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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 Health and Family Welfare (MoH&FW) has released the Drugs Amendment Rules, 2025, extending the deadline for implementing revised Good Manufacturing Practices (GMP) under Schedule M for small and medium drug manufacturers until December 31, 2025. Manufacturers are required to submit an application to the Central Licensing Authority for seeking the extension within three months of the notification.
Source: bit.ly/4gCo0U8

2. The Supreme Court has virtually summoned the Chief Secretaries of Andhra Pradesh, Delhi, and Jammu & Kashmir to explain their failure to act on misleading medical advertisements. The Court found these states non-compliant with previous orders on enforcing Rule 170 of the Drugs Rules, which prohibits advertisements of Ayurvedic, Siddha, or Unani drugs without licensing authorities’ approval.
Source: bit.ly/42Sm6vn

3. India’s National Medical Commission (NMC) has clarified that the Telemedicine Practice Guidelines 2020 do not allow Registered Medical Practitioners (RMPs) to remotely authenticate pathology and radiology lab reports without physical presence and supervision. This follows an RTI application which sought clarification on the use of cloud-based technologies like Telepathology and Teleradiology for signing and authenticating lab reports.
Source: bit.ly/40VinKX

4. India’s Ayushman Bharat Digital Mission (ABDM) has made significant strides, with millions of Ayushman Bharat Health Accounts (ABHA) created and a large number of health records linked to ABHA. This is part of the mission’s effort to build an interoperable digital health ecosystem. Thousands of health facilities have registered on the Health Facility Registry (HFR), and many healthcare professionals are now listed on the Healthcare Professional Registry (HPR). The mission also focuses on supporting rural areas through technology interventions like telemedicine, enhancing access to healthcare services.
Source: bit.ly/41ektXT

5. The European Medicines Agency (EMA) has introduced a standard procedure for manufacturers of certain high-risk medical devices to receive scientific advice on their intended clinical development strategy and proposals for clinical investigations. This initiative aims to enhance safety and performance by offering expert guidance on regulatory requirements before devices are submitted for approval. The move is designed to foster innovation while ensuring that devices meet rigorous standards.
Source: bit.ly/4jWxfRZ

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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 Madhya Pradesh High Court has ruled that rape survivors can undergo medical termination of pregnancy up to 24 weeks without requiring a court order. For pregnancies up to 20 weeks, a registered medical practitioner can perform the termination. This decision aims to streamline the process for survivors, reducing delays in accessing abortion services.
Source: bit.ly/4gkA5xi

2. The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) have released a draft standard evaluation protocol for the performance evaluation of Human Metapneumovirus (hMPV) real-time PCR kits. This protocol provides detailed procedures for testing, including preparation of hMPV RNA evaluation panels, RNA extraction, and guidelines for real-time PCR systems. It aims to ensure the quality and reliability of diagnostic kits for hMPV. Public comments are invited till March 15, 2025.
Source: bit.ly/3WGUcOW

3. India’s Andhra Pradesh Medical Council (APMC) has reportedly announced that permanent registrations for Foreign Medical Graduates (FMGs) will be granted only to those who comply with the National Medical Commission (NMC) guidelines. This includes verification of degrees through the respective Indian Embassies and additional internship requirements. A group of 25 FMGs has filed a writ petition in the Andhra Pradesh High Court regarding this matter.
Source: bit.ly/3WEXdzv

4. Representatives from several pharmaceutical industry groups are scheduled to meet with officials from the Central Drugs Standard Control Organisation (CDSCO). The agenda includes discussions on the implementation of Schedule M, which sets quality standards and good manufacturing practices for pharmaceutical companies. Industry representatives, particularly from MSME pharma manufacturers, are expected to request an extension of the implementation timelines for the revised Schedule M.
Source: bit.ly/3WJDVZU

5. The US FDA has identified cybersecurity vulnerabilities in certain patient monitors used in healthcare and home settings. These monitors display critical patient information such as temperature, heartbeat, and blood pressure. The FDA warns that these vulnerabilities could allow unauthorized individuals to access and potentially manipulate the monitors, leading to improper functioning. Additionally, connected networks may be compromised, and sensitive patient data, including personally identifiable and protected health information.
Source: bit.ly/3X53S6r

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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 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

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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 ruled that only the Central Government can regulate, prohibit, or restrict the sale of drugs. The judgment clarifies that drug inspectors and regulatory authorities cannot impose such bans or unilaterally declare a medicinal product as prohibited without a central notification.
Source: bit.ly/3DTt3Su

2. The Food Safety and Standards Authority of India (FSSAI) has reiterated the compliance requirements for e-commerce Food Business Operators (FBOs). They warned against operating without a valid FSSAI license or registration and making unsupported claims online. FBOs have been urged to adopt practices ensuring a minimum shelf life of 30% or 45 days before expiry at the time of delivery to the consumer, and to strictly adhere to food safety standards.
Source: bit.ly/3Z9lzmA

3. Indian Micro, Small, and Medium Enterprises (MSMEs) in the pharmaceutical sector are seeking a 3-year, condition-free extension for implementing Schedule M. They have cited financial constraints in upgrading their manufacturing sites to comply with Schedule M standards. In this context, they urge the Indian government to provide support in the form of financial and technical assistance to improve quality standards. The health ministry recently issued a draft notification proposing to extend the deadline for MSMEs to comply with revised Schedule M norms from 31st December 2024, to 31st December 2025.
Source: bit.ly/4fPf8u0

4. The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of azithromycin 250 mg tablets to ₹11.67 per tablet, up from ₹11.65, following a review order by the Department of Pharmaceuticals (DoP). The review addressed Cipla Ltd.’s claim that its product, Azee 250 mg tablets, with a 2.3% market share, was omitted from the initial pricing calculation. The NPPA identified discrepancies in the Pharmatrac database and included Cipla’s product in the updated price.
Source: bit.ly/40kDNB8

5. Maharashtra police has arrested a man who was allegedly running an illegal call center that sold controlled medicines, like Viagra and Tramadol, to U.S. citizens. The accused used VOIP technology to impersonate a legitimate pharmaceutical representative. Authorities have seized several gadgets and accessories from the call centre and charged the individual under various laws, including the Information Technology Act and the Indian Telegraph Act.
Source: bit.ly/405X1Kw

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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 Central Drug Standard Control Organization (CDSCO) has issued an updated draft list for the risk-based classification of medical devices. The new entries in the list include categories such as interventional radiology, radiotherapy, oncology, and Class A (non-sterile and non-measuring) devices. Stakeholders are required to submit their feedback within 30 days of the draft’s publication.
Source: bit.ly/422UCmg

2. India’s Ministry of Health and Family Welfare has issued a draft notification proposing an extension for small and medium manufacturers with an annual turnover of ₹250 crores or less to comply with the revised Schedule M of the Drugs Rules, 1945. Manufacturers eligible for this extension must submit an upgradation plan in Form A to the central licensing authority within three months. The proposed deadline for compliance is December 31, 2025. The Ministry has also invited objections and suggestions from stakeholders, which must be submitted within seven days of the notification’s publication.
Source: bit.ly/40mUugc

3. The U.S. Food and Drug Administration (FDA) has released draft guidance on using artificial intelligence (AI) to support regulatory decisions regarding the safety, effectiveness, or quality of drugs and biological products. This guidance proposes a framework to enhance the credibility of AI models in product submissions. The FDA invites public comments on the draft within 90 days.
Source: bit.ly/4fKHeXf

4. India’s new draft Digital Personal Data Protection Rules 2025 require companies transferring personal data of Indian users across international borders to comply with data localization norms. These provisions, which impose additional government restrictions on specific data transfers, are reportedly expected to complicate business operations.
Source: bit.ly/41ZXocd

5. The U.S. District Court recently dismissed negligence and strict liability claims against a non-profit that received an NIH grant and sub-granted part of it to a Wuhan lab allegedly linked to COVID-19. The court found no liability for contributing funding for research activities or basis for strict liability, emphasizing the weak causal connection and the risks of imposing unlimited liability on research funders.”
Source: bit.ly/4gJaS0v

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

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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 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

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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 (PIL) has been filed in the Madras High Court, alleging that transgender clinics in Tamil Nadu are engaging in unethical practices. These include the use of the banned two-finger test and violations of established health guidelines. The court has issued notices to the National Medical Council and the Tamil Nadu government, seeking their responses to these serious allegations.
Source: bit.ly/4fCPFnA

2. The Indian subsidiary of a major U.S. pharmaceutical company is under investigation for violating the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) guidelines by sponsoring foreign trips for 30 doctors. The government may take action against the company and the executive who signed the self-declaration of compliance. If proven, the doctors involved could lose their medical licenses and be prohibited from practicing medicine.
Source: bit.ly/409I4s3

3. India’s Allahabad High Court has overturned a National Consumer Disputes Redressal Commission (NCDRC) order that had mandated a compensation of ₹93 lakh from a doctor and hospital owner for alleged medical negligence during a C-section procedure in 2005. The High Court identified procedural errors in the NCDRC’s decision-making process, thereby nullifying the earlier order for compensation to be paid by the medical professionals involved.
Source: bit.ly/409s4pQ

4. India’s Karnataka High Court has granted temporary relief to pharmaceutical companies by directing the government to refrain from taking action against pharmaceutical companies producing nutraceuticals in drug-licensed units. This follows a challenge to Schedule M, which restricts the manufacturing of non-drug products in drug-licensed facilities
Source: bit.ly/40bT34c

5. The Jammu and Kashmir Medical Supplies Corporation Limited (JKMSCL) has ordered an immediate halt to the use of Bupivacaine Hydrochloride in Dextrose Injection USP (0.5%), 5mg/ml, 4ml ampoule, Batch Number AA40222, manufactured by Aishwarya Healthcare Ltd. This action follows a reported Adverse Drug Reaction (ADR) associated with the batch, which was manufactured in April 2024 and expires in March 2026. Medical officers have been instructed to cease using the affected batch immediately.
Source: bit.ly/408meFg

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 Food Safety and Standards Authority of India (FSSAI) has directed to reduce the sample size of Vitamin D2 for analysis as it is an expensive ingredient. Earlier a sample of 500g was drawn for analysis, however now a sample of at least 50g is to be drawn i.e., two samples of 25g each, from the imported consignment and after the analysis, the remaining 25g should be returned to the importer making the sample collection process more cost-effective.
Source:  bit.ly/4gN4R2m

2. The Federation of Pharmaceutical Entrepreneurs (FOPE) has highlighted the growing concern of Not of Standard Quality (NSQ) drugs in India and has proposed critical changes to the Drugs and Cosmetics Rules thereby calling for the inclusion of temperature, humidity, and photosensitive drugs under Schedule P. This proposed inclusion aims to enforce stricter shelf-life regulations for these types of drugs, ensuring they are subject to rigorous stability studies to verify their quality and safety throughout their shelf life.
Source: bit.ly/49VvAYw

3. The Telangana pharmaceutical industry has raised several concerns with the Department of Pharmaceuticals (DoP) and the Central Drugs Standard Control Organization (CDSCO), seeking clarity on certain provisions in the Revised Schedule M. These concerns primarily revolve around discrepancies between mandatory requirements and the WHO guidelines, which are generally regarded as voluntary and non-binding. The industry has also raised concerns about the production of nutraceuticals in facilities that are primarily designed for pharmaceutical manufacturing.
Source: bit.ly/49R29Xs

4. The National Pharmaceutical Pricing Authority (NPPA) has given an extension to one of the leading manufacturer of drug for the continued manufacturing of two of its scheduled Tetanus formulations until December 31, 2025. This extension follows company’s submission of Form IV, requesting approval to discontinue these formulations. Under Para 3 of the Drugs (Price Control) Order (DPCO), 2013, the government has the authority to direct manufacturers of active pharmaceutical ingredients (API), bulk drugs, or formulations to manufacture the drugs for adequate supply and accessibility of essential medicines.
Source: bit.ly/49TcdPC

5. The India’s Goods and Services Tax (GST) Council has introduced several significant changes to GST. Notably, gene therapy has been exempted from GST, and the decision on taxing restaurant services provided by electronic commerce operators at 5% has been deferred for further review. Additionally, the Council has clarified that caramel popcorn, due to its added sugar content, will attract a higher tax rate compared to salted or plain variants.
Source: bit.ly/3BFBNuT