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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

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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 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

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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 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

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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 has further extended the timelines for the filing of Quarterly Returns and Annual Returns of E-waste under E-waste Management Rules, 2022 for all registered entities on the online EPR portal till 31st December 2024.
Source: bit.ly/4eMsXZA

2. India’s Ministry of Health and Family Welfare (MoH&FW) is considering a proposal to amend the Medical Device Rules (MDR), 2017, to introduce specific timelines for various regulatory processes. These include conducting inspections, addressing non-conformities identified during inspections, and granting manufacturing licenses for medical devices across four classes (A, B, C, and D). The proposed changes aim to streamline approvals, enhance transparency, and improve regulatory efficiency in medical device manufacturing.
Source: bit.ly/4eH8aGL

3. The Indian Council of Medical Research (ICMR) has invited proposals for clinical studies on innovative medical devices and diagnostics under its Centre for Advanced Research (CAR) scheme. Offering up to ₹15 crore per project over five years, the scheme aims to validate and promote safe, effective, and regulatory-compliant healthcare technologies in India.
Source: bit.ly/4eH70vc

4. India’s Supreme Court has suggested the Central Government to formulate a policy on the construction of exclusive feeding rooms and childcare rooms in public places. Currently, there is no concrete law or policy on the feeding rooms and childcare rooms in public places.
Source: bit.ly/3ZiaQX1

5. The U.S. Food and Drug Administration (FDA) has released a guidance document titled Chemical Analysis for Biocompatibility Assessment of Medical Devices. This document outlines chemical characterization methods that can be used as alternatives to certain biological tests to demonstrate the biocompatibility of medical devices. It aims to enhance the consistency and reliability of analytical chemistry studies conducted as part of the biocompatibility assessment process for these devices.
Source: bit.ly/3OkJtFu

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 Drugs Controller General of India (DCGI) has directed the cosmetics industry to follow regulatory protocols and warned them against making “unusual and misleading claims” about the product that may overlap with the pharmaceutical sector. During a meeting with the cosmetics industry, the industry stakeholders sought relaxation of strict regulations for imported cosmetics, citing frequent custom rejections and significant financial losses.
Source: bit.ly/4eBnhBK

2. The Indian Pharmacopoeia Commission (IPC) has announced the implementation of the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs). Version 2.0, will be effective from 1st February 2025. The document aims to strengthen the pharmacovigilance systems of MAHs in India.
Source: bit.ly/4hRV1xH

3. The Pharmacy Council of India (PCI) has directed all registered pharmacists to verify their profiles on DIGI-PHARMed portal with their Ayushman Bharat Health Account (ABHA) numbers within 45 days. This verification aims to integrate pharmacists with the Healthcare Professional Registry (HPR).
Source: bit.ly/4fOxgVk

4. The U.S. Food and Drug Administration (FDA) has issued a warning to an Indian pharmaceutical company for manipulating product data, reports, and relevant details, as well as violating Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
Source: bit.ly/491sW2M
Source: bit.ly/4i249j5

5. The U.S. Food and Drug Administration (FDA) has issued a warning to a Chinese drugmaker for restricting investigators’ access to its facility and records, as well as limiting photography during a recent inspection. The manufacturer received a warning letter outlining significant violations of Current Good Manufacturing Practice (CGMP) guidelines for finished pharmaceuticals.
Source: bit.ly/491sW2M
Source: bit.ly/4i249j5

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. In a new Amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, the Food Safety and Standards Authority of India (FSSAI) has clarified that BIS standards mark requirement may no longer be necessarily applicable for manufacture and sale of infant milk food, infant formula and milk cereal based weaning food etc. as well as Condensed milk sweetened, condensed skimmed milk sweetened, milk powder, skimmed milk powder, partly skimmed milk powder and partly skimmed sweetened.
Source: bit.ly/4hkwSPN
Source: bit.ly/3BXUuK4

2. In a recent amendment to the  Food Safety and Standards (Contaminants, toxins and Residues) First Regulations, 2011, which shall come into force from 1st April 2025 the Food Safety and Standards Authority of India (FSSAI)has: (1) Simplified and reduced the number of prohibited use Antimicrobials including chloroform, stilbenes and other steroids, (2) Increased the permissible concentration for Antimicrobials in Honey, (3) reduced the concentration of antimicrobials in cattle.
Source: bit.ly/3AdyXMN

3. The Rajasthan Authority for Advance Rulings held that the vanilla mix being sold by a major manufacturer of consumer food products in the country would not be classified as an “ice-cream” for the purpose of taxation under the Goods and Services Act, 2017 (GST Act) due to sugar being the major ingredient at about 65%. This decision in contrast to the Supreme Court’s decision on similar grounds.
Source: bit.ly/3BW78sY
Source: bit.ly/3BQh9I0

4. The Supreme Court quashed a criminal case which had been filed against a major Indian bank for non-compliance with an order of the authority under the Income Tax Act, holding that an allegation of mens rea cannot be made against a juristic person such as the bank and that the intention of the officers and functionaries cannot be construed to be that of the juristic person itself.
Source: bit.ly/3C5fH4y

5. The Therapeutic Goods Administration (TGA), Australia’s regulator for Medical Devices has clarified some queries concerning its updated Essential Principles, which are necessary compliances for getting approval for devices in Australia. In this new update to the checklist, the TGA has reiterated its existing commitment to recognizing foreign approval standards, and has placed obligation on Sponsors to update the TGA if their Manufacturer Evidence may be expiring in 50 days, among other things.
Source: bit.ly/48jlWxM
Source: bit.ly/4eSYR7P

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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 Drugs Technical Advisory Body, in its 91st meeting, has recommended the exemption of several chemical contraceptives at specific dosage values, from the labelling requirements under Schedule H which would have limited sale by prescription only.
Source: bit.ly/3ZWiqqU

2. The Directorate General of Foreign Trade has amended the export policy for cough Syrup, amending an earlier notification, exempting the requirement for pre-export testing for jurisdictions including the USA, EU, and South Korea which may already have granted approval.
Source: bit.ly/3YfvOVP
Source: bit.ly/3YeH6tI

3. The Ministry of Environment Forest and Climate change has notified the Liquid Waste Management Rules, 2024 set to come into force from 1st October; which govern the treatment and management of liquid effluents arising from domestic and industrial activities including treatment of wastewater, sludge generated during treatment of wastewater and reuse/reutilization of any wastewater or sludge generated.
Source: bit.ly/3YhCpzl

4. In a recent public notice, the Central Government Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) has clarified that it does not license or ratify any AYUSH products or medicines, and warned against the advertising of AYUSH products as “Miracle Cures”. This comes in the light of the Ministry of AYUSH having repealed Rule 170 of the Drugs Rules, 1945, which regulated AYSUH advertising.
Source: bit.ly/4dzToBi
Source: bit.ly/3XXf9Fi

5. The European Commission’s Medical Device Coordination Group (MDCG) has issued a voluntary document to supplement its earlier Designation, re-assessment and notification of conformity assessment bodies and notified bodies, which is intended to guide notified bodies to impose corrective and preventative action.
Source: bit.ly/4eYr4JJ

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 notified the New Drugs and Clinical Trials (Amendment) Rules, 2024 which will take effect from1st April, 2025.These amended rules outlines the requirements for registration of the Clinical Research Organizations.
Source:  https://bit.ly/4ddpX81

2. India’s Central Food Regulator (FSSAI), has issued a show cause notice to a Tamil Nadu-based company that supplied ghee for making laddoos (prasadam) at the Tirupati Balaji temple, following the detection of animal fat in the laddoos. The company is required to respond to the charges by 23rd September, 2024, failing which appropriate action will be taken against them.
Source: https://bit.ly/3BheNln

3. The Government of India is reportedly planning to adopt a risk-based approach for monitoring the quality of imported consignments of medical devices at ports. This will involve random sampling of consignments of medical devices and testing of entire cargoes in case of critical diagnostic kits.
Source: https://bit.ly/3BhePtv

4. India’s central health regulator has declared five samples of drugs to be spurious based on the physical comparison and analytical tests done by the manufacturers and on the reports from State Licensing Authorities. The actual manufacturers, as claimed on the labels, have stated that they are not the actual manufacturers of these drugs and the drugs are spurious.
Source: https://bit.ly/3XTfUjP

5. India’s Directorate General of Foreign Trade (DGFT) has amended Chapter 5 of the Handbook of Procedures (HBP) 2023 under the Export Promotion Capital Goods (EPCG) Scheme. The EPCG Scheme, which allows pharma industry to import capital goods duty-free for producing quality goods and services to boost exports, has been updated to streamline its reporting requirements. The amendment eliminates the previous requirement for annual reporting of Export Obligation (EO) fulfilment and has been replaced with a periodic reporting system.
Source: https://bit.ly/4dkMUWC

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 Director General of Foreign Trade has issued a Trade Notice, reducing the amount of export eligible for net-subvention to only Rs. 5 Crore for MSMEs till 30th September 2024, and Rs. 2.5 Crores for manufacturing exporters as calculated till 20th June 2024.
Source: bit.ly/3zsuYM8

2. The Supreme Court has issued Notices in connection with a Public Interest Litigation challenging the constitutionality of Rule 9(ii) of the Clinical Establishments Rules, which seek to introduce a price-control mechanism on the cost of healthcare treatment.
Source: bit.ly/3zqVx48

3. The Supreme Court has issued an Order recommending that the High Court of West Bengal may consider withdrawing the anticipatory Bail granted to an accused under the Narcotic Drugs and Psychotropic Substances Act, and expressed that it was highly concerning that such anticipatory bail was granted.
Source: bit.ly/3BfCUAY

4. The State Drugs Controller of the State of Karnataka has announced that it will be using emergency medical tracking functions first introduced during the COVID-19 pandemic, to keep track of analgesic medication to prevent their misuse.
Source: bit.ly/47DyH5Z

5. Starting from 19th September 2024, if the investigation of a complaint received by the Competition Commission has lead to it passing an order ex-parte, it shall be mandatory to give notice of said order and provide the impugned parties an opportunity to be heard.
Source: bit.ly/4e8jtIB

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 Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO) have released Version 2.0 of the “Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products”. This document facilitates the submission of the safety profiles of drugs by MAHs (manufacturer, marketer, or importer of a drug) and outlines the timeline for the process.
Source: bit.ly/4dctGCs

2. India’s Central Drug Regulator (CDSCO) is reportedly considering a proposal to change the color of all antimicrobial drug strips to blue for safer usage and to visually differentiate these drugs to curb antimicrobial resistance (AMR). This proposal would apply to pharmaceutical drugs and medicines, including antibiotics, antivirals, anti-parasitics, and antifungal drugs.
Source: bit.ly/47BUL0P

3. India’s Department of Food and Public Distribution (DFPD) has asked the leading edible oil associations in India to maintain the maximum retail price (MRP) of edible oil until the stocks of the edible oil that are imported at 0% and 12.5% basic customs duty (BCD) are exhausted. The Government of India has increased the BCD on various edible oils, which is effective from 14th September 2024, to support domestic oilseed prices.
Source: bit.ly/4e9Gwmj

4. The International Organization for Standardization (ISO) has released the second edition of ISO 23500-1:2024, outlining requirements for the preparation and quality management of fluids used in hemodialysis and related therapies. This standard guides practitioners on handling dialysis and substitution fluids for advanced treatments like hemodiafiltration and hemofiltration.
Source: bit.ly/3Bjlzqt
Source: bit.ly/4gskk8H

5. India’s Maharashtra Food and Drugs Administration (FDA) has taken action against an Ayurvedic drug manufacturing company by seizing its products and prohibiting the further distribution of its Ayurvedic drugs due to improper labeling. The company has made false and misleading claims about the drugs and its treatment in its advertisements, which are prohibited under the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, and Rules, 1955.
Source: bit.ly/3ZucKUU