapid antigen in vitro...
FDA

Maha FDA detects 167 cases of price violations of masks

Based on the special drive led by Maharashtra Food and Drug Administration (FDA) Commissioner Abhimanyu Kale, around 167 cases of price violations...

Latest posts

NPPA releases draft of retail price calculation for 5 formulations

The National Pharmaceutical Pricing Authority (NPPA) has released draft version of proposed retail price calculation for five formulations, including a combination of...

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