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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 Health and Family Welfare has developed ONDLS Portal for receiving applications from small and medium scale pharmaceutical manufacturers who wish to avail benefit of extension from requirement to comply with new Good Manufacturing Practices (GMP) under revised Schedule M. Such applications must be strictly submitted online before lapse of three months from February 11, 2025. Submission of hard copy applications will no longer be accepted.
Source: https://bit.ly/4iEFh0U

2. The Indian Ministry of Health is working with Bureau of Indian Standards (BIS) to develop a standardized invoice format for hospitals, nursing homes, clinics and diagnostic centers. Once notified, clinical establishments will have to follow a standard invoice format with detailed and transparent breakdown of charges incurred by patient.
Source: https://bit.ly/4c4CM5w

3. India’s Supreme Court has held that even in consumer contracts which contain arbitration clauses, a consumer has the right to decide whether to pursue arbitration or approach the consumer forum for resolution of consumer dispute. The Court further reiterated that consumer disputes are non-arbitrable unless the consumer voluntarily opts for arbitration.
Source: https://bit.ly/4c4CPOK

4. The Directorate General of Foreign Trade (DGFT) has decided to withdraw the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme benefits for exports arising from Advance Authorizations (AAs), Special Economic Zones (SEZs), and Export Oriented Units (EOUs).
RoDTEP Scheme helps pharmaceutical exporters to get refund on taxes and duties on export.
Source: https://bit.ly/4c43M59

5. The Food Safety and Drug Administration (FDA) of Karnataka has reportedly increased inspections to address the issue of adulteration of tea powders and spices.
The decision has been taken due to reports of addition of harmful substances in food products, with the goal of reducing health risks to the public.
Source: https://bit.ly/4cjrdrr

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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 Consumer Disputes Redressal Commission (NCDRC) absolved a major Super Specialty Hospital from charges of medical negligence, and stated that the absence of specific specialists doesn’t imply improper treatment or breach of medical duty when a patient is under the care of a multi-disciplinary ICU team.
Source: bit.ly/4kGd0sh

2. The Karnataka government has reportedly proposed the establishment of a special court to handle cases related to the supply of fake and spurious drugs. This proposal aims to tackle drug-related frauds, speed up trials, reduce delays and impose stricter penalties on offenders.
Source: bit.ly/4bPYme3

3. As of March 12, 2025, the National Pharmaceutical Pricing Authority (NPPA) has fixed ceiling prices for 928 scheduled formulations and retail prices for over 3,200 new drugs, reducing average prices by approximately 17% leading to estimated annual savings of about ₹3,788 crore for patients.
Source: bit.ly/4bRQF7a

4. India’s Delhi High Court to examine the scope of Customs jurisdiction under the Prohibition of Electronic Cigarettes Act, 2019, following the seizure of “empty atomizer devices” which are not claimed to be licensed medical devices. Currently, the definition of electronic cigarette exempts products licensed under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4iIVRwb

5. The Food Safety and Standards Authority of India (FSSAI) has reportedly set an expert panel for reviewing the regulations for baby food, specifically focusing on prescribed limit of sugar in packaged food products for babies. This follows a report revealing Nestlé adds sugar to Indian baby food but not in high income countries.
Source: bit.ly/4hwdxdv

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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 Competition Commission of India (CCI) has reportedly raided offices of big advertisement and broadcasting firms as well as industry associations, on suspicion of fixing ad rates and undertaking price collusion. It is uncommon for CCI to raid industry associations, indicating possibility of cartelization.
The raid may affect advertisement by top brands.
Source: bit.ly/4iYMx7r

2. Pharmaceutical exporters have raised concerns about requirement to submit legal undertaking from API manufacturers in order to secure Export NOC from the Central Drug Regulator (CDSCO), on grounds that the APIs are procured from traders and not manufacturers, and manufacturers won’t readily agree to give legal undertaking. A new Export NOC system was introduced in March 2025 to expedite issuance of export NOC
Source: bit.ly/4iZDqTY

3. Representatives of leading cosmetics brands are reportedly demanding a separate law for regulation of cosmetics. The demand stems from the fact that cosmetics are regulated together with drugs under the current law i.e. Drugs and Cosmetics Act, 1940, because of which cosmetics are under system of significant licensing and inspection. The industry expects the law to require post-market notification as opposed to pre-market licensing.
Source: bit.ly/3DSCT7B

4. Google has recently announced a new health care update to its Search platform called the “What People Suggest” Feature, currently available only in the US. This new feature allows individuals with specific health conditions to compare their experiences with others. It utilizes artificial intelligence to collate online feedback from patients sharing similar diagnoses, enabling users to find insights on managing their conditions.
Source: bit.ly/421sKgK

5. The West Bengal Drug Control Administration is reportedly taking steps to closely monitoring discount pharmacies in order to eliminate counterfeit drugs. As part of the drive, inspectors will verifying purchase sources, inspect medicines, and enforce strict measures to ensure drug quality and public safety.
Source: bit.ly/4hIBxKk

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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 drug price control authority, the National Pharmaceutical Pricing Authority (NPPA) has issued an Office Memorandum instructing drug manufacturers to revise the prices of the drugs on which customs duty has been reduced.
Source: bit.ly/4gNNEVW

2. The Materiovigilance Programme of India’s Ministry of Health and Family Welfare has published an updated Draft Adverse Event Reporting Form for In-Vitro Medical Devices seeking public comment. The last date for receiving public comment is 5th March 2025.
Source: bit.ly/3Qn7kW2

3. In its recent meeting, the Drugs Consultative Committee (DCC), a policy advisory committee to India’s drug regulator, has raised the proposal to include Anti-microbial drugs in the definition of “New Drug” under the New Drugs and Clinical Trial (Rules), 2019 in an attempt to heighten the oversight of antimicrobial drugs.
Source: bit.ly/3QqZlao

4. India’s Union Ministry of Health and Family Welfare has revealed plans to include the human papillomavirus (HPV) vaccine in the national immunization program this year. During the recent Budget session of Parliament, Minister of State for Health stated that the details for its implementation are currently being worked out.
Source: bit.ly/4hH6dMR

5. Representatives of the Pharmaceutical industry in the United States are set to meet with the new administration in a bid to revise price-control regulations, and the United States government’s right to negotiate Drug Prices with pharmaceutical companies.
Source: bit.ly/4i5UEP4

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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. 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 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

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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 AYUSH has proposed an amendment to the First Schedule of the Drugs and Cosmetics Act, 1940, expanding the list of authoritative books for Ayurveda, Siddha, and Unani Tibb drugs. The updated list now includes more vernacular books with details such as the author’s name and language. These drugs must be manufactured according to the formulae described in the books listed in the First Schedule, as defined by the Act.
Source: bit.ly/40UqMhL

2. The Ministry of AYUSH has proposed an amendment to update the list of poisonous substances in Ayurveda, Siddha, Sowa-Rigpa, and Unani systems under Schedule E(I) of the Drugs Rules, 1945. The draft amendment has been published for public awareness, with a 30-day period for objections or suggestions. The amendment categorizes the poisonous substances by their botanical names and includes the drugs in the respective systems of medicine that are prepared using these substances.
Source: bit.ly/3QdJ6NP

3. India’s drug pricing regulator has directed all retailers and dealers, including online pharmacies, to display the current price list of medicines on their websites. This move aims to empower consumers and ensure they are not overpaying for their medications.
Source: bit.ly/41bnhEY

4. India’s Odisha Registered Pharmacists Association (ORPhA) has expressed disagreement to government’s classification of pharmacists as paramedics, despite the Pharmacy Council of India (PCI) stating they are independent healthcare professionals. The association has urged the health minister to take steps to avoid the classification, highlighting that pharmacists are specialized healthcare professionals who play a vital role in patient care through their expertise in areas like pharmaceutical sciences, pharmacology, and medication therapy management.
Source: bit.ly/3EtSniq

5. India’s central government has imposed a ban on the export of raw human hair valued at less than $65 per kilogram, as per a notification issued by the Directorate General of Foreign Trade (DGFT). The notification stated that the export policy for raw human hair has been changed from “restricted” to “prohibited.” However, exports will still be permitted without restrictions if the Free on Board (FOB) value is $65 or more per kilogram.
Source: bit.ly/4gBVKAU

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 advertising self-regulation body, the Advertising Standards Council of India (ASCI), has issued a report analyzing the conduct of the country’s leading online influencers. Notably, the report reveals that only 29% of the influencers have even made appropriate disclosures of material connection with brands/companies their content.
Source: bit.ly/4k649jp
Source: bit.ly/40NSywt

2. In pursuance of the Central government’s BioE3 policy, which was announced in November 2024, the Central Government Minister for Science and Technology has urged State Governments to set up BioE3 Cells to promote Center-state partnership in pursuance of the BioE3 policy aims.
Source: bit.ly/4jTZjW4
Source: bit.ly/40UBchz

3. India’s Health Ministry has reportedly established an expert working group that will monitor adverse effects of medical devices and IVDs which are reported under Materiovigilance Programme of India (MvPI), and will recommend measures to improve patient safety to Indian’s medical device regulator, the Central Drugs Standards Control Organization (CDSCO).
Source: bit.ly/3ExgA7l

4. Earlier this year, The United States Food and Drug Administration has issued a proposed new rule which would have introduced a cap on the nicotine content in cigarettes and other tobacco products, in an effort to curb deaths from nicotine addiction in the country.
Source: bit.ly/3WVFdRr

5. In cases of insurance claim of medical treatment costs for chronic illness, insurance providers cannot deny a claim on technical ground of absence of in-patient treatment, if the treating Doctor had determined outpatient treatment was sufficient for the patient: High Court
Source: bit.ly/3CWwSpM