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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 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

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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. The Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO) have released Version 2.0 of the “Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products”. This document facilitates the submission of the safety profiles of drugs by MAHs (manufacturer, marketer, or importer of a drug) and outlines the timeline for the process.
Source: bit.ly/4dctGCs

2. India’s Central Drug Regulator (CDSCO) is reportedly considering a proposal to change the color of all antimicrobial drug strips to blue for safer usage and to visually differentiate these drugs to curb antimicrobial resistance (AMR). This proposal would apply to pharmaceutical drugs and medicines, including antibiotics, antivirals, anti-parasitics, and antifungal drugs.
Source: bit.ly/47BUL0P

3. India’s Department of Food and Public Distribution (DFPD) has asked the leading edible oil associations in India to maintain the maximum retail price (MRP) of edible oil until the stocks of the edible oil that are imported at 0% and 12.5% basic customs duty (BCD) are exhausted. The Government of India has increased the BCD on various edible oils, which is effective from 14th September 2024, to support domestic oilseed prices.
Source: bit.ly/4e9Gwmj

4. The International Organization for Standardization (ISO) has released the second edition of ISO 23500-1:2024, outlining requirements for the preparation and quality management of fluids used in hemodialysis and related therapies. This standard guides practitioners on handling dialysis and substitution fluids for advanced treatments like hemodiafiltration and hemofiltration.
Source: bit.ly/3Bjlzqt
Source: bit.ly/4gskk8H

5. India’s Maharashtra Food and Drugs Administration (FDA) has taken action against an Ayurvedic drug manufacturing company by seizing its products and prohibiting the further distribution of its Ayurvedic drugs due to improper labeling. The company has made false and misleading claims about the drugs and its treatment in its advertisements, which are prohibited under the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, and Rules, 1955.
Source: bit.ly/3ZucKUU

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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 Government of India, reportedly plans to establish a distinct category for advanced coronary stents and increase its ceiling price. This change is intended to ensure that stent manufacturers launching next-generation devices in India are not affected by price control measures.
Source: bit.ly/4cOGnU4

2. India’s Department of Pharmaceuticals (DoP) is reportedly developing a ‘Disposal Policy’ for sound disposal of expired, leftover, substandard, spurious, and adulterated drugs from the sale premises and from the households to prevent environmental damage and curb antimicrobial resistance (AMR).
Source: bit.ly/47dCgQ2

3. The Karnataka High Court has directed the Drug Controller General of India to establish an efficient online system whereby the drug samples which are sent for test/analysis are expeditiously tested and analysed by the Government Analyst within 60 days and the reports sent by them are available online on a real-time basis.
Source: bit.ly/3Te2Umc

4. India’s Department of Telecommunications (DoT) has advised all unregistered Machine to Machine Service Providers (M2M SPs) and WPAN/WLAN Connectivity Providers for M2M services to register with the DoT by September 30, 2024, to prevent any disruption to their services. Failure to comply may result in the withdrawal of telecom resources from authorized telecom licensees.
Source: bit.ly/3Xeknft

5. The Indian Council of Medical Research (ICMR) is reportedly developing evidence-based guidelines for the empirical use of antibiotics to address antimicrobial resistance (AMR), which is a significant public health challenge in India
Source: bit.ly/4cROOhl

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. Due to a recent spike in cases, the Karnataka Government has declared dengue as an “epidemic” and to that effect has issued a notification under the Karnataka Epidemic Diseases Regulations, 2020. As part of the notification, the government has empowered Municipal Corporations across the state to carry out inspections of sites for compliance with mosquito prevention measures.
Source: bit.ly/3ThmkGK

2. Industry associations of manufacturers of Drugs and Medical Devices have called for an amendment of the Drugs (Prices Control) Order, 2013 to make pricing guidelines uniform for both Scheduled and non-scheduled formulations.
Source: bit.ly/3AJuTUn

3. India’s Central food regulator, the Food Safety and Standards Authority of India has issued a notification to re-operationalize The Food Safety Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022, in the interim of formulating new regulations.
Source: bit.ly/3ASeVYj

4. It is reported that IT’s upcoming meeting scheduled for 9th September, the Goods and Services Tax Council may take a decision on removing the existing 18% Goods and Services Tax on health insurance policies.
Source: bit.ly/3TjjrWa

5. In pursuance of its larger and long-term project of fighting and reducing anti-microbial resistance, the World Health Organization has issued a guidance directing management of “antibiotic waste” generated by manufacturers, which contributes to rising levels of anti-microbial resistance.
Source: bit.ly/4g922t1

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) is set to develop guidelines for the safe disposal of pharmaceutical waste which are expired and unused drugs and medicines, to curb antimicrobial resistance (AMR).
Source: bit.ly/3yOlfPY

2. The Indian Health Ministry has reportedly stated that 156 fixed dose combination (FDC) drugs recently banned were licensed by the State Licensing Authorities (SLA) without prior approval from the Drug Controller General of India (DCGI).
Source: bit.ly/3Xl6Xj7

3. Bureau of Indian Standards (BIS) certification will be mandatory for medical textile products covered by Quality Control Order from 1st October 2024. The products that will require certification and BIS mark are sanitary napkins, reusable sanitary pads/sanitary napkins, period panties, baby diapers, hospital bed linens, pillow covers, dental bibs and shoe covers intended for medical use.
Source: bit.ly/4e3FI1U

4. India’s major pharma companies have requested the Delhi High Court to quash the government’s recent notification banning 156 fixed-dose combination (FDC) drugs. They have also sought interim relief in their petitions to exhaust the stock that was manufactured before the notification came into effect, prohibiting any coercive measures against retailers and stockists until the stock is exhausted.
Source: bit.ly/3yUZFcw

5. India’s Central Pollution Control Board has issued a show cause notice to producers, importers, and brand owners (PIBOs) of plastic packaging, requiring them to file annual reports and fulfill Extended Producer Responsibility (EPR) obligations for the financial year 2022-2023 by September 1, 2024. Failure to comply will result in the imposition of environmental compensation (EC) and additional penalties.
Source: bit.ly/3XmQ5bF
Source: bit.ly/3XmQc75
Source: bit.ly/3yUZAWg

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TOP 5 HEALTH LAWS AND POLICY UPDATES

1. The Central Government is mulling including non-prescription Neutraceuticals currently regulated by the Central government food regulator the Food Safety Standards Authority of India, under the price control regime similar to Drug price regulation under the Drugs (Prices control) Order, 2013.
Source: bit.ly/4cRZVb7

2. The Supreme Court in continuation of prior orders issued acknowledging the concerns raised in a petition seeking to address the shortage of life saving Antiretroviral Drugs in the country, has granted the request of the petitioner to discuss the access of quality Antiretroviral Drugs to persons dealing with HIV.
Source: bit.ly/4cAATg9

3. The Central Government has issued a Draft Notification proposing amendment to the Drugs Rules, 1945, mainly intending to introduce restriction on advertising Drugs listed in Schedule G of the Rules.
Source: bit.ly/3Whm0Ke
Source: bit.ly/3VZZ0Or

4. Then United States Federal Trade Commission is set to take action against Drug supply middlemen and major pharmacy chains for use of anticompetitive tactics in negotiating Drug prices.
Source: bit.ly/3WgtAom

5. The World Health Organization has issued a new and updated list of pathogens, to reorient the prioritization in combating Antimicrobial Resistance.
Source: bit.ly/4czZdiw

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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.

Indian Drug Manufacturers will have to put in place prompt and effective recall procedure soon
At a meeting called by India’s Health Ministry with drug manufacturers, the Ministry has reportedly reminded all drug manufacturers that they will have to put in place a prompt and effective drug recall system. Such a drug recall system is a mandatory requirement of revised Schedule M of Drugs Rules, 1945, which is scheduled to come into effect on 27th June 2024 for large enterprises, and on 27th December 2024 for small and medium scale enterprises.
Source: bit.ly/3wbgKgZ

India’s central food regulator to conduct own testing and investigation into pre-packed spices manufactured in India
India’s Central Food Regulator (FSSAI) has recently issued a statement declaring that it is currently in the process of collecting samples of fruit and vegetables, fish products and spices and culinary herbs, as part of its scheduled surveillance for salmonella and other contaminants. This statement has come in light of the recent ban by Governments of Hong Kong and Singapore on certain brands of Indian spices, on the basis that the products contained Ethylene Oxide, a known carcinogen that can cause breast cancer and lymphoma.
Source: bit.ly/3UFCXgH

Supreme Court seeks explanation from Central Government on proposal to fix prices for ophthalmologic procedures
The Supreme Court has issued a Notice to the Central Government, seeking response on the nature of power and viability of regulations that permit government to uniformly fix the prices across private hospitals for Ophthalmologic procedures. The Court has clubbed this matter along with a pending case, where the Central Government has been directed by the Supreme Court to determine a policy to fix uniform prices for procedures done at private hospitals.
Source: bit.ly/4bzRdx9

If husband is unable to contribute gamete, then wife is not barred from seeking gamete from a donor for IVF: High Court
In a recent decision, the Calcutta High Court has held that, under India’s current regulatory regime surrounding In-Vitro Fertilization (IVF), there is no restriction that requires that either the egg or the sperm must come from the couple seeking the IVF themselves. A married woman may seek to obtain sperm from a third party donor.
Source: bit.ly/3Uocq68

Excessive prescription and use of Antibacterial medicine in treatment of COVID-19 has increased global Antimicrobial Resistance: WHO
The World Health Organization has recently posted findings from its Global Clinical Platform for COVID-19, which are an anonymized repository of worldwide treatment data. These findings have revealed that there has been rampant over-prescription and use of antibiotics worldwide, in the course of treating COVID-19, which has contributed to the globally rising Antimicrobial Resistance problem.
Source: bit.ly/4dnzWcb

Posted on

TOP 5 HEALTH LAWS & 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 Departmental Guidelines for sampling of Spurious Drugs, Medical Devices and Cosmetics Published
India’s apex regulatory body for drugs, medical devices and cosmetics, the Central Drugs Standards Control Organization, has published revised sampling guidelines for inspectors to follow in various states. All inspectors are required to collect at least 9 samples of drugs, and 1 sample of cosmetic or medical device in each month. The inspectors are supposed to be alert about feedback received from citizens and doctors in deciding which drugs, cosmetics and medical device brands they ought to sample and test for compliance with laws.
Source: bit.ly/3SDnLym

Social Media companies asked by High Court to handover details of persons who fraudulently operated certain accounts and channels
The Delhi High Court has ordered major social media companies including Facebook and Telegram to disclose identities of users accused of misusing trademark of major venture capital firm to cheat users by soliciting bogus investments. The court has also ordered concerned social media companies to provide details on action they will take to prevent further violation.
Source: bit.ly/3HXkxAP

WhatsApp and emails may be used to send legal notices for demanding unpaid amounts: High Court
The Allahabad High Court has reiterated that notice in cheque bounce case sent by WhatsApp or e-mail will be considered valid notice for the purposes of recovery under The Negotiable Instruments Act, 1881, and it will be presumed to have been dispatched and served on the same day.
Source: bit.ly/48f8Xf6

Popular Party Drugs added to list of Psychotropic Substances
The Indian Government has added popular synthetic party drugs, ADB-BUTINACA, Alpha-PiHP and 3 Methylmethcathinone (3-MMC), to list of psychotropic substances and notified small and commercial quantity of these substances for the purpose of fixing quantum of punishment for unlawful possession. Possessing psychotropic substances without permission or prescription is an offence under Narcotic Drugs and Psychotropic Substances Act, 1985.
Source: bit.ly/48ghuhM

WHO recommends antibiotics which should be exclusively put to human use to reduce chance of antimicrobial resistance
The World Health Organization (WHO) has updated its Medically Important Antimicrobials for Human Use (WHO MIA List), and reclassified antimicrobial drugs on basis of potential impact on human heath to limit the use of identified antimicrobials in other populations such as in plants and animals. The WHO hopes that reducing use of critical antimicrobial drugs in other population will reduce pace of antimicrobial resistance.
Source: bit.ly/49eVll9