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  • Dr. Reddy's gets CDSCO...

Dr. Reddy's gets CDSCO panel conditional nod to manufacture, market Nimesulide Granules

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2022-10-20T18:00:37+05:30  |  Updated On 20 Oct 2022 12:30 PM GMT
Dr. Reddys gets CDSCO panel conditional nod to manufacture, market Nimesulide Granules

New Delhi: Stressing that the drug product should only be made available with a prescription from a Registered Medical Practitioner, the Subject Expert Committee (SEC) functional under 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...

New Delhi: Stressing that the drug product should only be made available with a prescription from a Registered Medical Practitioner, the Subject Expert Committee (SEC) functional under 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 subjected to condition that the drug product should be available only under prescription of a Registered Medical Practitioner. Furthermore, the expert panel stated that the prescription should contain clearly displayed Medical Council Registration No. of the Physician.

This came after the firm presented their proposal of manufacturing and market 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 for ensuring 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 headache, 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 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 Analgesic & 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."
Also Read:Expert committee holds first meeting to examine WHO claims on Maiden Pharma case
Dr.Reddy dr reddys nimusulide cdsco panel nsaid sec committee 
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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