Last Updated on December 31, 2023 by The Health Master
New Delhi: Stressing that the drug product should only be made available with a prescription from a Registered Medical Practitioner (RMP), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to pharmaceutical major Dr. Reddy’s Laboratories to manufacture and market Nimesulide Granules for Oral Suspension 100mg for “Short-term treatment of inflammatory conditions including joint disorders such as rheumatoid arthritis, post-operative painful conditions and fever“.
The approval is subject to the condition that the drug product should be available only under the prescription of a Registered Medical Practitioner.
Furthermore, the expert panel stated that the prescription should contain a clearly displayed Medical Council Registration No. of the physician.
This came after the firm presented their proposal of manufacturing and marketing of Nimesulide Granules for Oral Suspension 100mg for “Short-term treatment of inflammatory conditions including joint disorders such as rheumatoid arthritis, post-operative painful conditions, and fever” along with different measures taken by them to ensure no misuse in children below 12 years of age before the committee.
Nimesulide is a relatively COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties.
Its approved indications are the treatment of acute pain, the symptomatic treatment of osteoarthritis, and primary dysmenorrhoea in adolescents and adults above 12 years old.
Nimesulide is generally well tolerated, but side effects can include headaches, dizziness, somnolence, gastrointestinal upset, nausea, abdominal discomfort, diarrhea, peripheral edema, and hypersensitivity reactions.
Due to concerns about the risk of hepatotoxicity, nimesulide has been withdrawn from the market in many countries. However, the mechanism of nimesulide hepatotoxicity is not known, but likely to be due to an idiosyncratic reaction to an intermediate of its metabolism. Nimesulide is extensively metabolized by the liver.
The therapeutic effects of Nimesulide are the result of its complete mode of action, which targets a number of key mediators of the inflammatory process, such as: COX-2-mediated prostaglandins, free radicals, proteolytic enzymes, and histamine.
At the recent SEC meeting for Analgesics & Rheumatology held on October 12th, 2022, the expert panel extensively evaluated the proposal presented by pharmaceutical major Dr. Reddy’s Laboratories to manufacture and market Nimesulide Granules for Oral Suspension 100mg for “Short-term treatment of inflammatory conditions including joint disorders such as rheumatoid arthritis, post-operative painful conditions and fever” along with different measures taken by them to ensure no misuse in children below 12 years of age.
After detailed deliberation, the committee recommended the manufacture and marketing of the drug product with the proposed indication, subject to the condition that “the drug product should be available only on the prescription of a Registered Medical Practitioner.”
The prescription should contain the clearly displayed Medical Council Registration No. of the physician.”
CDSCO Panel gives nod to study Anti Allergic Combination Drug
CDSCO Panel gives nod to study Elagolix Tablet
CDSCO Panel gives nod to Manufacture, Market Progesterone SR Tablet
CDSCO Panel gives nod for FDC Bempedoic Acid Plus Atorvastatin Calcium
CDSCO approves intra Nasal Vaccine for C-19 in adults
CDSCO panel wants justification on Protocol Amendments on Trail of Imlunestrant
Govt notifies rules to exempt certain medical devices under Class A
PCI to implement Pharmacy Practice Regulations, 2015
Drug alert: 59 out of 1456 samples declared as NSQ in September 2022
Govt notifies rules to ease New Drugs and Clinical Trials norms
USFDA issues form 483 with four observations to Alembic Pharma
Govt brings these eight substances under NDPS Act
CDSCO Panel gives nod to study Anti Allergic Combination Drug
DCGI notifies classification of 48 Medical Devices related to Oncology under MDR 2017
Procedure to obtain registration for Blood Storage Centre
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
