India’s rapid industrial growth, driven by rising consumer demand, has led to a surge in environmental pollution, particularly from plastic waste, e-waste, and batteries. To tackle this, the Central Pollution Control Board (CPCB) and State Pollution Control Boards (SPCBs) have introduced Extended Producer Responsibility (EPR) regulations. These rules make producers, importers, and brand owners responsible for managing the waste their products generate.
In India, EPR registration is now mandatory for specified producers, importers, and brand owners, requiring them to collect, recycle, and ensure the safe disposal of plastic waste, e-waste, and batteries. At the same time, it is also mandatory for businesses to implement a waste management awareness plan.
This blog provides a simple and clear guide to EPR registration in India. Read on to learn more.
What is the Extended Producer Responsibility (EPR)?
Extended Producer Responsibility (EPR) is a policy approach that holds Manufacturers, Importers, and Brand Owners of specified Electrical and Electronic Equipment (EEE), plastic packaging, and batteries accountable for managing the post-consumer stage of their products’ lifecycle. This includes collection, recycling, and environmentally sound disposal. Notified by the Ministry of Environment, Forest, and Climate Change (MoEF&CC), EPR is implemented by the Central Pollution Control Board (CPCB) and State Pollution Control Boards (SPCBs) to reduce waste, promote recycling, and encourage sustainable product design. Eligible manufacturers, importers, brand owners etc. must register under the EPR framework with the relevant regulatory authorities before conducting business in India.
Who requires EPR Registration?
Not all businesses in India require Extended Producer Responsibility (EPR) registration. EPR regulations specifically apply to entities involved in the production, import, or use of designated product categories, such as plastic packaging, electrical and electronic equipment (EEE), and batteries.
Thus, for medical devices with plastic packaging, electrical/electronic components, or batteries, the manufacturer/importer must obtain EPR certification.
How to Register for EPR?
General EPR registration process involves following steps:
- Preparation of Documents: This involves compiling a comprehensive set of documents, including a robust EPR plan which demonstrates the organizations commitment to environmental responsibility and is crucial for a successful application.
- Fill In the Application: Once all the necessary documents are prepared, the next step is to fill out the application form in the specified format prescribed by the relevant authority (CPCB or SPCB) and submit it along with the prepared EPR plan and other supporting documents.
- Fee Payment: The applicable EPR registration fee may vary based on product category and scale of operation and is submitted along with the application via the designated payment gateway specified by the CPCB or SPCB.
- Scrutiny: The CPCB/SPCB will scrutinize the application and verify the information provided and may, if necessary, ask for additional information or clarification.
- Grant of EPR Authorization: If the application is complete and satisfactory, the CPCB/SPCB will grant EPR authorization which includes a registration number and specifies the conditions for compliance.
List of Medical Devices Requiring EPR Registration in India
List of medical devices that require EPR registration in India are as follows:
- 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
- Analyzers 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. This includes items like mobile phones, tablets, or any other device used for sex selection and their accessories.
Validity
The EPR license validity as per the waste category is as follows:
- Plastic waste- Lifetime
- Electronic waste- 5 years
- Battery waste- 5 years
Benefits of Obtaining EPR Registration:
There are several benefits from obtaining EPR registration in India such as:
- Legal Compliance: EPR registration ensures that organizations comply with environmental regulations, helping them avoid penalties and legal issues.
- Brand Reputation: EPR registration demonstrates a brand’s commitment to environmental responsibility, which builds consumer trust, enhances goodwill, and strengthens brand image.
- Better Waste Management: EPR encourages organizations to collect and recycle waste, leading to better waste management. It also promotes the use of recycled materials, helping to reduce raw material costs.
- Streamlined Operations: By establishing a clear framework for waste management, companies can streamline operations and potentially reduce costs through more efficient material management.
How Regulatory Solutions India Can Help You?
Regulatory Solutions India (RSI) , with expertise since 2011, not only assists medical device companies with CDSCO regulatory compliance but can also help you obtain EPR registration from Pollution Control Board. We handle all required documentation, ensuring your devices meet all necessary regulatory standards and compliances that are required for seamless business operations in India.
Navigate the Indian medical device market with confidence. Our expertise ensures your products meet all safety and compliance standards. Discover how we can help. Visit us here.
