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 Pollution Control Board (CPCB) has extended the timelines for the filing of Extended Producer Responsibility (EPR) annul returns by producers of Battery waste and E-waste for the Financial Year (FY) 2023-2024 till 31st March 2025 and 31st January 2025 respectively. For E-waste the extension of timelines also applies to the filing of quarterly returns for the abovementioned FY.
Source: bit.ly/3WthHei
Source: bit.ly/4gcsPmW

2. India’s National Pharmaceutical Pricing Authority (NPPA) has issued an office memorandum (OM) requesting manufacturers and marketing companies of the scheduled formulations nicotine used for nicotine replacement therapy (NRT) to furnish the Price to Retailer (PTR) and Moving Annual Turnover (MAT) data, in value terms for October 2023, within 7 days from the issue of the OM. A format for submitting these details is also provided in the OM. This information is being sought to fix the ceiling prices of these formulations.
Source: bit.ly/4gnoEFb

3. India’s Central Drugs Standard Control Organization (CDSCO) has released a guidance document to support the development of rapid diagnostics for pathogen identification and Antimicrobial Susceptibility Testing (AST). The document offers guidance to innovators and developers on evaluating their tests and demonstrating their effectiveness.
Source: bit.ly/4heX8ue

4. The Kerala High Court (KHC) recently ruled that magic mushrooms are not classified as narcotic substances under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. After reviewing the legal status of psychedelic fungi, the honourable court concluded that since magic mushrooms are not specifically scheduled under Act, they are not subject to its restrictions.
Source: bit.ly/3CiZv0k

5. India’s Central Pollution Control Board (CPCB) has released draft guidelines for the Pharmaceutical Industry in India, which are currently classified as highly polluting. The guidelines outline criteria for the establishment of pharmaceutical units, including mandatory minimum distances from sensitive areas. Stakeholders and the public are invited to submit their comments and suggestions on the draft guidelines by February 5, 2025.
Source: bit.ly/4h1GC0Y

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. The Indian government has extended the deadline for small and medium pharmaceutical companies to comply with the revised Good Manufacturing Practices (GMP) under Schedule M of the Drugs and Cosmetics Act. The revised deadline is December 31, 2025, while the earlier deadline was January 1, 2025. This extension aims to assist smaller manufacturers in upgrading their facilities to meet stringent regulatory requirements.
Source: bit.ly/4a4HaAo

2. The Central Drugs Standard Control Organisation (CDSCO) and the Indian Council of Medical Research (ICMR) have released draft standard evaluation protocols for licensing in-vitro diagnostics (IVDs) under the Medical Devices Rules, 2017. These protocols aim to ensure quality and performance evaluation of IVDs, establishing uniformity in testing across various diagnostic kits. Stakeholders are invited to provide their feedback on the draft by February 15, 2025.
Source: bit.ly/40kTlWt

3. The Ministry of Electronics and Information Technology (MeitY) has released the draft Digital Personal Data Protection Rules, 2025, inviting public feedback until February 18, 2025. These rules aim to operationalize the Digital Personal Data Protection Act, 2023, which was enacted to enhance the framework for protecting digital personal data in India. The draft includes provisions for data localization, compliance requirements for significant data fiduciaries, timelines for storing data and ensuring that personal data is processed responsibly.
Source: bit.ly/3C63oFx

4. The Ministry of Commerce and Industry has launched the Open Network for Digital Commerce (ONDC) initiative to democratize digital commerce in India by fostering open networks for the exchange of goods and services. This initiative focuses on inclusivity, enabling small and medium enterprises (MSMEs) to access digital marketplaces while promoting innovation through open protocols. By creating a level playing field, ONDC seeks to reduce the dominance of large e-commerce platforms and enhance competition among sellers.
Source: bit.ly/4gHo1al

5. The Telangana Medical Council has issued a show-cause notice to a Hyderabad-based hospital for allegedly collaborating with unqualified practitioners and promoting fake doctors. This action follows the hospital’s involvement in sponsoring the medical program and advertising the same on social media, where unqualified individuals were reportedly encouraged. The hospital has been given a 10-day deadline to respond; failure to do so may result in punitive actions under the National Medical Commission (NMC) Act and other regulations.
Source: bit.ly/3BWAQhM

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 apex consumer court, the National Consumer Disputes Redressal Commission (NCDRC), has discharged a Kerala hospital and its doctor from allegations of negligence in an IVF case. The complainants had claimed that procedural lapses led to the failure of the treatment, but the commission found no evidence to support these claims and dismissed the charges.
Source: bit.ly/4fqZkxk

2. The Madhya Pradesh Medical Council reportedly proposes to introduce a system for renewing the doctor’s registration every five years. This will help track how many doctors are still in the state, how many have moved abroad, and how many passed away. The said measure aims to keep the medical registry updated and to ensure compliance with current medical standards.
Source: bit.ly/3ZU6XHX

3. The Delhi High Court has directed the Delhi Medical Council to ensure that patients can access doctor’s qualifications and mandated the public display of credentials. This decision addresses rising concerns about unqualified practitioners and delays in the verification process, aiming to enhance transparency and patient safety in healthcare.
Source: bit.ly/3VFWc9Q

4. India’s central food regulator, the Food Safety and Standards Authority of India (FSSAI), has released an updated list of recognized food testing laboratories, detailing their NABL accreditation validity as of December 12, 2024. These laboratories are authorized to analyze food samples under the Food Safety and Standards Act, 2006. The list includes validity details and contact information for laboratories in the Northern Region, with recognition guidelines governed by FSSAI’s directives.
Source: bit.ly/3ZREIK5

5. The Ministry of Environment, Forest and Climate Change has released a draft of Solid Waste Management Rules, 2024, to address unmanaged solid waste. The draft rules, published on December 9, 2024, will require compliance from various waste generators, including hotels and institutions, and will come into effect on October 1, 2025. The public is invited to submit objections or suggestions regarding the proposed rules by February 7, 2025.
Source: bit.ly/4fgKzw

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 Supreme Court’s National Task Force (NTF), panel of eminent doctors constituted to make an action plan for ensuring the safety of healthcare workers, has opined that there is no requirement for enacting a separate central legislation to protect the doctors as there are already enough legal provisions to ensure their safety.
Source: bit.ly/4fVmIDK

2. India’s Directorate General of Foreign Trade (DGFT) has issued a trade notice to harmonize and streamline pharma export process and bring in line Schedule-II (Export Policy) with the latest tariff codes under the Finance Act, 2024. A draft of Schedule-II covering Chapters 01-98 of the ITC (HS) codes is open for public feedback and comments till 27th November 2024.
Source: bit.ly/3Zo7SR3

3. India’s Ministry of Environment, Forest, and Climate Change has informed that all registered Producers, Importers, and Brand Owners (PIBOs) under the Extended Producer Responsibility (EPR) regime of Plastic Packaging registered during FY 2022-24 are required to file their Annual Returns (AR) for FY 2023-24 by 30th November 2024. Failure to do so will result in their AR being auto-filed and levy of penalty i.e., EPR targets for FY 2024-25 will be increased by 25% over and above the EPR target for FY 2023-24.
Source: bit.ly/3JqZRBH

4. To safeguard patient data and mitigate cybersecurity risks posed by vendor networks, Indian hospitals are reportedly advancing in cybersecurity practices. 89% of hospitals have implemented third-party risk management systems however only 10% hospitals have adopted holistic data privacy programs, underscoring area for improvement. Hospitals are reportedly recommended to allocate 12-15% of their budget over the next two years to cybersecurity and digital infrastructure to remain resilient against cyber threats.
Source: bit.ly/3Oj1ggl

5. The United States Drug Enforcement Administration (DEA) has reportedly extended pre-pandemic telehealth regulations for prescribing controlled substances till 31st December, 2025. This decision allows telemedicine providers to continue prescribing controlled medications without requiring in-person visits, while the agency evaluates public feedback on proposed permanent regulations.
Source: bit.ly/3YTYUcK

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 Supreme Court has ruled that a medical practitioner can only be held accountable for medical negligence if he lacks the necessary training or expertise or if he fails to use his reasonable skill in providing treatment, not because his treatment was unsuccessful.
Source: bit.ly/4e2eEzN

2. The Food and Drug Administration (FDA), Pune division has seized stock worth ₹1 crore due to misleading claims in two separate incidents. This includes ₹78 lakh worth of toothpaste with anti-inflammatory claims and ₹22 lakh worth of cosmetics with suspicious labels. In both cases, the FDA has alleged a violation of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and the samples have been sent for laboratory analysis.
Source: bit.ly/40hcyJa

3. India’s central drug regulator (CDSCO) has identified a list of 18 drugs declared as Not of Standard Quality (NSQ). 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/48njBSE

4. India’s central drug regulator (CDSCO) has identified four drug samples as spurious after drug inspectors in several states inspected them in September. Since the seized batch was not manufactured by the relevant pharmaceutical businesses, the manufacturer reported it as counterfeit. Drug samples are collected from sales and distribution locations as part of ongoing regulatory monitoring, and examined, and a list of spurious drugs is posted on the CDSCO portal once a month.
Source: bit.ly/3YqYqdE

5. To enhance guidelines and standards for the use of disinfectants and antiseptics in healthcare settings, the Indian Pharmacopoeia Commission (IPC) has released a draft of the new general chapter on disinfectants and antiseptics (Version 3.0) for public comments. The last date to submit comments is 8th December 2024.
Source: bit.ly/3YmXtmL

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 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

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. 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

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

 

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 food regulator, Food Safety and Standards Authority of India (FSSAI) has said that it is misleading to differentiate milk and milk products on whether they are made from A1 milk or A2 milk. All manufacturers and marketers and e-commerce entities have been directed to stop claims of A1 and A2 proteins present in the milk. All manufacturers have been given six months to exhaust all of the pre-printed labels containing claims about A1 and A2 proteins.
Source: bit.ly/4dz5awA

2. The Central Pollution Control Board (CPCB) has released updated guidelines for assessing environmental compensation to be levied on entities that violate the Plastic Waste Management Rules, 2016, including Extended Producer Responsibility (EPR) obligations.
Source: bit.ly/46Uh9lX

3. India’s Ministry of Health has banned the 156 fixed-dose combination (FDC) medications, commonly known as “cocktail drugs,” which include multivitamins, antibiotics, and painkillers. The ministry’s rationale is that these drugs have no there is no therapeutic justification and pose a risk to human health, even though there are safer alternatives available.
Source: bit.ly/3XfRVeq

4. The US Food and Drug Administration (FDA) has issued a draft guidance on pre-determined change control plans (PCCPs). The guidelines offer manufacturers a way to specify prospective modifications to a device and apply for premarket authorization for those changes in a marketing submission for the device. This eliminates the need for them to obtain FDA approval for each major change before it is implemented. The draft guidance is open to receiving comments from industry stakeholders till November 20, 2024.
Source: bit.ly/3AtTY5B

5. The Medicines and Healthcare products Regulatory Agency (MHRA), an agency of the Department of Health and Social Care in the United Kingdom, has ruled that a biopharmaceutical company has violated the country’s drug regulations by using a LinkedIn post to advertise prescription-only medicines to the general public.
Source: bit.ly/4fSmKgt

Posted on

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