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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. Mere title of a person within an organization such as Managing Director/ CEO does not automatically make the person criminally liable for offence committed by Company under Drug Laws. In order to make a person holding a managerial position in the company criminally liable, the complaint should have specific averments against such person which indicates that the person was in charge of and responsible for the conduct of the business of the company so far as it relates to the manufacture of the drug: High Court of Jammu and Kashmir
Source: bit.ly/4cYU4Rl

2. The Government of India is reportedly considering whether to stop marketing of look-alike and sound-alike drug brands in public interest. Under the current proposal, the brand names which were approved first by the drug regulator will be permitted to be marketed, and look-alike or sound-alike drug brands will be prohibited from being marketed.
Source: bit.ly/3SvoDFN

3. The Indian Government is reportedly considering whether to exempt Medical Devices which have been approved and sold in the European Union for two years from requirement of conducting clinical investigation in India prior to marketing authorization.
Source: bit.ly/4d3sJgC

4. The Delhi High Court has ordered an Ayurvedic medicine manufacturer to delete from all websites on the internet and social-media platforms claims which were beyond the scope of license and implied that the medicine it marketed could treat COVID-19.
Source: bit.ly/3WFxEyG

5. A prominent US based health savings account administrator has reported that it has suffered a data breach which has led to the loss of sensitive employee and customer information.
Source: bit.ly/4dkt525

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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 Missouri State Court has directed a multinational healthcare company to pay $495 million in damages over its specialised formula for premature infants which caused a girl to develop dangerous bowel disease. The Court ordered that the company did not warn doctors about infants receiving formula, having a greater risk of Necrotizing Enterocolitis (NEC) compared to infants who are breast-fed or given donor milk or human milk-derived formula
Source: bit.ly/46rTKb1

2. India’s Karnataka State Assembly has brought in a new bill which penalises any person found guilty of causing “intentional insult” to a doctor directly, on social media or using unauthorised audio or video. The penalty includes a jail term up to three months or a fine of ten thousand rupees. Intentional insult includes use of words, figures or gestures with an intent to insult, humiliate, disgrace, annoy or abuse a medical service personnel.
Source: bit.ly/4d0momi

3. India’s Kerala High Court has ordered that the Kerala Medical Association (“KMA”) is liable to pay Goods and Services Tax (GST) on the supply of goods and services to its members. KMA contended that it does not need to pay GST as it is registered as “charitable association” but the High Court held that KMA is liable to pay GST as 90% of its activities are non-charitable.
Source: bit.ly/3WF5x2G

4. Multinational Pharmaceutical Companies have requested the Indian Government to keep the free access medicines, provided under Patient Assistance Programme (“PAP”), outside the scope of Trade Margin Rationalisation (“TMR”). According to Pharma companies, medicines are made accessible and affordable through PAP and bringing them under the purview of TMR will impact their price and patients will end up paying more.
Source: bit.ly/3ykeaGu

5. Indian Government has built a health claims gateway, National Health Claims Exchange (NHCX), which aims to streamline and standardize health insurance claim processing, enhancing efficiency in the insurance industry. NHCX serves as a gateway for exchanging health claim information among insurers, third-party auditors, healthcare providers, beneficiaries, and other relevant entities and ensures interoperability, machine-readability, auditability, and verifiability, making the information exchange accurate and trustworthy.
Source: bit.ly/3WEmom2

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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 Public Interest Petition has been filed in the Delhi High Court, highlighting the need to require the use of verifiable Digital Signature on medical records and prescriptions to prevent fraud, misuse and fabrication of patient data.
Source: bit.ly/46qn6GP

2. The Indian Council of Medical Research has recently published Volume IV of the Standard Treatment Workflows which introduces new treatment methods for 32 common health conditions.
Source: bit.ly/3WCUqXO

3. The Indian government is set to launch a universal platform to track vaccination, U-Win which is reportedly based on the erstwhile Co-Win platform which had been maintained to track COVID-19 vaccinations,
Source: bit.ly/3SMCnfN

4. The West Bengal Clinical Establishment Regulatory Commission, the State level regulator of hospitals, clinics and healthcare centres, is set to issue an advisory mandating hospitals to pro-actively update the kin of patients on continued developments in health conditions to improve quality of counselling.
Source: bit.ly/4djmOUo

5. The United States Food and Drug Administration has finalized guidelines on the manner of use of Real World Data from Electronic Health Records, for the purpose of selecting and analysis of study data, as well as specifying limitation on the kind of data that can be used for clinical studies and regulatory decision making.
Source: bit.ly/3YfnV3i

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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. In its recent annual Budget announcement, the central government has proposed to waive customs tariffs on three additional drugs, used in treatment of cancer.
Source: bit.ly/4dinoSC

2. The Bombay High Court held a Director of a chemical manufacturer criminally liable for export of controlled substances from the country, holding that all officers of companies should keep themselves abreast of the latest regulations, and being ignorant of new notified compliance cannot excuse liability.
Source: bit.ly/46iRp22

3. The Madras High Court stayed a suspension order issued against a branch of a major fast food chain, holding that suspension cannot be ordered without giving an opportunity to improve its practices in pursuance of an Improvement Notice issued under Sec. 32(1) of the Food Safety Standards Act, 2006.
Source: bit.ly/3LFGne4

4. The Ethics and Medical Registration Board of the National Medical Commission of India, the country’s premier regulator of the medical profession has recently issued a decision proposing to expand the scope of qualified Doctors that may now be permitted to undertake spinal surgery. While previously only neurology specialists were permitted to operate on the spine, orthopedic specialists may also undertake the same with existing qualifications.
Source: bit.ly/46s1oCn

5. An appeals courts of the United States has rejected the petition of several US states against the reclassification of contraceptive medication, holding that no grounds were established to prove actual harm suffered by the State governments. as claimed.
Source: bit.ly/3zZpdFC

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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. The Union Health Ministry of India has been allocated a budget of Rs 90,958.63 crore for the financial year 2024-2025 in the Parliament’s interim Union Budget 2024 session. This budget is 12.96% higher than the budget that was allocated for the financial year 2023-24.
Source: bit.ly/3YnHCWu

2. The Union Health Ministry of India has announced a revision in the basic customs duties (BCD) with an aim to align with domestic capacity expansion for medical equipment such as X-ray tubes, flat panel detectors, including scintillators that will be used in the manufacture of medical X-ray machines for medical, surgical, dental, or veterinary use. The custom duty will be reduced from 15% to 5% until 31st May 2025.
Source: bit.ly/4fgx6GI

3. India’s Environment Ministry has issued a draft guidelines relating to the Uniform Consent Fee and the Grant, Refusal, or Cancellation of Consent to Establish & Consent to Operate. These guidelines aim to streamline the consent mechanism under the provisions of the Water Act and Air Act, enhance ease of doing business, minimize the compliance burden on industries, and reduce duplication of work concerning the issuance of consents.
Source: bit.ly/4cQs6af

4. India’s Environment Ministry has notified an Public Liability Insurance (Amendment) Rules, 2024. This amendment aims to increase scope of public liability insurance to environmental damage that may be caused by industrial accidents.
Source: bit.ly/3YihHjg

5. The India’s Central Drug Regulator (CDSCO) is reportedly planning to exempt the need for testing Cough Syrups intended for export to the US, UK, Canada, the European Union, Japan, Australia, Singapore, Korea, and Switzerland at prescribed laboratories.
Source: bit.ly/4df0ZFz

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Central Food Regulator the Food Safety Standards Authority, has introduced registration process for direct sellers to differentiate from Retailers, and make it easier to preserve exemption granted from regulation to direct sellers.

Source: bit.ly/4feuedl

 

2. The Kerala High Court in following with a recent decision of the Punjab High Court has held that the newly enforced Criminal Procedure (The Bharatiya Nagrik Suraksha Sanhita, 2024) will apply to all criminal appeals filed on or after 1st July 2024, the day of enforcement of the  new law. The court held that while the substantial right to appeal is preserved under the repealed statute, the procedural right will transfer over as per Sec. 531 of the new Code.

Source: bit.ly/4bQpMi4

 

3. Exports of Drugs and Pharmaceuticals have reportedly increased by 9.5% in the first quarter of FY 2024-25 year-on-year.

Source: bit.ly/4d3x3Nb

 

4. In response to recent reports that India has the 2nd highest number of unvaccinated children, the Indian government has clarified in a press release that, this statistic is misleading as such children only constitute a minute 0.11% of the nation’s population of children.

Source: bit.ly/3zQzFPw

 

5. The United States Food and Drug Administration has published Guidance for Human radiolabeled mass balanced studies, prescribing the information that sponsors need to submit, most notably now requiring a minimum of 6 participants for such studies as against the accepted variance between 4-6 participants.

Source: bit.ly/3y2UEy8

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Supreme Court ruled that mixing samples collected from contraband contained in various packages after a seizure violates the terms of the Narcotic Substances and Psychotropic Substances Act and the rules enacted under it. The court noted that the statutory rules require a specific procedure to be followed, and the Detecting Officer is obligated to follow the authorized procedure. No one can presume the nature of the substance based on speculations and conjectures.
Source: bit.ly/3zN4yV9

2. The Central Consumer Protection Authority fined a firm selling ayurvedic oil ₹ 10 lakh for violating consumer protection laws on misleading advertisements which claimed relief from joint pain without surgery or physiotherapy while promoting their joint-pain-relieving product.
Source: bit.ly/3W1YJum

3. Following the Central Government’s decision to replace British-era criminal procedure codes with Bharatiya Sanhitas, the Government of India held a meeting with the Drugs Control Officers (India) Welfare Association (DCO India) to change the name of the Drugs and Cosmetics Act, 1940, passed by the British Rulers to ‘Bharatiya Aushadhi awam Chikitsa Upakaran Adhiniyam’. The national conference of Indian drug regulators will hold in-depth discussions on the subject.
Source: bit.ly/3WphadL

4. The National Health Authority (NHA) and the Insurance Regulatory and Development Authority of India (IRDAI) collaborated to launch the National Health Claim Exchange (NHCX), a digital platform for exchanging insurance claims-related information among healthcare and insurance stakeholders. The NHCX will enable seamless interoperability of health claims processing, allowing citizens to track their insurance claim progress via mobile devices.
Source: bit.ly/3xQ9EPX

5. The US Food and Drug Administration (FDA) issued final question-and-answer guidance outlining how it assesses user fees for combination products, as well as the various programs available to sponsors for requesting user fee waivers under the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Amendments (MDUFA). The guideline offers background information on combination goods, how the agency calculates user fees for single and multiple applications, and how to request waivers or reductions in user costs.
Source: bit.ly/3y3roHw

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Consumer Affairs Ministry’s is proposing to amend labelling and packaging regulations for pre-packaged goods. Currently, certain large packages, like those exceeding 25 kilograms or liters, are exempt from displaying crucial information. This includes details like the maximum retail price (MRP), the date by which the product should ideally be consumed (best before date), who manufactured it, and where it came from (country of origin). Other exempt categories include cement, fertilizer, agricultural produce in 50 kg bags, and products destined for industrial or institutional use. The proposed amendment aims to close this loophole and ensure all these bulk packages are labelled clearly and consistently, just like retail products.
The proposed amendments are open for public consultation till 29th July 2024.
Source: bit.ly/4cZPiCG

2. Maharashtra state in India has reportedly announced a ban on sale of energy drinks with high caffeine content within 500-meter radius of schools. This directive aims to safeguard student health.
Source: bit.ly/467rxGj

3. India’s Karnataka Medical Council (“KMC”) has issued a show cause notice to a dermatologist alleging violation of Code of Medical Ethics, 2002 for advertising drugs/medicines on social media. The action on the part of KMC comes after it received a complaint from Indian Association of Dermatologist, Venerologists and Leprologists.
Source: bit.ly/3zLuAYY

4. India’s drugmakers are pushing the government to loosen price controls. They propose exempting all medicines under ₹5 and extending the exemption for patented drugs (currently 5 years) to 10 years. This comes amid rising costs for ingredients, prompting them to request a reduction in GST on these materials. The industry argues stricter controls stifle research and development.
Source: bit.ly/3S7oqIF

5. Indian Supreme Court has rejected Doctor’s plea for improved security, which is filed by a Delhi Medical Association. The apex court was hearing the DMA’s petition which also sought directions to the authorities to ensure adequate security at hospitals and medical centres to prevent attacks on doctors and healthcare workers by patients’ relatives and others. The Apex Court stated that currently laws exist to deal with such instances.
Source: bit.ly/3Ln9Fh9

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Indian Government has informed the Delhi High Court that it has been unable to notify rules for regulation of online sale of medicines. The Delhi High Court will now proceed to decide the legality of online sale of medicines in India.

Source: bit.ly/4cZRrOJ

 

2. A Swiss Biotech MNC has successfully obtained an interim injunction against an Indian Biosimilar Manufacturer which will prevent the manufacturer from launching the Biosimilar of Perjeta (Pertuzumab) on ground that it deliberately withheld information about receipt of regulatory marketing approval from the High Court.

Source: bit.ly/3zLi9Ms

 

3. India’s apex investigation agency, the Central Bureau of Investigation, has filed a charge sheet alleging violation of India’s bribery laws against a cardiologist, senior employees of a medical equipment MNC, and some distributors of medical equipment. The cardiologist was an employee of prominent government hospital and the complaint revolves around the collection of bribes by the cardiologist from medical equipment and stent suppliers for recommending their products to patients.

Source: bit.ly/3zy0PdM

 

4. India’s Delhi High Court has upheld the regulation which mandates pan masala companies to display statutory health warnings about the harmful effects of pan masala on 50% space on the front side of the packaging of such products. The Court ruled that the regulation brought in by the government gives effect to the legislative intent of safeguarding the larger public interest, which is paramount, and does not disproportionately impact the rights of the Petitioners.

Source: bit.ly/4cWwPHa

 

5. The United States Food and Drug Administration (FDA) releases draft guidance for companies on addressing online misinformation about their approved medical devices and drugs. The draft guidance stipulates that US FDA won’t enforce rules restricting promotion and marketing of drugs and medical devices, whenever drug and medical device companies issue specific communications to correct online misinformation about their approved drugs/devices or relevant therapeutic category.

Source: bit.ly/4deP3DZ

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Supreme Court has reportedly asked the Ministry of Information and Broadcasting to appropriately modify the self-declaration requirement imposed by the Supreme Court on all advertisements, such that the consumers remain protected against misleading advertisement, but the industry is not overly inconvenienced in the process of complying with the self-declaration requirement.
Source: bit.ly/3xYqk7C

2. The Supreme Court has ruled that not disclosing critical or material information about safety at the time of promotion of the product amounts to unfair trade practices.
Source: bit.ly/460Duxr

3. Central Drugs Standard Control Organization (CDSCO), India’s drug regulatory authority, is reportedly planning to take action against pharmaceutical companies that fail to implement barcodes or QR codes on the top 300 medicine brands identified by the National Pharmaceutical Pricing Authority (NPPA).
Source: bit.ly/3zJllrU

4. MeDevIS (Medical Devices Information System) online portal, the first worldwide open access clearing house for information on medical devices, was launched by the World Health Organization (WHO). It is intended to assist governments, regulators, and users in making decisions about the selection, procurement, and use of medical devices for diagnosing, testing, and treating diseases and health conditions. MeDevIS refers to two international naming systems for medical devices: the European Medical Device Nomenclature (EMDN) and the Global Medical Device Nomenclature (GMDN), which attempt to maintain data uniformity across borders.
Source: bit.ly/3zJQIm9

5. The U.S. Federal Trade Commission recently stated that a pharmacy benefit managers (PBM), who operate as middlemen between pharmaceutical firms and customers, have an excessive amount of influence over prescription drug costs due to the years-long dealmaking which has ultimately resulted in the consolidation of pharmacies and health insurance companies.
Source: bit.ly/3W0Mhee