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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 Ministry of Health and Family Welfare (MoH&FW) has released the Drugs Amendment Rules, 2025, extending the deadline for implementing revised Good Manufacturing Practices (GMP) under Schedule M for small and medium drug manufacturers until December 31, 2025. Manufacturers are required to submit an application to the Central Licensing Authority for seeking the extension within three months of the notification.
Source: bit.ly/4gCo0U8

2. The Supreme Court has virtually summoned the Chief Secretaries of Andhra Pradesh, Delhi, and Jammu & Kashmir to explain their failure to act on misleading medical advertisements. The Court found these states non-compliant with previous orders on enforcing Rule 170 of the Drugs Rules, which prohibits advertisements of Ayurvedic, Siddha, or Unani drugs without licensing authorities’ approval.
Source: bit.ly/42Sm6vn

3. India’s National Medical Commission (NMC) has clarified that the Telemedicine Practice Guidelines 2020 do not allow Registered Medical Practitioners (RMPs) to remotely authenticate pathology and radiology lab reports without physical presence and supervision. This follows an RTI application which sought clarification on the use of cloud-based technologies like Telepathology and Teleradiology for signing and authenticating lab reports.
Source: bit.ly/40VinKX

4. India’s Ayushman Bharat Digital Mission (ABDM) has made significant strides, with millions of Ayushman Bharat Health Accounts (ABHA) created and a large number of health records linked to ABHA. This is part of the mission’s effort to build an interoperable digital health ecosystem. Thousands of health facilities have registered on the Health Facility Registry (HFR), and many healthcare professionals are now listed on the Healthcare Professional Registry (HPR). The mission also focuses on supporting rural areas through technology interventions like telemedicine, enhancing access to healthcare services.
Source: bit.ly/41ektXT

5. The European Medicines Agency (EMA) has introduced a standard procedure for manufacturers of certain high-risk medical devices to receive scientific advice on their intended clinical development strategy and proposals for clinical investigations. This initiative aims to enhance safety and performance by offering expert guidance on regulatory requirements before devices are submitted for approval. The move is designed to foster innovation while ensuring that devices meet rigorous standards.
Source: bit.ly/4jWxfRZ

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 Ministry of Environment, Forest, and Climate Change has released draft rules under the Environment Protection Act, 1986, proposing Extended Producer Responsibility (EPR) for managing post-consumer waste from paper, glass and metal packaging along with sanitary products. These Rules aim to promote recycling, reuse, and waste-to-energy initiatives. Producers, importers, and brand owners must register and meet EPR targets from April 2026.
Source: bit.ly/49w0GFK

2. India’s Central Pollution Control Board (CPCB) has regulated the micro and small importers, producers, sellers and manufacturers of plastic raw materials and have mandated their registration on the EPR Plastic Portal. Filing of annual returns and compliance with all other EPR obligations is also outlined in the guidance issued by CPCB.
Source: bit.ly/49CJo9Z

3. India’s Supreme Court has reiterated that Ayurvedic/AYUSH doctors cannot claim parity with allopathic doctors, citing differences in academic qualifications and the standards of their respective courses. The court dismissed a petition by AYUSH doctors in Kerala, referring to past judgments that clarified the distinction in responsibilities and remuneration between allopathic and AYUSH practitioners.
Source: bit.ly/4iqyYhN

4. India’s Delhi District Consumer Commission has fined a leading FMCG company with a fine of ₹15 lakh for misleading advertisements about its “Fair and Handsome” cream, which claimed to provide fairness within three weeks without proper evidence. The Commission found the claims deceptive and an unfair trade practice, ordering the company to withdraw all misleading ads and packaging.
Source: bit.ly/3OPcMjE

5. India’s Central Drugs Standard Control Organization (CDSCO) has issued a circular thereby directing all State and Union Territory Drugs Controllers to ensure the approval of drugs and medical devices for rare diseases within 90 days of receiving applications to expedite the regulatory process and support faster access to treatment for rare diseases.
Source: bit.ly/3VvSFLl

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.

1. The Ministry of Agriculture and Farmers Welfare of India has issued Millets Grading and Marking Rules, 2024 (“Millet Rules”) which regulates packing, marking and labelling of millets intended for direct human consumption.
Source: bit.ly/4dkddNJ

2. India’s central drug regulator, the Central Drugs Standard Organisation, has circulated draft guidelines on good distribution practices for pharmaceutical products to ensure product traceability throughout the supply chain.
Source: bit.ly/4fGXKZy

3. India’s top consumer forum, the National Consumer Disputes Redressal Commission (“Commission”) has awarded a compensation of Rs.65 lakhs in a medical negligence case in which the doctors performed an elective surgery on a patient who was suffering from pre-existing ailment, which ultimately resulted in the death of the patient. The commission did not accept the defence of the hospital that the patient’s next of kin had consented to the procedure and were aware of the risks.
Source: bit.ly/3AgWYSK

4. Suicide Capsules are not medical devices or medicines: Swiss Medical Agency.
Source: bit.ly/4djGFU0

5. The Ministry of AYUSH has informed that it has identified approximately 26000 cases of misleading advertisements, but the State AYUSH departments have issued notices only 358 brands in last 4 years.
Source: bit.ly/4fJ7bYi