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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 NPPA’s Multidisciplinary Committee, in its recent meeting has reportedly decided to co-opt experts from AIIMS, MAMC, SIC Safdarjung and NIPER to evaluate industry requests for a distinct ceiling price on cementless knee implants. Under Drugs Price Control Order, 2013, manufacturers may petition for separate pricing if their product shows innovation or superiority over existing variants.
Source: bit.ly/3HQpizr

2. The Bureau of Indian Standards (BIS) has introduced two important standards, IS/IEC 63203-201-1:2022 which outlines the standards for measurement methods for basic properties of conductive yarns used in wearable electronic textiles and, IS 19173 (Part 1):2025 which is aligned with IEC/TR 80002-1:2009, offers guidance on applying ISO 14971 to medical device software, strengthening risk management practices.
Source: bit.ly/4ejatBw

3. The National Human Rights Commission has reportedly directed AIIMS Delhi to submit a report within 15 days following allegations that neuroradiology doctors bypassed institutional procurement norms, referring patients to buy flow-diverter brain implants from a private vendor. The complaint highlights significant cost burden and potential human rights violations.
Source: bit.ly/4kY4PqY

4. The Customs, Excise, and Service Tax Appellate Tribunal (CESTAT), New Delhi Bench, ruled that packing or repacking parts of Vibratory Compactors and Wheeled Tractor Loader Backhoes does not constitute “manufacture” under Central Excise Act, so no excise duty is payable.
Source: bit.ly/4eispvP

5. The Sikkim High Court has ordered the State Government to conduct the periodic inspections of all industries including pharmaceutical companies to verify that no effluents are being discharged into rivers. The court also noted groundwater extraction and urged timely completion of the Sikkim Springs & Groundwater Regulation Bill, 2025.
Source: bit.ly/4k5z1yW

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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 National Pharmaceutical Pricing Authority (NPPA) plans to consult subject matter experts to determine a separate pricing structure for cementless knee implants, aiming to ensure affordability and accessibility for patients requiring these advanced medical devices.
Source: bit.ly/43XywRM

2. The Indian Pharmaceutical Alliance (IPA) has expressed opposition to the government’s recent directive limiting the entry of medical representatives into Central government hospitals, arguing that such restrictions could hinder the dissemination of critical medical information to healthcare professionals.
Source: bit.ly/4kDnNCZ

3. The Ministry of Electronics and Information Technology (MeitY) is considering the discontinuation of the bundled consent mechanism, proposing stricter regulations to enhance data privacy and security standards in digital platforms.
Source: bit.ly/4kE8qdH

4. India has asserted its stance on protecting pharmaceutical innovations, countering recent patent infringement allegations from Switzerland, and emphasizing the country’s commitment to safeguarding public health interests.
Source: bit.ly/4n66Lzd

5. The U.S. Department of Agriculture is set to introduce new dietary guidelines for schools, aiming to reduce added sugars and sodium in meals, promote plant-based options, and support local agriculture, thereby enhancing student health and nutrition.
Source: bit.ly/3Hzzv2P

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 Health Ministry has requested the Department of Animal Husbandry and Dairying (DAHD) to share data on veterinary antibiotic manufacturers involved in the manufacturing, distribution, and sale of veterinary antibiotics. Additionally, members will be nominated for Antimicrobial Use (AMU) data collection and coordination with the Joint Working Group.
Source: bit.ly/4l6iHPD

2. India is expanding the availability of the HPV vaccine through Jan Aushadhi Kendras to improve accessibility and affordability. In addition, 116 essential generic medicines have been added to the national list thereby enhancing preventive healthcare efforts and strengthening the pharmaceutical supply chain.
Source: bit.ly/3FyEAIj

3. An Ayurveda professor from Banaras Hindu University (BHU) has written to Prime Minister of India, seeking an exemption under the Minamata Convention, an international treaty banning mercury use, to allow the continued use of mercury in traditional Ayurvedic medicines as it is vital for preserving their potency.
Source: bit.ly/45j9M8J

4. The United States Food and Drug Administration (US FDA) has released draft Questions & Answers (Q&A) guidance detailing the process for transferring ownership of 510(k) premarket notifications. Stakeholders may submit comments until August 4. The guidance aims to help sponsors ensure a smooth and compliant ownership transition process.
Source: bit.ly/4kBADSd

5. The United States Food and Drug Administration (US FDA) issued draft guidance and a proposed order outlining documentation for minor dosage form changes in highly soluble, highly permeable OTC monograph drugs. A separate order requires certain OTC monograph drugs to be packaged in single- or unit-dose containers for regulatory compliance.
Source: bit.ly/4jHnntZ

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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 Supreme Court has ruled that volume-based discounts are lawful and do not constitute discriminatory pricing, for such discounts to be considered discriminatory they must be applied unequally to similarly situated buyers in comparable transactions.
Source: bit.ly/4mghWEN

2. India’s Supreme Court has issued a notice to the central government on a petition seeking to make it mandatory for hospitals and clinical establishments to display service rates and charge fees within limits set by the Centre, in consultation with state governments. The Court noted that the failure to enforce this requirement stems from the government’s failure to specify the service charge limits which potentially impacts citizens’ fundamental right to healthcare.
Source: bit.ly/4jXJ75U

3. The High Court of Jammu & Kashmir and Ladakh has upheld a government advisory requiring retail and wholesale pharmacies to install CCTV cameras and adopt computerized billing systems. This measure aims to curb the sale of prohibited drugs and enhance transparency in pharmaceutical operations.
Source: bit.ly/4mgjrCV

4. In a proposed Free Trade Agreement with the UK, India has reportedly decided to reduce import duties on medical devices under the Production-Linked Incentive (PLI) scheme starting only from the sixth year. This phased approach aligns consumer needs with the Make in India programme, aiming to protect domestic manufacturers while gradually opening market access for UK exporters.
Source: bit.ly/4mlyPy8

5. The U.S. government’s order to align domestic drug prices with global rates may impact Indian pharmaceutical firms, many of which rely heavily on U.S. revenues. Though primarily targeting Big Pharma, the move could subject Indian generic manufacturers to pricing pressure, potentially disrupting their business models and profitability.
Source: bit.ly/4dkH0Xt

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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. Drugs Technical Advisory Board (DTAB) has proposed to mandate the immediate suspension of licenses for drugs classified as Not of Standard Quality (NSQ) in the public interest. Such suspensions would remain in effect unless the concerned manufacturers submit a satisfactory Corrective and Preventive Action (CAPA) plan. The proposal also includes corresponding amendments to the Drugs Rules.
Source: bit.ly/3EFg5Zx

2. Drugs Technical Advisory Board (DTAB) has proposed to classify all antimicrobials as “New Drugs” under the New Drugs and Clinical Trials Rules, 2019. This move aims to facilitate stricter regulatory oversight in light of growing concerns over antimicrobial resistance.
Source: bit.ly/3EFg5Zx

3. Drugs Technical Advisory Board (DTAB) has proposed that manufacturers of medical devices with a valid manufacturing or loan license need not apply for a sterilization loan license. Instead, they can submit documentary evidence in support of proper sterilization when applying for a manufacturing license, provided the sterilization site’s license number is included on the device label.
Source: bit.ly/3EFg5Zx

4. Drugs Technical Advisory Board (DTAB) has proposed amendments to the Medical Devices Rules, 2017, to include clear definitions for “registration certificate” and “registration certificate holder.”  This change aims to provide better regulatory clarity in the medical device industry.
Source: bit.ly/3EFg5Zx

5. The Indian Government is finalizing revised biosimilar guidelines to align with global standards. The updated ‘Guidelines on Similar Biologics’ focus on stricter quality standards, reducing animal testing, and promoting in-vitro studies, while adhering to the 3R principles (Replace, Reduce, Refine). The aim is to streamline approvals and ensure patient safety.
Source: bit.ly/3GFiunq

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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 Central Drugs Standard Control Organization has lifted the suspension on an eye drop for presbyopia and approved its phase IV clinical trial but by restricting false media publicity. The suspension was imposed for violating marketing norms by promoting the product as a replacement for reading glasses.
Source: bit.ly/4cXhGpW

2. Indian food regulator, FSSAI, has released a consultation paper proposing clear labelling norms for synthetic paneer, including terms like “non-dairy” or “contains no milk” on packaging and restaurant menus. Stakeholders are invited to submit their comments within 60 days.
Source: bit.ly/42w1ZBl

3. The Central Consumer Protection Authority has taken suo-moto action against five restaurants for violating guidelines and failing to refund mandatory service charges. Acting on consumer complaints, the authority issued notices, reinforcing that service charges must be voluntary and cannot be added to bills without consent.
Source: bit.ly/43coUTK

4. The Belgian Competition Authority has fined three pharmaceutical companies for entering into anti-competitive agreements with pharmacies to secure preferential shelf placement for their products. The authority found that such practices distorted fair competition and limited consumer choice in the over-the-counter (OTC) medicine market.
Source: bit.ly/4cTwLc6

5. India and the United States are set to begin in-person sectoral trade negotiations in late May, with a goal to finalize the first phase of a Bilateral Trade Agreement (BTA) by fall 2025. The talks will address key areas, including tariffs, services, and supply chains, with sectors such as pharmaceuticals and medical devices likely to be part of the broader discussions.
Source: bit.ly/42XoMXe

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 Pharmaceutical Association has reportedly urged the Drug Controller General of India to clarify the notification restricting anti-cold drug combinations for children under four. Guidance on handling of existing stocks and if pharmacies can dispense these drugs without the warning on label.
Source: bit.ly/3Gmnq0o

2. Several electronics companies have approached the Delhi High Court challenging the decision of Government to fix a floor price payable to E-waste recyclers. They argue that the mandatory payments are excessively high and will significantly increase business costs. Companies contend that the Government should let market forces determine the prices.
Source: bit.ly/3GlYTZt

3. Australia’s Therapeutic Goods Administration is seeking public feedback on a proposal to expand access of psilocybin (magic mushrooms) to terminally ill patients for existential distress, currently it is approved for treatment-resistant depression.
Source: bit.ly/42mBmA7

4. India’s drug technical advisory board is reviewing a proposal to waive the loan license requirement for medical device sterilization. If approved, manufacturers with valid licenses (Form MD-3/4 or MD-9/10) could use licensed sterilization facilities (Form MD-3 or MD-9) without separate approval.
Source: bit.ly/4cHcirb

5. The Ministry of Environment Forest and Climate Change has proposed draft rules under the Carbon Credit Trading Scheme, 2023, setting greenhouse gas emission intensity targets for industries. Public feedback is invited within 60 days. Suggestions can be sent to the Ministry via email.
Source: bit.ly/42IUtU3

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