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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 Drug Controller General of India (DCGI) has directed all State and UT Drug Controllers to regularly sample kumkum and colour powders at religious sites for testing for synthetic ingredients due to public health concerns. Kumkum is regulated as a cosmetic in Indian law and must meet BIS standards covering heavy metal limits, microbial safety, prescribed testing methods, and mandatory packaging and labelling requirements.
Source: h7.cl/1nnwz

2. India’s Ministry of Agriculture & Farmers Welfare has released the draft Pesticides Management Bill, 2025 to replace the Insecticides Act, 1968. The farmer-centric bill proposes stronger regulation of spurious pesticides, higher penalties, digital processes, mandatory lab accreditation, and promotion of biopesticides and indigenous manufacturing. Stakeholders can submit comments in the prescribed format by 4 February 2026.
Source: h7.cl/1inPA

3. The Tea Board of India has issued revised guidelines for registration of manufacturers of flavoured tea, reaffirming that every factory manufacturing flavoured tea must be registered as a bonafide manufacturer with the Tea Board. This makes the registration process for flavoured tea manufacturers clearer and more structured.
Source: h7.cl/1nnx8

4. The European Parliament has approved measures to strengthen EU supply of essential medicines by reducing dependence on non-EU countries. The proposals support domestic manufacturing through strategic projects, priority funding, EU-favoured procurement, joint purchasing, and coordinated stockpiles to prevent shortages of critical medicines such as antibiotics, insulin and vaccines.
Source: h7.cl/1nnwI

5. India’s Central Drug regulator has given approval to manufacture and sell a generic version of Ozempic (semaglutide) for diabetes, ahead of its patent expiry in March 2026. The company plans to launch 12 million injectable pens in the first year and partner locally for distribution. The company is also awaiting similar approval for the obesity drug Wegovy.
Source: h7.cl/1nnwM

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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. A multinational pharmaceutical company has approached the Delhi High Court to restrain the domestic pharma giant from launching its generic version of semaglutide, a widely prescribed drug for diabetes and weight loss. This is the second suit by the plaintiff innovator against local firms wanting to launch copies of the drug
Source: h7.cl/1g6X3

2. Department for Promotion of Industry and Internal Trade (DPIIT) has issued a draft framework mandating blanket licence for legally accessible content for AI-training, but deferring royalty payments until commercialisation. The plan sets up a centralised royalty-collection mechanism, replacing “zero-price licence” proposals.
Source: h7.cl/1g6X7

3. The Delhi High Court has temporarily barred a local supplier from using a mark found deceptively similar to a well-known ayurvedic brand, holding that the adoption appeared misleading and capable of confusing consumers. The Court restrained manufacture, sale, promotion, and any creation of third-party rights during the proceedings.
Source: h7.cl/1l00x

4. The Drug Consultative Committee has noted that some State Licensing Authorities (SLA) are issuing manufacturing licenses for new drugs without prior written approval from the Central Licensing Authority (CLA), as required under The New Drugs and Clinical Trials Rules, 2019. Members unanimously agreed that SLAs must obtain CLA approval before granting any such manufacturing permission.
Source: h7.cl/1g6Xk

5. The United States Food and Drug Administration has reportedly finalized guidance on promotional labeling and advertising for biologics and biosimilars, outlining standards to ensure accurate and non-misleading communications. The document clarifies expectations for data presentation, comparative claims, and identification of products, with specific caution against comparisons that imply reduced safety or effectiveness.
Source: h7.cl/1l00M

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

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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

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 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

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 approved adding the HPV vaccine to the Universal Immunisation Programme, targeting girls aged 9–14. This aligns with the June 2022 NTAGI recommendation and is supported by ongoing frontline healthcare worker training and rollout planning.
Source: shorturl.at/3e0T0

2. Meghalaya announced plans to introduce legislation requiring mandatory HIV/AIDS testing prior to marriage. The government is drafting a cabinet note and engaging district stakeholders to advance a mission mode HIV control policy.
Source: tinyurl.com/yfhymxdx

3. The India-UK Free Trade Agreement, signed on July 24, 2025, excludes patent term extensions and data exclusivity, safeguarding India’s generic drug industry. However, experts warn it restricts compulsory licensing by promoting voluntary licences and “adequate remuneration” clauses, and that this could undermine India’s ability to supply affordable medicines to developing countries.
Source: tinyurl.com/3wm9wwz9

4. The All-India Organisation of Chemists and Druggists (AIOCD), representing over 12 lakh chemists nationwide has reportedly urged the Drug Controller General of India to take urgent action, alleging that State Licensing Authorities are failing to stop illegal e pharmacies misusing draft notifications leading to unregulated online medicine sales and posing risks to public health.
Source: tinyurl.com/39b9a44n

5. Nathealth urged Niti Aayog to simplify healthcare regulations through a digital single-window system, highlighting burdensome compliance from 10–12 ministries. A white paper identified 85 regulatory challenges, calling for harmonisation across states to boost efficiency, innovation, and patient-focused care in hospitals, diagnostics, and medtech.
Source: tinyurl.com/5582rp5n

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 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

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 Drugs Technical Advisory Board is reportedly reviewing a proposal to limit the sale of over-the-counter drugs. Only 27 essential medicines, including painkillers, antacids, and oral contraceptives, may be allowed without a prescription, with strict controls on dosage and pack size.
Source: bit.ly/4jqjkD0

2. Delhi High Court has upheld the Government’s move to restrict the sale of an anti-cold drug without warning labels against use in children below 4 years after April 15, 2025. For earlier batches, companies must publish notices in two national newspapers, which won’t count as advertisements or violations of license conditions.
Source: bit.ly/3SaUOK0

3. India’s drug regulator has reportedly approved eye drops aimed at controlling myopia progression in children. This pediatric formulation, the first of its kind to be approved in India, has successfully completed Phase III trials and will be available as a prescription drug.
Source: bit.ly/444JxCp

4. A group of doctors with disabilities has urged the World Health Organisation to include sunscreen in its Essential Medicines List, citing its importance for people with albinism who are highly susceptible to UV radiation. They argued that sunscreen is a vital medical need and not a cosmetic.
Source: bit.ly/44KmxJ9

5. The U.S. FDA reportedly plans to phase out several synthetic food dyes linked to health concerns like attention deficit hyperactivity disorder (ADHD) and obesity. Two dyes will be banned soon, with six more to be removed by 2026, and new natural color additives will be approved.
Source: bit.ly/3EFTFXQ

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

 

 

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 Foreign Trade regulator, the Directorate General of Foreign Trade (DGFT) has recently issued a Trade Notice, cautioning exporters to no longer accept physical copy Certificate of Origin, and to only accept electronically issued Certificates of Origin since the deadline for using physical copies has passed on 31st December 2024.
Source: bit.ly/439cxs0
Source: bit.ly/439ayEk

2. In light of a recent international report regarding the misuse of drug combinations in various countries in the African continent, India’s Ministry of Health and Family Welfare has rescinded the export license and No Objection Certificate (NoC) of a manufacturer of the said combinations.
Source: bit.ly/4353Mzp

3. India’s Supreme Court, in its recent order has expressed that the medical educational institution admission guidelines, which requires that “both hands [should be] intact” for a person suffering from a disability to gain admission to a medical educational institution, is violative of disability rights and has no basis under law.
Source: bit.ly/3QyRKH0

4. In a recent order, the High Court of Kerala has instructed the State Government to issue a circular to all Doctors in the state, requiring the preservation of foetus in case of a Medical Termination of Pregnancy of a minor, and require permission from the State Government for the destruction of said foetus.
Source: bit.ly/4bblB1L

5. The recent decision of the United State Government to terminate employment of several employees of the United States Food and Drug Administration (FDA) has the possibility to cause delay in obtaining approvals and licenses from the FDA by members of the Medical Device industry.
Source: bit.ly/4hRolDN