Balancing MAGA and MIGA
While the PILLS Act, aims for “strategically incentivising reshoring of essential medicines” to the US, India Pharma Inc cannot do…
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Editor’s note
Trumping the Budget blues?
Perhaps the uncertainty of the Union Budget pales before the changes that US President Trump will make as he gets down to business…
2025: A year of stricter rules, course corrections?
Will 2025 see a more vigilant government when it comes to violations by pharma companies, be it GMP slip ups or the Uniform Code…
30 years and counting …
The pharma industry has breached many barriers, but we have miles to go before we can rest on our laurels
The quest for quality continues
It is considerably more difficult to live up to these professed codes of conduct off stage, as it needs to flow right from the…
Compliance, competition could be speed breakers
As India positions itself as part of the China+plus one strategy, China has a counter strategy: dumping of low cost imports and…
FDC ban exposes fault lines once again
Putting the patient first, before granting licences seems the solution
Finding the right balance for nutraceuticals
If nutraceuticals shift from FSSAI to CDSCO, they will also come under price control. While this is good for consumers, industry…
Revised Schedule M audits to test will, skill of regulators and regulated
As the US FDA raises quality expectations, investigations into its inspection practices are being closely watched by biopharma…
CDSCO cracks down on export licenses, antibiotic approvals
Can online courses and training programmes guarantee more effective regulation and better quality medicines?
Some action points for the next PM
As we vote in our next set of policymakers, a reality check shows that while the pharma sector in India has come a long way,…
A step towards global harmonisation of GMP inspection protocols
Linking purchase of electoral bonds to inaction on questionable quality standards is yet another warning to all pharma companies…
Transition times in the pharma universe
As India transitions to become the drug development BPO of the world, MNC pharma sharpens focus on next-generation cures and…
Decoding the skirmish over revised Schedule M
Both, large and mid/small size pharma companies, are vital parts of India’s pharma sector, one serving export markets, the other…
Will 2024 be a year of regulatory renaissance?
2024 will thus be a year to rebuild trust in the CDSCO, with more stringent regulations, coupled with stricter implementation of…
Navigating the shift from low-cost to highest value
The Draft National Pharmaceuticals Policy 2023 advocates a shift from “exceptional quality at low cost” to “exceptional quality at…
Building resilience to regulatory risks
Future growth of Indian pharma companies hinge on their ability to successfully navigate regulatory inspections
India Pharma Inc in M&A mode once again
While the big names are in the news, we could see a similar consolidation among pharma MSMEs which might not hit the headlines
NMC generics diktat strengthens call for pharma quality
Spanning companies of all sizes, the sector is only as strong as its weakest link
Proposed new drug law may still have flaws
The centre-state power equation works well in theory, as a system of checks and balances. But practice has been anything but…