CDSCO approvedSchedule H (Prescription Drug, to be sold by retail on the prescription of a Registered Medical Practitioner only). In India, it is often administered under supervision in a hospital setting due to potential infusion reactions and need for close monitoring. The exact class of schedule H may vary in some states to also include 'Rx' designation (prescription only). This drug is not OTC (Over-The-Counter). The drug should not be supplied to the general public for direct consumption without professional medical advice. It requires specialized handling and administration. As an injectable cytotoxic/immunomodulatory agent, it strictly falls under prescription-only medicine category and typically administered in controlled clinical environments. Thus, it is not OTC and requires prescription. Schedule H drugs are substances which are required to be sold by retail on the prescription of a Registered Medical Practitioner. Rituximab falls under this category. Given its nature and administration, it is also subjected to more stringent control measures beyond simple Schedule H, often requiring hospital-level administration and monitoring. While it fits the general criteria for Schedule H, its complex usage context often leads to it being managed under stricter hospital protocols akin to Schedule H1 or even X in practice for safety, although technically, the molecule itself is often listed as Schedule H. Therefore, Schedule H is the most appropriate classification based on general Indian drug regulations for prescription drugs. It is not an OTC medicine. Thus, it requires a prescription from a Registered Medical Practitioner and is to be sold by retail only on their prescription. Given its nature and administration requirements, it is generally supplied to hospitals and administered in a clinical setting by trained professionals. The legal classification is Schedule H. Many such advanced injectable medications, while technically Schedule H, are managed with heightened vigilance similar to the intent of Schedule H1 or X in practice due to their risk profile and administration complexity. However, strictly speaking, Schedule H is the correct official classification for prescription drugs. Therefore,ATC L01FA01
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AdalimumabSevereDatabaseDDInter
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CertolizumabSevereDatabaseDDInter
Available in India
37 branded formulations. Look up specific brands in the Drugs workspace.
Mechanism
Binds CD20 on B-lymphocytes causing depletion via complement-dependent and antibody-dependent cellular cytotoxicity and apoptosis; depletes normal and malignant CD20+ B cells (pre-B to mature, sparing plasma cells/stem cells).
Indications
CD20+ non-Hodgkin lymphoma and chronic lymphocytic leukaemiaRheumatoid arthritis (with methotrexate)ANCA-associated vasculitis (GPA/MPA)Pemphigus vulgaris; off-label many autoimmune diseases
Dosing
Adult
Oncology: 375 mg/m² IV per cycle (schedule by regimen). RA: 1000 mg IV days 1 and 15, repeat ~q6 months. Premedicate (antihistamine, paracetamol ± corticosteroid).