TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. we hope you enjoy reading it.

1. Maharashtra Health Minister has reportedly announced reforms for increased hospital safety such as independent third-party testing of medicines supplied to state hospitals. Other proposed reforms include stricter oversight on medicine procurement, manpower increase in Maharashtra Medical Goods Procurement Agency (MMGPA) and enhanced enforcement of the Bombay Nursing Act. Plans for regulating private labs, flying squads for inspections, and public hospital makeovers with standardised designs were also announced.
Source: bit.ly/3DE8QQy

2. The Central Pollution Control Board (CPCB) has issued show cause notices under the Environment (Protection) Act, 1986, to Producers, Importers, and Brand Owners (PIBOs) for failing to meet Extended Producer Responsibility (EPR) obligations under the Plastic Waste Management Rules, 2016. Non-compliance includes not filing annual returns for FY 2022-23 and FY 2023-24 and falling short of EPR targets. Affected entities must respond within 7 days or face Environmental Compensation (EC) penalties and stricter enforcement measures.
Source: bit.ly/3W3Deua

3. The Indian Council of Medical Research (ICMR) has released the draft second edition of the National Essential Diagnostics List (NEDL), inviting stakeholder suggestions by January 15, 2025. The revised list aims to enhance diagnostic services across all healthcare levels, including Ayushman Arogya Mandirs, Primary Health Centres (PHCs), and Community Health Centres (CHCs) and Sub-District Hospitals (SDHs) with a focus on underserved areas. It aligns with national health programmes and incorporates technological advancements like point-of-care testing to ensure accessibility and affordability.
Source: bit.ly/4059Qor

4. The Indian Government (Ministry of Textiles) has issued the Medical Textile (Quality Control) Amendment Order 2025. This amendment states that if the manufacturer / importer certified by the Bureau or any manufacturer / importer who has applied for certification has declared its old stock products  which are without BIS  Mark manufactured or imported before the commencement of the timeline of implementation (mentioned below) of the order, such manufacturer / importer shall be permitted to sell or display to offer to sell such declared stock up to 30th June, 2025. The key timelines are as follows: For Large and Medium Enterprises: 1st January, 2025 ; For Small and Micro Enterprises: 1st April, 2025
Source: bit.ly/4fDZi5q

5. India’s Union Health Minister has banned the manufacturing and sale of Non-Steroidal Anti-Inflammatory Drug (NSAID) drug nimesulide for animal use due to its toxicity to vultures, causing mortality through visceral gout and renal failure. The ban follows recommendations by the Drugs Technical Advisory Board (DTAB) and studies by the Bombay Natural History Society (BNHS). Safer alternatives are available, and measures to prevent misuse of the drug in humans have been proposed.
Source: bit.ly/4fOz8Nk

India’s Central Pollution Control Board issues guidance and clarifications on E-Waste Management

Important clarification issued by India’s Central Pollution Control Board (CPCB) under E-waste Management Rules, 2022 for the importers of Electrical and Electronic Equipment (EEE) who are not required to comply with Extended Producer Responsibility (EPR) requirements.

India’s Central Pollution Control Board has issued a clarification under E-waste Management Rules, 2022 (EWM Rules) identifying importers of Electrical and Electronic Equipment (EEE) who are not required to be registered as Producers under EWM Rules and therefore do not need to fulfil Extended Producer Responsibility (EPR) obligations. Such producers are required to submit certain documents to Customs/Port authorities as a proof of submission of those documents to CPCB.

List of Producers that are not required to be registered are as follows:

1. Producers that are engaged in import of Electrical and Electronic Equipment (EEE) including their consumables, components and spare parts which are not listed in Schedule 1 of the EWM Rules.

2. Producers that are engaged in import of Electrical and Electronic Equipment (EEE) including their consumables, components and spare parts which are listed in Schedule 1 of the EWM but are imported exclusively for the purpose of

a. selling to Producers that are already registered on the E-waste portal.
b. Self-use (Not for sale purpose)
c. Captive consumption for manufacturing and selling to producers already registered on EPR portal.

3. Consumers or bulk consumers who import EEE for self use and captive consumption are required to submit a self-declaration to Customs/Port authorities and submit copy of submitted self-declaration to Central Pollution Control Board.
Source: bit.ly/42kj9Bq

Important clarifications issued by Central Pollution Control Board w.r.t. Extended Producer Responsibility (EPR) compliances under E-waste Management Rules, 2022.

India’s Central Pollution Control Board (CPCB) has released certain notices and guidance document under E-Waste (Management) Rules, 2022 which have a significant impact on EPR obligations. A summary of these notices and guidance is reproduced below:

1. A fee structure has been introduced for the first time for registration of Recyclers, Refurbishers & Manufacturer, and annual maintenance charges have been prescribed for all registered stakeholders.

2. A new set of Frequently Asked Questions (FAQs) have been released which provide insights on sound management of E-waste, registration on E-Waste EPR Portal and fulfillment of EPR obligations.

3. Producers of E-waste will now have to first raise a purchase demand on registered Recycler or Refurbisher to purchase EPR certificate as per the recycling or refurbishing targets given by CPCB, without which the registered Recyclers or Refurbishers will not be able to transfer EPR credits to the Producers on the online EPR portal. Producers will not be able to meet EPR target for the FY 2023- 2024 if purchase demand is not raised.

4. All the registered Recyclers have been directed to recycle the e-waste available with them and generate EPR certificates for subsequent sales to Producers. All registered Recyclers have also been directed to transfer credits to Producers whenever purchase demand has been raised by the Producers, and not hold onto EPR credits.

5. Producers have been directed to fulfill their E-waste EPR obligations by purchasing EPR certificates for the FY 2023-2024 by 31st March, 2024.

6. Producers have been directed to submit their Annual and Quarterly returns by 31st April, 2024 for FY 2023-2024 as stipulated in the E-waste Management Rules, 2022.

Important Links
1. FAQ for E-waste: bit.ly/3HHuiCU
2. Fee Structure for registration for Recyclers: bit.ly/3SpMBkS
3. Notice for Producers: bit.ly/48XXFwK
4. Notice for Recyclers: bit.ly/48XhbJK