Why in News?

• The Ministry of Health and Family Welfare has recently notified that medical equipment would qualify as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act (D & CA), 1940 from 1^st April, 2020.

What does Section 3 of the Drugs and Cosmetics Act, 1940 says?

• The Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), specifies the devices intended for use in Human Beings or Animals as Drugs.

About Drugs Technical Advisory Board:

• Drugs Technical Advisory Board is a statutory bodyconstituted under the Drugs and Cosmetics Act, 1940.
• The function of DTAB is to advise the Central government and State government on technical matters related to drugs and cosmetics. It is a decision making body related to Drugs and Cosmetics in the country.
• It is also part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.

About the News:

• The Medical Devices Amendment Rules, 2020 were released recently which will come into force from 1st April, 2020.
• The Rules state that the medical devices shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO).
• Such registration is voluntary for a period of 18 months, after which it will be Mandatory.
• The move comes in the wake of years of controversy about faulty hip implants of Johnson & Johnson (J&J).
• DePuy, a subsidiary of Johnson & Johnson, engineered a hip replacement device that used metal in prosthetic components, commonly called “Articular Surface Replacement orASR hip implant”.
• The manufacture, import and sale of all medical devices will now need to be certified by the Central Drugs Standard Control Organisation.

What is the Concern?

• Concerns are being raised that the rules are very rigid and any non-conformity can be treated as a criminal offence by any drug inspector under the Act at his discretion.
• At present, only 23 medical devices have been classified as drugs. The latest notification gives a wide definition of the term medical devices.
• The devices used for diagnosis, monitoring, treatment, assistance for any injury or disability, investigation, replacement or modification or support of the anatomy or of a physiological process will come within the scope of the definition of ‘Drugs’.
• Medical equipment under this definition include implantable medical devices such as knee implants, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine etc.
• Primary intended action of the device in or on human body or animals should not be pharmacological or immunological or metabolic.

Why such Rules Initiated?

• The aim is to regulate all medical devices so that they meet certain standards of quality.
• Besides it will also make medical device companies accountable for quality and safety of their products.

What are the Possible Impacts?

• The decision is going to have a major impact on the small and Marginal Players, Largely Unorganised, in the low-value high volume segment of the medical devices industry.
• The hi-tech diagnostic imaging sector is dominated by large players and will be the least Impacted.

Way Forward:

• Merely expanding the scope of regulation to all devices is not enough in a moment of growing number of safety Disasters Involving Devices.
• Hence, there is a pressing need for framing of a New Medical Devices Act.