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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 imposed a ban on the manufacture, sale, transport, and use of 28 types of single-use plastic items across the areas like the Nilgiris, Kodaikanal, and the Agathiyar Biosphere. Banned items include plastic bottles, food wrapping films, thermocol plates and cups, plastic-coated tableware, straws, carry bags, etc.
Source: bit.ly/3RmpHuX

2. Indian food regulator FSSAI, in response to an RTI, has stated that it lacks authority to regulate baby milk products under the Infant Milk Substitutes, Feeding Bottles, and Infant Foods (Regulation of Production, Supply and Distribution) Act, which regulates baby food marketing, placing enforcement responsibility on the Women and Child Development Ministry.
Source: bit.ly/4lDCPts

3. India’s Health Ministry has released a notification restricting the manufacture and sale of a popular anti cold drug until there is a warning on labels stating they should not be used in children below four years. The notification will take effect from the date of its publication in the Official Gazette.
Source: bit.ly/3Y54v08

4. Private hospitals in Nagaland have reportedly suspended admitting patients under Ayushman Bharat, Pradhan Mantri Jan Aarogya Yojana and Chief Minister Health Insurance Scheme from April 17, 2025, due to unpaid dues. The Nagaland Private Doctors Association urged authorities to resolve the issue so services can resume without further delay.
Source: bit.ly/4cAsslY

5. The UK Government has enacted significant reforms to clinical trials regulation. Effective from April 11, 2025, with full implementation by April 2026, the new rules aim to streamline trial approvals, enhance patient safety, enable innovation, and help more people benefit from participating in vital research.
Source: bit.ly/4jDT5ZC

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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. Several global pharmaceutical companies have approached the European Commission demanding assistance in maintaining operations in the EU and to help Europe keep the pharma industry including measures to compensate them for the cost of pharmaceutical innovations. This move comes in the face of threatened U.S. tariffs on imports.
Source: bit.ly/3RgXrK6

2. A pharma giant has allegedly breached the UK’s Prescription Medicines Code of Practice Authority (PMCPA) for its cancer drug’s misleading prescribing information, which failed to clearly state that women using hormonal contraceptives needed to take additional measures to prevent pregnancy while on the drug.
Source: bit.ly/4lzu3MO

3. India’s Department of Pharmaceuticals (DoP) has invited expression of interest for selecting an agency to conduct a comprehensive study of India’s pharmaceutical and medical device supply chains, in order to identify regulatory hurdle.
Source: bit.ly/42zIx6O

4. Central Drugs Standard Control Organisation has directed States and Union Territories to urgently stop the manufacture, sale, and distribution of 35 unapproved Fixed Dose Combinations licensed without safety and efficacy evaluation under New Drug and Clinical Trials rules, 2019. Authorities must investigate, take action, and report compliance to ensure public health and regulatory consistency.
Source: bit.ly/4cw43hg

5. China has amended its GB 9685 standard for additives in food contact materials. The changes include expanded use in silicone rubber, revised usage limits, updated additive names, and new safety calculations. These updates, effective March 2025, aim to improve consumer safety and industry compliance.
Source: bit.ly/4cGqBfE

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 given Central government three months to enforce new food labelling rules which require Front-of-Pack-Warning Labels (FoPWL) for Packaged foods containing high level of sugar, salt, and saturated fat content, along with their recommended daily intake (RDA), in bold and prominent font on the front of packaging.
Source: bit.ly/3Eigy3s

2. Gujarat Food and Drug Control Administration has reportedly found fake QR codes on a top pharma brand’s medicine. Over 900 strips were seized in this counterfeit drug racket. A full-scale investigation, raids, forensic checks, and officer training are underway to trace sources and stop illegal supply chains.
Source: bit.ly/4lsuJna

3. A survey across 303 Indian districts reportedly reveals that most side effects among medicines are caused by antibiotics. One in two people reported side effects from allopathy or AYUSH medicines. Experts warn that misuse of antibiotics without prescriptions is rising antimicrobial resistance, posing serious public health concerns
Source: bit.ly/3YsVr5f

4. India’s Gujarat Food and Drug Control Administration (FDCA) has launched India’s first mobile app for licensing allopathic, cosmetic, and Ayurvedic products, issuing over 900 licenses online. The FDCA-mDMLA mobile app boosts efficiency, transparency, and ease of doing business allowing real-time access and digital services.
Source: bit.ly/4i9yvz6

5. China has reportedly approved an amendment to General Requirements for Labels and Instructions of Disinfection Products, which mandates clearer warnings, font size requirements, and restrictions on misleading branding to enhance safety, transparency, and compliance in the disinfection product industry. The amendment is effective from May 1, 2025.
Source: bit.ly/3Ehsx1f

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 CDSCO has upgraded its online system to automatically generate the Market Standing Certificate (MSC), Non-Conviction Certificate (NCC) and Neutral Code for medical devices. Consequently, manufacturers and importers must reapply for these certificates, as all previously issued ones will become non-functional from April 9, 2025.
Source: bit.ly/4j7NJWL
Source: bit.ly/4j7NMBV 

2. India’s Supreme Court has introduced new guidelines for interpreting deeds and contracts. The guidelines emphasize using the literal rule, where words are given their plain meaning unless absurdity arises. If necessary, the golden rule may be applied and a shift to purposive interpretation based on the document’s context and objectives, ensuring clarity in legal agreements.
Source: bit.ly/3Rc0TWh

3. The Bombay High Court issued an ex-parte ad-interim order against unidentified individuals selling counterfeit and illegally imported oral care products, restraining them from manufacturing, packaging, or distributing lookalike goods infringing trademark and copyright. A Court Receiver was appointed to oversee the identification and inventory of the infringing goods.
Source: bit.ly/3G5i9u0

4. The Supreme Court of India will hear petitions challenging the ₹50 lakh cap on government aid for rare disease treatments, including Spinal Muscular Atrophy (SMA), following a High Court order. The SMA drug is cheaper in China and Pakistan due to negotiations with the manufacturer. The SC suggested the Centre explore similar negotiations and consider flexibility in approving aid beyond the ₹50 lakh cap on a case-by-case basis.
Source: bit.ly/4lqJ2ss

5. The Government of Kerala has reportedly introduced digital payment systems in government hospitals to streamline service fee transactions, allowing patients to pay using UPI, debit, or credit cards. In addition, they have also introduced an online outpatient (OP) ticket, M-health app, and scan and book system.
Source: bit.ly/4crteSd

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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. Indian Ministry of Environment, Forest, and Climate Change (MoEF&CC) has introduced the Environment (Construction and Demolition) Waste Management Rules, 2025, effective from April 1, 2026. These Rules apply to construction, demolition, remodeling, renovation, and repair activities, with key provisions on Extended Producer Responsibility (EPR) and waste management plans.
Source: bit.ly/42AOQIu

2. India’s Central Drugs Standard Control Organization (CDSCO) has issued a Standard Operating Procedures (SOPs) to streamline the transfer of drugs manufactured in Special Economic Zones (SEZs) to domestic markets (Domestic Tariff Area) for sale and distribution. SEZ units are exempted from mandatory import and registration requirements, provided these drugs are not diverted for domestic sale and are used exclusively for export purposes.
Source: bit.ly/44ftUYL

3. Pune Municipal Corporation has issued notices to private hospitals instructing to not demand any advance deposit from patients seeking emergency medical care and to strictly follow the Bombay Nursing Home Registration Act, 1949, which forbids demanding any advance deposit from “emergency” patients.
Source: bit.ly/4j52xp2

4. A content creator agreed to remove part of a podcast after a company objected to a guest’s remarks about an antiseptic product. The guest’s claims were considered disparaging. The court-approved settlement also required related social media posts to be deleted to protect the product’s reputation.
Source: bit.ly/42sBOeV

5. A global agricultural company is helping Indian rice farmers adopt eco-friendly farming methods. These practices reduce harmful greenhouse gases. In return, the company will issue its first carbon credits, certified by Gold Standard, which environmentally conscious companies can purchase to offset their emissions.
Source: bit.ly/4iavSgm

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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 Ministry of Corporate Affairs (MCA) has proposed to expand eligibility for fast-track mergers, covering more unlisted companies and subsidiaries of companies that are not wholly owned and foreign companies merging into Indian subsidiaries. Stakeholder comments are invited until May 5, 2025.
Source: bit.ly/42sNtuj

2. AI technology scanned prescriptions from MBBS doctors and found that the same expensive medicines for serious diseases were being given to all patients, exposing a scam in Rajasthan’s free treatment scheme through fake and unnecessary prescriptions. Investigations are now underway against the accused.
Source: bit.ly/4jnNiY0
Source: bit.ly/3YkV8ta

3. The Indian government is reportedly planning to revise norms on the use of high Global Warming Potential (GWP) gases, such as hydrochlorofluorocarbons (HCFC), as refrigerants in refrigeration and air conditioning. This move aims to align with global environmental standards. The updated rules will require manufacturers to adopt alternative refrigerants and comply with new packaging and safety standards.
Source: bit.ly/4jmWrjo

4. The Madhya Pradesh Health Department has reportedly launched an investigation into unregistered physiotherapy clinics after concerns over registration violations were raised in the State Assembly. Despite 9,000 physiotherapists operating in the state, only 40 clinics are officially registered on the health portal.
Source: bit.ly/4coiMel

5. The government reportedly plans to bring online real-money gaming companies under anti-money laundering laws, requiring KYC, record-keeping, and reporting of suspicious transactions. This aims to curb unaccounted money but enforcing it on offshore platforms remains a major challenge.
Source: bit.ly/4iae19v

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 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

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 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