The Ministry of Health and Family Welfare is going to create a regulatory framework for regulation of medical devices. There will be no need to pass a separate law from the Parliament to regulate the market for medical devices by building a regulatory framework.
- The Drugs and Cosmetics Act, 1940 empowers the Ministry of Health and Family Welfare to create such a regulatory framework.
- The first effort to create such a regulatory framework was made by the Ministry in the year 2017 through the Medical Devices Rules, 2017. At that time, some medical devices were notified as a drug, but the current regulatory framework is likely to include all types of medical devices.
- Irresponsible and unethical treatment of patients by medical companies in India is being considered as the main reason. It is worth noting that some time ago there were widespread irregularities in the case of hip plant equipment.
Drugs and Cosmetics Act, 1960
- The Act was enacted before independence, which has been around 80 years.
- Under this Act, manufacture, import and distribution of drugs are regulated in India.
- The main goals of this Act are to determine the safety, efficacy and safety parameters of medicines and cosmetics in India.
Medical Equipment Rules, 2014
- It came into effect in January 2018 and is applicable to medical devices and in-vitro diagnostic medical devices.
- Through this, the process of obtaining license has been done online.
- Thus, this rule applies to certain medical devices whose use in the Indian market is subject to certain regulations.
Johnson & johnson hip implant case
- In the year 2018, Johnson & Johnson was in discussion about a defect in its hip plant. After the hip plant, cobalt-chromium leaked into people’s bodies with this medical device. This led to serious health problems such as metal contamination of the blood, excessive pain, damage to body parts etc.
- The Johnson & Johnson Company then compensated American patients who had an implant defect. But in India, the company was ordered by the government to give compensation to the 4700 people who have been victims of this problem but due to lack of effective regulation in India, the company challenged the order of the government.
- Thus companies like Johnson & Johnson in India are taking advantage of the lack of laws and regulations, as well as exploiting patients.
- This step of the Ministry of Health is an attempt to make rules with a medium of notification instead of law making from Parliament. It is worth noting that only Parliament has the right to impose new punishments and offenses, which cannot be done by any executive order. It is important to note that the Medical Equipment Rules 2017 do not provide any type of punishment.
- The Medical and Cosmetic Act provides for penalties for medicines of inferior and inappropriate standards. But the notification of medical devices as medicine will not solve the problem because the second list of this Act only prescribes appropriate standards for medicines but it does not set standards for medical devices. It is worth noting that it is not possible to pass judgment on the quality of a product without a standard.
- If the current proposal is accepted, it will violate the right to health of the people in India, but these devices will still remain in line with Indian drug law. Apart from this, even if action is taken against a drug maker, he will still avoid any major punishment. Lack of political will and lack of effective law and regulations can be considered as the main reason for this. The present proposal also makes no provision for action against willful pharmaceutical products manufactured by willful pharmaceutical companies.
- Setting standards for medical devices is a complex task, as these standards are based on relatively new technology and have an absolute lack of expertise.
- There is no provision in the current proposed framework for manufacturers of substandard medical devices. Under this framework, the manufacture and sale of a medical device can be restricted only under Section 26A.
- In view of the experiences of the Johnson & Johnson case, it seems clear that there is no provision of any punishment or punishment in India for an implant in a patient who has suffered a serious health loss.
- In order to provide justice to the people in the Johnson & Johnson case, the government faced extreme difficulty in enlisting such patients as no hospital or doctor was willing to inform the patients about the implant problem.
- Legislation should be passed by the Parliament for medical devices so that the provisions of punishment and punishment can be increased.
- According to medicine, a standard code for medical devices should be created. This will protect the rights of patients.
- There should be a provision for blacklisting such companies which willfully or intentionally manufacture such devices for greater benefit.
- Along with restricting the product, stringent action should also be taken against the manufacturing companies.
- A national registry related to the implantation of medical devices should be created and patients should be warned of the future danger and provide appropriate justice if required.
The Government of India is going to notify medical devices as medicine. Various apprehensions are being expressed about this move of the government. It is believed that the current regulatory framework of the government will not be able to protect the rights of patients. Also, notifying it as a medicine can also give rise to many problems as the nature of medicine and medical equipment are highly diverse. Therefore, the government should take decision by involving experts and various interest groups before such regulation so that India’s medical field is not adversely affected, and no patient is denied the right to his dignified life.
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Medical equipment in india
Medical equipment in india