Frequently Asked Questions

The food business operator (FBO) must apply online at the FSSAI official portal where he would be asked to upload company documents and will be asked to provide details of the manufacturing process of the food business. Also, the Government fee is deposited online. The application is then forwarded to the concerned Food Inspector, who conducts the inspection. If during the inspection the queries raised are satisfactorily answered, the FSSAI Registration is issued. 

• 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.

The National Small Industries Corporation (NSIC) is a Government organization tasked to promote small businesses in India by providing them financial assistance, infrastructure development and required information about their business. The NSIC registration for small businesses is mandatory to avail the benefits of the schemes initiated for the small industries.

• Access to Government tenders without any fee 
• Exemption for Earnest Money Deposit (EMD) for submitting Bid Documents for Government Contracts
• In tender participating MSMEs quoting price within price band of L1+15 per cent shall also be allowed to supply a portion upto 25% of requirement by bringing down their price to L1 Price where L1 is non MSEs.
• Every Central Ministries/Departments/PSUs shall set an annual goal of minimum Purchase/services procurement from MSMEs
• 25 % of total annual purchase of goods
• 25 % of total annual services
• Out of 25 %, 4 % shall be reserved for SC and ST
• Out of 25%, 3% shall be reserved for women
• 358 items are also reserved for exclusive purchase from MSMEs 
• Other Schemes and benefits are also provided under MSMEs
   

All the micro and small enterprises, as per the definition of the MSME Act, are eligible for NSIC Registration.

The applicant is required to visit the MSME official portal. From this portal, the NSIC is to be accessed. The required documents are to be submitted online and the NSIC certificate is generated. 

The Government fee for NSIC registration is Rs.5,000. The company hired for this certificate may charge you for the documentation and other services. 

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 if possesses a drugs manufacturing Business or a drugs wholesale business Registration

Documents required for CDSCO registration:

1. Drugs wholesale or drugs manufacturing busienss 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

Firstly the applicant must visit a centralized system for applications, 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 completely ready 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 then permission is granted for a particular activity and the conditions under which it can be performed. 

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. 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."

Drug 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 categorize 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 Licence
•    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) and X.
2. The sale of restricted Allopathic drugs by retail other than those specified in schedule C, C (1) and 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.
•    Proprietorship: ID & Address proof of the owner.
•    Partnership: Registered Partnership Deed.
•    Private Ltd/LLP: Certificate of Incorporation, MoA, and AoA.
•    Ownership: Sale Deed/Property Tax receipt.
•    Rented: Registered Rent Agreement and NOC from the landlord.
•    Layout: Blueprints of the Site Plan and Key Plan (showing the exact location and dimensions).
•    Affidavit of non-conviction of the proprietor/directors.
•    Affidavit for full-time engagement of the technical person
•    Affidavit for compliance with Drugs & Cosmetics Act
•    Undertaking for non-conviction
•    Self-declaration regarding storage conditions
•    Fee payment receipt / challan
 

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 
•    Mouth wash 
•    Breath spray
•    Other mouth wash/breath spray products
•    Tooth whiteners 
•    Other oral hygiene products