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 Government of India has in the Union Budget 2026–27, removed basic customs duty on 17 cancer drugs to reduce treatment costs. The move aims to ease the financial burden on patients, particularly for high-cost imported therapies, and improve access to essential cancer medicines across the country.
Source: h7.cl/1nZbu
#Drugs #Cancer #CustomDuty #Slashed #Budget2026

2. The Supreme Court of India has held that administering stem cell therapy for Autism Spectrum Disorder (ASD) outside an approved clinical trial setting is unethical and amounts to medical malpractice. The Court clarified that such therapy is not recognised as a sound and established medical practice due to the lack of scientific validation of safety and efficacy. The same is permissible only for an approved and monitored clinical trial with the intent to advance science.
Source: h7.cl/1nZbb

3. Maharashtra’s State Blood Transfusion Council has reportedly warned blood banks against collecting excess blood and transferring it to other states for profit. Violations, including commercial supply to plasma fractionation companies, may invite licence cancellation, as centres are directed to collect only patient-linked requirements to protect voluntary donation ethics.
Source: h7.cl/1iYh-

4. The Enforcement Directorate reportedly conducted searches at twenty six locations across multiple states as part of a probe into illegal international narcotics trafficking and money laundering. Investigations revealed a structured interstate drug network, leading to seizure of cash, narcotic substances, contraband, and incriminating documents indicating organised distribution and laundering activities.
Source: h7.cl/1nZbD

5. The Government of India has proposed amending the Drugs Rules, 1945 to designate Navi Mumbai International Airport (NMIA) as an authorised drug import entry point, making it a 12th approved airport, improving logistics and reducing congestion at existing ports. Stakeholders have been requested to submit comments withing 30 days.
Source: h7.cl/1nZbN

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.Kerala High Court has ordered against the usage of “Dr.” prefix by physiotherapists and occupational therapists who do not possess recognized medical qualification. The order came while considering challenges to recent curriculum provisions allowing such usage, the next hearing is scheduled on December 1, 2025.
Source: urli.info/1em0-

2.The National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling prices for six scheduled formulations, including riboflavin tablets, peritoneal dialysis solutions, ethyl alcohol, and human normal immunoglobulin. Manufacturers and importers are mandated to align MRPs to the notified prices, file Form V on IPDMS and ensure that retailers/distributors display price list in their premises.
Source: urli.info/1j9u0

3.The Delhi High Court has expressed concern over an advertisement by a leading ayurvedic drug company that labels rival company product as “dhoka” (fraud). The Court questioned whether the use of such terminology crosses the permissible threshold and amounts to impermissible disparagement of a competitor’s product.
Source: urli.info/1j8ZY

4.The Food Safety and Standards Authority of India (FSSAI) has notified the Food Safety and Standards (Import) First Amendment Regulations, 2025, effective May 1, 2026. The amendment allows FSSAI approved or globally recognized analytical methods and mandates that the notified or referral laboratory to submit duly signed food analysis reports within five days of receiving samples.
Source: urli.info/1j9up

5.The Ministry of Health and Family Welfare has issued a draft amendment to the Drugs Rules, 1945 to include cell or stem-cell derived products, gene therapeutic products and xenografts under the regulatory framework currently governing recombinant DNA derived drugs, aligning regulatory provisions and licensing forms with emerging Source:
advanced biological therapies.
Source: urli.info/1j9ta

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 Medical Association (IMA) has challenged the Maharashtra government’s decision allowing homeopaths to prescribe allopathic medicines after six months of certified training, calling it a threat to public health. The IMA has filed a petition in the Bombay High Court, urging an expedited resolution of the matter.
Source: bit.ly/4kl20ip

2. A government panel, the Drugs Consultative Committee (DCC) under CDSCO, has directed State Licensing Authorities not to issue manufacturing licenses for new drugs without prior approval from the Central Licensing Authority (CLA), as mandated by New Drugs Clinical Trial Rules 2019.
Source: bit.ly/3GC8A6l

3. India’s NITI Aayog has setup an expert panel to review quality concerns in India’s pharmaceutical manufacturing. It will assess regulatory gaps and challenges across 3,000 companies and 10,500 units. The goal is to align production with global standards, boost compliance, and ensure patient safety to uphold India’s global medicine supplier status.
Source: bit.ly/3GvWBHB

4. The Drugs Consultative Committee (DCC) has recommended inclusion of detachable Braille cards and voice-enabled QR codes on medicine packaging to enhance accessibility for visually impaired patients. The proposal aims to standardize inclusive labeling across pharma products, aligning with patient-centric and accessibility-first regulatory reforms.
Source: bit.ly/3TttpUw

5. The Drugs Consultative Committee (DCC) has approved amendments to Forms 27D/27DA and 28D/28DA under the Drugs Rules, 1945, enabling manufacturers to apply for licenses to produce stem cell-derived, gene therapy, xenograft, and modified-release products via both state and central authorities.
Source: bit.ly/3Ii5o0f

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.  A State Consumer Disputes Redressal Commission (SCDRC), Punjab has exonerated a private eye hospital from medical negligence allegations, finding no evidence that surgery was performed on the patient. The commission ruled that the claims were unfounded, thus dismissing the case against the hospital with no liability for damages.
Source: bit.ly/499Wxr0

2. The Delhi High Court has requested that the government create clear guidelines regarding doctors’ digital signatures on medical documents in order to reduce the use of unauthorized and fraudulent signatures in medical practices and to make clear the legal and regulatory implications of using digital signatures in healthcare.
Source: bit.ly/3YWXD4A

3. India’s Finance Minister, Nirmala Sitharaman has proposed to establish the creation of Bharat Food and Drug Administration (BFDA) to set global benchmarks for food and drug safety, similar to the US FDA. The emphasis to create such standard is to enhance India’s regulatory framework and strengthen its position in the global market.
Source: bit.ly/3V9E7Rb

4. The Indian government plans to amend the Drugs and Cosmetics Rules, 1945 to allow State Licensing Authorities (SLAs) and the Central Licensing Authority (CLA) to issue manufacturing licenses for products derived from stem cells and gene therapies. This move aims to streamline the regulatory process and promote the development of innovative therapies in India, enhancing compliance with global standards.
Source: bit.ly/3Os1VMx

5. The USFDA has finalized guidance for its 510(k) Third Party Review Program, which permits accredited third-party organizations to evaluate specific low- to moderate-risk medical devices for market clearance. The guidance is designed to expedite the review process to enhance efficiency in device approvals, ultimately facilitating quicker access to innovative medical technologies for patients.
Source: bit.ly/414wwHC