Frequently Asked Questions

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 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.
 

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 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. 

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 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.

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 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.