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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.

1. A national association of medical professionals, the Indian Medical Association has declared a 24-hour nationwide withdrawal of non-emergency services from 6 a.m. on 17th August, 2024 to protest against the alleged rape and murder of a trainee doctor at the state-run hospital in Kolkata. Essential services will be continued, but outpatient departments and elective surgeries will be halted. The withdrawal will operate across all sectors wherever modern medicine doctors are providing services.
Source: https://bit.ly/3YYu5oC

2. Under the direction of the Union Health Ministry, the National Medical Commission (NMC) has advised all medical colleges and institutions to create a policy that will ensure that all staff members, including faculty, medical students, and resident physicians, have a safe place to work on campus. Adequate safety precautions in the OPD, wards, casualties, hostels, and other open spaces on campus and in the residential quarters should be guaranteed by the policy.
Source: bit.ly/3YTA0eY

3. The National Green Tribunal has set aside a pharmaceutical company’s environmental clearance to expand its facility on grounds that even though it has an effluent treatment plant, the absence of pharmaceutical waste in treated waste water cannot be ruled out. The said pharmaceutical company was going to let out treated waste water into the sea and this may harm neighbouring aqua farms and have an adverse effect on human health when such aquatic food is consumed.
Source: bit.ly/3SVOneF

4. India’s anti-trust regulator, the Competition Commission of India (CCI), has dismissed a complaint alleging cartelisation by 29 pharmaceutical companies to manipulate government tenders for procurement of medicines on grounds that the compliant was vague and did not disclose sufficient details.
Source: bit.ly/3SXLPgl

5. The US government has announced first set of price cuts to popular prescription drugs which are part of  the government’s Medicare programme. The revised prices of the drugs, which include widely used blood thinners and arthritis medications, will take effect from 2026.
Source: bit.ly/3AFf94I

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.

India’s Supreme Court extends scope of misleading advertisement review to multinational and domestic FMCG manufacturers, doctors
In a proceeding against a major Ayurvedic products manufacturer for publication of misleading advertisements, India’s Supreme Court has clarified that the decisions and orders made in the ongoing case is not limited to the a particular manufacturer, rather is directed to all FMCG companies who are publishing misleading advertisements and doctors who are endorsing medicines to public after accepting consideration from pharmaceutical companies.
Source: bit.ly/44b832P

Indian Government to scrutinize organ transplants closely after receiving reports of foreign nationals involvement in organ donation
India’s Union Health Ministry, through the office of Director General of Health Services (DGHS), has ordered state authorities to compulsorily create a NOTTO (National Organ and Tissue Transplantation Organization) ID maximum within 2 days for the donor and recipient for both living-donor and deceased-donor transplants, citing reports of purported commercial dealings in organ transplants involving foreign nationals.
Source: bit.ly/3WcUKgk

New Telehealth Accreditation Program introduced in US
It has been reported that leading not-for-profit agencies in the US such as Joint Commission and National Committee for Quality Assurance (NCQA) will begin offering accreditation for telehealth services to qualified hospitals, ambulatory care centres, and behavioural health organizations in 2024. The accreditation is aimed at filling the gap of legally enforceable telehealth standards in the US.
Source: bit.ly/3W8MKgg

Employee non-compete clauses may soon be illegal in the US
The US Federal Trade Commission (FTC) has issued a final rule to promote competition by banning non-compete clauses in employee contracts nationwide. As per FTC, non-compete covenants in contracts prevent workers from taking a new job or starting a new business, which in turn harms competition.
Source: bit.ly/3UtDRg2

French Government to turn down bid from foreign pharmaceutical companies to buy domestic generic company
The Government of France is reportedly going to block foreign bidders including two Indian pharmaceutical companies from attempting to purchase a domestic generic pharmaceutical manufacturer. As per the French government, this decision has been taken in the national interest to safeguard the supply chain of medicines.
Source: bit.ly/3W8MIFa

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.

Drug manufacturing facility cannot manufacture food products: Central Drugs Regulator
India’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to take action against the drug manufacturers who are also manufacturing nutraceuticals and health supplements in the same facility. Under Indian law, a drug manufacturing facility cannot be used to manufacture food products. Nutraceuticals and health supplements are regulated as food products in India.
Source: bit.ly/4bUWpwg

Methodology to calculate Green Credit against Tree Plantations notified
India’s Ministry of Environment, Climate and Forest Change, has notified the methodology for calculating green credit in respect of tree plantation under Green Credit Rules, 2023 which were notified under The Environment Protection Act, 1986. A person desirous of purchasing green credits will have to make an application to the Administrator. 1 tree planted will be equal to 1 green credit.
Source: bit.ly/3wGJgqo

A person cannot be prosecuted for food related offence under Food Safety Law and Indian Penal Code simultaneously: Supreme Court
The Supreme Court of India has held that, since The Food Safety and Standards Act, 2006 (FSSA) has effect notwithstanding any other law, a food related offence will have to be pursued under FSSA and not under a general law such as the Indian Penal Code, 1860 (IPC).
Source: bit.ly/48whOZJ

Period Safety Update Reports (PSURs) of new drugs will have to be submitted online, physical submissions will not be accepted
The Indian Central Drug Regulator, Central Drugs Standard Control Organization (CDSCO), will accept PSURs of new drugs, subsequent new drugs (SND), fixed dose combinations (FDC), biologicals and veterinary drugs only through online medium from 11th March 2024. A PSUR is required to be submitted for a period of four years after receipt of marketing permission.
Source: bit.ly/3wDqZKE

Indian Government is incentivizing domestic drug manufacturers to develop cost effective treatment for rare health conditions
India’s medical research body, Indian Council of Medical Research (ICMR), has reportedly invited domestic drug companies to develop localized treatments for “priority rare genetic disorders” and has offered assistance in pre-clinical, clinical research and regulatory approvals. The aim for this initiative is to encourage domestic drug companies to develop cost-effective treatments for rare health conditions by offering assistance in clinical research.
Source: bit.ly/4bQQ3y4

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.

Drug manufacturing facility cannot manufacture food products: Central Drugs Regulator
India’s Central Drug Regulator, The Drugs Controller General of India (DCGI), has directed the state drug licensing authorities to take action against the drug manufacturers who are also manufacturing nutraceuticals and health supplements in the same facility. Under Indian law, a drug manufacturing facility cannot be used to manufacture food products. Nutraceuticals and health supplements are regulated as food products in India.
Source: bit.ly/4bUWpwg

Methodology to calculate Green Credit against Tree Plantations notified
India’s Ministry of Environment, Climate and Forest Change, has notified the methodology for calculating green credit in respect of tree plantation under Green Credit Rules, 2023 which were notified under The Environment Protection Act, 1986. A person desirous of purchasing green credits will have to make an application to the Administrator. 1 tree planted will be equal to 1 green credit.
Source: bit.ly/3wGJgqo

A person cannot be prosecuted for food related offence under Food Safety Law and Indian Penal Code simultaneously: Supreme Court
The Supreme Court of India has held that, since The Food Safety and Standards Act, 2006 (FSSA) has effect notwithstanding any other law, a food related offence will have to be pursued under FSSA and not under a general law such as the Indian Penal Code, 1860 (IPC).
Source: bit.ly/48whOZJ

Period Safety Update Reports (PSURs) of new drugs will have to be submitted online, physical submissions will not be accepted
The Indian Central Drug Regulator, Central Drugs Standard Control Organization (CDSCO), will accept PSURs of new drugs, subsequent new drugs (SND), fixed dose combinations (FDC), biologicals and veterinary drugs only through online medium from 11th March 2024. A PSUR is required to be submitted for a period of four years after receipt of marketing permission.
Source: bit.ly/3wDqZKE

Indian Government is incentivizing domestic drug manufacturers to develop cost effective treatment for rare health conditions
India’s medical research body, Indian Council of Medical Research (ICMR), has reportedly invited domestic drug companies to develop localized treatments for “priority rare genetic disorders” and has offered assistance in pre-clinical, clinical research and regulatory approvals. The aim for this initiative is to encourage domestic drug companies to develop cost-effective treatments for rare health conditions by offering assistance in clinical research.
Source: bit.ly/4bQQ3y4