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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 Bombay High Court’s Division Bench has stayed an order penalizing a leading AYUSH drug manufacturer for violation of an injunction order on the selling of camphor products thereby infringing another company’s organics’ trademark. Earlier the drug manufacturing company was imposed with a penalty for contempt of court after observing continued violations of the restraining order since 2023.
Source: bit.ly/3ZF02RK

2. India’s Delhi High Court has directed online platforms, including Telegram, to block accounts linked to an anonymous user threatening to leak an insurance company’s confidential customer data. The court emphasized that misuse of such data could lead to identity theft, fraud, and privacy violations and restrained the unidentified entity from sharing the data and ordered intermediaries to disclose its details.
Source: bit.ly/3VKUjbT

3. India’s Karnataka government has reportedly merged the Department of Food Safety and Standards with the Drug Control Department, renaming it as the Food Safety and Drug Administration (FDA). The move aims to streamline operations and enhance service delivery under a unified Commissioner. Officers and staff will now function under the FDA’s administrative control, with steps being taken to restructure rules and regulations. The decision follows similar mergers in states like Maharashtra, Gujarat, and Tamil Nadu.
Source: bit.ly/4flpL7B

4. The Union Ministry of AYUSH (MOA) will reportedly launch a national portal, ‘Trinetra’, for pharmacovigilance in Indian Systems of Medicine (ISM) to curb misleading advertisements. Announced at the World Ayurveda Congress in Dehradun, the portal will ensure quicker reporting of misleading advertisements thereby improving consumer safety. Experts emphasized the need to protect Ayurveda’s reputation and address false claims of “magic cures” and “side-effect-free” treatments.
Source: bit.ly/4gC7y6O

5. India’s Supreme Court has criticized the Delhi government for failing to provide data on daily solid waste generation, calling it a “shocking state of affairs.” Despite an order dated November 18, 2024, the data remains pending, prompting the Court to warn of contempt proceedings if an affidavit is not submitted by December 18, 2024. The Chief Secretary has been directed to appear before the Court on December 19. The Court expressed concern over untreated solid waste, linking it to public health risks and landfill fires.
Source: bit.ly/3ZZyXtK

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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 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

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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. A Public Interest Litigation before the Bombay High Court is being opposed by the Association of Oral and Maxillofacial Surgeons of India, arguing on the basis of a notification of the Dental Council of India dated 6th December 2021, that specialized Oral and Maxillofacial Surgeons registered with State Dental Councils should be permitted to carry on hair transplant surgeries.
Source: bit.ly/49yFtLx

2. The Central AYUSH Minister (Ayurveda, Unani, Siddha and Homeopathy) has stated in response to query in the Indian Parliament, that the ministry has followed a policy of co-location of AYUSH facilities at primary healthcare centres to encourage patients to make choice of treatment.
Source: bit.ly/41ssp8c

3. A lawsuit has been filed in the United States against the manufacturers of consumer food products, alleging that the products manufactured by the companies are “ultra-processed” and prone to causing chronic diseases among consumers.
Source: bit.ly/4goMQXO

4. The Union Health Ministry of India has reportedly urged states to classify snakebites as a notifiable disease, meaning it must be reported to the government by hospitals. This follows the launch of the National Action Plan for Prevention and Control of Snakebite Envenoming (NAPSE), which aims to reduce snakebite deaths by 50% by 2030. One of NAPSE’s recommendations is that snakebites be made a notifiable disease to better track and address the issue.
Source: bit.ly/4gxDPvG

5. The Ministry of Health and Family Welfare has stated that data on disciplinary actions against Registered Medical Practitioners (RMPs) over the past five years is not centrally maintained. It has advised states to promote the prescription of generic drugs and conduct prescription audits in public health facilities. The Indian Medical Council’s 2002 regulations mandate that physicians prescribe drugs by their generic names, legibly and preferably in capital letters, ensuring rational and appropriate use.
Source: bit.ly/3ZRLujb

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

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

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. India’s Ministry of Environment, Forests, and Climate Change has notified the E-Waste (Management) Second Amendment Rules, 2024. The amended rules outline actions to be taken in the event of any non-compliance and violation of the E-Waste (Management) Rules, 2022. Previously, the rules specified prosecution for certain violations such as providing false information, using forged certificates, willfully disregarding directions, or failing to cooperate in verification and audit proceedings along with the imposition of environmental compensation.
Source: bit.ly/4fR1F5c

2. India’s Food Safety and Standards Authority of India (FSSAI) has instructed e-commerce Food Business Operators (FBOs) to ensure that food products have a minimum shelf life of 30% or at least 45 days remaining until expiration at the time of delivery to the consumer. The authority also issued a warning against unsupported online claims and reiterated that no FBO can operate on e-commerce platforms without a valid FSSAI license or registration, underscoring the need for regulatory compliance.
Source: bit.ly/3Z9lzmA

3. India’s Ministry of Environment, Forests and Climate Change has notified the Air (Prevention and Control of Pollution) (Manner of Holding Inquiry and Imposition of Penalty) Rules, 2024. The rules establish the process for holding inquiries, including procedures for issuing notices, determining penalties, and addressing complaints regarding any act in contravention of the Air (Prevention and Control of Pollution) Act, 1981
Source: bit.ly/40Pwt21

4. India’s top consumer forum, the National Consumer Disputes Redressal Commission (NCDRC), has awarded a compensation of Rs. 25,000 in a medical negligence case in which the doctor issued an incorrect scan report, demonstrated deficiency in diagnosing the patient’s illness, and provided erroneous test results.
Source: bit.ly/4fSYUAF

5. India’s Karnataka High Court has ruled that the Appellate Authority has the implied power to issue an interim stay on the Internal Committee’s report under the Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act 2013 (POSH Act). The court observed that the Act does not explicitly prohibit the appellate authority from passing such an order. Since the authority can set aside the impugned proceedings, it also has the implied power to grant an interim stay.
Source: bit.ly/4fLZn7u

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 Standards Authority of India, now requires linking of new licenses with the Permanent Account Number (PAN) of the applicants, additionally existing Food Business Operators have been requested to keep their PAN data up-to-date.
Source: bit.ly/48QImab

2. The Telangana Drugs Control Authority has issued notices to private hospitals in Hyderabad and Telangana, requiring stricter compliance with purchasing requirements for Narcotics Drugs, under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS).
Source: bit.ly/4hJQoWf

3.  The Ministry of Environment, Forest and Climate Change has relaxed penalties under the E-Waste Rules, 2022 and the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. From hereon, the contravention of any provision of these Rules shall not give rise to environmental compensation.
Source: bit.ly/4fqrp8W

4. In pursuance of an ongoing process for recovery of sums on account of a judgment of the Court for misleading conduct by the Respondent, the Supreme Court has issued an Order to auction the Trade Mark of a prominent Indian Hospital chain, while at the same time refusing to make provision for valuating the same.
Source: bit.ly/3Z1rcDf

5. European Union Drug Regulator considering proposal to reduce the duration of regulatory data protection available to companies.
Source: bit.ly/4hGEvQZ

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 government has expanded the definition of Homeopathic medicine, to include all drugs except those drugs “which is administered by injectable route”.
Source: bit.ly/48C6E7n

2. The government has given more powers to Adjudicating Officers under the food laws. In addition to existing power, they have now been granted the additional power to investigate cases of supply of false information as well as unlicensed operation of food business.
Source: bit.ly/3NPfCVw

3. India’s drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has issued a price-control notification requiring a proportional reduction in price of the drugs resulting from the reduction in the Customs Duty and GST.
Source: bit.ly/3YPz7Du

4. The Indian Medical Association has taken objection to the proposal of the Central Government to introducing category of “Geriatric Nursing Practitioners”, and the designation of these nurses as Medical Practitioners, stating that this conflicts with qualification requirements under the National Medical Council Guidelines.
Source: bit.ly/4fu2IrI

5. Several industry associations representing the Homeopathic industry in the United States, have filed a lawsuit challenging the power of the United States Food and Drug Administration’s (US FDA) power to require New-Drug Approvals, and further the USFDA power to prosecute and penalize violations.
Source: bit.ly/3YuZxJz

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. In a new Amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, the Food Safety and Standards Authority of India (FSSAI) has clarified that BIS standards mark requirement may no longer be necessarily applicable for manufacture and sale of infant milk food, infant formula and milk cereal based weaning food etc. as well as Condensed milk sweetened, condensed skimmed milk sweetened, milk powder, skimmed milk powder, partly skimmed milk powder and partly skimmed sweetened.
Source: bit.ly/4hkwSPN
Source: bit.ly/3BXUuK4

2. In a recent amendment to the  Food Safety and Standards (Contaminants, toxins and Residues) First Regulations, 2011, which shall come into force from 1st April 2025 the Food Safety and Standards Authority of India (FSSAI)has: (1) Simplified and reduced the number of prohibited use Antimicrobials including chloroform, stilbenes and other steroids, (2) Increased the permissible concentration for Antimicrobials in Honey, (3) reduced the concentration of antimicrobials in cattle.
Source: bit.ly/3AdyXMN

3. The Rajasthan Authority for Advance Rulings held that the vanilla mix being sold by a major manufacturer of consumer food products in the country would not be classified as an “ice-cream” for the purpose of taxation under the Goods and Services Act, 2017 (GST Act) due to sugar being the major ingredient at about 65%. This decision in contrast to the Supreme Court’s decision on similar grounds.
Source: bit.ly/3BW78sY
Source: bit.ly/3BQh9I0

4. The Supreme Court quashed a criminal case which had been filed against a major Indian bank for non-compliance with an order of the authority under the Income Tax Act, holding that an allegation of mens rea cannot be made against a juristic person such as the bank and that the intention of the officers and functionaries cannot be construed to be that of the juristic person itself.
Source: bit.ly/3C5fH4y

5. The Therapeutic Goods Administration (TGA), Australia’s regulator for Medical Devices has clarified some queries concerning its updated Essential Principles, which are necessary compliances for getting approval for devices in Australia. In this new update to the checklist, the TGA has reiterated its existing commitment to recognizing foreign approval standards, and has placed obligation on Sponsors to update the TGA if their Manufacturer Evidence may be expiring in 50 days, among other things.
Source: bit.ly/48jlWxM
Source: bit.ly/4eSYR7P