Page 5 - Drug Controller General Of India

Glenmark under fire for over pricing, 'misguided' claims of Covid-19 drug

NCP legislator Amol Kolhe's letter to Health Minister Harsh Vardhan triggers the DCGI to seek details from the Mumbai-based drugmaker

Glenmark gets DCGI notice over 'false claims', price of Covid drug FabiFlu

The 'subject' of the letter was stated as: "Regarding the false claims and pricing of tab FabiFlu 200 mg (favipiravir) by Glenmark Pharmaceuticals Limited, India"

Why vaccines can't be launched overnight

Under normal circumstances, the development of new vaccines and treatments could take 10-20 years

Pharma industry steps up to cure black marketing of Covid-19 drugs

Some firms are now considering starting their own distribution centres in major cities

Drug controller approves Biocon's psoriasis drug for emergency Covid-19 use

The firm presented the phase II clinical trial results to the drug regulator which were deliberated upon by the Subject Expert Committee of the DCGI's office

Mylan gets DGCI nod, to launch generic remdesivir at Rs 4,800 per vial

Mylan's version comes after two Indian drugmakers, Cipla Ltd and privately-held Hetero Labs Ltd, launched their generic versions of the drug

Covaxin, ZyCov-D trails mark 'beginning of the end' of Covid-19: Scientist

The article has been published on the websites of the Press Information Bureau (PIB) and the Vigyan Prasar, which is a body under the ministry

Covid-19 crisis: Made-in-India remdesivir may come by end of June

Currently, the drug is allowed for "restricted emergency use" on severely ill hospitalised Covid patients in India.

Maharashtra may procure remdesivir from Bangladesh to treat Covid patients

State government to procure 10,000 vials for Rs 12 crore

Russia backing antiviral drug Avifavir for Covid fight good news for India

Avifavir, described by its developers in Russia as perhaps the most promising anti-Covid-19 drug in the world, is derived from Favipiravir.

Covid-19: Pune-based drug firm to export favipiravir to 18 countries

Favipiravir is under trial in many countries as a potential treatment for Covid-19

Glenmark gets DCGI nod for clinical trials of potential Covid-19 drug

As per the clinical trial protocol approved, 150 subjects with mild to moderate Covid-19 will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care

Covid-19 treatment: AIIMS to conduct clinical trials of plasma therapy

The AIIMS director stresses on the need to have good and well-conducted research trials before the therapy is recommended for routine use

Govt sanctions Rs 1,850 cr to ensure better drug monitoring systems

A significant share of this money will go into upgrading the Sugam portal - the e-governance solution for CDSCO.

Drug controller cracks whip on e-pharmacies selling drugs without licences

Last December the Delhi High Court had said online sale of medicines without a licence was injuncted, and had instructed the government to ensure that the same was prohibited forthwith

GSK suspends sale of antacid Zinetac after USFDA issues advisory

Indian drugmakers have also started testing their ranitidine products at various laboratories after the US FDA issued an advisory on the drug to health care professionals

Submit licence application data within 45 days: DCGI

If the companies do not submit such information within 45 days, the DCGI would dispose of such application with the incomplete data