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 Directorate General of Foreign Trade(DGFT), issued a Public Notice dated 1 June 2026 and has notified six new Standard Input Output Norms (SIONs) under the Chemical and Allied Product Group for specified pharmaceutical products. The notification enables Regional Authorities to grant Advance Authorisations without case-specific referrals to the Norms Committee, thereby reducing processing timelines, ensuring uniformity in approvals, and promoting ease of doing business for pharmaceutical exporters.
Source: shortlink.uk/1q-yS
2. The Delhi High Court directed CDSCO to review safety concerns over semaglutide injections within two months. A patient petition claims that manual calculation of dosage deviates from global pre-filled pen standards, risking overdose, underdose, and misuse. CDSCO must determine if approval aligns with patient safety and international practices.
Source: shortlink.uk/1q-xi
3. The Indian government is reportedly drafting new organ transplant rules to introduce Donation after Circulatory Death (DCD) and strengthen frameworks for organ swaps and brain-stem death donations. The proposed reforms aim to expand the donor pool, standardise transplant procedures, and improve access to life-saving organ transplants.
Source: shortlink.uk/1q-z5
4. The Maharashtra State Consumer Disputes Redressal Commission has held that obtaining a patient’s signature on a pre-printed consent form without adequately disclosing the nature of the procedure, associated risks, possible complications, and available alternatives does not constitute valid informed consent. The Commission observed that a mere signature on a standardised form cannot satisfy a doctor’s duty of disclosure and ruled that failure to obtain proper informed consent amounts to a deficiency in service. While the Commission found no evidence of medical negligence in the performance of the surgery or post-operative care, it held the medical practitioner liable for not securing valid informed consent and awarded compensation.
Source: shortlink.uk/1q-za
5. The Central Drugs Standard Control Organisation has directed pharmaceutical manufacturers to establish and maintain pharmacovigilance systems in line with revised Schedule M requirements. Companies must maintain dedicated adverse reaction monitoring mechanisms, appoint qualified pharmacovigilance officers and keep detailed records, with compliance subject to regulatory inspections.
Source: shortlink.uk/1q-xq
