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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 Central Drug and Medical Device Regulator, The Central Drugs Standard Control Organisation (CDSCO), has issued a public notice that it will reject applications if the queries to the applications are not responded within 90 days from the date of receipt of the query on its official application portal called SUGAM portal. A time-bound reminder and rejection mechanism for timely disposal of the pending applications has been introduced. Applications pending for two years will now be rejected after 30 days notice if no response is submitted.
Source: h7.cl/1i6LX

2. India’s Ministry of Commerce and Industry has extended the deadline for importers and manufacturers to obtain BIS certification for aluminium utensils and food and beverage cans covered under the Quality Control Order, 2026. The revised timelines are issued in a phase wise manner based on industry category, beginning from 1 October 2026.
Source: h7.cl/1i6L0

3. Several drug companies are cautious about a new fast approval program under the United States Food and Drug Administration. They fear quicker reviews may weaken scientific scrutiny, increase legal risk, and invite court challenges, even as others support faster access to important medicines for patients nationwide safely.
Source: h7.cl/1i6Lg

4. The Maharashtra Public Health Department has launched dedicated menopause clinics in Pune to provide specialised care for women’s physical and mental health needs. Weekly OPDs will be held every Wednesday at government hospitals, offering medical management, counselling, and lifestyle guidance. The initiative aims to address menopause-related health issues across urban and rural areas.
Source: h7.cl/1n5Uw

5. India’s Ministry of Agriculture and Farmers Welfare has announced that the Seed Act, 2026, to introduces a nationwide seed traceability through QR codes, mandate seed company registration, and impose penalties up to ₹30 lakh for substandard seeds, and safeguards the traditional seed systems and strengths transparency.
Source: h7.cl/1i6Lp

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 Department of Pharmaceuticals has amended the UCMPMD 2024, clarifying valuation of free evaluation samples at stockist price if self-manufactured or average purchase price if sourced externally. Companies in multiple associations may submit disclosures through one, with prior intimation to others and notification to the Department when switching.
Source: short-link.me/18ym-

2. India’s Health Ministry has proposed amendments to the New Drugs and Clinical Trials Rules, 2019, enabling simplified approval for bioavailability and bioequivalence (BA/BE) studies of oral drugs approved in India or select countries, for export purposes. The draft exempts certain drug categories and caps sample size at 48. Stakeholders may submit objections or suggestions by 27 September 2025.
Source: short-link.me/1d3UX

3. Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organization (CDSCO) have released draft protocols for evaluating In-Vitro Diagnostics (IVDs) for tuberculosis, including drug-resistant strains. Stakeholders can submit comments by September 7, 2025. Final protocols will be based on this feedback before final clearance is given by ICMR and CDSCO.
Source: short-link.me/18ylZ

4. India’s Punjab and Haryana High Court has ruled that legible medical prescriptions is a fundamental right of patients and doctors must write prescriptions in capital letters until Digitalization. PGIMER Chandigarh’s “Doctor Desk” e-prescription system is expected to be implemented within two years.
Source: short-link.me/18ym7

5. The Ministry of Health and Family Welfare has issued draft amendments to the New Drugs and Clinical Trials Rules, 2019. The proposals reduce approval timelines from ninety to forty-five working days and introduce a simplified notification system for manufacturing certain drugs meant for analytical and preclinical testing.
Source: short-link.me/1d3Vg