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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. India’s Drug Controller General (DCGI) has reaffirmed that the revised Schedule M good manufacturing practice norms will be enforced as scheduled from January 1, 2026, with no further extensions even amid industry calls for delays. The rule applies to all drug makers and aims to elevate quality standards, though many MSMEs cite compliance challenges and potential business impacts.
Source: h7.cl/1h1Ta

2. The Department of Pharmaceuticals has extended the deadline for manufacturers to apply under the Production Linked Incentive (PLI) Scheme for domestic manufacturing of critical KSMs, drug intermediates, and APIs until 16 January 2026. Applications must be submitted online through the designated portal, and all previously issued terms and conditions in the earlier notice will continue to apply.
Source: h7.cl/1lXQo

3. A plea filed recently in India’s Supreme Court, reportedly, argues that the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is outdated. It seeks recognition of AYUSH doctors as registered medical practitioners and calls for reforms to curb misleading drug advertisements while allowing truthful, evidence-based information.
Source: h7.cl/1lXPt

4. India is considering waiving customs duty on select pharmaceutical products manufactured in special economic zones and sold in the domestic market. The proposal aims to boost investment, strengthen domestic supply of critical medicines and vaccines, and support the pharmaceutical sector amid rising global trade pressures.
Source: h7.cl/1h1Ti

5. Australian health authorities had recently flagged concerns over counterfeit batches of anti-rabies vaccine circulating in India. The public sector manufacturer clarified that the issue pertained to a specific counterfeit batch identified in January 2025 which has since been removed from circulation. The company emphasized that genuine vaccines released through authorized channels remain safe.
Source: h7.cl/1lXPz

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 NPPA has extended the existing ceiling prices for orthopaedic knee implants until November 15, 2025. The earlier deadline was September 15. The extension allows time to review industry representations while maintaining current ceiling prices.
Source: short-url.org/1eQeU

2. India’s central drugs regulator, has introduced a new online provision, effective 11th September 2025 for “Subsequent Importer” applications. It allows companies to import medical devices and in-vitro diagnostics already approved by CDSCO for marketing in India. The initiative aims to simplify approvals, brand approvals, enhance transparency, and reduce processing timelines.
Source: short-url.org/1eQnm

3. India’s central drug authority has classified pharmaceutical cocrystals of approved active substances as new drugs under New Drugs and Clinical Trials Rules, 2019. Applicants must demonstrate superior properties over physical mixtures, with detailed validation, stability, and bioavailability/bioequivalence data. Submissions will be processed like new active substances, requiring full safety and efficacy evidence.
Source: short-url.org/1afgK

4. Pharmaceutical merchant association are reportedly urging India’s government to revise the rule prohibiting the export of pharmaceutical products labelled “For sale in India only.” They claim the regulation has led to substantial losses, hurting global competitiveness, restricting access for overseas patients, and causing market-share losses.
Source: short-url.org/1eQme

5. Reportedly, one of the leading toothpaste maker company in the United States will update its packaging from November 1 under a settlement order, showing “pea-sized” amounts for children under six to promote safe, age-appropriate fluoride use and address concerns that previous images encouraged potentially unsafe overuse by young children.
Source: short-url.org/1afh5

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 NPPA’s Multi-Disciplinary Committee (MDC) flagged a typographical error in major pharmaceutical drug manufacturing company’s IPDMS Form I, reporting retail price of tablet as ₹13 per tablet instead of ₹91, leading to incorrect pricing. MDC has cautioned the manufacturer to avoid such negligence to prevent procedural delays.
Source: short-link.me/1aSCE

2. The Indian government has reportedly clarified that there is no official classification of drugs as “life-saving drugs.” However, to ensure affordability and accessibility, 930 formulations listed in the National List of Essential Medicines (NLEM) are under price control, leading to significant price reductions and improved patient access.
Source: short-link.me/16tjO

3. The Chhattisgarh High Court, in a recent interim order, has permitted Bachelor of Pharmacy (B.Pharm) graduates to apply for Pharmacist (Grade-II) posts under the National Health Mission (NHM). The court deemed the NHM’s exclusion of degree holders as arbitrary, a violation of Articles 14 and 16 of the Constitution.
Source: short-link.me/1aSCL

4. Indian pharmaceutical exports specifically generics and biosimilars -are currently exempt from the U.S. tariffs, underscoring their indispensable role in ensuring affordable, high-quality medicines for U.S. consumers. With about 40% of generics and 15% of biosimilars in the U.S. supplied by India, Pharmexcil has reportedly urged sustained collaboration to preserve stable, resilient pharmaceutical supply chains.
Source: short-link.me/1aSCW

5. United States Food and Drug Administration experts recommended dropping the “black box” warning on estrogen-based menopause therapies, especially low dose vaginal estrogen arguing the label has deterred women from effective treatment. They cited updated evidence showing benefits in reducing heart attack and bone fracture risk. In India, doctors are optimistic this move will boost confidence in hormone therapy, which remains underused despite its potential benefits for millions of postmenopausal women.
Source: short-link.me/1aSCZ

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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. India’s Central government has reportedly exempted imported pharmaceutical high-density polyethylene (HDPE) medical-grade plastic from mandatory quality certification under Bureau of Indian Standards regulations to facilitate the production of syringes and IV cannulas and a steady supply of essential products in the healthcare sector.
Source: bit.ly/4ldtUOp

2. The Department of Pharmaceuticals (DoP) has reportedly declined to reveal the names of 30 doctors who accepted ₹1.91 crore worth of foreign trips from major pharmaceutical company. Citing privacy concerns, the DoP resisted disclosing details despite National Medical Commission (NMC) being asked to act. The decision has sparked criticism over transparency and ethical accountability in healthcare.
Source: bit.ly/3G400gp

3. The Karnataka State Pollution Control Board (KSPCB) has clarified that Biomass Briquette/Pellet manufacturing plants do not fall under the scope of the EIA Notification, 2006, which governs environmental impact assessments for specified projects.
Source: bit.ly/4n20u7l

4. The government of India is reportedly tightening oversight of online pharmacies offering rapid deliveries amid concerns over unverified prescriptions, safety, and compliance. A regulatory review is underway to enhance consumer protection and control the proliferation of unregulated digital pharma services.
Source: bit.ly/3G1nDpZ

5. India’s Uttarakhand High Court has quashed a case against a leading Ayurvedic drug manufacturer and its founders over alleged misleading medical advertisements claiming to cure conditions such as diabetes and high cholesterol. The Court cited lack of specific evidence or expert reports to support the allegation that the claims were misleading.
Source: bit.ly/3HZK8vW

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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. India’s Central Drugs Regulator (CDSCO) has clarified that modified or sustained-release form of a drug including gastro-resistant tablets/capsules, delayed-release tablets/capsules, or novel drug delivery systems will be regulated as ‘new drug’. New drugs must undergo clinical trials for obtaining manufacturing license
Source: bit.ly/41znUZe

2. India’s Central Licensing Authority (CLA) has directed manufacturers of unapproved fixed dose combination drugs to apply for permission to conduct Phase IV study / active post marketing surveillance within three months
Failure may result in cancellation of manufacturing license.
Source: bit.ly/3Xmpjjr

3. India’s Central Food Regulator (FSSAI) has reminded all food businesses that any post approval change in license information such as name of nominee, product category, expansion has to be communicated before such change takes place. Failure may result in cancellation of license.
Source: bit.ly/41AjyRq

4. India’s product standard setting body (BIS) has amended the Baby Diapers Standard 17509:2021. The amendment clarifies that actual dimensions of the diapers can vary based on the manufacturer’s design choices, with the diaper’s design being subject to the agreement between the buyer and seller.
Source: bit.ly/41znT7C

5. Clinical trial sponsors can add clinical trial sites and change the principal investigator (PI) by applying on SUGAM Portal.
The application for change of PI is deemed approved on application, and for addition of site within 30 days of application.
Source: bit.ly/41wrvHo

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 (DoP) released the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) providing guidelines to medical device companies for regulating monetary and non-monetary incentives given to Healthcare Professional (HCPs) for eliminating unethical conduct while organising promotional and training programs for such HCPs. The UCMPMD also sets guidelines for establishment of an ethics committee and entering of complaints on the UCMPMD portal set by the DoP.
Source: bit.ly/3AWUnOm

2. The pharmaceutical company that launched eye drops claiming that they can eliminate near-sightedness in 15 minutes has clarified that its claims were based on approved indications for treatment and Phase 3 clinical trial data and are not unethical or false.
Source: bit.ly/3z0wSn3

3. The Bombay High Court has granted an interim injunction to a Fast-Moving Consumer Goods (FMCG) company manufacturing health drinks against another FMCG company manufacturing fibre-nutritional drinks for circulating advertisements on WhatsApp groups that allegedly denigrated and disparaged the latter’s products.
Source: bit.ly/3APlUkz

4. The National Medical Commission (NMC) has withdrawn its previously issued public notice for the discontinuation of all courses offered by the College of Physicians & Surgeons (CPS), Mumbai as it was earlier regarded as being beyond the powers of the college to provide conduct examinations and award degrees. However, the earlier notification now stands withdrawn.
Source: bit.ly/3Zisquh

5. The US Court has held that expert testimony is a requirement in all medical negligence cases, and it is not enough for the claimant to establish that the doctor had not communicated the box-label warning to the patient or patient’s family, especially in cases where the patient’s claim was based on the absence of informed consent.
Source: bit.ly/3Zo6HkC

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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 Minister has reportedly confirmed that Central Drugs Standard Control Organization (CDSCO) will be the sole regulator of veterinary medicines in India and there is no proposals to establish a separate regulatory body for veterinary medicines in India.
Source: bit.ly/4cbgTQe

2. India’s Food regulator (FSSAI) has warned against use of unapproved non-specified ingredients, such as “Deionized apple juice concentrate,” in fruit juices.
Source: bit.ly/46swOZq

3. The State Drug Regulator (FDA) of Maharashtra is reportedly going to start an inspection drive to identify doctors and hospitals which are running an open shop for medicines without holding a valid pharmacy license.
Source: bit.ly/46rtHAZ

4. The Principal Bench and State Benches of Goods and Services Tax Appellate Tribunal (GSAT) have been established with effect from 1st September 2023.
Source: bit.ly/3A86tDM

5. The US Food & Drugs Administration (FDA) has warned a pharmaceutical company for sponsoring a celebrity paid promotion campaign on social media, in which the influencer promoted a drug but did not disclose essential risk information. The FDA found the post to be misleading.
Source: bit.ly/46rtI81

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Central Food Regulator the Food Safety Standards Authority, has introduced registration process for direct sellers to differentiate from Retailers, and make it easier to preserve exemption granted from regulation to direct sellers.

Source: bit.ly/4feuedl

 

2. The Kerala High Court in following with a recent decision of the Punjab High Court has held that the newly enforced Criminal Procedure (The Bharatiya Nagrik Suraksha Sanhita, 2024) will apply to all criminal appeals filed on or after 1st July 2024, the day of enforcement of the  new law. The court held that while the substantial right to appeal is preserved under the repealed statute, the procedural right will transfer over as per Sec. 531 of the new Code.

Source: bit.ly/4bQpMi4

 

3. Exports of Drugs and Pharmaceuticals have reportedly increased by 9.5% in the first quarter of FY 2024-25 year-on-year.

Source: bit.ly/4d3x3Nb

 

4. In response to recent reports that India has the 2nd highest number of unvaccinated children, the Indian government has clarified in a press release that, this statistic is misleading as such children only constitute a minute 0.11% of the nation’s population of children.

Source: bit.ly/3zQzFPw

 

5. The United States Food and Drug Administration has published Guidance for Human radiolabeled mass balanced studies, prescribing the information that sponsors need to submit, most notably now requiring a minimum of 6 participants for such studies as against the accepted variance between 4-6 participants.

Source: bit.ly/3y2UEy8

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Absence of essential medicines in a hospital constitutes medical negligence
India’s National Consumer Dispute Redressal Commission (NCDRC) has held that absence of an essential injectable medicine within the hospital, resulting in administration of an alternate injection to a patient who later died, constituted medical negligence. The court ordered the Hospital to pay Rs 25 Lakh as compensation.
Source: bit.ly/3UtaJ7u

Cost of conducting clinical trial of drug published in public domain for first time
Médecins sans frontières (MSF/doctors without borders), a non-governmental organization dedicated to delivering international medical aid, has published cost of conducting clinical trial of a new drug. As per MSF, no pharmaceutical company has published actual cost of conducting clinical trials, though such costs are frequently referenced to justify high drug prices.
Source: bit.ly/3wjvo5J

Indian standards for infant formula permit addition of sugar, therefore controversy surrounding added sugar in infant food unwarranted: Industry
A popular infant formula formulation company has clarified that the sugar content in their product is within the limits prescribed by India’s food regulator, Food Safety and Standards Authority of India (FSSAI). This clarification was issued after reports that the product being sold in low-and-middle income countries has high sugar content.
Source: bit.ly/3UsnaQH

Indian medical device regulator has allowed sale of sleep apnea devices post rectification of foam degradation issue
A major manufacturer of sleep apnea therapy devices has reportedly confirmed that its devices are sold in India without the foam degradation issue, which had previously caused it to recall its devices in India and around the world. In the US, the manufacturer has agreed to provide users of affected devices with new, updated, or equivalent devices with a renewed warranty or a refund.
Source: bit.ly/3WufUXh

Revised guidance for referencing of biological products by biosimilar drugs published for comments by US FDA
The US Food and Drugs Administration (USFDA) has released a revised guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products.” The guidance addresses various questions that manufacturers, packers, distributors, and their representatives/firms may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act).
Source: bit.ly/3wudFsl

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

Dear Reader, 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.

Draft GDP guidelines for pharmaceutical products published for comments
India’s Central Drugs Standard Control Organization (CDSCO) has released a draft guidance document titled “Guidelines on good distribution practices for pharmaceutical products” for comments. The Guidelines seek to eliminate the introduction of spurious, adulterated, misbranded and non-standard quality (NSQ) products into the market. It is intended to be applicable to all entities involved in any aspect of the storage and distribution of pharmaceutical products, including manufacturer as well as pharmacists and any other person dispensing medical products directly to a patient.
Source: bit.ly/4cQwypM

Agreements with Shared Workspace Providers accepted as valid proof of premises for obtaining food licenses
India’s central food regulatory authority, Food Safety and Standards Authority of India (FSSAI), has issued an advisory on the documents that may be submitted as proof of premises by importers, traders, e-commerce entities, re-labellers etc. who deal in food products and operate out of a shared workspace premises. Going forward, any legally valid agreement with workspace provider will be accepted. Such agreement may be a lease or rent agreement. However, entities who operate out of shared work-space will not be able to stock food products in shared workspace under the license.
Source: bit.ly/3JkMpzp

Documents which will be accepted as proof of possession of premises for food business is specified by Central Food Regulator
India’s central food regulatory authority, Food Safety and Standards Authority of India (FSSAI), has identified documents which will be accepted as proof of possession of premises by a Food Business Operator (FBO) as part of the food license application. Any food business operator, undertaking any business of food or beverage, including hotels, restaurants, food vending establishments, clubs, canteens, importers, merchant, exporters, e-commerce operators, transporters has to submit proof of possession of premise in order to obtain corresponding food license.
Source: bit.ly/3UiCgte

Waste management portals for plastic packaging and e-waste to get operational in a phase wise manner
India’s Central Pollution Control Board (CPCB) has clarified that the Extended Producer Responsibility portals for the management of Plastic Packaging waste and E-waste will get operational in a phase wise manner. For plastic packaging waste the portal is only functional for Chandigarh, Chhattisgarh, Goa & Puducherry whereas for e-waste the portal is operational for Maharashtra only. The users of the portal for other states are requested to wait till further notice.
Source: bit.ly/3JqZRBH
Source: bit.ly/3Jl1Es4

Popular protein supplements sold in India found to have lesser quantity of protein than declared on the label
A recent study has found that many popular brands of protein supplements sold in the Indian market do not have the same amount of protein as claimed on the label. In addition to the inconsistencies related to protein content, the study also found evidence of protein spiking, fungal toxins, pesticide residues, presence of heavy metals and compounds in protein supplements manufactured in India.
Source: bit.ly/3vU24CC