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Changing the Regulations for Class A Medical Devices and its Impact

The Govt. of India issued a draft notification GSR 710(E) on September 20th, 2022, and gave just 7 days’ time to the...

CDSCO Panel gives nod for FDC Bempedoic Acid Plus Atorvastatin Calcium

New Delhi: Exemed Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO)...

Govt notifies draft Rule to exempt these Medical Devices from licensing...

Download notification No. GSR 710(E) dt 20-09-2022, link is given below: The Ministry of health and family welfare (MoHFW) has issued a...

Govt is in final stage to cap margins of key medicines

New Delhi: The government is in the final stages of introducing trade margin rationalization (TMR) on about 100 odd pharmaceutical formulations, people aware of...

Drug alert: 45 out of 1330 samples declared as NSQ in...

Download the list of NSQ samples for August 2022, link is given below: The Central Drugs Standard Control Organisation (CDSCO) has declared...

Panel recommends a separate legislation for Medical Devices

Even as the Centre has indicated its plans to have a single Act for pharmaceuticals, medical devices, and cosmetics through a new...

CDSCO classified Non-sterile, Non-powered, Hand-held Surgical Instruments

Download the classification of medical devices dated 09-09-2022, link is given below: The Central Drugs Standard Control Organisation (CDSCO) has issued a...

CDSCO approves intra Nasal Vaccine for C-19 in adults

The Central Drugs Standard Control Organisation (CDSCO) has issued restricted emergency use approval to Bharat Biotech’s recombinant nasal vaccine for primary immunization...

Drug Rules 1945 amended to allow parallel submission of manufacturing &...

Download notification No. GSR 654(E) dt-24-08-2022: The Union ministry of health and family welfare (MoHFW) has issued the final notification amending the...

CDSCO panel wants justification on Protocol Amendments on Trail of Imlunestrant

The Subject Expert Committee (SEC) operating under the Central Drug Standard Control Organization (CDSCO) has advised the company to present the protocol...

Dr VG Somani to continue as DCGI for next three months

The latest notification from the Ministry of Health and Family Welfare has notified that Dr. V G Somani will continue to hold...

Drug alert: 53 out of 1337 samples declared as NSQ in...

Download the list of NSQ samples for July 2022, link is given below: The Central Drugs Standard Control Organisation (CDSCO) has declared...

9th edition of Indian Pharmacopoeia released: Details

9th edition of Indian Pharmacopoeia released The Indian Pharmacopoeia Commission (IPC) launched the ninth edition of the Indian...

Govt is set to ban Codeine-based Cough Syrups and formulations

The government is set to ban popular codeine-based cough syrups and formulations following concerns raised by MPs recently about their misuse of...

7,700 drug samples declared not of standard quality

New Delhi: A total of 7,700 samples of drugs were declared not of standard quality (NSQ) and another 670 were declared spurious...

CDSCO issues alert on Blood Purification Device hemoperfusion cartridge

The Central Drugs Standard Control Organisation (CDSCO) has issued a medical device alert on Baxter Healthcare’s Absorba Hemoperfusion Cartridge 300 C and...

No extension in deadline for registration of Medical Devices

New Delhi: The majority of the medical devices in India will come under the licensing regime from October 1, as notified by the central government, with...

CDSCO panel gives nod to study Dupilumab with these conditions

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to pharmaceutical...

CDSCO releases draft guidance documents on IVD Medical Devices

Download the draft guidance documents, links are given below: As part of its efforts to bring all the medical devices under the...

Quality certificates of Medical Devices by other entities not a replacement...

Download DCGI Notice dt 11-07-2022 Regarding Licensing of Class A and Class B Medical Devices: The drug regulator has said that the...

Drug alert: 26 out of 1096 samples declared as NSQ in...

Download the list of NSQ samples for June 2022, link is given below: The Central Drugs Standard Control Organisation (CDSCO) has declared...

DCGI approves India’s first mRNA vaccine against C-19

Gennova Biopharma announced that its mRNA vaccine – Gemovac-19 – against C-19 has received the Emergency Use Authorisation (EUA) from the office...

Medical device alert: CDSCO issues alert on batches of peripheral stent...

Download the Medical Device Alert dated 21-06-2022: The Central Drug Standard Control Organisation (CDSCO) issued a medical device alert on 21-06-2022 on...

Bar code or QR code: Govt issues draft Rule to mandate...

Download notification No. 448(E) dated 14-06-2022, link is given below: Centre has issued a draft Rule vide notification No. 448(E) dated 14-06-2022,...

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