Government Classifies Medical Devices As Drugs To Improve Quality And Price Control

In a notification released on 11th February, 2020, the Central Government in consultation with the Drugs Technical Advisory Board(DTAB) classified medical devices as drugs w.e.f 1^st April, 2020.

The definition of devices to be classified as drugs cover all existing medical devices being sold in the market, ranging from disposable syringes to MRI and CT Scan equipment.

Prior to this notification, only 23 medical devices were classified as drugs and were required to undergo the deliberate registration and analysis procedure.

The devices shall also be registered in CDSCO's online registration system from now. However, using the online the registration system will be voluntary for a period of 18 months and mandatory thereafter.

What’s Good?

While the drug license registration process is very detailed and comprehensive application procedure, involving months of careful analysis, trials and approvals. Medical devices(mainly low and medium risk) enjoyed a more lenient process of registration and control.

 

Devices such as disposable syringes, disinfectants, surgical gloves classified as Class A or B were either not required to obtain a registration or the regulation was not very strict. This often resulted in sub-standard and forfeited products on the market which lacked quality and were probable of causing harm to the safety of the user.

Bringing medical devices under the category of drugs will ensure that better and high-quality manufacturing procedures are followed. Resulting in more refined and better quality products being sold in the market.

This would also prevent duplicacy of products and will offer manufacturers a healthy and competitive market.

What’s Bad?

Classifying medical devices as drugs will result in more stringent approval and inspection procedures. That may greatly affect small and medium businesses manufacturing low-risk Class A or B devices like masks or gloves. Not every manufacturer can bear the expenses of the drug licensing process. Especially if he/she manufactures multiple devices.

Important Considerations

Even being a groundbreaking event, this reclassification is neither unexpected nor immediate. The authorities have been pondering over this matter for more than a year and have outlooked every possible aspect.

These new rules are not immediate in effect. Since Class A&B medical devices have been exempted from compliance for a period of 30 months from 1st April 2020. Whereas Class C & D devices have been provided relaxation for a period of 42 months.

India is the fourth largest medical device market in Asia. While the sale of medical devices covers 30% of the total Indian pharma market.

With that said, this reclassification will ensure that the quality of medical devices sold in India is up to the mark and comparable to global standards.