Moderna would seek EUA in US for COVID-19 vaccine based on early data
If the interim readout is deemed by the independent safety committee as positive with 70 or 80 or 90 per cent efficacy, we will…
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Regulations/Policies
Dr Reddy’s announces settlement of Revlimid capsules patent litigation with Celgene in US
Celgene has agreed to provide Dr Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the US…
CDSCO asks Karnataka Drug Controller to grant Jan Aushadhi licenses to registered pharmacists only
Allows the state authority to take appropriate actions in this matter
UQC standardisation processes disturb pharma exports, experts raise concerns
On August 18, 2020, the commissioner of customs issued an advisory towards standardisation of UQCs for purposes of export/import…
Serum Institute receives DCGI approval to resume trials of Oxford COVID-19 vaccine
The DCGI has, however, put certain conditions like taking extra care during screening, providing additional information in…
Parliament passes Institute of Teaching and Research in Ayurveda Bill 2020
It will be an Institution of National Importance (INI) and will provide training of personnel in all important branches of…
Industry urges government to define, implement OTC regulations on priority
A draft report of OTC Drug regulations and the proposed OTC drug list have been submitted to the Drugs Consultative Committee…
Pfizer and BioNTech submit proposal to US FDA to expand COVID-19 vaccine trial
The companies expect that a conclusive readout on efficacy is likely by the end of October
Clinical trials of AstraZeneca-Oxford COVID-19 vaccine candidate resumes in UK
This is following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so
PNB Vesper gets DCGI nod to test proprietary drug PNB 001 in COVID-19 patients
A study will be conducted on 40 moderately-ill COVID-19 patients at BMJ Medical College, Pune who are on oxygen support
KSRPO asks government to bring in centralised drug enforcement department
Highlights need for uniformity in designations and functioning mechanisms of all state FDAs
DCGI instructs industry to follow defined pathways for application submission of rational FDCs
It gives six months to the manufacturers to submit the applications
DCGI issues notice to Serum Institute over AstraZeneca-Oxford COVID-19 vaccine trial suspension
If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocol, said SII in response to…
TN’s industrial policy shall offer specific higher incentives for sunrise sectors
Dr Neeraj Mittal, MD & CEO, Guidance, Industries Department, Government of Tamil Nadu showcases how the State is an ideal…
Kerala FDA raids premises of firm making illegal hand sanitisers
Officials seize materials, finished formulations and equipment worth Rs six lakhs
US FDA issues warning to Mylan for Telangana plant
It has also recommended the company to engage a cGMP Consultant
US FDA releases guidance to detect and prevent nitrosamines in drugs
It recommends steps, including a comprehensive risk assessment strategy and other actions
Plans to revamp D&C Act 1940, launch Sugam portal Version II: Dr Eswara Reddy
The CDSCO is also making a list of government facilities for R&D and innovation and will be making it available on their…
Only drug inspectors can probe, file FIRs for certain cognizable offences under D&C Act 1940:…
Industry experts and regulators appreciate judgement but seek clear SOPs for implementation
US FDA broadens EUA for Veklury (remdesivir) to treat all hospitalised COVID-19 patients
The expansion is supported by the FDA’s analysis of additional data from two randomised, controlled clinical trials that included…