CDSCO Panel Nod To MSD's Sotatercept Label Change, Expands Prescribing Rights to Cardiologists
New Delhi: The Subject Expert Committee (SEC) under Central Drugs Standard Control Organisation's (CDSCO) Cardiovascular division has approved MSD Pharmaceuticals' proposal to expand prescribing rights for Sotatercept, a pulmonary arterial hypertension (PAH) drug, allowing both Registered Pulmonologists and Registered Cardiologists to prescribe the biologic, instead of limiting it to pulmonologists alone.
The committee's decision was made during the SEC Cardiovascular meeting held on 10th July 2025 at CDSCO headquarters in New Delhi.
MSD Pharmaceuticals had requested approval to revise the warning statement printed on the packaging of the product. The existing statement restricted the sale of the drug to prescriptions from a Registered Pulmonologist only. The proposed change requested that the product label be updated to allow prescription by a Registered Pulmonologist or Registered Cardiologist.
After detailed deliberation, the committee agreed to the proposal and recommended the approval of the amended warning statement. The updated label will now read:“To be sold by retail on the prescription of a Registered Pulmonologist or Registered Cardiologist only.”
Sotatercept is supplied as a powder for solution for injection in 45 mg and 60 mg single-dose vials. It is a recombinant fusion protein under the biological division, and it plays a role in the treatment of pulmonary arterial hypertension (PAH). While pulmonologists have traditionally managed PAH cases, cardiologists also frequently treat patients with associated cardiovascular complications.
Supplied in single-dose vials of 45 mg and 60 mg, Sotatercept is administered via subcutaneous injection. Its mechanism of action involves the inhibition of the TGF-beta superfamily signaling pathway, targeting the vascular remodeling seen in PAH patients.
The committee’s recommendation was formally recorded as part of the SEC Cardiovascular division’s proceedings on 10th July 2025.
