Government notifies Organ Preservative Solutions as DRUGS with immediate effect

New Delhi: In a move to monitor and assure quality Organ Preservative Solutions (OPS) the Government has specified OPS as "Drugs."

Through a recent Gazette Notification, the Central 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 "drug" 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.

In pursuance of the same, the Government specified OPS intended for external or internal use in human beings as drugs. The notice reads;

In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following device intended for external or internal use in human beings as drugs with immediate effect, namely:— “Organ preservative solution”

Organ preservative solution (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.

Commenting on the move MTaI Chairman Mr Pavan Choudary told Medical Dialogues, " Bringing this device under regulation will enable monitoring of its quality irrespective of the manufacturer. As a result of the regulation, supply of OPS of assured quality would be facilitated and the number of deaths due to organ failure will reduce as the solution enables storage and transportation of harvested organs to any location."

Choudhary further spoke about similar steps that will help improve organ harvesting and transplant output immensely.

"The government should now move on to the next measure in revolutionising organ transplantation in India. It should introduce an amendment to the Transplantation of Human Organs Act to make it mandatory for the doctor to remove those patients who are braindead off the ventilator. It will improve organ harvesting and transplant output immensely. Each such patient can save eight lives through organ donation," he added.

A month ago, the Government had notified 8 medical devices as "drugs" including all implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator.

Medical Dialogues had earlier reported that in a significant move to provide safety to patients and regulate the quality of diagnostic and medical devices in India, the health ministry had notified eight medical equipment, including all implantable devices, as “drugs” under Section 3 of the Drugs and Cosmetics Act, effective from April 1, 2020.

Also Read: Eight medical devices including CT, MRI, X-ray notified as DRUGS by the health ministry