| |SEPTEMBER 20268TOP STORIESNEW MEDICAL DEVICE RULE COULD HIT COSTS AND EXPORT FLEXIBILITYDELHI H1N1 ALERT: HEALTH MINISTER CALLS KEY REVIEW MEETINGWHAT TRIGGERED SUN PHARMA'S LATEST US DRUG RECALL?GLENMARK EXTENDS ITS U.S. INJECTABLE PORTFOLIO WITH CALCIUM GLUCONATEGOA'S NEW CANCER RULE COULD CHANGE HOW CASES ARE TRACKEDIndia's new Medical Device Rule could increase compliance costs for manufacturers. The rule requires makers to disclose details of outsourced sterilization facilities on device labels. The medical device rule is aimed at improving traceability and transparency in the sector.Under the new requirement, medical device manufacturers must mention the licence number of sterilization facilities used by subcontractors. This applies when sterilization is outsourced to another facility. The move is expected to give regulators greater visibility into the sterilization process. It could also help trace devices back to the facilities involved in their processing. POA H1N1 Alert has prompted a key health review meeting in Delhi. Health Minister Dr Pankaj Kumar Singh will lead the meeting at the Delhi Secretariat this afternoon. The H1N1 Alert comes as officials review hospital preparedness and testing measures across the city.Senior Delhi Government officials will attend the meeting. Representatives from the Municipal Corporation of Delhi (MCD) will also join. Municipal health officers and government hospital representatives are expected to participate. POThe latest drug recall by Sun Pharmaceutical Industries has drawn attention to a manufacturing quality issue involving its epilepsy medicine carbamazepine. The company is voluntarily recalling 1,968 bottles of the anticonvulsant after consumers reported black spots on tablets.Sun Pharma began the recall following a complaint about black specks. The company later identified cGMP deviations linked to the manufacturing process as the underlying cause. The affected batch came from Taro Pharmaceutical's Haifa Bay facility in Israel. The US FDA classified the action as a Class II recall, indicating potential temporary or medically reversible health consequences POCalcium Gluconate has become the latest addition to Glenmark Pharmaceuticals' U.S. injectable portfolio. The company recently launched calcium gluconate injection USP across three presentations in the American market. The launch targets a market that recorded approximately 69.9 million in annual sales for these presentations in the 12 months ended June 2026, according to IQVIA data. The opportunity adds commercial relevance to Glenmark's continued focus on building its U.S. injectable portfolio and serving institutional healthcare demand. Glenmark also notes this move as its strategy to build a differentiated, sustainable U.S. injectables business focused on institutional demand and supply resilience. POGoa's new cancer rule could change how cancer cases are tracked across the state. The Goa government has declared cancer a notifiable disease, making case reporting mandatory. The move is aimed at improving the collection of cancer data. It could also help authorities understand the state's cancer burden more clearly.Under the new notification, healthcare facilities will have to report cancer cases to the government. This will provide health officials with more regular and structured data. The decision comes as cancer remains a major public health concern in India. Better data can help governments plan screening, treatment, and other healthcare services. PO
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