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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 Pollution Control Board (CPCB) has extended the timelines for the filing of Extended Producer Responsibility (EPR) annul returns by producers of Battery waste and E-waste for the Financial Year (FY) 2023-2024 till 31st March 2025 and 31st January 2025 respectively. For E-waste the extension of timelines also applies to the filing of quarterly returns for the abovementioned FY.
Source: bit.ly/3WthHei
Source: bit.ly/4gcsPmW

2. India’s National Pharmaceutical Pricing Authority (NPPA) has issued an office memorandum (OM) requesting manufacturers and marketing companies of the scheduled formulations nicotine used for nicotine replacement therapy (NRT) to furnish the Price to Retailer (PTR) and Moving Annual Turnover (MAT) data, in value terms for October 2023, within 7 days from the issue of the OM. A format for submitting these details is also provided in the OM. This information is being sought to fix the ceiling prices of these formulations.
Source: bit.ly/4gnoEFb

3. India’s Central Drugs Standard Control Organization (CDSCO) has released a guidance document to support the development of rapid diagnostics for pathogen identification and Antimicrobial Susceptibility Testing (AST). The document offers guidance to innovators and developers on evaluating their tests and demonstrating their effectiveness.
Source: bit.ly/4heX8ue

4. The Kerala High Court (KHC) recently ruled that magic mushrooms are not classified as narcotic substances under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. After reviewing the legal status of psychedelic fungi, the honourable court concluded that since magic mushrooms are not specifically scheduled under Act, they are not subject to its restrictions.
Source: bit.ly/3CiZv0k

5. India’s Central Pollution Control Board (CPCB) has released draft guidelines for the Pharmaceutical Industry in India, which are currently classified as highly polluting. The guidelines outline criteria for the establishment of pharmaceutical units, including mandatory minimum distances from sensitive areas. Stakeholders and the public are invited to submit their comments and suggestions on the draft guidelines by February 5, 2025.
Source: bit.ly/4h1GC0Y

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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 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

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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 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 Food Safety and Standards Authority of India (FSSAI), in its 45th meeting, decided that the amendment to the Food Safety and Standards (Labelling and Display) Regulations, 2020, will be enforceable from 1st July 2025. This is subject to the condition that at least 180 days have passed from the date of notification of the amendment. Additionally, in cases of emergency, a separate decision may be taken regarding enforcement.
Source: bit.ly/3BPK9jH

2. The Supreme Court of India recently ruled that while courts have the authority to order the seizure of vehicles pending trial under the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act), there is no provision in the Act that prohibits the return of seized vehicles. The Court emphasized that owners of such vehicles should be given an opportunity to be heard regarding the restoration of possession, particularly if they had no knowledge of the transport of narcotic or psychotropic substances,
Source: bit.ly/3DNibWg

3. The Rajasthan High Court, in a matter seeking to quash a petition against pathologists at a hospital accused of falsifying reports based on signature irregularities, held that cases of medical negligence must be subjected to a higher degree of scrutiny. The court further stated that mere irregularities in documents do not constitute falsification.
Source: bit.ly/3C2O64y

4. India’s Directorate General of Foreign Trade (DGFT) has issued a public notice regarding procedure for exporting certified organic products from the country. The new procedure requires that all ‘organic products’ intended for export should carry a Transaction Certificate issued by a National Accredited Body under the National Program for Organic Production (NPOP) and should be labelled in accordance with the NPOP. A revised NPOP will come into force from 5th July 2025
Source: bit.ly/4j48uD1

5. The US Food and Drug Administration has issued a finalized guidelines under the Advanced Manufacturing Technologies Designation Program, whereby manufacturers are able to obtain designation of the manufacturing process which may either reduce development time of drug or maintain supply of life-supporting, life-sustaining or critical drug.
Source: bit.ly/4j3H3Jr

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 Standard Control Organization (CDSCO) has issued an updated draft list for the risk-based classification of medical devices. The new entries in the list include categories such as interventional radiology, radiotherapy, oncology, and Class A (non-sterile and non-measuring) devices. Stakeholders are required to submit their feedback within 30 days of the draft’s publication.
Source: bit.ly/422UCmg

2. India’s Ministry of Health and Family Welfare has issued a draft notification proposing an extension for small and medium manufacturers with an annual turnover of ₹250 crores or less to comply with the revised Schedule M of the Drugs Rules, 1945. Manufacturers eligible for this extension must submit an upgradation plan in Form A to the central licensing authority within three months. The proposed deadline for compliance is December 31, 2025. The Ministry has also invited objections and suggestions from stakeholders, which must be submitted within seven days of the notification’s publication.
Source: bit.ly/40mUugc

3. The U.S. Food and Drug Administration (FDA) has released draft guidance on using artificial intelligence (AI) to support regulatory decisions regarding the safety, effectiveness, or quality of drugs and biological products. This guidance proposes a framework to enhance the credibility of AI models in product submissions. The FDA invites public comments on the draft within 90 days.
Source: bit.ly/4fKHeXf

4. India’s new draft Digital Personal Data Protection Rules 2025 require companies transferring personal data of Indian users across international borders to comply with data localization norms. These provisions, which impose additional government restrictions on specific data transfers, are reportedly expected to complicate business operations.
Source: bit.ly/41ZXocd

5. The U.S. District Court recently dismissed negligence and strict liability claims against a non-profit that received an NIH grant and sub-granted part of it to a Wuhan lab allegedly linked to COVID-19. The court found no liability for contributing funding for research activities or basis for strict liability, emphasizing the weak causal connection and the risks of imposing unlimited liability on research funders.”
Source: bit.ly/4gJaS0v

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. The Revised Schedule M of the Drugs Rules, 1945 which has come into force on the 28th December 2023, is now fully applicable to all manufacturers with turnover less than Rs. 250 Crores starting from 1st January 2025.
Source: bit.ly/4iZXAOt

2. India’s Central Drug Regulator has directed that the process to file applications for (1) addition of new Clinical Trial Site and (2) Change of Principal Investigator should henceforth be made online through the SUGAM Portal maintained by the regulator. An application for addition of clinical trial site is deemed approved if no objection received in 30 days of upload and an application for change of Principal investigator is deemed approved on the day of upload.
Source: bit.ly/4j1Kwbp

3. In order to curb instances of re-use and re-branding of expired food products by businesses India’s Central Food Regulator is now requiring all licensed Food Business Operators to upload the following data to the online portal on a quarterly basis once feature is activated:

a.  Quantity of food items rejected due to not meeting quality standards.
b. Quantity of expired food items returned by the business.
c. A detailed report of how the expired/ rejected food items were handled, including manner of disposal/ return/ destruction.

Provided that all licensed business should commence record-keeping in preparation of activation of upload feature on FoSCoS portal.
Source: bit.ly/3PjW8sP

4. The Delhi High Court recently held that a claim for medical negligence cannot be sustained on the basis that the patient had a certain expectation with respect to the quality of care, holding that no evidence was forthcoming that the Doctor’s conduct lead to harm to the patient.
Source: bit.ly/49YPn9m

5. The Foreign Contribution (Regulation) Rules, 2011 have been amended, permitting associations to carry-forward the unspent administrative expenses into the next financial year, provided that reason for carry-over needs to be mentioned in Form FC-4.
Source: bit.ly/4gOxvAo

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 District Consumer Disputes Redressal Commission (DCDRC) in Kochi has ordered a hospital and its doctor to pay ₹5 lakh in compensation after treating a patient for COVID-19 despite her RT-PCR test returning negative. The court found that the hospital failed to inform the patient of her negative status and administered unnecessary COVID-related treatments, causing significant mental and physical distress.
Source: bit.ly/40oTuIN

2. India’s drug regulator, CDSCO has identified 41 drug samples as ‘Not of Standard Quality’ (NSQ) following tests conducted in November, with an additional 70 samples flagged by state laboratories. Two samples were also found to be spurious, linked to unauthorized manufacturers. The Union Health Ministry has initiated investigations and emphasized that the identification of NSQ drugs is part of routine surveillance to enhance the quality of medicines available in the market.
Source: bit.ly/3PgINRZ

3. A pathologist in Maharashtra has been suspended and removed from the Medical Register by the Maharashtra Medical Council for three years for allowing a laboratory to use its signature while operating with an expired license.
Source: bit.ly/4fCsw4C

4. Homeopathic practitioners in Maharashtra are now permitted to prescribe allopathic medicines, provided they have completed a certified course in modern pharmacology, as per a new clarification from the Maharashtra Food and Drug Administration (FDA). However, the action has been criticized by the Indian Medical Association (IMA) as “mixopathy,” as it raises concerns about patient safety and the integrity of medical practice.
Source: bit.ly/41SZsCy

5. The Indian Medical Association (IMA) has launched the IMA AMR Smart Hospital Project, an initiative aimed at combating Antimicrobial Resistance (AMR) through advanced Antimicrobial Stewardship (AMS) and Infection Prevention and Control (IPC) practices. This certification program, the first of its kind globally, seeks to promote best practices in antimicrobial usage across hospitals and enhance patient safety.
Source: bit.ly/3DBawdC

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