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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 Supreme Court of India has dismissed a Public Interest Litigation (PIL) seeking quality regulation for “prasad” food items distributed at religious places, stating that the Food Safety and Standards Authority of India (FSSAI) already oversees food safety standards.
Source: bit.ly/4eYIJAX

2. The District Consumer Disputes Redressal Commission in Delhi has ordered a compensation of Rs. 48 lakhs against a hospital and its doctors for performing surgery without the necessary expertise and proper disease assessment. The commission found that the medical professionals manipulated records to obscure the actual causes of the complications, which constituted medical misconduct and negligence.
Source: bit.ly/4iiLHTM

3. The Ministry of Consumer Affairs, Food & Public Distribution has issued draft rules for clinical electrical thermometers, inviting feedback from stakeholders by December 30, 2024. The draft rules provides technical standards of clinical electrical thermometers to ensure the accurate measurement of body temperature is recorded in clinical settings.
Source: bit.ly/3CVrjYs

4. India’s food regulator, the Food Safety and Standards Authority of India (FSSAI) has designated packaged drinking water and mineral water as “High-Risk Food Categories” after the removal of mandatory Bureau of Indian Standards (BIS) certification for these products. This decision will now require the manufacturers to undergo annual risk-based inspections and third-party audits before obtaining licenses or registrations.
Source: bit.ly/4i8DO3b

5. The Ministry of Consumer Affairs has released draft rules for non-invasive automated sphygmomanometers, inviting comments from stakeholders by December 30, 2024. The draft rules aim to establish regulatory standards for the measurement of blood pressure using these devices. The scope of the draft includes specifications for the design, performance, and testing methods required to ensure accuracy and reliability in clinical settings.
Source: bit.ly/3OC0Ku6

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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 apex food regulator, Food Safety Standard Authority of India (FSSAI), has launched an online portal “Food Import Rejection Alert (FIRA)” for alerts on food import rejections and to ensure traceability and transparency. Also, food consignments from Sri Lanka, Bangladesh, Japan, China & Turkey has been rejected as they fell short of the standards.
Source: bit.ly/49aLJIT

2. Delay in clearance of import consignments of essential components has reportedly resulted in the disruptions in the manufacture of medical devices in India.
Source: bit.ly/3OpyhHx

3. India’s National Standards Body, Bureau of Indian Standards (BIS) to reportedly prioritize development of standards for 214 critical medical devices post consultation with the Department of Pharmaceuticals (DoP). Standards set to be completed by December 2025.
Source: bit.ly/3B2ZtZJ

4. India’s Meghalaya High Court has called for ban on manufacture, marketing and use of plastic of less than 120 microns.
Source: bit.ly/3Z4VT9C

5. The US Food and Drug Administration (FDA) has announced a temporary enforcement policy to enable certain sterilization site changes for Class III medical devices that are sterilized using ethylene oxide (EtO). Affected medical device manufacturers requesting enforcement discretion must submit an “informal notification” along with certain information to FDA.
Source: bit.ly/3OpairY
Source: bit.ly/3Zpx6OT

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.  A State Consumer Disputes Redressal Commission (SCDRC), Punjab has exonerated a private eye hospital from medical negligence allegations, finding no evidence that surgery was performed on the patient. The commission ruled that the claims were unfounded, thus dismissing the case against the hospital with no liability for damages.
Source: bit.ly/499Wxr0

2. The Delhi High Court has requested that the government create clear guidelines regarding doctors’ digital signatures on medical documents in order to reduce the use of unauthorized and fraudulent signatures in medical practices and to make clear the legal and regulatory implications of using digital signatures in healthcare.
Source: bit.ly/3YWXD4A

3. India’s Finance Minister, Nirmala Sitharaman has proposed to establish the creation of Bharat Food and Drug Administration (BFDA) to set global benchmarks for food and drug safety, similar to the US FDA. The emphasis to create such standard is to enhance India’s regulatory framework and strengthen its position in the global market.
Source: bit.ly/3V9E7Rb

4. The Indian government plans to amend the Drugs and Cosmetics Rules, 1945 to allow State Licensing Authorities (SLAs) and the Central Licensing Authority (CLA) to issue manufacturing licenses for products derived from stem cells and gene therapies. This move aims to streamline the regulatory process and promote the development of innovative therapies in India, enhancing compliance with global standards.
Source: bit.ly/3Os1VMx

5. The USFDA has finalized guidance for its 510(k) Third Party Review Program, which permits accredited third-party organizations to evaluate specific low- to moderate-risk medical devices for market clearance. The guidance is designed to expedite the review process to enhance efficiency in device approvals, ultimately facilitating quicker access to innovative medical technologies for patients.
Source: bit.ly/414wwHC

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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 Madras High Court has refused to impose a ban on advertisements by doctors and hospitals in the media, stating that it cannot expect media outlets to verify every advertisement on fake drugs, hospitals and treatments. The court acknowledged concerns about misleading advertisements and stated that doctors and hospitals should have self-regularisation and in case of violation the Medical Commission should take action.
Source: bit.ly/3CzfDu4
2. The Supreme Court of India raised serious concerns about live surgery broadcasts, citing risks to patient safety and informed consent. The court noted the absence of officials from the National Medical Commission and the Central Government during a hearing, emphasizing the need for guidelines to regulate such practices effectively.
Source: bit.ly/4fyc8CM3.

3. The Union Minister for Chemicals and Fertilizers, Jagat Prakash Nadda, has launched a new initiative called the “Scheme for Strengthening the Medical Device Industry,” to enhance manufacturing, skill development, clinical studies, and infrastructure in the medical device sector. It includes five sub-schemes designed to reduce import dependence and promote domestic production, ultimately supporting India’s goal of self-reliance in healthcare.
Source: bit.ly/4fjICRq

4. The Supreme Court of India has ordered the government to enforce mandatory accessibility rules under the Rights of Persons with Disabilities (RPWD) Act, 2016 emphasizing the need for compliance to ensure public spaces are accessible for disabled individuals. The court has given the government three months to establish clear guidelines and penalties for non-compliance.
Source: bit.ly/3UNULWl

5. Reportedly, government entities in India are exempt from the Digital Personal Data Protection (DPDP) Act, 2023, which permits them to process personal data under specific circumstances without following the Act’s normal provisions. Hospitals, however, are not granted this exemption and must therefore abide with data privacy regulations.
Source: bit.ly/3CkdRwZ

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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

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. In a new Amendment to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, the Food Safety and Standards Authority of India (FSSAI) has clarified that BIS standards mark requirement may no longer be necessarily applicable for manufacture and sale of infant milk food, infant formula and milk cereal based weaning food etc. as well as Condensed milk sweetened, condensed skimmed milk sweetened, milk powder, skimmed milk powder, partly skimmed milk powder and partly skimmed sweetened.
Source: bit.ly/4hkwSPN
Source: bit.ly/3BXUuK4

2. In a recent amendment to the  Food Safety and Standards (Contaminants, toxins and Residues) First Regulations, 2011, which shall come into force from 1st April 2025 the Food Safety and Standards Authority of India (FSSAI)has: (1) Simplified and reduced the number of prohibited use Antimicrobials including chloroform, stilbenes and other steroids, (2) Increased the permissible concentration for Antimicrobials in Honey, (3) reduced the concentration of antimicrobials in cattle.
Source: bit.ly/3AdyXMN

3. The Rajasthan Authority for Advance Rulings held that the vanilla mix being sold by a major manufacturer of consumer food products in the country would not be classified as an “ice-cream” for the purpose of taxation under the Goods and Services Act, 2017 (GST Act) due to sugar being the major ingredient at about 65%. This decision in contrast to the Supreme Court’s decision on similar grounds.
Source: bit.ly/3BW78sY
Source: bit.ly/3BQh9I0

4. The Supreme Court quashed a criminal case which had been filed against a major Indian bank for non-compliance with an order of the authority under the Income Tax Act, holding that an allegation of mens rea cannot be made against a juristic person such as the bank and that the intention of the officers and functionaries cannot be construed to be that of the juristic person itself.
Source: bit.ly/3C5fH4y

5. The Therapeutic Goods Administration (TGA), Australia’s regulator for Medical Devices has clarified some queries concerning its updated Essential Principles, which are necessary compliances for getting approval for devices in Australia. In this new update to the checklist, the TGA has reiterated its existing commitment to recognizing foreign approval standards, and has placed obligation on Sponsors to update the TGA if their Manufacturer Evidence may be expiring in 50 days, among other things.
Source: bit.ly/48jlWxM
Source: bit.ly/4eSYR7P

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 Drugs Technical Advisory Board (DTAB) has approved a proposal to amend the New Drugs and Clinical Trials (ND&CT) Rules, 2019 to eliminate the two-step certificate issuance process for biomedical and health research ethics committee registration. Now, a system for reviewing and examining all ethics committee documents has been put in place at Department of Health Research (DHR). This process allows for the removal of redundant work and resource use, and only final certificates can be directly issued to ethics committees.
Source: bit.ly/3A8haGQ

2. To improve India’s whole digital healthcare infrastructure, a new certification program for hospital information systems (HIS) and electronic medical records (EMR) has been introduced by the National Accreditation Board for Hospitals and Healthcare Providers (NABH). The program offers Basic and Advanced maturity levels that are valid for two years. The NABH portal will open for registration on December 1, 2024.
Source: bit.ly/3UjzcN7

3. The Drugs Controller General of India (DCGI) plans to amend the Medical Devices Rules, 2017, to include quality control provisions for non-sterile, non-invasive Class A medical devices like thermometers and stethoscopes. Currently exempt from licensing, these devices will now require manufacturers to comply with a quality management system.
Source: bit.ly/3NApDpw

4. The Madras High Court has ruled that Siddha practitioners are permitted to practice modern medicine but are prohibited from storing allopathic drugs without a valid license under the Drugs and Cosmetics Act, 1940.
Source: bit.ly/4hs9VKT

5. The World Health Organization (WHO) has prepared a draft guideline for food packaging to include health impact labels on the front, emphasizing the need for clearer consumer information regarding potential health risks associated with food contact materials. The draft received public comments till October 11, 2024 and will release the final guidelines in 2025.
Source: bit.ly/3BQlKKm

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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

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 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

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 Pharmacopoeia Commission (IPC) and India’s Central Drug Authority (CDSCO) have released Version 2.0 of the “Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products” wherein they have extended the timelines to report non-serious adverse events within 90 calendar days from the previous proposed timelines of 30 days.
Source: bit.ly/4dctGCs

2. Drugs Consultative Committee (DCC), which advises the Central and State Governments on uniform implementation of drug laws in India, has reportedly advised all the State Licensing Authorities (SLA) to ensure that all applications are exclusively received and processed through the Online National Drugs License System (ONDLS) portal only.
Source: bit.ly/4ejO8Tr

3. The Federal Court of Australia has heavily penalized and ordered one of the leading manufacturers and suppliers of medical devices for unlawfully supplying Infuse Bone Graft Kit without LT Cage. The Australian Register of Therapeutic Goods (ARTG) prevents the supply of Infuse Bone Graft Kit without LT Cage.
Source: bit.ly/3XChUMd
Source: bit.ly/4dlv5H1

4. The World Health Organization (WHO) has released guidance on best practices for clinical trials to improve the design, conduct, and oversight of clinical trials in countries of all income levels. The guidance provides recommendations to the national health authorities, regulatory authorities, funders, and others on how to facilitate clinical trials to generate evidence on health interventions in addition to practical concerns.
Source: bit.ly/47Fc0hI
Source: bit.ly/4ezzQxN

5. India’s Central Drug Licensing Authority has reportedly introduced new guidelines to lower the frequency of drug testing for imports from nations like the US, Australia, Japan, Canada, and the European Union, to one sample from every two years’ worth of consignments or one sample out of every 20 consecutive consignments, whichever occurs first provided the drug samples maintain a clean record with no quality failures in the last five years.
Source: bit.ly/3Bgacjo