Beyond highly developed pharma markets! Wild card access to less explored, high entry barrier…
Sameer Kolhe, President, Maypharm Life Sciences highlights that COVID-19 brings some ‘challenging’ markets within reach for the…
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Browsing Tag
pharma regulations
KSRPO asks government to bring in centralised drug enforcement department
Highlights need for uniformity in designations and functioning mechanisms of all state FDAs
Only drug inspectors can probe, file FIRs for certain cognizable offences under D&C Act 1940:…
Industry experts and regulators appreciate judgement but seek clear SOPs for implementation
FDA publishes revised MAPP, Consolidation of ANDAs by the Office of Generic Drugs
This MAPP describes the process for reviewing and approving or denying requests to consolidate previously approved ANDAs submitted…
US FDA publishes compliance policy for quantity of samples retained for BA and BE studies
It applies only to the requirements for retention of reserve samples contained in 21 CFR 320.38(c)
D&C Act 1940 should be reframed: Pharma stakeholders
It needs to be updated to suit the industry's present scenario and growth prospects
Mission Atma Nirbhar in pharma
BR Sikri, Chairman, FOPE, highlights that the pharma sector is key to India’s economic progress and ensuring its self-reliance in…
Debate on GST for hand sanitisers continue, SKCDA seeks details from Karnataka FDA
The association has also written letters to different government authorities seeking clarity on the classification of hand…
In the pharma industry, technology has become a mandate for some compliances
Bino George, Director, Solution Consulting, Infor India, a global business cloud software solutions provider, explains how the…
Industry asks govt to take out minimum investment criteria from PLI scheme
Pharma stakeholders believe that this modification in the scheme will benefit the industry, patients and the nation in the long…