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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. Due to a recent spike in cases, the Karnataka Government has declared dengue as an “epidemic” and to that effect has issued a notification under the Karnataka Epidemic Diseases Regulations, 2020. As part of the notification, the government has empowered Municipal Corporations across the state to carry out inspections of sites for compliance with mosquito prevention measures.
Source: bit.ly/3ThmkGK

2. Industry associations of manufacturers of Drugs and Medical Devices have called for an amendment of the Drugs (Prices Control) Order, 2013 to make pricing guidelines uniform for both Scheduled and non-scheduled formulations.
Source: bit.ly/3AJuTUn

3. India’s Central food regulator, the Food Safety and Standards Authority of India has issued a notification to re-operationalize The Food Safety Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022, in the interim of formulating new regulations.
Source: bit.ly/3ASeVYj

4. It is reported that IT’s upcoming meeting scheduled for 9th September, the Goods and Services Tax Council may take a decision on removing the existing 18% Goods and Services Tax on health insurance policies.
Source: bit.ly/3TjjrWa

5. In pursuance of its larger and long-term project of fighting and reducing anti-microbial resistance, the World Health Organization has issued a guidance directing management of “antibiotic waste” generated by manufacturers, which contributes to rising levels of anti-microbial resistance.
Source: bit.ly/4g922t1

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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. Pharmaceutical companies will have to submit details of their expenditures incurred on sponsoring activities to the medical professionals within two months after the end of each financial year on the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) portal as part of implementation of the UCPMP Code 2024.
Source: bit.ly/47bQOjc

2. India’s Health Ministry has introduced guidelines to improve quality of healthcare services in government hospitals and healthcare institutions. Hospitals will now be required to report adherence to these guidelines and submit proposals for approval, specifically when significant changes or funding is involved.
Source: bit.ly/3XaYSMz

3. Pharmaceutical industry in India has reportedly voiced its concern over the delay in processing and issuance of review orders on the website by Department of Pharmaceuticals (DoP). The consequence of delay in processing of review orders may results in halt of business activities thereby imposing manufacturers to sell the scheduled formulation or a new drug at a ceiling price which is under review.
Source: bit.ly/4cUYrMa

4. India’s Central Drugs Standard Control Organization (CDSCO) is reportedly launching various digital initiatives, such as Online National Drug License System (ONDLS) and Track and Trace System, to transparently, and efficiently manage pharmaceutical regulations.
Source: bit.ly/47ai41s

5. Quality standards for MDMA and Psilocybine, well known psychedelic compounds has been prescribed by Australia’s Therapeutic Goods Administration (TGA).
Source: bit.ly/47a9jVm
Source: bit.ly/478wBLf

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

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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 Supreme Court has stayed the repeal of Sec. 170 of the Drugs, Rules 1945 which regulated Advertisement of AYUSH products by the AYUSH Ministry, to address the ultra-vires nature its policy regarding AYUSH advertisement.
Source: bit.ly/4e4qOZz
Source: bit.ly/4dDnIvK

2. The National Commission for the Indian System of Medicine has restated its position, as it has taken in an advisory issued earlier on 16th July, that practitioners of AYUSH medicine should not represent themselves as “Cannabis experts” as it may constitute a “Misrepresentation of qualification” under Regulation 27 of the National Commission for Indian System of Medicine (Ethics and Registration) Regulation, 2023.
Source: bit.ly/3APXRls
Source: bit.ly/4cLHaFl

3. The Supreme Court has issued a Notice to the Central and State Governments and their departments, seeking a response on policy position regarding braille accessibility and integration into (1) Medical packaging, (2) Consumer Goods packaging, and (3) Implementation of braille in all aspects of public and private sectors.
Source: bit.ly/3AHLUOP

4. The office of Director General of Foreign Trade has issued draft modalities for setting up E-commerce Export Hubs which will support infrastructure for cross-border e-commerce trade, and has requested for submission of detailed proposals for set-up of E-commerce Export Hubs.
Source: bit.ly/3ASWEd6

5. The Drug Enforcement Administration, part of the United States Department of Justice has issued a notice that it will be holding hearings regarding the subject-matter of a Federal level reclassification of Cannabis from a Schedule I to Schedule III substance.
Source: bit.ly/4dCiQXN

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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. Use of artificial yellow food coloring ‘Tartrazine’ in food items like moong dal is not food adulteration as ‘Tartrazine’ is a permitted food coloring under the Prevention of Food Adulteration Rules, 1955; India’s Supreme Court.
Source: bit.ly/4718Tk4

2. Food Safety and Standards Authority of India (FSSAI) has withdrawn the clarification for selling / marketing of milk and milk products in the name of A1 & A2 for further consultation. Previously, FSSAI had clarified that it is misleading to differentiate milk and milk products on whether they are made from A1 milk or A2 milk and had thereby directed to remove such claims from such products including e-commerce websites.
Source: bit.ly/4778axU

3. Retail prices to be reportedly reduced by 50% of anti-diabetic drug Empagliflozin, which is expected to go off patent in March 2025 under Drugs Price Control Order, 2013.
Source: bit.ly/470IFxW

4. Indian Pharmaceutical Industry has urged to amend and delete the term “retailer” from the definition of dealer under Drugs Price Control Order, 2013 (DPCO). Manufacturers and importers are required to furnish price list to dealers. The inclusion of ‘retailer’ within the definition of ‘dealer’ has led to confusion over the extent of this obligation, potentially extending the manufacturer’s and importer’s liability beyond wholesalers to include retailers as well. If approved, Retailers, who typically interact with consumers directly, would be excluded from the manufacturer’s direct regulatory responsibilities, thereby allowing the focus to remain on the wholesale distribution channel.
Source: bit.ly/3ABX4Vs

5. QR Codes / Bar Codes may reportedly be made mandatory for vaccines, cancer drugs and antibiotics to validate the authenticity of drugs and prevent the supply of counterfeits.
Source: bit.ly/475pDGH

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. All medical practitioners (doctors) who practice modern medicine will have to mandatorily register on the new National Medical Register established by the National Medical Commission.
Source: bit.ly/3YYlPoE

2. The Indian Government is reportedly considering to ban 34 multivitamin drugs.
Source: bit.ly/4e0490u

3. The Indian Government is planning to publish a new policy for promoting bio-technology sector called BioE3 (Biotechnology for Economy, Environment and Employment) Policy.
Source: bit.ly/3MiPNfw

4. A leading e-commerce giant has set up rest areas facility for its delivery partners in India. The rest area will have facilities like air conditioning, seating areas, drinking water, and mobile charging stations as a measure to provide them better working conditions.
Source: bit.ly/3MkPYHl

5. Amid rising cases of mpox globally, the World Health Organization (WHO) has reportedly relaxed the rules for its health partners to hold commercial discussions on mpox vaccines. It has also declared that partners like GAVI and UNICEF can begin purchasing mpox vaccines before WHO approves them.
Source:  bit.ly/3Z0RWV0

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 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. Indian pharmaceutical manufacturers will have to prove compliance with revised Good Manufacturing Practices at the time of renewal of manufacturing license, as per media reports.
Source: bit.ly/3MAGjg9

2. A woman who has filed for divorce should be treated as a divorced woman for the purposes of medical termination of pregnancy, and therefore will have the right to terminate her pregnancy: High Court
Source: bit.ly/4fNDhT7

3. The Multidisciplinary Committee of Experts (MDC), which advises the National Pharmaceutical Pricing Authority (NPPA), will invite an officer not below the rank of Deputy Controller of Patents and Designs, to evaluate eligibility for exemption of patented drug from application of price control law.
Source: bit.ly/46Ya8jY

4. A new scheme to boost domestic medical device industry in India is under works and will reportedly be launched in a month.
Source: bit.ly/4fUqrSU

5. A new portal for reporting adverse events of drugs, vaccines and medical devices has been launched by Indian Pharmacopoeia Commission. The adverse event may be reported by consumers and medical practitioners.
Source: bit.ly/4dxeUXY

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 Drug Controller in Kerala has reportedly stated that there is no objection to display discount on flex board of retail drug stores. However, all retail drug stores are required to display a price list of medicines which will allow consumer to evaluate which drugs are available at a discount and make informed choices.
Source: bit.ly/4ctkgT3

2. As per India’s Central Food Regulator, the claim of 100% fruit juice on packaging of juices which are reconstituted from fruit concentrate, or which are not reconstituted but to which water has been added, is misleading and therefore prohibited. Any pre-printed packaging material which contains the misleading claim should be utilized by the Food Business Operators (FBOs) before 31st December 2024. Fruit juices manufactured before 31st December 2024 but which carry the misleading claim on the package will be permitted to be sold in the market until their expiry.
Source: bit.ly/4fV2gDN

3. A trademark infringement suit filed by a U.S. fast-food burger chain has been decided in favor of a Pune-based burger joint on the grounds of prior use and honest use in India.
Source: bit.ly/4dGZLmY

4. Indian medical gloves manufacturers have raised strong objection with Indian government about ongoing import of chlorinated gloves into India despite there being a ban on its use by healthcare facilities.
Source: bit.ly/3AyqQdG

5. 12% of all spices tested between May and July have reportedly failed to meet quality standards.
Source: bit.ly/3AwNV0b