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Pharma companies will no longer ne required to seek a test licence and may proceed with pharmaceutical development upon submitting an online intimation to CDSCO, except in certain cases, as part of broad simplication notified by the Union Health Ministry. Union Health Ministry has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country. The amendment is line with the directions of Prime Minister Narendra Modi to reduce regulatory burden and promote Ease of Doing Business, the ministry sais Under the existing regulatory framework, pharmaceutical companies are required to obtain a test licence from the Central Drugs Standard Control Organization (CDSCO) for the manufacture of small quantities of drugs intended for examination, research, or analysis purposes. Through the notified amendments, thi
Biotech firm Biocon on Thursday said it has raised Rs 4,150 crore through a Qualified Institutions Placement (QIP) process. The initiative saw issuance of 1,12,664,585 equity shares of face value Rs 5 each to eligible qualified institutional buyers at the issue price of Rs 368.35 per share, the Bengaluru-based firm said in a regulatory filing. The QIP, which opened on January 12 and closed on January 14, attracted strong investor interest from a broad mix of domestic and international participants, reflecting robust confidence in the company's growth prospects, it added. The proceeds from the QIP will be primarily utilised to meet the cash consideration payable to Mylan Inc. (Viatris) for buying out its shareholding in Biocon Biologics Ltd, including repayment of debt availed in this regard, Biocon said. The company recently announced its board has approved a strategic corporate action to acquire all remaining minority shareholdings, including Viatris' stake, thereby making Biocon
Apollo Pharmacy plans to open two new stores every day, targeting to grow its customer base to 10 crore within the next five years, its CEO P Jayakumar said on Friday. The omni-channel pharmacy network, which has crossed the 7,000-store mark with the opening of its latest store in Ayodhya, Uttar Pradesh, aims to strengthen the neighbourhood pharmacy reach. "We will continue to expand by opening two new stores every day and grow our customer base to 100 million within the next five years, ensuring that the highest-quality medicines remain within everyone's reach," Jayakumar said in a statement. Apollo HealthCo operates Apollo Pharmacy that serves users across over 19,000 pin codes. Apollo HealthCo Executive Chairperson Shobana Kamineni said at present, Apollo Pharmacy serves over one million orders every day. "The 7,000-store milestone reflects the scale Apollo has built and the trust families place in us. We will continue to deepen access, strengthen India's neighbourhood pharmacy
Aurobindo Pharma is currently incurring a loss at its China-based facility and expects the plant to achieve break-even by the end of the fiscal year, according to its CFO S Subramanian. The Hyderabad-based drug major remains confident about sustaining its growth momentum and driving value creation across all businesses, he said. "China (plant), as on date in the quarter, I will be incurring a loss of around maybe a million dollars, but, probably, we will be able to achieve the break-even between Q3 and Q4 and after that, China will start moving up in the overall contributing to the growth of the EBITDA growth," Subramanian said in an analyst call. The oral-solid-dosage (OSD) facility in China continues to ramp up, advancing towards the capacity of two billion, backed by European approval of ten products and three local product approvals, he stated. The site is on track to deliver EBITDA break-even by Q3-Q4 FY26, reinforcing its strategic importance to the global network, he added.
Drugmakers Glenmark and Dr Reddy's Laboratories are recalling products in the US due to manufacturing issues, according to the US Food and Drug Administration (USFDA). As per its latest Enforcement Report, the US health regulator noted that a US-based unit of Glenmark Pharmaceuticals is recalling 26,928 packs of oral contraceptive medication in the US. Mahwah, New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the affected lot of Viorele, Desogestrel and Ethinyl Estradiol (USP, 0.15 mg/ 0.02 mg) and Ethinyl Estradiol tablets due to "failed impurities/degradation specifications." The affected lot was produced at Mumbai-headquartered drug maker's Goa manufacturing facility. The drug firm issued the Class II nationwide recall on September 3, 2025. USFDA stated that a US-based subsidiary of Dr Reddy's Laboratories is recalling the medication used to provide muscle relaxation during surgery. Princeton, New Jersey-based Dr. Reddy's Laboratories, Inc is recalling 571 vials o
