Leiutis marks global milestone with CDSCO approval for Synthetic Cannabidiol Oral Solution for mild…
Leiutis Pharmaceuticals LLP has announced that the Central Drugs Standard Control Organisation (CDSCO) has granted regulatory…
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Regulations/Policies
Centre notifies Drugs (Seventh Amendment) Rules, 2026
Expands Schedule H2 to include vaccines, antimicrobials and anticancer drugs
NPPA integrates Pharma Jan Samadhan with Pharma Sahi Daam portal
The unified platform enables users to check the prices of scheduled and non-scheduled medicines and lodge complaints related to…
CDSCO clarifies regulatory pathway for formulation intermediates
According to the circular, formulation intermediates intended for use in modified-release dosage forms, including sustained…
India is well on its path to strongly push back the perception battle of quality
As we mark International Clinical Trial Day today, Dr Seema Pai, President, ISCR explains to Viveka Roychowdhury why it is…
Clinical exclusivity for indigenous medicines can improve long-term affordability and access
Nikkhil Masurkar, CEO, Entod Pharmaceuticals opines that in the absence of clinical data exclusivity, competitors may obtain…
SPDS hosts Dissolution Science Programme for FDA inspectors
The Society for Pharmaceutical Dissolution Science (SPDS) conducted a highly interactive value-adding programme on Dissolution…
Pharma tariff bombshell: Navigating challenges, building resilience
Chakravarthi AVPS, International Trade & Business Relations Expert in pharmaceuticals, opines that for India Pharma Inc, the…
Trump imposes 100 per cent tariff on patented drugs; impact on India to be limited
Industry experts weigh in on the latest tariff move. They highlight limited near-term disruption but caution about long-term risks…
FDA’s curb on overseas cell processing to hit smaller cell and gene therapy companies:…
Regulators haven’t specified how many trials are affected, though therapies like CAR-T, which sometimes use overseas manufacturing…
48 Projects approved under the PLI Scheme for promotion of domestic manufacturing of KSMs/ DIs and…
Production Linked Incentive Scheme aims to avoid disruption in supply of critical active pharmaceutical ingredients (APIs) used to…
Govt provides update on schemes implemented in the pharma sector
The PRIP scheme has been launched with an outlay of ₹ 5,000 crore to transform India’s Pharma MedTech sector
FOPE, PharmaState Academy, complete one year of the PULSE program
Session 23 focused on Manufacturing under Loan License or Contract in light of the Revised Schedule M Guidelines
Beauty, boosters and the law: Who’s watching India’s wellness market?
Biplab Lenin, Partner; and Anam Chowdhary, Associate, Cyril Amarchand Mangaldas, stress that regulatory vigilance on the…
Addressing US FDA challenges in Indian sterile drug manufacturing – Part 3
In this final instalment, Manish Bhatkar, Founder & CEO, RedLotus Pharmtech, transitions from analysis to action. Drawing on…
Addressing US FDA challenges in Indian sterile drug manufacturing – Part 2
In this second part, Manish Bhatkar, Founder & CEO, RedLotus Pharmtech continues the discussion on FDA expectations, with…
Pharma and medtech marketing: Navigating the imminent disclosure deadline
Kunal Gupta, Partner, White-Collar Crime Practice and Sahil Bansal, Counsel - White-Collar Crime Practice, Trilegal stress that…
7 common compliance issues faced by the pharmaceutical industry in India
Mahesh Krishnamoorthy, Managing Director, Core Integra stresses that compliance in pharma is non-negotiable; highlights seven key…
US drug pricing order – Implications for India’s pharma sector
Ravi Shah, Partner, Cyril Amarchand Mangaldas explains that while the policy is designed to cut costs for US patients, its effects…
CDSCO issues compliance framework for SEZ-to-DTA drug transfers
New circular standardises licensing pathway for domestic diversion of SEZ-manufactured drugs; however system-level changes raise…