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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 Department of Pharmaceuticals (DoP) has invited applications for R&D funding in six key areas- (1) New Chemical Entity, New Biological Entity and Phyto-pharmaceuticals (2) Complex generics and Biosimilars (3) Precision medicine (Targeted innovative therapeutics) (4) Medical devices (5) Orphan Drugs and (6) Drug development for AMR funding upto INR 100 Cr (1000   illion) is available.
Source: bit.ly/41AvbXF
Source: bit.ly/4bJLVQU

  1. The Indian government is reportedly considering lowering tariffs on imports of US medical devices to ease trade tensions. Such a policy decision would run counter to India’s Make in India policy and preference to procure medical devices manufactured in India for government hospitals.
    Source: bit.ly/41zI3x8
  1. The UK Government is reportedly proposing to raise the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2%. The ‘payment rate’ is the revenue that pharma companies refund to government from sales of branded medicines to the National Health Service (NHS)
    Source: bit.ly/3DSk30j
  1. France has become the second European country, after Denmark, to ban per- and polyfluoroalkyl substances (PFAS) in certain products, including cosmetics, textiles, and ski wax addressing concerns over health and environment. The production, import, export, and sale of PFAS-containing goods will be prohibited in France from  January 2026
    Source: bit.ly/420sUVI
  1. The European Commission has proposed a bill to reduce the European Union’s dependence on India and other countries for antibiotics and other essential medicines by requiring Member States to procure medicines on parameters other than price, in order to incentivize domestic manufacturing. The bill, called Critical Medicines Act, is under consideration.
    Source: bit.ly/4ii2whc
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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 of India has warned States and Union Territories of initiating contempt proceedings for failing to take action against misleading advertisements. It emphasized that authorities must ensure strict enforcement of laws to prevent such advertisements. The Court’s remarks come in light of a petition filed by the Indian Medical Association against a leading Ayurveda product manufacturing company on grounds of misleading claims and advertisements.
Source: bit.ly/3C3w9D4

2. India’s Bombay High Court, in a recent ruling, emphasized that authorities must uphold basic human rights, particularly in medical negligence cases. It stated that failure to provide adequate healthcare can violate a patient’s right to life and dignity. The court called for greater accountability and stricter enforcement of healthcare standards.
Source: bit.ly/3DVQlqO

3. The Food Safety and Standards Authority of India (FSSAI) has issued an order on 3rd January, 2025, to promote ease of doing business. It has decided that any changes or amendments to the Food Safety Standards (Labelling and Display) Regulations 2020 will be enforced starting from 1st July each year. The enforcement date will always be 1st July, with a minimum of 180 days between the notification of amendments and their enforcement. This policy applies to both labelling regulation changes and other food safety standards related to labelling. This move is aimed at enhancing regulatory predictability for food business operators while also improving consumer knowledge and transparency.
Source: bit.ly/4h001PO

4. The Indian Prime Minister’s Office (PMO) has directed the Indian Health Ministry to take appropriate steps to label oxygen cylinders clearly, distinguishing between industrial oxygen and medical oxygen. This action follows lawmaker Ajeet Madhavrao Gopchade’s appeal, emphasizing the importance of such measures for patient safety.
Source: bit.ly/4ais9eB

5. The U.S Food and Drug Administration (US FDA) has banned the use of Red No. 3 dye in food items and oral drugs due to potential links to cancer. The decision follows concerns raised by studies suggesting that the high exposure of dye could be carcinogenic.
Source: bit.ly/42f7YvR

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 Standard Authority of India (FSSAI), has launched an online portal “Food Import Rejection Alert (FIRA)” for alerts on food import rejections and to ensure traceability and transparency. Also, food consignments from Sri Lanka, Bangladesh, Japan, China & Turkey has been rejected as they fell short of the standards.
Source: bit.ly/49aLJIT

2. Delay in clearance of import consignments of essential components has reportedly resulted in the disruptions in the manufacture of medical devices in India.
Source: bit.ly/3OpyhHx

3. India’s National Standards Body, Bureau of Indian Standards (BIS) to reportedly prioritize development of standards for 214 critical medical devices post consultation with the Department of Pharmaceuticals (DoP). Standards set to be completed by December 2025.
Source: bit.ly/3B2ZtZJ

4. India’s Meghalaya High Court has called for ban on manufacture, marketing and use of plastic of less than 120 microns.
Source: bit.ly/3Z4VT9C

5. The US Food and Drug Administration (FDA) has announced a temporary enforcement policy to enable certain sterilization site changes for Class III medical devices that are sterilized using ethylene oxide (EtO). Affected medical device manufacturers requesting enforcement discretion must submit an “informal notification” along with certain information to FDA.
Source: bit.ly/3OpairY
Source: bit.ly/3Zpx6OT

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. 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 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 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

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TOP 5 HEALTH LAWS AND POLICY UPDATES

The US Food and Drug Administration (FDA) has finalized guidance on circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The latest guidance extends the US FDA’s existing inspection standards for drug manufacturing companies to include device manufacturing companies as well.
Source: bit.ly/3XCVD2s

The Department of Pharmaceuticals (DoP) expanded its committee on drug and medical device pricing reform and added key public stakeholders to the committee as special invitees. This special invitees include patient advocacy groups, healthcare providers, and the medical community.
Source: bit.ly/3XDmJ9z

Indian government has formed a committee to assess the feasibility of allowing nutraceutical production within existing drug manufacturing facilities. This follows the recent update to Schedule M of Drugs Rules, 1945, which mandates separate production areas for nutraceuticals and pharmaceuticals.
Source: bit.ly/45JefzF

India’s Drugs Technical Advisory Board (DTAB) is evaluating a ban on chloramphenicol and nitrofuran antibiotics in animal feed due to misuse concerns in poultry and livestock.
Source: bit.ly/3zleFAo

New guidelines on the withdrawal of life support from terminally sick patients have been released by the Ministry of Health and Family Welfare (MOHFW) for healthcare providers and are to remain open for public comments for one month. The guidelines emphasize patient’s autonomy and their right to decline life-sustaining treatment (LST), even if doing so results in death.
Source: bit.ly/3RH4D2P

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.

India’s Supreme Court extends scope of misleading advertisement review to multinational and domestic FMCG manufacturers, doctors
In a proceeding against a major Ayurvedic products manufacturer for publication of misleading advertisements, India’s Supreme Court has clarified that the decisions and orders made in the ongoing case is not limited to the a particular manufacturer, rather is directed to all FMCG companies who are publishing misleading advertisements and doctors who are endorsing medicines to public after accepting consideration from pharmaceutical companies.
Source: bit.ly/44b832P

Indian Government to scrutinize organ transplants closely after receiving reports of foreign nationals involvement in organ donation
India’s Union Health Ministry, through the office of Director General of Health Services (DGHS), has ordered state authorities to compulsorily create a NOTTO (National Organ and Tissue Transplantation Organization) ID maximum within 2 days for the donor and recipient for both living-donor and deceased-donor transplants, citing reports of purported commercial dealings in organ transplants involving foreign nationals.
Source: bit.ly/3WcUKgk

New Telehealth Accreditation Program introduced in US
It has been reported that leading not-for-profit agencies in the US such as Joint Commission and National Committee for Quality Assurance (NCQA) will begin offering accreditation for telehealth services to qualified hospitals, ambulatory care centres, and behavioural health organizations in 2024. The accreditation is aimed at filling the gap of legally enforceable telehealth standards in the US.
Source: bit.ly/3W8MKgg

Employee non-compete clauses may soon be illegal in the US
The US Federal Trade Commission (FTC) has issued a final rule to promote competition by banning non-compete clauses in employee contracts nationwide. As per FTC, non-compete covenants in contracts prevent workers from taking a new job or starting a new business, which in turn harms competition.
Source: bit.ly/3UtDRg2

French Government to turn down bid from foreign pharmaceutical companies to buy domestic generic company
The Government of France is reportedly going to block foreign bidders including two Indian pharmaceutical companies from attempting to purchase a domestic generic pharmaceutical manufacturer. As per the French government, this decision has been taken in the national interest to safeguard the supply chain of medicines.
Source: bit.ly/3W8MIFa