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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 National Pharmaceutical Pricing Authority (NPPA) has directed drug manufacturers to reduce the maximum retail price (MRP) of three crucial cancer drugs i.e., Trastuzumab Deruxtecan, Osimertinib, and Durvalumab. This is in line with reduction of customs duty and GST rates on these medications.
Source: bit.ly/4fBQ3Dd

2. Delhi High Court has granted a permanent injunction against a pharma company which had imitated the design and presentation of a drug manufactured by another pharma company. This ruling highlights the requirement for pharma companies to ensure a distinctive packaging to avoid copyright Infringement claims.
Source: bit.ly/40AprhH

3. The All India Organization of Chemists and Druggists (AIOCD) has urged the Drug Controller General of India (DCGI) to restrict a partnership between a rapid delivery platform and an e-pharmacy, citing concerns over regulatory and quality compliance issues that could potentially jeopardize patient safety.
Source: bit.ly/4fDJEqS

4. The Himachal Pradesh High Court has directed the state government to implement a QR code system to assess the quality of medicines in the state. This QR code will provide consumers with key information about the medicine, including production and expiry dates, unit details, batch numbers, and component specifics in order to enhance consumer awareness and transparency in medicine quality.
Source: bit.ly/3YE20Bw

5. UK government is set to launch ‘World-First’ Genomics-Led pandemic warning system. The system will utilize the technology to flag and monitor potential outbreaks of bacterial or viral diseases.
Source: bit.ly/4fBdyw6

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 Union AYUSH Ministry has prohibited to advertise Ayurveda, Siddha, Unani, and Homeopathy drugs with claims of “miraculous or supernatural effects” in order to prevent misleading advertisements with unverified claims. The ministry instructed that such drugs should contain a caution to be taken under medical supervision on its label. Additionally, the ministry issued a public notice clarifying that it does not certify, grants license or approves any company for making ayurvedic drugs.
Source: bit.ly/4eXXjsL
2. India’s central drug regulator (CDSCO) is actively investigating social media influencers who promote false claims, quick fixes and misleading medical content.
Source: bit.ly/4eGfqDC 

3. The Pune division of the Food and Drug Administration (FDA) has taken action against three drug firms for violating the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. The firms were found selling Ayurvedic medicines with misleading claims to cure diabetes, arthritis, and kidney ailments, leading to the seizure of products.
Source: bit.ly/3XUC5Fe

4. The Delhi High Court ruled that a mere fraction of a cause of action occurring in a jurisdiction is insufficient to invoke the court’s territorial jurisdiction. The decision of the court said that in order to raise the territorial jurisdiction of a specific court, there must be a significant link of the matter to the specified territory, reinforcing the standards for filing cases in the court.
Source: bit.ly/3ZXxPr1

5. The Medicines and Healthcare products Regulatory Agency (MHRA) in UK has unveiled its 2024/25 business plan, which prioritizes enhancing access to innovative healthcare technologies while optimizing service delivery. Key initiatives of the plan include the implementation of new IT systems and a commitment to public engagement and diversity in regulatory processes, aimed at reinforcing the UK’s position in life sciences and improving pandemic preparedness.
Source: bit.ly/3BES5Ux

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