India plastic packaging EPR for medical products: scoping the obligations

The rules define plastic packaging as packaging material made using plastics to protect, preserve, store and transport products (rule 3(oa)). List each pack the business places on the Indian market, with its material, size, the product it holds, and whether it is sold in India or exported against an export order. Packaging used for products exported against an export order is outside the main EPR duty in rule 9(1) (rule 2(3)).

Then assign each pack to one of the five categories in Schedule II, paragraph 5.1. Category I is rigid plastic packaging. Category II is flexible plastic packaging of one or more plastic layers, including plastic sheets and covers, carry bags, sachets and pouches. Category III is multilayered packaging with at least one layer of plastic and at least one layer of another material. Category IV covers compostable plastic sheets, carry bags and commodities, and Category V, added on 14 March 2024, covers biodegradable ones.

Take a fictional company, Quarnby Medical. Its Indian subsidiary imports diagnostic test kits in rigid cases with 500 ml reagent bottles, inside sterile pouches of paper and plastic, on pallets wrapped in stretch film. An Indian contract manufacturer also fills a sterile irrigation solution into 1 litre rigid bottles sold under Quarnby's registered brand. That gives three categories: the cases and bottles are Category I, the stretch film is Category II, and the paper and plastic pouches are Category III.

Three roles carry the obligations, and one company can hold more than one.

An importer imports any plastic packaging, or any commodity with plastic packaging, for commercial use (rule 3(k)). Quarnby's subsidiary is the importer of the kits and their packaging. The Central Pollution Control Board's (CPCB) guidance says importers report the packaging that comes with imported products.

A brand owner sells any commodity under a registered brand label or trademark (rule 3(b)). The subsidiary is the brand owner for the irrigation solution.

A producer makes plastic packaging or intermediate material, and includes a contract manufacturer that makes products using plastic packaging for a brand owner (rule 3(s)). Quarnby's contract manufacturer is a producer.

Micro and small enterprises have some relief. Producers and brand owners that are micro or small enterprises fall outside the main EPR obligations, but producers among them must still register and meet the recycled content targets (Schedule II, paragraphs 4, 6.1 and 7.8). Importers get no such relief, whatever their size. No one may deal with an unregistered producer, importer or brand owner (paragraph 6.3), so check the registration of each supplier and contract manufacturer as well.

The only medical provisions are the exemptions from the recycled content and reuse targets, introduced on 31 March 2026. Before then, CPCB granted exemptions case by case, under the 2022 EPR guidelines. Now the company decides whether one applies and records the legal basis in its annual return on the centralised online portal.

Each exemption needs a specific provision. The recycled content targets don't apply where a central government law, a rule of a statutory body such as the Central Drugs Standard Control Organisation (CDSCO), or a mandatory Indian standard doesn't permit recycled plastic in that packaging (Schedule II, paragraphs 7.2(d), 7.3(d) and 7.4(e)). The reuse targets for brand owners don't apply where it doesn't permit reuse of that rigid packaging (paragraph 7.4(b)). A general view that medical packaging needs virgin plastic isn't a provision.

For Quarnby, the pallet film and outer cases keep their targets unless a provision covers them. The irrigation solution differs if it is a drug made under Schedule M to the Drugs Rules. Schedule M, Part I, paragraph 14.26 (as revised on 28 December 2023) bans second-hand or used containers and closures, which supports a reuse claim for its 1 litre bottles. The same paragraph requires containers and closures to meet pharmacopoeial requirements, and paragraph 14.26.3 applies the Indian Pharmacopoeia to packaging material.

The Pharmacopoeia's chapter on primary packages, as published in 2018, prohibits post-manufactured material in plastic containers. It also requires that no post-consumer recycled material is used, and requires virgin plastic for containers of parenteral preparations. The same rules apply to plastic closures. That supports a recycled content claim for the bottles and their caps, once Quarnby's team confirms the wording in the 2026 edition, in force since 1 July 2026. The chapter covers only primary packaging. No equivalent provision applies to the reagent bottles in the test kits, which are medical devices.

Packaging that ends up as bio-medical waste at a hospital isn't excluded either. The Bio-Medical Waste Management Rules 2016 govern how healthcare facilities handle that waste, and neither set of rules exempts the packaging from EPR.

Registration is one-time, through CPCB's centralised online portal (rule 13(2)). A company registers separately for each role it holds, and units in different States register separately, with one registration per role in each State (Schedule II, paragraph 6.5). CPCB registers companies operating in more than two States, and the State board or committee registers the rest. No business may be done without registration (paragraph 6.2).

The targets for 2026-27, the year from 1 April 2026 to 31 March 2027, step up each year. Recycling must make up at least 70% of the EPR target for Category I, and 50% for Categories II and III. Recycled content must reach 40% for Category I, 10% for Category II and 5% for Category III, where Category III counts only the plastic layers. Brand owners of rigid packaging from 0.9 to under 4.9 litres or kilograms must reuse 15%, and larger sizes have their own reuse targets.

Producers, importers and brand owners file an annual return by 30 June after the end of each financial year (paragraph 10.6), so the 2026-27 return is due by 30 June 2027. The central government may allow returns up to nine months late (paragraph 12.9), and returns for 2024-25 were extended to 31 March 2026. Any shortfall incurs environmental compensation, which doesn't discharge the obligation (paragraph 9; rule 18). Since 23 January 2025, rule 19 has also allowed penalties under the Environment (Protection) Act.

Marking applies too. Each plastic pack carries the producer's, importer's or brand owner's name and registration number, printed in English (rule 11(1)). Since 1 July 2025, a barcode, QR code or unique number may carry this information instead, if CPCB is informed (rule 11(1A)). Rule 11(1) doesn't apply to packaging covered by rule 26 of the Legal Metrology (Packaged Commodities) Rules 2011, or where printing isn't technically feasible. That packaging needs CPCB approval, and the details go on the packaging that holds the units together. Packaging with recycled content is labelled to IS 14534:2023 (rule 11(2)).

Write the assessment as one record per pack. It gives the material and category, the legal entity and its role, the registrations by role and State, and the year's targets. It also records any exemption claimed with the provision cited, the marking method and the return due date.

For Quarnby, the record shows the subsidiary as importer for three categories and brand owner for one. It names the contract manufacturer and its registration. If Schedule M applies to the irrigation solution, the record gives reuse and recycled content claims for its 1 litre bottles and caps, citing paragraph 14.26 and the Indian Pharmacopoeia chapter on primary packages. The test kits, pouches and film carry no claim.

Then watch for changes. The rules have been amended 11 times since 2016, twice since January 2025. The 2026 exemption wording itself came from a draft of 3 June 2025 that changed before adoption. The 31 March 2026 amendment also asked CPCB to issue audit guidelines for recycled content. Check the Gazette of India for amendments and CPCB's portal for extensions and guidance before each return.