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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.

Insurance Regulator Removes Barrier to offering Insurance Policy to Senior Citizens among other underserved demographics
India’s Central level Insurance regulator the IRDAI has recently issued the Insurance Regulatory and Development Authority of India (Insurance Products) Regulations, 2024, where it has removed the barrier to insurance for persons over the age of 65 years. Previously, persons defined as “Senior Citizens” were not catered to, in terms of fresh insurance policy offerings.
Source: bit.ly/3JsNLIj

Pharmacists who were not personally dispensing medication at pharmacy penalized by Karnataka Pharmacy Council
The Executive Committee of the Pharmacy Council of the Indian State of Karnataka, by exercise of powers under Section 36 of the Pharmacists Act, 1948 has decided to take disciplinary action against certain Pharmacists for violation under Section 42 whereby only Pharmacists are permitted to dispense medication. It was found that several Pharmacists in the state were absent from their posts and had only been registered with their pharmacies for namesake.
Source: bit.ly/3QB2jtJ

Consumer Affairs Ministry has urged FSSAI to initiate Action against major food manufacturer for high sugar content in infant formula
India’s Central Consumer Affairs Secretary, in a recent letter to the Central Food Regulator (FSSAI), has urged it to initiate action against a major food product manufacturer, in light of the recent serious allegations regarding the heightened sugar content in the infant formula the company has been marketing in India.
Source: bit.ly/3xUo0Ox

India’s Central Bank has published Draft Circular regulating Point-of-Sale Payment Aggregators: Requiring compliance with Guidelines for online Payment Aggregators
India’s Central Bank, the Reserve Bank of India, has issued a Draft Circular for regulation of Payment Aggregators providing point-of-sale services, whereby, within 3 months of publication of final version of this Notification, all entities that are currently providing such services will be mandated to adapt and comply with all requirements concerning Guidelines on governance, merchant on-boarding, customer grievance redressal and dispute management framework, baseline technology recommendations, security, fraud prevention and risk management framework, as provided in a prior Notification on Regulation of Payment Aggregators and Gateways published in 2020.
Source: bit.ly/3U7NwY7
Source: bit.ly/3w55rHa

EU may revise categorization of Personal vs Commercial Confidential Data in Marketing Authorization Process
The European Union Regulator has begun consultation regarding an update to the current regulation surrounding what constitutes Personal data vs Commercial Confidential data in respect of protecting business secrets in marketing authorization applications submitted by pharmaceutical and medical devices companies.
Source: bit.ly/3JvpCRA

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.

Draft Guidance on Vaccine Approval and Quality Monitoring at port of Import published by Central Drug Regulator for Public Commect
The Central Government has recently published a draft of guidance on (1) regulatory framework for conducting vaccine related clinical trials, marketing approval, manufacture, import/ export and post marketing assessment and (2) Risk Based Approach for monitoring quality of imported drugs, medical devices and IVDs at customs ports. Public Comment is sought on these above Guidance Notes, within 30 days of publication i.e. by 10th May 2024.
Source: bit.ly/3xIoiIv
Source: bit.ly/4cVOpvL

Merchants Association Request Central Government Intervention to Stabilize trade of Medicines and Medical Devices with Africa
The Federation of Pharmaceutical and Allied Products Merchant Exporters, an industry association of small and medium sized importers and exporters, has advocated for fiscal and trade policy intervention including continued efforts to stabilize Rupee value, by the Government to stabilize the export of Medicine and Medical Products to Africa, which has seen a sharp decline due to rising shipping tariffs caused by ongoing geopolitical conflicts.
Source: bit.ly/3Q8qlvT

Threefold Increase in FDI in Healthcare and Medical Device Sector in India during latter half of FY 2023-2024
Foreign Direct Investment (FDI) into the Hospital and Diagnostic Sectors in the country has increased by about 90% in the last quarter of 2023-24, as compared to the same quarter the previous year. Moreover, the Medical and Surgical Implements Sector has also seen a nearly 1/3rd growth by proportion during the same time. The total FDI received in hospital and medical devices sector stood at USD 462 Million.
Source: bit.ly/3U6Km70

Modern medicine Doctor body Expresses Concerns regarding Introduction of Integraded School of Medicine as Treatment
The Indian Medical Association, a professional representative body of Doctors, has expressed its concerns regarding the proposal of the Central Government to institute Integrated Medicine, which would offer treatments which are a mix of allopathic, homeopathic and traditional medicine. The Council expressed concern that due to the vast gulf in the manner of training, specialization and expertise between the various schools of medicine means that integration and cross practice treatment may pose severe risk to patient.
Source: bit.ly/3U6yi5E

EU and Japan harmonize Pharmacopoeia for ease of doing Business and regulatory Burden
The European Directorate for the Quality of Medicine and Healthcare, and the Japanese Ministry of Health, Labour and Welfare have entered into a Memorandum of Cooperation and Confidentiality, to coordinate efforts to harmonize the European and Japanese Pharmacopoeia, a move that would reduce the regulatory burden on manufacturers operating in the twin jurisdictions, with respect to carrying out compendial tests and IP approval.
Source: bit.ly/3UmRBJo

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.

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.

Periodic Safety Update Reports for Medical Devices to be filed only through online portal of CDSCO
The Central Medical Devices Regulator of India (Central Drugs Standards Control Organization) has issued a circular, stating that starting on 1st April 2024 it will require and restrict all manufacturers of Medical Devices/ In-vitro Devices to make submission of Periodic Safety Update Reports, only on the online portal and that offline mode of submission of application will not be accepted going forward.
Source: bit.ly/3TEO74B

Absence of Regulation of Second-Hand Medical Devices being Imported into India flagged by Parliamentary Panel
The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in a recent report, has highlighted that currently India’s Central Medical Device Regulations (Medical Devices Rules, 2017) do not regulate second-hand medical devices. The Committee has recommended framing policy to ensure its quality and safety, as well as introducing possible restrictions on import of second-hand or refurbished Medical Devices into India.
Source: bit.ly/3VsdCaQ

Supreme Court Orders Director of Company as well as Endorser of offending Advertisement to be present for Contempt Proceedings relating to misleading advertisements
As part of the ongoing action being taken against a major Indian Ayurvedic Medicine manufacturer for publication of misleading advertisements regarding its products in contravention of an undertaking provided to the Court, the Supreme Court, in pursuance of determining whether to pursue contempt proceedings against the manufacturer, has issued an order requiring the physical presence of the Director of the entity as well as a prominent Ayurvedic Yoga practitioner who had given his endorsement to the claims made in the offending advertisements of the Company.
Source: bit.ly/3vu45VQ

Delhi High Court orders suspension of accounts accused of impersonation of prominent investment group despite objection that no evidence of involvement is provided.
In pursuance of ongoing action against certain anonymous persons impersonating a prominent Investment group and misleading the general public, the Delhi High Court has issued a further order to messaging platform WhatsApp to take action to remove/ block access to certain accounts/ messaging groups, despite objection from the platform that the account/ messaging groups have been prove to neither violate T&Cs of WhatsApp, nor having carried out any illegal activity.
Source: bit.ly/3vkn7hu

EU Parliamentary Committee votes to present amendment to increase exclusivity period for orphan drugs and introduce extended regulatory data-protection period.
The European Parliamentary Committee on Environment, Public Health and Food Safety has voted in favour of introducing several amendments to the current EU Pharmaceutical Directive, including a controversial proposal to increase the exclusivity period for Orphan Drugs from 10 to 11 years, as well as an extended regulatory data-protection period of 9 years; both decisions that industry experts believe may have adverse consequences for competition in the EU Pharmaceutical Market.
Source: bit.ly/3Vr9zeK

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.

Hospitals and pharma companies in India bought electoral bonds worth 9 billion Rupees
Indian hospitals and pharma companies have reportedly bought electoral bonds for approximately Rs. 900 crore. Electoral bonds bought by businesses are later encashed by political parties, and until recently, the identity of businesses that bought electoral bonds was kept confidential.
Source: bit.ly/43qtXyz

New portal for filing consumer complaints to be introduced
India’s Central Consumer Protection Authority (CCPA) will reportedly launch a dedicated online complaint portal for consumers to file complaints against misleading advertisements and unfair trade practices. The timing of the launch of the portal is intended to coincide with World Consumer Rights Day (March 15).
Source: bit.ly/3ViSKCP

New guidelines that will differentiate brand extension and surrogate advertisements to be notified soon
India’s Central Consumer Protection Authority (CCPA) has reportedly formed a committee to deal with the issue of differentiation of genuine brand extensions from surrogate advertisements. Brand extensions are advertisements by companies that extend existing brands into new product categories. For example, advertisements by alcohol companies to sell music CDs, glasses, soda, etc. under the same brand name. However, if the products covered brand extensions are not available for sale in the open market, then such advertisements become surrogate advertisements.
Source: bit.ly/3Tll3hn

EU may soon adopt a single compulsory license regime for medicines in crisis situations
The European Union Parliament is reportedly going to consider a proposal to allow manufacturers of critical medicines to manufacture them for all member states without the consent of the patent holder in crisis situations. Under the current law, even if one State of the EU grants a compulsory license to a manufacturer to manufacture a critical medicine in a crisis situation, the medicine cannot be exported or sold in other EU states unless the concerned State also grants some kind of immunity against the import of such medicine into that State.
Source: bit.ly/3Vp0Iud

Brand owners now responsible for collection of any plastic packaging waste
The Ministry of Environment has amended the Plastic Waste Management (Amendment) Rules, 2024. All brand owners who use plastic packaging on the product package are obligated to collect plastic packaging waste. However, if the brand owners have met the Extended Producer Responsibility targets by contracting with a registered recycler, then physical collection of plastic packaging waste may not be required.
Source: bit.ly/3PrvG0L

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.

Major Indian Ayurvedic Medicine Manufacturer to be tried for Contempt of Court for publishing misleading drug advertisements
India’s Supreme Court is reportedly set to issue a Contempt Notice to a major Ayurvedic medicines manufacturer in India after it found out that the manufacturer had published a misleading advertisement claiming permanent relief for certain chronic conditions such as Diabetes and Liver Cirrhosis. In November 2023, the manufacturer had given an undertaking to the Supreme Court that it will not publish misleading advertisements or disparage allopathy. The Supreme Court has also questioned the Indian government for its inaction over publication of misleading advertisements by the manufacturer despite existence of a law which makes publication of misleading advertisement punishable with imprisonment.
Source: bit.ly/42U33yI

Doctors will have to obtain registration with State Medical Council of every State where they practice: Delhi HC
The High Court of Delhi has upheld the legality of a notice issued by Delhi Medical Council which made it mandatory for Doctors to register with the Council if they wanted to practice in the State of Delhi. The Doctors argued that it was an onerous requirement which would require them to register in every State they practice in. However, the Court held that the intent of the law is to require Doctors to register in every State that they practice in, and that Doctors have the option to register with multiple State Medical Councils in India.
Source: bit.ly/3TgHANw

Cosmetic Importers asked to provide sales details in a bid to curb import of counterfeit cosmetics
In an effort to curb the import of counterfeit cosmetic products, India’s Central Cosmetics Regulator, Drugs Controller General of India, has directed importers of cosmetics who import cosmetics already registered by authorized importers, to furnish annual sales details such as number of consignments, imported quantity, total cost of imported cosmetics of each consignment, along with warehouse details.
Source: bit.ly/42T2IMR

Central Government has to fix ceiling prices of medical treatment within 2 months: Supreme Court
The Supreme Court has directed the Central Government publish ceiling prices for medical treatments offered by Hospitals all over the country within 2 months. If the Central Government fails to do so, the Supreme Court has said that it will direct Central Government to fix medical treatment costs stipulated under Central Government Health Scheme as ceiling price of medical treatment offered by Hospitals for the whole country.
Source: bit.ly/3wsyHHs

India Seeks to delay implementation of EU Carbon Emissions Limits
India is set to conduct negotiation with the European Union regarding the implementation of the Carbon Control Regime, seeking a complete elimination of the Carbon Border Adjustment Mechanism, failing which India will seek an extension of timelines for reduction of emissions. It is expected that in order to comply with requirements under EU Carbon Control Regime, Indian exporters will have to make significant capital investment will increase cost of production.
Source: bit.ly/42S7DxH