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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 Supreme Court of India has ruled that company directors and officials are not vicariously liable for corporate offences without specific statutory provisions and evidence of personal involvement. While companies may be held accountable for employee’s misconduct, directors’ liability requires proof of their direct actions. Mere association with the company is insufficient to attract a liability.
Source: bit.ly/3PvHNJK

2. The Supreme Court of India, while hearing a PIL against multinational pharmaceutical companies, raised ethical concerns over clinical trials in poorer countries. It highlighted the exploitation of vulnerable populations and the lack of oversight in such practices thereby urging stricter regulations to protect participants’ rights. The Drugs and Clinical Trial Rules, 2019, notified under the Drugs and Cosmetics Act, 1940, mandate provisions like Ethics Committees and compensation for trial-related injuries or deaths.
Source: bit.ly/3DNYBt4

3. The Jammu & Kashmir and Ladakh High Court has initiated contempt proceedings against a prominent Indian law firm for allegedly misquoting a 2010 judgment related to the Sawalkote Hydro-Electric Project. The court observed that the law firm had misrepresented judicial findings in a legal notice that was issued by the court which might potentially amount to criminal contempt.
Source: bit.ly/423xnZz

4. The Bombay High Court emphasized that intelligence levels should not determine parental rights while deciding a case involving a woman’s right to motherhood with borderline intellectual disability. The court reviewed a petition seeking termination of the woman’s 21-week pregnancy, with a medical report confirming her fitness for pregnancy.
Source: bit.ly/3Cb5Evd

5. India’s healthcare stakeholders, ahead of Budget 2025, are urging reduced customs duties (~37%) on advanced cancer therapies, drugs, and treatment equipment. They seek tax reforms, including GST rationalization, increased healthcare spending to 2.5-3% of GDP, long-term financing options, telemedicine expansion, and infrastructure incentives. Emphasis is also laid on digital health and preventive care to ensure equitable access nationwide
Source: bit.ly/4gJousH

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.

Supreme Court of India pulls up State Licensing Authority for failing to take action against misleading advertisements by leading ayurvedic manufacturer
India’s Central Ayush Ministry recently filed an affidavit in the Supreme Court of India to explain the steps it has taken against a leading manufacturer of Ayurvedic products after receiving several complaints against the manufacturer for making false and derogatory claims against modern medicine. The affidavit states that no action has been taken in the past two years by the State Licensing Authority, despite several orders from the Supreme Court, Right to Information (RTI’s), and directives from the Prime Minister’s Office (PMO). The Supreme Court has now asked the State Licensing Authority to issue its reply.
Source: bit.ly/4aDTxmc

Relaxation of penalties for certain offences involving drugs, medical devices and cosmetics to take effect from December 31, 2024
The Indian Government has decided to relax the penalties for offences relating to drugs, medical devices and cosmetics that are of the nature of violation of conditions of license or failure to label in the prescribed manner. These offences typically invited punishment of imprisonment and fine, but may now be compounded by the payment of a penalty both before or after institution of prosecution. The decision was notified under the Jan Vishwas (Amendment of Provisions) Act, 2023. The Government has now notified the date of coming into effect of the relaxation as December 31, 2024.
Source: bit.ly/3U0yhS4
Source: bit.ly/3THGUjd

Major technology company admits to collecting information from private browsing, agrees to destroy data as part of the settlement
A major technology company, known for operating a popular internet search engine, has agreed to destroy billions of data records to settle a lawsuit. The suit claimed that the search engine company was secretly tracking the internet use of people who thought that they were browsing privately. Under the settlement, the search engine will update disclosures about what it collects in “private” browsing and will also let the users block third party cookies for five years.
Source: bit.ly/3vIwHL9

Industry demands that US FDA should give prior notice before conducting remote regulatory assessments
The US Food and Drug Administration’s (USFDA’s) revised guidance for conducting remote regulatory assessments (RRAs) has received comments from the industry. A clear demand from the industry is that the US FDA should provide advance notice for mandatory assessments and discuss observations before taking any regulatory action.
Source: bit.ly/3xieXXJ

Written patient consent required for sensitive examinations on anesthetized patients in US
The United States Department of Health and Human Services has recently released a new guidance as per which hospitals have to mandatorily obtain written informed consent from anesthetized patients for breast, pelvic, prostate, and rectal exams performed on them for educational and training purposes. If hospitals do not obtain the explicit consent and violate the patient privacy rights, they may become ineligible for participation in the Medicare and Medicaid programs, as well as become liable for fines and investigations.
Source: bit.ly/3U1M8aX