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In a move aimed at speeding up approvals for new drugs, the government has changed the way testing permissions are granted, allowing companies to begin laboratory testing immediately after filing applications instead of waiting for detailed scrutiny. In an official circular, the country's apex drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), said it has decided that "No Objection Certificate (NOC) for testing of drug samples at the designated laboratories (IPC, Ghaziabad; CDTL, Mumbai; CDL at CRI, Kasauli; or NIB, Noida) shall be issued immediately upon receipt of applications in the concerned division." Earlier, the regulator examined detailed specifications submitted by applicants before issuing permission for testing. These included "Type of formulation, dosage form, Critical Quality Attributes (CQAs), and general characteristics of the product," along with "Product development reports, forced degradation studies, and other relevant data, in ...
Sun Pharma will maintain a disciplined approach when it comes to acquisitions in order to allow the business to grow organically while remaining attractive for shareholders, according to Chairman Dilip Shanghvi. The Mumbai-based drug major is also evaluating biosimilar segments, he stated. "I think the US continues to be an important part of our focus, specifically for innovative medicines," Shanghvi said when asked about the company's M&A strategy in an analyst call. The company is interested in selling innovative medicines globally, he added. "For emerging markets, we are looking at what you call tuck-ins or smaller acquisitions, which we can look at integrating with our existing business to get scale in the emerging markets," he added. The drug major has consistently indicated that it wants to remain disciplined about acquisition, Shanghvi said. "Our focus is on finding a way to grow our business organically at a rate so that we continue to be an attractive investment ...