Drugs & Cosmetics Act and PWM: Effects on Medical Devices

The Drugs & Cosmetics Act of 1940, underpinning the regulatory framework for healthcare in India, has paved the way for remarkable advancements in medical diagnostics and treatment through the innovation and implementation of medical devices. India’s healthcare sector, expected to reach $50 billion by 2025, is not only a testament to its rapid growth but also to its commitment towards integrating sustainable practices, notably through Extended Producer Responsibility (EPR) for waste management. The Central Drug Standard Control Organisation (CDSCO) enforces stringent regulations under the Drugs & Cosmetic Act of 1940 and the Medical Devices (Amendment) Rules, 2020, ensuring that medical devices manufactured and imported meet high safety and environmental standards. 

EPR for Medical Devices in India: Classification and Compliance

In May 2023, India’s Central Pollution Control Board (CPCB) introduced revisions to regulations concerning plastic packaging and other items, specifically targeting manufacturers and importers of medical devices. Concurrently, there were updates made to the E-Waste Product List. These changes significantly impacted those involved in the medical device sector by introducing new fees associated with plastic waste management and altering the requirements for applications and registrations.In the context of EPR, waste medical devices in India are classified into four risk levels according to the Drugs & Cosmetics Act Section 3(b)(iv):

1. Class A: Low risk (e.g., thermometers)
2. Class B: Low-to-moderate risk (e.g., needles)
3. Class C: Moderate-to-high risk (e.g., ventilators)
4. Class D: High risk (e.g., heart valves).

Revision of the Plastic Waste Management (PWM) Rules by CPCB

In May 2023, the CPCB of India updated PWM rules, affecting medical device sectors. Key changes include compulsory plastic waste management fees, streamlined application processes for a two-week review, and a July 1, 2023, compliance deadline for imported medical devices. Initial licenses are now valid for one year, renewable for three, as per the 2016 guidelines. Importantly, products can enter customs with proof of pending PWM application, ensuring continuous market access. 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.

Producers, Importers, Brand Owners and Extended Producer Responsibility Compliance

PIBOs, representing producers, importers, and brand owners, encompass all businesses that use plastic in packaging their products, regardless of their turnover or operational scale. Falling under the EPR mandate, these entities are obligated to undertake comprehensive responsibilities to ensure environmental sustainability. They must register on the EPR Portal and submit a detailed action plan that outlines their approach to recycling, reusing materials, incorporating recycled content, and ensuring proper end-of-life disposal of plastics. Additionally, participation in the collection and recovery of plastics is optional but encouraged. Compliance also requires the timely submission of annual returns, reinforcing their commitment to fulfilling EPR mandates.

Plastic Waste Management(PWM) Compliance for Medical Device Importers:

The registration fees for managing plastic waste are determined by the annual volume of waste produced, measured in tonnes per annum (TPA)

Plastic Quantification: 

• Required for licensing, covering all packaging types. 
• Import-related plastic waste must be reported.
• Recycling Goals: CPCB mandates recycling targets and the use of recycled materials in packaging
• E-Waste Rules: Additional regulations for certain devices.

Furthermore, manufacturers are obligated to incorporate a specified minimum proportion of recycled plastic into their packaging. This requirement will see a gradual increase on an annual basis, extending through to 2027

The EPR Authorization or Registration Process

The process for obtaining EPR authorization or registration involves several critical steps, designed to ensure compliance with EPR mandates. This includes the preparation and submission of documentation, followed by application scrutiny and approval. For EPR registration, entities must submit a comprehensive set of documents along with Form-1, including but not limited to:

• Address proof of the manufacturer/importer.
• GST certificate details with the address proof of the manufacturing unit.
• Company registration documents or Import Export Code letter.
• Agreements with dealers, collection centers, dismantlers, recyclers, and TSDFs.
• RoHS compliance self-declaration in the prescribed format.
• Technical documents, including supplier declaration, product descriptions, materials, parts, sub-assemblies, and analytical test results.
• Permissions/licenses from relevant ministries or government departments for marketing or business operations.
• TIN and PAN card details, incorporation certificate, and Import Export Code (IEC) for importers.
• Authorization from State Pollution Control Boards (SPCBs)/Pollution Control Committees (PCCs).
• Estimated budget for Extended Producer Responsibility (EPR).

India’s Environmental Protection and Waste Management Legislation

India’s efforts in environmental protection and waste management are supported by significant legislation, beginning with the Environmental Protection Act of 1986. This foundational act has been followed by specific rules targeting hazardous wastes, plastic waste, bio-medical waste, and e-waste. These regulations collectively aim to ensure the safe disposal of hazardous materials, reduce plastic pollution, manage medical waste, and recycle e-waste, recognizing its potential as a resource. Effective management of e-waste is essential for safeguarding environmental and human health, highlighting the importance of these regulations in promoting sustainability and resource recovery.

Morulaa’s Role in Addressing EPR Challenges for Overseas Manufacturers

As India continues to advance in healthcare and medical device innovation, the integration of environmental sustainability into these advancements is increasingly critical. For overseas manufacturers looking to navigate the complexities of India’s regulatory environment, particularly in terms of plastic waste management and adherence to the Drugs and Cosmetics Act Morulaa offers a direct and effective pathway to compliance and market entry. Morulaa’s comprehensive services are designed to streamline the regulatory compliance process, ensuring manufacturers can focus on their core operations while meeting India’s stringent environmental and safety standards. To get in touch you could either email us on admin@morulaa.com or Click Here.

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