Medical Equipment Notified as ‘Drugs’

From coming April 1 2020, all medical devices sold in the country would be treated as drugs and would be regulated under the Drugs and Cosmetics Act of 1940, the ministry of health and family welfare notified.

• The Drugs Act was formulated in 1940 in pursuance of recommendations of Chopra Committee constituted in 1930 by the Government of India. 
• The Act regulates the import, manufacture and distribution of drugs in India.
• The primary objective of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to prescribed quality standards. 

The notification:

• According to the notification, all medical devices would be treated as drugs in India and they would be regulated under the Drugs and Cosmetics Act, 1940.
• The ministry also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices.
• 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 the quality and safety of their products, a senior official said.
• Notification also read that 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 April 1, 2020.
• Once notified, the manufacture, import and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO).
• Further, once the notification is issued, the CDSCO will also be the nodal authority to investigate complaints related to the quality and safety aspects of medical devices and can suspend the registration or cancel licences of firms.

Devices covered:

• All devices, including instruments, apparatus, appliances and implants, whether used alone or in combination for various purposes like diagnosis, prevention, monitoring, treatment, alleviation of any disease, investigation, replacement or modification or support of the anatomy among others, will be regulated under the legislation.
• At present, only 23 categories of medical devices are regulated under the law.

Past recommendations:

• The country's highest advisory body on technical issues related to drugs and medical devices, the Drugs Technical Advisory Board (DTAB), had in April 2019 recommended that all medical devices should be notified as drugs under the Drugs and Cosmetics Act.

Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices:

• The medical devices referred shall be registered with the central licensing authority via an online portal established by the CDSCO for the purpose.
• The manufacturer of a medical device or any person who imports any medical device will have to upload the information related to that medical device for registration on the "Online System for Medical Devices" established by the CDSCO for this purpose.
• Further, the notification also provides timelines for medical devices that will be notified under the Act with effect from April 1 -- 30 months for low and moderate-risk devices (Classes A and B), 40 months for moderately high and high-risk devices (Classes C and D).
• Upon the expiry of these periods, all provisions of the Medical Devices Rules 2017 will apply to the respective devices.

Conclusion:

• While this is a positive step, as per the timeline, it will still take a long time before many higher-risk devices are regulated.
• Consumer groups remain sceptical about how the CDSCO's current ability to regulate devices under the wider scope. They are varying of CDSCO’s competence, expertise and most importantly its commitment towards patient safety given its dismal track record.
• Thereby, the need of the hour is comprehensive reforms to strengthen the regulatory mechanism about patients' safety. These may include guidelines for the approval of devices including clinical investigation requirements, oversight of marketing and promotion, putting in place a robust and functioning system of adverse event reporting accessible to the public, rules for voluntary and statutory recalls, and patient compensation scheme.