- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Inclisiran be sold by retail under prescription of cardiologist only: CDSCO panel tells Novartis Healthcare
New Delhi: Rejecting the drug major Novartis Healthcare's proposal for amendment in the warning statement of Inclisiran Solution for injection, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has stated that the drug Inclisiran Solution for injection should be prescribed with a warning statement as ‘To be sold by retail under the prescription of a cardiologist only’.
This came after Novartis Healthcare presented the proposal for amendment in the warning statement of permission granted to import and market Inclisiran Solution for injection before the committee.
Inclisiran is a medication that reduces levels of low-density lipoprotein (LDL) cholesterol, also known as "bad cholesterol." It's used to treat: High LDL cholesterol, atherosclerotic cardiovascular disease (ASCVD), ASCVD risk-equivalents, and heterozygous familial hypercholesterolemia.
Inclisiran is a synthetic, double-stranded RNA (siRNA) molecule that's injected subcutaneously. It's taken up by the liver cells. It binds to and degrades PCSK9 mRNA, which reduces the production of PCSK9 protein. This reduces the amount of LDL cholesterol in the blood.
At the recent SEC meeting for Cardiovascular held on 6th November 2024, the expert panel reviewed the proposal for amendment in the warning statement of permission granted to import and market Inclisiran Solution for injection
After detailed deliberation, the committee did not recommend the amendment in the warning statement.
Furthermore, the expert panel added that the drug Inclisiran solution for injection should be prescribed with a warning statement as follows:
‘To be sold by retail under the prescription of cardiologist only’.
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.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751