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How New Plastic Waste Management (PWM) Rules in India Are Affecting Medical Device Manufacturers
Published on: August 18th, 2023
In May of 2023, India’s Central Pollution Control Board (CPCB) issued an update on plastic packaging and other products to all manufacturers and importers of medical devices. At the same time, the CPCB has updated the E-Waste Product List. These updates will affect medical device manufacturers and importers in a number of important ways, including fees for handling plastic waste and new application and registration rules.
Plastic waste management (PWM) requirements will now be imposed on all product importation and full compliance is required by July 1, 2023. Applications will be processed within two weeks and the licenses will remain valid for 1 year and then renewed for three years at a time per the Waste Management Rules, 2016 (page 10). Should the application not be approved at the time of importation, customs agents are to allow the importation or products with evidence of a submitted PWM application.
While not onerous, accounting for the plastic being imported and obtaining the appropriate registrations are requirements for manufacturers importing into India moving forward. Please contact us if you require assistance.
What This Means to Medical Device Manufacturers
The most important items to know about the PWM requirements, as they pertain to medical device manufacturers, are as follows:
- The manufacturer or their importer must obtain an Extended Producer’s Responsibility (EPR) registration to import any medical device (product) using plastic material or plastic packaging.
- This requirement began April 1, 2023; however, an extension was granted until June 20, 2023 for companies that had already applied for registration but had not yet received it.
- Manufacturers or importers will need to quantify the plastic content of their products and become licensed based on that calculation.
- Plastic packaging included in this requirement includes
- Category I: Rigid plastic packaging;
- Category II: Flexible plastic packaging of single layer or multilayer (more than one layer with different types of plastic), plastic sheets or similar and covers made of plastic sheet, carry bags, plastic sachet or pouches;
- Category III: Multilayered plastic packaging (at least one layer of plastic and at least one layer of material other than plastic);
- Category IV: Plastic sheet or similar used for packaging as well as carry bags made of compostable plastics.
- Additionally, the plastic waste being created in the importation process must also be quantified and reported.
- The CPCB has also set target goals for the minimum level of recycling of plastic packaging waste and mandatory use of recycled plastic in packaging waste.
- Plastic packaging included in this requirement includes
- The process is not overly complicated but is a new requirement for importing products into India. Asia Actual’s local Delhi office has been providing this support to clients ahead of the deadline and is available to assist if needed.
- Some medical devices may also need to meet additional e-waste requirements. More information to come. Please contact us if you believe your product may require E-Waste management.
Plastic Waste Management (PWM) Requirement List
The new guidelines outline that waste from plastic packaging must be managed and collected in a manner that is environmentally sustainable, as laid out in the EPR of the producer, importer or brand owner.
Per the new requirements, there will be recycling charges administered according to the following:
|* GST is extra as applicable.|
Application Process for PWM Registration Application
The following information will be required when applying for PWM registration.
- The category of plastic (please see the attached Excel file for more information –categories are listed with the images).
- The quantity (in kilograms) of plastic packaging. This includes various measurements such as thickness, and either primary or secondary packing or final bubble wrap or any sheet used for the shipment.
The application fees for PWM registration are based on waste generated in tonnes per Annum (TPA).
|Plastic Waste Generation (TPA)||Application Fee (Rupees)|
|<1000||10000 Rs ≈ US $120|
|1000-10000||20000 Rs ≈ US $240|
|>10000||50000 Rs ≈ US $600|
Registration Grace Period
For companies in India who have not acquired the registration certificate, they have the opportunity to import on the basis of the registration application, according to a notification issued by the Regulatory Authority.
The notification states that any importer that has begun the registration process but has not yet received approval can import on the basis of registration submission.
Plastic Waste Recycling Goals
With the implementation of the new requirements, India wishes to improve the management of plastics entering and used in the country. As stated in the draft Plastic Waste Management Rules, 2022: “The Producer shall ensure minimum level of recycling (excluding end of life disposal) of plastic packaging waste collected under Extended Producer Responsibility Target, category-wise…”
Below is the minimum level of recycling (excluding end-of-life disposal) of plastic packaging waste (% of extended producer responsibility target), which increases annually until 2027:
|Plastic packaging category||2024-
Additionally, manufacturers will be required to use a minimum percentage of recycled plastic in packaging, again increasing annually until 2027:
|Plastic packaging category||2024-2025||2025-2026||2026-2027||2027 onwards|
E-Waste Registration Requirements
Additionally, there are some changes being made to requirements surrounding registering electronic waste, or e-waste. Some products (including several medical devices) are being added to the E-Waste Product List organized by the CPCB.
If a certain product is listed, the product will need to be registered as e-waste under the manufacturer’s EPR. Contact us to learn if your product is affected by the E-Waste requirements.
Additional Information and Important Links
Further information on Plastic Waste Management (PWM) rules/requirements can be found at the links below from the CPBC:
- 2nd Amendment of Plastic Waste Management Rules, 2022
- Guidelines on Extended Producer Responsibility for Plastic Packaging
- Draft Plastic Waste Management Rules, 2022
- Draft Notification on Extended Producer Responsibility (EPR)
- Plastic Waste Management Rules, 2016, as amended, 2021
- Plastic Waste Management Rules, 2016, as amended, 2018
Come Grow With Us
Please contact us if you need more information on medical device registration in Vietnam. Asia Actual has an office in Vietnam located in Ho Chi Minh City staffed by experienced, bilingual regulatory and commercial professionals that will address any questions or provide support.
Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asian markets through independent license holding, direct fulfillment, and a variety of sales channel support services.