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 Pharmaceuticals Export Promotion Council of India (Pharmexcil) has invited its members to identify export challenges and propose strategies to enhance pharmaceutical exports. Members have been asked to report on specific tariff and non-tariff barriers affecting trade and suggest innovative solutions, which will be collected through a dedicated “Issues & Strategies” section on the Pharmexcil website. This initiative aims to address existing hurdles and foster collaboration for the growth of India’s pharmaceutical industry in global markets.
Source: bit.ly/4gi7n09

2. The Karnataka government has suspended the state drugs controller for not taking procedural actions against the pharma company which supplied the substandard lactate IV fluid which resulted in the death of women. The use of this faulty intravenous fluid is believed to have contributed to serious complications during surgeries at a district hospital.
Source: bit.ly/3VsRQCP

3. The Health Research Authority (HRA) has proposed to simplify the process of seeking and recording consent for low-risk clinical trials in the UK. While the method for discussing trials with potential participants remains unchanged, the new approach allows prescribers to document consent directly in a participant’s medical record instead of requiring a written consent form. This ensures that informed consent is still legally mandated, and participants can withdraw at any time, while aiming to reduce administrative burdens and enhance trial efficiency.
Source: bit.ly/3BgotNm

4. The Fertiliser Association of India (FAI) has emphasized for setting a pricing hierarchy for fertilisers based on their nutrient content and suggested that di-ammonium phosphate (DAP), priced at Rs 1,350 per 50-kg bag, should be the most expensive one due to its high nutrient value. This price is currently lower than that of muriate of potash and complex fertilisers, which raises concerns about nutrient balance in agriculture as farmers increasingly turn to alternatives with less phosphorus content.
Source: bit.ly/41iwV9i

5. The Union Ministry of Women and Child Development has launched the upgraded SHe-Box portal to streamline the reporting and monitoring of sexual harassment complaints in workplaces across India. This centralized platform allows women to file complaints easily and ensures timely processing by Internal and Local Committees in government and private sectors, promoting a safer work environment.
Source: bit.ly/49pCxk5

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