Inclisiran be sold by retail under prescription of cardiologist only: CDSCO panel tells Novartis Healthcare

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’.

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