Manufacturing permissions after lapse of new drug status: A critical review
As per NDCT Rules under Rule 2 (w) subclause (v) "new drug" means, (v), shall continue to be new drugs for a period of four years…
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Guest Blogs
AI in pharma: Disruption, displacement, and a new digital dawn
Dr Rajendra Pratap Gupta, Chairman of the Academy of Digital Health Sciences and Former Advisor to the Health Minister of India,…
Kyasanur Forest Disease – How far is a regulatory approved vaccine?
Dr Priyabrata Pattnaik, Former Deputy MD, Indian Immunologicals, informs about the Kyasanur Forest Disease (KFD), a zoonotic viral…
Guaranteeing continuity of medicine supply through AI innovation
Whenever we speak of pharmaceutical innovation, we often focus on novel molecules or path-breaking therapies. The COVID 19…
AI and real-world evidence: The next frontier in clinical research
In the rapidly evolving world of clinical research, few developments hold as much promise—or provoke as much debate—as the…
Even pills ask you to diet and exercise, India must rethink its shortcut to health
Partner Biplab Lenin and Associate Anam Chowdhary, Cyril Amarchand Mangaldas highlight how CDSCO’s recent approvals for GLP drugs…
Beyond the PDF: Why biopharma’s communication must catch up with Its science
Tamanna Khanna, Co-founder of Agram Konnect, explains why biopharma must transform communication formats to match scientific pace…
The high cost of compromise: Why patient safety must come first
Dr Ranjit Barshikar, CEO – QbD International, United Nations Advisor cautions that India’s reputation as the ‘Pharmacy of the…
Pharma tariff bombshell: Navigating challenges, building resilience
Chakravarthi AVPS, International Trade & Business Relations Expert in pharmaceuticals, opines that for India Pharma Inc, the…
Cell therapy’s next chapter: Industry embraces in-vivo innovation
Nikhil C Bhanumathi, Principal Clinical Lead, Thermo Fisher Scientific highlights that Cell therapy is entering a bold new phase…
Driving innovation in India’s pharma R&D through cell and gene therapy
Saransh Chaudhary, President, Global Critical Care, Venus Remedies and CEO, Venus Medicine Research Centre highlights how…
Patent Rule Amendments 2024: Who gained who lost in amendment of FORM 27?
Essay relates to main amendments of 2024 relating to FORM 27, compares with erstwhile requirements to find out who gained and who…
GST 2.0 is a tailwind for India’s Nutraceuticals
The 56th GST Council has recommended a simplified structure with two principal slabs—5% and 18%, plus a 40% “demerit” slab for…
The myth of drug traceability in India
India launched a drug traceability programme more than a decade ago with the objective of stemming the flow of counterfeit…
Nostalgia or euphoria of past employment
Pharmaceutical industry provides opportunities very fast and people opt new employments very fast. In a professional journey…
Pharma outsourcing trends 2025: Partnership, precision, and resilience
Outsourcing plays a critical role in modern drug development and manufacturing – one which has gained increasing importance in…
Jan Vishwas Act 2025: Decriminalisation and penalisation of drug offences through compounding
Dr Suresh R Saravdekar, Former Assistant Director, Ministry of Medical Education & Research, Maharashtra & Honorary…
Technology-driven regulatory landscape
Ravi Sharma explains how technology is reshaping regulatory affairs, highlighting the growing role of AI, harmonisation efforts,…
Why pharma needs an HRMS built for continuous learning
In this article, Sonali Chowdhry highlights why the pharmaceutical industry needs a Human Resource Management System (HRMS)…
India levels up in solving complex drug formulation challenges
Chetan Shah highlights how India’s pharmaceutical industry is advancing from bulk drug production to complex formulations,…