Revised guidance on quality & safety documents

Source: PharmaBiz The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) […]
Delhi HC bars Natco Pharma from selling cancer drug Olaparib

Source: Economic Times The Delhi High Court has barred Natco Pharma from manufacturing and selling cancer drug Olaparib either under the brand name ‘BRACANAT’ or under other brand names till further orders. “…the defendant (Natco) is in fact exploiting the suit patent by manufacturing and selling Olaparib. It is also admitted that this exploitation has take place in the 19th year of the […]