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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.

India takes baby steps in regulation of Artificial Intelligence, puts in place prior consent requirement before deployment of AI
India’s Ministry of Electronic & Information Technology has reportedly advised platforms and intermediaries which employ artificial intelligence (“AI”) models or generative AI software, algorithms to mandatorily obtain government approval before offering their services. Additionally, platforms or intermediaries using unreliable AI models or algorithms should label themselves as “under testing” and take explicit consent from users, making them aware of potential errors in the technology.
Source: bit.ly/430rwT8

Indian Government to hold discussions with private hospitals on capping of medical treatment rates
India’s Ministry of Health and Family Welfare is reportedly in discussion with major corporate hospitals on the possibility of capping of medical treatment rates. India’s Supreme Court last week had directed the Ministry to exercise its powers under Clinical Establishment Rules for prescribing ceiling prices of medical treatments, and threatened that if it did not do so, the Court will itself direct the Ministry to notify Central Government Health Scheme (CGHS) rates as ceiling prices for medical treatments across the country.
Source: bit.ly/3wGw6di

Eye drops in India may soon have to be sold in transparent bottles to detect contamination
India’s central drug regulator, the Drugs Controller General of India, has called a meeting with pharmaceutical manufacturer associations to propose the use of transparent bottles in packaging eye drops. It is expected that use of transparent bottles will help detect contamination and particulate matter, so that any damage to the eye due to contaminated or spurious eye drops may be avoided. Most eye drops are currently sold in opaque bottles.
Source: bit.ly/3UX4Lxv

Yogurt makers may lawfully claim that it can reduce the risk of type 2 diabetes: US FDA
The U.S. Food and Drug Administration has reportedly allowed dairy-based yogurt makers to claim that Yogurt may reduce the risk of type 2 diabetes. However, the US FDA has recommended that the claim may be used carefully in yogurts that contain high levels of added sugar.
Source: bit.ly/3STFDF2

Legal validity of US Medicare drug price negotiation program upheld
A federal judge in Delaware in US has upheld the legal validity of U.S government’s condition that manufacturers of Top 10 drugs which are used in Medicare health insurance program will have to reduce prices or stop supplying to the program. This is the third positive court ruling in favour of US Government in the last few weeks on the subject of price negotiations.
Source: bit.ly/4bZbOM8

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

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.

Major Indian Ayurvedic Medicine Manufacturer to be tried for Contempt of Court for publishing misleading drug advertisements
India’s Supreme Court is reportedly set to issue a Contempt Notice to a major Ayurvedic medicines manufacturer in India after it found out that the manufacturer had published a misleading advertisement claiming permanent relief for certain chronic conditions such as Diabetes and Liver Cirrhosis. In November 2023, the manufacturer had given an undertaking to the Supreme Court that it will not publish misleading advertisements or disparage allopathy. The Supreme Court has also questioned the Indian government for its inaction over publication of misleading advertisements by the manufacturer despite existence of a law which makes publication of misleading advertisement punishable with imprisonment.
Source: bit.ly/42U33yI

Doctors will have to obtain registration with State Medical Council of every State where they practice: Delhi HC
The High Court of Delhi has upheld the legality of a notice issued by Delhi Medical Council which made it mandatory for Doctors to register with the Council if they wanted to practice in the State of Delhi. The Doctors argued that it was an onerous requirement which would require them to register in every State they practice in. However, the Court held that the intent of the law is to require Doctors to register in every State that they practice in, and that Doctors have the option to register with multiple State Medical Councils in India.
Source: bit.ly/3TgHANw

Cosmetic Importers asked to provide sales details in a bid to curb import of counterfeit cosmetics
In an effort to curb the import of counterfeit cosmetic products, India’s Central Cosmetics Regulator, Drugs Controller General of India, has directed importers of cosmetics who import cosmetics already registered by authorized importers, to furnish annual sales details such as number of consignments, imported quantity, total cost of imported cosmetics of each consignment, along with warehouse details.
Source: bit.ly/42T2IMR

Central Government has to fix ceiling prices of medical treatment within 2 months: Supreme Court
The Supreme Court has directed the Central Government publish ceiling prices for medical treatments offered by Hospitals all over the country within 2 months. If the Central Government fails to do so, the Supreme Court has said that it will direct Central Government to fix medical treatment costs stipulated under Central Government Health Scheme as ceiling price of medical treatment offered by Hospitals for the whole country.
Source: bit.ly/3wsyHHs

India Seeks to delay implementation of EU Carbon Emissions Limits
India is set to conduct negotiation with the European Union regarding the implementation of the Carbon Control Regime, seeking a complete elimination of the Carbon Border Adjustment Mechanism, failing which India will seek an extension of timelines for reduction of emissions. It is expected that in order to comply with requirements under EU Carbon Control Regime, Indian exporters will have to make significant capital investment will increase cost of production.
Source: bit.ly/42S7DxH

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.

Guidelines to differentiate brand extension from surrogate advertising issued
In a meeting with stakeholders, the Department of Consumer Affairs (DoCA) has clarified the difference between brand extension advertisements which are permitted, and surrogate advertisements which are not permitted. A brand extension advertisement should not contain direct or indirect references to prohibited products. It should also not use colour, layout, or presentations associated with the prohibited products.
Source: bit.ly/42PKVGk

Draft Pharmacovigilance Guidance Document published for comments
A draft of the revised Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products has been published for comments. The last date for providing comments is March 23, 2024. This guidance document facilitates MAHs to setup & implementation of uniform Pharmacovigilance System for pharmaceutical products in the Indian market in the post-licensure period.
Source: bit.ly/3SSrfgw

Many small and medium pharmaceutical manufacturing units have been ordered shut down after increased surveillance
India’s central drug regulator, Central Drugs and Standards Control Organization (CDSCO), and state-level drug licensing authorities have reportedly issued show-cause notices to several drug small and medium manufacturers in the State of Punjab and Himachal Pradesh on grounds of poor quality control, and have also directed some of them to stop manufacturing.
Source: bit.ly/3I88UqP

Pharma MNCs exit domestic market due to regulatory headwinds
Many multinational pharmaceutical companies are reportedly cutting back on operations and manufacturing in India as part of a global strategic review due to regulatory headwinds on account of price control, rising costs, competition, and unfavourable intellectual property climate.
Source: bit.ly/42PaWW9

Frozen embryos should be treated as children: US Court
The Alabama State Supreme Court has ruled that frozen embryos in test tubes should be treated as ‘children’. This ruling has forced in vitro fertilization (IVF) providers in Alabama to stop treating patients, raising questions about the procedure’s continued availability in the state.
Source: bit.ly/3I8T4vR

Posted on

TOP 5 HEALTH LAWS & 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.

India’s Competition Watchdog gets new powers to issue interim orders to stop potentially infringing action, until case is finally decided
The Indian Government has made Section 33 of The Competition Act, 2002 effective from 20th February 2024. The Section gives powers to Competition Commission of India (CCI) to prevent commission of any potentially anti-competitive action or combination, including mergers and acquisitions, until it reaches a final decision on the matter. This new power puts the CCI’s powers on par with that of other anti-trust regulators around the world.
Source: bit.ly/4bFlPhj

Under narcotics law, the weight of carrier articles used to carry narcotics cannot be included in calculation of weight of narcotics seized: High Court
India’s Delhi High Court has held that ‘carrier articles’ do not qualify as ‘neutral substances’ in which narcotics are mixed, and therefore their weight cannot be included in the calculation of the weight of the narcotics seized from the accused. The weight of contraband is a critical criteria in deciding whether the quantity of contraband seized from accused is of small quantity or commercial quantity, which has direct ramification on accused’s ability to get bail and ultimately on the tenure of imprisonment.
Source: bit.ly/4bD9OJv

India’s Insurance Regulator will increase scrutiny of health and savings plan aimed at elderly in a bid to keep a check on misselling
India’s insurance regulator, the Insurance Regulatory and Development Authority of India (IRDAI), is proposing to introduce several checks in insurance products aimed at the elderly, including mandatory video verification before policy acceptance. There is also a proposal to restrict targets and incentives for insurance products sold to elderly through banks.
Source: bit.ly/4bFHWEr

Acute shortage of Doctors licensed to inspect workers in hazardous industries and food establishments reported in Maharashtra
Maharashtra’s labour department has reportedly not renewed licenses of many authorized certifying surgeons (ACS) for the past one and half years. The ACS are responsible for carrying out medical examination of workers in hazardous industries once in six months, and very hazardous industries once every month.
Source: bit.ly/3I7fm1c

Telemedicine abortions are safe and effective: Study.
A study published in Nature Medicine has confirmed that telemedicine abortions conducted after video call or text message consultations are safe and effective as in-person care. In India, medical termination of pregnancy (MTP) is not permitted except under direct supervision of a registered medical practitioner duly qualified to conduct MTP.
Source: bit.ly/3OPUNKB

Posted on

TOP 5 HEALTH LAWS & 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.

Indian Government tacitly endorses use of AI in screening patients
India has started a pilot telemedicine project called “Aarogya-Doctor on Wheels”. The unique aspect of the pilot project is that it is leveraging Artificial Intelligence (AI) for screening patients. The patient narrates his illness or complaint in his native language and the AI understands the language and responds to the patient in the same language. Once the patient has been screened, he is referred to a specialist doctor for teleconsultation.
Source: bit.ly/3SISGt8

Code for regulation of marketing practices of medical devices industry will continue to remain in a draft form for some time
The Department related Standing Committee on Chemicals and Fertilizers has stated that draft Uniform Code for Pharmaceutical/Medical Device Marketing Practices (“UCMPMD”) will be finalized once the Supreme Court adjudicates a related writ petition, in which it has been prayed that code for regulation of pharmaceutical marketing practices (UCPMP) be given the status of law.
Source: bit.ly/49J8Mdb

Home based care models should be developed specifically for elderly population: Government Policy Think Tank
Taking note of the fact that there are more than 100 million elderly people in India, India’s apex government think-tank, NITI Ayog, has made case for development of Comprehensive and Integrated Senior Care Package. The package will include all aspects of senior care such as home-based care models, R&D in geriatric care, palliative and end-of-life services, Capacity building healthcare professionals and caregivers, development of assistive devices such as Mobility aids, Personal emergency response systems, Medication reminders, Smart home technology and Hearing and visual aids.
Source: bit.ly/3T5XYjP

Courts should be slow in granting anticipatory bail in narcotic matters, if the quantity is large: Supreme Court
India’s Supreme Court has held that in bail matters pertaining to dealing in illegal Narcotics Drugs and Psychotropic Substances, the Courts should first satisfy itself that accused may not be guilty of the offence alleged and that accused is not likely to commit any offence while on bail.
Source: bit.ly/3uGeCx2

Promotion of prescription drugs by Social Media Influencers in US a cause of concern, but US FDA may not have jurisdiction to regulate them
The US Food and Drug Administration (US FDA) is under scrutiny for its inability to regulate social media influencers engaged in marketing of prescription drugs without providing warnings about risks associated with their use. US FDA is reportedly unsure whether it can or cannot regulate such actions of social media influencers.
Source: bit.ly/3OMCYfj