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 Ministry of AYUSH has notified an amendment to the Drugs Rules, 1945, inserting Schedule TB, which specifies the standards for the delivery mechanism, preservatives, and excipients that must be complied with in order to obtain a license for the manufacture of Ayurveda, Siddha, Unani, or other traditional medicines that use a nasal spray as a delivery mechanism.
Source: bit.ly/4j9pCHs

2. India’s Directorate General of Foreign Trade (DGFT) has notified the revised Schedule II (Export Policy) whereby, the terms of export have been updated in conformity with the Finance Act, 2024.
Source: bit.ly/4jss5x0

3. India’s indirect tax regulator has issued a circular clarifying the conditions for eligibility for the interest waiver scheme introduced by the GST Council late last year. In addition to submitting applications and filing Forms GST SPL-01 and GST SPL-02, applicants are also required to withdraw any appeal application filed against demand orders, notices, or statements for which the interest waiver is being sought.
Source: bit.ly/40ohfzs

4. India’s Parliamentary Standing Committee on Chemicals and Fertilizers, in its most recent report, has expressed concern that the low number of IVD manufacturers selected under the PLI incentive scheme may not be sufficient to meet the country’s domestic requirements
Source: bit.ly/42a7zuM

5. The United States Federal Trade Commission (US FTC) has alleged that several of the country’s largest insurance companies entered into vertical arrangements with benefit managers to mark up the prices of common and essential prescription medicines, totalling USD 7.3 billion between 2017 and 2022.
Source: bit.ly/4fXStMi

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 Supreme Court of India has ruled that only the Central Government can regulate, prohibit, or restrict the sale of drugs. The judgment clarifies that drug inspectors and regulatory authorities cannot impose such bans or unilaterally declare a medicinal product as prohibited without a central notification.
Source: bit.ly/3DTt3Su

2. The Food Safety and Standards Authority of India (FSSAI) has reiterated the compliance requirements for e-commerce Food Business Operators (FBOs). They warned against operating without a valid FSSAI license or registration and making unsupported claims online. FBOs have been urged to adopt practices ensuring a minimum shelf life of 30% or 45 days before expiry at the time of delivery to the consumer, and to strictly adhere to food safety standards.
Source: bit.ly/3Z9lzmA

3. Indian Micro, Small, and Medium Enterprises (MSMEs) in the pharmaceutical sector are seeking a 3-year, condition-free extension for implementing Schedule M. They have cited financial constraints in upgrading their manufacturing sites to comply with Schedule M standards. In this context, they urge the Indian government to provide support in the form of financial and technical assistance to improve quality standards. The health ministry recently issued a draft notification proposing to extend the deadline for MSMEs to comply with revised Schedule M norms from 31st December 2024, to 31st December 2025.
Source: bit.ly/4fPf8u0

4. The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of azithromycin 250 mg tablets to ₹11.67 per tablet, up from ₹11.65, following a review order by the Department of Pharmaceuticals (DoP). The review addressed Cipla Ltd.’s claim that its product, Azee 250 mg tablets, with a 2.3% market share, was omitted from the initial pricing calculation. The NPPA identified discrepancies in the Pharmatrac database and included Cipla’s product in the updated price.
Source: bit.ly/40kDNB8

5. Maharashtra police has arrested a man who was allegedly running an illegal call center that sold controlled medicines, like Viagra and Tramadol, to U.S. citizens. The accused used VOIP technology to impersonate a legitimate pharmaceutical representative. Authorities have seized several gadgets and accessories from the call centre and charged the individual under various laws, including the Information Technology Act and the Indian Telegraph Act.
Source: bit.ly/405X1Kw

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 Supreme Court of India has dismissed a review petition against its judgment from October 2023, which refused to recognize the right of same-sex couples to enter into marriages or have civil unions. The review petitions challenged the October ruling as being “manifestly unjust” and inconsistent with constitutional values.
Source: bit.ly/3Cg5BOK

2. India’s Parliamentary Committee, in its fifth report on the Department of Pharmaceuticals’ (DoP) 2024-2025 budget, expressed concern over the unavailability of essential medicines at Jan Aushadhi Kendras (JAKs) under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP). The report highlighted the absence of life-saving drugs such as Benzylpenicillin, Atropine, Streptomycin, and medicines for tuberculosis and mental illnesses. It recommended conducting feasibility studies to include these critical drugs in the PMBJP list.
Source: bit.ly/4gN2Tzf

3. The Karnataka State Dental Council (KSDC) has notified that engaging in facial aesthetic treatments and hair transplant procedures constitutes “unethical practice” for dentists. This could result in their disqualification from the dental register. This comes amidst an ongoing case in the Bombay High Court concerning the qualifications of dentists to perform aesthetic procedures.
Source: bit.ly/3Prz7UW

4. The Goa Human Rights Commission (GHRC) has recommended that the state government establish additional rehabilitation homes for mental health patients. The commission has also directed the government to expedite the establishment of such rehabilitation homes and to submit an action report within 90 days. The aim is to improve the care and reintegration of these patients into society.
Source: bit.ly/4jcCT2c

5. The Indian state of Odisha has launched the Odisha Pharmaceutical Development Cell (OPDC) to position itself as a global leader in the pharmaceutical industry. The initiative aims to attract international investments and foster innovation. According to reports, the Odisha Pharmaceutical Policy 2025 will provide investment incentives, R&D support, and skill development frameworks. The state targets investments worth ₹50,000 crores through these initiatives.
Source: bit.ly/3DQx22b

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 Pollution Control Board (CPCB) has directed Plastic Waste Processors (PWPs) to upload valid GST e-Invoices for the sale of product for the purpose of EPR certificate generation on the EPR portal for plastic packaging. The invoices must include key details like Buyer GST number, Seller GST Number, IRN No., HSN code, Invoice Number and QR code, ensuring they are signed, clearly visible, and readable.
Source: bit.ly/4fGikIn

2. India’s Food Safety and Standards Authority of India (FSSAI) has reportedly constituted a panel that is in the process of finalizing guidelines to monitor microplastics and nanoplastics in food and bottled water. This move follows alarming findings of their presence in both branded and non-branded salt and sugar products consumed in India.
Source: bit.ly/4iXJrl4

3. India’s Karnataka High Court has temporarily barred government action against pharmaceutical companies manufacturing nutraceuticals in drug-licensed facilities until its next hearing. This follows challenges by industry bodies and stakeholders against Schedule M of the Drugs and Cosmetics Act, which prohibits the production of non-drug items, like nutraceuticals, in drug manufacturing premises.
Source: bit.ly/41WVEQI

4. Doctors in the Indian state of Maharashtra have raised concerns over a directive from the state’s Food and Drugs Control Department (FDA), which allows homeopaths with a modern pharmacology certificate to prescribe allopathic medicines, despite a pending case in the Bombay High Court. They have also questioned the eligibility of homeopaths to prescribe modern medicine. The directive permits chemist retailers and wholesalers in the state to sell allopathic medicines prescribed by such homeopaths.
Source: bit.ly/424Awbg

5. The Chief Medical and Health Officer (CMHO) of a district in Madhya Pradesh, India, has warned private hospitals against employing BAMS/BHMS doctors as RMOs or duty doctors, particularly in ICUs and emergency departments, instead of qualified MBBS doctors and the violations may lead to registration cancellations under the Nursing Home Act. This comes amid nationwide concerns over patient safety and the misuse of medical designations, with healthcare experts calling for stricter oversight and accountability.
Source: bit.ly/3DOcMhw

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. A Public Interest Litigation (PIL) has been filed in the Madras High Court, alleging that transgender clinics in Tamil Nadu are engaging in unethical practices. These include the use of the banned two-finger test and violations of established health guidelines. The court has issued notices to the National Medical Council and the Tamil Nadu government, seeking their responses to these serious allegations.
Source: bit.ly/4fCPFnA

2. The Indian subsidiary of a major U.S. pharmaceutical company is under investigation for violating the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) guidelines by sponsoring foreign trips for 30 doctors. The government may take action against the company and the executive who signed the self-declaration of compliance. If proven, the doctors involved could lose their medical licenses and be prohibited from practicing medicine.
Source: bit.ly/409I4s3

3. India’s Allahabad High Court has overturned a National Consumer Disputes Redressal Commission (NCDRC) order that had mandated a compensation of ₹93 lakh from a doctor and hospital owner for alleged medical negligence during a C-section procedure in 2005. The High Court identified procedural errors in the NCDRC’s decision-making process, thereby nullifying the earlier order for compensation to be paid by the medical professionals involved.
Source: bit.ly/409s4pQ

4. India’s Karnataka High Court has granted temporary relief to pharmaceutical companies by directing the government to refrain from taking action against pharmaceutical companies producing nutraceuticals in drug-licensed units. This follows a challenge to Schedule M, which restricts the manufacturing of non-drug products in drug-licensed facilities
Source: bit.ly/40bT34c

5. The Jammu and Kashmir Medical Supplies Corporation Limited (JKMSCL) has ordered an immediate halt to the use of Bupivacaine Hydrochloride in Dextrose Injection USP (0.5%), 5mg/ml, 4ml ampoule, Batch Number AA40222, manufactured by Aishwarya Healthcare Ltd. This action follows a reported Adverse Drug Reaction (ADR) associated with the batch, which was manufactured in April 2024 and expires in March 2026. Medical officers have been instructed to cease using the affected batch immediately.
Source: bit.ly/408meFg

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 Food Safety and Standards Authority of India (FSSAI) has directed to reduce the sample size of Vitamin D2 for analysis as it is an expensive ingredient. Earlier a sample of 500g was drawn for analysis, however now a sample of at least 50g is to be drawn i.e., two samples of 25g each, from the imported consignment and after the analysis, the remaining 25g should be returned to the importer making the sample collection process more cost-effective.
Source:  bit.ly/4gN4R2m

2. The Federation of Pharmaceutical Entrepreneurs (FOPE) has highlighted the growing concern of Not of Standard Quality (NSQ) drugs in India and has proposed critical changes to the Drugs and Cosmetics Rules thereby calling for the inclusion of temperature, humidity, and photosensitive drugs under Schedule P. This proposed inclusion aims to enforce stricter shelf-life regulations for these types of drugs, ensuring they are subject to rigorous stability studies to verify their quality and safety throughout their shelf life.
Source: bit.ly/49VvAYw

3. The Telangana pharmaceutical industry has raised several concerns with the Department of Pharmaceuticals (DoP) and the Central Drugs Standard Control Organization (CDSCO), seeking clarity on certain provisions in the Revised Schedule M. These concerns primarily revolve around discrepancies between mandatory requirements and the WHO guidelines, which are generally regarded as voluntary and non-binding. The industry has also raised concerns about the production of nutraceuticals in facilities that are primarily designed for pharmaceutical manufacturing.
Source: bit.ly/49R29Xs

4. The National Pharmaceutical Pricing Authority (NPPA) has given an extension to one of the leading manufacturer of drug for the continued manufacturing of two of its scheduled Tetanus formulations until December 31, 2025. This extension follows company’s submission of Form IV, requesting approval to discontinue these formulations. Under Para 3 of the Drugs (Price Control) Order (DPCO), 2013, the government has the authority to direct manufacturers of active pharmaceutical ingredients (API), bulk drugs, or formulations to manufacture the drugs for adequate supply and accessibility of essential medicines.
Source: bit.ly/49TcdPC

5. The India’s Goods and Services Tax (GST) Council has introduced several significant changes to GST. Notably, gene therapy has been exempted from GST, and the decision on taxing restaurant services provided by electronic commerce operators at 5% has been deferred for further review. Additionally, the Council has clarified that caramel popcorn, due to its added sugar content, will attract a higher tax rate compared to salted or plain variants.
Source: bit.ly/3BFBNuT

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 Parliamentary Committee on Consumer Affairs, Food and Public Distribution, has noted in a recent report, that the National Test House (NTH) of the Consumer Protection Department does not currently have the expertise or offer the services for regulation certification of Radiation Emitting Medical Devices (including MRI machines and X-Ray machines etc.).
Source: bit.ly/4iKKIfi

2. The National Human Rights Commission of India, having taken Suo-Moto cognizance of a recent report concerning the negligent transfusion of blood to a patient in Rajasthan, has issued Notices to the Chief Secretary of the State of Rajasthan to conduct a thorough investigation into the circumstances of negligent blood transfusion.
Source: bit.ly/3ZCj4Z0

3. The Indian Minister of State for Health has clarified that the Central Drug Regulator, currently does not have any intention or proposal to ban Rantidine in the country, and that State Drug Controllers have been instructed to test for the levels of possible carcinogen N-nitrosodimethylamine in the wake of a warning issued by the United States Food and Drug Administration and European Medicines Agency.
Source: bit.ly/3P2aKgf
Source: bit.ly/49GB4pR

4. India’s Central Drugs Regulator, in supersession of an earlier Amendment in 2022, has issued an amendment to the Medical Devices Rules, specifying laboratories, and the Medical Devices that the laboratories are designated to test.
Source: bit.ly/3PnjiyF

5. The European Medicines Agency is set to implement to the proposed Electronic Product Information program to adapt pharmaceutical label information for easier representation on e-commerce platforms after conducting a successful pilot program.
Source: bit.ly/3DyWkS8

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 Bombay High Court’s Division Bench has stayed an order penalizing a leading AYUSH drug manufacturer for violation of an injunction order on the selling of camphor products thereby infringing another company’s organics’ trademark. Earlier the drug manufacturing company was imposed with a penalty for contempt of court after observing continued violations of the restraining order since 2023.
Source: bit.ly/3ZF02RK

2. India’s Delhi High Court has directed online platforms, including Telegram, to block accounts linked to an anonymous user threatening to leak an insurance company’s confidential customer data. The court emphasized that misuse of such data could lead to identity theft, fraud, and privacy violations and restrained the unidentified entity from sharing the data and ordered intermediaries to disclose its details.
Source: bit.ly/3VKUjbT

3. India’s Karnataka government has reportedly merged the Department of Food Safety and Standards with the Drug Control Department, renaming it as the Food Safety and Drug Administration (FDA). The move aims to streamline operations and enhance service delivery under a unified Commissioner. Officers and staff will now function under the FDA’s administrative control, with steps being taken to restructure rules and regulations. The decision follows similar mergers in states like Maharashtra, Gujarat, and Tamil Nadu.
Source: bit.ly/4flpL7B

4. The Union Ministry of AYUSH (MOA) will reportedly launch a national portal, ‘Trinetra’, for pharmacovigilance in Indian Systems of Medicine (ISM) to curb misleading advertisements. Announced at the World Ayurveda Congress in Dehradun, the portal will ensure quicker reporting of misleading advertisements thereby improving consumer safety. Experts emphasized the need to protect Ayurveda’s reputation and address false claims of “magic cures” and “side-effect-free” treatments.
Source: bit.ly/4gC7y6O

5. India’s Supreme Court has criticized the Delhi government for failing to provide data on daily solid waste generation, calling it a “shocking state of affairs.” Despite an order dated November 18, 2024, the data remains pending, prompting the Court to warn of contempt proceedings if an affidavit is not submitted by December 18, 2024. The Chief Secretary has been directed to appear before the Court on December 19. The Court expressed concern over untreated solid waste, linking it to public health risks and landfill fires.
Source: bit.ly/3ZZyXtK

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. A Public Interest Litigation before the Bombay High Court is being opposed by the Association of Oral and Maxillofacial Surgeons of India, arguing on the basis of a notification of the Dental Council of India dated 6th December 2021, that specialized Oral and Maxillofacial Surgeons registered with State Dental Councils should be permitted to carry on hair transplant surgeries.
Source: bit.ly/49yFtLx

2. The Central AYUSH Minister (Ayurveda, Unani, Siddha and Homeopathy) has stated in response to query in the Indian Parliament, that the ministry has followed a policy of co-location of AYUSH facilities at primary healthcare centres to encourage patients to make choice of treatment.
Source: bit.ly/41ssp8c

3. A lawsuit has been filed in the United States against the manufacturers of consumer food products, alleging that the products manufactured by the companies are “ultra-processed” and prone to causing chronic diseases among consumers.
Source: bit.ly/4goMQXO

4. The Union Health Ministry of India has reportedly urged states to classify snakebites as a notifiable disease, meaning it must be reported to the government by hospitals. This follows the launch of the National Action Plan for Prevention and Control of Snakebite Envenoming (NAPSE), which aims to reduce snakebite deaths by 50% by 2030. One of NAPSE’s recommendations is that snakebites be made a notifiable disease to better track and address the issue.
Source: bit.ly/4gxDPvG

5. The Ministry of Health and Family Welfare has stated that data on disciplinary actions against Registered Medical Practitioners (RMPs) over the past five years is not centrally maintained. It has advised states to promote the prescription of generic drugs and conduct prescription audits in public health facilities. The Indian Medical Council’s 2002 regulations mandate that physicians prescribe drugs by their generic names, legibly and preferably in capital letters, ensuring rational and appropriate use.
Source: bit.ly/3ZRLujb

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 Ministry of Environment, Forest, and Climate Change has released draft rules under the Environment Protection Act, 1986, proposing Extended Producer Responsibility (EPR) for managing post-consumer waste from paper, glass and metal packaging along with sanitary products. These Rules aim to promote recycling, reuse, and waste-to-energy initiatives. Producers, importers, and brand owners must register and meet EPR targets from April 2026.
Source: bit.ly/49w0GFK

2. India’s Central Pollution Control Board (CPCB) has regulated the micro and small importers, producers, sellers and manufacturers of plastic raw materials and have mandated their registration on the EPR Plastic Portal. Filing of annual returns and compliance with all other EPR obligations is also outlined in the guidance issued by CPCB.
Source: bit.ly/49CJo9Z

3. India’s Supreme Court has reiterated that Ayurvedic/AYUSH doctors cannot claim parity with allopathic doctors, citing differences in academic qualifications and the standards of their respective courses. The court dismissed a petition by AYUSH doctors in Kerala, referring to past judgments that clarified the distinction in responsibilities and remuneration between allopathic and AYUSH practitioners.
Source: bit.ly/4iqyYhN

4. India’s Delhi District Consumer Commission has fined a leading FMCG company with a fine of ₹15 lakh for misleading advertisements about its “Fair and Handsome” cream, which claimed to provide fairness within three weeks without proper evidence. The Commission found the claims deceptive and an unfair trade practice, ordering the company to withdraw all misleading ads and packaging.
Source: bit.ly/3OPcMjE

5. India’s Central Drugs Standard Control Organization (CDSCO) has issued a circular thereby directing all State and Union Territory Drugs Controllers to ensure the approval of drugs and medical devices for rare diseases within 90 days of receiving applications to expedite the regulatory process and support faster access to treatment for rare diseases.
Source: bit.ly/3VvSFLl