Regulation of medical devices in India
In India, the regulation of medical devices is governed by the Drugs and Cosmetics Act, 1940 and the rules framed thereunder. Medical devices are classified as drugs under the Drugs and Cosmetics Act, 1940 and are regulated as such. As per the Drugs and Cosmetics Act, 1940, a medical device is defined as any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by its manufacturer to be used in conjunction with the device.
However, the range of medical devices offered today is substantially more comprehensive than in 1940. Therefore, a need to address the gaps in the current regulatory framework for medical devices was felt. In 2018, the government released a draft of Medical Devices (Quality, Safety and Efficacy) Regulations, 2018 (“the proposed Regulations”) for public consultation.
The proposed Regulations were to replace the provisions of the Drugs and Cosmetics Act, of 1940 and the rules framed thereunder with respect to medical devices.
The proposed Regulations were notified on 26th December, 2018 and they:
i) provide for classification of medical devices based on the risks associated with their use;
ii) establish a system of registration and licensing of medical devices;
iii) set standards for quality, safety and efficacy of medical devices;
iv) provide for clinical investigations and post-market surveillance of medical devices; and
v) establish a National Regulatory Authority for medical devices.
On 11th February, 2020, the Ministry of Health and Family Welfare issued a notification giving a new definition of medical devices, the new definition is:-
All devices including an instrument, apparatus, appliance, implant, material or another article, whether used alone or in combination, including software or an accessory, intended by its manufacturer to be used especially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
a) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
b) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
c) investigation, replacement or modification or support of the anatomy or of a physiological process;
d) supporting or sustaining life;
e) disinfection of medical devices; and
f) Control of conception
Testing of medical devices
Before being released for public use, medical devices are tested in order to assess their safety and efficacy. Testing may be performed by the manufacturer, by an independent testing laboratory, or by the national regulatory authority.
After a medical device has been released for public use, post-market surveillance is conducted to monitor the device’s safety and efficacy. Post-market surveillance may be performed by the manufacturer, by an independent surveillance organization, or by the national regulatory authority.
The Central Licensing Authority (“the authority”) is the nodal agency regulating medical devices in India. The authority is headed by the Drug Controller General of India.
Responsibilities of the Central Licensing Authority
The Central Licensing Authority is responsible for
i) granting licenses for the import and manufacture of medical devices;
ii) inspecting manufacturing premises;
iii) testing samples of medical devices;
iv) investigating complaints about medical devices; and
v) taking action against erring manufacturers.
The Medical Devices Technical Advisory Board
The Central Licensing Authority is assisted by a Medical Devices Technical Advisory Board (the advisory board), which is responsible for advising the authority on technical matters.
The advisory board consists of a chairman, two members from the Indian Council of Medical Research, two members from the Department of Health Research, one member each from the All India Institute of Medical Sciences and the National Institute of Pharmaceutical Education and Research, four other members with expertise in the field of medical devices.
The advisory board in India aims to provide scientific and technical advice on the regulation of medical devices; coordinate and oversee the activities of the medical devices testing laboratories; review the classification of medical devices; and recommend measures for the safety, quality, and efficacy of medical devices.
Recall of the J&J hip implants and the Indian standards
An interesting case study in the regulation of medical devices in India is the recall of Johnson & Johnson’s hip implants. In 2010, Johnson & Johnson’s hip implants were found to be defective and were recalled from the market. The recall was initiated by the United States Food and Drug Administration and the action was later followed by the Indian regulators. The recall was a result of post-market surveillance conducted by the FDA. The FDA had found that the hip implants were failing at an unusually high rate and were causing serious health problems in patients. The recall was a joint effort of the FDA and the Central Licensing Authority. The Indian regulators had conducted inspections of Johnson & Johnson’s manufacturing premises and had tested samples of the hip implants. The investigations had revealed that the hip implants were not up to the standards set by the Indian regulators. The recall of the hip implants was a major setback for Johnson & Johnson in India. The company was forced to suspend sales of its hip implants in India and had to recall all the implants that had been sold in
The Indian regulators issued notice to the company, directing it to submit a detailed plant of action to recall the hip implants from the market. As an interim direction, they directed the company to halt manufacturing new implants.
In India, manufacturers have to comply with several requirements:
The essential requirements in regulating medical devices in India are that they should be safe and effective; of good quality; suitable for its intended use; manufactured in accordance with the Good Manufacturing Practices; properly labeled; packed in a manner that protects it from damage.
The quality requirements in the regulation of medical devices in India are they should be designed and manufactured in a way that ensures its safety and efficacy; made of materials that are safe and suitable for their intended use; free from defects; properly sterilised; and properly packaged.
The safety requirements in the regulation of medical devices in India are they should be designed and manufactured in a way that minimizes the risks of injury to the user and to third parties; designed and manufactured in a way that minimizes the risks of cross-contamination; designed and manufactured in a way that minimizes the risks of electrical shocks; designed and manufactured in a way that minimizes the risks of fire; designed and manufactured in a way that minimizes the risks of mechanical injury; designed and manufactured in a way that minimizes the risks of chemical injury; designed and manufactured in a way that minimizes the risks of radiation injury; sealed in a way that protects it from contamination; and designed and manufactured to minimise the risks of biohazardous material injury.
The labelling requirements prescribe that the medical devices must be labelled in a language that is comprehensible to the user; labelled in a way that allows easy identification of the manufacturer; allows easy identification of the place of manufacture; easy identification of the batch number; identification of the expiry date; provides instructions for use; provides warnings and precautions; and storage conditions.
The clinical requirements stipulate that the medical devices in India should be clinically tested before being introduced in the market; submitted to the Central Licensing Authority for review and approval; made available to the scientific community for peer review; conducted in accordance with the protocol approved by the Central Licensing Authority; monitored by an independent Ethics Committee; registered with a clinical trial registry; and reported in a scientific journal.
Post-market surveillance requirements
The post-market surveillance requirements in the regulation of medical devices in India are monitored after being introduced in the market; submitted to the Central Licensing Authority for review and approval; made available to the scientific community for peer review; conducted in accordance with the protocol approved by the Central Licensing Authority; monitored by an independent Ethics Committee; registered with a clinical trial registry; and reported in a scientific journal.
New Drugs, Medical Devices and Cosmetics Bill, 2022
The draft of the ‘New Drugs, Medical Devices and Cosmetics’ Bill, 2022 (NDMDC) in India has caused much debate due to its many shortcomings. The Indian medical device industry has heavily criticised this bill stating that it will cause irreparable damage to their sector and exert additional regulations on domestic manufacturers. Although this bill aims to ensure proper regulation of drugs and medical devices for safer healthcare, several inefficacies must be considered before passing this bill into law. This analysis will focus predominantly on the potential impact of NDMDC on the medical device industry, including issues such as accessibility, cost-effectiveness, outdated guidelines and technical concerns raised by regulatory authorities.
Accessibility: NDMDC introduces several rules and regulations that will adversely affect the accessibility of drugs, medical devices and cosmetics in India. The bill proposes to increase the number of approved safety and efficacy tests and inspection protocols, drastically increasing production costs and reducing product affordability and availability. This could further lead to increased cost to the consumer and a reduction in access to healthcare services.
Cost-effectiveness: The implementation of NDMDC will cause the cost of production to increase due to the additional tests and inspections required. This could make locally-produced medical devices and drugs less cost-effective when compared to imported products. This could also reduce the competitiveness of domestic manufacturers in the market, further harming the industry.
Outdated Guidelines: The current guidelines for medical devices and cosmetics included in the draft of NDMDC are highly outdated and may not take into consideration the advancements made in the medical field in recent years. This could limit innovation and make it difficult for the industry to adopt new technologies and practices. …
Technical Concerns: The proposed bill has received criticism from technical bodies and regulatory authorities due to its lack of scientific accuracy in assessing the efficacy of medical devices. This could lead to companies and manufacturers being held liable for product safety and efficacy, even if produced according to approved guidelines.
The NDMDC bill needs to be revised to ensure that it meets the requirements of both local and international manufacturers and offers a degree of flexibility for the industry in order to foster innovation and competition. The bill must also be modified to ensure scientific accuracy and proper clarity in medical devices, drugs and cosmetics definitions.
While the new bill is an important step forward in ensuring drug and medical device safety, it has several shortcomings that must be addressed in order to benefit the industry. It is essential that the bill is revised to ensure clarity in the definitions and technical accuracy to ensure that India’s population is able to access safe and quality healthcare services.
Annexure - 1
A non-exhaustive list of electronic medical devices in India:
||Timely diagnosis and monitoring of oxygen levels in the body
||Used for imaging organs and other structures inside the body
||Computer Tomography (CT) Scan
||To diagnose cancer and other diseases; measure blood flow; study the brain; and evaluate joint function
||Magnetic Resonance Imaging (MRI) machines
||Non-invasive imaging that starts with a powerful magnet to create images of tissues inside the body
||Used to hear sounds from within different parts of the human body such as lungs or heart
||Electrocardiograph (ECG) Machine
||To quickly detect heart rate irregularities and other cardiac abnormalities such as heart attack and congestive heart failure
||To mechanically support a patient’s breathing by injecting air into the lungs at set frequencies and volumes
||To identify any kind of blockage in the digestive system due to stomach ulcers or gall bladder issues
||Dialysis Machine/ Hemodialyzer/ Kidney Dialyser
||For kidney dialysis as part of treatment for life-threatening kidney problems such as chronic renal failure
||For delivering controlled amounts of medication such as insulin, analgesic drugs and other treatments into a patient’s bloodstream over a prolonged period of time with great precision & accuracy
||Neurological Monitors Trace & Neuroscanner
||For neurological monitoring including nerve pathways analysis during critical surgeries like spine surgery which requires a judgement call from the surgeon to monitor vibrations all through operation duration for pinpointing nerve locations before stopping vital parameters to the patient’s wellbeing
||Shoulder Abduction Orthosis/Brace
||To provide shoulder stability post orthopaedic surgeries so retina kinds joint instability is prevented when surgical procedures have been done in the shoulder region
||For quick diagnosis & treatment options associated with different joints without the need for open surgery
||Designed to restart life when electrical malfunctions take place inside the human body which restricts heartbeat
||Used naturally slow down irregular heartbeat activities & restoring natural track
||Utilize these testing batteries enable the detection of current audiometric hearing threshold levels