LegalRaasta Knowledge portal https://www.legalraasta.com/blog/ Information on company registration, FSSAI, IEC, MSME, trademark, ISO and registrations Mon, 30 Jun 2025 07:53:58 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.1 How does Cotton Certification Affect Market Prices? https://www.legalraasta.com/blog/cotton-certification-market-prices/ Mon, 30 Jun 2025 07:53:58 +0000 https://www.legalraasta.com/blog/?p=32237 India is experiencing the effects of elevated cotton prices. The BIS-certified cotton sector experienced a notable transformation within the textile industry in 2025. Have you wondered what the main reasons for the cotton price change are? What things are forcing a change in the cost of cotton in India? But it is common to mention [...]

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India is experiencing the effects of elevated cotton prices. The BIS-certified cotton sector experienced a notable transformation within the textile industry in 2025. Have you wondered what the main reasons for the cotton price change are? What things are forcing a change in the cost of cotton in India? But it is common to mention that the cotton certification can bring a change in the market price. This, however, is contingent upon cotton production, which must be sustainable for usage. Unlike conventional cotton, the demand for BIS cotton bales, which is ethically produced, is high in India as well as in other nations’ markets. In this comprehensive guide, we will discover those factors for cotton certification that affect marketing prices, roles, advantages, and many more. Let’s explore it in more detail.

The Foundation of Value: Cotton Quality

The history of the Indian economy mostly describes cotton as the “white gold.” The cotton, which is used for multiple purposes, touches millions of lives. But a question always circulates about how the quality of cotton brings changes in the market. Before discussing the cotton BIS certification, let’s first understand its importance. The key factors that make cotton “white gold” are

Staple Length:  This property assesses the maturity and fineness of a single cotton fiber. In the textile industry, such cotton is used for its stronger, finer, and more durable functions.

Strength: The individual cotton is described as a better fabric. This is because there is very little chance of its breaking during weaving or spinning. 

Micronaire: This property measures an individual cotton fiber’s full growth and elegance. 

Color: The white fibers are simpler to dye; therefore, the white cotton is mostly preferred for cloth production. 

When the property or the quality of cotton enhances, its price in the market increases directly. It naturally commands a better price. The textile manufacturers mostly offer the best price for the cotton due to its quality and other purposes. 

Cotton BIS Certification to Ensure Trust and Quality

Have you ever thought about how the quality and the safety of cotton are ensured? What is the process, and who regulates its activities in India? This is where the cotton certification in Indian plays a vital role. The certification for cotton is recognized as a symbol of trust and quality. Through the mark, the customers and the dealers come to know that it aligns with certain Indian standards. In India, the Bureau of Indian Standards (BIS) is the primary authority that grants licenses for cotton.

BIS certification for cotton means that the cotton bales have been tested and meet the specific quality guidelines set by the Indian government under the IS 12171 standard. This includes checks on fiber length, strength, fineness, and impurity levels.

What Are the Advantages of Cotton Certification in India?

The registration ensures to the customers that the product meets the specific safety and quality standards. The product verification is the way to enhance a brand’s credibility. Here are the reasons why the cotton BIS registration is crucial. 

Quality Assurance: The cotton in bulk has undergone a quality check. Through this property, the customers come to know that the cotton is consistent in quality. It is important in today’s textile industry. The common qualities of cotton are strength, length, color, and moisture content. 

Customer Trust: The symbol of BIS on the products builds the trust of customers. Both domestic and international customers favored acquiring registered cotton products.

Global Standard: The BIS certification aligns with the international safety and quality of cotton. This is beneficial for cotton manufacturers, importers, and distributors to enter international markets. The licensing of cotton enhances the image of the industry in other markets, which helps it to trade independently. 

Market Access: In most of the country, including India, obtaining the BIS license for cotton is a mandatory requirement. Although the license allows cotton businesses to enter booming Indian markets. Even for the government tender, you need to secure a valid license.

How does Certification Directly Affect Market Prices?

In the previous section, we discussed the importance of BIS certification for cotton. Now, let’s discover how the cotton registration impacts the market value:

  • Premium for Quality

Frequently, the cotton certified by BIS and displaying the ISI mark commands a premium price. What could be the reason for it? Well, this is because the cotton certification assured the buyers that it contained the fiber of premium quality. 

  • Customer Demand

 In the markets, the investors and the consumers only look for eco-friendly and ethically produced textiles. This can only be obtained when the product is tested before the market presentation. As a result, there is a significant demand for BIS certification registration for cotton.

  • Market Segmentation

The Fair Trade and the Global Organic Textile Standard allow the cotton manufacturers or businesses to charge a price if their products are ethical and eco-friendly. 

  • Premium Pricing

The features, like organic, especially BIS-certified cotton, command a higher price in the markets. This is because such cotton possesses the perceived value, which directly increases its demand in the markets. 

  • Labor-intensive practices

For the production of organic cotton, there is a need for specific labor. The labor-intensive process directly increases with the production of organic cotton. This leads to higher production costs, which affect the market price value. 

User Query: Why are BIS Cotton Bales Important for Bandage Manufacturers?

Conclusion | Registration for Cotton in India

Market price fluctuations are influenced by multiple factors. For ethical and sustainable cotton production, the need for certified BIS cotton increases. But it often results in higher prices for certified products. To expand your business in a market with elevated prices, it is advisable to register your cotton enterprise with the Bureau of Indian Standards at this time. We are here to help and guide the inspiring entrepreneurs who want to fit into booming markets. Apply now for a cotton BIS license.

Frequently Asked Questions

  1. What is one main reason that affects the price of cotton?

Ans. The international supply is one of the major factors that significantly affects the price of cotton. 

  1. Who is responsible for deciding the cotton price in India?

Ans. In India, the Government of India, of the Ministry of Agriculture and Farmers’ Welfare, is the one that calculates the cotton price. 

  1. What is the Indian Standard for cotton?

Ans. IS 12171: 2019 is the Indian Standard number for cotton bales in India.

  1. What does ISO stand for?

Ans. The “ISO” stands for International Organization for Standardization. It demonstrates the symbol, mark, or logo. 

  1. How is the price of cotton determined? 

Ans. The price of cotton is calculated by the forces of supply and demand in the market. 

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Why are BIS Cotton Bales Important for Bandage Manufacturers? https://www.legalraasta.com/blog/cotton-bales-bandage-manufacturers/ Sat, 28 Jun 2025 11:31:45 +0000 https://www.legalraasta.com/blog/?p=32233 For the manufacturing of bandages, the cotton bales play an important role. The production of bandages depends on cotton, as it is the primary raw material. As we know, cotton is the raw material for many bandages. The properties of cotton make it appropriate for healing. Therefore, the quality of cotton bales is important. To [...]

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For the manufacturing of bandages, the cotton bales play an important role. The production of bandages depends on cotton, as it is the primary raw material. As we know, cotton is the raw material for many bandages. The properties of cotton make it appropriate for healing. Therefore, the quality of cotton bales is important. To maintain their high-quality standards, the Bureau of Indian Standards mandates the compulsory registration of BIS for cotton bales.

It means the bandage manufacturers who use cotton as raw material are required to register with the national authority. In this comprehensive guide, we will explore the importance of BIS cotton bales for bandage operators, manufacturing processes, and many more. Let’s explore it in more detail.

Need for BIS Cotton in Bandage Manufacturing Industry

In the bandage manufacturing industry, only BIS-certified cotton is allowed to be used. Here is why the cotton is crucial for bandage manufacturing:

  • Raw Material: The cotton bales are the raw fibers that are processed into absorbent cotton. It means the cotton fibers are the base material for all types of bandages.
  • Absorbency: The cotton bales provide absorbent cotton. The property to soak up fluids makes the absorbent cotton more essential. It is used for effective wound care.
  • Softness and Comfort: The property of softness of cotton fiber makes it more comfortable to wear during the injury. 
  • Versatility: The cotton bales act as a versatile material. This property allows the manufacturer to design any type of bandage, like roller or gauze bandages. 
  • Sterility: The absorbent nature of cotton ensures its sterility. Such bandages are used for surgical and medical operations. 

Why the BIS Certification for Cotton Bandages is Crucial? 

The BIS registration for cotton bandages is a legal formality. Apart from it, the license also serves several roles, which are

Meets Indian Standards

Cotton BIS registration signals that the bandages comply with the relevant Indian standard (IS) for bandages. IS 863 is for handloom cotton bandage cloth. 

Reduce the risk of infections

The license ensures that the cotton bale bandages meet stringent safety standards, which is important to eliminate the risk of possible infections. 

Prevents substandard products

The cotton bales’ BIS certification restricts the use of unsafe or substandard products. This is important for both healthcare distributors and the clients.

Customers’ Trust

The ISI mark on cotton bandages signifies that these products have been subjected to rigorous testing to meet safety and quality standards.

Market credibility

To operate the medical institutions in India, they required the BIS-certified products. This is important to increase the market credibility. 

Mandatory for Sale

The registration BIS certificate for cotton is a legal formality for all manufacturers and distributors. Without the license, they cannot work in the Indian medical textiles industry. 

Government tender benefits

A significant number of government healthcare tenders and institutions require a BIS certification. This makes the compulsory registration for manufacturers to enter in markets.

International recognition

The BIS cotton bales license for bandages meets the international exporting of medical textiles. It demonstrates compliance with national standards.

Legal Penalties

Without a valid license, the cotton bandage manufacturers can face serious penalties, even the worst fines or imprisonment. The BIS Act of 2016 delineates the regulations about noncompliance in cotton bandages.

Conclusion | Cotton Bales Bandage BIS Standards

In essence, the BIS-certified raw cotton is used in the bandage manufacturing industry to produce a safe, reliable product that meets the compulsory quality benchmarks. Apart from the safety and quality standards for customers, the manufacturers also get market access with a valid certificate in India. 

User Query: How to Establish Cotton Bales Export Business From India?

Frequently Asked Questions

  1. What is the BIS ISI mark for cotton bandage cloth?

Ans. The BIS ISI mark for cotton bandage cloth is IS 863: 1988. 

  1. What material is required for bandage cloth?

Ans. There is a need for cotton fiber as a material for bandage cloth.

  1. For cotton yarn manufacturing, which Indian Standard must be followed?

Ans. The manufacture of the cotton yarn of bandage cloth shall conform to the specific required outline in IS 171. 

  1. What does the ISI mark signify in the medical textiles industry?

Ans. This mark serves as a symbol of safety and quality.

  1. Is acquiring a license for cotton bandages essential?

Ans. Yes, the BIS certification for cotton bale bandages is important, as it ensures product quality and safety standards before presenting it in the market. 

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How to Renew the CDSCO Drug Registration Certificate Digitally in 2025? https://www.legalraasta.com/blog/renew-cdsco-drug-certificate-digitally/ Fri, 27 Jun 2025 11:13:58 +0000 https://www.legalraasta.com/blog/?p=32229 Medical drugs are used to treat human illnesses, manage chronic conditions, and enhance overall health. This is important to give them a healthy and quality life. Have you ever wondered what would happen if the medicines don't meet the quality standards or are supplied with expired drugs? This not only damages the chain of the [...]

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Medical drugs are used to treat human illnesses, manage chronic conditions, and enhance overall health. This is important to give them a healthy and quality life. Have you ever wondered what would happen if the medicines don’t meet the quality standards or are supplied with expired drugs? This not only damages the chain of the pharmaceutical industry but also has a profound impact on consumer health. To keep the quality and the safety of drugs high, the Central Drugs Standard Control Organization (CDSCO) mandates the use of a drug license. It means that all manufacturers and importers are required to register with the regulatory authorities. 

In addition, the renewal of the CDSCO drug certificate is crucial. The renewal of a drug license ensures that the manufacturers and distributors are adhering to regulatory standards and also following safety standards. On the other side, the digital developments made the drug registration renewal more seamless. In this comprehensive guide, we will explore how you can renew your CDSCO certificate for a drug with the online portal, the process, benefits, and much more.

Why Do Manufacturers Need a Drug License in India?

Under the Drugs and Cosmetics Act, 1940, securing a license for the drug business is important. The drug certification ensures the pharmaceutical products’ quality, safety, and efficacy standards. The license rules were published to protect the health of the public by manufacturers, sales, and distributors’ working activities. With license registration, the authority gets access so they can confirm whether the manufacturing process of the drug is accurate or not. 

The licensing is not only a formality, but it is one of the most vital steps to safeguard the health of consumers. If you are operating a pharmacy business in India, you can register with the Central Drugs Standard Control Organization, which serves as the regulatory authority. 

The importance of Drug Certificate Renewal

For the manufacturers and distributors, renewing the drug safety certification is crucial to managing the legal and ethical operations. These operations ensure the consumer’s safety and uplift business credibility to the next step.

Here is why you need to renew your registered drug license:

Renewal Importance 

Explanation

Legal Compliance and Operations

  • The drug certificate acts as a prerequisite for legally managing the pharmaceutical business within India as well as on the borders. 

  • The registration indicates that the enterprise complies with the Drugs and Cosmetics Act of 1940, along with other significant regulations.

  • Without legal repercussions, the operators can manage the drug business. 

Public Health and Safety

  • The certification ensures that the drug businesses are continuously meeting the safety and quality standards.

  • The renewal is required to protect consumers from counterfeit or substandard drugs.

  • The renewal conducts the inspection to identify whether the units are serious about the drug safety and quality.

Business Credibility and Trust

  • Continue adhering to the safety and quality standards, which boost the trust and confidence of the public.

  •  It also builds trust among the partners and suppliers. It demonstrates a commitment to drug standardization practices.

  • With the renewal process, the businesses enhance their image in the competitive markets.

Market Access and Growth

  • The pharmaceutical license in India enables a pathway to establish connections with certified manufacturers and drug distributors.

  • The valid certificate makes the path that offers new opportunities, which is important to enter other markets.

  • By renewing the license, the businesses can maintain the supply chain within the area.

Avoiding Penalties and Legal Issues

  • Avoiding the renewal of a registered drug license can lead to potential penalties, which can include fines or strict action.

  • By renewing the license, the businesses can protect their operations from legal risks and also help to maintain an accurate record. 

  • Apply for renewal before the license expires, which avoids disruptions.

Drug Certificate Validity for a Specific Period

Drug safety certifications are valid for a specific period, and the validity depends mostly on the jurisdiction. The variety of licenses and the guidelines further define how long a certificate can be used in the market. Several nations, including India, allow a drug license to be used by the manufacturer for 5 years. It means that, before the coming of the expiry date, businesses are required to apply online for their renewal.

However, if the manufacturers and the distributors fail to meet the license renewal standards, it can raise a serious concern that there can be strict legal actions or seizure. 

Step-by-Step: Process for Drug Safety Certification Renewal Digitally

For the safety drug license renewal, the business needs to follow a comprehensive process. Interestingly, the online renewal registration made the process easier. The digital steps are increasing the document’s security. In addition, the steps start from registering on the online portal to submitting the application form. The steps are

Start Early: Begin the renewal process at least 30-60 days before the license expiry. It saves time processing.

Online Application: For the drug license application, log in to the official CDSCO online portal.

Registration: If you are new to the portal, create an account for application submission. 

Application Form: As per the type of license, fill out Form 19, Form 19A, Form 19B, or Form 19. Most review the application form before its submission to avoid errors or rejection.

Document Submission: Attach the necessary documents with the application form.

  • A copy of the existing drug certificate
  • Evidence of ownership or lease of the premises
  • Technical staff education with proof of experience
  • The other major certificate reflects the license type and the regulatory rules.

Fee Payment: Pay the mandatory license drug renewal through the online portal.

Inspection: To ensure compliance, the authority may conduct the inspection. 

Final Approval: After a successful verification, the authority will issue the renewed drug safety license. 

User Query: All About New Drug Approval by CDSCO in India

Final Words | Drug Renewal Licence in India

The license renewal is the core part to continue the operations in the pharmaceutical industry. The renewal identifies that the drug operator meets the regulatory standards and rules. 

This process is further vital to protect the health of the general public from substandard products. Understanding the importance of certificate renewal encourages the business to take a protective step. Overall, applying digitally for the renewal ensures legal compliance, manages the license privileges, and gives access to work without the fear of legal penalties. The online procedure is cost-effective and efficient. This further reduces the physical paper submission, which is beneficial to improve accessibility. The digital steps offer real-time updates and notifications related to authority guidelines. Meanwhile, to complete the application accurately, connect with the Legal Raasta experts who help businesses apply for their license for renewal. Reduce the burden and processing period with our professionals’ guidance and support. 

Frequently Asked Questions

  1. What is the name of the CDSCO online portal?

Ans. To obtain the license or renew it, visit the SUGAM portal.

  1. What is the fee for renewing a drug license?

Ans. The registration fee depends on the type of drug license and certain rules. In Delhi, the retail drug license renewal fees range from Rs 1,500 to Rs 3,000. It can be increased if the applicant applies for renewal late.

  1. What is the online fee for renewing a drug certificate in Uttar Pradesh?

Ans. For the drug certificate renewal, the applicant needs to pay Rs 3000, which must be paid online.

  1. What are Forms 20B and 21B?

Ans. Under the Drugs and Cosmetics Act, 1940, these forms act as the drug license in India for wholesalers.

  1. Who is the head of CDSCO?

Ans. In India, the CDSCO head department is the Drugs Controller General of India (DCGI). 

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How to Obtain BIS Hallmark Certification for Gold Jewelry? https://www.legalraasta.com/blog/obtain-hallmark-certification-gold-jewelry/ Thu, 26 Jun 2025 09:48:16 +0000 https://www.legalraasta.com/blog/?p=32222 Imagine you are purchasing the gold and didn't receive the purity composition despite paying a high amount. How will it feel? Therefore, the Indian government established a rule under which securing a license for the gold business is mandatory. The BIS hallmark serves as a certification mark that signifies the purity and superior quality of [...]

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Imagine you are purchasing the gold and didn’t receive the purity composition despite paying a high amount. How will it feel? Therefore, the Indian government established a rule under which securing a license for the gold business is mandatory. The BIS hallmark serves as a certification mark that signifies the purity and superior quality of gold. According to the Consumer Protection Affairs Act of 1986, obtaining the BIS hallmark on gold is mandatory.

In addition, the gold hallmarking scheme was published by the Bureau of Indian Standards in 2000. Whether you are serving as a manufacturer, importer, distributor, or seller, registering for the BIS gold hallmark is vital. But what is the BIS hallmark registration process? Let’s explore how businesses can secure the BIS hallmark for their gold business. 

What is BIS Gold Hallmarking?

Hallmarking is an extensive process that assesses the purity of metals such as gold and silver. The process ensures the gold and silver purity and fineness. Meanwhile, hallmarking for gold and silver is important to guarantee the customers of its safety, quality, and purity. For the gold, the hallmark is tagged as the “Mark of Quality.” On the gold, the mark indicates that it is pure and does not contain other metals. 

Why is Gold Hallmarking Essential in India?

The following points highlight the significance of hallmarking:

  • Quality Assurance: In India, the BIS hallmark is utilized for gold. The certified golds, which bear the hallmark, ensure that the metal is pure and fine. It signifies that the amount customers pay, regardless of the quality of the metal composition. 
  • Customer Protection: The Bureau of Indian Standards mandates the hallmark for gold to protect the customers from fraudsters and misrepresentation. In the Indian marketplace, it doesn’t allow the entry of lower-purity gold items. 
  • Trust and Transparency: The symbol creates the bond of trust between the seller and customer. The seller’s confidence in customers that their products meet the regulatory standards and are also certified by the authority.
  • Resale Value: The certified and pure hallmarked gold has more resale value. It guarantees quality, which is favorable to the receiver and the lender. 
  • Legal Formality: In India, hallmarking for the precious metal is mandatory. It means those who are operating the gold business in India must adhere to the hallmarking guidelines.
  • International Trade: The compliance of Indian gold hallmarks meets the other country’s regulations. It helps to increase international recognition. This makes an easy route for global trade.
  • Facilitate loan: The lenders are only preferred to provide the loan to the certified, hallmarked businesses. The lenders know that the hallmark jewelry contains a good amount of purity. 

The Gold Jewelry BIS Hallmark Registration Process

To obtain their hallmark license, the applicant needs to register on the Bureau of Indian Standards online portal. For transparency and traceability, the authority mandates the six-digit HUID on gold. This distinctive identification number must be prominently displayed on gold jewelry. The jewelers who are seeking to secure the hallmark registration license need to follow

Online Registration 

Create an account on the BIS online portal and navigate to the “hallmarking” option. Complete the application form for jeweler registration.

Document Preparation

Collect the essential documents, including the business registration proof certificate, identity proof, premises proof documents, GST registration certificate, and many other documents.

Registration Fee

The jeweler needs to pay the registration and processing fee. The amount can be paid online through the BIS portal.

Inspection

To ensure compliance and the premises process, the inspection may be conducted by a Bureau of Indian Affairs inspector. You must align with BIS standards. 

Hallmark license issue

The hallmark registration certificate will be issued by the Bureau of Indian Standards after the successful verification and premises inspection. 

Which documents are needed for Gold Hallmark Certification?

For the BIS hallmark, the jeweler is required to provide several documents with the application form. Below is an example of the documents necessary for a BIS hallmark license: 

  • The registered partnership deed (if applicable)
  • Registration Certificate from ROC (If a company)
  • The Certificate of CA (if it is a proprietorship firm)
  • The Certificate of GST registration
  • The Income Tax Assessment Order
  • Sale or lease deed agreement
  • Most recent property tax receipt
  • Registration certificate
  • Previous financial year GST return certificate

The Gold Purity Testing: Three Steps

Before issuing the license to the gold jeweler, the products need to pass the three lab testing stages. These stages are:

Testing Stages

Explanation

Homogeneity testing 

This represents the primary test conducted for gold. The samples of items are tested to ensure whether they align with the mandatory regulatory standards. The sample signifies the whole consistency in its composition. 

Purity testing 

The purity testing process is designed for jewelry. The jewelry undergoes a rigorous testing procedure to ensure its value, purity, and fineness. 

Individual item marking 

After the jewelry purity test, each piece is marked with the BIS hallmark. The jewelry item also features a BIS logo, the purity standard, and a six-digit HUID.

What is the fee for a hallmark certificate? 

The fee-related details have been outlined by the Indian government in BIS guidelines. Well, the hallmark registration license depends on the turnover. The required fee charges are –

Turnover

Application Fee

Registration Fee

Turnover of Rs 5 crore

Rs 20,000

Rs 7,500

Turnover between Rs 5 crore and 25 crore

Rs 20,000

Rs 15,000

Turnover between Rs 25 crore and 100 crore

Rs 20,000

Rs 40,000

Turnover above Rs 100 crore

Rs 20,000

Rs 80,000

Conclusion | BIS Hallmark License for Jewelry

By navigating the BIS license registration process for gold hallmark, you can protect your business from potential penalties. The registration with the relevant authority offers multiple benefits and also facilitates international trade opportunities. Proper guidance and support can streamline the registration steps. With the assistance of Legal Raasta experts, secure the BIS hallmark license for your gold enterprise.

Frequently Asked Questions

  1. Who issued the BIS license for gold?

Ans. In India, the BIS registration certificate for gold is issued by the Bureau of Indian Standards.

  1. Can I sell the gold without a hallmark license?

Ans. No, operating the gold jewelry business in India without the BIS hallmark is illegal.

  1. Can I get a gold loan without a hallmark? 

Ans. Yes, but it may create several challenges, and the amount might also be lower compared to certified hallmark gold. 

  1. What is the difference between the HUID hallmark and the BIS hallmark? 

Ans. The BIS hallmark is the identifier for gold purity, while the HUID hallmark is a six-digit unique identification number for traceability and identification. 

  1. Which bank has the highest interest rate for a gold loan?

Ans. HDFC and Axis banks are at the top, where interest rates increase to 17% p.a. onwards. 

 

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All About New Drug Approval by CDSCO in India https://www.legalraasta.com/blog/new-drug-approval-cdsco/ Wed, 25 Jun 2025 07:18:04 +0000 https://www.legalraasta.com/blog/?p=32216 In Indian, the  Central Drugs  Standard Control Organization was established under the Ministry of Health and  Family Welfare. The working properties of the Indian CDSCO system are similar to the United States Food and Drug Administration (FDA). This serves a mandatory role to grant permission for the new drugs. In addition, with the developments, the [...]

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In Indian, the  Central Drugs  Standard Control Organization was established under the Ministry of Health and  Family Welfare. The working properties of the Indian CDSCO system are similar to the United States Food and Drug Administration (FDA). This serves a mandatory role to grant permission for the new drugs. In addition, with the developments, the governing authority established various rules and regulations. On the other side, the authority updated the new guidelines for the approval of new drugs. Before the implementation of this policy, the operators were following the New Drugs and Clinical Rules, 2019. In this comprehensive guide, we will explore the new policy by CDSCO related to new drugs, CDSCO registration importance, and what changes it brings to the Indian drug sector. Let’s discover it in more detail.

What does the term ‘New Drugs’ Signify for CDSCO?

The Central Drugs Standard Control Organization in India acts as the primary authority for new drugs. It is responsible for ensuring the medical drugs quality and safety before approving them. Meanwhile, under the Drugs and Clinical Trials Rules, 2019, the word “new drug” is categorized. 

This signifies that whether you are an importer or manufacturer, securing the CDSCO certificate is crucial. Have you ever thought about which types of drugs are highlighted as the new drugs by the CDSCO? Before shedding light on it, let’s take a look at the background of the draft guidance on approval of clinical trials and new drugs. 

CDSCO’s Policy Regarding Clinical Trials and New Drugs

A safe and effective drug is important for humans. For the drugs, the clinical approval guidelines have been highlighted under Rules 122A, 122B, 122D, 122DA, 122DAA, and 122E. But what are the requirements of the new drug approval and clinical trials? Well, as per the authority policy, the approval and the clinical trials of new drugs depend on their nature. The medications classified as ‘new drugs’ are

  • Drugs that contain a certain amount of pharma elements or phytopharmaceutical drugs. These types of drugs must not have been previously recorded by the other nation. To claim its safety and efficacy, it must be approved by the Central Licensing Authority. 
  • The second kind of new drug headline underlines the involvement of the Central Licensing Authority for a specific aspect.
  • This pertains to two or more drugs that possess a fixed-dose combination. It indicates that each fixed dose must be asserted separately with a specific ratio.
  • Any drugs that are granted by the relevant Central Licensing Authority possess a developed or sustained structure. 

What do the CDSCO General Considerations Signify? 

  1. Under the Drugs and Cosmetics Act, the policy is based on the governing authority’s compliance. The rules are made under it by keeping the parameters strong. 
  2. On the other side, if manufacturers or experts bring a new drug to operate their business, they need to obtain the license in Form 29. 
  3. The new drug businesses can obtain the license from the relevant State Licensing Authority, updated by the CDSCO. 
  4. CDSCO NOC also notified that the new drugs will be manufactured only after securing the license in Form-29.

What Steps are involved in acquiring a License in Form 29?

The State Licensing Authority is responsible for issuing the license in Form-29. It is required for manufacturers who are looking for new drug clinical trials. It is also required that the application must have the signature of the firm’s head. Here is the drug license registration process:

Form 30: The manufacturers of the “new drugs” are required to apply for a test license. While the test license is issued in Form 30. Before securing the Form-30, register with the relevant State Licensing Authority.

ONDLS Portal: In a few states of India, you need to apply for a test license through the One-Nation-One-Platform portal, in short, the ONDLS portal.

Purpose: With the license, the manufacturers are allowed to examine drugs for safety and quality purposes.

Validity: The drug test license, also known as “Form-29,” is valid for three years from the date of its issuance.

Renewal: The manufacturer is required to renew it after its expiration date.

The Supporting Documents for the Drug Certificate

For a new drug test license, the applicant is required to provide multiple documents along with the application form. You need to provide:

  • Partnership deed or director details, or proprietorship declaration.
  • The firm ownership certificates.
  • Complete the layout of the premise with a plan.
  • The list of machinery and equipment facilities.
  • Applicant’s photo proof and ID
  • Permission certificate from the State Pollution Control Board.
  • The certificate of affidavit
  • Secure the CT-11, CT-14, or CT-15 forms from CDSCO for “new drugs.” 

Sum Up | CDSCO Registration for the New Drug Approval

The CDSCO licensing promotes the new drug development in India. The certification for new drug approval is crucial to enhance their safety and efficacy. A premium drug approval is essential to decrease the disease issues in the nation. Meet the CDSCO standards and move forward to a developed nation. Make your CDSCO registration journey more seamless with Legal Raasta professionals. 

FAQ| CDSCO Registration Certificate for Drugs

  1. What is Form 29 License?

Ans. The Form 29 license is secured by the drug manufacturers to examine, test, and analyze new drugs.

  1. Who requires the wholesale or retail drug license?

Ans. The retail medical stores are required to register with the CDSCO to obtain a wholesale or retail drug license

  1. Which act allows Indian doctors to open a medical store?

Ans. Under the Drugs and Cosmetics Act, 1940, Indian doctors can open a pharmacy shop. They need to obtain the license before opening the store, which is provided by the CDSCO in India. 

  1. What are the two common acts for drugs?

Ans. The key acts are the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, and the Drugs and Cosmetics Act, 1940.

  1. Which State in India is at the top in drugs?

Ans. The high consumption of drugs is in India’s Uttar Pradesh State. It is followed by Bihar and Kerala.

 

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Mandatory Implementation of 6-digit HUID- BIS Hallmarking https://www.legalraasta.com/blog/6-digit-huid-bis-hallmarking/ Wed, 25 Jun 2025 06:14:43 +0000 https://www.legalraasta.com/blog/?p=32211 For the Indians, the gold and silver serve a highly reputable symbolic purpose. The composition of gold represents wealth, divinity, and good fortune. Gold is extensively utilized in religious ceremonies, festivals, and Indian weddings. But who cares about the gold purity? For the people, gold is not only about a metal but also about the [...]

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For the Indians, the gold and silver serve a highly reputable symbolic purpose. The composition of gold represents wealth, divinity, and good fortune. Gold is extensively utilized in religious ceremonies, festivals, and Indian weddings. But who cares about the gold purity? For the people, gold is not only about a metal but also about the deep connection with its purity. Conversely, for gold and silver, the national authority, the Bureau of Indian Standards, serves as the purity identifier. The regulatory authority allows only gold and silver jewelry in the market that has a hallmark.

This means that for consumers, the BIS gold hallmarking serves as a form of identification. To enhance the purity of the gold jewelry or artifacts, the national authority published a new policy in 2023. The authority mandates the use of HUID for the gold. This comprehensive guide will shed light on why the manufacturers need a 6-digit hallmark Unique Identification Number for gold, its purpose, the registration process, and much more. Let’s discuss it in more detail.

What is HUID for BIS Gold Hallmarking?

On April 1, 2023, the Bureau of Indian Standards implemented a policy related to BIS hallmarking for gold. The authority mandates that all gold operators use the HUID. Concerning gold, HUID refers to “Hallmark Unique Identification.” It contains a 6-digit unique number. The authority has further clarified that the gold trade is prohibited in Indian markets without the 6-digit HUID.

Before its implementation, the gold jewelers were operating without HUID. To clear the stock of 4-digit hallmarked articles, the authority gave the businesses more than one year. In short, the HUID for gold acts as a fingerprint that ensures its purity and transparency.

Why is HUID Vital for BIS Gold Jewellery in India?

As of April 1, 2023, every newly manufactured gold jewelry item is required to display a six-digit Hallmark Unique Identification number. This is a compulsory regulation for gold businesses operating in India. This stipulation is a component of the mandatory hallmarking scheme established by the Bureau of Indian Standards (BIS). Here is why HUID is important for gold:

Traceability: HUID for gold creates a tracking route. This allows for tracking of gold jewelry from the supplier to the customers. It ensures transparency as well as accountability.

Purity Identifier: HUID is a core part of BIS hallmarking in India. It is an element of trust for the customers. The gold they are purchasing contains the gold purity ensured by HUID.

Customer Protection: The Hallmarking Unique Identification (HUID) restricts the entry of gold fraudsters. This indicates that for the price you are paying, you are receiving standard quality.

Legal Requirement: Operating the gold business without the HUID mark is an illegal act. For this non-compliance, the operator can face strict action, including a potential fine or imprisonment if the violation is significant.

Note: To verify the HUID of the gold jewelry you have bought, you can utilize the BIS Care app.

How to Verify the Authenticity of Gold Jewelry?

The customers can now verify their purchased gold. The authority published the BIS Care App that permits customers to check the gold purity. By verifying the number, you will get the details of the gold item, purity, details of the jeweler, and the hallmarking center. The steps for authenticity verification are

BIS Care App

Download the BIS care app on any device via the App Store.

Locate the HUID Number

The 6-digit unique identification number is inscribed on the gold jewelry. 

Select “Verify HUID.”

Next, with the verification by selecting the option “verify HUID” on the app.

Enter Code

For verification, enter the six-digit code.

Ensure Details 

The screen displays the details of the gold item as well as the jeweler’s information and hallmarking date. 

The Penalties with BIS Hallmarking Non-Compliance

Whether you are a manufacturer, importer, or retailer, registering with the Bureau of Indian Standards is mandatory for gold jewelry. However, non-compliance with the BIS hallmark can raise significant penalties. Here is a breakdown:

Monetary Penalties: Under the BIS Act 2016, the gold operators can face the minimum penalty of Rs 200,000 for non-compliance. Well, the fine penalty amount can be increased further. Thus, the BIS registration for gold hallmarking is a mandatory step. 

Imprisonment: In addition to fines, imprisonment is another penalty that can be more severe. The non-compliant offender may face imprisonment for up to two years or more. The length of imprisonment is depends upon the severity of the violation. 

Legal Action: The Bureau of Indian Standards can take legal or criminal action against the offender. The people who misuse the BIS standard mark, including the hallmark, can face strict legal action.

BIS Hallmarking Renewal to Stay Compliant

The renewal of the BIS hallmarking is a comprehensive process in which the operators renew their license to use the BIS hallmark. BIS hallmarking license renewal after a certain period, which marks the legal requirement. In more detail:

  1. The Bureau of Indian Standards promotes adherence to the Quality Management System (QMS) among manufacturers.
  2. If manufacturers obtain a BIS hallmarking license for gold, they must renew it promptly.
  3. Typically, the BIS hallmarking registration is valid for two years. Prior to the expiration of the license number, it is advisable to apply online for renewal with BIS.
  4. Renewal of the BIS license for hallmarking requires maintaining the same products and providing no changes to the product or standard. 
  5. During the BIS Hallmark registration for renewal, the manufacturer is required to pay the renewal fee along with the annual advance minimum marking fee.
  6. If the manufacturer applies for renewal after the license expiry date, the late fee will be marked. For the late BIS certificate for gold renewal, you will be charged Rs 5000.
  7. The 6-digit hallmarking with HUID is mandatory for selling or buying gold in India.

Conclusion | BIS Hallmark Registration for Gold in India

Since April 1, 2023, all gold businesses have needed to use the mark of HUID on their gold products. HUID is a 6-digit unique identification number that signifies the principles of transparency, trust, and traceability. The code protects the customers from fraudsters and ensures the amount they pay receives the same purity and quantity of items. BIS certification represents a more accessible commitment to ensuring customer safety. To align with national authority requirements, get in touch with Legal Raasta experts. The firm specializes in providing comprehensive gold hallmarking certificates. 

FAQ |  BIS Act in India for gold Jewelry Hallmarking

  1. What if there is no HUID?

Ans. Gold jewelers can suffer from serious legal risks if they do not display the unique identification number. 

  1. Can a BIS hallmark be fake?

Ans. Yes, the BIS-hallmarked jewelry can be fake.

  1. What does 916 hallmarked gold jewelry signify?

Ans. The code 916 highlights the composition of 22-karat gold. It means the jewelry that has these numbers contains 91.6% gold.  

  1. What is the fee for BIS certificate renewal?

Ans. To renew the BIS license online, an application fee of Rs 28,000 is required.

  1. Under which Ministry does BIS monitor?

Ans. The Bureau of Indian Standards operates under the Ministry of Consumer Affairs, Food and Public Distribution.

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