Question : STEROID IN EYE DROPS



(a) whether the Government is aware that a large number of Pharmaceutical companies are manufacturing steroid eye drops which can lead to blindness;

(b) if so, the details thereof;

(c) whether the Government exercises any check on the Pharmaceutical companies manufacturing steroid eye drops about percentage of steroid in eye drops;

(d) if so, the details thereof; and

(e) the steps taken/proposed by the Government to ensure manufacture of steroid eye drops according to the specifications to avoid blindness?

Answer given by the minister


MINISTER OF THE STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NABI AZAD)

(a) & (b): Eye drops containing steroid are permitted to be marketed for treating certain specified diseases of the eye. Misuse of these formulations could lead to medical complications. These preparations are required to be sold on the prescription of a Registered Medical Practitioner (RMP) only.

(c) to (e): Eye drops containing steroid are required to be manufactured under a valid license and in accordance with the approved composition and standard prescribed for them under the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945 rules made there under.