Industry positive about CDSCO’s move to digitalise regulatory approvals
Stakeholders share suggestions for a smooth transition
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Category
Regulations/Policies
NLEM 2020: Should patented drugs be included in it?
At the National Consultation Stakeholders meeting held in August for the revision of NLEM 2015, industry stakeholders requested…
NAFDAC blacklists Gujarat pharma firm, Mars Remedies
The firm has been blacklisted by the Nigerian agency for allegedly manufacturing substandard and falsified Ciprofloxacin 500 mg…
US FDA authorises phase 1 trial of ImmunityBio’s COVID-19 vaccine candidate hAd5
Ongoing development proceeding for oral, inhalational and intranasal administration of hAd5
TSHA-102 from Taysha gets rare paediatric disease and orphan drug designations for Rett syndrome
Taysha anticipates that it will submit an Investigational New Drug (IND) application for TSHA-102 to the FDA in 2021
US FDA issues warning letter to Shilpa Medicare for Jadcherla facility, Telangana
The company believes that the warning letter will have minimum impact of disruption of supplies and the existing revenues from…
Dr Reddy’s seeks DCGI approval for Phase 3 clinical trials of Sputnik V in India
The Indian pharma company has partnered with RDIF to conduct clinical trials Russian COVID-19 vaccine
EMA to review MAA for avalglucosidase alfa, enzyme replacement therapy to treat Pompe disease
The MHRA in the UK has granted Promising Innovative Medicine designation for avalglucosidase and US FDA has granted it…
Industry experts discuss regulatory roadmap for pharma industry
The stakeholders highlight the changes needed in the Indian regulatory system to meet changing demands, emerging concerns, at…
Panacea Biotec gets warning letter from US FDA for Baddi facility
The company informs that it is in the process of providing a thorough and comprehensive response to the USFDA within the statutory…
NPPA caps price of liquid medical oxygen and medical oxygen cylinders
The ex-factory price cap of LMO and oxygen gas cylinders will be applicable to domestic production
DGFT extends implementation date of track and trace for parent-child packaging to April 1, 2021
As per an earlier directive, it was scheduled for implementation from October 1, 2020
Future pharma policies will be aligned to India’s vision of attaining PICS membership: Navdeep Rinwa
The industry should design their facilities to comply with international regulatory requirements, he said
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…
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…