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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 licensing authority has permitted importers and manufacturers of Class C and D medical devices to affix stickers with revised Maximum Retail Price (MRPs) reflecting reduced GST rates which are effective from 22 September 2025. The stickered MRP must reflect the reduced GST, and the changes must be implemented within 3 months from the date of this order.
Source: short-url.org/19uui

2. The Himachal Pradesh High Court held that stocking allopathic medicines without a valid licence amounts to an “offer for sale” under Section 27 of the Drugs and Cosmetics Act. Displaying medicines in a clinic rack was deemed sufficient to establish intent to sell.
Source: short-url.org/1e2Yz

3. Delhi High Court has temporarily stopped the drug regulator (CDSCO) from initiating criminal proceedings against a major online marketplace accused for listing unapproved drugs. The platform contends it functions only as an intermediary and is protected under law.
Source: short-url.org/1e2YG

4. The Orissa High Court has asked the Odisha Government to respond within two weeks to a PIL seeking mandatory use of Individual Donor Nucleic Acid Testing (Individual Donor Nucleic Acid Testing) in all government and affiliated blood banks. The plea argues that the existing NAT-PCR screening is outdated and less effective in early detection of HIV, Hepatitis B, and Hepatitis C infections.
Source: short-url.org/1e32Q

5. A Parliamentary Standing Committee on Finance has called on the Centre to decentralise the Ayushman Bharat-PMJAY scheme by using mobile health units and telemedicine hubs, especially in tribal and hilly regions. The move aims to improve accessibility, strengthen outreach, and ensure coverage penetrates underserved geographies.
Source: short-url.org/1e2YU

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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 Consumer Affairs Ministry has permitted manufacturers, packers, and importers to revise MRPs on unsold pre-packaged goods post-GST changes, reflecting only the tax difference. Original MRP must remain visible. Revisions via stickers or stamping are allowed. Conditions include newspaper ads, dealer notifications, and apply until December 31, 2025, or stock exhaustion which ever is earlier.
Source: short-url.org/1dU94

2. The Department of Consumer Affairs has proposed an amendment to the Legal Metrology (Approval of Models) Rules, 2011, introducing a validity period of 10 years for domestic and 5 years for imported model approvals. Public comments are invited before October 9, 2025 through emails.
Source: shorturl.at/7wExv

3. The Soybean Processors Association of India has reportedly objected to FSSAI’s ‘Eat Right India’ post promoting olive oil, calling it elitist and biased. They argue it undermines public confidence in affordable, nutritious local oils like soybean and mustard, and urge its withdrawal to protect consumer trust and national interests.
Source: shorturl.at/zkeaL

4. The FSSAI has constituted a committee to modernize India’s organic-food and agricultural products’ regulatory framework by revising certification rules, usage of the India Organic label, and aligning standards with global benchmarks. While the scope spans organic agricultural products, the authority has not provided a timeline for rollout.
Source: shorturl.at/AQnA5

5. The Retail Distribution Chemist Alliance (RDCA) has cautioned that the shift reducing GST on most medicines from 12% to 5%, effective September 22, 2025, is financially unviable for pharmacies due to unrecoverable input tax credit, risking severe medicine shortages without urgent relief.
Source: shorturl.at/oAEhB

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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 Corporate Affairs has broadened fast-track merger eligibility to include more unlisted firms and companies with debt under INR 100 crore and no defaults, as well as mergers involving holding companies and their unlisted subsidiaries even if not wholly owned streamlining consolidation and ease-of-business push.
Source: shorturl.at/viKVh

2. India’s Ministry of Health and Family Welfare has proposed amendments to the New Drugs and Clinical Trials Rules, 2019, expanding provisions for test licenses. The draft mandates prior permission or notification for manufacturing investigational drugs for trials, bioavailability/bioequivalence studies, and analysis and excludes sensitive categories sex hormones, cytotoxics, beta-lactams, biologics with live microorganisms, and narcotic/psychotropic substances from the simplified notification pathway.
Source: short-url.org/1dQTc

3. The Karnataka Pharma Retailers & Distributors Organization (KPRDO) urged reconsideration of a new 24×7 medicine delivery service via a quick commerce platform, citing conflict with longstanding pharmacy owners, regulatory hurdles amid a Delhi High Court injunction banning online medicine sales, and risks of drug misuse via teleconsultations.
Source: shorturl.at/lldc0

4. Drug regulators from five northern states reportedly met in Chandigarh to address counterfeit and psychotropic drug threats. They agreed to form an interstate coordination committee, adopt a unified tracking portal, conduct surprise inspections, implement SOPs, and strengthen cross-border enforcement through stricter legal and regulatory actions.
Source: shorturl.at/NG50D

5. The Supreme Court has refused to entertain a plea challenging the legality of declaring individuals as “brain dead” under the Transplantation of Human Organs and Tissues Act, 1994. The Court emphasized that the determination of brain-stem death is a matter of legislative policy and declined to question its validity.
Source: shorturl.at/MPWKA

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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 Government of India has reduced GST to NIL on 36 lifesaving drugs and cut GST on key medical devices and supplies from 18%/12% to 5%, effective September 22, 2025. Pharma and medical device companies must revise MRPs accordingly and comply with pricing norms under The Drugs Price Control Order and anti-profiteering provisions.
Source: shorturl.at/dRaT8

2. CDSCO has announced that Institutional Biosafety Committee (IBSC) approvals will now be sufficient for biopharma companies seeking CT-10 permissions to manufacture test items from Category I and II genetic engineering experiments.
Source: shorturl.at/ACkQm

3. Maharashtra’s Medical Education Department has instructed the Maharashtra Medical Council (MMC) to begin registering homeopathic practitioners who’ve completed the one-year Certificate Course in Modern Pharmacology (CCMP) under a separate registry. The Indian Medical Association (IMA) has strongly opposed the move deeming it risky to public health, and plans to escalate the matter to the Bombay High Court.
Source: shorturl.at/Ge5OT

4. India’s GST Council has reduced the goods and services tax on diagnostic kits, reagents, and medical devices from 12–18% to 5%, effective September 22, 2025. While this lowers the cost base for labs, experts caution that reagent expenses account for only ~20% of diagnostic test costs, so the actual price drop for patients may be a modest 2–5%, depending on providers’ pricing strategies.
Source: shorturl.at/WvZHI

5. CDSCO has introduced a dedicated “Not of Standard Quality” (NSQ) alerts portal on its official website, enabling Industry experts to access real-time updates on substandard drug batches.
Source 1: shorturl.at/oMBXn
Source 2: shorturl.at/J7Pma

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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 Department of Pharmaceuticals has amended the UCMPMD 2024, clarifying valuation of free evaluation samples at stockist price if self-manufactured or average purchase price if sourced externally. Companies in multiple associations may submit disclosures through one, with prior intimation to others and notification to the Department when switching.
Source: short-link.me/18ym-

2. India’s Health Ministry has proposed amendments to the New Drugs and Clinical Trials Rules, 2019, enabling simplified approval for bioavailability and bioequivalence (BA/BE) studies of oral drugs approved in India or select countries, for export purposes. The draft exempts certain drug categories and caps sample size at 48. Stakeholders may submit objections or suggestions by 27 September 2025.
Source: short-link.me/1d3UX

3. Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO) have released draft protocols for evaluating In-Vitro Diagnostics (IVDs) for tuberculosis, including drug-resistant strains. Stakeholders can submit comments by September 7, 2025. Final protocols will be based on this feedback before final clearance is given by ICMR and CDSCO.
Source: short-link.me/18ylZ

4. India’s Punjab and Haryana High Court has ruled that legible medical prescriptions is a fundamental right of patients and doctors must write prescriptions in capital letters until Digitalization. PGIMER Chandigarh’s “Doctor Desk” e-prescription system is expected to be implemented within two years.
Source: short-link.me/18ym7

5. The Ministry of Health and Family Welfare has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019. The proposals reduce approval timelines from ninety to forty-five working days and introduce a simplified notification system for manufacturing certain drugs meant for analytical and preclinical testing.
Source: short-link.me/1d3Vg

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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. Indian state Tamil Nadu has informed the Madras High Court that it is cracking down on illegal organ transplants after a kidney racket surfaced. Licenses of two hospitals were suspended for forged approvals, and reforms have been proposed, including stronger oversight and awareness campaigns. The court is set to review the progress in this matter.
Source: short-link.me/1bV1v

2. India’s Parliamentary Committee has urged an expansion of the Drugs (Prices Control) Order (DPCO) to cover more cancer drugs, noting that many oncology medications remain unaffordable. The panel also recommended regular market assessments, stricter oversight of generic drug quality, streamlined regulatory pathways, and strengthened domestic research to improve access.
Source: short-link.me/1bV1y

3. Months after India halted imports of refurbished medical devices, medical devices companies are reportedly urging limits on such restrictions and seeking inclusion in the government’s Electronics Repair Services Outsourcing (ERSO) pilot to support repair operations. The Medical Technology Association of India (MTaI) warns the ban could impact healthcare access.
Source: short-link.me/1bV1A

4. A parliamentary panel recommends nationwide expansion of palliative care under the National Programme for Palliative Care (NPPC), urging robust outcome indicators to assess quality of life impact. The Committee seeks integration with all hospital levels, insurance schemes, and occupational rehabilitation for survivors.
Source: short-link.me/17sHl

5. Delhi’s Drug Control Department has confirmed that all 48 tested samples of suspected counterfeit cancer medicines met quality standards and were found genuine. As part of ongoing anti-counterfeit efforts, authorities collected a total of 127 samples, with results for the remaining 79 still pending.
Source: short-link.me/1bV1E

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Mandatory Documents to be submitted for import of ayurvedic drugs

INTRODUCTION
In India, the regulatory framework for Ayurvedic drugs has remained unclear, as the forms prescribed under the Drugs Rules, 1945 (“Drugs Rules”) for obtaining an import license are not appropriate for Ayurvedic drugs.
The Madras High Court in the case of M/s Axeon Marketing India v. Assistant Commissioner of Customs has clarified the steps to be followed for the import of Ayurvedic drugs into India.
In this article we have listed the documents required and steps to be followed for the import of ayurvedic drugs into India.

The following are the essential steps to be followed, along with the required documents:

1. Submission of regulatory documents
Despite the absence of specific licensing forms, importers should proceed by compiling a comprehensive documentation to present to Customs authorities and the State Licensing Authority (“SLA”). This should include:
– Copy of invoice
– Packing list which includes the details of contents of each package
– Manufacturer’s test report
– Manufacturing license (from the country of origin)
– Specimen sample
– Label (The label must comply with the labelling requirements given under Rule 161 of the Drugs Rules.)

2. Testing by Central Drugs Standard Control Organization-accredited laboratory (“CDSCO lab”)
It is now mandatory that imported Ayurvedic drugs be tested at a CDSCO lab in India to ensure compliance with Indian safety and quality standards. The imported drug must meet standards equivalent to those applicable to similar Ayurvedic drugs already manufactured and approved in India.
– The importer is required to submit imported drug samples to a CDSCO lab, where testing will be conducted under the supervision of SLA of the state in which the laboratory is located.
– The cost for testing will be borne by the Indian importer
– If a satisfactory report is received from such laboratory, the concerned SLA will issue a certificate confirming that the manufacturing process of the imported drugs is in conformity with the process prescribed for the manufacture of ayurvedic drugs in India.

3. Submission of certificate issues by SLA
– A copy of the certificate issued by the SLA must be submitted to the Customs Department.

4. Receipt of Assistant Drug Controller’s No Objection Certificate (“NOC”)
– This document is issued by the port office of CDSCO.
– The NOC indicates that the consignment meets all applicable regulatory requirements
– Invoice, packing list, manufacture’s test report, manufacturing license, specimen sample, label may be examined before giving NOC by port office.

CONCLUSION
A guidance document governing the import of Ayurvedic drugs already existed, however, it did not mandate testing of the imported drug by a CDSCO lab. After the recent judgment by the Hon’ble Madras High Court, this requirement has now been made compulsory. Therefore, importers must comply with this requirement, along with all other steps outlined above, to obtain import clearance.

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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 Directorate General of Trade Remedies (DGTR) has recommended a three-year safeguard duty on select steel imports, which is expected to hike costs for medical devices using 316L stainless steel (e.g., surgical tools, implants). This could pressure production margins, inflate end-user prices, and strain India’s competitiveness in domestic and export markets.
Source: short-link.me/17nS4

2. A high level inter departmental committee has reportedly commenced drafting rules to regulate the import of refurbished medical devices into India. Presently, imports are only allowed for high-end high value devices that haven’t been phased out overseas, contain no hazardous materials, and have a minimum seven-year residual life.
Source: short-link.me/1bQ2x

3. The Ministry of Health and Family Welfare has formed a national committee to draft guidelines for brain stem death certification, including for children. The expert panel will also develop training modules, certification criteria, monitoring tools, and audit systems to improve organ donation and critical care practices across the country.
Source: short-link.me/17nSk

4. NATHEALTH urges standardizing the GST input slab at 5% for healthcare and enabling input tax credit wherever output GST applies. The move aims to reduce hidden embedded taxes, estimated at 5.5–6% of provider revenue easing cost burdens on hospitals and diagnostic labs.
Source: short-link.me/1bQ2O

5. A parliamentary standing committee has reportedly recommended accelerating the rollout of a single-dose HPV vaccine to strengthen cervical cancer prevention. The panel also urged expansion of oncopathology infrastructure, especially in underserved regions like the Northeast.
Source: short-link.me/17nSB

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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 Food Safety and Standards Authority of India has classified packaged drinking water as a high-risk category, mandating pre-licence inspections of packaging facilities and annual risk-based audits for existing licence holders. This move aims to ensure hygiene and quality standards, aligning bottled water regulation with stricter public health norms.
Source: short-link.me/17nQx

2. Big private hospitals in India are opposing the General Insurance Council’s common empanelment proposal, arguing it lacks clarity on tariffs, timely claim settlements, and dispute resolution for short payments. They demand wider consultation and revisions before acceptance, stressing the framework must address operational challenges while ensuring insurers’ goal of streamlined empanelment and policyholder access.
Source: short-link.me/1bQ13

3. The GST Group of Ministers (GoM) has reportedly proposed eliminating the current 18% GST on individual life and health insurance premiums. The constituted panel will present recommendations by October 2025 and the final will be taken by GST Council.
Source: short-link.me/17nQT

4. The Pharmaceuticals Export Promotion Council of India is reportedly collaborating with stakeholders to launch an online logistics platform to integrate exporters, importers, service providers, and regulators. The tool aims to centralise compliance, bidding, warehousing, insurance, routing, digital documentation, tracking and feedback.
Source: short-link.me/1bQ1l

5. India’s central drug regulator has recently mandated that exported drugs must retain at least 60% of their shelf life, prompting pharmaceutical companies to discard older inventory and incur significant financial losses. Industry stakeholders caution that the rule introduces substantial economic and logistical strain without offering adequate flexibility.
Source: short-link.me/1bQ1u

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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 Commerce & Industry introduced the Jan Vishwas (Amendment of Provisions) Bill, 2025 in Lok Sabha to decriminalise 288 minor offences under 16 central laws, including the Drugs and Cosmetics Act. It proposes replacing imprisonment with monetary penalties and improvement notices to ease compliance, boost business confidence, and cut litigation. The Bill now awaits Parliamentary committee review.
Source 1: short-link.me/1bGZT
Source 2: short-link.me/1bGZX

2. India’s Central Pollution Control Board (CPCB) has introduced an automated alerts protocol for OCEMS (Online Continuous Emission/Effluent Monitoring Systems). Compliance issues now trigger tiered warnings: Yellow (Level I), Orange (Level II), and Red (Level III), requiring escalating actions from record-keeping to immediate shutdowns and detailed incident reporting.
Source: short-link.me/1bH01

3. The Health Ministry has reversed the requirement for doctors to register on the National Medical Register just months after making it mandatory. The change comes after fewer than 1 percent of doctors enrolled, facing a process tangled with Aadhaar mismatches and affidavit demands, leaving most applications unapproved.
Source: short-link.me/1bH03

4. Delhi’s Drug Control Administration issued a strict advisory to chemist associations, mandating the immediate cessation of over-the-counter sales of pregabalin and tapentadol due to rising misuse for intoxication and addiction. The directive demands accurate stock records under the Drugs Rules, 1945, and warns of strict penalties for non-compliance.
Source: short-link.me/17f6F

5. The Food Safety and Standards Authority of India has reportedly formed a committee to evaluate whether added sugar should be permitted in infant food. This follows criticism for major manufacturer of infant food for adding sugar in infant food sold in India. Current food regulations allow limited sucrose/fructose only if essential, capped at 20% of total carbohydrates.
Source: short-link.me/17f6L