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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.

1. The State Consumer Disputes Redressal Commission (SCDRC) has directed a consultant surgeon at a hospital in Erode to pay ₹5 lakh as compensation to the family of a patient who died during treatment for colon cancer. The Commission concluded that while there was no medical negligence during the surgery, the surgeon failed to secure proper cardiac evaluation prior to the procedure, which was deemed a significant oversight.
Source: bit.ly/3UHgY8t

2. The All India Organization of Chemists and Druggists (AIOCD) has raised concerns over a potential partnership between a popular fast delivery company and an online pharmacy aimed at delivering medicines within 10 minutes. AIOCD warns that this ultra-fast delivery model may bypass essential safety regulations, compromising patient safety and increasing the risk of antimicrobial resistance due to unregulated medicine distribution.
Source: bit.ly/4hzeSBr

3. The Drugs Controller General of India (DCGI) has mandated that no cosmetics can be imported unless their ‘use-by’ date is at least six months from the import date. The regulator also prohibited the import of cosmetics containing hexachlorophene and those tested on animals post-November 2014.
Source: bit.ly/4hElgr2

4. The Supreme Court has directed the National Medical Commission (NMC) to establish new guidelines for admitting persons with disabilities into medical courses, emphasizing the need for inclusivity in the healthcare sector. This decision follows a case involving a candidate with muscular dystrophy who was initially disqualified from pursuing an MBBS due to stringent disability criteria.
Source: bit.ly/3YAwWCG

5. The Central Pollution Control Board (CPCB) has issued guidelines to be used by State Pollution Control Boards (SPCBs) and Pollution Control Committees (PCCs), to assess and determine the processing capacities of E-Waste recycling facilities.
Source: bit.ly/3YBbcGK

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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.

1. The ministry of environment, forest and climate change has recently issued an office memorandum stating a revised list of high end and high value used / refurbished medical equipment for import. MRI, CT and radiography devices are some of the new inclusions in the list. This may lead to unchecked import of refurbished medical devices in India, and potentially risk patient safety. This will also negatively impact Make in India Initiatives. (Order attached).
Source: bit.ly/4hqd4ea

2. The Central Consumer Protection Authority (CCPA) has given the quick e-commerce companies a notice of 15 days for violations related to packaged product disclosures mandated under the Legal Metrology Act, which mandates online and offline retailers to display key product information, maximum retail price, expiration date, weight, manufacturer details, etc on packaged goods. This re-emphasises regulatory stance on consumer safety and disclosure requirements.
Source: bit.ly/3YEp5oF

3. The Central Board of Indirect Taxes and Customs (CBIC ) under the aegis of Ministry of Finance has issued Notification No. 69/2024-Customs (N.T.) dated October 23, 2024, updating the tariff values for imported commodities such as that of edible oils such as Palm Oil and Soya, brass scrap, gold, silver etc (Notification attached).
Source: bit.ly/3BUSmm7

4. Institutions of the Council of Scientific and Industrial Research (CSIR) has designed ‘FluoriPCR’, a device which will help test for food adulteration and presence of bacteria, viruses and fungi etc in food items, increasing the affordability to conduct such tests.
Source: bit.ly/3YqBBah

5. Medical Device Coordination Group (MDCG) has updated the guidance on the application of MDR requirements to ‘legacy devices’ and ‘old’ devices, taking into account the amendments to Regulation (EU) 2017/745 on medical devices (MDR) has been amended by Regulation (EU) 2023/607
Source: bit.ly/3YGoCm7

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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

1. India’s Health Ministry has notified the New Drugs and Clinical Trials (Amendment) Rules, 2024 which will take effect from1st April, 2025.These amended rules outlines the requirements for registration of the Clinical Research Organizations.
Source:  https://bit.ly/4ddpX81

2. India’s Central Food Regulator (FSSAI), has issued a show cause notice to a Tamil Nadu-based company that supplied ghee for making laddoos (prasadam) at the Tirupati Balaji temple, following the detection of animal fat in the laddoos. The company is required to respond to the charges by 23rd September, 2024, failing which appropriate action will be taken against them.
Source: https://bit.ly/3BheNln

3. The Government of India is reportedly planning to adopt a risk-based approach for monitoring the quality of imported consignments of medical devices at ports. This will involve random sampling of consignments of medical devices and testing of entire cargoes in case of critical diagnostic kits.
Source: https://bit.ly/3BhePtv

4. India’s central health regulator has declared five samples of drugs to be spurious based on the physical comparison and analytical tests done by the manufacturers and on the reports from State Licensing Authorities. The actual manufacturers, as claimed on the labels, have stated that they are not the actual manufacturers of these drugs and the drugs are spurious.
Source: https://bit.ly/3XTfUjP

5. India’s Directorate General of Foreign Trade (DGFT) has amended Chapter 5 of the Handbook of Procedures (HBP) 2023 under the Export Promotion Capital Goods (EPCG) Scheme. The EPCG Scheme, which allows pharma industry to import capital goods duty-free for producing quality goods and services to boost exports, has been updated to streamline its reporting requirements. The amendment eliminates the previous requirement for annual reporting of Export Obligation (EO) fulfilment and has been replaced with a periodic reporting system.
Source: https://bit.ly/4dkMUWC

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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 Drug Controller in Kerala has reportedly stated that there is no objection to display discount on flex board of retail drug stores. However, all retail drug stores are required to display a price list of medicines which will allow consumer to evaluate which drugs are available at a discount and make informed choices.
Source: bit.ly/4ctkgT3

2. As per India’s Central Food Regulator, the claim of 100% fruit juice on packaging of juices which are reconstituted from fruit concentrate, or which are not reconstituted but to which water has been added, is misleading and therefore prohibited. Any pre-printed packaging material which contains the misleading claim should be utilized by the Food Business Operators (FBOs) before 31st December 2024. Fruit juices manufactured before 31st December 2024 but which carry the misleading claim on the package will be permitted to be sold in the market until their expiry.
Source: bit.ly/4fV2gDN

3. A trademark infringement suit filed by a U.S. fast-food burger chain has been decided in favor of a Pune-based burger joint on the grounds of prior use and honest use in India.
Source: bit.ly/4dGZLmY

4. Indian medical gloves manufacturers have raised strong objection with Indian government about ongoing import of chlorinated gloves into India despite there being a ban on its use by healthcare facilities.
Source: bit.ly/3AyqQdG

5. 12% of all spices tested between May and July have reportedly failed to meet quality standards.
Source: bit.ly/3AwNV0b

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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 number of cosmetic products which can be added to a single application for the import registration certificate of cosmetics has been limited to fifty (50) products from 16th August 2024.
Source: bit.ly/4dbUnrX

 2. The Central government has reportedly prepared a draft of the Standard Veterinary Treatment Guidelines (SVTG) covering 274 diseases across 12 major livestock species with an aim to create uniform treatment protocols, lessen variation in prescription practices, and improve compliance among veterinarians and other prescribers.
Source: bit.ly/3SNEnnU

3. The Supreme Court of India has given a deadline of 12th October 2024 to implement the law for regulation of allied healthcare practitioners.
Source: bit.ly/3SNqR3L

4. The Madras High Court has reportedly directed the Indian Council of Medical Research (ICMR) to opine whether there were vested interests involved in the ban on pioglitazone, an antidiabetic drug, which was later revoked.
Source: bit.ly/3SLbmcm

5. The US Food & Drug Administration (FDA) has reportedly rejected a proposal to approve psychedelic – MDMA as a treatment for post-traumatic stress disorder (PTSD) citing safety and efficacy concerns.
Source: bit.ly/3YDYqJf

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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

1. India’s central food regulator has approved a proposed Amendment to the Food Safety Standards (Labelling and Display) Regulations, 2020, to now indicate the per-serving Recommended Dietary Allowances, sugar, salt and sodium content in larger font.
Source: bit.ly/4bB3IYw

2. Association of Indian Medical Device Industry has requested the Ministry of Finance to increase the import tariffs on Medical Devices, correct the inverted duty structure, and to introduce new cap on trade margin in a bid to encourage the development of indigenous industry and competition.
Source: bit.ly/3VWQSOP

3. The Ministry of Consumer Affairs has set up a meeting with Automobile manufacturers operating India, and various Automobile manufactures Associations in an effort to onboard these companies on the Right-to-Repair portal maintained by the Ministry, and which has already onboarded several consumer electronics companies.
Source: bit.ly/4coI0bD

4. The Supreme Court, in the course of ongoing proceedings, has granted the Central Government an additional period of 8 weeks to frame a National Policy on Distribution of Menstrual Products (to adolescent children).
Source: bit.ly/4cTgvGV

5. The European Commission’s Medical Device Coordination Group has issued a new guidance amending the Guidance on “Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746” regarding the classification of In-Vitro Medical Devices at the pre-market introduction stage. The new amendment provides differential Conformity Assessment for the Devices based on their classification; The guidance has also provided an annex differentiating an In-Vitro Medical Device and a Companion Diagnosis.
Source: bit.ly/3Y2Ffbs

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.

Supreme Court clarifies when a patient’s negligence may be reduced due to pre-existing conditions
India’s Supreme Court has laid down the situations in which a patient’s claim for compensation due to medical negligence may be reduced on the grounds of pre-existing conditions. These are: First, when a latent condition of the patient has been unearthed; Second, when the negligence on the part of the wrongdoer re-activates a patient’s pre-existing condition that had subsided due to treatment; Third, wrongdoer’s actions aggravate known, pre-existing conditions, that have not yet received medical attention; and Fourth, when the wrongdoer’s actions accelerate an inevitable disability or loss of life due to a condition possessed by the patient even when the eventuality would have occurred with time, in the absence of the wrongdoer’s actions. This rule is commonly referred to as the ‘egg-shell skull’ rule.
Revised penalty will apply, even if the offence took place before the penalty is revised: Supreme Court
India’s Supreme Court has held that a repealed provision will cease to operate from the date of repeal and the substituted provision will commence to operate from the date of its substitution. The Court was dealing with a matter involving the determination of penalty for loss of liquor in transit. The unamended rule, which existed at the time when the breach happened, provided for a penalty of four times the duty payable on liquor.  The amended rule provided for a penalty equal to the duty payable on liquor. Since no additional guidance for the application of the amended rule was prescribed, the Supreme Court held that the amended penalty provision would apply.
Proceedings related to alcohol content in drugs under excise laws and drug laws can run concurrently: High Court
India’s Gujarat High Court has clarified that action under the Drugs & Cosmetics Act does not exempt an individual from prosecution if a case is made out under the Gujarat Prohibition Act, 1949. In this case, a pharmaceutical manufacturer had allegedly violated the State’s prohibition law by selling intoxicating substances as ayurvedic medicine and, therefore, was facing action against the excise laws as well as drug laws.
Limits on the import of Isopropyl alcohol relaxed
India’s Directorate General of Foreign Trade (DGFT) has notified the discontinuation of safeguard measures on the import of isopropyl alcohol (IPA) through a trade notice. Earlier, country-wise quantitative restrictions (QR) were imposed on the import of IPA into India.
Used imported medical devices with a minimum shelf life of 5 years are not waste: Tribunal
India’s Hyderabad Bench of Customs, Excise, and Service Tax Appellate Tribunal (CESTAT) has held that used medical devices with a minimum residual life of 5 years or more are not e-waste or hazardous waste. In this matter, a hospital had imported used medical equipment for internal use but the Customs had seized the capital equipment on grounds that the used medical equipment qualified as hazardous waste under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016
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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.

Delay condonation should be evaluated based on reasons provided and not merits of case: Supreme Court
In a recent decision, the Supreme Court held that in condoning delay for a filing for which limitation period has been stipulated under the Limitation Act, 1963, a Court should not base its decision on whether such delay has been condoned in a similar matter, evaluating delay on merits of the fact situation, but rather each delay should be evaluated on the grounds pleaded in the application for its condonation.
Source: bit.ly/49MllnH

Central Government to take strict action against non-compliance with quality maintenance in manufacture of fire-resistant fabrics raw material
The Indian Central Government is intending to take stringent action against violators of the Bureau of Indian Standards (BIS) Quality Control Order for raw material used to manufacture fire-resistant fabric used in upholstery used in commercial spaces such as cinema halls, conference halls etc. Pursuant to issue of this Quality Control Order, only those raw material that have been certified by the BIS may be used in manufacture of commercial space upholstery. However, this Quality Control Order does not apply to upholstery used in households or those manufactured for export.
Source: bit.ly/4cKT4R3

Indian Government partners with Quality Council of India to improve services at Central Government run hospitals
India’s Central Ministry of Health and Family Welfare has entered into a Memorandum of Understanding with the Quality Council of India, to help improve quality standards for healthcare delivery at government run hospitals and help the hospitals get accredited by the National Accreditation Body for Hospitals/ Laboratories.
Source: bit.ly/3Ub0ful

Prices of imported Active Pharmaceutical Ingredient see sharp decline due to action against cartelized manufacturers
Despite an increase in demand in the Indian domestic pharmaceutical manufacturing sector for Active Pharmaceutical Ingredients (APIs), indicated by a 39% increase in year-on-year imports, the price of APIs being imported from China and other countries has reduced significantly to pre-COVID levels. This reduction is suspected to be caused by breaking-down of manufacturing cartels. This reduction in prices of API signifies an increase in profit margins for Indian firms which have traditionally been depended on Chinese imports.
Source: bit.ly/43Qlo0d

ECHR holds that inaction against climate change may be considered violation of human rights
The European Court of Human Rights has issued an award in favour of several Switzerland based petitioners who brought claims against their Government. The Court held that the European Convention on Human Rights envisages citizens right to be protected by their government against adverse effects of climate change. The petitioners had claimed that the inaction of the Swiss government and insufficient mitigation measures had caused a violation of the petitioners’ human rights, since such inaction by the government has increased their likelihood of dying of heat stroke.
Source: bit.ly/3JbMLZ6

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.

Environmental Compensation Guidelines for Plastic Waste Published
India’s Central Pollution Control Board (CPCB) has issued guidelines for the assessment of Environmental Compensation (EC) for violation of The Plastic Waste Management Rules, 2016. The Producers, Importers, Brand Owners and Manufacturers of plastic packaging will have to pay environmental compensation (EC) for non-compliance with the marking or labelling requirements, non-registration on the Plastic Packaging Waste EPR portal, shortfall in EPR targets, non-filing of annual returns etc. EC would also be levied on the generators of waste for non-segregation of plastic packaging waste at source and littering. The environmental compensation will be higher (15 – 20%) than the EPR credit charges prevailing in the market to ensure that it acts as a deterrent. The guidelines also specify the minimum and maximum amount of environmental compensation to be levied for violations of specific provisions of the Plastic Waste Management Rules, 2016.
Source: bit.ly/3U6zhUJ

Importer of cosmetics inadvertently receives import registration for cosmetic product without applying for it
India’s Central Regulatory Body for Cosmetics, The Central Drugs Standard Control Organization (CDSCO), recently cancelled the import registration certificate of an importer of cosmetics after it realized that it had inadvertently granted registration certificate even though the importer had not applied for it. CDSCO has attributed the mistake to some technical issues.
Source: bit.ly/3vNc0xQ

Hair transplantation by doctor with M.B.B.S. degree only does not automatically result in negligence, if standard of care not compromised by doctor: National Consumer Commission
India’s National Consumer Dispute Redressal Commission (NCDRC) in Hyderabad refuse to fasten liability for medical negligence on a Doctor with M.B.B.S, who had performed a hair transplant surgery. The NCDRC observed that the M.B.B.S. course syllabus includes study of the dermis, and that a doctor with a M.B.B.S. degree has the qualifications and expertise to undertake minor surgeries of dermis such as hair transplantation.
Source: bit.ly/3PWQBZN

Indian hospitals have started using Artificial Intelligence extensively: Report
India’s major hospital chains have reportedly started using artificial intelligence (AI) for prediction, prevention, diagnosis, and personalized management. These hospital chains are also commercializing their AI solution by licensing it with smaller hospitals.
Source: bit.ly/43Ua6rF

French Government decides to impose fines on patients if they miss appointment with doctors
The French government has decided to impose a fine of five euro ($5.50) on patients who miss doctor appointments or cancel them with less than twenty-four hours’ notice. The Government homes that this initiative would free up missed appointments for other patients. It is reported that over 27 million doctor consultations go waste in France due to patient absences.
Source: bit.ly/49p7Iug