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 The US Food and Drug Administration (FDA) has issued a draft guidance on pre-determined change control plans (PCCPs).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 The draft guidance is open to receiving comments from industry stakeholders till November 20, 2024.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

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.

1. India’s Environment Ministry has proposed to introduce extended producers responsibility for scrap of non-ferrous metals by way of amendment to Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2016.
Source: bit.ly/4fQHG7E

2. The deadline for declaration and registration of exotic animal species in possession of various individuals, organizations, zoos, etc is 28th August 2024. The registration of these exotic animal species is to be done in the PARIVESH 2.0 portal.
Source: bit.ly/3XaaXTA

3. India’s apex telecom regulator, the Telecom Regulatory Authority of India (“TRAI”) has issued directions to curb misuse of messaging services and protect consumers from fraudulent practices. TRAI has mandated that the messages containing URLs/ APKs/ OTT links/ Call back numbers, which are not whitelisted will not be sent with effect from 1st September 2024.
Source: bit.ly/3Xeorhb

4. A Texas Court has stayed the operation of ban on non-compete agreements stating that the Federal Trade Commission (FTC) lacks the authority to ban non-compete agreements which was supposed to go into effect 4th September 2024.
Source: bit.ly/3SYlZsy

5. The Supreme Court of India, while observing the working conditions of doctors and healthcare professionals and their susceptibility to violence, has constituted a ten (10) member task force to formulate a national framework (protocol) for ensuring their safety and facilities. The task force will submit its interim report within three (3) weeks and final report within two (2) months.
Source: bit.ly/4cHpv1C

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.

1. The State Excise Department of Orissa has recently issued a notification to declare separated leaves of the Cannabis plant, also referred to as Bhang, as “intoxicant” under the State Excise law. Prior to this notification, Orissa was one of the few states where Bhang was not regulated as intoxicant.
Source: bit.ly/46J2NVn

2. India’s drug price regulator, NPPA, has rejected a price revision plea of a manufacturer of drug on grounds that it had failed to communicate revision of prices of the drug in Form II of Drugs (Prices Control) Order, 2013 within prescribed timeline of 15 days.
Source: bit.ly/3M6bBuX

3. The Bombay High Court has observed that an egg/ sperm donor in an in-vitro fertilization scenario cannot seek the same rights as a parent.
Source: bit.ly/3YQVPeO

4. All entities who are not registered as telemarketers will not be able to make promotional calls. If any complaint is received against such entity, then it will be blacklisted for two years.
Source: bit.ly/3AsgYSM

5. The Telecom Regulatory Authority of India, the country’s internet and telecommunications regulator has issued an order to telecom and internet service providers to disconnect and remove access for unregistered telemarketers who are carrying out voice-promotional calls. Once disconnected, such persons shall be required to submit a compliance report within 1 week, and may be given an opportunity to register with the TRAI.
Source: bit.ly/4dD3eCE

 

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.

1. The number of cosmetic products which can be added to a single application for the import registration certificate of cosmetics has been limited to fifty (50) products from 16th August 2024.
Source: bit.ly/4dbUnrX

 2. The Central government has reportedly prepared a draft of the Standard Veterinary Treatment Guidelines (SVTG) covering 274 diseases across 12 major livestock species with an aim to create uniform treatment protocols, lessen variation in prescription practices, and improve compliance among veterinarians and other prescribers.
Source: bit.ly/3SNEnnU

3. The Supreme Court of India has given a deadline of 12th October 2024 to implement the law for regulation of allied healthcare practitioners.
Source: bit.ly/3SNqR3L

4. The Madras High Court has reportedly directed the Indian Council of Medical Research (ICMR) to opine whether there were vested interests involved in the ban on pioglitazone, an antidiabetic drug, which was later revoked.
Source: bit.ly/3SLbmcm

5. The US Food & Drug Administration (FDA) has reportedly rejected a proposal to approve psychedelic – MDMA as a treatment for post-traumatic stress disorder (PTSD) citing safety and efficacy concerns.
Source: bit.ly/3YDYqJf

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.

1. The Ministry of Agriculture and Farmers Welfare of India has issued Millets Grading and Marking Rules, 2024 (“Millet Rules”) which regulates packing, marking and labelling of millets intended for direct human consumption.
Source: bit.ly/4dkddNJ

2. India’s central drug regulator, the Central Drugs Standard Organisation, has circulated draft guidelines on good distribution practices for pharmaceutical products to ensure product traceability throughout the supply chain.
Source: bit.ly/4fGXKZy

3. India’s top consumer forum, the National Consumer Disputes Redressal Commission (“Commission”) has awarded a compensation of Rs.65 lakhs in a medical negligence case in which the doctors performed an elective surgery on a patient who was suffering from pre-existing ailment, which ultimately resulted in the death of the patient. The commission did not accept the defence of the hospital that the patient’s next of kin had consented to the procedure and were aware of the risks.
Source: bit.ly/3AgWYSK

4. Suicide Capsules are not medical devices or medicines: Swiss Medical Agency.
Source: bit.ly/4djGFU0

5. The Ministry of AYUSH has informed that it has identified approximately 26000 cases of misleading advertisements, but the State AYUSH departments have issued notices only 358 brands in last 4 years.
Source: bit.ly/4fJ7bYi

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.

1. A leading pharmaceutical association reportedly has urged the Indian government to implement a predictable drug pricing policy by refraining from using Para 19 of the Drug Pricing Control Order, which gives power to the Government to cap prices of non-essential drugs and medical devices in public interest without advance notice.
Source: bit.ly/4dw7a8j

2. The National Consumer Disputes Redressal Commission (NCDRC) has held that doctors who have qualification of M.B.B.S, M.D. (medicine) are sufficiently qualified to treat ICU patients without requiring additional specialized intensive care training since no such training has been prescribed by National Medical Commission.
Source: bit.ly/3Yts4kh

3. Australia has approved the medical use of MDMA (Methylene Dioxy Methyl Amphetamine) and psilocybin for treating PTSD and depression. The drugs will be available under strict regulations, with treatments costing between A$15,000 and A$30,000, and with no current insurance coverage.
Source: bit.ly/46CttHg

4. India’s Central Food regulator, (FSSAI) has reintroduced restriction on re-using cooking oil that has developed total polar compounds (TPC) of more than 25% by adding fresh oil. Any cooking oil that has 25% or more content of TPC is not permitted to be used.
Source: bit.ly/4d8pvIT

5. India’s Department of Consumer Affairs has extended the last date for receiving public comments on the proposed amendment of rule 3 of the Legal Metrology (Packaged Commodity) Rules, 2011 to 30th August 2024. The proposed amendment aims to close loopholes and ensure that all bulk packages are labelled clearly and consistently, just like retail products.
Source: bit.ly/4dgRE0n

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.

1. India’s Central Board of Indirect Taxes and Customs (CBIC) has restored the concessional 10% import duty on lab chemicals starting August 1, with the condition that the importers declare that the goods will be used for lab or R&D purposes only, and will not be traded or sold after import. However, undenatured ethyl alcohol remains excluded and continues to face a 150% duty.
Source: bit.ly/3yjWrPv

2. India’s Union Health Ministry has urged the Board of Control for Cricket in India (BCCI) and the Sports Authority of India (SAI) to take measures to prevent surrogate advertising of tobacco and alcohol products by sportspersons. This move aims to curb indirect promotion of such products through sports sponsorship and advertising, and to safeguard public health and prevent the normalization of tobacco and alcohol consumption.
Source: bit.ly/3WKcaRg

3. India’s Union Minister, on behalf of life insurance corporation employees, has requested India’s Finance Minister to withdraw the 18% GST imposed on life and medical insurance premiums as high tax rate is burdensome and could negatively impact the accessibility and affordability of essential insurance services.
Source: bit.ly/4c5QXWd

4. India’s state consumer forum has directed an insurance company to pay the mediclaim to the claimant on the grounds that pre-existing conditions of diabetes mellitus cannot be the cause for cardiac arrest as diabetes is a lifestyle related ailment and denial of entire mediclaim is not acceptable when such ailment is so pervasive in India.
Source: bit.ly/4d6iDLZ

5. India’s AYUSH ministry has disclosed that it has received 38,539 complaints of misleading advertisements related to Ayush drugs in the last seven years. These complaints have been reported to the State Licensing Authorities (SLAs) for further action.
Source: bit.ly/4c84cpt

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.

1. The Supreme Court, while hearing the Patanjali case on misleading advertisements, has asked the Union of India to respond to a question about whether the clinical trial rules for AYUSH drugs have been diluted, particularly in the context of new indications. The amicus for the Court while presenting the matter proposed strict measures for regulating misleading advertisements, such as the effective use of existing penalty mechanisms, prior approval of ads before issuance of licenses, effective inter-state cooperation, and a tie-up between the GoI and ASCI to address complaints.
Source: bit.ly/4d21OSv

2. The Supreme Court while hearing a petition filed by the Indian Medical Association (IMA) challenging Patanjali Ayurved’s misleading advertisements has directed the Ministry of Ayush to create a centralised dashboard where citizens across the country can access information about the action taken in response to their complaints.
Source: bit.ly/4d35inT

3. The Department of Pharmaceuticals (DoP) has extended the deadline for filing a self-declaration under the Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP) to August 31st, 2024. The prior date for filing the self-declaration was July 31st, 2024.
Source: bit.ly/3LLmm5R

4. The Consumer Product Safety Commission (CPSC) in the United States has reportedly placed responsibility on large e-commerce companies for the sale of dangerous third-party products on its platforms, issuing a directive covering more than 400,000 products that violated flammability standards.
Source: bit.ly/3YtFwom

5. The US Food and Drug Administration (USFDA) warned several giant online retailers about selling unapproved chemical peel skin products and asked them to immediately stop marketing them as they could potentially harm customers. The USFDA issued the directive after determining that the items in question included chemicals in high amounts that necessitated medical care.
Source: bit.ly/4caYQJY

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.

1. Mere title of a person within an organization such as Managing Director/ CEO does not automatically make the person criminally liable for offence committed by Company under Drug Laws. In order to make a person holding a managerial position in the company criminally liable, the complaint should have specific averments against such person which indicates that the person was in charge of and responsible for the conduct of the business of the company so far as it relates to the manufacture of the drug: High Court of Jammu and Kashmir
Source: bit.ly/4cYU4Rl

2. The Government of India is reportedly considering whether to stop marketing of look-alike and sound-alike drug brands in public interest. Under the current proposal, the brand names which were approved first by the drug regulator will be permitted to be marketed, and look-alike or sound-alike drug brands will be prohibited from being marketed.
Source: bit.ly/3SvoDFN

3. The Indian Government is reportedly considering whether to exempt Medical Devices which have been approved and sold in the European Union for two years from requirement of conducting clinical investigation in India prior to marketing authorization.
Source: bit.ly/4d3sJgC

4. The Delhi High Court has ordered an Ayurvedic medicine manufacturer to delete from all websites on the internet and social-media platforms claims which were beyond the scope of license and implied that the medicine it marketed could treat COVID-19.
Source: bit.ly/3WFxEyG

5. A prominent US based health savings account administrator has reported that it has suffered a data breach which has led to the loss of sensitive employee and customer information.
Source: bit.ly/4dkt525

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.

1. A Missouri State Court has directed a multinational healthcare company to pay $495 million in damages over its specialised formula for premature infants which caused a girl to develop dangerous bowel disease. The Court ordered that the company did not warn doctors about infants receiving formula, having a greater risk of Necrotizing Enterocolitis (NEC) compared to infants who are breast-fed or given donor milk or human milk-derived formula
Source: bit.ly/46rTKb1

2. India’s Karnataka State Assembly has brought in a new bill which penalises any person found guilty of causing “intentional insult” to a doctor directly, on social media or using unauthorised audio or video. The penalty includes a jail term up to three months or a fine of ten thousand rupees. Intentional insult includes use of words, figures or gestures with an intent to insult, humiliate, disgrace, annoy or abuse a medical service personnel.
Source: bit.ly/4d0momi

3. India’s Kerala High Court has ordered that the Kerala Medical Association (“KMA”) is liable to pay Goods and Services Tax (GST) on the supply of goods and services to its members. KMA contended that it does not need to pay GST as it is registered as “charitable association” but the High Court held that KMA is liable to pay GST as 90% of its activities are non-charitable.
Source: bit.ly/3WF5x2G

4. Multinational Pharmaceutical Companies have requested the Indian Government to keep the free access medicines, provided under Patient Assistance Programme (“PAP”), outside the scope of Trade Margin Rationalisation (“TMR”). According to Pharma companies, medicines are made accessible and affordable through PAP and bringing them under the purview of TMR will impact their price and patients will end up paying more.
Source: bit.ly/3ykeaGu

5. Indian Government has built a health claims gateway, National Health Claims Exchange (NHCX), which aims to streamline and standardize health insurance claim processing, enhancing efficiency in the insurance industry. NHCX serves as a gateway for exchanging health claim information among insurers, third-party auditors, healthcare providers, beneficiaries, and other relevant entities and ensures interoperability, machine-readability, auditability, and verifiability, making the information exchange accurate and trustworthy.
Source: bit.ly/3WEmom2