India will regulate organ preservative solutions (OPS) as drugs, according to a new official notification.
The government has included Organ Preservative Solutions (OPS) to the list of notified medical devices placing it under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics (D&C) Act 1940 with immediate effect.
Section 3(b) of the Drugs and Cosmetics (D&C) Act 1940 talks about “drugs” as inclusive of such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals.
According to a Gazette notification, issued to this effect, the government specified OPS intended for external or internal use in human beings as drugs. OPS is a crucial medical device that is used to supply oxygen and vital nutrients to harvested organs, thereby increasing their life and maintaining their vitality.