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 Drugs Rules, 1945 through its first amendment introduces standards for Ayurveda, Siddha, and Unani (ASU) nasal drugs, focusing on manufacturing and standardizing dosage forms in traditional medicine. Traditional nasya preparations, including powdered churnas, grathas, and thailams, will also be standardized under these rules.
Source: bit.ly/40M88Zm

2. India’s Parliamentary Panel has recommended to Union health ministry to consider covering the cost of medicines, particularly for long-term treatments like cancer, under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PMJAY). The Committee’s 159th report highlighted that the Ministry’s submission suggests the possibility of such a provision. In a previous 151st report, the Committee had urged the government to provide free medicines for long-term illnesses to all PMJAY beneficiaries across states.
Source: bit.ly/4hIIv2s

3. India’s Union Budget 2025 has introduced the “Heal in India” initiative, aiming to boost medical tourism. Kerala is expected to be a major beneficiary due to its world-class healthcare infrastructure and traditional wellness practices like Ayurveda. The initiative aims to streamline visa norms for international patients, positioning Kerala as a leading destination for health and wellness tourism.
Source: bit.ly/4hJReS4

4. India’s Food Regulator, Food Safety and Standards Authority of India (FSSAI)
is reportedly considering new health warning on the labels of alcohol bottles, following a Bombay High Court’s directive on cancer warnings, similar to that on cigarette packs. Currently, alcohol bottles carry two health risk warnings, and industry representatives argue these are sufficient.
Source: bit.ly/3Etn0nY

5. Argentina’s government has decided to ban gender change treatments, including hormone therapy and surgeries, for minors and impose restrictions on housing trans women in women’s prisons. This move aligns with similar legislative pushbacks in countries such as the UK, Sweden, Finland, and the US, with the aim of protecting children’s mental health
Source: bit.ly/3Q7elKv

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 warned States and Union Territories of initiating contempt proceedings for failing to take action against misleading advertisements. It emphasized that authorities must ensure strict enforcement of laws to prevent such advertisements. The Court’s remarks come in light of a petition filed by the Indian Medical Association against a leading Ayurveda product manufacturing company on grounds of misleading claims and advertisements.
Source: bit.ly/3C3w9D4

2. India’s Bombay High Court, in a recent ruling, emphasized that authorities must uphold basic human rights, particularly in medical negligence cases. It stated that failure to provide adequate healthcare can violate a patient’s right to life and dignity. The court called for greater accountability and stricter enforcement of healthcare standards.
Source: bit.ly/3DVQlqO

3. The Food Safety and Standards Authority of India (FSSAI) has issued an order on 3rd January, 2025, to promote ease of doing business. It has decided that any changes or amendments to the Food Safety Standards (Labelling and Display) Regulations 2020 will be enforced starting from 1st July each year. The enforcement date will always be 1st July, with a minimum of 180 days between the notification of amendments and their enforcement. This policy applies to both labelling regulation changes and other food safety standards related to labelling. This move is aimed at enhancing regulatory predictability for food business operators while also improving consumer knowledge and transparency.
Source: bit.ly/4h001PO

4. The Indian Prime Minister’s Office (PMO) has directed the Indian Health Ministry to take appropriate steps to label oxygen cylinders clearly, distinguishing between industrial oxygen and medical oxygen. This action follows lawmaker Ajeet Madhavrao Gopchade’s appeal, emphasizing the importance of such measures for patient safety.
Source: bit.ly/4ais9eB

5. The U.S Food and Drug Administration (US FDA) has banned the use of Red No. 3 dye in food items and oral drugs due to potential links to cancer. The decision follows concerns raised by studies suggesting that the high exposure of dye could be carcinogenic.
Source: bit.ly/42f7YvR

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. Doctors can sell medicines to their patients without obtaining a separate license for selling drugs after complying with all the conditions specified under the Drugs Rules, 1945: Bombay High Court
Source: bit.ly/4cqy94s

2. Drugs which are approved in USA, UK, Japan, Australia, Canada and EU have been exempt from requirement to conduct clinical trials in India before securing a marketing approval, if they fall into the categories of Orphan Drugs for Rare Diseases, Gene and Cellular Therapy Products, New Drugs used in Pandemic Situations, New Drugs for Special Defense Purposes, and New Drugs that represent a significant therapeutic advance.
Source: bit.ly/4cmWZ4W

3. India’s Central Drug Regulator (CDSCO) has made it mandatory to follow WHO Technical Report Series (TRS) guidelines in so far as they relate to Good Manufacturing Practices, such as the “WHO Good Manufacturing Practices for Sterile Pharmaceutical Products.”
Source: bit.ly/3yyC4y6

4. India’s Central Government is reportedly planning to introduce a separate marketing practices code for medical devices. The proposed code aims to establish a voluntary framework to regulate marketing practices within the medical devices industry.
Source: bit.ly/4dvF6BY

5. Indian Government has revised hazardous residue standards for fruits and vegetables meant for domestic consumption and introduced new hazardous residue standards for fruits and vegetables meant for export purposes. Fruits and vegetables meant for export should comply with standards set by the Codex Alimentarius Commission or the importing country’s requirements.
Source: bit.ly/4fDKLYM