Colecalciferol

New Delhi: Drug manufacturers in India identified as producing Not of Standard Quality (NSQ) drugs may soon face suspension of their respective product manufacturing licenses. During the 92nd meeting of the Drugs Technical Advisory Board (DTAB)—comprising top-level policymakers and industry stakeholders—it was noted: “It is very important that once a drug is declared NSQ, the license of such a product shall be suspended immediately in the public interest.” According to the meeting details shared by the Central Drugs Standard Control Organisation (CDSCO), the DTAB recommended appropriate amendments to the Drug Rules. It further stated that a suspended product license should only be reinstated after a thorough root cause analysis and the implementation of corresponding Corrective and Preventive Action (CAPA). The matter came up for discussion following a proposal to suspend product permissions for batches declared NSQ by government analysts from official testing laboratories. As per government data, in FY 2023–24, 2,988 drug samples were declared Not of Standard Quality. Most recently, during its March 2024 quality inspections, central and state laboratories under the CDSCO flagged 131 drug samples as NSQ. While the quality review data for April is yet to be released, as of March, laboratories had flagged 379 NSQ drug samples, including paracetamol, vitamin D3 supplements, anti-diabetic pills, and medications for high blood pressure, among others. Some of the common reasons cited for flagging samples as NSQ include issues with dissolution, appearance of the solution, presence of visible particulate matter, and description. Currently, under Rule 143 of the Drugs and Cosmetics Rules, 1945, the Licensing Authority is empowered to suspend the license of any licensee who has failed to comply with the conditions of the license or any provisions of the Drugs and Cosmetics Act, 1940, or the rules framed thereunder. In 2023, it was reported that the Centre halted drug production at 31 firms and cancelled or suspended product licenses of 50 firms for non-compliance with quality control norms. However, according to the Health Ministry, “The failure is specific to the drug products of the batch tested by the government laboratory, and it does not warrant concerns about other drug products available in the market.” Every month, central and state drug testing laboratories assess the quality of drug batches collected by regulatory bodies. The identification of drug samples as NSQ is based on failure to meet one or more specified quality parameters. The term "Not of Standard Quality" is defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. By Online Bureau ,

Expanded Product Line Targets Growing Demand for Proactive Wellness Solutions in Clinics, Med Spas, 503A Pharmacies, and Telehealth Practices Across the United States WEST PALM BEACH, Fla. and EXTON, Pa., April 23, 2025 /PRNewswire/ -- ProRx Pharma, the leading health and wellness 503B outsourcing facility, today announced the addition of six new injectable products designed to support the rising demand for preventive care: Gonadorelin, Liraglutide, Vitamin D3, and Phenylephrine HCl as well as two Tri-Mix injection options. These high-quality standalone injectables are now available for bulk shipping to licensed medical facilities in 26 states and for direct-to-consumer shipping nationwide through ProRx's growing network of 503A pharmacies, clinics, med spas and telehealth providers. "Patients are taking charge of their health like never before," said Kurt Lunkwitz, chief operating officer at ProRx. "Physicians are following suit, integrating wellness therapies into their practices to meet the demand for more proactive, functional care. This trend is only going to continue. The continued expansion of our health and wellness line is a direct response—and a step toward making preventative health more accessible and streamlined." What's New: The Products Each of the six new offerings comes with its own National Drug Code (NDC) number and an extended Beyond Use Date (BUD), providing both flexibility and longer shelf life for providers: Gonadorelin ( 1 mg/mL, 6 mg / 6 mL vial ) A gonadotropin-releasing hormone agonist which is used in fertility medicine and to treat amenorrhea and hypogonadism. Gonadorelin may promote testosterone production; may support fertility, libido, and hormonal balance. Liraglutide ( 0.75 mg, 1 mg, 2 mg, 3 mg [custom dosing] ) A powerful GLP-1 receptor agonist for weight and blood-sugar management. Liraglutide may aid in weight loss, appetite suppression, and blood-sugar control. Vitamin D3 ( 50,000 IU/mL, 5 mL vial ) A high-dose solution for those with critically low vitamin D levels. Vitamin D3 may support immune function, bone health, mood, and Vitamin D repletion. Tri-Mix #1 ( 30 mg / 1 mg / 10 mcg/mL, 5 mL vial ) The first of two strength offerings for erectile dysfunction (ED) therapy. Tri Mix #1 may improve erectile response through smooth muscle relaxation and blood flow. Tri-Mix #2 ( 30 mg / 2 mg / 20 mcg/mL, 5 mL vial ) A stronger ED therapy offering. Tri-Mix #2, may provide more ED support for patients needing increased vasodilation. Phenylephrine HCl ( 0.1% 2 mL vial) A critical safety solution for patients using Tri-Mix therapies. Phenylephrine HCl may reverse prolonged erection or priapism due to ED therapy. The introduction of these six new products comes on the heels of ProRx announcing its first four preventative-care offerings the first week of April: Sermorelin, NAD+, Glutathione and MIC/B6/B12. Exclusive Launch at A4M Conference ProRx is showcasing its full line of preventative-care products at the A4M 33rd Annual Spring Conference taking place April 24-26 in West Palm Beach, Florida. At Booth 527, attendees will get an exclusive first look at all 10 products in the new product line and be able to speak with ProRx's experts about the company's compliance and quality-assurance programs. About ProRx Pharma ProRx Pharma is an FDA-registered cGMP facility focused on providing essential compounded medications to meet the need for medications on the FDA drug shortage and bulks list with an emphasis on preventative health. The company produces products and formulations for medical institutions, physician offices, and 503A pharmacies, with a specialization in producing high-quality products to ensure patients have access to the medications they need during critical shortages. For more information, visit SOURCE ProRx Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED