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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

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

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. Pharmaceutical companies will have to submit details of their expenditures incurred on sponsoring activities to the medical professionals within two months after the end of each financial year on the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) portal as part of implementation of the UCPMP Code 2024.
Source: bit.ly/47bQOjc

2. India’s Health Ministry has introduced guidelines to improve quality of healthcare services in government hospitals and healthcare institutions. Hospitals will now be required to report adherence to these guidelines and submit proposals for approval, specifically when significant changes or funding is involved.
Source: bit.ly/3XaYSMz

3. Pharmaceutical industry in India has reportedly voiced its concern over the delay in processing and issuance of review orders on the website by Department of Pharmaceuticals (DoP). The consequence of delay in processing of review orders may results in halt of business activities thereby imposing manufacturers to sell the scheduled formulation or a new drug at a ceiling price which is under review.
Source: bit.ly/4cUYrMa

4. India’s Central Drugs Standard Control Organization (CDSCO) is reportedly launching various digital initiatives, such as Online National Drug License System (ONDLS) and Track and Trace System, to transparently, and efficiently manage pharmaceutical regulations.
Source: bit.ly/47ai41s

5. Quality standards for MDMA and Psilocybine, well known psychedelic compounds has been prescribed by Australia’s Therapeutic Goods Administration (TGA).
Source: bit.ly/47a9jVm
Source: bit.ly/478wBLf

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.

1. A leading pharmaceutical association reportedly has urged the Indian government to implement a predictable drug pricing policy by refraining from using Para 19 of the Drug Pricing Control Order, which gives power to the Government to cap prices of non-essential drugs and medical devices in public interest without advance notice.
Source: bit.ly/4dw7a8j

2. The National Consumer Disputes Redressal Commission (NCDRC) has held that doctors who have qualification of M.B.B.S, M.D. (medicine) are sufficiently qualified to treat ICU patients without requiring additional specialized intensive care training since no such training has been prescribed by National Medical Commission.
Source: bit.ly/3Yts4kh

3. Australia has approved the medical use of MDMA (Methylene Dioxy Methyl Amphetamine) and psilocybin for treating PTSD and depression. The drugs will be available under strict regulations, with treatments costing between A$15,000 and A$30,000, and with no current insurance coverage.
Source: bit.ly/46CttHg

4. India’s Central Food regulator, (FSSAI) has reintroduced restriction on re-using cooking oil that has developed total polar compounds (TPC) of more than 25% by adding fresh oil. Any cooking oil that has 25% or more content of TPC is not permitted to be used.
Source: bit.ly/4d8pvIT

5. India’s Department of Consumer Affairs has extended the last date for receiving public comments on the proposed amendment of rule 3 of the Legal Metrology (Packaged Commodity) Rules, 2011 to 30th August 2024. The proposed amendment aims to close loopholes and ensure that all bulk packages are labelled clearly and consistently, just like retail products.
Source: bit.ly/4dgRE0n

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.

E-Commerce websites instructed to avoid marketing Milk/ cereal/ malt based drinks as “Energy Drinks”
India’s Food Standards Regulator (the Food Safety Standards Authority of India) has issued an advisory to e-commerce websites, requiring them to ensure that proprietary foods, i.e. foods that are not categorized under the Food Standards Regulations, specifically those currently registered as analogues to milk/ cereal/ malt based beverage, should not be advertised as “Health Drink”/ “Energy Drink”, as only carbonated/ non-carbonated water-based flavoured drinks are regulated as “Health Drink” and “Energy Drink”.
Source: bit.ly/3xlfzvD

Drug Price Regulator may examine prevalent drug substitution and discounting prices offered by major drug retail stores in India
The Indian Central Drugs Regulator (CDSCO) has reportedly requested the Central Drugs Price Regulatory Body (NPPA) to investigate drug substitution and discounting practices of a major pharmacy chain on the basis a complaint raised by State Chemists and Druggists’ Association of the State of Karnataka (KCDA). In its complaint, the KCDA has alleged that the major pharmacy chain has been deliberately undercutting prices, sustained by substitution of prescribed drugs with other cheaper but identical formulations and unreasonably increasing its profit margins, which is currently violative of regulations applicable to pharmacists, as well as pricing norms of drugs.
Source: bit.ly/4cJSJOg

Vaccine manufacturers may have to provide manufacturing and sales data to government soon
The advisory body to India’s Central Drugs Regulator, the Drugs Consultative Committee, has requested various State-level Drug Licensing Authorities to ensure submission of details of the manufacture and sale of vaccines within the states to the Central Drugs regulator (Central Drugs Standards Control Organization), for the purpose of meeting obligation for the Global Benchmarking of Vaccines of the World Health Organization.
Source: bit.ly/3PJkAEw

Major Ayurvedic Medicine manufacturer may be on hook for contempt of court after Supreme Court rejects its apology for publishing misleading advertisements
In its ongoing proceedings against a major Ayurvedic medicine manufacturer for publication of misleading advertisements in contravention of undertaking given by it to the Supreme Court, the Court has refused to accept the apology which was tendered by the manufacturer, and rejected submissions of the manufacturer that: (1) The restriction on advertisement under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 is archaic and may be relaxed since the manufacturer now has scientific data to back its claims, and (2) that the manufacturer should not be held liable for an advertisement issued by an independent marketing department.
Source: bit.ly/4akJen5

Australia updates Medical Device Recall Procedure
The Australian Therapeutics Goods Administration, which regulates medical devices at the central level in the country, has published a revised version of the Uniform Recall Procedure for Therapeutic Goods (URPTG), which relaxes regulatory burden of importers and manufacturers of medical devices. The revised URPTG provides additional clarity on procedure for immediate recall, clarifying timing of release of recall information by the regulator, modifying Customer Response Forms, and eases the filing requirements under the law by making all templates for recall action publicly available on the website of regulator.
Source: bit.ly/3TAZJEo