Frequently Asked Questions

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.

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.

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

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

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.

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

• 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 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 Business is required to apply online for FSSAI Central Registration, if a food business operator (FBO), whether an individual or an entity, is engaged in the manufacturing of food articles or in packaging, storage, retailing, and transportation of food articles and the annual turnover is more than Rs.20 crore or the business has multiple units in different States.

The applicant is required to apply online for the FSSAI State Registration, if a food business operator (FBO), whether an individual or an entity, is engaged in the manufacturing of food articles or in packaging, storage, retailing, and transportation of food articles and the annual turnover is between Rs.14 Lakh to Rs.20 Crore.

A food business operator (FBO) who is involved in the manufacturing, sale, storage etc of the food articles and the annual sale is less than Rs.12 Lakh, then the application made to the Food Safety & Standards Authority of India (FSSAI) and the license thus issued is known as FSSAI Basic Registration. 

The expenses for the BIS Registration of a product include the Government fee, Laboratory fee and the Consultant charges, if hired. The Government fee depends on the type of product and may range from Rs.40,000 to up to Rs.1,00,000. The Laboratory Testing charges also range in the same amount. A consultant hired for the BIS Registration may quote anything between Rs.25,000 to Rs.50,000. 

The applicant is required to apply online for the BIS Registration of a product. The product submitted are tested on the specifications in a BIS Laboratory for the performance, quality and other parameters set by the BIS. After the lab results are received and the product is found compliant on all the parameters, the BIS Registration for that product is issued. 

The documents required for Bureau of Indian Standards (BIS) registration:
•    Manufacturing process flow chart, factory layout list of machinery and testing equipment and quality control plan or procedures.
•    List of machinery & equipment
•    List of testing equipment (In-house or external laboratory
•    Internal quality checks
•    Calibration certificates for testing equipment
•    Control procedures for raw materials & finished goods
•    Trademark or brand registration (if applying in a brand name) and brand authorization letter where the brand owner and manufacturer differ.
•    Details of the manufacturing unit, including full address, ownership details and contact information.
 

BIS Registration is a crucial quality and safety certification process in India.BIS Registration (CRS) is the official green light from the Indian government, through the Bureau of Indian Standards, that a mandatory-listed electronic product has been tested and complies with the necessary safety and quality standards for the Indian consumer market. For products under mandatory certification schemes, obtaining the BIS registration is a legal requirement to manufacture, sell, distribute, or import them into India. It helps enforce uniform national standards across various industries. An online application is submitted to BIS, along with the test reports and required technical/legal documentation.

The BIS Act, 1986 came into effect on 23rd December 1986. As per the provisions of the BIS Act, the Bureau of Indian Standards was established as the National Standards Body of India, under the Department of Consumer Affairs, Ministry of Consumer Affairs, Food and Public Distribution, Government of India.
The main functions of the Bureau of Indian Standards are as following:

•    Introduction of technical Formulations for goods and services
•    Implementation of System Certification Scheme
•    Implementation of Product Certification Scheme
•    Monitoring the Compulsory Registration Scheme
•    Implementation of Foreign Manufacturers Certification Scheme
•    Execution of Hall Marking Scheme
•    Implementation of Laboratory Recognition Scheme
•    Regulating the sale of Indian Standards
•    To allot resources and implementation of Consumer Affairs Activities
•    To allot resources and implementation of Promotional Activities
•    To undertake Training Services for various stakeholders
•    To develop and implement National & International level Information Services

• Covering Letter 
• Fees (Challan)
• Authorization Letter
• Rent agreement/Property papers
• CIN/ Partnership deed
• List of technical staff
• Site Plan/Layout Plan/Naksha
• SPCB Pollution Registration 
• Lab Report
• Details of Manufacturing Process
   

• Firstly, we are required to get a layout plan/ Naksha of the facility prepared by a qualified architect, this layout plan should be compliant with the AYUSH laws of the respective State. 
• Then, we need to get the layout plan/naksha of the facility approved by the District Health Officer/Chief Medical Officer of the District.
• After the layout plan is approved, we apply, online or offline, along with other documents, to the State AYUSH Department for the type of license as per our requirement.
• The concerned Government Official visits the site and performs site inspection.
• After the issues raised during site inspection are dealt with, the AYUSH Registration is issued. 
   

There is different Govt. fee for application for various Registrations under AYUSH Department. The fee also varies from one State to another. It is generally between Rs.1000 to Rs.2000, for most types of licenses.

• To develop the ancient medicine system in India with more researched and documented evidence
• To provide the facility and infrastructure for development of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy medicines
• To preserve the culture of India and promote the ancient culture by way of ayurvedic medicines
• To regulate the manufacturing and Import of Indian Ayurvedic medicines
   

• AYUSH Manufacturing Registration
• AYUSH Loan Registration / Third Party Manufacturing Registration
• AYUSH Import License

AYUSH stands for Ayurveda, Unani, Siddha and Homeopathy. Any individual or a business entity desirous of manufacturing medicines of any of the types stated above need to have an AYUSH Registration.

The documents required for an application to the Odisha State Pollution Control Board (OSPCB).
•    Pan Card of the unit
•    GST registration certificate
•    Udyam Registration / MSME Certificate (if applicable)
•    Site Plan/Layout Plan
•    Land documents (registration deed, lease deed or sale deed)
•    Manufacturing process flow chart
•    NOC from local body / Panchayat / Municipality
•    Details of machinery & equipment
•    Plant layout/factory layout drawing
 

The Odisha Pollution Control Board (OSPCB) classifies industries into different categories for CTE/CTO Registration based on their pollution potential. This classification system categorizes industries into four main groups: Red, Orange, Green, and White, based on their potential to pollute the environment.

Criteria for Classification

•    Water Polluter Score (PIW): Assesses effluent volume, BOD/COD, Ph., suspended solids and chemicals discharged.
•    Air Polluter Score (PIA): Evaluates stack emissions (PM, Sox, Ox) fugitive emissions/odors and fuel quantity/type.
•    Raw Materials and Manufacturing Process: The specific materials used and the technology/process adopted can lead to splitting an industrial sector into different sub-categories (e.g., electric heating vs. coal/wood fired heating) based on the expected pollutant generation.
 

The Odisha State Pollution Control Board (OSPCB) holds responsibilities under the Water (Prevention and Control of Pollution) Act 1974, Air (Prevention and Control of Pollution) Act 1981, Water Cess Act 1977, and rules/notifications of the Environment (Protection) Act 1986 to prevent pollution, improve air quality, and promote clean water bodies across the state. 

Consent Management (CTE/CTO):

•    Granting Consent to Establish (CTE): Issuing mandatory permission to all new or expanding industries, mines, and projects before they commence construction. This is to ensure pollution control is designed into the project from the start.
•    Granting and Renewing Consent to Operate (CTO): Issuing permission for a unit to start and continue production, only after confirming that the installed pollution control devices meet the prescribed standards. The renewal is periodic (e.g., Red Category industries often require renewal every 5 years).
 

The key benefits of obtaining OSPCB registration:
•    Regulatory Approval: Grants permission to operate, confirming pollution control measures meet standards and reducing legal risks
•    Electricity Connection: Required by the local power distribution company.
•    Water Connection: Required for accessing industrial water supply.
•    Municipal License/Trade License: Required for commercial operations from local authorities.
•    CGWA NOC: Required for permission to withdraw ground water for commercial/industrial/mining usage. 
 

The Odisha State Pollution Control Board (OSPCB) performs core functions categorized into enforcement, advisory, and monitoring to prevent and control water and air pollution under the Water (PCP) Act 1974, Air (PCP) Act 1981, Water Cess Act 1977, and Environment (Protection) Act 1986 rules. These functions are broadly classified into three main categories: Enforcement (Regulatory), Advisory, and Monitoring/Facilitation.

1.  Enforcement (Regulatory) Functions

•    Granting Consent to Establish (CTE) to new industries, mines, and projects before construction begins.
•    Granting and periodically renewing Consent to Operate (CTO) to functioning units, ensuring they meet environmental standards.

2.  Advising the State Government

•    Environmental policies
•    Pollution control strategies

3.  Pollution Monitoring

•    Establishing and operating a network of monitoring stations (both manual and continuous) to assess Ambient Air Quality (AAQ) and Water Quality.
 

Odisha State Pollution Control Board (OSPCB) registration refers to the online process for industries and businesses to obtain mandatory consents, primarily Consent to Establish (CTE) and Consent to Operate (CTO), required under pollution control laws before starting or running operations. The most important forms of OSPCB "Registration" are the statutory consents required for projects that have the potential to cause air or water pollution. These registrations ensure compliance with environmental norms for air, water, and waste management, categorized by industry type (Green, Orange, and Red) based on pollution potential.

The documents required for Madhya Pradesh Pollution Control Board (MPPCB) registration and application typically include:
•    Aadhar card and PAN card of the authorized person
•    Certificate of Incorporation for companies or Partnership deed for partnerships
•    Proof of land ownership or rent agreement
•    MSME/Udyam Registration Certificate
•    Site layout plan / Factory layout
•     Manufacturing process description
•    GST Certificate
•    Environmental statement in case of renewal or expansion
 

The Authorizations issued by the Madhya Pradesh Pollution Control Board are as following:

• Hazardous Waste Management Authorization
• Plastic Waste EPR site inspections for Plastic Manufacturers and plastic wate Recyclers
• E-Waste EPR site inspections for Electronics items Manufacturers & E-Waste Recyclers
• Bio-Medical Waste Management Authorization
• Battery Waste EPR site inspections for Battery Manufacturers and Battery Recyclers
• Construction & Demolition Waste Management Authorization