Frequently Asked Questions

• The Basic registration Government fee for FSSAI is Rs.100 per year and in one application, Govt fee for a maximum of five years can be submitted. The validity of 5 years of FSSAI cRegistration is thus issued.
• The annual fee for trading in a food business is Rs.2000 per year, for an online application for FSSAI State Registration, which may increase to Rs.3,000 for a milk business, meat business or manufacturing and packaging food business. The Government Fee for a maximum of 5 years can be submitted in one FSSAI Online Application having 5 years of validity.
• The Government fee is Rs.7,500 per year for an online application for FSSAI Central Registration and can be submitted for a maximum of five years with a five-year validity period.
• The concerned Food Inspector may demand a laboratory report of the water if water usage is involved in manufacturing food articles, which needs to be submitted. The water testing laboratory may charge between Rs.3,000 to Rs.5,000.

Under the Directorate General of Health Services, Ministry of Women, Child & family welfare, Government of India, established the Central Drugs Standard Control Organisation (CDSCO), to perform the functions envisaged in The Drugs & Cosmetics Act, 1940. In order to ensure the safety, efficacy and quality of the medical products manufactured, imported and distributed in the Union Territory of India there has been the constant endeavour of the CDSCO to bring out a high level of transparency, accountability and uniformity in its services. To handle the specific tasks of regulating chemicals, drugs, pharmaceuticals and medical devices in India, 8 divisions were made by Central Drugs Standards Control Organisation (CDSCO). These are:

1.  Bioavailability/Bioequivalence (BA/BE) studies

2.  New Drugs Development and permissions

3.  Import & Registration of Drugs and Cosmetics

4.  Biological studies

5.  Cosmetics regulation 

6.  Medical Device & Diagnostics permissions

7.  The Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC)

8.  Clinical Trials

Under The Ministry of Health & Family Welfare, CDSCO, a nodal agency for monitoring of the existing drugs & pharmaceuticals, the introduction of new drugs & pharmaceuticals in the Indian market, individual/institute/business entity planning to import new drugs & formulations in India,  and to conduct Clinical trials/ bioavailability/bioequivalence studies, is required to get the CDSCO license to do so prior to the actual import of the substance.

To import drugs and substances which are not included in the Schedule X of the Drugs & Cosmetics Act, 1945, an individual or business entity is allowed only if it possesses a valid Drugs Manufacturing License or a Drugs Wholesale License.

Documents required for CDSCO registration:

1. Drugs wholesale or drugs manufacturing business registration, mentioning the products approved

2.  Valid RC duly attested by the Indian agent/ manufacturer.

3.  Permission from CDSCO under Rule 122A, if a new Drug is to be imported

4. Original labels/ specimen labels attested by the importer for bulk drugs/ finished formulation as per Rule 96 & 97 of the Drugs & Cosmetics Act, 1945

Documents required

1. An Undertaking by the applicant detailing the required facilities such as equipment, instruments & personnel for the manufacturing of medical devices

2. List of equipment and instruments used for manufacturing

3. List of qualified personnel employed by the applicant

4. Justification of submitted quantity to be manufactured by the applicant

5. Test protocols for testing finished medical devices/equipment

6. Quality Management Certificates from the war material supplier

7. Manufacturing license issued by the State Pollution Control Board

8. Site Layout / Site Plan

9. Certification of a site with a detailed raw component

10. DPR/Process Flow Chart

Documents Required for CDSCO Registration:

1. Covering Letter mentioning the purpose of application
2. Authorisation from the manufacturer (duly authenticated)
3. Filled in Part-I of the Second Schedule 
4. List of Ingredients along with its percentage contents
5. Labels of proposed products
6. Specifications and testing methods
7. Pack insert
8. Manufacturing Licenses/undertaking for no provision of manufacturing license in the Country.
9. Free Sale Certificate (duly authenticated)
10. Non-Animal Testing Declaration
11. Declaration for Heavy Metal and Hexachlorophene content.

First the applicant must visit a centralized system for applications, the SUGAM portal of the CDSCO. Then, he/she is required to choose the kind of certification to apply for. Then the required documents are uploaded and the company details are entered into the system. Once the application is complete and the requisite fee for Central Drugs Standard Control Organisation registration is submitted, the application is forwarded to the concerned officer of the CDSCO, who performs a site inspection and issues clarifications. After the inspection queries are answered satisfactorily, the CDSCO certificate is issued.

Drugs business registration refers to the legal process of incorporating and licensing a pharmaceutical company or entity involved in manufacturing, importing, distributing, or marketing drugs, primarily under India's CDSCO regulations. The Drugs business registration" is often used to refer to two distinct but equally mandatory steps for starting a pharmaceutical or medical business. Post-incorporation, secure CDSCO approvals like Form 40 for foreign manufacturing site registration, import licenses, and marketing authorization after clinical trials, if applicable. This is the most critical and complex part, often what people mean when they say "Drugs Business Registration."

The Drugs Registration refers to the regulatory approvals required for pharmaceutical products before they can be manufactured, imported, sold, or distributed, varying by country and governed by bodies like India's CDSCO or the US FDA. The types of registration are generally categorized by the nature of the drug (new vs. generic) and the regulatory pathway of the specific country.

International Registration Procedures

•    Centralized Procedure (EU): A single application to the European Medicines Agency (EMA) that allows marketing across all EU member states.
•    Import Registration: Required when a drug manufactured in one country is registered for sale in another (common in India's CDSCO or China's NMPA).

Main License Types in India

•    India’s Drugs and Cosmetics Act categorises drug registrations primarily as licenses for different activities. Key types include manufacturing licenses for producing drugs, sale licenses (retail via Form 20/21 or wholesale) and import licenses (Form 10/41).

Import Registration & Import Licence

•    Required for importing drugs into India.
•    Registration Certificate (Form 41) – For foreign manufacturers and their products

Sale Licences

•    Required for selling, stocking, exhibiting, or distributing drugs.
•    Retail Drug Licence
•    Wholesale Drug Licence

Cosmetics Registration (Related Category)

•    Though separate from drugs, cosmetic products require registration for import (Form COS-2).
 

1.  The sale of Allopathic drugs by retail other than those specified in Schedule C, C(1) & X.

2.  The sale of restricted Allopathic drugs by retail other than those specified in schedule C, C (1) & X.

3.  Wholesale of Allopathic drugs other than those specified in Schedule C, C (1) and X.

4.  The sale of Homoeopathic medicines by retail.

5.  The sale of Homoeopathic Medicines by wholesale.

6.  Retail sale of Allopathic drugs specified in Schedule C & C.

7.  Wholesale of Allopathic drugs specified in Schedule C & C.

8.  Retail sale of restricted Allopathic drugs specified in Schedule C 

9.  Retail sale of drugs specified in Schedule  X. 

10.  Wholesale of drugs specified in Schedule X.

Drugs Manufacturing Registration (Manufacturing Licence) is issued by the State Drugs Control Department under the Drugs & Cosmetics Act, 1940 and Rules, 1945. Domestic and foreign manufacturers, replacers, relabels, and related facilities must submit this information electronically via the FDA's eDRLS system.

Documents Required for Drugs Manufacturing Registration

•    Statutory Application Forms
•    The form you use depends on the category of drugs you intend to manufacture:
•    Form 24: For drugs other than those in Schedules C, C1, and X (General Allopathic medicines).
•    Form 24-F: For drugs specified in Schedule X (Narcotics/Psychotropics).
•    Form 25 / Form 28: These are the actual licenses granted upon approval.

Constitution of Firm

•    Partnership Deed / LLP Agreement / MOA & AOA (Company)
•    PAN Card of firm/company
•    List of Directors / Partners with ID & address proof

Technical Personnel Documentation

•    Qualification Certificates: Self-attested copies of B. Pharm, M. Pharm, or B. Sc/M. Sc (Chemistry/Microbiology) degrees.
•    Experience Certificates: Minimum 18 months of practical experience in manufacturing/testing is typically required.
•    Appointment & Acceptance: Appointment letters from the firm and acceptance letters from the technical staff.
•    Registration: For pharmacists, a valid registration certificate from the State Pharmacy Council

Product & Manufacturing Details

•    List of drugs to be manufactured (with dosage form)
•    Master formula records
•    Manufacturing process flow chart
•    Stability study protocol (where applicable)
•    Product labels & pack inserts (draft)

Legal & Ownership Documents

--    Partnership: Partnership Deed.
--    Private Ltd/LLP: Certificate of Incorporation, Memorandum of Association (MoA), and Articles of Association (AoA).
•    Premises Ownership: Registered Rent Agreement (if leased) or Sale/Ownership Deed (if owned).
•    Identity Proof: PAN Card and Aadhaar of all Directors/Partners/Proprietor.
•    Board Resolution: Authorizing a specific person to sign and submit the application.
 

To start a drug retail or wholesale business in India, you must apply to the State Drugs Control Department via Form 19. While many documents are common to both, the "Technical Person" requirement differs significantly. 

Documents Required for Drugs Retail & Wholesale Business Registration
These documents establish the legal identity of your business and the suitability of your shop/warehouse.

1.  GST Certificate
2.  Rent/lease agreement
3.  Adhaar card & PAN card of Authorised signatory
4.  Degree & PCI Registration of the qualified person
5.  Adhar card & PAN Card of qualified person
6.  HVAC details of the storage area
7.  Electricity Bill
8.  Site Layout Plan

As per section 3(aaa) of the Drugs and Cosmetics Act, 1940, “cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.

•    Face Care Products 
•    Face Mask
•    Eye Care Product
•    Lip Care Product
•    Hand Care Product
•    Body care product
•    Foot Care Products
•    External intimate care products
•    Chemical exfoliation products 
•    Mechanical exfoliation products 
•    Skin lightening products
•    Other skincare products 
•    Soap products 
•    Bath/shower products 
•    Make-up remover products 
•    External Intimate hygiene products 
•    Other skin cleansing products 
•    Chemical depilatories 
•    Physical epilation products 
•    Other body hair removal products 
•    Bleach for body hair
•    Products with antiperspirant activity 
•    Products without antiperspirant activity 
•    Shaving products
•    Pre- / after-shaving products 
•    Other shaving and pre- / after- shaving products 
•    Foundation
•    Concealer 
•    Other face make-up products 
•    Mascara 
•    Eye shadow 
•    Eye pencil 
•    Eyeliner 
•    Other eye make-up products 
•    Lipstick 
•    Lipstick sealer 
•    Other lip make-up products 
•    Body or face paint, including "carnival make-up" 
•    Other make-up products 
•    Hydroalcoholic perfumes 
•    Non-hydro alcoholic perfumes 
•    Before and after sun products Sun protection products 
•    Self-tanning products 
•    Other sun and self-tanning products 
•    Other skin products 46. Hair conditioner
•    Scalp and hair roots care products 
•    Anti-hair loss products 
•    Other hair and scalp care and cleansing products 
•    Antidandruff products 
•    Oxidative hair colour products 
•    Non-oxidative hair colour products 
•    Hair bleaching and dye remover products 
•    Other hair colouring products 
•    Products for temporary hair 
•    styling Permanent wave products 
•    Hair relaxer/straightener products 
•    Other hair styling products
•    Hair sun protection products 
•    Other hair and scalp products
•    Nail varnish / Nail make-up
•    Nail varnish remover 
•    Nail varnish thinner 
•    Nail bleach
•    Other nail varnish and remover products
•    Nail care products 
•    Nail hardener 
•    Other nail care/nail hardener products 
•    Nail glue remover 
•    Cuticle remover/softener 
•    Nail sculpting products 
•    Other nail and cuticle products 
•    Toothpaste 
•    Tooth cleansing powder/salt 
•    Other tooth care products 
•    Mouthwash 
•    Breath spray
•    Other mouthwash/breath spray products
•    Tooth whiteners 
•    Other oral hygiene products

•    Cosmetics Manufacturing Registration
•    Cosmetics Loan Registration
•    Cosmetics Import & Site Registration

• Warehouses
• Trading of packaged food items/non-perishable products
• Trading of cement and steel items
• Trading in textiles/readymade garments
• Trading in plastic items
• Trading in consumer durables
• Trading of consumer electronics
   

For Proprietorship business

• ID proof of the proprietor
• GST Registration
• Shops and Establishment Act Certificate
• Electricity bill/rent agreement
• Details of the business activity

For Private limited company

• Certificate of Incorporation (CIN)
• GST Registration
• Company PAN card
• Board declaration for authorized signatory
• ID proof of the Authorized signatory
• Electricity bill/rent agreement
• Details of business activity
   

The applicant is required to apply online, in case the Municipal Corporation has this facility, otherwise, a hard copy application in a prescribed format is to be submitted to the Municipal Authority. The Government fee is submitted and the documents uploaded or attached to the hard copy application. The concerned officer may inspect the premises where the business activity is taking place. After the queries issued by the inspector are suitably answered, the Trade Registration is issued. 

The Government fee for a new trade Registration application may range from Rs.500 to Rs.25,000, depending on the Municipal Corporation. Besides, if an agency is hired for this work, it may charge you. 

• Wireless Planning & Coordination Wing (WPC) is a division of Wireless Planning and Finance Wing (WPF) of the Department of Telecom (DoT) under the Ministry of Electronics and Information Technology (MeiT), Government of India. The chief mandate of WPC wing is to plan and coordinate the efforts to control and regulate the wireless devices in India for their safety, privacy and interference with other electronic devices. 
• An entity engaged in manufacturing or import of wireless devices is required to get Equipment Type Approval (ETA) & Import License (IL) certificate from the Wireless Planning and Coordination (WPC) wing. In the electronics and telecommunication market of India, various types of wireless communication are available such as mobile phones, Cordless telephones, Zigbee wireless technology, GPS, Wi-Fi, satellite television, and wireless computer parts.