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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 Drug Regulator the Central Drugs Standards Control Organization (CDSCO) has been made an affiliate member of the International Medical Device Regulators Forum (IMDRF). The application submitted by the Indian Government has been accepted contingent on the adoption of comprehensive regulation of Medical Devices in alignment with the existing international standards.
Source: bit.ly/3TQ1GOb

2. India’s Ministry of Health and Family Welfare has introduced Guidelines for Withdrawal of Life Support in Terminally Ill Patients, which sets out the institutional oversight requirements to facilitate ethical and informed decision-making in this regard.
Source: bit.ly/4eReyf6

3. The Supreme Court has held that in case of criminal suits which have an overwhelming civil quality, i.e. are based on private wrongs, where the parties to such criminal suits have already settled with each other, High Courts should exercise their powers under Sec. 482 of the CrPC and quash the underlying criminal proceedings.
Source: bit.ly/4dyF1wQ

4. India’s Central Drugs regulatory authority the Central Drugs Standards Control Organization (CDSCO) has decided that it will initiate action against a manufacturer of eye-drops, which had recently made social-media posts and conducted conferences regarding its new product, which had come under scrutiny for the claim that it would manage near-sightedness, and in pursuance of that, forwarded the matter to the State Drug Regulator of the state of Gujarat where the company is based.
Source: bit.ly/4dtuYJL

5. A prominent US based medical systems and medical devices manufacturer which has suffered a data-breach of its systems leading to the leak of sensitive personal and medical information of its patients, is currently facing a class-action lawsuit on grounds that the breach was caused due to non-adherence to industry standard practices in data storage and security.
Source: bit.ly/3BHdjRl

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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 drug regulator (CDSCO) has identified 59 drug samples as Not of Standard Quality (NSQ) in August, including products from major pharmaceutical manufacturers. The action has come after several states and union territories failed to report NSQ data, prompting the CDSCO to emphasize the need for timely submissions to enhance drug safety oversight.
Source: bit.ly/4drUUFz
Source: bit.ly/3zCDmJ0

2. The District Consumer Disputes Redressal Commission-II in Visakhapatnam has awarded a compensation of Rs. 15 lakhs in a medical negligence case and has found the private eye institute, its director, and two ophthalmologists guilty as they failed to meet their medical obligations by neglecting the crucial pre-surgery test of the patient leading to a loss of eyesight of the patient.
Source: bit.ly/3N6HST2

3. The Punjab and Haryana High Court has ordered the attachment of the salaries of several health officials, including the state health secretary for a potential diversion and unauthorised use of funds. The court held that the state cannot withhold the amount released by the central government due to hospitals under the Ayushman Bharat scheme and has asked for a detailed explanation from the state in the matter.
Source: bit.ly/3zCDt7o

4. India’s health ministry has issued draft regulations amending the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 to limit the Maximum Residue Limits (MRL) of pesticides/insecticides in each food community. The notification invites objections and suggestions from stakeholders regarding the proposed changes till November 17, 2024.
Source: bit.ly/47MlQOV

5. The Indian government has released a notification to include Acupuncture under the category “Other Care Professionals” in the schedule of the National Commission for Allied and Healthcare Professions Act, 2021.
Source: bit.ly/3ZJqXNO

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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 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

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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 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

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 Drugs Consultative Committee (DCC) has reportedly recommended to make Sugam portal database of all the products with brand names accessible to the general public to address the issue of different drug formulations of different therapeutic categories being sold with same or similar brand names in the nation.
Source: bit.ly/3XMWBbV2. The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has revised the accreditation standards for hospitals which will come into effect on January 1, 2025. No surveillance assessment will be conducted as per the old accreditation standard by NABH after 31st March 2025.
Source: bit.ly/47ydjPr

3. India’s Central Food Regulator will approve import of food consignments from Bhutan on the strength of Health Certificate issued by Bhutan Food and Drug Authority provided they are manufactured by the approved list of establishments of Bhutan.
Source: bit.ly/4gmtRxY

4. U.S. Food and Drug Administration has warned a major pharmaceutical company for making false and misleading claims about the benefits of a migraine pill in a television advertisement by a famous sports person. The claims were made against the results that were demonstrated in clinical trials.
Source: bit.ly/4gtau6m

5. A group of experts constituted by NITI Aayog to prepare a framework for action for emergency response and preparedness to address future pandemic, has recommended making the Central Drugs Standard Control Organisation (CDSCO) an independent regulatory authority. They have recommended to provide CDSCO with approved Standard Operating Procedures (SOPs) for Accelerated Emergency Use Authorisation for innovations and provisions for fast-tracking the process during pandemics.
Source: bit.ly/3XNynys

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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. 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

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 regulator (CDSCO) has released draft guidelines on Good Clinical Practices Rules to align India’s clinical trial rules with international standards. The draft is open for comments by October 12, 2024.
Source: https://bit.ly/3XpPdSr

2. India’s premier consumer forum ordered a major medical device manufacturer to pay compensation to one of the claimants who had suffered adverse reactions as a result of faults in the surgical-implants which they had received from it.
Source: https://bit.ly/3ztLCe5

3. India’s statutory body regulating medical education, National Medical Commission (NMC) has issued revised guidelines removing sodomy and lesbianism from the category of unnatural sexual offences from its curriculum of medical education.
Source: https://bit.ly/3Xr5Kp7

4. India’s union health ministry has expanded the health insurance scheme under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) to cover citizens aged 70 years and above, regardless of their income. The ministry will issue new, unique cards to senior citizens for the availment of the benefit.
Source: https://bit.ly/3XsD2nQ

5. The US Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) hearing aid. The hearing aid will be integrated into the hearing device of a giant electronic brand through software updates allowing the device to function as personalised hearing aid. The feature is aimed at helping users with their perceived mild-to-moderate hearing impairment.
Source: https://bit.ly/4e2LEsn

 

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 made it mandatory for students pursuing medical education in Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa, and Homoeopathy (AYUSH) to clear the National Exit Test (NExT) after graduation. This requirement will apply to medical graduates from the 2021-2022 batch.
Source: bit.ly/4egpEdy

2. India’s central drug regulator (CDSCO) has asked a pharmaceutical company to explain its claims that its eyedrops can augment near vision in 15 minutes and that it has received marketing approval from CDSCO.
Source: bit.ly/4eyIWLp

3. The Bombay High Court restricted the CEO of a leading e-commerce luxury brand from hiring individuals from another e-commerce beauty brand on grounds that the CEO was misusing employee personal data that it had access to when he was the Chief Business Officer of the rival e-commerce beauty brand.
Source: bit.ly/4glsuzN

4. India’s central drug regulator (CDSCO) has issued an order providing guidance for industry on Pharmacovigilance Requirements for biological products.
Source: bit.ly/4dVKiQ7

5. India’s Directorate General of Foreign Trade (DGFT) has released a public notice amending the timeline for meeting the export obligation of drugs which have been imported from unregistered source.
Source: bit.ly/47qXv1a

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. Pharmaceutical companies will have to submit details of their expenditures incurred on sponsoring activities to the medical professionals within two months after the end of each financial year on the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) portal as part of implementation of the UCPMP Code 2024.
Source: bit.ly/47bQOjc

2. India’s Health Ministry has introduced guidelines to improve quality of healthcare services in government hospitals and healthcare institutions. Hospitals will now be required to report adherence to these guidelines and submit proposals for approval, specifically when significant changes or funding is involved.
Source: bit.ly/3XaYSMz

3. Pharmaceutical industry in India has reportedly voiced its concern over the delay in processing and issuance of review orders on the website by Department of Pharmaceuticals (DoP). The consequence of delay in processing of review orders may results in halt of business activities thereby imposing manufacturers to sell the scheduled formulation or a new drug at a ceiling price which is under review.
Source: bit.ly/4cUYrMa

4. India’s Central Drugs Standard Control Organization (CDSCO) is reportedly launching various digital initiatives, such as Online National Drug License System (ONDLS) and Track and Trace System, to transparently, and efficiently manage pharmaceutical regulations.
Source: bit.ly/47ai41s

5. Quality standards for MDMA and Psilocybine, well known psychedelic compounds has been prescribed by Australia’s Therapeutic Goods Administration (TGA).
Source: bit.ly/47a9jVm
Source: bit.ly/478wBLf

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 Regulator (CDSCO) is set to develop guidelines for the safe disposal of pharmaceutical waste which are expired and unused drugs and medicines, to curb antimicrobial resistance (AMR).
Source: bit.ly/3yOlfPY

2. The Indian Health Ministry has reportedly stated that 156 fixed dose combination (FDC) drugs recently banned were licensed by the State Licensing Authorities (SLA) without prior approval from the Drug Controller General of India (DCGI).
Source: bit.ly/3Xl6Xj7

3. Bureau of Indian Standards (BIS) certification will be mandatory for medical textile products covered by Quality Control Order from 1st October 2024. The products that will require certification and BIS mark are sanitary napkins, reusable sanitary pads/sanitary napkins, period panties, baby diapers, hospital bed linens, pillow covers, dental bibs and shoe covers intended for medical use.
Source: bit.ly/4e3FI1U

4. India’s major pharma companies have requested the Delhi High Court to quash the government’s recent notification banning 156 fixed-dose combination (FDC) drugs. They have also sought interim relief in their petitions to exhaust the stock that was manufactured before the notification came into effect, prohibiting any coercive measures against retailers and stockists until the stock is exhausted.
Source: bit.ly/3yUZFcw

5. India’s Central Pollution Control Board has issued a show cause notice to producers, importers, and brand owners (PIBOs) of plastic packaging, requiring them to file annual reports and fulfill Extended Producer Responsibility (EPR) obligations for the financial year 2022-2023 by September 1, 2024. Failure to comply will result in the imposition of environmental compensation (EC) and additional penalties.
Source: bit.ly/3XmQ5bF
Source: bit.ly/3XmQc75
Source: bit.ly/3yUZAWg