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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. The Jharkhand High Court has quashed criminal proceedings against an MBBS doctor charged under Section 304A of the Indian Penal Code for causing death by negligence, following a patient’s death after gallbladder surgery at his clinic. The allegations included medical negligence and violations under the Scheduled Castes and Scheduled Tribes (Prevention of Atrocities) Act. The court found no evidence of malicious intent or negligence on the doctor’s part, leading to the dismissal of the charges.
Source: bit.ly/4jiLOzc

2. India’s Central Pollution Control Board (CPCB) has released guidelines for the transportation and storage of used oil under the Extended Producer Responsibility (EPR) framework, effective from April 1, 2024. These guidelines outline the roles and responsibilities of collection agents, who are tasked with safely collecting, storing, and transporting used oil while adhering to environmental regulations. The framework aims to ensure proper management of hazardous waste and facilitate a more sustainable approach to oil recycling.
Source: bit.ly/3DTNDSR

3. India’s Central Pollution Control Board (CPCB) has released a methodology for conducting a gap analysis on biomedical waste management, aimed at improving compliance with existing regulations. This initiative is part of the CPCB’s ongoing efforts to ensure better environmental and public health outcomes related to the disposal of hazardous waste.
Source: bit.ly/4fYFBFq
Source: bit.ly/3PyGXfq

4. The U.S. Food and Drug Administration has released updated guidance regarding the notification process for manufacturers concerning permanent discontinuances or interruptions in the manufacturing of medical devices, as mandated by Section 506J of the FD&C Act. This guidance aims to prevent or mitigate shortages of critical medical devices during public health emergencies by requiring timely notifications from manufacturers about potential supply disruptions. The document also includes a list of devices that fall under this requirement and outlines the necessary information that must be provided.
Source: bit.ly/4hh2XqP

5. The U.S. Food and Drug Administration has released draft guidance proposing major changes to the accelerated approval pathway for drugs. These changes aim to strengthen the evidence and procedures required for quickly approving new medications, ensuring they deliver real clinical benefits while maintaining safety and effectiveness. The updates reflect the FDA’s commitment to improving the approval process for important therapies and addressing concerns about how these drugs perform once they reach the market.
Source: bit.ly/4hf9N09

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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. India’s Central Pollution Control Board (CPCB) has directed Plastic Waste Processors (PWPs) to upload valid GST e-Invoices for the sale of product for the purpose of EPR certificate generation on the EPR portal for plastic packaging. The invoices must include key details like Buyer GST number, Seller GST Number, IRN No., HSN code, Invoice Number and QR code, ensuring they are signed, clearly visible, and readable.
Source: bit.ly/4fGikIn

2. India’s Food Safety and Standards Authority of India (FSSAI) has reportedly constituted a panel that is in the process of finalizing guidelines to monitor microplastics and nanoplastics in food and bottled water. This move follows alarming findings of their presence in both branded and non-branded salt and sugar products consumed in India.
Source: bit.ly/4iXJrl4

3. India’s Karnataka High Court has temporarily barred government action against pharmaceutical companies manufacturing nutraceuticals in drug-licensed facilities until its next hearing. This follows challenges by industry bodies and stakeholders against Schedule M of the Drugs and Cosmetics Act, which prohibits the production of non-drug items, like nutraceuticals, in drug manufacturing premises.
Source: bit.ly/41WVEQI

4. Doctors in the Indian state of Maharashtra have raised concerns over a directive from the state’s Food and Drugs Control Department (FDA), which allows homeopaths with a modern pharmacology certificate to prescribe allopathic medicines, despite a pending case in the Bombay High Court. They have also questioned the eligibility of homeopaths to prescribe modern medicine. The directive permits chemist retailers and wholesalers in the state to sell allopathic medicines prescribed by such homeopaths.
Source: bit.ly/424Awbg

5. The Chief Medical and Health Officer (CMHO) of a district in Madhya Pradesh, India, has warned private hospitals against employing BAMS/BHMS doctors as RMOs or duty doctors, particularly in ICUs and emergency departments, instead of qualified MBBS doctors and the violations may lead to registration cancellations under the Nursing Home Act. This comes amid nationwide concerns over patient safety and the misuse of medical designations, with healthcare experts calling for stricter oversight and accountability.
Source: bit.ly/3DOcMhw

Posted on

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. India’s Central Pollution Control Board (CPCB) has issued a Show Cause Notice to Producers, Importers, and Brand Owners (PIBOs) of Plastic Packaging for non-compliance with the Plastic Waste Management Rules, 2016. PIBOs must file their Annual Report and pay Annual Processing Charges for the FY 2023-24 to fulfill their Extended Producer Responsibility (EPR) obligations by 30th November 2024 to avoid levying of environmental compensation under the Environmental (Protection) Act, 1986.
Source: bit.ly/3Zs0XWY

2. India’s Directorate General of Foreign Trade (DGFT) has amended ITC (HS) 2022, Schedule-I (Import Policy), to align the latest tariff schedules and the Finance Act 2024 (No. 2 of 2024). The changes include updates to ITC (HS) codes through additions, deletions, amendments, splits, and mergers, aimed at streamlining import regulations, clarifying compliance standards, and fostering ease of doing business in international trade.
Source: bit.ly/3ZrYaNm

3. India’s Allahabad High Court has ruled that under the Food Safety and Standards Act, 2006 (FSS Act 2006), an offence will be considered to have occurred when the food analyst’s report confirming the violation is received, rather than when the food sample was collected by the Food Safety Officer. The ruling clarifies the timeline for initiating legal action under the Act.
Source: bit.ly/3Vc5hqA

4. India’s Goods and Services Tax Network (GSTN) has issued an advisory informing taxpayers about the launch of a new e-Services app, replacing the old e-Invoice QR Code Verifier app. The new app offers features like scanning QR codes to verify B2B e-invoices, provides GSTIN search functionality and most up-to-date information regarding approved B2B e-Invoice.
Source: bit.ly/4i7crX3

5. The Health Sciences Authority (HSA) of Singapore has taken action to combat the illegal sale and distribution of health products by removing over 3,000 unauthorized health products listings from local e-commerce and social media platforms. In the course of this operation, the authority has issued 1,471 warnings to sellers in an effort to safeguard consumers from substandard or counterfeit products.
Source: bit.ly/4ic7gF8

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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. India’s Central pollution regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022.
Source: bit.ly/49ahqlK

2. A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected.
Source: bit.ly/417xJxQ

3. In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary.
Source: bit.ly/3ZbT0Ur

4. After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.
Source: bit.ly/3CXRxcH
Source: bit.ly/4f5AYJz

5. The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets.
Source: bit.ly/415u1EU

Posted on

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. India’s apex food regulator, Food Safety and Standards Authority of India (FSSAI) has reportedly commenced initiatives to frame guidelines for the safety and labelling of lab-grown meat, dairy, and egg products, reflecting a growing interest in sustainable food options within India.
Source: bit.ly/490hvIG

2. The Delhi High Court has granted a renowned food brand an injunction against its competitor for trademark infringement of its brand, which has been registered since 1986. The court determined that the competitor’s use of the mark for products could mislead consumers and harm the reputation of the original band, directing them to cease using the trademark and remove infringing products from e-commerce platforms.
Source: bit.ly/4fTj2Cp

3. The Department of Pharmaceuticals (DoP) is reportedly developing a ‘Disposal Policy’ to safely remove unused and expired drugs from sale premises and households, addressing environmental concerns linked to improper disposal.
Source: bit.ly/4eFRlfF

4. The Central Pollution Control Board (CPCB) has issued a direction to all State Pollution Control Boards (SPCBs) and Pollution Control Committees (PCCs) to enforce Rule 4(h) and 4(ha) of the Plastic Waste Management (PWM) Rules which provides mandatory marketing and labelling compliance for the manufacturers of compostable plastic carry bags or commodities before selling such products in the market.
Source: bit.ly/3YXveeD

5. The Competition Commission of India (CCI) has fined a major tech company ₹213.14 crore for misusing its dominant position over a messaging app’s 2021 privacy policy, which forced users to accept new data sharing terms. The CCI found this policy unfair because it didn’t allow users to opt out, and it ordered the company to make changes to provide clearer choices about data sharing and better explanations for users.
Source: bit.ly/3CxU9Oi

Posted on

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. The State Consumer Disputes Redressal Commission (SCDRC) has directed a consultant surgeon at a hospital in Erode to pay ₹5 lakh as compensation to the family of a patient who died during treatment for colon cancer. The Commission concluded that while there was no medical negligence during the surgery, the surgeon failed to secure proper cardiac evaluation prior to the procedure, which was deemed a significant oversight.
Source: bit.ly/3UHgY8t

2. The All India Organization of Chemists and Druggists (AIOCD) has raised concerns over a potential partnership between a popular fast delivery company and an online pharmacy aimed at delivering medicines within 10 minutes. AIOCD warns that this ultra-fast delivery model may bypass essential safety regulations, compromising patient safety and increasing the risk of antimicrobial resistance due to unregulated medicine distribution.
Source: bit.ly/4hzeSBr

3. The Drugs Controller General of India (DCGI) has mandated that no cosmetics can be imported unless their ‘use-by’ date is at least six months from the import date. The regulator also prohibited the import of cosmetics containing hexachlorophene and those tested on animals post-November 2014.
Source: bit.ly/4hElgr2

4. The Supreme Court has directed the National Medical Commission (NMC) to establish new guidelines for admitting persons with disabilities into medical courses, emphasizing the need for inclusivity in the healthcare sector. This decision follows a case involving a candidate with muscular dystrophy who was initially disqualified from pursuing an MBBS due to stringent disability criteria.
Source: bit.ly/3YAwWCG

5. The Central Pollution Control Board (CPCB) has issued guidelines to be used by State Pollution Control Boards (SPCBs) and Pollution Control Committees (PCCs), to assess and determine the processing capacities of E-Waste recycling facilities.
Source: bit.ly/3YBbcGK

Posted on

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. India’s Central Drug Regulator (CDSCO) is set to develop guidelines for the safe disposal of pharmaceutical waste which are expired and unused drugs and medicines, to curb antimicrobial resistance (AMR).
Source: bit.ly/3yOlfPY

2. The Indian Health Ministry has reportedly stated that 156 fixed dose combination (FDC) drugs recently banned were licensed by the State Licensing Authorities (SLA) without prior approval from the Drug Controller General of India (DCGI).
Source: bit.ly/3Xl6Xj7

3. Bureau of Indian Standards (BIS) certification will be mandatory for medical textile products covered by Quality Control Order from 1st October 2024. The products that will require certification and BIS mark are sanitary napkins, reusable sanitary pads/sanitary napkins, period panties, baby diapers, hospital bed linens, pillow covers, dental bibs and shoe covers intended for medical use.
Source: bit.ly/4e3FI1U

4. India’s major pharma companies have requested the Delhi High Court to quash the government’s recent notification banning 156 fixed-dose combination (FDC) drugs. They have also sought interim relief in their petitions to exhaust the stock that was manufactured before the notification came into effect, prohibiting any coercive measures against retailers and stockists until the stock is exhausted.
Source: bit.ly/3yUZFcw

5. India’s Central Pollution Control Board has issued a show cause notice to producers, importers, and brand owners (PIBOs) of plastic packaging, requiring them to file annual reports and fulfill Extended Producer Responsibility (EPR) obligations for the financial year 2022-2023 by September 1, 2024. Failure to comply will result in the imposition of environmental compensation (EC) and additional penalties.
Source: bit.ly/3XmQ5bF
Source: bit.ly/3XmQc75
Source: bit.ly/3yUZAWg

Posted on

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. India’s central food regulator, Food Safety and Standards Authority of India (FSSAI) has said that it is misleading to differentiate milk and milk products on whether they are made from A1 milk or A2 milk. All manufacturers and marketers and e-commerce entities have been directed to stop claims of A1 and A2 proteins present in the milk. All manufacturers have been given six months to exhaust all of the pre-printed labels containing claims about A1 and A2 proteins.
Source: bit.ly/4dz5awA

2. The Central Pollution Control Board (CPCB) has released updated guidelines for assessing environmental compensation to be levied on entities that violate the Plastic Waste Management Rules, 2016, including Extended Producer Responsibility (EPR) obligations.
Source: bit.ly/46Uh9lX

3. India’s Ministry of Health has banned the 156 fixed-dose combination (FDC) medications, commonly known as “cocktail drugs,” which include multivitamins, antibiotics, and painkillers. The ministry’s rationale is that these drugs have no there is no therapeutic justification and pose a risk to human health, even though there are safer alternatives available.
Source: bit.ly/3XfRVeq

4. The US Food and Drug Administration (FDA) has issued a draft guidance on pre-determined change control plans (PCCPs). The guidelines offer manufacturers a way to specify prospective modifications to a device and apply for premarket authorization for those changes in a marketing submission for the device. This eliminates the need for them to obtain FDA approval for each major change before it is implemented. The draft guidance is open to receiving comments from industry stakeholders till November 20, 2024.
Source: bit.ly/3AtTY5B

5. The Medicines and Healthcare products Regulatory Agency (MHRA), an agency of the Department of Health and Social Care in the United Kingdom, has ruled that a biopharmaceutical company has violated the country’s drug regulations by using a LinkedIn post to advertise prescription-only medicines to the general public.
Source: bit.ly/4fSmKgt

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TOP 5 HEALTH LAWS AND POLICY UPDATES

The new criminal code, Bharatiya Nyaya Sanhita (BNS) has replaced the Indian Penal Code (IPC) and introduced stricter penalties for medical negligence. Registered Medical Practitioners can now face up to two years in jail and fines for medical negligence. The new law will apply from July 1, 2024.
Source: bit.ly/3RXnx5t

The Central Pollution Control Board (CPCB) has extended the last date of filing of annual returns by the registered producers, importers, brand owners (PIBOs) and plastic waste processors for FY 2022-24 and FY 2023-24 respectively till September 2024. The earlier timeline to file the annual returns were June 30, 2024 and April 30, 2024 respectively.
Source: bit.ly/3XQtxAY

In an effort to decrease reliance on imports and to promote domestic production of medical devices, the Department of Pharmaceuticals (DoP) reportedly intends to launch a new program that will provide shared facilities for medical device parks or clusters that are formed with the exclusive financial assistance of the state governments.
Source: bit.ly/3xU6b2u

The Enforcement Directorate (ED) is investigating an alleged nationwide network of contraband dealers and has placed several pharmaceutical companies under scrutiny who are engaged in the production of drugs and opioids as a measure to prevent the creation of illicit distribution networks through fraudulent sale and supply bills.
Source: bit.ly/3VNzoEw

The United States Food and Drug Administration (USFDA) has published a draft guidance that removes the requirement of undertaking switching studies for applicants undertaking an approval for treating Biosimilars as interchangeable. The USFDA has now made switching studies optional for biosimilar approvals. Hence, persons applying for approval for Biosimilars may now use computer modelling based on the current acceptable analytical technologies to demonstrate the Biosimilars as interchangeable.
Source: bit.ly/4eQUudy

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Draft GDP guidelines for pharmaceutical products published for comments
India’s Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document titled “Guidelines on good distribution practices for pharmaceutical products” for comments. The Guidelines seek to eliminate the introduction of spurious, adulterated, misbranded and non-standard quality (NSQ) products into the market. It is intended to be applicable to all entities involved in any aspect of the storage and distribution of pharmaceutical products, including manufacturer as well as pharmacists and any other person dispensing medical products directly to a patient.
Source: bit.ly/4cQwypM

Agreements with Shared Workspace Providers accepted as valid proof of premises for obtaining food licenses
India’s central food regulatory authority, Food Safety and Standards Authority of India (FSSAI), has issued an advisory on the documents that may be submitted as proof of premises by importers, traders, e-commerce entities, re-labellers etc. who deal in food products and operate out of a shared workspace premises. Going forward, any legally valid agreement with workspace provider will be accepted. Such agreement may be a lease or rent agreement. However, entities who operate out of shared work-space will not be able to stock food products in shared workspace under the license.
Source: bit.ly/3JkMpzp

Documents which will be accepted as proof of possession of premises for food business is specified by Central Food Regulator
India’s central food regulatory authority, Food Safety and Standards Authority of India (FSSAI), has identified documents which will be accepted as proof of possession of premises by a Food Business Operator (FBO) as part of the food license application. Any food business operator, undertaking any business of food or beverage, including hotels, restaurants, food vending establishments, clubs, canteens, importers, merchant, exporters, e-commerce operators, transporters has to submit proof of possession of premise in order to obtain corresponding food license.
Source: bit.ly/3UiCgte

Waste management portals for plastic packaging and e-waste to get operational in a phase wise manner
India’s Central Pollution Control Board (CPCB) has clarified that the Extended Producer Responsibility portals for the management of Plastic Packaging waste and E-waste will get operational in a phase wise manner. For plastic packaging waste the portal is only functional for Chandigarh, Chhattisgarh, Goa & Puducherry whereas for e-waste the portal is operational for Maharashtra only. The users of the portal for other states are requested to wait till further notice.
Source: bit.ly/3JqZRBH
Source: bit.ly/3Jl1Es4

Popular protein supplements sold in India found to have lesser quantity of protein than declared on the label
A recent study has found that many popular brands of protein supplements sold in the Indian market do not have the same amount of protein as claimed on the label. In addition to the inconsistencies related to protein content, the study also found evidence of protein spiking, fungal toxins, pesticide residues, presence of heavy metals and compounds in protein supplements manufactured in India.
Source: bit.ly/3vU24CC