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Food Safety & Drugs Regulation
Food, drug, cosmetic, and AYUSH products face the most rigorous regulatory enforcement in India — and also attract the most consumer complaints that trigger licence suspensions. Getting the licence type right, GMP documentation in order, and the inspection-ready on the first visit is not optional. S.K. Enterprises manages the full licensing cycle from site inspection readiness through to licence grant, renewal, and post-grant compliance.
Overview
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Share your requirement and we'll prepare a clear action plan — timeline, documentation checklist, and cost estimate.
Book a ConsultationWhatsApp usLicences & Schemes
For food businesses with annual turnover below ₹20 crore. Required for manufacturers, storage providers, transporters, and retailers operating within one state.
For businesses with turnover above ₹20 crore, importers, multi-state operators, and e-commerce food platforms. Issued by the Central Licensing Authority.
Licence for cosmetic manufacturers operating their own licensed premises, under the Cosmetics Rules 2020. Issued by the State Drug Controller.
Allows a cosmetic brand owner without manufacturing facilities to produce under licence at a COS-1 contract manufacturer.
Mandatory for importing cosmetics into India — a COS-8 import registration certificate from CDSCO is required before customs clearance.
Manufacturing licence for Ayurvedic, Siddha, and Unani drugs. Requires GMP inspection of the manufacturing premises by the State AYUSH Department.
Licence for wholesale or retail sale of Ayurvedic, Siddha, and Unani preparations, issued by the State AYUSH Licensing Authority.
Renewal application for AYUSH manufacturing licences — timely renewal avoids lapse and the need for a fresh inspection.
For wholesale of Schedule G, H, and OTC drugs. Requires a licensed premises, refrigeration where needed, and a qualified pharmacist.
Covers wholesale of controlled substances (Schedule H1, X). Stricter premises and record-keeping requirements apply.
Process
We determine the correct licence — FSSAI State or Central, COS-1/2/8, AYUSH form type, or drug wholesale licence — based on your business model, product category, and turnover.
For manufacturing licences (FSSAI, COS-1, AYUSH), we conduct a pre-inspection audit of your facility against GMP requirements, identifying and resolving gaps before the official inspection.
We compile the complete document set: site layout, GMP compliance declaration, product category maps, technical personnel details, lab equipment inventory, and formulation specifics where required.
We file on FSSAI's Food Licensing and Registration System (FLRS) or the State Drug/AYUSH portal, coordinate the inspection visit, and accompany the inspector on the day.
FSSAI and drug licences require annual or periodic renewal. We track renewal dates, file on time, and flag any regulatory changes (new standards, product additions) affecting existing licences.
Documents
Company/firm registration, GST, PAN
Food safety management system (FSMS) documents
FSSAI Central applications
Site layout, floor plan showing product flow and storage
Product list with category codes (FSSAI) or formulation (AYUSH/Cosmetics)
Technical personnel qualifications
Food technologist, pharmacist, or chemist depending on licence
Lab equipment inventory and calibration records
GMP compliance certificate / ISO 22716 (for cosmetics)
Labelling draft for all products
We guide you through document preparation, certification of copies, and formatting requirements specific to each authority.
FAQ
CDSCO Medical Devices
Full licensing support across all four device classes — manufacturing, import, loan, test, and wholesale licences plus ISO 13485.
EPR & Pollution Control
EPR registration for plastic, e-waste, battery, and tyre waste on the CPCB portal, plus CTE & CTO consents from State Pollution Control Boards.
Gov. & Corporate Reg.
Trademark, IEC & DGFT, GeM portal onboarding, GST/MSME/company incorporation, and PESO storage & gas cylinder licences from one desk.
Tell us what you need — we'll assess your requirements and come back with a clear action plan. No jargon, no obligation.