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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. The Drug Controller General of India (DCGI) has directed all State and UT Drug Controllers to regularly sample kumkum and colour powders at religious sites for testing for synthetic ingredients due to public health concerns. Kumkum is regulated as a cosmetic in Indian law and must meet BIS standards covering heavy metal limits, microbial safety, prescribed testing methods, and mandatory packaging and labelling requirements.
Source: h7.cl/1nnwz

2. India’s Ministry of Agriculture & Farmers Welfare has released the draft Pesticides Management Bill, 2025 to replace the Insecticides Act, 1968. The farmer-centric bill proposes stronger regulation of spurious pesticides, higher penalties, digital processes, mandatory lab accreditation, and promotion of biopesticides and indigenous manufacturing. Stakeholders can submit comments in the prescribed format by 4 February 2026.
Source: h7.cl/1inPA

3. The Tea Board of India has issued revised guidelines for registration of manufacturers of flavoured tea, reaffirming that every factory manufacturing flavoured tea must be registered as a bonafide manufacturer with the Tea Board. This makes the registration process for flavoured tea manufacturers clearer and more structured.
Source: h7.cl/1nnx8

4. The European Parliament has approved measures to strengthen EU supply of essential medicines by reducing dependence on non-EU countries. The proposals support domestic manufacturing through strategic projects, priority funding, EU-favoured procurement, joint purchasing, and coordinated stockpiles to prevent shortages of critical medicines such as antibiotics, insulin and vaccines.
Source: h7.cl/1nnwI

5. India’s Central Drug regulator has given approval to manufacture and sell a generic version of Ozempic (semaglutide) for diabetes, ahead of its patent expiry in March 2026. The company plans to launch 12 million injectable pens in the first year and partner locally for distribution. The company is also awaiting similar approval for the obesity drug Wegovy.
Source: h7.cl/1nnwM

Posted on

TOP 5 HEALTH LAWS & POLICY UPADATES

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 Government of India has notified the Legal Metrology (Packaged Commodities) Second Amendment Rules, 2025, effective 1 February 2026. The amendment removes pan masala from an earlier exemption, mandating that all pan masala packages, regardless of size, must fully comply with the standard declaration requirements prescribed under the rules.
Source: h7.cl/1kzQU

2. Central Pollution Control Board has issued a notice allowing plastic packaging producers, importers, and brand owners facing a shortage of Cat II/III recycling certificates to use End-of-Life (EOL) certificates to meet their FY 2024–25 recycling obligations. Now, 1 ton of Cat II/III recycling obligation can be fulfilled using 1.5 tons of EOL certificates.
Source: h7.cl/1kzQI

3. The U.S. Food and Drug Administration (FDA) has issued draft guidance reducing or eliminating the requirement for non human primate toxicity testing for certain monoclonal-antibody therapies. This change may shorten preclinical timelines and lower costs, while promoting alternative safety evaluation methods.
Source: h7.cl/1fEU5

4. India’s drug regulator has been alerted that fake versions of widely used medicines may be circulating after Puducherry officials seized several suspected counterfeit samples. States and Union Territories have also been asked to maintain “strict vigil” on the movement of these batches of widely popular medicines.
Source: h7.cl/1kw0M

5. The Supreme Court has issued notice to the Union Government on a petition seeking a statutory framework for criminal prosecution in medical negligence cases. The plea highlights that no rules have been created despite the Jacob Mathew judgment in 2005 and urges independent, multi-stakeholder inquiry panels to ensure fair, unbiased investigations.
Source: h7.cl/1fETM