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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 Supreme Court, while hearing the Patanjali case on misleading advertisements, has asked the Union of India to respond to a question about whether the clinical trial rules for AYUSH drugs have been diluted, particularly in the context of new indications. The amicus for the Court while presenting the matter proposed strict measures for regulating misleading advertisements, such as the effective use of existing penalty mechanisms, prior approval of ads before issuance of licenses, effective inter-state cooperation, and a tie-up between the GoI and ASCI to address complaints.
Source: bit.ly/4d21OSv

2. The Supreme Court while hearing a petition filed by the Indian Medical Association (IMA) challenging Patanjali Ayurved’s misleading advertisements has directed the Ministry of Ayush to create a centralised dashboard where citizens across the country can access information about the action taken in response to their complaints.
Source: bit.ly/4d35inT

3. The Department of Pharmaceuticals (DoP) has extended the deadline for filing a self-declaration under the Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP) to August 31st, 2024. The prior date for filing the self-declaration was July 31st, 2024.
Source: bit.ly/3LLmm5R

4. The Consumer Product Safety Commission (CPSC) in the United States has reportedly placed responsibility on large e-commerce companies for the sale of dangerous third-party products on its platforms, issuing a directive covering more than 400,000 products that violated flammability standards.
Source: bit.ly/3YtFwom

5. The US Food and Drug Administration (USFDA) warned several giant online retailers about selling unapproved chemical peel skin products and asked them to immediately stop marketing them as they could potentially harm customers. The USFDA issued the directive after determining that the items in question included chemicals in high amounts that necessitated medical care.
Source: bit.ly/4caYQJY

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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. 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

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. India’s Supreme Court has reportedly asked the Ministry of Information and Broadcasting to appropriately modify the self-declaration requirement imposed by the Supreme Court on all advertisements, such that the consumers remain protected against misleading advertisement, but the industry is not overly inconvenienced in the process of complying with the self-declaration requirement.
Source: bit.ly/3xYqk7C

2. The Supreme Court has ruled that not disclosing critical or material information about safety at the time of promotion of the product amounts to unfair trade practices.
Source: bit.ly/460Duxr

3. Central Drugs Standard Control Organization (CDSCO), India’s drug regulatory authority, is reportedly planning to take action against pharmaceutical companies that fail to implement barcodes or QR codes on the top 300 medicine brands identified by the National Pharmaceutical Pricing Authority (NPPA).
Source: bit.ly/3zJllrU

4. MeDevIS (Medical Devices Information System) online portal, the first worldwide open access clearing house for information on medical devices, was launched by the World Health Organization (WHO). It is intended to assist governments, regulators, and users in making decisions about the selection, procurement, and use of medical devices for diagnosing, testing, and treating diseases and health conditions. MeDevIS refers to two international naming systems for medical devices: the European Medical Device Nomenclature (EMDN) and the Global Medical Device Nomenclature (GMDN), which attempt to maintain data uniformity across borders.
Source: bit.ly/3zJQIm9

5. The U.S. Federal Trade Commission recently stated that a pharmacy benefit managers (PBM), who operate as middlemen between pharmaceutical firms and customers, have an excessive amount of influence over prescription drug costs due to the years-long dealmaking which has ultimately resulted in the consolidation of pharmacies and health insurance companies.
Source: bit.ly/3W0Mhee

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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

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Madras Court in a recent order, held that the current status-quo regarding online sale of Drugs i.e. sale being facilitated only through licensed chemists and pharmacists shall prevail, until either the Central Government frames rules or the Delhi High Court issues further orders/judgment.
Source: bit.ly/45Uxfv2

2. The Jharkhand High Court has reaffirmed precedent laid down by the Supreme Court in Martin F. D’Souza v Mohd. Ishfaq, that a private complaint against a doctor for medical negligence should only initiated by a consumer forum or criminal court, the same should be referred to a doctor/expert panel to ascertain whether there is a prima-facie case for negligence.
Source: bit.ly/3VRPooP

3. In light of recent surge in cases of dengue in Bengaluru, the Karnataka Government has issued an order to cap the price of Dengue NSI Antigen and ELISA Igm Antibody tests, conducted in Private Hospitals and Diagnostic Centres, at Rs. 250, and 300 respectively.
Source: bit.ly/3LdE1ms

4. The Delhi High Court has recently held that conversations on WhatsApp will be considered electronic record under Sec. 65B of the Act and require the necessary certificate from a person responsible for operating the computer device to generate the WhatsApp message.
Source: bit.ly/4eMwb0p

5. The head of the US’s AI task force, among others, has stepped down from his role as director at the Coalition for Health AI, the recently set up Industry Body that was aimed at guiding the US Government for setting up policy framework for regulating AI use in the Healthcare Sector.
Source: bit.ly/3VQ4zyW

 

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TOP 5 HEALTH LAWS AND POLICY UPDATES

The new criminal code, Bharatiya Nyaya Sanhita (BNS) has replaced the Indian Penal Code (IPC) and introduced stricter penalties for medical negligence. Registered Medical Practitioners can now face up to two years in jail and fines for medical negligence. The new law will apply from July 1, 2024.
Source: bit.ly/3RXnx5t

The Central Pollution Control Board (CPCB) has extended the last date of filing of annual returns by the registered producers, importers, brand owners (PIBOs) and plastic waste processors for FY 2022-24 and FY 2023-24 respectively till September 2024. The earlier timeline to file the annual returns were June 30, 2024 and April 30, 2024 respectively.
Source: bit.ly/3XQtxAY

In an effort to decrease reliance on imports and to promote domestic production of medical devices, the Department of Pharmaceuticals (DoP) reportedly intends to launch a new program that will provide shared facilities for medical device parks or clusters that are formed with the exclusive financial assistance of the state governments.
Source: bit.ly/3xU6b2u

The Enforcement Directorate (ED) is investigating an alleged nationwide network of contraband dealers and has placed several pharmaceutical companies under scrutiny who are engaged in the production of drugs and opioids as a measure to prevent the creation of illicit distribution networks through fraudulent sale and supply bills.
Source: bit.ly/3VNzoEw

The United States Food and Drug Administration (USFDA) has published a draft guidance that removes the requirement of undertaking switching studies for applicants undertaking an approval for treating Biosimilars as interchangeable. The USFDA has now made switching studies optional for biosimilar approvals. Hence, persons applying for approval for Biosimilars may now use computer modelling based on the current acceptable analytical technologies to demonstrate the Biosimilars as interchangeable.
Source: bit.ly/4eQUudy

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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.

Absence of essential medicines in a hospital constitutes medical negligence
India’s National Consumer Dispute Redressal Commission (NCDRC) has held that absence of an essential injectable medicine within the hospital, resulting in administration of an alternate injection to a patient who later died, constituted medical negligence. The court ordered the Hospital to pay Rs 25 Lakh as compensation.
Source: bit.ly/3UtaJ7u

Cost of conducting clinical trial of drug published in public domain for first time
Médecins sans frontières (MSF/doctors without borders), a non-governmental organization dedicated to delivering international medical aid, has published cost of conducting clinical trial of a new drug. As per MSF, no pharmaceutical company has published actual cost of conducting clinical trials, though such costs are frequently referenced to justify high drug prices.
Source: bit.ly/3wjvo5J

Indian standards for infant formula permit addition of sugar, therefore controversy surrounding added sugar in infant food unwarranted: Industry
A popular infant formula formulation company has clarified that the sugar content in their product is within the limits prescribed by India’s food regulator, Food Safety and Standards Authority of India (FSSAI). This clarification was issued after reports that the product being sold in low-and-middle income countries has high sugar content.
Source: bit.ly/3UsnaQH

Indian medical device regulator has allowed sale of sleep apnea devices post rectification of foam degradation issue
A major manufacturer of sleep apnea therapy devices has reportedly confirmed that its devices are sold in India without the foam degradation issue, which had previously caused it to recall its devices in India and around the world. In the US, the manufacturer has agreed to provide users of affected devices with new, updated, or equivalent devices with a renewed warranty or a refund.
Source: bit.ly/3WufUXh

Revised guidance for referencing of biological products by biosimilar drugs published for comments by US FDA
The US Food and Drugs Administration (USFDA) has released a revised guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products.” The guidance addresses various questions that manufacturers, packers, distributors, and their representatives/firms may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act (PHS Act).
Source: bit.ly/3wudFsl

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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.

NOC for the manufacture of unapproved drugs meant for export will be issued by the Central Drug Regulator
India’s Central Drug Regulator (CDSCO) will be the competent authority to issue the No Objection Certificate (NOC) required by pharmaceutical companies for the manufacture of unapproved, new, or banned drugs for export purposes, starting from 15th May 2024. The NOC will be issued by the zonal offices of CDSCO. The application for NOC will have to be made online. Prior to CDSCO, it was the State Licensing Authorities that issued NOCs.
Source: bit.ly/4dkZO8u

Producers of Batteries can meet EPR Targets and file Annual Returns by June 30, 2024
The deadline for meeting Extended Producer Responsibility (EPR) targets and submitting annual returns by the producers of all types of batteries has been extended to June 30, 2024.
Source: bit.ly/4a0Uynx

Private hospitals demand payment of interests from the government on delay of reimbursement for treatment under Ayushman Bharat Scheme
India’s Association of Healthcare Providers (AHPI) has raised concerns over inordinate delay in receiving reimbursement for treatment provided to Ayushman Bharat beneficiaries, which impedes cash flow and poses serious operational issues for all hospitals. The Association has urged that the government pay 1 percent interest on payments delayed beyond one month under the Ayushman Bharat scheme, which is the Central Government’s flagship universal health coverage scheme, as well as change of package rate to allow beneficiaries to avail of continued benefits from the Ayushman Bharat Scheme
Source: bit.ly/3wimXHQ

US government likely to ease restrictions on regulation of Marijuana
The U.S. Drug Enforcement Administration (DEA) is likely to reclassify marijuana as a less dangerous drug by moving it from a tightly regulated class to a less tightly regulated class. Although the DEA’s proposal would highlight the medical benefits of cannabis, it would not allow its use for recreational purposes. The White House Office of Management and Budget is reportedly still in the process of reviewing the idea.
Source: bit.ly/4a2osrm

Form 483 notice need not to be responded by manufacturers of medical devices within 15 days: US Medical device experts
According to US Food and Drug Administration (FDA) officials, a medical device manufacturing company is not required to respond to a Form 483 notice (Notice of Inspectional Observations) within 15 days. The 15-day deadline for response applies to warning letters and not to Form 483 notices, though the FDA advises that if the manufacturer wishes to respond to a Form 483 notice, then it should do so within 15 days of the notice.
Source: bit.ly/44FHVxn

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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.

New Framework to be created to separately regulate prices of Medical Devices
In response to demands from industry associations, India’s Central Drug Price Regulator, the National Pharmaceutical Pricing Authority (NPPA), in collaboration with the Department of Pharmaceuticals is reportedly in the process of developing a special pricing framework for Medical Devices comparable to similar prevailing regulations in other jurisdictions.
Source: bit.ly/49Wh8hc

Testing Standards for stability testing of In-Vitro Diagnostic Medical Devices have been prescribed to obtain manufacturing/ import license
India’s Central Drugs Standards Regulator (CDSCO) has released a draft Guideline regarding conduct of Stability Studies for In-Vitro Diagnostic Medical Devices (IvDMD). These guidelines cover the standards and testing for determining the overall shelf life, individual component stability, stability during transportation as well as, in-use stability of IvDMD. These guidelines are applicable for all manufacturers who are in preparation of submitting a pre-market review document in pursuance of obtaining a manufacturing/ import license under the Medical Devices Rules, 2017.
Source: bit.ly/4aP4TUJ

Students pursuing courses in Indian System of medicine will have to give exit test prior to applying for Registration as a practitioner of Indian System of Medicine: Delhi HC
In a recent decision, the Delhi High Court has held that only those students that have already obtained their respective recognized qualifications (either a BAMS, or BUMS degree) would be permitted to initiate the process for registering as a practitioner of Indian Traditional Medicine. This decision was taken on the basis of Sec. 15(1) of the National Commission for Indian School of Medicine Act, 2020 which mandates a common final exit test to be cleared prior to registration with State Register.
Source: bit.ly/3JxjPLo

Government relaxes obligation of deductees to pay higher TDS for persons whose PAN remained inactive for FY 2023-2024
In pursuance of Circular No. 3 of 2023, a person whose PAN (Permanent Account Number) has become inoperative has been subject to a higher rate of TDS. The Central Board of Direct Taxes has issued a notification recently, which relaxes this obligation of persons to deduct at a higher rate of TDS, for all transactions dated till 31st March 2024 provided that the linked PAN is reactivated before 31st May 2024.
Source: bit.ly/4aR96HE

AI Taking up more of Doctors’ time since it needs more training and monitoring
In a set of recently published studies at various teaching hospitals, it was revealed that using AI to manage patient interaction and medical records to assist Doctors has in fact, lead to Doctors spending more time on the tasks delegated to the AI, since the Doctors were now required to train and supervise the AI in addition to carrying out their regular responsibilities for these tasks.
Source: bit.ly/3Wg75QU