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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 Drugs Regulator (CDSCO) has clarified that modified or sustained-release form of a drug including gastro-resistant tablets/capsules, delayed-release tablets/capsules, or novel drug delivery systems will be regulated as ‘new drug’. New drugs must undergo clinical trials for obtaining manufacturing license
Source: bit.ly/41znUZe

2. India’s Central Licensing Authority (CLA) has directed manufacturers of unapproved fixed dose combination drugs to apply for permission to conduct Phase IV study / active post marketing surveillance within three months
Failure may result in cancellation of manufacturing license.
Source: bit.ly/3Xmpjjr

3. India’s Central Food Regulator (FSSAI) has reminded all food businesses that any post approval change in license information such as name of nominee, product category, expansion has to be communicated before such change takes place. Failure may result in cancellation of license.
Source: bit.ly/41AjyRq

4. India’s product standard setting body (BIS) has amended the Baby Diapers Standard 17509:2021. The amendment clarifies that actual dimensions of the diapers can vary based on the manufacturer’s design choices, with the diaper’s design being subject to the agreement between the buyer and seller.
Source: bit.ly/41znT7C

5. Clinical trial sponsors can add clinical trial sites and change the principal investigator (PI) by applying on SUGAM Portal.
The application for change of PI is deemed approved on application, and for addition of site within 30 days of application.
Source: bit.ly/41wrvHo

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

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 food regulator, Food Safety and Standards Authority of India (FSSAI) has said that it is misleading to differentiate milk and milk products on whether they are made from A1 milk or A2 milk. All manufacturers and marketers and e-commerce entities have been directed to stop claims of A1 and A2 proteins present in the milk. All manufacturers have been given six months to exhaust all of the pre-printed labels containing claims about A1 and A2 proteins.
Source: bit.ly/4dz5awA

2. The Central Pollution Control Board (CPCB) has released updated guidelines for assessing environmental compensation to be levied on entities that violate the Plastic Waste Management Rules, 2016, including Extended Producer Responsibility (EPR) obligations.
Source: bit.ly/46Uh9lX

3. India’s Ministry of Health has banned the 156 fixed-dose combination (FDC) medications, commonly known as “cocktail drugs,” which include multivitamins, antibiotics, and painkillers. The ministry’s rationale is that these drugs have no there is no therapeutic justification and pose a risk to human health, even though there are safer alternatives available.
Source: bit.ly/3XfRVeq

4. The US Food and Drug Administration (FDA) has issued a draft guidance on pre-determined change control plans (PCCPs). The guidelines offer manufacturers a way to specify prospective modifications to a device and apply for premarket authorization for those changes in a marketing submission for the device. This eliminates the need for them to obtain FDA approval for each major change before it is implemented. The draft guidance is open to receiving comments from industry stakeholders till November 20, 2024.
Source: bit.ly/3AtTY5B

5. The Medicines and Healthcare products Regulatory Agency (MHRA), an agency of the Department of Health and Social Care in the United Kingdom, has ruled that a biopharmaceutical company has violated the country’s drug regulations by using a LinkedIn post to advertise prescription-only medicines to the general public.
Source: bit.ly/4fSmKgt