Frequently Asked Questions

Industrial Radiography means a non-destructive process for testing materials by using ionizing radiation. The business entity planning to operate or operating radiography devices for industrial radiography facility specified under the Atomic Energy (Radiation Protection) Rules, 2004.

Documents required

1. Passport size Photograph of Radiation Professional
2. KYC of the Radiation Professional
3. Qualification documents/Marksheet of Radiation Professional
4. Final Safety Analysis Report (FSAR)
5. Quality Assurance Manual (QAM) 
6. Radiation Protection Manual (RPM)
 

A business entity that wants to operate or already operating a gamma irradiation chamber facility is required to get this Registration as per the Atomic Energy (Radiation Protection) Rules, 2004, issued by AERB. 

Documents required

1. Passport size Photograph of Radiation Professional
2. KYC of the Radiation Professional
3. Qualification documents Marksheet of Radiation Professional
4. Final Safety Analysis Report (FSAR)
5. Quality Assurance Manual (QAM) 
6. Radiation Protection Manual (RPM)
 

To apply and get a Registration from AERB, a business entity must desire to manufacture medical diagnostic X-ray equipment & X-ray tubes. As per the Atomic Energy (Radiation Protection) Rules, 2004, all the entities as the manufacturers/ suppliers/ users of X-ray equipment require Atomic Energy Regulatory Board (AERB) Registration for carrying out these activities.

Procedure :

1. The first step is to get the permission for procurement/ import of X-ray tubes and X-ray equipment

2. Details of the Radiation testing facility during demonstration of Type Approval

3. Details of the radiation protection devices

4. Details of the quality assurance equipment

5. Details of the qualified person for radiation testing, quality assurance and servicing of diagnostic x-ray equipment

6. Details of each model of X-ray equipment and their AERB approval

7. Details of Radiation Safety Officer (RSO) & his/her comments/recommendations

Any business entity planning to export the prescribed materials, minerals or a plant designed, adopted or manufactured for the production, development and use of atomic energy or for research into matters of atomic energy or any other prescribed equipment/items is required to have this Registration.

Documents required

1. Complete Filled and signed copy of Import form by the applicant

2. Detailed Company Profile for export of prescribed substance

3. Copy of End User Certificate of foreign buyer/consignee/end user

4. Copy of the Purchase Order

5. AERB NOC if prescribed substance is also radioactive

6. Utilization statement of previous export Registration issued by AERB

7. Technical details of material annexed along with the application

It is the responsibility of the Atomic Energy Regulatory Board (AERB) for enforcing the Atomic Energy Act of 1962 rules and regulations in order to ensure radiological protection in the Country and also oversee the implementation of the Factories Act of 1948, ensuring industrial protection in the Department of Atomic Energy's units under its jurisdiction. Ensuring the use of ionising radiation and nuclear energy in India does not pose an unacceptable risk to people's health or the environment is the mission of AERB.

The Central Electricity Regulatory Commission (CERC) has been appointed as the Market Regulator and Bureau of Energy Efficiency (BEE) as the Administrator for trading of ESCerts on the power exchanges. The Power System Operation Corporation Limited (POSOCO) has been engaged as the Registry for permitting Designated Consumers as eligible entities for trading of ESCerts and the book-keeping of the ESCerts issued by the Bureau of Energy Efficiency. The trading of Energy Saving Certificates (ESCerts) is to be performed on Tuesdays on two power exchanges named IEX and PXIL.

An Energy Saving Certificate is a certificate issued to those Designated Consumers (DCs) who have overachieved their energy saving targets in any PAT (Perform Achieve and Trade) Cycle. These certificates are then bought by those DCs which have under achieved their energy saving targets.

1.    Induction Motors
2.    Agriculture Pump Sets
3.    Ceiling Fans
4.    Domestic Liquefied Petroleum Gas (LPG) Stoves
5.    Washing Machines
6.    Computers (Notebook/Laptops)
7.    Ballast (Electronic/Magnetic)
8.    Office Equipment’s (Printer, Copier, Scanner, MFD’s)
9.    Diesel Engine Driven Mono set Pumps for Agriculture Purposes
10.    Solid State Inverters
11.    Diesel Generators
12.    Chillers
13.    Microwave Ovens
14.    Solar Water Heaters
15.    Light Commercial Air Conditioners
16.    Deep Freezers
17.    UHD Televisions
18.    Air Compressors

1.    Direct Cool Refrigerator
2.    RAC (Cassette, Floor Standing Tower, Ceiling, Corner AC)
3.    Distribution Transformer
4.    Room Air Conditioner
5.    Tubular Fluorescent Lamp
6.    Frost Free (No-Frost) Refrigerator
7.    Electric Geysers
8.    Color TV
9.    Variable capacity Air Conditioners
10.    LED

A Label describes the energy efficiency of a system (in the form of energy use, efficiency or energy cost). ‘’Labels’’ primarily provide customers with the knowledge they need to make an educated purchase. Labels are divided into two categories:
1.    Comparative label- Allows customers to compare the energy consumption of comparable goods and consider lifetime operating costs when making a purchase.
2.    Endorsement Label- Provides a ‘certification' to potential buyers to let them know that the product is extremely energy efficient for its category

A BEE Standard is a benchmark for electrical items to test their usage of energy and to limit their usage of energy by defining test protocols for their testing.

The total cost for Equipment Type Approval (ETA) and WPC Registration is Rs.55,000. 

First, for Equipment Type Approval (ETA), we need Radio Frequency (RF) Test report from any ISO 17025 accredited Foreign lab or NABL accredited Indian lab. Once we have the Radio Frequency test report, we apply for WPC Registration.

For ETA (Equipment type Approval)

•    Radio Frequency (RF) Test report either from a Foreign lab having ISO 17025 accreditation or NABL accredited Indian lab.
•    Board declaration for authorized signatory
•    ID Proof of the authorized signatory
•    Product Technical Details.

For Import License (IL)

•    ETA certificate
•    Purchase Order
•    Proforma Invoice
 

•    Beacon
•    CORDECT/CDMA
•    Captive Radio paging
•    Wide Area Radio Paging
•    Captive Radio Trunking
•    Public Mobile Radio Trunking Service (PMRTS)
•    Captive VSAT
•    Commercial VSAT
•    GSM
•    Earth station for foreign mission
•    Experimental
•    FM Community Broadcast
•    FM Broadcast
•    SW Broadcast
•    Terrestrial Broadcast
•    Fixed/Mobile-HF/VHF/UHF-Land Based
•    Fixed/Mobile-HF/VHF/UHF-Land Based (additional category)
•    HF/VHF for Foreign Mission
•    MW Broadcast
•    MW link for Foreign Mission
•    MW link for Cellular (GSM)
•    MW link for WLL(CDMA)
•    Link for Point to Point Communication
•    MW link for Point to Multipoint (for ISP, ILD, NLD)
•    MW link for wide area Radio Paging
•    Radar
•    Remote Controller
•    SCADA
•    Satellite Broadcast
•    Satellite Network-Gateway for ISP, ILD, NLD
•    Satellite Network-Receive only Earth Station
•    Satellite News Gathering
•    Shot Range UHF Hand Held Radio (USR)
•    Spread Spectrum

• 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.
   

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. 

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. 

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
   

• 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
   

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

•    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

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.

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

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.
 

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.

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).
 

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."