US FDA raises concerns over production processes at the US unit of Wockhardt
US FDA has already banned the import of generic drugs from its two plants in India
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Issues with recent changes to clinical trials regulations
Bhavik Narsana, Partner, Sameer Sah, Principal Associate and Arijeet Mukherjee, Associate, Khaitan & Co aim to identify the…
Advantages and challenges of AV recording in clinical trials
Dr YK Gupta, Head Department of Pharmacology and Spokesperson AIIMS, and Lt Col (Dr) Prafull Mohan, Senior Resident, Department of…
Denied a chance of a cure
15 year-old Nidhi Shirol, who has Pompe Disease, receives life saving enzyme replacement therapy free of cost, but cannot be part…
Putting cancer on trial
Clinical trials are sometimes the only option for cancer patients to access newer drugs when standard treatment has been…
Speeding up tri@ls
Patients have so far been recruited for trials by sponsors or CROs. However, the social media bandwagon offers an interesting…
Consent by camera: When visuals dont tell the full story
The regulator has mandated AV consents as superior to the written process in terms of generating more tamper-proof evidence and…
Patient recruitment: A paralysed process?
Despite enormous patient pool availability at low cost, CROs are still battling with issues in patient recruitment for clinical…
My doctor hero
The issue of post trial access to investigational drugs has not seen as much debate in India. Express Pharma presents the…
Arvind Remedies signs MoU with SRM University, Kattankulathur, Tamil Nadu
To launch new drugs for diabetes and coronary heart disease