Complying with DPDP 2023
Diwakar Dayal, Managing Director & Country Manager at SentinelOne explains the provisions of the Digital Personal Data…
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Regulations/Policies
MoHFW announces revised Schedule M under the Drugs (Amendment) Rules, 2023
Small and medium manufacturers with an annual turnover of less than Rs 250 crore have 12 months to comply with the guidelines,…
Lex Witness to host 9th Annual Pharma Legal & Compliance Summit 2023 in Mumbai
The summit is scheduled for December 8, 2023 at the Courtyard by Marriott, Mumbai, Andheri East
Health Ministry releases draft National Pharmacy Commission Bill, 2023
It seeks to repeal the Pharmacy Act of 1948 and replace the Pharmacy Council of India with a national commission
NPPA slashes prices on 33 FDCs drugs
This move affects pharma companies like JB Chemicals, Eris Lifesciences, Zydus Healthcare, Cipla, Sun Pharma, Sanofi India, and…
Dr Mansukh Mandaviya launches national R&D and Innovation Policy and PRIP scheme
The scheme will focus on transforming India into a high-volume, high-value player in the global market of pharmaceuticals, meeting…
NCLAT validates insolvency resolution process in Hindustan National Glass case
Recognises AGI Greenpac's acquisition of HNG
DCGI issues advisory about Digene Gel following Abbott’s voluntary recall
The advisory instructs healthcare professionals to promptly report any suspicious cases of adverse events linked to this product
US FDA places partial clinical hold on Gilead’s studies on Magrolimab for AML treatment
The FDA action follows the previously announced discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk…
Industry backlash may reshape EU compulsory pharma licensing reform: GlobalData
Both Johnson & Johnson and Pfizer criticised the changes by referencing the positive role of patents in incentivising their…
Pharma to face more pricing pain as new legislation expands scope of Inflation Reduction Act:…
Any successful legislation that builds off from the Inflation Reduction Act could signal further policy changes for US drug…
143 pharma companies get show cause notices from CDSCO post inspections
Mansukh Mandaviya, Union Health Minister divulged this information in a written reply to a question in Rajya Sabha
WHO flags Cold Out cough syrup over higher limits of diethylene and ethylene glycol
The batch had 0.25 per cent of diethylene glycol and 2.1 per cent of ethylene glycol, when the acceptable safety limit for both is…
Marksans announces completion US FDA PADE inspection
The inspection was conducted at its Goa, Verna manufacturing facility from July 31, 2023 to August 4, 2023
Ten stakeholders write to Health Minister to recall New Drugs, Cosmetics & Medical Devices Bill
They call for a consultation meeting with a fresh committee under the Chairmanship of ICMR/DST/DBT and key stakeholders for…
Centhaquine set to enter US-FDA approved Phase 3 clinical trial in US and Europe
Pharmazz India obtained marketing authorization for the management of Hypovolemic shock Lyfaquin (INN: Centhaquine) in India in…
Lupin gets EIR from US FDA for Pithampur Unit-2 facility
The EIR was issued post the last inspection of the facility conducted from March 21-29, 2023
USFDA inspects JB Pharma’s manufacturing facility at Panoli, Gujarat
The facility received no observations and no Form 483 was issued
CCI clears Edelweiss-Biocon Biologics deal
The deal has been cleared under the green channel route
How will green chemistry transform the future of pharma manufacturing
Implementing green chemistry in pharma manufacturing can reduce waste and pollution, improve efficiency, and promote…