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

Posted on

Frequently Asked Questions (FAQ’s) on regulatory compliances associated with GST rate reduction for retailers of medicines in India

On September 03, 2025, The Goods & Services Tax Council announced the revision in Goods and Services Tax (GST) rates for medicines. The revised GST rates came into effect on September 22, 2025. In this article, we have answered frequently asked questions (FAQs) by retailers about the sale of medicines with revised MRP due to revision of GST.

[If you are short on time, please read response to Q. 4 and 8]

1. Will the revised GST rates apply to stock of medicines already present in the market?

Yes. The reduced GST rates will apply to the stock of medicines already present in the market on or after September 22, 2025, irrespective of the fact that it was manufactured, imported or packed prior to September 22, 2025.

The price of the medicines available in the market on or after September 22, 2025 will have to be reduced to reflect the reduction in GST rates.

2. How will a retailer find out the revised price of medicines on and after September 22, 2025?

The retailer should receive a revised price list in Form V of the DPCO from the manufacturer, importer, or marketer of the medicines, reflecting the reduced MRP due to the revision in GST rates. The Form V contains reduced GST rate applicable to medicine and revised MRP.

3. What if the retailer has not received revised price list (Form V) from the manufacturer or importer of medicines?

If a retailer of medicine has not received revised price list in Form V of DPCO from manufacturer or importer of the medicine, then retailer should sell the medicine at a reduced price, after applying revised GST rate. Please refer to response to Q. 4 for calculation of price at which the retailer should sell the medicine.

4. Can the retailers sell medicines at the same MRP without revising GST rates?

No, retailers must comply with the revised GST rates from September 22, 2025, even if the old MRP printed on the pack of medicine has not changed.

There are two likely scenarios for the retailer:

  • If the retailer of medicines has received the revised price list (Form V):

    • The retailer cannot sell the medicine at old MRP and all medicines must be sold at the revised GST and reduced MRP as is mentioned in Form V.

  • If the retailer of medicines has not received the revised price list (Form V):

The medicine still cannot be sold at old MRP that is printed on the pack of the medicine. It will have to be sold at a GST-reduced price, which may be arrived at after applying reduced GST to sum of retailer’s procurement price and retailer’s standard margin for the medicine.

5. If a retailer sells stock of medicines at a price higher then revised MRP, what are the consequences for the retailer?

Retailers selling medicines at a price higher than the reduced MRP can be proceeded against under the applicable GST laws and Essential Commodities Act, 1955 for violation of said laws.

6. Is retailer legally obligated to return stock to manufacturer or importer of medicine for re-labelling with revised MRP?

No. Re-labelling with reduced MRP is not a mandatory legal obligation on the manufacturers and importers of medicines. Therefore, the retailer is not legally obligated to return the stock of medicine for re-labelling. However, if the retailer is returning the stock, it must be done in a phased manner to avoid any shortage of medicines in the market.

7. If the stock of medicine with a retailer has not been re-labelled, is the retailer required to display the revised price list of medicines to retail consumers?

Irrespective of whether the stock of medicines has been re-labelled with revised MRP or not, a retailer should display the revised price list received from the manufacturers or importers of medicines at a conspicuous part of its premises.

8. What are key compliances in relation to revision of GST rates for medicines that a retailer of medicines should be aware of?

A retailer of medicines should undertake the following compliances in relation to the revision of GST rates for medicines on or after September 22, 2025:

  • Sell medicines at reduced price after applying revised GST rates (refer to response to Q. 4 for details);
  • Verify the revised GST rate and reduced MRP against the revised price list in Form V received from the manufacturer or importer of medicines;
  • Display the revised price lists of medicines received from the manufacturers or importers on a conspicuous part of the premises where they carry on business;
  • Issue tax invoice with revised GST rates;
  • Not alter, tamper, over-sticker or re-label the existing product packaging;
  • If reduced MRP has been declared on the package, ensure that both original MRP and reduced MRP are visible and the reduced MRP declaration does not hide or alter other declarations on the package.
  • Ensure that there is no shortage of medicines, if stock of medicines is recalled by the manufacturer or importer for re-labelling of reduced MRP.
  • Ensure that reduced MRP declaration on the label (if any) has been made in the correct format.
  • Ensure that products manufactured or imported after September 22, 2025 declares reduced MRP on the package.
  • Do not refuse to sell available medicines to retail consumers.
  • Sell loose quantity of medicines at price which is pro-rated to GST reduced price (where Form V has not been received or stock has not been relabelled with reduced MRP) or pro-rated to reduced MRP known to the retailer.
  • Update billing systems, including online billing software with revised GST rates effective September 22, 2025.

9. What are the consequences of failure to display the revised price list in Form V of DPCO by the retailers on or after September 22, 2025?

The failure to display price list for medicines in Form V of DPCO will constitute a violation of DPCO and may lead to penal action under the Essential Commodities Act, 1955 resulting in fine and imprisonment.

Disclaimer: This article contains personal views of the authors and should not be considered as legal advice.

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 World Anti-Doping Agency will reportedly classify non-diagnostic use of carbon monoxide to its prohibited method list while preserving its controlled medical and diagnostic use. WADA reportedly said that its use could increase erythropoiesis – the process of creating new red blood cells.
Source: short-url.org/1bq0M

2. The Indian Supreme Court has recently clarified that under the Maintenance and Welfare of Parents and Senior Citizens Act, 2007, the applicant’s eligibility as a senior citizen is determined on the date of filing the application, not when it is adjudicated. The ruling ensures timely recognition of rights and prevents denial of benefits due to procedural delays.
Source: short-url.org/1g4st

3. The Kerala High Court has called on the State Government to consider setting up dedicated Narcotic Drugs and Psychotropic Substances courts in every judicial district to clear the pending cases and enable speedy trials as there are only two special courts currently operational.
Source: short-url.org/1g4sw

4. Odisha government plans to expand Ayurvedic infrastructure by launching integrated AYUSH hospitals, Panchakarma centers, and Ayurvedic colleges. The state aims to boost Ayurvedic education, treatment, and preventive healthcare under the National AYUSH Mission to ensure wider public access.
Source: short-url.org/1g4sC

5. The U.S. Department of the Treasury’s OFAC has sanctioned two Indian nationals, and their India-based pharmacy for supplying hundreds of thousands of counterfeit prescription pills laced with fentanyl and methamphetamine to U.S. consumers.
Source: short-url.org/1g4sI

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 is planning to impose a Minimum Import Price (MIP) on certain active pharmaceutical ingredients and intermediates including potassium clavulanate to deter cheap imports (especially from China) and strengthen domestic raw material production under the PLI scheme.
Source: short-url.org/1fZwh

2. The Delhi High Court has allowed the company to use of the phrase “why settle for ordinary Chyawanprash” in advertisements, but directed removal of the reference “made with 40 herbs”, deeming it disparaging. The court said the remaining claim is permissible as puffery and not misleading.
Source: short-url.org/1fZwo

3. The Bombay High Court has quashed the drug regulator’s stop-production orders against two pharmaceutical companies. The court found the actions violated statutory procedures and denied the companies a fair hearing. However, it clarified that regulators may take fresh action if proper procedures are followed.
Source: short-url.org/1fZwB

4. Telecom Regulatory Authority of India has issued the draft Telecommunication (Broadcasting and Cable) Services Interconnection (Addressable Systems) (Seventh Amendment) Regulations, 2025, seeking stakeholder inputs by 6 October 2025. The draft mandates annual financial year audits, stricter infrastructure sharing rules, and aims for enforcement from 1 April 2026.
Source: short-url.org/1fZwO

5. The Directorate General of Trade Remedies has rescheduled the oral hearing in the anti dumping sunset review of methyl acetoacetate imports from China to October 8, 2025. The review will decide if duties must continue to prevent dumping and protect domestic industry.
Source: short-url.org/1fZwV