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DRUG SAFETY ALERT!

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The Indian Pharmacopoeia Commission (IPC) has issued a Drug Safety Alert regarding an adverse drug reaction (ADR) identified through the PvPI database. Suspected Drug: Sulfamethoxazole + Trimethoprim Indications: Urinary Tract Infection, Respiratory Tract Infection (including Bronchitis, Pneumonia), infections in Cystic Fibrosis, Melioidosis, Listeriosis, Brucellosis, Granuloma Inguinale, Otitis Media, Skin Infection, Pneumocystis Carinii Pneumonia. Adverse Drug Reaction (ADR) Observed: Leukopenia To Healthcare Professionals, Patients, and Consumers: We urge everyone to closely monitor for the possibility of Leukopenia if you are using Sulfamethoxazole + Trimethoprim for any of the indicated conditions. If you encounter this or any other adverse drug reaction: Please report it to the NCC-PvPI, IPC by filling out the Suspected Adverse Drug Reactions Reporting Form/Medicines Side Effect Reporting Form for Consumer. ⬇️ Download the form here: http://www.ipc.gov.in 📞 You can also report b...

Clarification of IP General Chapter 2.5.4 (i). Uniformity of Dosage Units

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Revised draft general chapters of IP (Microbiology) for stakeholders comments dated 05/08/2022; last date for receiving comments at IPC 20 September 2022

1. Revised Bacterial Endotoxin (2.2.3) 2. Revised Effectiveness of Antimicrobial Preservatives (2.2.2) 3. Revised Microbial Contamination in Non sterile Products (2.2.9)

Extension of validity of WHO GMP/Certificate of Pharmaceutical Product (COPP)

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Notice regarding Processing of application for BA/BE permission issued in Form CT-07 and Import Licence issued in Form CT-17 for Export

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Revised Guidance list of Laboratories on Performance Evluation of IVDm

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Definition, Responsibility & labelling requirements for marketer of the drugs

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