Swedish drug maker AstraZeneca has filed a lawsuit against India's generic firm Lupin for allegedly violating its valid patents on its gastric reflux disease drug Nexium (esomeprazole magnesium delayed release capsules) though seeking to sell a generic version in US.
Media ads promoting morning after emergency contraceptive pills too are under scanner
DCGI's directive to issue CoPP only through CDSCO has already been stayed by 2 high court orders
EU authorities allege patent violations in Indian generic shipments headed to Latam countries
A regional Indian High Court has issued an injunction staying an order that aimed to restrict issuance of product manufacturing licences by state drug agencies, throwing a spanner on the central drug authority's efforts to streamline the licensing practices to ensure quality of drug products manufactured across the country.
US FDA seized drug products manufactured at Caraco’s facilities in Detroit in June
WHO South Asia region rejects agenda to stop generics exported from India branding them as fake and counterfeits
Registration of clinical research organizations which conduct human studies on drugs, cosmetics and medical devices would soon be made mandatory in India.
Ranbaxy recalls one batch of one of the Ranbaxy's largest selling pills - Sotret – following US FDA recommendation.
India is yet to start the practice of inspecting factories abroad that export drugs to the country.