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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 Delhi High Court has allowed an Indian drugmaker to manufacture the lifesaving spinal muscular atrophy drug Risdiplam and rejected a global pharmaceutical company’s injunction plea. The Court emphasized that public interest and affordable access to life-saving treatments outweigh corporate monopoly and profits.
Source: bit.ly/4c5xRB8

2. India’s Ministry of Health and Family Welfare has released National Guidelines on Medical Oxygen Management and launched a capacity-building program at AIIMS Delhi to improve oxygen supply. It aims to train 200 experts and help hospitals use oxygen efficiently by reducing waste and enhancing patient care.
Source: bit.ly/43wfF1t

3. Online gaming companies are challenging Tamil Nadu’s night-time ban on online rummy, arguing it’s an indirect prohibition. They also oppose mandatory Aadhaar verification, asserting there are alternative methods for player identity. The Madras High Court adjourned the case for further hearing.
Source: bit.ly/3Y9k8DE 

4. President of USA reportedly has plans to impose a 25% or higher tariff on imported pharmaceuticals in USA which could increase costs for Indian drug exports, potentially reducing their competitiveness in the U.S. market.
Source: bit.ly/42lBv6I

5. Indian Council of Medical Research (ICMR), in collaboration with AIIMS has utilized drones to transport corneas for transplantation, reducing delivery time significantly. This advancement enhances efficiency in healthcare logistics, helping bridge the gap between donor sites and recipients while ensuring timely medical interventions.
Source: bit.ly/3FJQ8rP

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 Ministry of Health and Family Welfare has developed ONDLS Portal for receiving applications from small and medium scale pharmaceutical manufacturers who wish to avail benefit of extension from requirement to comply with new Good Manufacturing Practices (GMP) under revised Schedule M. Such applications must be strictly submitted online before lapse of three months from February 11, 2025. Submission of hard copy applications will no longer be accepted.
Source: https://bit.ly/4iEFh0U

2. The Indian Ministry of Health is working with Bureau of Indian Standards (BIS) to develop a standardized invoice format for hospitals, nursing homes, clinics and diagnostic centers. Once notified, clinical establishments will have to follow a standard invoice format with detailed and transparent breakdown of charges incurred by patient.
Source: https://bit.ly/4c4CM5w

3. India’s Supreme Court has held that even in consumer contracts which contain arbitration clauses, a consumer has the right to decide whether to pursue arbitration or approach the consumer forum for resolution of consumer dispute. The Court further reiterated that consumer disputes are non-arbitrable unless the consumer voluntarily opts for arbitration.
Source: https://bit.ly/4c4CPOK

4. The Directorate General of Foreign Trade (DGFT) has decided to withdraw the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme benefits for exports arising from Advance Authorizations (AAs), Special Economic Zones (SEZs), and Export Oriented Units (EOUs).
RoDTEP Scheme helps pharmaceutical exporters to get refund on taxes and duties on export.
Source: https://bit.ly/4c43M59

5. The Food Safety and Drug Administration (FDA) of Karnataka has reportedly increased inspections to address the issue of adulteration of tea powders and spices.
The decision has been taken due to reports of addition of harmful substances in food products, with the goal of reducing health risks to the public.
Source: https://bit.ly/4cjrdrr

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 clarified the manner of labelling on battery, battery pack or equipment having battery or battery pack by notifying an amendment to the labelling requirements prescribed under the Battery Waste Management Rules, 2022. Now, labelling declarations can be made through QR Code or product information brochure.
Source: bit.ly/3XgF3Vc

2. Indian Government has reinforced its requirement for the electronic issuance of Certificates of Origin (CoO), cautioning exporters and agencies against using manually issued certificates. The Directorate General of Foreign Trade (DGFT), under the Ministry of Commerce and Industry, has issued a Trade Notice reminding all stakeholders that any CoO issued outside the online eCoO 2.0 platform will be deemed to be invalid after the specified deadlines.
Source: bit.ly/43aT6PC
Source: bit.ly/3XjttZn

3. India’s Karnataka Government has requested the Union Health Ministry to implement a system for sharing alerts about drugs that fail quality tests. This initiative aims to tackle the issue of substandard injectable drugs that do not pass sterility tests.
Source: bit.ly/43dDjji

4. India’s Health Ministry has reportedly revoked the export NOCs and manufacturing licenses for exporting unapproved Tapentadol and Carisoprodol combination drugs to West Africa. Both drugs are individually approved in India, but their combination is not. Reportedly a shipment to Ghana is also under investigation.
Source: bit.ly/4hXNxc8

5. India’s Supreme Court has recently emphasized the need for establishing a mechanism to address complaints related to misleading medical advertisements and called for strict action to curb such deceptive ads. The Court also highlighted the importance of consumer protection and ensuring that advertisements in the medical field do not mislead.
Source: bit.ly/3D7kVxG

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 Pharmaceuticals Export Promotion Council of India (Pharmexcil) has invited its members to identify export challenges and propose strategies to enhance pharmaceutical exports. Members have been asked to report on specific tariff and non-tariff barriers affecting trade and suggest innovative solutions, which will be collected through a dedicated “Issues & Strategies” section on the Pharmexcil website. This initiative aims to address existing hurdles and foster collaboration for the growth of India’s pharmaceutical industry in global markets.
Source: bit.ly/4gi7n09

2. The Karnataka government has suspended the state drugs controller for not taking procedural actions against the pharma company which supplied the substandard lactate IV fluid which resulted in the death of women. The use of this faulty intravenous fluid is believed to have contributed to serious complications during surgeries at a district hospital.
Source: bit.ly/3VsRQCP

3. The Health Research Authority (HRA) has proposed to simplify the process of seeking and recording consent for low-risk clinical trials in the UK. While the method for discussing trials with potential participants remains unchanged, the new approach allows prescribers to document consent directly in a participant’s medical record instead of requiring a written consent form. This ensures that informed consent is still legally mandated, and participants can withdraw at any time, while aiming to reduce administrative burdens and enhance trial efficiency.
Source: bit.ly/3BgotNm

4. The Fertiliser Association of India (FAI) has emphasized for setting a pricing hierarchy for fertilisers based on their nutrient content and suggested that di-ammonium phosphate (DAP), priced at Rs 1,350 per 50-kg bag, should be the most expensive one due to its high nutrient value. This price is currently lower than that of muriate of potash and complex fertilisers, which raises concerns about nutrient balance in agriculture as farmers increasingly turn to alternatives with less phosphorus content.
Source: bit.ly/41iwV9i

5. The Union Ministry of Women and Child Development has launched the upgraded SHe-Box portal to streamline the reporting and monitoring of sexual harassment complaints in workplaces across India. This centralized platform allows women to file complaints easily and ensures timely processing by Internal and Local Committees in government and private sectors, promoting a safer work environment.
Source: bit.ly/49pCxk5