AYUSH & BIS Certification for Herbal Cosmetics – Complete Guide 2025

Introduction

The Indian herbal cosmetics market is experiencing an unprecedented boom, driven by a powerful consumer shift towards natural, safe, and traditional wellness solutions. For entrepreneurs and small businesses, this presents a massive opportunity to build a successful brand. The essential first step in this journey is securing the right AYUSH certification for herbal cosmetics, a mandatory requirement for products marketed under traditional Indian systems of medicine. However, launching a successful herbal cosmetics brand isn’t just about creating excellent products; it’s about skillfully navigating a complex web of regulations to guarantee quality, safety, and absolute legality. This comprehensive 2025 guide is designed to demystify the two most critical certifications in India: the AYUSH license and the BIS certification. We will break down the complete processes, outline the specific requirements, and explain why these certifications are non-negotiable pillars for your brand’s long-term success and credibility in a competitive marketplace.

Why is Certification Crucial for Your Herbal Cosmetics Brand?

In a market saturated with options, establishing your brand’s legitimacy from day one is paramount. Certifications are not mere formalities; they are foundational assets that communicate trust, quality, and professionalism to your customers and partners. They serve as a powerful signal that your business is committed to adhering to the highest standards of safety and efficacy, setting you apart from unregulated competitors. For any serious entrepreneur, understanding the value of these certifications is the first step toward building a sustainable and respected brand in the herbal cosmetics industry.

• Build Consumer Trust: Certifications act as a tangible seal of approval. They assure customers that your products are not only authentic and made with high-quality ingredients but are also manufactured in a safe and hygienic environment, building lasting loyalty.
• Ensure Legal Compliance: Operating without the necessary licenses is a significant legal risk. It can lead to severe penalties, including substantial fines, seizure of your entire product inventory, and even legal action against the business owners. Understanding AYUSH compliance for cosmetic products is the first step to protecting your business from these devastating consequences.
• Gain Market Access: Securing market access is a major hurdle for new brands. Many large retailers, established distributors, and major e-commerce platforms like Amazon and Flipkart mandate these certifications as a prerequisite for listing products, making them a gateway to wider distribution channels.
• Achieve a Competitive Edge: A certified product inherently stands out in a crowded market. It signals professionalism, a deep commitment to quality, and a respect for consumer safety, which can be a powerful differentiator and a key part of your marketing message.

Deep Dive: What is AYUSH Certification for Herbal Cosmetics?

The term “AYUSH” is central to the traditional wellness space in India, but understanding its specific role in cosmetics regulation is crucial for compliance. It is the primary legal framework that governs any product claiming to be based on Ayurvedic, Unani, or Siddha principles. This certification is not about product performance in a modern scientific sense but about the authenticity of its formulation and the integrity of its manufacturing process according to traditional texts and guidelines. Obtaining this license is the legal key to labeling and marketing your products as “Ayurvedic,” a designation that holds immense value and trust among Indian consumers.

Understanding the Ministry of AYUSH’s Role

The Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH) is the primary government body responsible for developing, promoting, and regulating traditional and alternative medicine systems in India. Its mandate extends beyond medicine to include wellness products and cosmetics that are based on these ancient systems. Under the Drugs and Cosmetics Act, 1940, and its subsequent rules, any cosmetic product that is marketed with claims of being “Ayurvedic,” “Siddha,” or “Unani” must be manufactured under a specific license issued by the respective State AYUSH authority. This legal requirement ensures that the product’s formulation, ingredients, and manufacturing process adhere strictly to the principles laid out in traditional scriptures and meet modern safety and hygiene standards, safeguarding consumers from fraudulent or unsafe products.

Types of AYUSH Licenses for Cosmetic Manufacturing

The regulatory framework provides different licensing options to accommodate various business models, from large-scale manufacturers to small startups. Choosing the right type of license is a critical strategic decision that depends on your capital investment, infrastructure, and long-term business goals. Each license type has distinct requirements regarding premises, technical staff, and investment, offering flexibility for entrepreneurs entering the herbal cosmetics market.

• Full Manufacturing License: This license is intended for businesses that have their own complete manufacturing unit. It requires significant investment in premises, machinery, an in-house testing lab, and the employment of qualified technical staff as prescribed by the law. This option offers the greatest control over the entire production process.
• Loan License: This is an ideal pathway for small businesses, startups, and marketing-focused brands. A loan license allows you to manufacture your products using the facilities of a third-party manufacturer who already holds a full license and is certified for Good Manufacturing Practices (GMP). Your brand owns the product formulation and marketing rights, while the manufacturing is outsourced to a compliant facility.
• Third-Party Manufacturing: Functionally similar to a loan license, this is a contractual arrangement where you outsource the entire manufacturing process to a licensed facility. It is one of the most popular models for new brands as it minimizes capital expenditure on infrastructure and allows them to focus on product development, branding, and sales.

A Step-by-Step Guide: The AYUSH Herbal Cosmetics Certification Process

The AYUSH herbal cosmetics certification process is a systematic procedure managed at the state level by the respective Directorate of AYUSH. While minor procedural details and portal interfaces may differ from one state to another, the core steps involving documentation, application, inspection, and final approval remain fundamentally consistent across the country. A thorough understanding of this process and diligent preparation are key to avoiding delays and ensuring a smooth journey toward obtaining your manufacturing license. It is a meticulous process designed to verify every aspect of your proposed operation, from the legal standing of your company to the technical qualifications of your staff.

Step 1: Pre-requisites and Documentation Checklist

Before initiating the online application, the most critical phase is the comprehensive preparation of all required documents. Having a complete and accurately organized file is essential, as incomplete or incorrect documentation is the most common reason for application rejection or significant delays. This stage requires careful attention to detail and a clear understanding of all the herbal cosmetics certification requirements India.

• Company Registration: You must provide proof of your business’s legal identity, such as the registration certificate for a Proprietorship, Partnership Firm, LLP, or Private Limited Company.
• Premises: Documents proving legal possession of the premises are required, which could be a title deed for owned property or a registered rental/lease agreement. A detailed layout plan of the manufacturing unit or office space, blueprinted by a certified architect, is also mandatory.
• Technical Staff: The application must include detailed information about the qualified technical personnel who will oversee the manufacturing process. This typically includes their consent letters, qualification certificates (e.g., a BAMS degree for an Ayurvedic practitioner or a B.Pharm degree), registration details, and proof of experience.
• Product Details: You must prepare a complete list of all the cosmetic products you intend to manufacture, along with their detailed formulations. Each formulation must specify every ingredient with its quantity and reference the authoritative Ayurvedic/Siddha/Unani text from which it is derived.
• Other Documents: Other essential documents include the GST registration certificate, Udyam Aadhar (MSME registration), ID and address proofs of the directors/proprietor, and a list of laboratory and manufacturing equipment (in the case of a full manufacturing license).

Step 2: Online Application Submission

Once all your documents are in order, the next step is to formally submit your application through the designated online portal of your state’s AYUSH department. This digital-first approach has streamlined the process, making it more transparent and efficient. It is crucial to fill out all sections of the application form with complete accuracy, as the information provided will be cross-verified against your submitted documents.

• Navigate to your respective State AYUSH department’s official online portal and file the application, which is typically Form 31 for a cosmetic manufacturing license.
• Carefully upload high-quality scanned copies of all the documents as per the checklist provided on the portal.
• Pay the prescribed government fees through the integrated online payment gateway. The fee amount varies based on the type of license and the number of products.
• Pro-Tip: Every state maintains its own portal for licensing. You can easily find the official website by searching online for “AYUSH Department [Your State Name]” to begin the 2025 guide to AYUSH certification.

Step 3: Scrutiny and Premises Inspection

After your online application is successfully submitted, it enters the scrutiny phase, where it is reviewed by a designated AYUSH Drug Inspector. This official is responsible for meticulously verifying the completeness and correctness of your application and all attached documents. If the paperwork is found to be in order, the inspector will schedule a physical inspection of your premises. This on-site visit is a critical part of the process, designed to ensure that the actual facility complies with all regulatory standards, including Good Manufacturing Practices (GMP), proper hygiene protocols, waste disposal systems, and the availability of all declared machinery and equipment. For loan license applications, the inspector will visit the third-party manufacturer’s facility to confirm its compliance and capacity.

Step 4: Grant of License

Following a successful premises inspection where the Drug Inspector is satisfied with the compliance standards, they will prepare and submit a positive report to the State Licensing Authority. Based on this recommendation, the authority will formally approve your application and grant the AYUSH Manufacturing License. This official license is the legal document that authorizes you to manufacture and market your herbal cosmetics. The law mandates that this license must be displayed prominently at your registered office or manufacturing premises. It is also important to note that the license comes with a defined validity period, typically five years, and must be renewed in a timely manner to ensure uninterrupted legal operation.

Navigating BIS Certification for Herbal Cosmetics India

While the AYUSH license governs the traditional and formulation aspects of your product, another critical layer of regulation comes from the Bureau of Indian Standards (BIS). The role of BIS is fundamentally different; it focuses on standardized quality, safety, and performance benchmarks for products sold in India, irrespective of their “herbal” or “synthetic” origin. Navigating the BIS certification for herbal cosmetics India landscape is essential because compliance is often mandatory for specific product categories. This certification provides consumers with a tangible assurance of quality through the well-recognized ISI mark, making it a powerful tool for building market credibility and ensuring your products meet national safety standards.

What is the Bureau of Indian Standards (BIS)?

The Bureau of Indian Standards (BIS) is the official National Standards Body of India, operating under the Ministry of Consumer Affairs, Food & Public Distribution. Its primary mission is the harmonious development of standardization, marking, and quality certification activities. BIS establishes quality standards, known as Indian Standards (IS codes), for thousands of products and services. For manufacturers, BIS grants licenses to use the coveted ISI mark on products that consistently conform to these established standards. The overarching goal of BIS certification for herbal cosmetics India is to ensure that products available to Indian consumers meet stringent benchmarks for safety, quality, performance, and reliability, thereby protecting public health and promoting consumer confidence.

Is BIS Certification Mandatory for Herbal Cosmetics?

This is a critical question for every cosmetic brand owner. While the AYUSH license is mandatory for products claiming to be “Ayurvedic,” BIS certification is mandatory only for specific cosmetic product categories that have been officially notified by the central government. This list is updated periodically to include more products under the mandatory certification scheme. For example, certain types of skin creams, skin powders, and some hair products are required to adhere to specific IS codes and bear the ISI mark to be legally sold in India. It is therefore absolutely crucial for manufacturers to stay updated and check the latest notifications on the official BIS website to understand the current BIS guidelines for herbal products and determine if their specific product falls under the mandatory certification list.

• External Link: Always refer to the official Bureau of Indian Standards website for the updated list of products under the mandatory certification scheme.

The Complete Guide to BIS Certification India: The Process

The BIS registration process for herbal cosmetics is a highly structured and standardized procedure managed centrally by the Bureau of Indian Standards. Unlike the state-level AYUSH process, the BIS certification scheme is uniform across the entire country, ensuring that the same high standards are applied to all manufacturers, regardless of their location. This process is rigorous and involves multiple stages, from laboratory testing to factory audits, all designed to verify that a manufacturer has the systems in place to consistently produce goods that meet the specified Indian Standard.

Step 1: Identify the Applicable Indian Standard (IS Code)

The very first and most crucial step in the BIS certification journey is to correctly identify the specific Indian Standard (IS) code that applies to your cosmetic product. Each product category has a unique IS code that outlines all the technical specifications, performance requirements, testing methods, and safety parameters it must meet. For instance, skin creams are covered under the standard IS 6608:2004, which details requirements for pH value, stability, and absence of heavy metals. Incorrectly identifying the IS code can lead to your application being rejected, so it is vital to research and confirm the correct standard for your product before proceeding.

Step 2: Application and Lab Testing

Once the correct IS code is identified, the next phase involves product testing and application submission. You must get a sample of your product tested by a BIS-recognized third-party laboratory. This lab will conduct a series of tests as prescribed in the relevant IS code and will issue a detailed test report. This report serves as primary evidence that your product conforms to the national standard. Concurrently, you must submit the formal application for a BIS license online through the official BIS portal, known as Manak Online. All required documents, including the crucial lab test report, company details, and process flow charts, must be uploaded with the application.

• External Link: The complete application is filed online on the BIS Manak Online Portal.

Step 3: Factory Inspection and Audit

After your application and test reports have been scrutinized by BIS officials, a factory audit will be scheduled. A designated BIS officer will conduct a physical inspection of your manufacturing facility. The primary objective of this audit is to verify that your company possesses the necessary infrastructure, manufacturing processes, quality control systems, and in-house testing facilities to consistently produce goods that meet the Indian Standard. The officer will review your quality control records, calibrate your testing equipment, and observe the manufacturing process from raw material intake to final product packaging. This is a thorough evaluation of your entire quality assurance ecosystem.

Step 4: Grant of License and ISI Mark Usage

If the factory audit is successful and the BIS officer is satisfied with your manufacturing and quality control capabilities, and if your product’s lab test reports are in order, the Bureau of Indian Standards will grant you the license. This license gives you the legal right to affix the standard ISI mark on your certified products’ packaging. The ISI mark is one of India’s most recognized symbols of quality and safety. Using this mark on your herbal cosmetics can significantly enhance their market credibility, build immediate consumer trust, and provide a substantial competitive advantage over non-certified products.

AYUSH vs. BIS Certification: Key Differences for Your Business

While both certifications are related to quality and compliance, they operate in different domains and serve distinct purposes. Understanding their differences is key to developing a robust compliance strategy for your herbal cosmetics brand.

Basis of Comparison	AYUSH Certification	BIS Certification
Governing Body	Ministry of AYUSH (State Level)	Bureau of Indian Standards (Central)
Primary Focus	Authenticity of traditional formulation (Ayurvedic, Unani, etc.) and Good Manufacturing Practices (GMP).	Product quality, safety, and performance against a national standard (IS code).
Applicability	Mandatory for products marketed as “Ayurvedic,” “Siddha,” or “Unani” cosmetics.	Mandatory only for specific product categories notified by the government.
Certification Mark	AYUSH Premium Mark (Voluntary, for quality) / No mandatory mark on the product itself.	ISI Mark (Mandatory for certified products).

Conclusion

In the dynamic and highly competitive Indian herbal cosmetics market, regulatory compliance is not merely an option—it is the bedrock upon which a trustworthy and successful brand is built. Securing the necessary AYUSH certification for herbal cosmetics is the absolute legal prerequisite to manufacture and market your products as authentic traditional formulations. Simultaneously, you must remain vigilant and check for any mandatory BIS certification requirements that may apply to your product category to ensure you meet national quality and safety standards. This dual-compliance approach protects your business legally and significantly enhances its credibility with consumers.

Navigating these complex regulatory pathways, from documentation to inspections, can be daunting for any entrepreneur. Don’t let paperwork and intricate procedures slow down your vision. Contact TaxRobo’s experts today for seamless assistance with company registration, licensing, and compliance, and let us help you build your brand the right way.

Frequently Asked Questions (FAQs)

Q1. Is AYUSH certification mandatory to sell all herbal cosmetics in India?

A manufacturing license from the State AYUSH authority is mandatory if you wish to label, market, and legally claim your product as an “Ayurvedic,” “Siddha,” or “Unani” cosmetic. For general herbal products that do not make such specific claims, other regulations under the Drugs and Cosmetics Act may apply, but an AYUSH license is the standard and legally required pathway for the traditional cosmetics category.

Q2. How long does the AYUSH herbal cosmetics certification process usually take?

The timeline for obtaining an AYUSH license can typically range from 2 to 4 months. This duration is dependent on several factors, including the specific state’s processing times, the completeness and accuracy of your submitted documentation, and the availability and schedule of the drug inspector for the premises inspection. A well-prepared and meticulously organized application can significantly speed up the entire process.

Q3. Can I apply for both AYUSH and BIS certifications for the same product?

Yes, absolutely, and in some cases, you may be legally required to. For example, a product marketed as an “Ayurvedic skin cream” would first need an AYUSH manufacturing license to validate its formulation and manufacturing process. If “skin creams” as a category are also on the BIS mandatory certification list, then it would additionally require BIS certification to legally use the ISI mark and be sold in the market.

Q4. What are the renewal requirements for these licenses?

An AYUSH manufacturing license is generally valid for a period of five years. To maintain legal compliance, it must be renewed by submitting a renewal application along with the requisite fees to the state authority before its expiry date. Similarly, a BIS license also has a specific validity period and has its own renewal procedures, which must be followed diligently to ensure the certification remains active and you can continue to use the ISI mark.

Q5. What are the penalties for selling cosmetics without the necessary certifications?

Selling cosmetic products without the required licenses is a serious offense under the Drugs and Cosmetics Act, 1940, and the BIS Act. The penalties can be severe and detrimental to a business. They can include hefty monetary fines, the immediate seizure and confiscation of all product stock, and in serious cases, even imprisonment for the business owners or directors. It is a significant legal and financial risk that is not worth taking.