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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 Union AYUSH Ministry has prohibited to advertise Ayurveda, Siddha, Unani, and Homeopathy drugs with claims of “miraculous or supernatural effects” in order to prevent misleading advertisements with unverified claims. The ministry instructed that such drugs should contain a caution to be taken under medical supervision on its label. Additionally, the ministry issued a public notice clarifying that it does not certify, grants license or approves any company for making ayurvedic drugs.
Source: bit.ly/4eXXjsL
2. India’s central drug regulator (CDSCO) is actively investigating social media influencers who promote false claims, quick fixes and misleading medical content.
Source: bit.ly/4eGfqDC 

3. The Pune division of the Food and Drug Administration (FDA) has taken action against three drug firms for violating the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. The firms were found selling Ayurvedic medicines with misleading claims to cure diabetes, arthritis, and kidney ailments, leading to the seizure of products.
Source: bit.ly/3XUC5Fe

4. The Delhi High Court ruled that a mere fraction of a cause of action occurring in a jurisdiction is insufficient to invoke the court’s territorial jurisdiction. The decision of the court said that in order to raise the territorial jurisdiction of a specific court, there must be a significant link of the matter to the specified territory, reinforcing the standards for filing cases in the court.
Source: bit.ly/3ZXxPr1

5. The Medicines and Healthcare products Regulatory Agency (MHRA) in UK has unveiled its 2024/25 business plan, which prioritizes enhancing access to innovative healthcare technologies while optimizing service delivery. Key initiatives of the plan include the implementation of new IT systems and a commitment to public engagement and diversity in regulatory processes, aimed at reinforcing the UK’s position in life sciences and improving pandemic preparedness.
Source: bit.ly/3BES5Ux

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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. In the most recent 91st Meeting of the Drugs Technical Advisory Board (DTAB) which advises the central government on drug regulatory policy matters, the DTAB has recommended the use of QR code to identify genuine anti-cancer medication, in recognition of recent cases of spurious drugs sale coming to light.
Source: bit.ly/3zP609I

2. The DTAB, has provided rationale for its decision to reject waiver of Clinical Performance Evaluation for IN-Vitro Devices (IVDs) which are already approved internationally. The DTAB expressed its opinion that the performance of IVDs are variable based on the population, and their performance and effectiveness cannot be taken for granted across demographic lines.
Source: bit.ly/3ZV6hT7

3. The Indian Ministry of Environment Forest and Climate Change has notified the new Ecomark Rules, aimed at replacing the erstwhile Ecomark Scheme, 1991. These rules specify criteria for approving ecomark for a product including: recyclability, reduction in pollution and use of non-recyclable resources, and sustainability of production process.
Source: bit.ly/3TXRP9a

4. The Bombay High Court clarified that any seized sample would have to be separated and the individual components of the Cannabis plant identified, because Ganja is defined under the Narcotic Drugs and Psychotropic Substances, Act 1985 only as the “flowering tops” of the Cannabis plant, and for that reason the seeds and leaves cannot be counted towards identifying whether an accused was carrying “commercial quantity” of Ganja.
Source: bit.ly/3NgyD2P

5. In a departure from government policy, the Drugs Consultative Commission (DCC) decided that including the International Nomenclature of Cosmetics Ingredients would be difficult to accommodate, and for that reason all cosmetics manufacturers should continue to adhere to the applicable standards set by the Bureau of Indian Standards (BIS) for their ingredients.
Source: bit.ly/3NduBbB

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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 Central Drug Regulator the Central Drugs Standards Control Organization (CDSCO) has been made an affiliate member of the International Medical Device Regulators Forum (IMDRF). The application submitted by the Indian Government has been accepted contingent on the adoption of comprehensive regulation of Medical Devices in alignment with the existing international standards.
Source: bit.ly/3TQ1GOb

2. India’s Ministry of Health and Family Welfare has introduced Guidelines for Withdrawal of Life Support in Terminally Ill Patients, which sets out the institutional oversight requirements to facilitate ethical and informed decision-making in this regard.
Source: bit.ly/4eReyf6

3. The Supreme Court has held that in case of criminal suits which have an overwhelming civil quality, i.e. are based on private wrongs, where the parties to such criminal suits have already settled with each other, High Courts should exercise their powers under Sec. 482 of the CrPC and quash the underlying criminal proceedings.
Source: bit.ly/4dyF1wQ

4. India’s Central Drugs regulatory authority the Central Drugs Standards Control Organization (CDSCO) has decided that it will initiate action against a manufacturer of eye-drops, which had recently made social-media posts and conducted conferences regarding its new product, which had come under scrutiny for the claim that it would manage near-sightedness, and in pursuance of that, forwarded the matter to the State Drug Regulator of the state of Gujarat where the company is based.
Source: bit.ly/4dtuYJL

5. A prominent US based medical systems and medical devices manufacturer which has suffered a data-breach of its systems leading to the leak of sensitive personal and medical information of its patients, is currently facing a class-action lawsuit on grounds that the breach was caused due to non-adherence to industry standard practices in data storage and security.
Source: bit.ly/3BHdjRl

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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 National Consumer Disputes Redressal Commission (NCDRC) has directed one of the medical device company to pay ₹35 lakh to a consumer as compensation for medical complications arising from the inherently defective design of hip replacement device.
Source: bit.ly/3XP4bla

2. India’s Ministry of Environment, Forest and Climate Change has issued the Ecomark Rules, 2024, detailing the criteria for granting the “Ecomark”. These rules intend to promote environmentally friendly products and support green industries.
Source: bit.ly/47PY0ly

3. India’s District Consumer Dispute Redressal Commission (DCDRC) of North East Delhi, has ordered a leading hospital to pay compensation for negligence to a patient who had met with a road accident on the ground of deficiencies in the services and failure to meet medical obligations.
Source: bit.ly/3ByeP8E

4. India’s Bombay High Court has issued a restraining order in a trademark infringement case against five juice center outlets in Kerala for unauthorized use of the Haji Ali trademark. The court observed the outlets continued using the name, trademark, and logo of Mumbai’s iconic Haji Ali Juice Centre despite the termination of their franchise agreement.
Source: bit.ly/3XP4RXK

5. The Indian Pharmacopoeia Commission (IPC), under India’s Health Ministry, has issued a drug alert regarding the rampant use of “Tetracycline.” The commission advises both doctors and patients to exercise caution while prescribing this medication, as it may cause adverse reactions, specifically Fixed Drug Eruption (FDE).
Source: bit.ly/3Yb5nkp

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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 Punjab and Haryana High Court has urged the Indian government to introduce a legislation to regulate the preservation and disposal of blood in the country. Currently, the sale and disposal of blood is governed by executive instructions issued as guidelines by Centre and State governments.
Source: bit.ly/3TSStVv

2. India’s Central Pollution Control Board has further extended the timeline for filing the Annual Returns for Plastic Packaging Waste for the FY 2023-2024 for Producers, Importers and Brand Owners with Extended Producers Responsibility Registration to 30th November 2024. Previously, this deadline had been extended from 30th June 2024 to 30th September 2024.
Source: bit.ly/3JqZRBH

3. India’s Central Drugs Control Authority may reportedly direct drug regulators across all States and Union Territories (UTs) for uniform implementation of norms for new drugs, specifically regarding the approval of gastro-resistant and delayed-release dosage forms under the New Drugs and Clinical Trial (NDCT) Rules, 2019. The 64th Drugs Consultative Committee (DCC) meeting highlighted inconsistencies in the approval process for these products, which are classified as “New Drugs.”
Source: bit.ly/3XPOtq4

4. India’s Allahabad High Court has directed the Uttar Pradesh government to issue a standard operating procedure (SOP) for Chief Medical Officers (CMOs) and doctors regarding the medical termination of pregnancy (MTP) for timely abortions and proper implementation of existing laws.
Source: bit.ly/47MSBvk

5. India’s National Organ & Tissue Transplant Organization (NOTTO) has released a Standard Operating Procedure (SOP) for Human Organ Transportation by various modes like air, ambulance/ other vehicle, Trains, etc. The SOP includes standardized packaging, mandatory labelling with detailed donor and recipient information, handling of organ box and requirement of a medical personnel to accompany the organs along with necessary documentation.
Source: bit.ly/3BovUBR

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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 central drug regulator (CDSCO) has identified 59 drug samples as Not of Standard Quality (NSQ) in August, including products from major pharmaceutical manufacturers. The action has come after several states and union territories failed to report NSQ data, prompting the CDSCO to emphasize the need for timely submissions to enhance drug safety oversight.
Source: bit.ly/4drUUFz
Source: bit.ly/3zCDmJ0

2. The District Consumer Disputes Redressal Commission-II in Visakhapatnam has awarded a compensation of Rs. 15 lakhs in a medical negligence case and has found the private eye institute, its director, and two ophthalmologists guilty as they failed to meet their medical obligations by neglecting the crucial pre-surgery test of the patient leading to a loss of eyesight of the patient.
Source: bit.ly/3N6HST2

3. The Punjab and Haryana High Court has ordered the attachment of the salaries of several health officials, including the state health secretary for a potential diversion and unauthorised use of funds. The court held that the state cannot withhold the amount released by the central government due to hospitals under the Ayushman Bharat scheme and has asked for a detailed explanation from the state in the matter.
Source: bit.ly/3zCDt7o

4. India’s health ministry has issued draft regulations amending the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 to limit the Maximum Residue Limits (MRL) of pesticides/insecticides in each food community. The notification invites objections and suggestions from stakeholders regarding the proposed changes till November 17, 2024.
Source: bit.ly/47MlQOV

5. The Indian government has released a notification to include Acupuncture under the category “Other Care Professionals” in the schedule of the National Commission for Allied and Healthcare Professions Act, 2021.
Source: bit.ly/3ZJqXNO

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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. Indian government is planning to launch the Trinetra portal to register complaints against Ayurvedic product advertisements making exaggerated, misleading or deceptive claims, concealing important details, or showing deceptive images that can misguide consumers, influence their decisions and result in unfair practices. The portal will enable speedy redressal of complaints through a central registry system and an AI-based redressal mechanism.
Source: bit.ly/3ZGp1pp

2. The government has notified draft rules to amend the Cigarettes and other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Rules, 2004. The draft rules aim to mandate the display of non-skippable anti-tobacco health spots and disclaimers about the harmful effects of tobacco use for films and online curated content platforms.
Source: bit.ly/3MWfUt8

3. The Union Health Ministry has announced that the National Medical Register (NMR) has received 20,000 applications, linking doctor registration to Aadhaar for authenticity. The National Medical Commission has further been asked to initiate efforts for increasing medical seats to add 75,000 more undergraduate and postgraduate seats for aspiring medical professionals.
Source: bit.ly/3XCGcpe

4. India’s Narcotics Commissioner has extended the deadline for companies dealing with psychotropic substances to register themselves on the CBN Online Portal to December 31, 2024. Earlier, this deadline was September 30, 2024. Any failure to register by the revised date will result in the cancellation of registrations, while companies are advised to continue submitting quarterly returns as previously required.
Source: bit.ly/3TDTSPC

5. The High Court of Jammu and Kashmir has recommended proper training for officials of the Drug Controller department to address the high rate of technical defects in prosecutions related to substandard drugs. The court highlighted that many cases fail due to procedural non-compliance, urging the Health and Medical Education Department to implement corrective measures to prevent premature quashing of complaints under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4etb82g

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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. To combat antimicrobial-resistance the Drugs Consultative Committee, which advises the Central and State Governments on conduct of Drug regulation in the country, has, in its 64th meeting recommended amendment to the Drug Rules to regulate sale of antibiotic Drugs to manufacturers who may not have a license under the Drug regulations.
Source: bit.ly/4evHfhA

2. The Punjab and Haryana High Court upheld the position that under the Narcotic Drugs and Psychotropic Substances Act, 1985, upon seizure, the entirety of the bulk of the seized substance need not be sent to the Forensic Laboratory, rather merely a select homogenized sample thereof would be sufficient.
Source: bit.ly/4gx15uL

3. The Supreme Court has ordered the Central Government Ministry of Health and Family welfare, and the Government of Kerala to file counter-affidavits explaining the delayed action in setting up a special committee to study the effectiveness of the Rabies vaccine.
Source: bit.ly/3MXwwAE

4. The High Court of Bombay has struck down the insertion of Rule 3 of Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Amendment Rules, 2023, which empowered the government to set up fact-check units on the ground that this violated the fundamental right to equality and to carry on trade and business.
Source: bit.ly/4diYthg

5. The United States Federal Trade Commission has formally initiated litigation against Pharmacy Benefit Managers which act as middlemen between Drug Companies and Insurers, for deliberately driving the price of insulin higher for consumers and receiving rebates from manufacturers in the process.
Source: bit.ly/3zrNfcq

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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 Director General of Foreign Trade has issued a Trade Notice, reducing the amount of export eligible for net-subvention to only Rs. 5 Crore for MSMEs till 30th September 2024, and Rs. 2.5 Crores for manufacturing exporters as calculated till 20th June 2024.
Source: bit.ly/3zsuYM8

2. The Supreme Court has issued Notices in connection with a Public Interest Litigation challenging the constitutionality of Rule 9(ii) of the Clinical Establishments Rules, which seek to introduce a price-control mechanism on the cost of healthcare treatment.
Source: bit.ly/3zqVx48

3. The Supreme Court has issued an Order recommending that the High Court of West Bengal may consider withdrawing the anticipatory Bail granted to an accused under the Narcotic Drugs and Psychotropic Substances Act, and expressed that it was highly concerning that such anticipatory bail was granted.
Source: bit.ly/3BfCUAY

4. The State Drugs Controller of the State of Karnataka has announced that it will be using emergency medical tracking functions first introduced during the COVID-19 pandemic, to keep track of analgesic medication to prevent their misuse.
Source: bit.ly/47DyH5Z

5. Starting from 19th September 2024, if the investigation of a complaint received by the Competition Commission has lead to it passing an order ex-parte, it shall be mandatory to give notice of said order and provide the impugned parties an opportunity to be heard.
Source: bit.ly/4e8jtIB

Posted on

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 central drug regulator (CDSCO) has released draft guidelines on Good Clinical Practices Rules to align India’s clinical trial rules with international standards. The draft is open for comments by October 12, 2024.
Source: https://bit.ly/3XpPdSr

2. India’s premier consumer forum ordered a major medical device manufacturer to pay compensation to one of the claimants who had suffered adverse reactions as a result of faults in the surgical-implants which they had received from it.
Source: https://bit.ly/3ztLCe5

3. India’s statutory body regulating medical education, National Medical Commission (NMC) has issued revised guidelines removing sodomy and lesbianism from the category of unnatural sexual offences from its curriculum of medical education.
Source: https://bit.ly/3Xr5Kp7

4. India’s union health ministry has expanded the health insurance scheme under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) to cover citizens aged 70 years and above, regardless of their income. The ministry will issue new, unique cards to senior citizens for the availment of the benefit.
Source: https://bit.ly/3XsD2nQ

5. The US Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) hearing aid. The hearing aid will be integrated into the hearing device of a giant electronic brand through software updates allowing the device to function as personalised hearing aid. The feature is aimed at helping users with their perceived mild-to-moderate hearing impairment.
Source: https://bit.ly/4e2LEsn