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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 Ministry of AYUSH has notified an amendment to the Drugs Rules, 1945, inserting Schedule TB, which specifies the standards for the delivery mechanism, preservatives, and excipients that must be complied with in order to obtain a license for the manufacture of Ayurveda, Siddha, Unani, or other traditional medicines that use a nasal spray as a delivery mechanism.
Source: bit.ly/4j9pCHs

2. India’s Directorate General of Foreign Trade (DGFT) has notified the revised Schedule II (Export Policy) whereby, the terms of export have been updated in conformity with the Finance Act, 2024.
Source: bit.ly/4jss5x0

3. India’s indirect tax regulator has issued a circular clarifying the conditions for eligibility for the interest waiver scheme introduced by the GST Council late last year. In addition to submitting applications and filing Forms GST SPL-01 and GST SPL-02, applicants are also required to withdraw any appeal application filed against demand orders, notices, or statements for which the interest waiver is being sought.
Source: bit.ly/40ohfzs

4. India’s Parliamentary Standing Committee on Chemicals and Fertilizers, in its most recent report, has expressed concern that the low number of IVD manufacturers selected under the PLI incentive scheme may not be sufficient to meet the country’s domestic requirements
Source: bit.ly/42a7zuM

5. The United States Federal Trade Commission (US FTC) has alleged that several of the country’s largest insurance companies entered into vertical arrangements with benefit managers to mark up the prices of common and essential prescription medicines, totalling USD 7.3 billion between 2017 and 2022.
Source: bit.ly/4fXStMi

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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 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. The Indian government has extended the deadline for small and medium pharmaceutical companies to comply with the revised Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Act. The revised deadline is December 31, 2025, while the earlier deadline was January 1, 2025. This extension aims to assist smaller manufacturers in upgrading their facilities to meet stringent regulatory requirements.
Source: bit.ly/4a4HaAo

2. The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) have released draft standard evaluation protocols for licensing in-vitro diagnostics (IVDs) under the Medical Devices Rules, 2017. These protocols aim to ensure quality and performance evaluation of IVDs, establishing uniformity in testing across various diagnostic kits. Stakeholders are invited to provide their feedback on the draft by February 15, 2025.
Source: bit.ly/40kTlWt

3. The Ministry of Electronics and Information Technology (MeitY) has released the draft Digital Personal Data Protection Rules, 2025, inviting public feedback until February 18, 2025. These rules aim to operationalize the Digital Personal Data Protection Act, 2023, which was enacted to enhance the framework for protecting digital personal data in India. The draft includes provisions for data localization, compliance requirements for significant data fiduciaries, timelines for storing data and ensuring that personal data is processed responsibly.
Source: bit.ly/3C63oFx

4. The Ministry of Commerce and Industry has launched the Open Network for Digital Commerce (ONDC) initiative to democratize digital commerce in India by fostering open networks for the exchange of goods and services. This initiative focuses on inclusivity, enabling small and medium enterprises (MSMEs) to access digital marketplaces while promoting innovation through open protocols. By creating a level playing field, ONDC seeks to reduce the dominance of large e-commerce platforms and enhance competition among sellers.
Source: bit.ly/4gHo1al

5. The Telangana Medical Council has issued a show-cause notice to a Hyderabad-based hospital for allegedly collaborating with unqualified practitioners and promoting fake doctors. This action follows the hospital’s involvement in sponsoring the medical program and advertising the same on social media, where unqualified individuals were reportedly encouraged. The hospital has been given a 10-day deadline to respond; failure to do so may result in punitive actions under the National Medical Commission (NMC) Act and other regulations.
Source: bit.ly/3BWAQhM

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 Parliamentary Committee on Consumer Affairs, Food and Public Distribution, has noted in a recent report, that the National Test House (NTH) of the Consumer Protection Department does not currently have the expertise or offer the services for regulation certification of Radiation Emitting Medical Devices (including MRI machines and X-Ray machines etc.).
Source: bit.ly/4iKKIfi

2. The National Human Rights Commission of India, having taken Suo-Moto cognizance of a recent report concerning the negligent transfusion of blood to a patient in Rajasthan, has issued Notices to the Chief Secretary of the State of Rajasthan to conduct a thorough investigation into the circumstances of negligent blood transfusion.
Source: bit.ly/3ZCj4Z0

3. The Indian Minister of State for Health has clarified that the Central Drug Regulator, currently does not have any intention or proposal to ban Rantidine in the country, and that State Drug Controllers have been instructed to test for the levels of possible carcinogen N-nitrosodimethylamine in the wake of a warning issued by the United States Food and Drug Administration and European Medicines Agency.
Source: bit.ly/3P2aKgf
Source: bit.ly/49GB4pR

4. India’s Central Drugs Regulator, in supersession of an earlier Amendment in 2022, has issued an amendment to the Medical Devices Rules, specifying laboratories, and the Medical Devices that the laboratories are designated to test.
Source: bit.ly/3PnjiyF

5. The European Medicines Agency is set to implement to the proposed Electronic Product Information program to adapt pharmaceutical label information for easier representation on e-commerce platforms after conducting a successful pilot program.
Source: bit.ly/3DyWkS8

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. 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 regulator has issued a Notification extending the deadline to 31st December 2024, for submitting quarterly filings for the FY 2023-24 for all entities registered under the Hazardous and Other Wastes (Management and Transboundary Movement) Amendment Rules, 2022.
Source: bit.ly/49ahqlK

2. A District Consumer forum in the State of Maharashtra has held that the refusal of returns by a e-commerce service provider, under a blanket “no-returns” policy constituted a “unfair trade practice” and awarded compensation to consumer whose return of sub-standard product had been rejected.
Source: bit.ly/417xJxQ

3. In a recently published response to a query received by it under the Right to Information Act, 2005, the Delhi Medical Council clarified that, since only medical practitioners registered with the council and having recognized qualifications in Allopathic medicine are permitted to practice medicine in Delhi: Dentists, who are registered with the Dental Council are not licensed to perform aesthetic and cosmetic treatment which is not medically necessary.
Source: bit.ly/3ZbT0Ur

4. After considerable negotiation, India has signed the final act of the Riyadh Design Law Treaty which aims to establish protections for Industrial Design patents, the treaty specifies procedural guardrails which member states can adopt into their own local design patent protection regulations.
Source: bit.ly/3CXRxcH
Source: bit.ly/4f5AYJz

5. The United States Supreme Court has declined to hear petition by manufacturers of tobacco products, challenging the decision of the Federal Government of the United States to include graphic visual warnings on cigarette packets.
Source: bit.ly/415u1EU

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.  A State Consumer Disputes Redressal Commission (SCDRC), Punjab has exonerated a private eye hospital from medical negligence allegations, finding no evidence that surgery was performed on the patient. The commission ruled that the claims were unfounded, thus dismissing the case against the hospital with no liability for damages.
Source: bit.ly/499Wxr0

2. The Delhi High Court has requested that the government create clear guidelines regarding doctors’ digital signatures on medical documents in order to reduce the use of unauthorized and fraudulent signatures in medical practices and to make clear the legal and regulatory implications of using digital signatures in healthcare.
Source: bit.ly/3YWXD4A

3. India’s Finance Minister, Nirmala Sitharaman has proposed to establish the creation of Bharat Food and Drug Administration (BFDA) to set global benchmarks for food and drug safety, similar to the US FDA. The emphasis to create such standard is to enhance India’s regulatory framework and strengthen its position in the global market.
Source: bit.ly/3V9E7Rb

4. The Indian government plans to amend the Drugs and Cosmetics Rules, 1945 to allow State Licensing Authorities (SLAs) and the Central Licensing Authority (CLA) to issue manufacturing licenses for products derived from stem cells and gene therapies. This move aims to streamline the regulatory process and promote the development of innovative therapies in India, enhancing compliance with global standards.
Source: bit.ly/3Os1VMx

5. The USFDA has finalized guidance for its 510(k) Third Party Review Program, which permits accredited third-party organizations to evaluate specific low- to moderate-risk medical devices for market clearance. The guidance is designed to expedite the review process to enhance efficiency in device approvals, ultimately facilitating quicker access to innovative medical technologies for patients.
Source: bit.ly/414wwHC

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 and Standards Authority of India (FSSAI) has reportedly commenced initiatives to frame guidelines for the safety and labelling of lab-grown meat, dairy, and egg products, reflecting a growing interest in sustainable food options within India.
Source: bit.ly/490hvIG

2. The Delhi High Court has granted a renowned food brand an injunction against its competitor for trademark infringement of its brand, which has been registered since 1986. The court determined that the competitor’s use of the mark for products could mislead consumers and harm the reputation of the original band, directing them to cease using the trademark and remove infringing products from e-commerce platforms.
Source: bit.ly/4fTj2Cp

3. The Department of Pharmaceuticals (DoP) is reportedly developing a ‘Disposal Policy’ to safely remove unused and expired drugs from sale premises and households, addressing environmental concerns linked to improper disposal.
Source: bit.ly/4eFRlfF

4. The Central Pollution Control Board (CPCB) has issued a direction to all State Pollution Control Boards (SPCBs) and Pollution Control Committees (PCCs) to enforce Rule 4(h) and 4(ha) of the Plastic Waste Management (PWM) Rules which provides mandatory marketing and labelling compliance for the manufacturers of compostable plastic carry bags or commodities before selling such products in the market.
Source: bit.ly/3YXveeD

5. The Competition Commission of India (CCI) has fined a major tech company ₹213.14 crore for misusing its dominant position over a messaging app’s 2021 privacy policy, which forced users to accept new data sharing terms. The CCI found this policy unfair because it didn’t allow users to opt out, and it ordered the company to make changes to provide clearer choices about data sharing and better explanations for users.
Source: bit.ly/3CxU9Oi