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 Supreme Court of India by dismissing a review petition held that doctors and medical professionals rendering paid services will fall under the Consumer Protection Act 1986.
Source: bit.ly/3EJukMp

2. The Department of Telecommunications (DoT) has directed social media and application hosting platforms to remove content enabling Caller ID spoofing, citing violations of the Telecommunications Act, 2023. The advisory warns that tampering with telecom identifiers is a cognizable and non-bailable offence, and platforms failing to comply may face legal action.
Source: bit.ly/4k8UNDu

3. The Indian Pharmaceutical Association (IPA) has raised serious concerns over the National Pharmaceutical Pricing Authority (NPPA) mandate for all offline and online pharmacies to display current drug prices on their websites to protect consumers from overpaying as impractical and unfeasible.
Source: bit.ly/4k3GEY3

4. The WHO’s 2025 update to the International Classification of Diseases (ICD-11) introduces a new module for traditional medicine, recognizing Ayurveda, Siddha, and Unani systems alongside conventional healthcare. This move strengthens their role in global health reporting, research, and policymaking, fostering integrative healthcare.
Source: bit.ly/4kagsv4

5. The Food Safety and Standards Authority of India (FSSAI) has proposed a draft amendment to the Food Safety and Standards (Labelling and Display) Regulations, 2020. Key changes include mandatory bold labeling of added sugar, saturated fat, and sodium content, a compulsory logo as provided on all milk and milk products, and clearer front-of-pack declarations for coffee-chicory mixtures. Public objections or suggestions can be submitted within 60 days from the date issuance of notification.
Source: bit.ly/40Zx4ws

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 Drugs Rules, 1945 through its first amendment introduces standards for Ayurveda, Siddha, and Unani (ASU) nasal drugs, focusing on manufacturing and standardizing dosage forms in traditional medicine. Traditional nasya preparations, including powdered churnas, grathas, and thailams, will also be standardized under these rules.
Source: bit.ly/40M88Zm

2. India’s Parliamentary Panel has recommended to Union health ministry to consider covering the cost of medicines, particularly for long-term treatments like cancer, under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PMJAY). The Committee’s 159th report highlighted that the Ministry’s submission suggests the possibility of such a provision. In a previous 151st report, the Committee had urged the government to provide free medicines for long-term illnesses to all PMJAY beneficiaries across states.
Source: bit.ly/4hIIv2s

3. India’s Union Budget 2025 has introduced the “Heal in India” initiative, aiming to boost medical tourism. Kerala is expected to be a major beneficiary due to its world-class healthcare infrastructure and traditional wellness practices like Ayurveda. The initiative aims to streamline visa norms for international patients, positioning Kerala as a leading destination for health and wellness tourism.
Source: bit.ly/4hJReS4

4. India’s Food Regulator, Food Safety and Standards Authority of India (FSSAI)
is reportedly considering new health warning on the labels of alcohol bottles, following a Bombay High Court’s directive on cancer warnings, similar to that on cigarette packs. Currently, alcohol bottles carry two health risk warnings, and industry representatives argue these are sufficient.
Source: bit.ly/3Etn0nY

5. Argentina’s government has decided to ban gender change treatments, including hormone therapy and surgeries, for minors and impose restrictions on housing trans women in women’s prisons. This move aligns with similar legislative pushbacks in countries such as the UK, Sweden, Finland, and the US, with the aim of protecting children’s mental health
Source: bit.ly/3Q7elKv

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 Kerala High Court has emphasized the need for caution among investigating officers when implicating doctors under the POCSO Act for failing to report offenses. The court highlighted that such actions should not be taken lightly, especially in cases where there is no clear evidence of deliberate intent or negligence. This ruling aims to protect medical professionals from unwarranted legal repercussions that could arise from misunderstandings or misinterpretations of their responsibilities.
Source: bit.ly/4jxbEiQ

2. The Allahabad High Court has criticized government doctors for referring patients to private hospitals for financial gain, labelling the practice as a “menace.” The court directed the Uttar Pradesh government to formulate a policy to prevent doctors in state medical services from engaging in private practice, emphasizing the need for them to prioritize patient care in public hospitals. This ruling aims to ensure that government healthcare professionals fulfil their responsibilities without the influence of monetary incentives.
Source: bit.ly/3Cy62Eg

3. A leading Indian food company has recalled four tonnes of red chilli powder after the Food Safety and Standards Authority of India (FSSAI) ordered the action due to excessive pesticide residue levels in product samples. The company is advising customers to return the affected 200-gram packets for a full refund and is implementing stricter quality control measures with its suppliers to prevent future issues.
Source: bit.ly/3PTGhBw

4. A parliamentary panel has urged the National Pharmaceutical Pricing Authority (NPPA) to establish Price Monitoring and Resource Units (PMRUs) in all remaining states and union territories i.e. Andaman and Nicobar Island, Tamil Nadu, Delhi, Sikkim and Manipur. The initiative aims to enhance drug price monitoring and ensure the availability of essential medicines across India. Currently, PMRUs are operational in only a few regions, and expanding their reach is seen as crucial for better consumer awareness and accessibility.
Source: bit.ly/3CeopOJ

5. India’s Union Health Ministry has requested a legal opinion regarding the extension of the compliance deadline for revised Schedule M standards for micro, small, and medium enterprises (MSMEs) in the pharmaceutical sector. The proposed final draft could grant these companies an additional 12 months to meet the new requirements, which were initially set to take effect on January 1, 2025. This extension responds to requests from MSMEs for more time to upgrade their facilities and processes.
Source: bit.ly/3EdyI62

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 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. The Food Safety and Standards Authority of India (FSSAI), in its 45th meeting, decided that the amendment to the Food Safety and Standards (Labelling and Display) Regulations, 2020, will be enforceable from 1st July 2025. This is subject to the condition that at least 180 days have passed from the date of notification of the amendment. Additionally, in cases of emergency, a separate decision may be taken regarding enforcement.
Source: bit.ly/3BPK9jH

2. The Supreme Court of India recently ruled that while courts have the authority to order the seizure of vehicles pending trial under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act), there is no provision in the Act that prohibits the return of seized vehicles. The Court emphasized that owners of such vehicles should be given an opportunity to be heard regarding the restoration of possession, particularly if they had no knowledge of the transport of narcotic or psychotropic substances,
Source: bit.ly/3DNibWg

3. The Rajasthan High Court, in a matter seeking to quash a petition against pathologists at a hospital accused of falsifying reports based on signature irregularities, held that cases of medical negligence must be subjected to a higher degree of scrutiny. The court further stated that mere irregularities in documents do not constitute falsification.
Source: bit.ly/3C2O64y

4. India’s Directorate General of Foreign Trade (DGFT) has issued a public notice regarding procedure for exporting certified organic products from the country. The new procedure requires that all ‘organic products’ intended for export should carry a Transaction Certificate issued by a National Accredited Body under the National Program for Organic Production (NPOP) and should be labelled in accordance with the NPOP. A revised NPOP will come into force from 5th July 2025
Source: bit.ly/4j48uD1

5. The US Food and Drug Administration has issued a finalized guidelines under the Advanced Manufacturing Technologies Designation Program, whereby manufacturers are able to obtain designation of the manufacturing process which may either reduce development time of drug or maintain supply of life-supporting, life-sustaining or critical drug.
Source: bit.ly/4j3H3Jr

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 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. The Revised Schedule M of the Drugs Rules, 1945 which has come into force on the 28th December 2023, is now fully applicable to all manufacturers with turnover less than Rs. 250 Crores starting from 1st January 2025.
Source: bit.ly/4iZXAOt

2. India’s Central Drug Regulator has directed that the process to file applications for (1) addition of new Clinical Trial Site and (2) Change of Principal Investigator should henceforth be made online through the SUGAM Portal maintained by the regulator. An application for addition of clinical trial site is deemed approved if no objection received in 30 days of upload and an application for change of Principal investigator is deemed approved on the day of upload.
Source: bit.ly/4j1Kwbp

3. In order to curb instances of re-use and re-branding of expired food products by businesses India’s Central Food Regulator is now requiring all licensed Food Business Operators to upload the following data to the online portal on a quarterly basis once feature is activated:

a.  Quantity of food items rejected due to not meeting quality standards.
b. Quantity of expired food items returned by the business.
c. A detailed report of how the expired/ rejected food items were handled, including manner of disposal/ return/ destruction.

Provided that all licensed business should commence record-keeping in preparation of activation of upload feature on FoSCoS portal.
Source: bit.ly/3PjW8sP

4. The Delhi High Court recently held that a claim for medical negligence cannot be sustained on the basis that the patient had a certain expectation with respect to the quality of care, holding that no evidence was forthcoming that the Doctor’s conduct lead to harm to the patient.
Source: bit.ly/49YPn9m

5. The Foreign Contribution (Regulation) Rules, 2011 have been amended, permitting associations to carry-forward the unspent administrative expenses into the next financial year, provided that reason for carry-over needs to be mentioned in Form FC-4.
Source: bit.ly/4gOxvAo

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 consumer court, the National Consumer Disputes Redressal Commission (NCDRC), has discharged a Kerala hospital and its doctor from allegations of negligence in an IVF case. The complainants had claimed that procedural lapses led to the failure of the treatment, but the commission found no evidence to support these claims and dismissed the charges.
Source: bit.ly/4fqZkxk

2. The Madhya Pradesh Medical Council reportedly proposes to introduce a system for renewing the doctor’s registration every five years. This will help track how many doctors are still in the state, how many have moved abroad, and how many passed away. The said measure aims to keep the medical registry updated and to ensure compliance with current medical standards.
Source: bit.ly/3ZU6XHX

3. The Delhi High Court has directed the Delhi Medical Council to ensure that patients can access doctor’s qualifications and mandated the public display of credentials. This decision addresses rising concerns about unqualified practitioners and delays in the verification process, aiming to enhance transparency and patient safety in healthcare.
Source: bit.ly/3VFWc9Q

4. India’s central food regulator, the Food Safety and Standards Authority of India (FSSAI), has released an updated list of recognized food testing laboratories, detailing their NABL accreditation validity as of December 12, 2024. These laboratories are authorized to analyze food samples under the Food Safety and Standards Act, 2006. The list includes validity details and contact information for laboratories in the Northern Region, with recognition guidelines governed by FSSAI’s directives.
Source: bit.ly/3ZREIK5

5. The Ministry of Environment, Forest and Climate Change has released a draft of Solid Waste Management Rules, 2024, to address unmanaged solid waste. The draft rules, published on December 9, 2024, will require compliance from various waste generators, including hotels and institutions, and will come into effect on October 1, 2025. The public is invited to submit objections or suggestions regarding the proposed rules by February 7, 2025.
Source: bit.ly/4fgKzw

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 Bombay High Court refused to quash criminal proceedings against Hindustan Coca-Cola over allegations of selling adulterated ‘Canada Dry’ in 2001. The company argued that delays in prosecution deprived it of the right to re-test the samples, but the Court held that the company failed to exercise this option in time. The Court also declined to extend an interim stay, allowing the case to proceed after being stalled for 14 years.
Source: bit.ly/3DeG8FP

2. India’s Delhi Food Authorities are set to inspect health supplement manufacturing units after a fake protein supplement factory was uncovered for producing adulterated protein powder without the required FSSAI licensing. This action was prompted by a complaint from a consumer who suffered severe health issues after using the product. Samples of various powders and supplements have been seized for testing.
Source: bit.ly/3OS7Dav

3. India’s Union Health Ministry has amended the Medical Devices Rules, 2017, to designate three Central Drugs Testing Laboratories (CDTL) in Chennai, Kolkata, and Mumbai for testing surgical and medical examination gloves. In addition, 27 government analysts across six labs have been assigned to test various medical devices, including gloves, bandages, and syringes. This initiative is part of broader efforts to strengthen regulatory oversight and streamline testing processes to improve medical device monitoring and compliance in India.
Source: bit.ly/3OTpU7r

4. The Directorate General of Trade Remedies (DGTR) has extended the deadline for filing responses in the anti-dumping investigation on calcium carbonate filler masterbatch imports from Vietnam to January 3, 2025, following stakeholder requests. The investigation, initiated in September 2024, aims to assess whether these imports are harming India’s domestic industry through price undercutting and rising volumes. Preliminary findings suggest significant dumping margins, with potential anti-dumping duties under consideration to protect local manufacturers.
Source: bit.ly/4fjBy6p

5. The Kenyan Pharmacy and Poisons Board has flagged the unregistered and substandard cancer drug Floracil 1000 (Fluorouracil 1000mg/2ml) and warned against its sale or use. Manufactured by an Indian company, the drug has been censured following routine surveillance. The Board also issued a quarantine order for Mefnac Oral Suspension due to suspected contamination with harmful chemicals. Legal action will be taken against those violating the directives, and the public is urged to report substandard drugs.
Source: bit.ly/3VExLtn

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, the Food Safety and Standards Authority of India (FSSAI) has issued a advisory to e-commerce Food Business Operators (FBOs) to ensure that: (1) Last-mile delivery systems are made more robust, and persons handling last-mile delivery are given suitable training to handle the food items, and (2) The e-commerce FBOs are compliant with the labelling requirements as specified in relevant regulations, keeping the listings on the website consistent with content of actual food label.
Source: bit.ly/4f0zEaA

2. India’s Ministry of Finance has published an Office Memorandum seeking public comment up to the 10th of December, on certain amendments to the prevailing insurance regulations in the country. These proposed amendments include among other things, permitting a 100% Foreign Direct Investment in the insurance sector through the automatic-route, and permitting insurers to undertake offer of more than one class of insurance.
Source: bit.ly/4ifYwxT

3. India’s Central Ministry of Consumer Affairs is reportedly developing an online portal to handle the licensing, verification and stamping of weighing and measurement instruments as well as to provide a source of information on verified trade instruments for consumers.
Source: bit.ly/41km5Q6

4. The High Court of the States of Punjab and Haryana held that outside of introduction of evidence to the effect, the mere failure of a medical surgery/ procedure would itself not be sufficient to establish medical negligence claims, especially if the patient had been appropriately sensitized of the risks involved.
Source: bit.ly/49nlkrJ

5. In its finalized version of the regulations regarding Pre-determined Change Control Plans, the US Food and Drug Administration has plainly classified Artificial Intelligence (AI) as a sub-set of Machine Learning softwares when it comes to regulation of Medical Devices, and further makes it mandatory that in making submissions the version of the device software need to be submitted with the FDA to ensure version control.
Source: bit.ly/4imQQu2