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 Department of Consumer Affairs has uploaded the list of revised retail sale prices declared by companies in response to the recent GST rate changes. This update reflects company’s adjustments to the new tax rates, impacting pricing across various product categories, including drugs and medical devices.
Source: https://short-url.org/1cK-p

2. Investigations into the cough syrup incident have reportedly revealed that the manufacturer allegedly paid a 10% commission to the doctor for prescribing the syrup. Authorities are continuing their probe, focusing on both the manufacturer and the doctor’s involvement in the case.
Source : https://short-url.org/1cK-H

3. The National Medical Commission is reportedly planning to prohibit pharma and medical device promotions during live surgery broadcasts, citing misuse for marketing over education. Live surgeries will be allowed only for new procedures, with recordings preferred for others, to prevent ethical breaches and ensure patient safety in medical demonstrations
Source: https://short-url.org/1cK-P

4. The Delhi High Court has permitted the launch of an affordable generic version of a drug used to treat spinal muscular atrophy, upholding that a credible challenge was raised to the patent and emphasising that affordable access to life-saving treatment outweighs the need for injunctive relief in public interest.
Source : https://short-url.org/1cL07

5. The US Food and Drug Administration (FDA) reviewed a direct-to-consumer TV advertisement by a major drug manufacturer and found it false and misleading. According to the FDA, the ad’s rapid visuals, background music, and frequent scene changes distracted viewers, hindering understanding of important risk information and creating a misleading perception of the drug’s effectiveness among consumers.
Source : https://short-url.org/1cL04

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 Trade and Economic Partnership Agreement (TEPA) with the European Free Trade Association (EFTA), effective October 1, 2025, reportedly excludes medical devices and pharmaceuticals from duty concessions, keeping them protected to safeguard domestic industries. While 92.2% of EFTA and 82.7% of India’s tariff lines are liberalised, sensitive healthcare products will face phased tariff reductions over 5–10 years.
Source: https://short-url.org/1hoSo

2. Central drug regulator (CDSCO) is reportedly set to conduct nationwide inspections and audits of cough syrup manufacturing units after child deaths in Madhya Pradesh were linked to toxic syrups. States and union territories have been directed to submit lists of manufacturers for surveillance, aiming to strengthen quality control and prevent contamination-related tragedies.
Source: https://short-url.org/1cGQR

3. Department of Pharmaceuticals has launched sensitisation programmes to guide pharmaceutical and medical technology companies on the amended Promotion of Research and Innovation in Pharma-MedTech Sector scheme. The sessions will help companies to understand the revised guidelines, and digital application process to ensure smooth participation.
Source: https://short-url.org/1cGR3

4. India’s Central food authority has issued a draft amendment to Packaging regulations 2018 to restrict the use of Poly- and perfluoroalkyl substances (PFAs) in food contact materials. It also states that food materials made with polycarbonate and epoxy resins must be free from Bisphenol A (BPA) and its derivatives. Objections / suggestions are awaited from the industry stakeholders for a period of 60 days from the date of publication.
Source: https://short-url.org/1hoTb

5. State drug inspectors are reportedly seeking enforceable powers to arrest and detain offenders, aiming to curb the growing menace of spurious drugs. The demand follows the recent incident involving contaminated cough syrup sold to paediatric patients, which resulted in multiple child deaths.
Source: https://short-url.org/1hoTt

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 authority has mandated manufacturers of pharmaceuticals to comply with strict testing of raw materials and excipients of every batch and each batch of final product and maintaining records. During inspections, State and UT Drug Controllers will inspect the licensee’s batch release records, ensure there is a robust vendor qualification system, and confirm that raw materials are sourced only from approved vendors.
Source: https://short-url.org/1csET

2. Central Drugs Standard Control Organization (CDSCO) has launched a 100-day awareness campaign on the Goods and Services Tax reduction on medicines and medical devices. Chemists and druggists associations are directed to encourage their members to display awareness posters at pharmacies. Compilation of photographs of the activities undertaken are to be submitted to CDSCO’s headquarter.
Source: https://short-url.org/1csHq

3. The Department of Consumer Affairs has granted three-month permit to leading FMCG, personal care, and medical device firms to use preprinted packaging despite labelling errors. Corrections such as unit sale price, company name, or customer care information must be declared using stamping, stickers, or online printing.
Source: https://short-url.org/1csCZ

4. India has notified its first binding Green House Gas (GHG) emission intensity targets for aluminium, cement, chlor-alkali, and pulp & paper sectors under the GHG Emission Intensity Target Rules, 2025. Industries must reduce emissions per output unit, trade carbon credits, and face penalties for non-compliance, boosting market-driven decarbonization.
Source: https://short-url.org/1habB

5. India’s Central Drug Regulator, CDSCO, has issued a notice inviting stakeholder comments to address disparities in new drug approvals. While the first applicant must conduct full local clinical trials and bioequivalence studies, subsequent applicants gain approval based solely on chemical, pharmaceutical, and bioequivalence data. This creates inequality in regulatory burden and costs. CDSCO seeks feedback by November 7, 2025, to develop fairer drug approval policies.
Source: https://short-url.org/1csDm

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 has reiterated that import of drugs, will be permitted only through notified ports under Rule 43-A of the Drugs Rules, 1945. The designated entry points have been mapped with customs’ ICEGATE system to ensure regulatory oversight and streamline import clearances.
Source: https://short-url.org/1h02u

2. India’s Directorate General of Trade Remedies has initiated an anti-dumping probe into imports of harming domestic producers. The investigation will assess the extent of dumping and its impact for need of anti-dumping duties under Indian laws.
Source: https://short-url.org/1gZMy

3. The National Human Rights Commission has reportedly issued notices to several state governments over multiple child deaths allegedly caused by contaminated cough syrup. It has also directed the drug regulator and Health Ministry to investigate spurious drug supply. Recently, similar action was taken over a gas leak in Maharashtra.
Source: https://short-url.org/1ciNX
https://short-url.org/1ciLx

4. Indian government have reportedly assured Jan Aushadhi Kendra retailers that it will review the newly introduced zero-distance policy, which removed the 1 km minimum distance requirement between outlets in cities with populations of over one million. Retailers are seeking rollback, citing significant losses in sales and profitability due to increased competition.
Source: https://short-url.org/1ciMf

5. The All India Organization of Chemists and Druggists (AIOCD) has reportedly incorporated its first pharmaceutical Limited Liability Partnership (LLP) in Kerala, marking a significant step in empowering local wholesalers to compete with corporate and foreign players. This initiative aims to consolidate traditional distributors into corporate entities, enhancing efficiency and resource pooling.
Source: https://short-url.org/1ciLM

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 authority has released guidance to identify spurious drugs under the Drugs Rules, 1945. Earlier, the rules mandated QR codes on all APIs from January 2023 and barcodes or QR codes on the top 300 drug brands from August 2023. The authority has now issued a process flow to verify drug authenticity.
Source : https://short-url.org/1gVQq

2. India’s Central Drug Regulator has allowed manufacturers to apply for Certificate of Pharmaceutical Product/World Health Organization – Good Manufacturing Practices (COPP/WHO-GMP) certificates while product license applications are under review by the State Licensing Authority. Final COPP/WHO-GMP certificate will be issued after product approval.
Source: https://short-url.org/1gVUB

3. India’s central government has proposed the Assistive Technology (Standards and Accessibility) Rules, 2025, requiring all assistive devices to meet Bureau of Indian Standards quality standards. The draft ensures transparent procurement, financial aid, repair support, and a toll-free helpline, with an online Assistive Technology Portal for device certification, supply tracking, and grievance redressal.
Source: https://short-url.org/1ceKb

4. The Food Safety and Standards Authority of India has kept the spice enforcement drive (whole & powder) in abeyance until further orders. All state food safety commissioners and regional directors have been instructed not to initiate any action under the earlier directive until further instructions.
Source:
https://short-url.org/1ceKS
https://short-url.org/1gVSp

5. The US Food and Drug Administration (FDA) is seeking public input on evaluating AI-enabled medical devices, including generative AI tools. The aim is to enhance patient outcomes, public health, and accelerate medical innovation, while regulating these advanced technologies
Source: https://short-url.org/1ceLs

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 Pharmacopoeia Commission (IPC), traditionally responsible for preparing standards for medicines, is now reportedly expanding its role to prepare standards for medical devices in collaboration with the Bureau of Indian Standards (BIS). It has also begun auditing medical device companies and is developing monographs which will outline standards and specifications for medical equipment. This initiative aims to enhance India’s credibility in medical device manufacturing and support export growth.
Source: short-url.org/1c9pE

2. The Telangana High Court set aside a blanket injunction order in a trade secret dispute, holding that confidential information and trade secrets must be clearly identified and proven. It ruled that the trial court erred by granting a blanket restraint and directed a fresh hearing in accordance with law.
Source: short-url.org/1gQnE

3. The Indian government has amended the export policy for rice (both Basmati and non-Basmati) to non-EU European countries, removing the requirement for Export Inspection Council (EIC) certification until April 2, 2026. The EIC certification will, however, remain mandatory for exports to the EU, the UK, Iceland, Liechtenstein, Norway, and Switzerland.
Source: short-url.org/1gQlT

4. The Pharmaceuticals Export Promotion Council (Pharmexcil) has asked pharma exporters to submit cases of delayed or non-payment by overseas buyers to help frame a Standard Operating Procedure (SOP). This SOP aims to streamline the process of addressing payment-related grievances and Pharmexcil’s timely intervention.
Source: short-url.org/1c9p-

5. Tamil Nadu Food and Drugs Administration (FDA) is investigating the license of a local cough syrup manufacturer following child deaths in Madhya Pradesh linked to contaminated cough syrup produced by the company. The scrutiny in Tamil Nadu began after a formal request from the Madhya Pradesh Drugs Control Authority and the state drug regulator. In response to these incidents, India’s Union Health Ministry has issued an advisory urging the rational use of pediatric cough syrups banning them for children under two years, advising caution for older children, and promoting rest and hydration as preferred treatments.
Source: short-url.org/1gQng
Source: short-url.org/1c9qC

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 Department of Pharmaceuticals has issued revising guidelines under the Promotion of Research & Innovation in Pharma-MedTech (PRIP) Scheme that enhances support for MSMEs and startups, introduces milestone-based funding, and raises grant ceilings for early and later stage projects, with higher support for strategic innovation areas. Applications can be submitted through the online portal.
Source: short-url.org/1bYPF

2. The Department of Pharmaceuticals has amended its 2023 Pharma-MedTech R&D scheme, earmarking ₹5,000 crore till 2030. Key updates include funding up to ₹100 crore per project, Centres of Excellence at NIPERs, industry-academia collaboration, and priority focus on new drugs, complex generics, biosimilars, and novel medical devices
Source: short-url.org/1gEoB

3. The Reserve Bank of India has announced that banks can now finance acquisitions, with increase in loan limits against listed shares and IPO financing. These steps are expected to boost liquidity, enable smoother strategic deals, and provide corporates greater flexibility in accessing capital.
Source: short-url.org/1bYPm

4. India’s Consumer Affairs Ministry is reportedly scrutinising e-commerce platforms for cash-on-delivery charges and delayed or denied prepaid refunds, practices that may constitute unfair trade or service deficiency. The probe could mandate COD surcharge waivers, stricter refund timelines, and penalties, as withheld payments let platforms earn interest, leaving customers feeling cheated.
Source: short-url.org/1bYPW

5. Private hospitals in Telangana are allegedly paying unqualified Rural Medical Practitioners and Paramedical Practitioners commission amounting to up to 40% of the hospitalisation charges for patient referrals.
Source: short-url.org/1gEoZ

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 Ministry of Environment, Forest and Climate Change has extended the deadline for filing annual returns by Producers, Importers, and Brand Owners (PIBOs) of plastic packaging for 2024–2025 until November 30, 2025.
Source: short-url.org/1bS0C

2. The Delhi High Court, while deciding a trademark dispute, ordered customs at Mundra port to inspect containers suspected to contain dental-hygiene products which are allegedly packaged in deceptively similar manner to a leading brand’s red blue trade dress. The court found a prima facie likelihood of dilution of goodwill but withheld injunctive relief until confirmation from customs.
Source: short-url.org/1gxoM

3. Pursuant to over 3,000 complaints concerning the non-passage of tax cuts or “dark patterns” in discounting and price presentation, the government has reportedly summoned top e-commerce firms for hiking the prices or not reducing prices after recent GST reduction, even after September 22, 2025. It is scrutinising over 50 product categories and expects visible consumer price relief during the festive season.
Source: short-url.org/1bS2N

4. The Government of India has extended the RoDTEP (Remission of Duties and Taxes on Exported Products) scheme beyond September 30, 2025, until March 31, 2026. This scheme refunds hidden duties and taxes to exporters. It covers DTA (Domestic Tariff Area) units, Advance Authorisation holders, SEZ units, and EOUs at existing rates within the approved budget.
Source: short-url.org/1bS1c

5. The Delhi High Court has quashed an FIR against a manufacturer of medicines and injections that “may cause serious harm to the patient.” The Court held that only Drug Inspectors can prosecute offences under the Drugs and Cosmetics Act. Police registration of such FIRs was deemed beyond jurisdiction.
Source: short-url.org/1bS1W

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 Delhi High Court has recently ruled that businesses cannot justify failure to reduce prices after a GST rate cut by claiming to have increased the product quantity, especially when such changes are made without informing consumers. Continued non-compliance may lead to GST registration cancellation under anti-profiteering provisions.
Source: short-url.org/1gqnP

2. Central Drugs Standard Control Organization (CDSCO) has clarified that combi-packs of lyophilized injections with standard diluents (e.g., sterile water or saline) used for over four years will not be treated as new drugs, allowing State Licensing Authorities approval. Combi-packs with different diluents will still require CDSCO approval as new drugs.
Source: short-url.org/1gqnS

3. The Ministry of Labour and Employment has released draft Factories Workers Rules under the OSHW Code, 2020, inviting comments until 6th November 2025. The rules mandate safety, health, and welfare measures, including sanitation, ventilation, separate facilities, first-aid, nutrition, and emergency preparedness, with obligations varying by workforce size.
Source: short-url.org/1gqo1

4. Over the next five years, drugs worth $236 billion globally are slated to lose patent protection, paving the way for generic drugs and biosimilars. This “patent cliff” allows Indian pharma to capture market share, grow revenues, and lower drug costs for patients globally.
Source: short-url.org/1gqo6

5. Over the past five years, National Medical Commission (NMC) Ethics & Medical Registration Board has dismissed 162 appeals filed by patients/families alleging medical negligence. India’s Central Health Ministry has now reportedly begun a review of this, planning to consult with NMC to understand and address potential procedural bias.
Source: short-url.org/1bLfY

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 Delhi government’s ban on sending genetic samples outside the city for prenatal tests like NIPT and PGT, reportedly, faces strong opposition from diagnostic labs in Delhi. The labs have raised concerns that it will overload local labs, cause delays, increase costs, and limit access for patients in NCR and nearby states, urging reconsideration of the directive.
Source: short-url.org/1gmX1

2. The Bombay High Court has in a customs case held that allowing re-testing of seized goods is a trade facilitation measure. Denials must be rare and when made should be supported by written reasons. The court emphasized that refusal to retest should not be the norm.
Source: short-url.org/1gmXa

3. The Indian government will reportedly require all hospitals, both public and private, to include an Adverse Drug Reaction reporting form in every patient admission record. This under the Pharmacovigilance Programme of India aims to standardise monitoring of drug safety and better protect patients from adverse effects.
Source: short-url.org/1bHWo

4. The Committee for Control and Supervision of Experiments on Animals (CCSEA) has clarified that beagle dogs procured from breeders registered with State Animal Welfare Boards or State Animal Husbandry Departments are strictly for breeding colonies, not for experimentation. For testing, dogs must be sourced from CCSEA registered establishments.
Source: short-url.org/1bHWu

5. To ease certificate issuance delays, India’s central drug licensing authority reportedly has plans of shifting data verification in the CoPP (Certificate of Pharmaceutical Product) process to later stages instead of initial stage and conduct verification themselves bypassing initial scrutiny by state regulators.
Source: short-url.org/1gmXq