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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 District Consumer Court in Jaipur has issued legal notices to certain Indian film actors for making misleading claims in a pan masala advertisement and misrepresenting the product. The petition seeks action against the actors for misleading consumers with false claims.
Source: bit.ly/3XH8gbQ

2. India’s top music labels have filed a suit against an AI company on grounds that AI Company has used copyrighted music and sound recordings to train its AI models without authorization. The outcome of the suit will bring clarity on the legality of use of copyrighted material by AI companies to train AI.
Source: bit.ly/4ilUqnz

3. Indian rubber glove manufacturers have raised concerns over the import and stockpiling of low-quality, non-medical gloves by importers in anticipation of potential notification of Medical and Surgical Gloves (Quality Control) Order (QCO). After QCO, only BIS certified gloves for medical use will be permitted to be sold in India.
Source: bit.ly/3Dna2YV

4. The former CEO of a leading U.S. diagnostic company has reportedly pleaded guilty to charges over defective lead-testing devices that posed a public health risk. The company had failed to inform US Food and Drug Administration about inability of its product to meet the claims made on the label and was prosecuted for marketing misbranded products.
Source: bit.ly/41Dod3X

5. India’s National Pharmaceutical Pricing Authority (NPPA) will reportedly consider additional data sources, including IPDMS, web sources, and market surveys, to set ceiling prices for scheduled formulations. This decision comes in wake of concerns about the limited coverage of Pharmatrac, particularly regarding hospital supply products.
Source: bit.ly/41Doh3H

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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 National Pharmaceutical Pricing Authority has announced that all applications for retail price fixation of new drugs in Form I must be submitted through the dedicated online portal, Integrated Pharmaceutical Database Management System (IPDMS 2.0) from April 1, 2025. At present, Form I applications for the retail price fixation of new drugs are being submitted via email.
Source: bit.ly/4i4aKJw

2. India’s small retailers are facing challenges as quick-commerce giants are allegedly engaged in deep discounting  for the products sold through their platform. The All India Consumer Products Distributors Federation has urged the Competition Commission of India to investigate these discounting pricing practices.
Source: bit.ly/4ixzqtB

3. The Information Technology Industry Council (ITI) urges the government to delay children’s data processing rules under the Digital Personal Data Protection (DPDP) Rules, 2025, as global tech firms are facing operational challenges. They recommend aligning age verification with international standards.
Source: bit.ly/3QQV1l0

4. The Indian Council of Medical Research’s new guidelines exempt Ayush-approved medicines from additional safety evidence from animal studies or phase I/II human clinical trials in integrative research. However, non-codified traditional medicines must undergo full regulatory approval and adhere to applicable regulations.
Source: bit.ly/3QQWkAq

5. The Competition Commission of India (CCI) has ruled that a hospital’s intentional misleading of consumers, involving the misrepresentation of its surgeon’s qualifications and false advertising, does not raise any concerns under the provisions of the Competition Act 2002 and is outside CCI’s jurisdiction.
Source: bit.ly/3Fbvl05

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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. Various State Pharmacy Councils are reportedly planning to issue notices to pharmacists who work in medical shops that advertise discounts through physical discount boards, warning them that working in such shops is unethical and illegal, and may result in cancellation of registration.
Source: bit.ly/4h0LByd

2. India’s Supreme Court has stayed the Kerala High Court order which had directed Central Government to continue to support a patient suffering from rare disease, even after the medical expense of the patient crossed the Rs. 50 lakh limit imposed by The National Policy for Rare Diseases.
Source: bit.ly/41B8zHE

3. Beverage manufacturers will have to use rigid plastic packaging such as PET bottles that contain at least 30% recycled plastic content. India’s Ministry of Environment had introduced this requirement as part of Extended Producer Responsibility (EPR) for plastic producers.
Source: bit.ly/4hVwTts

4. State Drug Controllers are reportedly finding it difficult to prosecute drug manufacturers based in other states who manufacture substandard drugs because information required for prosecution is not readily made available by State Licensing Authority of State in which the manufacturer is located.
Source: bit.ly/4h5WvTj

5. India’s Central Drug Regulator (CDSCO) is reportedly planning to simplify Export No Objection Certificate (NOC) issued for unapproved drugs, by removing buyer and quantity-specific limitations, based on the exporting company’s export history. This may improve regulatory efficiency and ease manpower strain.
Source: bit.ly/3F3Tdm6

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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 Madras High Court has refused to pass interim order staying the controversial gaming law in Tamil Nadu, which prohibits minors under 18 years from playing games and generally imposes restrictions on gaming between 12 am and 5 pm.
Source: bit.ly/43hwJYX

2. Andhra Pradesh’s Director of Medical Education has instructed government medical colleges and hospitals to ensure doctors prescribe drugs using generic names. The ethical guidelines applicable to doctors mandate prescription in generic names, and brand name may be used in addition.
Source: bit.ly/43nG6WS

3. India’s Department of Pharmaceuticals (DoP) has established a technical committee to devise strategies aimed at enhancing supply chain resilience and reducing reliance on China for pharmaceutical products. This initiative, part of the Indo-Pacific Economic Framework, aims to strengthen key industries like healthcare and chemicals.
Source: bit.ly/43aZ1UZ

4. India’s Central Food Regulator (FSSAI) will reportedly release new Maximum Residue Level (MRL) values for 98 spices, up from the current values for 18 spices. A SOP guidance to fix MRL for pesticides is expected to be published soon as well.
Source: bit.ly/4h19LZl
Source: bit.ly/41luW2f

5. Delhi High Court has remarked that the government should put in place a legal framework to tackle “e-infringement” of trademarks in e-commerce. Since multiple parties are involved in e-commerce, it is difficult to determine who is responsible for infringement.
Source: bit.ly/4hX8TpY

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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. The Karnataka High Court has ruled that cases involving offences related to the manufacture, sale, and distribution of drugs and cosmetics under Chapter IV can only be tried in a sessions court. The magistrate court must send the case to the Sessions Judge for trial. The court clarified that while no court lower than a Sessions Court can try these offences, it does not mean that the Sessions Court can take cognizance of the case directly without a committal order from the Magistrate’s Court.
Source: bit.ly/41uSVNZ

2. The Kerala High Court ruled that a married woman can undergo IVF with donor sperm even if her husband exceeds the age limit under the Assisted Reproductive Technology (Regulation) Act, 2021 as long as he provides consent. The Court laid down that the age criteria apply individually to men and women, ensuring fair access to ART services.
Source: bit.ly/4gTEffT

3. The Ministry of Textiles has released a comprehensive list of technical textile products included under the Production Linked Incentive (PLI) Scheme. This list encompasses medical and hygiene textiles like baby diapers, sanitary napkins, surgical dressings, and compression stockings. The scheme is designed to enhance India’s production capabilities in healthcare textiles, increase global competitiveness, and create job opportunities.
Source: bit.ly/3F5jW1w

4. The European Commission is seeking feedback from stakeholders on a proposal to extend the option of providing electronic instructions for use (eIFU) for all medical devices, not just high-risk products. The Commission’s proposal suggests that manufacturers of medical devices and their accessories be permitted to provide instructions in electronic form, rather than on paper, for professional users, in line with Regulation (EU) 2017/745. This move aims to reduce paper waste and improve accessibility for healthcare professionals.
Source: bit.ly/41hBFdz

5. Amid the looming threat of a 25% tariff on pharmaceutical imports, Indian drugmakers, are confident they can remain competitive in the US generics market. Major Indian drug manufacturers emphasized that shifting production to the US isn’t feasible, and Indian companies will continue offering cost-effective alternatives despite the tariff.
Source: bit.ly/41hqCRL

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 Directorate General of Foreign Trade (DGFT) has launched an online module for filing the Annual Remission of Duties and Taxes on Exported Products (RoDTEP) Return (ARR), aimed at streamlining the process for pharma exporters. The module is available on the DGFT Portal and simplifies ARR filing, eliminating the need for physical documents.
Source: bit.ly/4hxQShu

2. India’s Parliamentary Standing Committee on Chemicals and Fertilisers has urged the Centre to actively implement recommendations from the Standing Forum on Medical Device Association, focusing on streamlining logistics and transitioning to licensing all types of medical devices.
Source: bit.ly/40XAnp8

3. The Directorate General of Foreign Trade (DGFT) has withdrawn the Track and Trace System for pharmaceutical exports under the Foreign Trade Policy (FTP), which required barcoding on primary packaging. The withdrawal is attributed to the implementation of the Ministry of Health & Family Welfare’s (MoH&FW) own barcode/QR code system, along with the fact that most export destinations have their own traceability systems.
Source: bit.ly/4aQDzqc

4. India’s Finance Minister has announced that 36 life-saving drugs, including cancer treatments, will be exempted from basic customs duty. Additionally, 37 more medicines will also benefit from this exemption. Furthermore, 6 life-saving medicines will be added to a list with a concessional 5% customs duty. The GST rate on cancer drugs like Trastuzumab, Osimertinib, and Durvalumab has been reduced from 12% to 5%. A new 13 Patient Assistance Programme has also been introduced.
Source: bit.ly/40UODPz

5. India’s Finance Minister in its 2025-26 Union Budget, announced that gig workers will be included in the Pradhan Mantri Jan Arogya Yojana (PMJAY) health insurance scheme. This will provide healthcare coverage to nearly 10 million online platform workers, offering financial protection to a sector that previously lacked structured benefits.
Source: bit.ly/4gmQwsN

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 Council of Medical Research (ICMR) has issued an Expression of Interest (EoI) for organizations, companies, and manufacturers to develop and produce a lateral flow-based point-of-care device for serum ferritin quantification. Serum ferritin is an important biomarker for diagnosing iron deficiency or anemia. The deadline for submitting the EoI is February 28, 2025.
Source: bit.ly/4jCmvrJ

2. The Pharmacy Council of India (PCI) has requested pharmacists facing registration issues on the DIGI-PHARMed portal due to existing identity proof in the system, to submit their details along with a declaration. This initiative is part of the Council’s efforts to eliminate fake or incorrect data by blocking incomplete entries and asking affected pharmacists to create new profiles with valid information.
Source: bit.ly/3Ee0e3q

3. The Federation of Pharma Entrepreneurs (FOPE) is urging the Union government to address GST rationalization due to challenges like low liquidity and increasing compliance burdens in the pharmaceutical industry. FOPE highlighted that the current GST structure has created an inverted duty structure, causing significant working capital blockages and operational inefficiencies, which impacts the critical role of the Indian pharma sector in healthcare, employment, and exports.
Source: bit.ly/3WC6Nmu

4. The National Medical Commission (NMC) is investigating around 30 doctors who took foreign trips to Monaco and Paris, sponsored by a drug manufacturer under the pretext of a dermatology conference. The doctors may face censure or suspension from the Indian Medical Register for three months to over a year, depending on the severity of the violation. This follows a reprimand from the Department of Pharmaceuticals (DoP) over the drug company’s sponsorship of the Rs 1.91 crore trips.
Source: bit.ly/4aCPis9

5. India’s Chhattisgarh High Court has ruled that when determining whether a mixture of narcotic drugs or psychotropic substances constitutes a “small quantity” or “commercial quantity,” both the quantity of the offending drug and the neutral substance mixed with it should be considered.
Source: bit.ly/4jAW8Ti

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. we hope you enjoy reading it.

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

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

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

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

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

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. we hope you enjoy reading it.

1. India’s central drug regulator (CDSCO) has called for urgent input from the pharmaceutical industry on regulatory challenges and opportunities for innovation. Stakeholders in the pharmaceutical industry, including companies, researchers, and healthcare providers, are invited to share obstacles to drug approval, difficulties in meeting compliance requirements, and barriers to entering new markets and are encouraged to reach out to CDSCO through its official communication channels.
Source: bit.ly/3PNEUnW

2. The National Medical Commission (NMC) has proposed a draft regulation that grants a one-year senior residency exemption to doctors with foreign postgraduate medical qualifications from five English-speaking countries (United Kingdom, United States of America, Canada, Australia, and New Zealand) to join medical colleges as faculty.
Source: bit.ly/4hlIQZn

3. The Union Cabinet approved the continuation of the National Health Mission (NHM) for another five years, until 2030, which was scheduled to end in 2025. This decision comes after the NHM achieved significant milestones in the past decade, improving healthcare access and quality in India.
Source: bit.ly/4h2YEzV

4. The National Pharmaceutical Pricing Authority (NPPA) has asked pharmaceutical companies and marketing companies of Iohexol, a diagnostic agent to submit price and market data. This action follows a directive from the Department of Pharmaceuticals (DoP) to review the drug’s pricing.
Source: bit.ly/4h9DqR4

5. The U.S. Food and Drug Administration (FDA) has approved a nasal spray as a monotherapy for the treatment of adults with treatment-resistant depression. This marks a significant advancement in mental health treatment, as the nasal spray is the first and only medication approved for this purpose.
Source: bit.ly/40G1bdv