Medical Devices: Tighter Control

Health Care Comments Off

From December 1, all devices will be treated as drugs and come under the purview of the Central Drugs Standards Control Organisation which will regulate them

By Dr KK Aggarwal

According to a draft notification, the health ministry proposes to notify all medical devices under a section of the Drugs and Cosmetics Act, 1940, which would define them as “drugs” starting from December 1. In April, the Drugs Technical Advisory Board (DTAB) had recommended this change.

The draft notification reads: “In pursuance of sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of December, 2019.”

Under this Act, drugs are defined as those devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central government.

Therefore, apart from chemicals, plants, medical devices, medical implants, medical diagnostics, vaccines, blood and medical disposables also qualify as drugs.

Medical devices are essential components of treatment and include thermometers, blood pressure instruments, nebulisers, inhalers, anaesthesia equipment, reagents, pacemakers, knee and hip replacement implants, etc. The increased scrutiny of medical devices came in the aftermath of the recall of Johnson & Johnson’s faulty hip implants which impaired many patients for life.

That created the need for a national registry of medical implants so that in case of a recall, every device can be traced. Also, the MRP of devices was often decided by hospitals and profit margins ranged from 100 percent to 700 percent. Once medical devices are classified as drugs, the Central Drugs Standards Control Organisation (CDSCO), the drug regulator, will regulate them.

The Indian Medical Device Rules, 2017, was implemented with effect from January 1, 2018, and has detailed provisions for the regulation of manufacture, import, sale and distribution of medical devices covered under the Act to ensure their quality. In February 2019, the government had put implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separators under the purview of Section 3(b)(iv) of the Drugs and Cosmetics Act.

However, many more need to be included at the earliest. Before February, CDSCO regulated the safety, efficacy and quality of 23 devices. Out of these, 15 are notified under the Act.

Out of the 23 medical devices listed as drugs, four—cardiac stents, drug eluting stents, condoms and intra-uterine devices—have been included in the National List of Essential Medicines and are under price control by virtue of being included in Schedule-I of the Drugs (Price Control) Order, 2013.

Further, the government has also notified the ceiling prices of orthopaedic knee implants under paragraph 19 of the Drugs (Price Control) Order, 2013. The MRPs of the remaining medical devices, being under the non-scheduled category, are monitored to ensure that no manufacturer increases the maximum retail price by more than 10 percent of the price during the preceding 12-month period.

But most of the medical devices still remained unregulated. An unregulated medical device industry leads to corruption, heavy profiteering and loss of life if a default occurs in any device.

Use and reuse of catheters and pacemaker implants have been controversial for quite some time. In the current era, the use of catheters, ventilator circuits, nebulisers and such devices need to be redefined and regulated.

Therefore, the government’s move to bring all medical devices under the Drugs and Cosmetics Act is a welcome step. This will ensure quality, availability and affordability in healthcare facilities. If implemented, the country’s drug regulator will enforce standards to ensure safety and effectiveness of these products.

To ensure that CDSCO can regulate more medical devices, DTAB had recommended the creation of another post of additional drugs controller, with four joint drug controllers under him, as well as hiring over 200 new officers in various other posts. However, the change should have a defined transition period and be implemented in a phased manner, including a voluntary registration phase to regulate all devices at one go.

Articles 14, 15 and 21 of the Constitu­tion gives us the right to health without discrimination. This right includes the right to get safe and affordable medical devices. This “right to health” is to be fulfilled by the State (Article 47) subject to resources (Article 41).

The government, therefore, can and should regulate all medical devices and cap the prices of essential ones by invoking Section 3 of the Essential Commodities Act. In terms of drugs, this is already done by bringing the National List of Essential Drugs under the DPO (Drug Price Control Order, 2013). Once the devices are classified as drugs, they will be further classified under essential and non-essential. The prices can then be regulated under the Drug Price Control Order.

Once a device is implanted in the body, its safety and quality need to be ensured. And once it has been included in the Drugs and Cosmetics Act, no device can be introduced without a medical trial for which stringent ICMR guidelines are available.

As the clinical trials of these medical devices were not regulated, patients did not get free devices, full information or compensation if they failed. Due to the lack of regulation, most international companies were shifting their clinical trials to India and using Indian patients for new interventions.

Recently, one of my patients was referred for stenting and included in a trial for a drug eluting balloon and ended up paying for the treatment. If it was part of a trial, he should have been given full information about the trial and treated free. Like in the drug industry, every new drug molecule or its modification needs a clinical trial, but it is not happening in the medical device industry.

The clinical trials of medical devices are costly and time consuming. It is for this reason that the Indian Drug Controller should collaborate with neighbouring countries so that a study done in India is not repeated in Nepal, China or Sri Lanka. Similarly, studies done in China, Sri Lanka and Nepal need not be repeated in India. India is a mix of Aryans (Nepal population), Dravidians (Sri Lanka) and Mongolians (China). So why waste resources.

Dr KK Aggarwal

Padma Shri Awardee

President Confederation of Medical Associations in Asia and Oceania (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA