Common CDSCO Registration Challenges And Solutions

In India, the import, sale, manufacturing, and distribution of drugs and cosmetics are regulated under the Cosmetic Rules 1945 and the Drugs and Cosmetic Act 1940. CDSCO Medical Device Registration, import, manufacturing, sale, distribution, and clinical investigation are governed through the Medical Device Rules, 2017.

In accordance with these acts, the Ministry of Health and Family Welfare, Directorate General of Health Services established the CDSCO (Central Drugs Standard Control Organization). The CDSCO is responsible for approving new drugs, controlling the quality of imported drugs, and conducting clinical trials. CDSCO lays down the guidelines and standards for drug management. It provides expert advice to coordinate the activities of State Drug Control Organizations. As a national regulatory body, CDSCO is also responsible for granting licences for some specific critical drugs like blood products, vaccines, sera, IV fluids, etc.

Let’s delve deeper into the CDSCO’s functioning, registration, challenges, and solutions.

What is CDSCO Registration in the Pharma Industry?

The pharmaceutical industry plays a pivotal role in offering affordable medicines, creating employment opportunities across manufacturing, distribution and research, and improving healthcare accessibility. In India, the industry has ensured the well-being of its citizens and transformed the nation into a leading generic drug supplier. To regulate the industry, the government established CDSCO which will work in the best interest of the public and ensure that only safe and effective drugs and cosmetics reach the market.

The CDSCO (Central Drugs Standard Control Organization) oversees various types of pharmaceuticals, cosmetics, medical devices, and diagnostics registration. The major types of CDSCO registration are:

● CDSCO New Drug Approval: The approval is granted to new drugs that are yet to be marketed in India. An applicant can also seek new drug approval if the drug is already registered but recently modified. Further, the applicant must submit pre-clinical and clinical data.

● CDSCO Medical Device Registration: CDSCO mandates medical device manufacturers, sellers, and distributors to obtain this approval for medical devices in India. It offers authorization after categorizing medical devices under four categories namely A, B, C, and D.

● Import Licence: CDSCO issues import licences to those entities that import medical devices, cosmetics, and drugs for commercial purposes. The licence ensures compliance with safety and quality standards while importing medical products.

● Manufacturing Licence: Entities who wish to manufacture medical devices, pharmaceuticals, and other products have to obtain this licence. It assures adherence to quality norms and regulatory standards.

● Cosmetic Authorization: Involves obtaining registration for marketing makeup and skincare products in India.

● Export Registration: Entities who are planning to export their medical devices, pharmaceuticals, drugs, and cosmetics are required to obtain a CDSCO export licence.

● Clinical Trial Approval: Applicants who are willing to conduct clinical trials of medical devices, drugs and healthcare products to test their safety and any potential side effects, must obtain this approval through the Clinical trial registration process.

● Dossier Approval: A dossier is a collection of documents that includes details on a drug’s purity, identity, strength, and quality. CDSCO reviews dossiers for clinical trials and new drugs. The licence ensures compliance with regulatory standards prior to its registration in India.

Through these registrations, the CDSCO assures the Competitive Advantage of CDSCO Certification for Your Brand and enhances trust and credibility in the brand’s products.

Obtain CDSCO Registration for Medical Devices and Drugs

Through CDSCO, Indian agents, importers, corporates, and Indian subsidiaries of foreign businesses can apply for new drugs, subsequent new drugs, investigational new drugs, fixed-dose combinations, rDNA derived drugs, blood bank licence, drug manufacturer licence, and authorization for importing and manufacturing vaccines, among others. The CDSCO registration process in India includes the following stages:

● Submit Your Application: Fill in all the details on the User Profile specifying details about the products, quality management systems, manufacturing process, clinical data (if applicable), and other requested information.

● Evaluation: Upon submission of the application form and documents, CDSCO thoroughly reviews all the details and assesses whether the applicant meets safety and quality standards and fulfils other regulatory requirements.

● Resolution of Query: CDSCO can request additional information from the applicant if the necessity arises. It is necessary to furnish all the requested information and provide clarification (if requested) to complete the evaluation process.

● Rejection or Approval: After evaluating the application, CDSCO will either accept or reject the grant of registration. In case of the absence of sufficient data, inadequate documentation, and non-compliance, CDSCO can reject the application.

● Registration Issuance: Those who fully satisfy and comply with the stipulated Drug and cosmetics rules will receive their RC (registration Certificate) from CDSCO, enabling them to market their products in India.

In addition, the CDSCO Medical Device Registration is provided by categorizing medical devices into four classes depending on their varying risk:

● Class A – Low Risk: Includes medical devices that cause minimal to no harm to patients and users, for example, surgical gloves, bandages, stethoscopes, and other basic medical instruments.

● Class B – Low to Moderate Risk: Includes syringes, blood pressure monitors, and hypodermic needles that may cause harm to patients if malfunction. However, the harm will not be life-threatening.

● Class C – Moderate to High Risk: Cause serious harm to patients and includes bone fixation plates, artificial heart valves, catheters, etc.

● Class D – High Risk: Includes highly risky medical equipment that can cause life-threatening damages in case it malfunctions. For instance, pacemakers, ventilators, and heart or lung machines.

Challenges and Solutions in CDSCO Registration

CDSCO’s primary objective is to bring accountability, transparency, and uniformity to the drugs and cosmetic industry. It ensures that the quality of the medical products is up to the mark and is safe to use. Regulations of CDSCO span across drugs and cosmetics manufacturing, import, and distribution throughout the nation.

CDSCO Medical Device Registration and authorization for other medical products are fundamental to comply with the established measures for bringing safety, quality control, and efficacy before products reach the Indian market. Despite the robust mechanism, applicants often struggle with hurdles that come along the way while obtaining CDSCO authorization. These are as follows:

● Excessive Documentation: The CDSCO registration process is time–consuming and involves excessive paperwork. Applicants have to compile and submit large volumes of administrative and technical documents like manufacturing information, clinical trial data, and labelling information. To tackle this issue, applicants can consult an expert to get better clarity and streamline document compilation and submission to the CDSCO.

● Timelines and Delays: Obtaining CDSCO registration is a time-consuming process. The authority deals with different product categories and the complexity of such applications varies to a great extent. Thus, registration often takes several months and delays product launches and import of better medical devices, drugs, and cosmetics. Applicants can partner with consultants who will help them expedite the entire review process by liaising with regulatory authorities.

● Technical Complexity: Assessing the efficacy and safety of medical products requires specialized and experienced technical experts. However, several companies do not have such experts who can assist in understanding the technical aspects of the product and enhance conformity with the stipulated guidelines. To navigate through the technical complexities of CDSCO registration, it is essential to build strong partnerships with local key stakeholders and connect with experts to get a better understanding of the entire process.

● Frequent Amendments: The CDSCO regulatory requirements are complex, nuanced, and intricate which makes it difficult to comply with all the regulations. The task becomes even more strenuous for those who are new entrants in the market. Further, frequent amendments in the rules and acts can cause confusion and uncertainty in the market. For this, it is necessary to stay updated about any changes in the acts by carefully examining the released circulars.

How CDSCO Certification Enhances Exports for Indian Products? The CDSCO licence is a strategic legal approach to enhance exports of medical devices, drugs and cosmetics from India. The authorization is pivotal in increasing the credibility and trust in Indian pharmaceutical products and medical equipment. It helps international markets, authorities, and suppliers to be at ease since registration shows that the product is manufactured with utmost safety and causes no harm to the public and environment.

Conclusion

In India, state authorities regulate the manufacturing, sale, and distribution of drugs. Whereas central authorities are responsible for approving new drugs, conducting clinical trials, controlling imported drugs’ quality, and enforcing standards for drug management in India. In a significant move, CDSCO was handed over the task of overseeing the majority of the regulatory process and acting as a central licence-approving authority under the existing acts.

CDSCO evaluates and approves new drugs and medical devices for quality, safety, and efficacy before it is marketed and sold in India. If the products or devices fail to meet the criteria and comply with specified parameters, CDSCO holds the right to reject the authorization application. The authority is also delegated the responsibility to conduct audits and inspections of manufacturing units and further enhance compliance with the standards. Connect with Legal Raasta Private Limited to obtain your CDSCO Medical Device Registration and authorization for drugs and cosmetics in a hassle-free and time-bound manner, all this done at minimal cost.