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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.

Good Distribution Practices may be implemented in India for pharmaceutical products soon
India’s Drugs Consultative Committee (DCC) has recommended that draft of revised Good Distribution Practices (GDP) guidelines for pharmaceutical products should be made mandatory soon. The DCC is of the view that there is a gap in the law which requires owners of premises such as warehouses to ensure appropriate storage condition for drugs, but no such requirement exists for transporters who transport the drugs, and this affects the quality of drugs.
Source: bit.ly/49cMPCk

TB vaccine clinical trials begins in India
A Hyderabad based biotechnology company has started Phase 3 clinical trials of tuberculosis (TB) vaccine called MTBVAC among the adults in India. The vaccine is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from human strain, unlike the BCG vaccine.
Source: bit.ly/495Zuak

Medical and Sales Representatives’ body says new Pharma Marketing Code lacks teeth
The Federation of Medical and Sales Representatives’ Associations of India (FMRAI) has criticized the newly notified Uniform Code for Pharmaceuticals Marketing Practices (UCPMP), describing it as a futile effort. It stated that the new code lacks statutory enforcement and contains no explicit penal provisions against unethical marketing by pharmaceutical and medical device companies.
Source: bit.ly/495ZAic

Fire safety in hospitals should be evaluated by Government before Summer Season: Disaster Management Body
India’s Union Health Ministry and National Disaster Management Authority (NDMA) have jointly issued an advisory to all States and Union Territories (UT’s) to take proactive measures to check fire safety compliance of all hospitals before the incoming summer season.
Source: bit.ly/4akq9Bg

No change in surrender value norms for life insurance policies: Insurance Regulator
The Insurance Regulatory and Development Authority of India (IRDAI) has decided to retain the current surrender value requirements for life insurance policies due to concerns over higher surrender value expressed by the industry. Surrender value in life insurance is an amount paid by the insurer to the policyholder when the policy is terminated prior to the policy’s maturity date.
Source: bit.ly/43zOkcL

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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.

Panel of auditors to audit the promotional expenses of pharma and medical device companies will be appointed soon: Government
The Secretary, Department of Pharmaceuticals, has reportedly said that the government will appoint a panel of auditors who can undertake risk-based audits from time to time, to evaluate whether the promotional expenses, especially towards conferences and workshops, have been incurred in an ethical manner as per the Uniform Code for Pharmaceutical Marketing Practices 2024. Any discrepancy will be reported to the appropriate government agency or authority.
Source: bit.ly/49SNs5f

Industry welcomes the new Uniform Code for Pharmaceutical Marketing Practices
The pharmaceutical industry has reportedly welcomed the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP). According to news reports, the industry feels that the new code is a step ahead towards the advancement of the industry as it ensures ethical and healthy engagement between the pharmaceutical industry and medical professionals.
Source: bit.ly/4a6SZWd

Nutraceutical and food supplement regulations are to be tightened further
The Food Safety and Standards Authority of India (FSSAI) is in the process of tightening the regulations for nutraceuticals and health supplements. This move was prompted by the receipt of several complaints by the FSSAI about the presence of non-compliant health supplements on the market and the fact that the over-the-counter availability of nutraceuticals and health supplements is resulting in people consuming supplements along with drugs, which increases the risk of adverse effects.
Source: bit.ly/3wXMsOU

A major e-commerce entity was fined Rs 25 lakh due to its inaction to remove counterfeit products from the marketplace
A State Consumer Commission in India has imposed a fine of Rs. 25 lakhs on a major e-commerce entity on the grounds that the e-commerce entity failed to correct the listing of a product, which it was aware was a counterfeit product. By failing to remove the listing, the Commission held that the e-commerce entity had engaged in dark patterns and unjust enrichment.
Source: bit.ly/3IBUsaH

EU to extend regulatory data protection for innovator drugs to 7.5 years
The European Union is set to extend regulatory data protection for innovator drugs to 7.5 years, with one extra year of incentives if the drug meets an unmet medical need and clinical trials are conducted in the EU. There is a proposal to grant an additional 3 years of protection from generics, taking the total protection to a maximum of 11.5 years.
Source: bit.ly/3IxEIWl

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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.

Scientific works are not protected under India’s Copyright Law: High Court
India’s High Court of Andhra Pradesh has held that India’s copyright law only protects original literary, dramatic, musical and artistic works. It does not protect scientific works, as covered under books of Mathematics, Physics, Chemistry, Botany and Zoology used by Students. The Court clarified that mathematical equations and science subjects do not qualify as ‘original works’ because they are the matter of fact and nature.
Source: bit.ly/432GSqc

All rare disease drugs imported into India will be exempted from requirement to pay customs duty: High Court
India’s Delhi High Court has issued an order exempting drugs and medicines used in therapy for rare diseases from requirement of payment of customs duty. Prior to the order, the exemptions from payment of customs duty was limited to drugs used for treatment of Spinal Muscular Atrophy (SMA) or Duchenne Muscular Dystrophy (DMD). Earlier the Court had directed the National Rare Diseases Committee to hold deliberations with manufacturing and marketing companies to explore the possibility of procuring the medicines at a reasonable price.
Source: bit.ly/3T1H2JN

Flow of counterfeit products into Indian market to be checked through a new surveillance system
India’s Ministry of Consumer Affairs is planning to develop a new surveillance system to identify counterfeit products sold in the retail market. The Ministry proposes to collect samples soon after they enter the retail market and test them under new laboratories which will be set-up specifically for the purposes.
Source: bit.ly/3T5EKta

Online gaming guidelines to prevent compulsive gaming in India to be published
India’s Department of Consumer Affairs (DoCA) is planning to commission a research on the disruptive impulse control behavioural patterns of digital consumption that may cause vulnerabilities. The initial part of the research will be focused on online gaming addiction. The research would later be expanded to identify the underlying factors of excessive consumption of online content. The findings of the research would be used to provide policy inputs for framing of the Guidelines for protecting the interests of the consumers.
Source: bit.ly/3T1hXPb

US BioSecure Act to impact Indian biotechnology companies providing services or manufacturing products for US market
The BIOSECURE Act which has been introduced in the US House of Representatives prohibits US federal agencies from entering into contract with any entity that uses biotechnology equipment or services from a biotechnology company of concern to perform a federal contract. Some Chinese companies have been identified as biotechnology company of concern, and the list may be expanded to include companies from Russia, Iran and North Korea as well.
Source: bit.ly/3V5yQeq

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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

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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.

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

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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 announces completion of Genome Sequencing Project
The Department of Biotechnology (DBT) has announced the completion of the Genome India Project, the largest project to sequence 10,000 genomes of the Indian population. The initiative was launched in 2020. Owing to the project, the DBT has now created a reference genetic database as well as a biobank of Indian blood samples for future research.
Source: bit.ly/48C0G55

Draft guidance on post approval changes of biologics published by India’s drug regulator
India’s central drug regulator (CDSCO) has published draft guidance on ‘Post Approval Changes in Biological Products: Quality Safety and Efficacy Documents’ for comments. The draft guidance categorizes post approval changes relating to safety and efficacy depending on their seriousness and reporting requirements.
Source: bit.ly/48Bhnxi

Hospitals in India report increase in the average revenue per occupied bed (ARPOB)
As per reports, the average revenue per occupied bed (ARPOB) in major hospitals in India has increased in the last nine month and is set to increase 8-10% in next financial year. The ARPOB was estimated to be Rs. 45,800 per day in FY23. The factors driving growth are focus on specialized procedures and fast (morning/evening) discharges.
Source: bit.ly/3P0YxZy

USFDA to increase annual inspection of pharmaceutical facilities in India
The US Drug Administration (USFDA) is reportedly set to increase the number of inspections at Indian drug manufacturing units in 2024 due to increasing concerns about the quality of pharmaceuticals manufactured in those facilities.
Source: bit.ly/3UVrM3O

World’s biggest beef producer sued for greenwashing
The New York Attorney General has filed a lawsuit against the world’s largest beef producer on the ground that it has no viable plan to achieve net zero greenhouse gas emissions by 2040, as claimed by it. The Attorney General has accused the beef manufacturer of misleading the public about its environmental impact to increase sales.
Source: bit.ly/3P3Ak4V

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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.

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

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.

Couples seeking surrogacy will be allowed to use donor gametes only if either partner suffers from a disabling medical condition
India’s Ministry of Health and Family Welfare has notified the Surrogacy (Regulation) Amendment Rules, 2024, which removes the earlier requirement that barred the use of donor gametes for surrogacy. Now, couples intending to opt for surrogacy, can use donor gametes if either spouse is certified by the District Medical Board as having a medical condition which prevents the spouse form contributing the gamete.
Source: bit.ly/3T4Ortd

Antibiotics to be sold in blue cover by medical stores and hospital pharmacies in Kerala
In a first of its kind development, the Health Department of the Government of Kerala has instructed all the hospital pharmacies and medical stores in Ernakulum to sell antibiotics in a blue cover effective immediately. All medical stores have also been directed to display a poster stating that antibiotics will not be given without a doctor’s prescription. This initiative has reportedly been taken to control the use of antibiotics.
Source: bit.ly/3T4OiGb

Insurance companies should cover costs of medical equipment if it forms an integral part of the medical treatment: Consumer Court
India’s Vadodara District Consumer Disputes Redressal Commission has upheld the complaint of a person who was denied insurance coverage for cost of BPAP device for Sleep Apnea treatment post discharge from hospital. As per the consumer court, medical insurance should cover the cost of equipment required for treatment after discharge from the hospital, because it forms integral part of the medical treatment.
Source: bit.ly/3SLOjgJ

Smartwatches and rings should not be used for measuring blood sugar levels for diabetes management: USFDA
The US Food and Drug Administration (USFDA) has warned users that it has not approved any non-invasive smartwatches or rings that use sensors to measure blood sugar levels for diabetes management, and relying on them for blood sugar measurements could have serious implications.
Source: bit.ly/3wt4B6P

New Medical Device Quality Management System Rules published by USFDA
The US Food and Drug Administration (USFDA) has issued a final rule on Quality Management System Regulation (QSMR) for medical devices. The rule intends to reduce regulatory burden on the manufacturers and importers of medical device by enhancing global harmonization in device regulation for Quality Management Systems.
Source: bit.ly/48pxmyy

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