Indian Pharmaceutical Alliance says the study relies on FDA Adverse Event Reporting System data, which captures link between drugs & adverse events, but does not prove causation.
The report, released at Global Pharmaceutical Quality Summit in Mumbai, draws comparison of incidences of ‘official action indicated' after USFDA inspections a decade apart.
The proposed extension for drugmakers in adopting Schedule M of Drugs and Cosmetics Act and Rules comes mainly at the behest of RSS-backed Laghu Udyog Bharti, it is learnt.
Patent expiry would mean that drugmakers will be able to launch generic versions of the blockbuster drugs, which are typically priced up to 90 percent lower than their innovator drug.
New Delhi: On 18 April, Mumbai-headquartered Marksans Pharma, a drugmaker that supplies generic drugs in over 50 countries around the world, received form 483,...
Report by Organisation of Pharmaceutical Producers of India and Ernst & Young says growth could be propelled by expansion in the domestic market, spurred by India's economic growth.
CDSCO says two cough syrups manufactured by Ankleshwar-based Norris Pharma were found to contain Ethylene Glycol (EG) & Diethylene Glycol (DEG) beyond acceptable limits.
The groups say Draft Patents (Amendment) Rules could make it harder to challenge patent applications, impede process of obtaining compulsory licences & effect transparency in system.
Exercise by Central Drugs Standard Control Organisation began as crackdown on small & medium drugmakers, but is being expanded to include major firms after complaints over quality control.
For an industry globally classified as hazardous, protections such as health insurance and a provident fund for workers are necessities. In Sivakasi, they remain elusive.
The industry forecasts exports are set to grow 16% in 2025-26, boosted by surplus domestic production and a drive to push into 26 underserved global markets with strong potential.
Indigenisation level will progressively increase up to 60 percent with key sub-assemblies, electronics and mechanical parts being manufactured locally.
It is a brilliant, reasonably priced, and mostly homemade aircraft with a stellar safety record; only two crashes in 24 years since its first flight. But its crash is a moment of introspection.
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