Frequently Asked Questions

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

 

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

If an individual or a business entity wants to have a restaurant or a hotel in Delhi, it is required to have a number of licenses and permissions from various Government departments. This takes a toll on the business owner because if the business owner is busy making rounds of various Government departments, he will not have the time to conduct his actual business activity. To overcome this, Ministry of Home Affairs, Government of India has started a single window type of licensing for hotels and restaurants in Delhi.

•    Labor Department License/ Shops and Establishment Act Certificate
•    Delhi Pollution Control Committee (DPCC) Consent to Establish (CTE) or Consent to Operate (CTO) Certificate
•    Health Trade License (HTL) from respective Municipality
•    Fire NOC from Fire Department
•    Structural Audit of the Building by an Architect 
•    Structural audit of the electrical systems
•    Tourism License from the Department of Tourism (DOT)
•    Liquor License from the Department of Excise Duty
•    Eating House license from Delhi Police
•    Music playing license from Delhi Police
•    Police verification (PCC) of the employees of the hotels or restaurants
 

•    KYC of the authorized person
•    GST certificate/CIN certificate
•    Partnership deed/MOA
•    Rent Agreement/Property Papers
•    Copy of last paid water bill
•    Copy of last paid electricity bill
•    Layout plan/Naksha
 

The applicant is required to visit the official website of MHA licensing in Delhi. After that he is required to create a login ID and password, received in the email of the applicant. Later Rs.1000 Government fee is to be submitted. Once that is done, the applicant can apply for a new or renewal of the any of the licenses stated in point 2 above. 

The initial cost of MHA licensing login and password creation is Rs.1000. After that the applicant can submit the Government fee for a new or renewal of any particular license, for which he wants to apply. For example, the Government fee for DPCC CTE certificate may be Rs.3000, for Health Trade license it could range anywhere between Rs.5000 for East Delhi Municipal Corporation to Rs.25,000 or more for South Delhi Municipal Corporation. The Government fee for renewal of Eating House License is Rs.300. There is no fee for Fire NOC application. 

The Micro, Small, and Medium Enterprises (MSME) sector has come up with great influence in the Indian economy over the last five decades. The MSMEs have played a crucial role in providing basic employment and generated a chunk of revenue for the economy. Atam nirbhar Bharat is part of MSME and the Indian Government has launched various schemes and policies to encourage small-scale industries. The Central Government has also notified various provisions of the MSME Development Act, 2006.

• Micro- Investment in P&M or Equipment doesn’t exceed one crore and turnover doesn’t exceed Five crore
• Small- Investment in P&M or Equipment doesn’t exceed Ten crores and turnover doesn’t exceed Fifty crore
• Medium- Investment in P&M or Equipment doesn’t exceed fifty crore and turnover doesn’t exceed Two hundred and Fifty crore
   

• Easier Bank Loans
• Cost-benefit in Trademark/Patents registration
• Exemption in Overdraft interest rate
• Security against payment
• Reduced cost of electricity 
• Reimbursement of ISO certification cost

• ID proof of the Authorized Person
• GST Certificate
• Contact details of Authorized Person
• Annual Turnover details
• Investment Details
   

There is no Government fee for MSME registration certificate. Metacorp charges Rs.1,000 for MSME registration.

The applicant is required to visit the MSME portal and create a login ID and password. After that, the required documents are to be uploaded on the portal. The MSME certificate is generated after the complete application is submitted. 

• 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