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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 Jharkhand High Court has quashed criminal proceedings against an MBBS doctor charged under Section 304A of the Indian Penal Code for causing death by negligence, following a patient’s death after gallbladder surgery at his clinic. The allegations included medical negligence and violations under the Scheduled Castes and Scheduled Tribes (Prevention of Atrocities) Act. The court found no evidence of malicious intent or negligence on the doctor’s part, leading to the dismissal of the charges.
Source: bit.ly/4jiLOzc

2. India’s Central Pollution Control Board (CPCB) has released guidelines for the transportation and storage of used oil under the Extended Producer Responsibility (EPR) framework, effective from April 1, 2024. These guidelines outline the roles and responsibilities of collection agents, who are tasked with safely collecting, storing, and transporting used oil while adhering to environmental regulations. The framework aims to ensure proper management of hazardous waste and facilitate a more sustainable approach to oil recycling.
Source: bit.ly/3DTNDSR

3. India’s Central Pollution Control Board (CPCB) has released a methodology for conducting a gap analysis on biomedical waste management, aimed at improving compliance with existing regulations. This initiative is part of the CPCB’s ongoing efforts to ensure better environmental and public health outcomes related to the disposal of hazardous waste.
Source: bit.ly/4fYFBFq
Source: bit.ly/3PyGXfq

4. The U.S. Food and Drug Administration has released updated guidance regarding the notification process for manufacturers concerning permanent discontinuances or interruptions in the manufacturing of medical devices, as mandated by Section 506J of the FD&C Act. This guidance aims to prevent or mitigate shortages of critical medical devices during public health emergencies by requiring timely notifications from manufacturers about potential supply disruptions. The document also includes a list of devices that fall under this requirement and outlines the necessary information that must be provided.
Source: bit.ly/4hh2XqP

5. The U.S. Food and Drug Administration has released draft guidance proposing major changes to the accelerated approval pathway for drugs. These changes aim to strengthen the evidence and procedures required for quickly approving new medications, ensuring they deliver real clinical benefits while maintaining safety and effectiveness. The updates reflect the FDA’s commitment to improving the approval process for important therapies and addressing concerns about how these drugs perform once they reach the market.
Source: bit.ly/4hf9N09

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 government has extended the deadline for small and medium pharmaceutical companies to comply with the revised Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Act. The revised deadline is December 31, 2025, while the earlier deadline was January 1, 2025. This extension aims to assist smaller manufacturers in upgrading their facilities to meet stringent regulatory requirements.
Source: bit.ly/4a4HaAo

2. The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) have released draft standard evaluation protocols for licensing in-vitro diagnostics (IVDs) under the Medical Devices Rules, 2017. These protocols aim to ensure quality and performance evaluation of IVDs, establishing uniformity in testing across various diagnostic kits. Stakeholders are invited to provide their feedback on the draft by February 15, 2025.
Source: bit.ly/40kTlWt

3. The Ministry of Electronics and Information Technology (MeitY) has released the draft Digital Personal Data Protection Rules, 2025, inviting public feedback until February 18, 2025. These rules aim to operationalize the Digital Personal Data Protection Act, 2023, which was enacted to enhance the framework for protecting digital personal data in India. The draft includes provisions for data localization, compliance requirements for significant data fiduciaries, timelines for storing data and ensuring that personal data is processed responsibly.
Source: bit.ly/3C63oFx

4. The Ministry of Commerce and Industry has launched the Open Network for Digital Commerce (ONDC) initiative to democratize digital commerce in India by fostering open networks for the exchange of goods and services. This initiative focuses on inclusivity, enabling small and medium enterprises (MSMEs) to access digital marketplaces while promoting innovation through open protocols. By creating a level playing field, ONDC seeks to reduce the dominance of large e-commerce platforms and enhance competition among sellers.
Source: bit.ly/4gHo1al

5. The Telangana Medical Council has issued a show-cause notice to a Hyderabad-based hospital for allegedly collaborating with unqualified practitioners and promoting fake doctors. This action follows the hospital’s involvement in sponsoring the medical program and advertising the same on social media, where unqualified individuals were reportedly encouraged. The hospital has been given a 10-day deadline to respond; failure to do so may result in punitive actions under the National Medical Commission (NMC) Act and other regulations.
Source: bit.ly/3BWAQhM

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. Application process for (1) Manufacture/ import a New Drug/ formulation, or conduct clinical trial, (2) Manufacture/ import of new bulk drug substance, and (3) Import of finished formulation of a new drug will henceforth exclusively take place online on the SUGAM portal, and processing of offline application has been retroactively paused from 16th August 2024.
Source: bit.ly/3z9EX92 

2. All registered Doctors are required to re-register their MBBS qualifications on the newly operationalized National Medical Register Portal and shall be provided a Unique Identification Number.
Source: bit.ly/3TyGpsl
Source: bit.ly/3zy4PLE3. The central drugs regulator of India, the Drugs Controller General of India has issued a revised Guidelines and checklists for Zonal, Sub-Zonal and Port-officers of the State Drug Authorities providing updated policy on how to conduct their duties.
Source: bit.ly/3TuM2b3

4. The Indian Pharmacopoeia Commission has clarified that in the event of a conflict of interpretation between the newly released digital version of the Indian Pharmacopoeia 2022, and the print version the print version shall win out.
Source: bit.ly/4gqZ2IA

5. In addition to requiring audio-visual warnings during presentation of films, the Central government will require all online curated content publishers to display a non-skippable anti-tobacco audio-visual advertisement, as well as place a static message for the duration of display of use of tobacco and tobacco products in the curated content. This requirement shall be effective form March 2025.
Source: bit.ly/3XMqTvq

Posted on

TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Madras Court in a recent order, held that the current status-quo regarding online sale of Drugs i.e. sale being facilitated only through licensed chemists and pharmacists shall prevail, until either the Central Government frames rules or the Delhi High Court issues further orders/judgment.
Source: bit.ly/45Uxfv2

2. The Jharkhand High Court has reaffirmed precedent laid down by the Supreme Court in Martin F. D’Souza v Mohd. Ishfaq, that a private complaint against a doctor for medical negligence should only initiated by a consumer forum or criminal court, the same should be referred to a doctor/expert panel to ascertain whether there is a prima-facie case for negligence.
Source: bit.ly/3VRPooP

3. In light of recent surge in cases of dengue in Bengaluru, the Karnataka Government has issued an order to cap the price of Dengue NSI Antigen and ELISA Igm Antibody tests, conducted in Private Hospitals and Diagnostic Centres, at Rs. 250, and 300 respectively.
Source: bit.ly/3LdE1ms

4. The Delhi High Court has recently held that conversations on WhatsApp will be considered electronic record under Sec. 65B of the Act and require the necessary certificate from a person responsible for operating the computer device to generate the WhatsApp message.
Source: bit.ly/4eMwb0p

5. The head of the US’s AI task force, among others, has stepped down from his role as director at the Coalition for Health AI, the recently set up Industry Body that was aimed at guiding the US Government for setting up policy framework for regulating AI use in the Healthcare Sector.
Source: bit.ly/3VQ4zyW

 

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.

State Consumer Commissions continue to dilute intermediary safe-harbour protection for e-commerce marketplace
A State Consumer Commission in India has held a major e-commerce marketplace company liable for delivery of incorrect goods to customers, on the grounds that since it offered a ‘fulfilling’ service on behalf of the seller, it was not merely an intermediary but also an agent of the seller. The marketplace was made to pay punitive damages, in addition to mental harassment, on grounds that it may have unscrupulously exploited an unknown uncounted number of consumers.
Source: bit.ly/49VuNW0

Kochi and Thiruvananthapuram proposed to be added to the list of airports from where drugs may be imported
India’s Ministry of Health and Family Welfare has issued a draft notification that will add Kochi and Thiruvananthapuram to the list of airports from which pharmaceutical drugs may be imported into India. The Drugs Rules, 1945 specify that pharmaceutical drugs may be imported into India from a specified number of airports only. The clearance of drugs requires the approval of the Additional Drugs Controller (ADC) Customs, who is generally posted at the customs wing of the airport.
Source: bit.ly/49zbUZ8

Dengue Vaccine Clinical Trials to start soon in India
A major Japanese drug maker has reportedly received clearance from India’s vaccine regulator, Central Drugs Standards Control Organization, to start clinical trials of the dengue vaccine. The vaccine will be contract manufactured by a major biotech company in India.
Source: bit.ly/49OyQ7b

Many medical device companies settled allegations of kickbacks given to doctors in 2023: US Department of Justice
The US Department of Justice (DoJ) has issued a press release that it has recorded the highest number of settlements and judgements in its history. Some of major settlements involved allegations of unlawful kickbacks medical device companies to doctors, in form of above-fair market value supervision fees or remuneration for medical directorships and improper donation of capital equipment.
Source: bit.ly/49X0H4H

Fair-use defense against copyright infringement by AI companies will be tested in new trial by media companies against Open AI
In a new set of lawsuits in the US, media companies are not alleging copyright infringement by AI companies to train the algorithm, but instead alleging that before training, the AI companies removed information from the training material which established that the material was copyrighted, such as the name of the author the news. The Digital Millennium Copyright Act or DMCA, law in the US reportedly prohibits the removal of information that can help copyright holders detect infringement, including article titles, author names, and copyright dates.
Source: bit.ly/3Ih1MbA