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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 RBI’s revised draft for the Foreign Exchange Management (Export and Import of Goods and Services) Regulations, 2025, mandates repatriation of unutilized advances if imports aren’t completed within the contract period. If outstanding advances exceed Rs 25 crore, future imports must be secured with an irrevocable standby letter of credit or an international bank guarantee.
Source: bit.ly/4jrYGCl

2. Major global pharma companies are reportedly setting up Global Capability Centres (GCCs) in India, driven by the country’s tech talent amid the global economic slowdown. Experts predict that India’s GCC sector will surpass $100 billion by 2030, with significant growth in the Life Sciences and Healthcare sector.
Source: bit.ly/4j1ZZYO

3. The Gujarat Food and Drug Administration has reportedly assured the Indian medical device manufacturers that the differential pricing order for cardiac stents, implemented under the Ayushman Bharat scheme, will be repealed. Under this scheme, stents approved by the US FDA are priced at Rs 25,000, while those approved by the Indian regulator are priced at Rs 12,000.
Source: bit.ly/42lIV8K

4. India’s Department of Animal Husbandry and Dairying (DAHD) has mandated that all poultry farms across the country must register with their respective state animal husbandry departments within a month. This initiative is part of the Centre’s strategy to enforce strict biosecurity measures in response to the ongoing H5N1 avian influenza outbreak affecting multiple states.
Source: bit.ly/4251YFL

5. The Supreme Court of India reportedly rejected a plea to ban children under 13 from social media which was filed over concerns about mental health and addiction. It stated the issue is a policy matter for the government, not the judiciary, and advised approaching relevant authorities or Parliament.
Source: bit.ly/4cqw7Tx

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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) has revised its inspection checklist for food businesses operators in General manufacturing, Milk & milk products, Meat processing, Fish products processing, and Catering, and has reclassified food-grade packaging materials from ‘Non-Critical’ to ‘Critical.’ It has also mandated that food-grade packaging materials used in these food businesses must have a Certificate of Conformity issued by an NABL-accredited laboratory.
Source: bit.ly/4jmTFei

2. The Central Drugs Standard Control Organization (CDSCO) has clarified that the brand name of the medical device must be included in the Free Sale Certificate (FSC) issued to the legal manufacturer when filing an import licence application form. If not specified in the FSC, “Not Applicable” should be mentioned.
Source: bit.ly/3YhBEWi

3. The Central Drugs Standard Control Organization (CDSCO) has clarified the packaging and labelling requirements of non-sterile medical devices intended to be sterilized before use. The finished product package must include Instructions For Use (IFU) which specify the method of sterilization to be used for the device prior to its end-use.
Source: bit.ly/3YhBEWi

4. The Central Drugs Standard Control Organization (CDSCO) has clarified that domestic manufacturers of medical devices need not obtain ISO 13485:2016 certificate to obtain a manufacturing license under the Medical Devices Rules, 2017.
Source: bit.ly/3YhBEWi

5. The state government of Kerala has started taking action against online purchase of unauthorised medicines, including anabolic steroids. Kerala state drug control department is inspecting gyms across the state to identify unauthorised medicines and their misuse.
Source: bit.ly/41XmHLv

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 amended the definitions of micro, small, and medium enterprises (MSMEs) on March 21, raising investment and turnover limits.  This reclassification will move many medium-sized businesses to the small enterprise category, enabling access to benefits like public procurement, the GeM platform, and dispute resolution services.
Source: bit.ly/4iQlc7N

2. The Rajasthan High Court quashed a drug complaint, ruling that failing a dissolution test is a minor defect and not the ground for prosecution if the active pharmaceutical ingredient is within standard limits. The court held that slower dissolution doesn’t affect efficacy or make the drug spurious by itself.
Source: bit.ly/43DZJKO

3. The United States Food and Drug Administration (US FDA) has rejected in vitro studies conducted by an India-based contract research organization due to significant data integrity issues. Certain generics relying on bioequivalence data from the affected studies are marked with a “BX,” indicating insufficient evidence for therapeutic equivalence, thereby impacting their market status and sale.
Source: bit.ly/3FPn9mB

4. The Association of Indian Medical Device Industry (AiMED) has reportedly criticized Gujarat Government’s new pricing for drug-eluting stents, which sets USFDA-approved stents at double the price of domestic-approved ones. The association urged the state to reverse the decision, noting that such price disparities are not observed globally.
Source: bit.ly/4hXrfWM

5. According to a fact sheet issued by the White House after the US President’s announcement, pharmaceutical products are not yet subject to reciprocal taxes, providing relief to Indian pharmaceutical companies that earn significant revenues from exports to the United States.
Source: bit.ly/3YdSJAy

 

 

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. CDSCO has proposed a draft list to revise the existing classification list of cardiovascular and neurological devices, categorizing 351 cardiovascular and 202 neurological devices under a risk-based classification. Stakeholders can review and submit feedback within 30 days via a Google Form before finalization.
Source: bit.ly/3QYf29q

2. The central government has no plans to set up a special tribunal for medical negligence cases. Instead, such cases are handled by State Medical Councils, which can take disciplinary action against doctors. Appeals can be made to the National Medical Commission (NMC).
Source: bit.ly/42jt9LX

3. The 2025 National Trade Estimate Report states that unclear licensing guidelines and import procedures under India’s Medical Device Rules have delayed U.S. exports of refurbished medical devices. Since April 2024, CDSCO has suspended approvals for existing and new import licenses, effectively blocking refurbished medical device imports.
Source: bit.ly/4lfgp1s
Source: bit.ly/41W3pWY

4. The Central Consumer Protection Authority fined three lotion companies for falsely claiming in e-commerce ads that their products whiten skin instantly. The Bureau of Indian Standards found no scientific proof. The companies removed their ads and were warned of a ₹50 lakh fine for repeat violations.
Source: bit.ly/3G2pB94

5. India’s Delhi High Court upheld Consumer Protection Authority guidelines barring automatic service charges addition in restaurant bills. It was further held that collecting such service charge under other names constitutes an unfair trade practice. Additionally, GST cannot be charged on service charges.
Source: bit.ly/4j88ukG

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 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

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. All insurance and healthcare policies are by law required to accommodate mental healthcare treatment under the Mental Healthcare Act, 2017. Therefore, even if an explicit provision exists in a current policy, it cannot be ground to refuse reimbursement for mental healthcare services availed under the policy: High Court.
Source: bit.ly/3Qm1LHg

2. The District Consumer Disputes Redressal Forum in Gujarat has recently held that insurance providers cannot rely on a discrepancy in documentation to deny a claim for treatment, provided that the justification letter of the treating doctor sufficiently addresses the eligibility of a claimant under the policy.
Source: bit.ly/41ivGqj

3. The National Human Rights Commission (NHRC) has recently held a core-group meeting to recognize the impact of progressive disabilities and possible changes in applicable law to address the same. The NHRC has also proposed to re-visit the current 40% benchmark for disabilities, to accommodate cases of persons with progressive disabilities.
Source: bit.ly/4hEfMwb

4. A Consumer technology product manufacturer has recently won its invalidation petition before a Federal Court of the United States, with this, the complainant in this matter now has complete and undisputed Intellectual Property rights in the US, over the underlying technology for detecting heart-rate in wearables.
Source: bit.ly/432ybye

5. The World Health Organization released new findings highlighting a concerning lack of awareness about alcohol’s link to cancer in Europe. It called for clear, prominent tobacco-style warnings, particularly in the region with the highest alcohol consumption. While the WHO has consistently warned about alcohol’s cancer risk and supported labeling, this is the first time it has directly called for new government regulations.
Source: bit.ly/4102Vxj

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 Central Drug regulator, the Central Drugs Standards Control Organization (CDSCO) has issued an instruction manual for manufacturers and importers of devices not having predicate devices, to file Periodic Safety Update Report on the Medical Device Portal.
Source: bit.ly/4g5ORaV

2. India’s Delhi High Court held in a recent order that petitions regarding patent infringement, during the lifetime of a patent will continue to be valid even after the expiry of the term of the patent itself, since the cause of action has arisen at a time when the patent was still active.
Source: bit.ly/3PL3TYU

3. India’s central level regulator of the medical profession and education, the National Medical Commission has issued a draft Teachers’ Eligibility Qualifications, where it is proposed to permit non-medical personnel with Masters and PhD level degrees to teach Anatomy, Physiology and Biochemistry at medical educational institutions.
Source: bit.ly/40HAW6o

4. A premier commercial body of India’s restaurant business operators are currently mulling legal action against quick-commerce companies which have created a business model of undercutting the restaurant business through the use of private-label food products.
Source: bit.ly/4auFgsV

5. The European Pharmacopoeia has adopted three general standards for mRNA based vaccines, (1 mRNA vaccines for human use (5.36), covering mRNA packaged in lipid nanoparticles, (2) mRNA substances for the production of mRNA vaccines for human use, and (3) NA templates for the preparation of mRNA substances. These standards are expected to set a framework of control for regulatory control and approval of mRNA vaccines across the EU and all jurisdictions that accept EU Pharmacopoeia standards.
Source: bit.ly/4ar8HMK

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 Supreme Court of India has dismissed a Public Interest Litigation (PIL) seeking quality regulation for “prasad” food items distributed at religious places, stating that the Food Safety and Standards Authority of India (FSSAI) already oversees food safety standards.
Source: bit.ly/4eYIJAX

2. The District Consumer Disputes Redressal Commission in Delhi has ordered a compensation of Rs. 48 lakhs against a hospital and its doctors for performing surgery without the necessary expertise and proper disease assessment. The commission found that the medical professionals manipulated records to obscure the actual causes of the complications, which constituted medical misconduct and negligence.
Source: bit.ly/4iiLHTM

3. The Ministry of Consumer Affairs, Food & Public Distribution has issued draft rules for clinical electrical thermometers, inviting feedback from stakeholders by December 30, 2024. The draft rules provides technical standards of clinical electrical thermometers to ensure the accurate measurement of body temperature is recorded in clinical settings.
Source: bit.ly/3CVrjYs

4. India’s food regulator, the Food Safety and Standards Authority of India (FSSAI) has designated packaged drinking water and mineral water as “High-Risk Food Categories” after the removal of mandatory Bureau of Indian Standards (BIS) certification for these products. This decision will now require the manufacturers to undergo annual risk-based inspections and third-party audits before obtaining licenses or registrations.
Source: bit.ly/4i8DO3b

5. The Ministry of Consumer Affairs has released draft rules for non-invasive automated sphygmomanometers, inviting comments from stakeholders by December 30, 2024. The draft rules aim to establish regulatory standards for the measurement of blood pressure using these devices. The scope of the draft includes specifications for the design, performance, and testing methods required to ensure accuracy and reliability in clinical settings.
Source: bit.ly/3OC0Ku6

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

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

1. India’s apex food regulator, Food Safety Standard Authority of India (FSSAI), has launched an online portal “Food Import Rejection Alert (FIRA)” for alerts on food import rejections and to ensure traceability and transparency. Also, food consignments from Sri Lanka, Bangladesh, Japan, China & Turkey has been rejected as they fell short of the standards.
Source: bit.ly/49aLJIT

2. Delay in clearance of import consignments of essential components has reportedly resulted in the disruptions in the manufacture of medical devices in India.
Source: bit.ly/3OpyhHx

3. India’s National Standards Body, Bureau of Indian Standards (BIS) to reportedly prioritize development of standards for 214 critical medical devices post consultation with the Department of Pharmaceuticals (DoP). Standards set to be completed by December 2025.
Source: bit.ly/3B2ZtZJ

4. India’s Meghalaya High Court has called for ban on manufacture, marketing and use of plastic of less than 120 microns.
Source: bit.ly/3Z4VT9C

5. The US Food and Drug Administration (FDA) has announced a temporary enforcement policy to enable certain sterilization site changes for Class III medical devices that are sterilized using ethylene oxide (EtO). Affected medical device manufacturers requesting enforcement discretion must submit an “informal notification” along with certain information to FDA.
Source: bit.ly/3OpairY
Source: bit.ly/3Zpx6OT