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.

India’s Central Food Regulator (FSSAI) has published draft of the certificate required to be procured by importer of vegan food, from regulatory authority of exporting authority, in order to import vegan food into India. Objections may be submitted by 30th April 2025.
Source: bit.ly/4hbimbQ

2. Karnataka State Government is reportedly working on a Not of Standard Quality (NSQ) drug recall policy. In addition to recall, if a batch of medicines is found spurious or NSQ, the manufacturing and distribution license may get suspended until corrective actions are taken.
Source: bit.ly/4ioKGc0

3. India’s Environment Ministry (MoEFCC) has issued an SOP which clarifies that white-category industries can be exempted from obtaining consent to establish (CTE) only when they submit a self-declaration of compliance with applicable environmental laws. White category industries are least polluting industries.
Source: bit.ly/43mS433

4. India’s Central Pollution Control Board (CPCB) has discovered major non-compliances during audit of plastic packaging waste recyclers such as the absence of production capacity relative to Extended Producer Responsibility (EPR) certificates issued and the absence of GST invoices for sales transactions. Brand owners should not buy EPR certificates from such recyclers.
Source: bit.ly/43fNDXY

5. India’s Supreme Court has clarified that for an activity to be construed as “manufacturing” process requiring license under Factories Act 1948, the activity need not transform goods or necessarily produce an entirely new product that is commercially recognized as different.
Source: bit.ly/43fNQdI

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 Union Health Ministry of India has been allocated a budget of Rs 90,958.63 crore for the financial year 2024-2025 in the Parliament’s interim Union Budget 2024 session. This budget is 12.96% higher than the budget that was allocated for the financial year 2023-24.
Source: bit.ly/3YnHCWu

2. The Union Health Ministry of India has announced a revision in the basic customs duties (BCD) with an aim to align with domestic capacity expansion for medical equipment such as X-ray tubes, flat panel detectors, including scintillators that will be used in the manufacture of medical X-ray machines for medical, surgical, dental, or veterinary use. The custom duty will be reduced from 15% to 5% until 31st May 2025.
Source: bit.ly/4fgx6GI

3. India’s Environment Ministry has issued a draft guidelines relating to the Uniform Consent Fee and the Grant, Refusal, or Cancellation of Consent to Establish & Consent to Operate. These guidelines aim to streamline the consent mechanism under the provisions of the Water Act and Air Act, enhance ease of doing business, minimize the compliance burden on industries, and reduce duplication of work concerning the issuance of consents.
Source: bit.ly/4cQs6af

4. India’s Environment Ministry has notified an Public Liability Insurance (Amendment) Rules, 2024. This amendment aims to increase scope of public liability insurance to environmental damage that may be caused by industrial accidents.
Source: bit.ly/3YihHjg

5. The India’s Central Drug Regulator (CDSCO) is reportedly planning to exempt the need for testing Cough Syrups intended for export to the US, UK, Canada, the European Union, Japan, Australia, Singapore, Korea, and Switzerland at prescribed laboratories.
Source: bit.ly/4df0ZFz