Licenses — FSSAI, Drug & Medical — Guides & Insights | LeegAl

19 Articles

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Guest House and Homestay Registration: Licences Needed

by Gaurav Kumar

Running a guest house or homestay in India typically needs registration with the state tourism department under its homestay or bed-and-breakfast scheme, a municipal trade licence, FSSAI registration if serving food, a fire NOC above size thresholds, GST if turnover crosses limits, and reporting of foreign guests to authorities through Form C.

Complete Guide

23-Sept-2026

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AGMARK Certification: Complete Guide for Food Producers

by Gaurav Kumar

AGMARK is a quality certification for agricultural and allied products under the Agricultural Produce (Grading and Marking) Act, 1937, administered by the Directorate of Marketing and Inspection (DMI). Packers obtain a Certificate of Authorisation, test products at approved labs and grade them to AGMARK standards. It is voluntary for most products but required for certain items under food regulations.

Complete Guide

23-Sept-2026

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BIS Hallmarking Registration for Jewellers: Complete Guide

by Gaurav Kumar

Hallmarking of gold jewellery and artefacts is mandatory in notified districts, and jewellers selling such items must register with the Bureau of Indian Standards. Each hallmarked item carries a 6-digit HUID, the BIS mark and purity grade, tested at a BIS-recognised assaying and hallmarking centre. Registration is online and fees depend on turnover.

Complete Guide

23-Sept-2026

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Cosmetics Import Registration with CDSCO (Cosmetics Rules 2020)

by Gaurav Kumar

Imported cosmetics must be registered with CDSCO under the Cosmetics Rules, 2020 before import. The manufacturer or its authorised Indian agent applies online in Form COS-1 with product details, ingredient lists, free sale certificate, labels and test data, and receives a registration certificate. Labels must meet Indian requirements, and banned ingredients are not permitted.

Complete Guide

23-Sept-2026

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CDSCO Approvals Explained: Drugs, Devices and Cosmetics

by Gaurav Kumar

The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India, is India's central regulator for drugs, medical devices and cosmetics. It approves new drugs and clinical trials, issues import licences and registrations, licenses higher-risk medical devices, and registers imported cosmetics. Most applications are filed online through its portals.

Complete Guide

23-Sept-2026

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AYUSH Manufacturing License: Ayurveda, Siddha, Unani Guide

by Gaurav Kumar

Manufacturing Ayurveda, Siddha or Unani medicines requires a licence from the State Licensing Authority (AYUSH) under the Drugs and Cosmetics Act, 1940 and Rules, 1945. Applicants need a factory complying with Good Manufacturing Practices under Schedule T, qualified technical staff, quality control arrangements, and product formulations based on authoritative texts or approved as patent and proprietary medicines.

Complete Guide

23-Sept-2026

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Wholesale Drug License: Requirements and Process

by Gaurav Kumar

A wholesale drug licence, issued in Forms 20B and 21B by the State Drugs Control Department, allows sale of medicines to retailers, hospitals and other licensees. It requires suitable premises and storage and a competent person, either a registered pharmacist or a person meeting prescribed education and experience criteria in dealing with drugs.

Complete Guide

23-Sept-2026

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Drug Manufacturing License in India: Complete Guide

by Gaurav Kumar

Manufacturing allopathic drugs requires a licence from the State Licensing Authority, jointly inspected with CDSCO for certain categories, under the Drugs and Cosmetics Rules, 1945. Applicants need a facility compliant with revised Schedule M GMP, qualified technical staff for manufacturing and testing, and product permissions, with new drugs needing CDSCO approval.

Complete Guide

23-Sept-2026

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FSSAI Annual Return: Who Files, Due Date and Late Fee

by Gaurav Kumar

Licensed food manufacturers, importers and certain other licensees must file an annual return on FoSCoS by 31 May for the previous financial year, reporting food products handled, quantities and value. Dairy licensees have separate half-yearly returns. Late filing attracts a late fee, commonly Rs 100 per day.

Complete Guide

23-Sept-2026

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Retail Drug License (Medical Store): Complete Guide

by Gaurav Kumar

A retail drug licence, issued by the State Drugs Control Department in Forms 20 and 21 (and 20F, 21C where applicable), allows sale of medicines to consumers. It requires suitable premises of the prescribed minimum area, refrigeration for cold-chain drugs, and a registered pharmacist present during business hours. Prescription and sale records must be maintained.

Complete Guide

23-Sept-2026

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FSSAI License Renewal: Timeline, Process and Late Fees

by Gaurav Kumar

FSSAI registrations and licences must be renewed on FoSCoS before they expire, by filing the renewal application with fees for the new validity period of one to five years. Renewals filed after expiry attract a daily late fee within the permitted window, and a licence that lapses beyond that must be applied for afresh, interrupting business.

Complete Guide

23-Sept-2026

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Central FSSAI License: Who Needs It and How to Apply

by Gaurav Kumar

A Central FSSAI licence is required for food businesses with turnover above Rs 20 crore, importers and exporters of food, e-commerce food operators, units in central government premises such as airports and ports, and head offices of multi-state businesses. It is applied for in Form B on FoSCoS, costs Rs 7,500 per year and is issued by FSSAI's central licensing authority.

Complete Guide

23-Sept-2026

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