Why Should Consumers Prefer CDSCO-Certified Products?

The Central Drugs Standard Control Organization (CDSCO) was operationalized in 1940 when the Drugs and Cosmetics Act was passed. CDSCO regulate the import, manufacture, sale, and distribution of pharmaceutical products in India. The broader objective behind its establishment was to ensure that pharma products sold in the market are effective, safe, and meet quality standards for consumer use.

Consumers in the pharmaceutical industry are not just the patients but also the healthcare service providers, pharmaceutical companies, healthcare professionals, etc. These stakeholders are encouraged to opt for CDSCO-certified products as they are safe and effective and maintain quality standards.

A CDSCO Import Certificate Consultant also play a pivotal role in the entire CDSCO ecosystem by offering comprehensive guidance in seamlessly obtaining the import licence for medical devices and pharmaceuticals in India.

Let’s delve deeper and understand the role of the consultant and why consumers must go for CDSCO-certified products over unauthorized products.

Why Consumers Should Opt for CDSCO-Certified Products?

CDSCO certification is a prerequisite for exporting, importing, manufacturing, selling, or distributing medicines, cosmetics, and medical devices in India. The authorization ensures that the product meets government-approved standards and creates no health risks. For consumers, the certification mark assists in avoiding counterfeit or substandard medicines or cosmetics in the market. CDSCO-certified products eventually signal the fact that the product is legally approved by the government and is of high quality. Medical Equipment Manufacturers also require CDSCO Certification. CDSCO authorization provides the following fundamental advantages to its consumers.

• Safety: CDSCO certification of drugs and medical devices demonstrates that the product has fulfilled the necessary regulatory practices and has been examined through rigorous surveillance and quality checks. To pass a product on safety parameters, the national regulatory authority extensively reviews its documents and manufacturing process and conducts clinical trials to assess potential risks it poses to the users.
• Quality: CDSCO establishes quality standards for drugs and cosmetics including guidelines on labelling, specifications for ingredients, manufacturing process, and other sets of rules that ensure products meet a minimum threshold of quality. In addition, the drug inspectors of CDSCO conduct random sampling of products where it picks up its samples randomly from the market and get it tested in designated laboratories. If the product fails on the quality parameter, CDSCO examines the next five consignments of the same product.
• Efficacy: Efficacy of a drug refers to its ability to create maximum response and produce desired results. Measuring efficacy is important to determine whether the drug or medical device is effectively performing its intended function. To promote and gauge efficacy, CDSCO is striving to streamline the registration process, consistently evaluating pharmaceuticals and medical devices, and focusing on accountability and transparency.
• Public Health: One of the major objectives of CDSCO is to promote and protect public health in India. Public health encompasses the broader vision of improving the health of communities, preventing diseases, promoting healthy lifestyles, and empowering government agencies to enact policies that achieve these goals. CDSCO promote this by setting standards, regulating imports, approving drugs only after due diligence, and licencing new drugs, critical medicines, blood bank registrations, etc.
• Credibility: The credibility of a medicine or medical device signals its trustworthiness and reliability. CDSCO authorities are continuously trying to enhance the credibility of products by reviewing the proposed drug or device by professional experts in relevant fields.

Often questions arise over How CDSCO Certification Builds International Partnerships? CDSCO certification opens up access to wider international markets owing to the numerous benefits associated with it.

Types of CDSCO Registration Offered in India

A CDSCO Import Certificate Consultant lower the stress of obtaining a licence to import pharmaceuticals and medical devices into India. However, the services of consultants are not just limited to import licences but also encompass various other types of registration provided by CDSCO. These are as follows:

• Drug Manufacturing Licence: Obtaining a valid manufacturing licence is essential for manufacturers engaged in drugs or medical device production. The licence remains valid indefinitely unless suspended or cancelled by the authorities.
• Import Licence: The CDSCO import licence enables businesses to import medicines, cosmetics, and medical equipment in India. This ensures that the imported items meet the stated regulatory requirements and are safe for further use or distribution in the market.
• New Drug Approval: Manufacturers are mandated to obtain permission before introducing a new drug or combination of drug(s) in India. The drug is approved only after a rigorous evaluation of pre-clinical and clinical data.
• Medical Device Certificate: CDSCO also grant certification with regards to medical devices by obtaining necessary information like its manufacturing process, intended use, manufacturing design, etc. The authority classifies medical devices into four different risk classes namely A, B, C and D to streamline the entire registration process.
• Cosmetic Registration: Manufacturers, importers, sellers or distributors are mandated to obtain registration to sell skincare products, personal hygiene items, and makeup to Indian consumers. The registration enables greater compliance with safety, quality, and labelling regulations that protect consumer’s interests and ensure their well-being.
• Clinical Trial Approval: Organizations or businesses that intend to conduct clinical trials are required to first get approval from CDSCO. This ensures that trials are based on mandated protocols and comply with ethical and safety standards.
• Certificate of Pharmaceutical Product: Obtaining a Certificate of Pharmaceutical Product licence is necessary for companies that are involved in exporting pharmaceuticals. The certification demonstrates that the product is authorized to be sold in India and commits to manufacturing and quality regulatory practices.
• GMP Certificate: WHO’s Good Manufacturing Practices certification sets out guidelines for producing goods as per set quality standards. CDSCO regulate GMP for drugs, cosmetics, and medical devices and conducts risk-based inspections to ensure compliance with GMP.
• Wholesale Drug Licence: The licence is issued to distributors and wholesalers, which authorize them to store and distribute drugs, medical devices, or cosmetics in India. However, the entities are obliged to follow the storage guidelines and other requirements to obtain certification.

What are the Labelling Requirements of CDSCO?

Labelling guidelines of CDSCO are issued with the intent to ensure that consumers get all the necessary information by having just one brief glance at the label of the product.

According to the Drugs and Cosmetic Act and Medical Device Rules, any manufacturer and importer are required to follow the labelling guidelines laid out by the CDSCO. For instance, labels on the container or drug packaging must contain the name of the drug, name and address of the manufacturer, batch number, licence number, and date of expiry. In addition, the regulations specify that these particulars must appear in a conspicuous position in both innermost and outer packaging. If the medicine is for external application, it is necessary to print ‘FOR EXTERNAL USE ONLY’ in bold and capital letters clearly on the label.

As per the guidelines, no seller or distributor can sell drugs or medical devices without labelling them. The information must be either printed or written in indelible ink. In the context of cosmetics, the outer label of the product must carry a declaration of the net content such as 50ml or 200ml, etc. The content must be expressed in weight for solid items and fluid measure used in case of liquid.

However, this rule does not apply to perfume packaging or other items whose net content does not exceed 60 ml or 30 gms in the case of solid or semi-solid cosmetics.

The packaging must contain the list of ingredients listed in descending order of volume or weight in cosmetics. In case cosmetics can cause any serious hazard, every inner label must clearly indicate a warning or caution to be observed by the consumer, provide adequate directions for its safe usage, and specify the names and quantity of ingredients that are poisonous or hazardous.

Connect with a CDSCO Import Certificate Consultant to understand the lengthy yet mandatory labelling requirements and ensure conformity with these rules to avoid any financial or legal repercussions.

Benefits of CDSCO Registration in India

Having a CDSCO registration in India provides several benefits, including legal authorization for products to seamlessly enter the markets. The certification ensures that products are compliant with the stringent standards set for their safety, quality and efficacy. CDSCO registration serves as a mark of approval from a responsible regulatory authority. This enhances trust and confidence among customers and creates opportunities for producers to tap larger markets.

CDSCO Import Certificate Consultant assists in complying with the stipulated regulations concerning the import of pharmaceuticals, cosmetics, and medical devices. It helps in adhering to the Good Manufacturing Practices (GMP) regulations and maintaining high production standards throughout the production process.

Why Medical Equipment Manufacturers Need CDSCO Certification? Medical equipment manufacturers are mandated to obtain CDSCO authorization to ensure that their devices meet the highest safety and quality standards, comply with the Medical Device Rules 2017 regulations, and manufacture devices that are safe to use by patients and healthcare providers.

Final Thoughts

Filing extensive disclosures regarding the manufacturing process, product composition, and compliance with safety and quality parameters throughout the production is a part of the registration process. Several consider obtaining the CDSCO authorization a daunting task owing to the number of complex regulatory rules, intricate paperwork, complex process of application, etc.

To streamline this entire procedure, companies often take the assistance of a CDSCO Import Certificate Consultant who provides the much-needed guidance and support in registration for not just importing products but also exporting, manufacturing, and distributing medical products and devices within and outside the nation. Legal Raasta has a team of experienced and professional consultants with profound knowledge of the CDSCO regulatory framework. Connect with us to understand the intricacies of CDSCO registration and obtain your licence at minimal prices!