Govt Adds Organ Preservative Solutions To Drugs

New Delhi, 4 April 2019: The Central government has added 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.

The proposal to include OPS in the notified medical equipment list was backed by the Drug Technical Advisory Body, the country’s highest drug advisory group, at its meeting in February this year. Once a device is notified, manufacturers and importers will have to get the regulatory body’s nod to sell these products in the domestic market. The devices are defined as ‘drugs’ under the D&C Act for the purpose of price and quality control and regulated using the Medical Device Rules 2017.

There are only a few Indian companies that manufacture OPS and much of these products are currently imported. “It is a highly critical device, especially for a county like India where there is a wide gap between the number of organs required and the organs available. I am glad the government has decided to regulate this segment,” Medical Technology Association of India (MTaI) chairman and director general Pavan Choudary told Pharmabiz. 

According statistics available, more than two lakh people await kidney transplant in the country, but only five per cent or about 10,000 people get one. Fifty-thousand patients await heart, but in 2017, only 339 deceased heart donations were witnessed.

Regulating the OPS segment is crucial as safe solutions are imperative to prevent clotting in harvests with blood present, reduce stress and deterioration associated with ex vivo handling, and decrease the risk of microbial growth. They are essential for storing vital organs such as kidney and liver, better transplantation outcomes, less histological damage, and improved function of organs.

At present, India doesn’t have a comprehensive law to regulate the medical devices industry. A medical devices regulatory bill, first drafted a decade ago, is yet to take effect and the draft has been lying with the ministry since 2016. 

Since last year, the Central Drugs Standard Control Organisation has been adding medical devices to its notified list. In February this year, the health ministry brought all implantable medical devices along with CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machines and bone marrow cell separator under the regulatory framework. This rule will come into force in April 2020.

According to industry experts, regulating medical equipment one by one as per D&C Act provisions has proved largely ineffective in ensuring patient safety and often resulted in harassment of manufacturers, arbitrary decisions and corruption in the past, as it creates confusion whether similar or connected devices and accessories have to be regulated or not.

“I have been advocating the regulation of medical devices as a product group using horizontal standards of safety and performance rather than device by device. In the current approach, we would never get to 5,000-plus devices said to be in the market,” says Anil Jauhri, chief executive officer of National Accreditation Board for Certification Bodies.

Domestic manufacturers are batting for regulating key medical device categories based on risk proportion, saying this would be more effective than adhoc addition to the notified list. Pharmabiz