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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

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.

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

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.

1. India’s Environment Ministry is planning to exempt white category industries i.e., low environment risk industries from the requirement to obtain consent before establishing and operating an Industry provided the industry makes a self-declaration to the concerned pollution control board.
Source: https://bit.ly/3LygA7t
Source: https://bit.ly/4d7nqNv

2. India’s environment ministry is planning to exempt industries who have already obtained Environmental Clearance (EC) from obtaining environmental consent to establish the industry.
Source: https://bit.ly/3LygA7t
Source: https://bit.ly/4d7nqNv

3. After Odisha and West Bengal, other states in India are reportedly considering to allow online sale and home delivery of alcoholic beverages.
Source: https://bit.ly/3WiXAyu

4. Indian Pharmacopoeia Commission (IPC) has waived off the Target Animal Batch Safety Test (TABST), which involved administering vaccine overdoses to animals to test each batch of vaccine for safety of a specific species starting from 1st July 2024.
Source: https://bit.ly/3WAR8U3
Source: https://bit.ly/4fgy3is

5. EU antitrust regulators have officially accepted a pharmaceutical giant’s pledge not to disparage its competitor’s iron deficiency treatment medicine.
Source: https://bit.ly/3zSqMFn

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. Multinational Pharmaceutical Companies in India have reportedly sought relaxation of mandatory 50% cut in price of essential medicines after expiry of patent on ground that it hinders innovation.

Source: bit.ly/4bWhHIN

2. India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has issued directions to the effect that if any food sample is found to be unsafe in the primary lab report, it would result in an order prohibiting further distribution of such food. If the food sample is confirmed to be unsafe by a referral food lab, then the food will have to be recalled.

Source: bit.ly/3Yji2SR

3. A nutritional supplement firm was fined by District Consumer Commission for making misleading claims on the label of its protein supplement regarding the nature of protein content. According to the commission, making misleading claims on label amounts to deficiency of services.

Source: bit.ly/4dcHoWs

4. India’s Jammu and Kashmir High Court has dismissed a criminal complaint instituted against a retailer of medicines for failing to reveal details of manufacturer of a spurious drug. The High Court held that since the Drug Inspector already had the details, the non-provision of requested information did not constitute an offence under The Drugs and Cosmetics Act, 1940.

Source: bit.ly/4bSxPLd

5. India’s food regulator, The Food Safety and Standards Authority of India (FSSAI), has introduced a new license category for registration of direct sellers. Direct sellers are not permitted to sell infant milk and infant milk substitutes.

Source: bit.ly/4fdxhlZ

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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. India’s drug regulator will implement the mandate of printing of QR codes to curb counterfeiting. The top-selling brands have reportedly said that they have already started integrated QR codes and bar codes for tracking and compliance checks.
Source: bit.ly/4d80PzG

2. Indian Health Ministry has issued draft rules under the Drugs and Cosmetics Act, 1940 relating to compounding of minor offences and violations. The draft rules establish a system for companies to settle minor violations of the Act, like manufacturing drugs without proper procedures, outside of court. Companies can apply to a designated compounding authority with relevant documents, and if approved, avoid prosecution. This aims to resolve issues efficiently without lengthy court cases, but serious offenses like selling adulterated drugs are not eligible for compounding.
Source: bit.ly/3zLSKlT

3. India’s Drug Control Officers collective proposal to Indian Government for changing the name of the Drugs and Cosmetics Act, 1940 to ‘Bharatiya Aushadhi awam Chikitsa Upakaran Adhiniyam’ has received mixed responses from the industry and various stakeholders. While some have reasoned that change of name of the Act is the need of the hour and should be done as early as possible, others have questioned the need and purpose of the exercise.
Source: bit.ly/4d9IsdV

4. India’s Pharmacy Regulator, the Pharmacy Council of India (“PCI”) has extended the deadline for submission of statutory documents till 31st July, 2024 by new institutions and existing institutions that have applied for introduction of new course. PCI stated that the documents should be submitted on its compliance portal only. No other mode other than the PCI Compliance portal will be entertained for submission of documents.
Source: bit.ly/3y0YeZE

5. Indian Health Minister stresses on India’s need for world class regulatory framework for Pharma and Medical Device Industry to ensure better quality of products. The Minister also stated the importance of transparency in India’s apex drug regulator the Central Drugs Standard Control Organisation (CDSCO). The Union Health Minister stated that it is important for CDSCO to be in continuous dialogue with the drugs and medical devices industry to understand their issues and support them to fulfill the quality expectations and standards of CDSCO.
Source: bit.ly/4d5XuBd

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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. The Supreme Court has issued its decision in a matter concerning the legality of exercise of powers by the National Pharmaceutical Pricing Authority (NPPA) in levying overcharging fees against an entity that claimed not to be a “distributor” or a “dealer” as defined under the Drugs (Prices Control) Order, 1995, since it had a dual role. The Court held that there is no mutual exclusivity between a dealer and a distributor, and dismissed the appeal.
Source: bit.ly/3xPkgP1

2. The National Medical Commission, has mandated the presence and maintenance of a Tobacco Cessation Centre at all hospitals attached to Medical Colleges across the country.
Source: bit.ly/3WdIjzk

3. To curb rise in misleading advertisements, the Central Government may soon introduce regulation to restrict the advertisement of Diabetes, Sex Hormone and Oncology medication, and may require approval and permission to make claims of efficacy for these Drugs.
Source: bit.ly/46nCjst

4. The Ministry of Health and Family Welfare has published Draft Drugs (Amendment) Rules, 2024 whereby it intends to amend Rule 96 requiring inclusion of details of Drug excipients on retail labels of Drugs.
Source: bit.ly/463YZO9

5. The European Commission has published and adopted the Artificial Intelligence Act, which will regulate the inclusion and integration of AI into Medical Devices and In-Vitro Devices. This Act is set to come into force on the 2nd August 2024.
Source: bit.ly/3Y5qCUV