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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 Drugs Regulator (CDSCO) has clarified that modified or sustained-release form of a drug including gastro-resistant tablets/capsules, delayed-release tablets/capsules, or novel drug delivery systems will be regulated as ‘new drug’. New drugs must undergo clinical trials for obtaining manufacturing license
Source: bit.ly/41znUZe

2. India’s Central Licensing Authority (CLA) has directed manufacturers of unapproved fixed dose combination drugs to apply for permission to conduct Phase IV study / active post marketing surveillance within three months
Failure may result in cancellation of manufacturing license.
Source: bit.ly/3Xmpjjr

3. India’s Central Food Regulator (FSSAI) has reminded all food businesses that any post approval change in license information such as name of nominee, product category, expansion has to be communicated before such change takes place. Failure may result in cancellation of license.
Source: bit.ly/41AjyRq

4. India’s product standard setting body (BIS) has amended the Baby Diapers Standard 17509:2021. The amendment clarifies that actual dimensions of the diapers can vary based on the manufacturer’s design choices, with the diaper’s design being subject to the agreement between the buyer and seller.
Source: bit.ly/41znT7C

5. Clinical trial sponsors can add clinical trial sites and change the principal investigator (PI) by applying on SUGAM Portal.
The application for change of PI is deemed approved on application, and for addition of site within 30 days of application.
Source: bit.ly/41wrvHo

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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 Allahabad High Court recently ruled that a Food Business Operator cannot be held liable for ingredients purchased in sealed packets from a licensed manufacturer with a proper invoice, even if they are found to be unsafe. The court clarified that liability for unsafe products rests with the manufacturer or distributor.
Source: bit.ly/4hAlyip

2. India’s Department of Consumer Affairs has issued a draft Legal Metrology (Packaged Commodities) Amendment Rules, 2025 thereby relaxing the requirement to make labelling declarations at one place on the principal display panel (PDP) for the packages containing medical devices. Currently, all declarations are required to be made at one place on the PDP. The draft is open for public comments till 12th March 2025.
Source: bit.ly/40UsX4R

3. India’s Intellectual Property (IP) Office has issued a draft Guidelines for processing patent applications related to AYUSH systems, including Ayurveda, Yoga, Unani, Siddha, and Homeopathy. The guidelines aim to provide clarity to the filing and processing patent applications of Ayush systems and related inventions. Stakeholders are invited to provide feedback by February 28, 2025.
Source: bit.ly/3WZjWXa

4. India’s National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling prices of antibiotics Azithromycin and Amoxicillin-Clavulanic Acid under the Drugs (Prices Control) Order (DPCO), 2013. The revisions account for a 0.00551% impact from the Wholesale Price Index (WPI) for 2024.
Source:  bit.ly/3EBV7u4

5. Jammu and Kashmir’s Health Department had issued clear directives to ensure compliance with the prescription guidelines. However, doctors in government hospital have continued to disregard these guidelines thereby imposing a significant financial burden on the patients. Under these guidelines, doctors are required to write prescriptions in legible capital letters along with their name, designation and signatures.
Source: bit.ly/40YI1yl

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 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

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 Consumer Affairs has set a timeline for compliance with amendments to the Legal Metrology (Packaged Commodities) Rules, 2011. Changes to labelling provisions will be enforced on either January 1st or July 1st, after a minimum 180-day transition period from notification. The revised rules mandate clear, legible, and standardized labels on packaged goods, ensuring consumers have key details such as net quantity, MRP, manufacturing date, country of origin, and manufacturer information. This move is aimed at enhancing consumer protection, business ease, and reducing compliance burdens for industry stakeholders.
Source: bit.ly/3CxjgRQ

2. The Supreme Court of India ruled that domicile-based reservation for postgraduate medical admissions under State Quotas violates the right to equality under Article 14 of the Constitution. However, the Court clarified that the judgment will not impact existing domicile reservations or affect students currently studying or who have already graduated under such categories.
Source: bit.ly/4juOHwG

3. India’s Central medical devices regulator, Central Drugs Standard Control Organization (CDSCO) and Indian Council of Medical Research (ICMR) has issued a draft standard In-Vitro Diagnostics (IVDs) evaluation protocol to evaluate the quality and performance of IVD’s. The protocol once approved will be used by IVD manufacturers testing labs in India. Public comments are invited on the draft standard before March 15, 2025.
Source: bit.ly/3QhIAyF

4. India’s Ministry of Health and Family Welfare has confirmed the addition of the Human Papillomavirus (HPV) vaccine to the country’s Universal Immunization Program (UIP), a major step in preventing cervical cancer, which is one of the leading causes of cancer-related deaths among women in India. While the vaccine’s inclusion in the UIP has been officially announced, the exact timeline for its roll-out has yet to be determined. The move aims to combat cervical cancer by offering free vaccination to girls aged 9-14 years.
Source: bit.ly/3WHhkgp

5. China has approved its first stem cell therapy for commercial use, despite mixed clinical trial results. The therapy is intended for patients with neurological disorders, including spinal cord injuries. The approval has raised concerns about the safety and effectiveness of the treatment, as the trials showed only limited evidence of efficacy, and there are calls for more rigorous oversight in stem cell-based treatments.
Source: bit.ly/3WI0Uoa

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 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. 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 Supreme Court’s National Task Force (NTF), panel of eminent doctors constituted to make an action plan for ensuring the safety of healthcare workers, has opined that there is no requirement for enacting a separate central legislation to protect the doctors as there are already enough legal provisions to ensure their safety.
Source: bit.ly/4fVmIDK

2. India’s Directorate General of Foreign Trade (DGFT) has issued a trade notice to harmonize and streamline pharma export process and bring in line Schedule-II (Export Policy) with the latest tariff codes under the Finance Act, 2024. A draft of Schedule-II covering Chapters 01-98 of the ITC (HS) codes is open for public feedback and comments till 27th November 2024.
Source: bit.ly/3Zo7SR3

3. India’s Ministry of Environment, Forest, and Climate Change has informed that all registered Producers, Importers, and Brand Owners (PIBOs) under the Extended Producer Responsibility (EPR) regime of Plastic Packaging registered during FY 2022-24 are required to file their Annual Returns (AR) for FY 2023-24 by 30th November 2024. Failure to do so will result in their AR being auto-filed and levy of penalty i.e., EPR targets for FY 2024-25 will be increased by 25% over and above the EPR target for FY 2023-24.
Source: bit.ly/3JqZRBH

4. To safeguard patient data and mitigate cybersecurity risks posed by vendor networks, Indian hospitals are reportedly advancing in cybersecurity practices. 89% of hospitals have implemented third-party risk management systems however only 10% hospitals have adopted holistic data privacy programs, underscoring area for improvement. Hospitals are reportedly recommended to allocate 12-15% of their budget over the next two years to cybersecurity and digital infrastructure to remain resilient against cyber threats.
Source: bit.ly/3Oj1ggl

5. The United States Drug Enforcement Administration (DEA) has reportedly extended pre-pandemic telehealth regulations for prescribing controlled substances till 31st December, 2025. This decision allows telemedicine providers to continue prescribing controlled medications without requiring in-person visits, while the agency evaluates public feedback on proposed permanent regulations.
Source: bit.ly/3YTYUcK

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 Pollution Control Board (CPCB) has clarified that producers of plastic packaging in the micro & small category do not have to EPR fulfill obligations with effect from Financial Year 2023-24. However, they will have to file annual returns for the financial year 2023-24.
Source: bit.ly/3JqZRBH

2. India’s Directorate General of Trade Remedies (DGTR) has initiated an anti-dumping probe into Vietnamese imports of calcium carbonate filler masterbatch to determine how these imports affect the nation’s domestic industry. The medical sector uses this product for pouches, blister packaging, and individual-wrap containers. The DGTR will examine market patterns, injury claims, alleged dumping tactics and anti-dumping measures necessary to shield local manufacturers from unfair competition.
Source: bit.ly/3AF2Vtc

3. India’s Ministry of AYUSH has notified the Drugs (Fifth Amendment) Rules, 2024, which revise licensing procedures for homoeopathic medicines. The requirement for renewing manufacturing and loan licenses has been removed, making it valid in perpetuity subject to submission of self declaration.
Source: bit.ly/3YT6BBc

4. The State Drug Controller of Tamil Nadu has reportedly clarified that there is no legal provision for issuing separate licenses for pharmaceutical marketing companies or marketers. Pharmaceutical marketers and other stakeholders have been advocating for an amendment to the Drugs and Cosmetics Act (D&C Act) to include a provision for granting separate licenses for pharmaceutical marketers.
Source: bit.ly/3CbsZNh

5. In an effort to reduce exaggerated health claims made by supplement manufacturers about illness treatment or risk reduction, the government panel have proposed to transfer power from the Food Safety and Standards Authority of India (FSSAI) to a drugs regulator. The expert group was initially formed to examine how to handle the challenges that overlap between drugs and nutraceuticals.
Source: bit.ly/3YSrjRG

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