The Indian healthcare sector has gone through a significant change in the 21st century, and over these years, it has become one of the most growing sectors in India, and it is expected to grow to $50 billion by the year 2025.
EPR for Waste Medical Devices are an essential part of the healthcare industry. They are used for various purposes, such as treating and diagnosing diseases. The Indian medical device market is among the top 20 medical device markets globally. Medical devices deal with the safety and health of a patient; therefore, their manufacturing is done in a strictly regulated environment. For this purpose, the CDSCO, also known as Central Drug Standard Control Organisation (CDSCO), has developed structured rules and regulations for medical devices in India along with the Medical Devices (Amendment) Rules, 2020. CDSCO works under the ambit of the Drugs and Cosmetic Act of 1940.
Extended producer responsibility (EPR) is a waste management technique that involves including all environmental costs incurred by a product throughout the course of its life cycle in the product’s market price. Thomas Lindhqvist presented the idea for the first time in Sweden in a formal report to the Swedish Ministry of the Environment in 1990.
According to the EPR rules, electronic waste must be collected and recycled by at least 60 per cent by 2023 for electronics manufacturers and other businesses that produce e-waste; by the years 2024 and 2025, these percentages will rise to 70% and 80%, respectively.
Companies must register on a website and provide information about their annual production and e-waste collection goals. There are further rules specifically outlined for recyclers, refurbishers, and bulk buyers. The execution and coordination of the exchange of EPR certificates would be managed by a steering committee under the direction of the chairman of the Central Pollution Control Board (CPCB).
Medical device regulation in India
The developments in the healthcare sector, especially in terms of drugs and medical devices, have bought a significant change in the lives of people. EPR for Waste Medical Devices have increased the ability of doctors to diagnose and treat any disease, making it one of the most significant contributions towards the quality of health and life of a human being.
The Central Drugs Standard Control Organisation, also called as CDSCO, is a National Regulatory Authority of India. It comes under the preview of Directorate General of Health Services under the Ministry of Health & Family Welfare. It performs similar duties to those of the National Medical Products Administration (NMPA) of China, the European Medicines Agency (EMA), the PMDA of Japan, the Food and Drug Administration (FDA) of the United States, the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, and the European Medicines Agency (EMA) of the European Union. Additionally, CDSCO and state regulators are jointly in charge of issuing licences for certain specialised categories of drugs, including vaccines, blood and blood products, IV fluids, and sera.
Before 2005, India had no regulations governing medical devices. Today, however, there are registration processes for specific medical device types that are covered by the Medical Device Rules. While the list of regulated products is exhaustive, the CDSCO occasionally adds products to the list.
The term EPR for Waste Medical Devices have been defined under Section 3(b)(iv) of the Drugs & Cosmetics Act, and it has been classified into four (4) classes as per their risk level. The classification is as follows:
- Risk class A: This includes low- risk medical devices. For example: thermometers and tongue depressors;
- Risk class B: This includes Low- to moderate-risk medical devices. For example: hypodermic needles;
- Risk class C: This includes moderate-to high-risk medical devices. For example: lung ventilators and bone fixation plates;
- Risk class D: This includes high-risk medical devices. For example: heart valves and implantable defibrillators.
All the manufacturer of EPR for Waste Medical Devices in India must undergo the assessment procedure to ensure their compliance with the quality and safety standards before they are allowed to sell in Indian markets. For this purpose, CLAA, also known as Central License Approving Authority, has adopted the regulatory standards, the BIS full form Bureau of Indian Statistics and ISO full form International Organization for Standardization for quality management systems. So to meet these quality standards, all the medical device manufacturers are required to register themselves with these organisations; also, to expedite the whole process of registration, the central government has opened the SUGAM portal.
The following applicants can register via the CDSCO web portal to register their medical devices:
- Indian Agents
- Foreign Enterprises holding Indian Subsidiary
Lately, the status of a medical device was also enlarged beyond the 23 previously notified EPR for Waste Medical Devices on April 1, 2020, requiring that all medical devices be registered under The Drugs and Cosmetics Act of 1940. Beginning October 1, 2022, all Class A and B medical devices must be imported with an Import License. All remaining Class C and D devices that have yet to be notified will require Import Licenses by October 1, 2023.
What are EPR – E-Waste (Management) Rules 2022?
On November 2, 2022, the Ministry of Environment, Forests, and Climate Change published the E-Waste (Management) Rules 2022. The regulations will go into effect on April 1, 2023.
This regulation mandates that all electrical and electronic equipment producers, manufacturers, refurbishers, and recyclers must register on the portal, collect any e-waste generated during the creation of such equipment, ensure its refurbishment, and ensure its recycling or disposal. The Entities must register on the portal, choose the appropriate category (maker, producer, refurbisher, recycler, etc.), and then log in. If an entity falls under more than one category, it must register separately under each one. It is prohibited for any organisation to operate without registration.
Every entity is required to submit annual and quarterly returns in the prescribed format via the portal by the end of the month immediately following the quarter or year to which the return relates. All manufacturers, producers, refurbishers, dismantlers, and recyclers involved in the production, sale, transfer, purchase, refurbishment, dismantling, recycling, and processing of e-waste or electrical and electronic equipment specified in Schedule I are subject to these restrictions.
List of medical devices for EPR Registration
The list of EPR for Waste Medical Devices that must have EPR certification in order to continue manufacturing and selling in the Indian market is provided below:-
- Medical Devices (With the Exception of All Implanted and Infected Products)
- Radiotherapy equipment and accessories
- Cardiology equipment and accessories
- Dialysis equipment and accessories
- Pulmonary ventilators and accessories
- Nuclear Medicine Equipment and accessories
- Laboratory equipment for in vitro diagnosis and accessories
- Analysers and accessories
- Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) Scanner, Computed Tomography (CT) Scanner, & Ultrasound Equipment along with accessories
- Fertilization tests equipment and accessories
- Other electric devices, tools, and kits that are used for preventing, screening, detecting, monitoring, evaluating, reviewing, examining, investigating, probing, or treating illnesses, diseases, disorders, afflictions, infections, injuries, trauma, abuse, or disabilities, such as mobile phones, tablets, or any other device with the capability of sex selection and their accessories.
What are PIBOs?
The phrase PIBOs is referred to all the producers, importers and brand owners that uses plastic in packing their goods, irrespective of the turnover or scale of operation of their business, these will come under the obligation of EPR and therefore have to fulfil the following responsivities:
- PIOS are required to register on the EPR Portal
- They are required to submit their action plan
- Finally needs to fulfil all the following obligations:
- Use of Recycled content
- End of life disposal
- Optional engagement in collection and recovery of the plastics
- Submit their annual returns on time
Meaning of ROHs
RoHS is an abbreviated term for Restriction of Hazardous Substances and is also known as the Directive 2002/95/EC. It is derived directly from the European Union and is created solely to restrict the implementation of some hazardous substances found in most electrical and electronic products.
RoHS helps restrict certain hazardous substances in electrical and electronic equipment. This initiative aims to bring down the use of harmful substances and bring down the environmental effect and health impacts of electronics.
Benefits of EPR Registration Certificate
There are many benefits of EPR registration for medical devices, some of them are discussed below:-
- EPR encourages e-waste (Electrical and electronics waste) recycling and reuse, which lowers the cost of raw materials for producers and manufacturers.
- EPR ensures that e-waste is managed in an environmentally responsible way, reducing the negative effects of e-waste on the environment.
- EPR authorization from the Central Pollution Control Board (CPCB) improves the market reputation of the product and brand.
- EPR encourages sustainable development, which reduces waste production and resource usage.
Process involved in the EPR registration
The process of EPR Authorization or EPR Registration involves the following steps mentioned below:-
- Documentation: Before submitting the application, the applicant must complete all necessary paperwork along with an EPR authorization plan.
- Filling out the application in the required format: The applicant must include an EPR plan and complete the application in the required manner.
- Offline application submission: The applicant must submit an offline application to the appropriate department together with a thorough producer profile and EPR plan.
- Application scrutiny: A CPCB official will examine the application, and the CPCB will decide whether to approve the EPR plan. If the submitted documents are not full, a CPCB representative may reply with a checklist within 25 days for clarification.
- Grant of EPR approval: The EPR plan must be approved by the Chairman of CPCB after being examined by the relevant officials. The divisional head issues the EPR authorisation following the approval of the EPR plan.
List of documents for EPR registration
Here is the list of documents that you will be needed for EPR registration. All the documents are required to be submitted along with form-1
- Address proof documents of the Manufacturer/Importer.
- Details of your GST certificate with the address prof of your manufacturing unit.
- Copy of documents/certificate of Company Registrar or Directorate of company or Import Export code letter.
- A Copy of the agreement document with all the dealers, collection centres, dismantlers, recyclers, treatment, storage and disposal facilities (TSDFs) etc.
- Self-declaration for compliance with RoHS in the format prescribed.
- A copy of technical documents, such as supplier declaration- description of product, document for materials, parts, and/or sub-assemblies and analytical test result)
- A copy of the permissions/licenses from the relevant ministry/government department for marketing various products or for doing the business. The list is given below:
- Your TIN details
- Your PAN card details
- A copy of your Incorporation certificate
- Copy of IEC in case you are an importer
- A Copy of authorization issued by the SPCBs/PCCs
- Copy of all the other EPR-related documents
- Make the estimated budget for Extended Producer Responsibility (EPR)
Other waste management laws in India
The waste management in our country is done by the by MoEF also knows as Ministry of Environment, Forest and Climate Change. The ministry work together with the state and central pollution control board. Along with this central government has also enacted various laws to deal with the issue of waste management, these are as follows:
Environmental Protection Act of 1986
The above act was enacted by the government in the year 1986 to provide the protection to the environment related issues. The act has given power to the central as well as state government to make laws regarding waste management in the country. It is one of the oldest legislation for environmental protection and waste management.
Hazardous Wastes (Management, Handling and Transboundary Movement) Rules of 2008
Management of hazardous waste is a very complex issue to tackle with; therefore, certain rules and regulations are required. Keeping this in mind, the central government enacted the Hazardous Wastes (Management, Handling and Transboundary Movement) Rules of 2008. The rules put an obligation on the occupier of hazardous waste to safely discharge the waste into the environment. As per the rules, an occupier is defined as a person who operates a plant or a factory that produces hazardous waste as a result of their operation.
The Plastic Waste (Management and Handling) Rules of 2011
The above rules were enacted to set up a regulatory framework to control the manufacturing, usage and recycling of plastic waste.
Bio-Medical Waste Management Rules of 2016
The above rules were enacted to set up a regulatory framework for the bio medical waste. These waste s are usually generated during the treatment, immunization and treatment of human beings or animals or in research activities.
E- Waste (Management and Handling) Rules of 2011
The above rules were enacted to set up a regulatory framework to manage the disposal of e-waste and ways to recycle them.
E-Waste management is crucial since it contains dangerous materials that can have a negative impact on both the environment and human life. We can protect our environment and avert any potential harm to human health by properly disposing of E-Waste. E-Waste can also be viewed as a resource that contains materials that are beneficial to the economy and can be recovered to produce valuable metals, glass, aluminium, copper, and polymers.
Read our Article: How To Get A RoHS Certification In India?