Government Proposes Strict Debarment Rules for Submitting False Information Under Drugs Act
The Ministry of Health and Family Welfare has published draft rules proposing stringent penalties, including the debarment of applicants, found guilty of submitting misleading, fake, or fabricated documents and information across various regulatory parts of the Drugs Rules, 1945.
Proposed Changes to Licensing for Liquid Antiseptics
The draft rules, called the Drugs (… Amendment) Rules, 2025, propose to redefine the sale licensing requirements for liquid antiseptics, distinguishing between household use and professional use. The amendment seeks to replace the existing entry for liquid antiseptics with two new defined categories based on the product’s intended end-user
Government Notifies Opium Cultivation Policy for 2025-26
The Ministry of Finance has officially notified the annual licensing policy for opium poppy cultivation for the crop year 2025-26. The policy, effective from October 1, 2025, to September 30, 2026, specifies the cultivation tracts and sets detailed eligibility criteria for licenses across four states. The policy distinguishes between two methods of cultivation: for opium gum (lancing) and for poppy straw (unlanced), with different conditions for each.
FSSAI Proposes Fixed Renewal Cycles and Longer Validity Periods for Food Licenses
The Food Safety and Standards Authority of India (FSSAI) is exploring changes to the renewal process and validity periods for food licenses and registrations, aiming for uniformity and reduced burden on Food Business Operators (FBOs). The authority has released a Consultation Paper seeking stakeholder comments on proposals to introduce fixed renewal cycles and longer validity options, potentially up to 10 years for certain businesses. This notice was issued on May 20, 2025.
FSSAI Mandates Closure Reports for Expired Food Licenses/Registrations
The Food Safety and Standards Authority of India (FSSAI) has issued a directive mandating all Food Business Operators (FBOs) whose FSSAI License or Registration expired during the financial year 2024-25 to submit a Closure Report. This order was issued on May 16, 2025.
New ‘KoB’ Category For Anganwadi Centers & Waiver Of Registration Fees
The Food Safety and Standards Authority of India (FSSAI) has decided to waive registration fees for Anganwadi (ICDS) Centers and introduce a new “Kind of Business” (KoB) category specifically for these centers.
FSSAI Mandates Mandatory Update of Nominee Details & Updates To Modifications
The Food Safety and Standards Authority of India (FSSAI) has issued a directive to all Food Business Operators (FBOs) regarding the mandatory update of Form IX nominee details, along with the introduction of an auto-approval provision for certain modifications in the Food Safety Compliance System (FoSCOS).
FSSAI Makes PAN Mandatory for Food Business Licenses and Registrations
All new applications for FSSAI licenses and registrations, as well as renewals and modifications, must include the PAN number of the FBO. This is effective from October 22, 2024. Existing FBOs whose renewal or modification is not imminent are required to update their PAN details on the FoSCOS portal as soon as possible.
FSSAI Re-operationalizes Food Safety Licensing Amendment Regulations, 2021
The Food Safety And Standards Authority Of India (FSSAI) had first introduced an amendment titled Food Safety and Standards (Licensing and Registration of Food Business) Amendment Regulations, 2018. FSSAI, by the present notice dated July 19, 2024, has issued a direction re-operationalizing this amendment regulation.
Reactivation of Auto-Rejected FSSAI Licensing/ Registration Applications
This facility will be available to those FBOs (Food Business Operators) whose applications were auto-rejected because they did not respond to the queries of the authorities within the stipulated time. This procedure will streamline the process of reactivation of auto-rejected applications. It will reduce waiting time for the approval of authorities in handling request for reactivation of auto-rejected applications.
Registrations Discontinued for Manufacturers of Fortified Rice Kernel
The Food Safety and Standards Authority of India (FSSAI) has issued an order to strengthen the quality control mechanism for Fortified Rice (FR), Fortified Rice Kernel (FRK) and Pre-mix for FRK. This order was based upon a review of the existing regulatory mechanism of manufacturing FR and FRK. It was issued on 8th November, 2023.
FBOs Can Choose Periodicity of FSSAI Instant Renewal Licence
Effective from November 8, 2023, Food Business Operators (FBOs) applying for new licenses/registrations or seeking renewal will now have the flexibility to choose the validity period for their licenses. The revised guidelines empower FBOs to select a validity period ranging from 1 to 5 years in their applications.