How CDSCO Certification Boosts Trust And Safety?

The Central Drugs Standard Control Organization (CDSCO) functions under the Directorate General of Health Services of the MoHFW (Ministry of Health and Family Welfare). CDSCO is a national regulatory authority responsible for conducting clinical trials, approving new drugs, enforcing standards for drugs, and controlling the quality of imported drugs. The organization also coordinates the activities of the State Drugs Control Organizations. It aims to bring uniformity in the implementation and enforcement of the Drugs and Cosmetic Act 1940 and 1945 and Medical Device Rules 2017.

CDSCO Drugs Registration and CDSCO Medical Device Certification aims to promote public health by ensuring the quality, safety, and efficacy of medical devices, drugs, and cosmetics. Keep reading to explore how CDSCO certification reinforces trust, enhances credibility, and ensures safety in the pharmaceutical industry.

How to Obtain CDSCO Certification in India?

To obtain CDSCO Medical Device Certification, corporations, importers, Indian agents, and foreign companies with Indian subsidiaries can apply on online. The applicant can follow the below-mentioned steps to initiate the application:

• An applicant has to visit the website and sign up to create login credentials.
• The manufacturing unit cannot directly register on the portal.
• Corporate entities first have to create login credentials for the unit of manufacturing, and these credentials will then be used by the manufacturing unit to successfully log on to the portal.
• Applicants are then required to provide information regarding the ‘purpose of registration’.
• Proceed to submit ID proof details, Corporate Address Proof, Power of attorney, Wholesale licence or Manufacturing licence, to be submitted in PDF format.
• Upon filing all the necessary details, and after clicking on the ‘submit’ button, a confirmation link will be sent to the user’s registered email address.

How does CDSCO Promote Trust and Safety?

Market reputation plays a significant role in the pharmaceutical industry. A strong brand image establishes trust with healthcare providers and patients, enabling companies to drive their sales and revenue while opening up business avenues in the international pharmaceutical market. The CDSCO Medical Device Certification creates a perception that the product has passed through rigorous quality and safety checks before reaching consumers. The certification promotes safety as well as trust in the following ways:

Quality Assurance: The Drugs and Cosmetics (Amendment) Act, 2008 establishes the provision of penalties for offences in case the drug is found adulterated and spurious and has serious implications on public health. The penalty specifies imprisonment which may extend for life and create liability to pay fines in lakhs.

Legal provisions for quality assurance encourage manufacturers to produce quality drugs, cosmetics, and medical devices. CDSCO regulate the quality through regular risk-based inspections and audits. Monitoring is done through random sampling where samples of drugs are collected randomly from the market and tested in designated laboratories. Quality products protect public health, enhance regulatory compliance, enhance market access, and enhance brand reputation.

Clinical Confidence: CDSCO certification promotes pharmacovigilance by overseeing PvPI (Pharmacovigilance Programme of India), which collects, analyses, and reports adverse drug reactions to the concerned authorities. In simpler terms, it monitors and manages the safety of vaccines and medicines.

CDSCO collect data on adverse reactions caused by the drugs to identify potential safety concerns. Based on the analysed data, CDSCO makes regulatory decisions such as issuing safety alerts to the public, updating drug labels, and taking stringent action in worst-case scenarios. Further, the FSSAI and DCGI approval validates the drugs’ efficacy and promotes their usage in medical practice not just in the domestic healthcare sector but internationally as well.

Global Recognition: CDSCO Certification Builds International Partnerships and CDSCO certificate creates a robust testament to the product’s safety and quality from the perspective of overseas pharmaceutical markets. It relays the message that the drugs or medical devices are safe to use and can be readily introduced for consumer consumption.

Medical products and devices that have already been certified by CDSCO often experience smoother global clinical trials and early regulatory approvals in the international market since these products are already backed by approval from a responsible government authority.

Guidance and Training: To ensure that the certified drugs and medical devices are safe to use, CDSCO guide how to manufacture and design medical devices. It issues guidelines and documents specifying the necessary standards, quality control measures, and procedures one should adopt in the production and import process. Manufacturers can also seek technical support and clarification from CDSCO regarding application forms, data submission, and documentation, among others.

CDSCO’s guidance, training, and assistance throughout the process enable manufacturers to strictly adhere to regulatory instructions and thus decrease the risk of product recalls and losses that may arise due to legal restrictions. It creates trust among stakeholders and protects the image of the entire pharmaceutical sector from being tarnished in the eyes of the world.

Transparency: The CDSCO evaluation process has brought transparency in the production, testing, and distribution of pharma products and devices. Transparency creates a positive perception and communicates the vision of the company that focuses on people’s safety and well-being.

The national regulatory authority also brings efficiency and transparency in pricing, clinical trials, and production. CDSCO communicate its findings to the public and releases a list of failed and banned drugs to create awareness among the masses.

Obtain CDSCO Medical Device Certification to sell and distribute your medical devices, pharmaceuticals, cosmetics, and IVDs in India. Ensure regulatory compliance with CDSCO regulations to tap opportunities in the global market and enable consumers to establish trust in your brand and products.

What is the Pharmacovigilance Programme of India?

Pharmacovigilance (PV) refers to the activities and science of detection, assessment, collation, prevention, and understanding of an Adverse Event (AE) or any other issues in a drug. India is one of the largest producers of generic drugs and vaccines across the world. It has also established a pharmacovigilance system under the oversight of CDSCO to monitor the safety profile of pharmaceutical products that are marketed and sold in the nation.

The CDSCO receive drug safety-related recommendations from the PvPI (Pharmacovigilance Programme of India) committee that is headed by the Drugs Controller General of India (DCGI). The suggestions enable CDSCO to take appropriate regulatory actions to implement the programme.

The PvPI covers the following category of pharmaceutical products:

• Drugs, new drugs, fixed-dose combinations, etc.
• Radio pharmaceuticals
• Phyto pharmaceuticals products
• Biologicals including cell lines, culture-based products, biosimilars, etc.

The Pharmacovigilance Programme of India was operationalized in 2010 and aims to safeguard the health of the Indian population by ensuring that the benefits associated with the usage of medicines outweigh the risks arising from their use.

Consumers Prefer CDSCO-Certified Products and CDSCO certified drugs & medical devices ensure their safety, quality, efficacy, and credibility among users. It also ensures that products meet international standards like WHO GMP and ICH. Further, the PvPI bolster this by conducting medical inquiries, obtaining information from patients and caregivers, taking follow-ups and reports from the internet, etc.

What are CDSCO Drug Recall Guidelines?

CDSCO has issued guidelines to remove defective drugs and medical devices from use or distribution. These guidelines apply to all classes of drugs including biologicals and vaccines.

The recall is a step taken to withdraw or remove drugs in which deficiencies are detected with regard to their quality, safety, and efficacy. In the context of quality, a drug can be Not of Standard Quality, Spurious Drugs, and Adulterated. Safety and efficacy involve recalling due to serious adverse reactions or death in extreme cases. Recalls also withdraw drugs that are prohibited under the Drugs and Cosmetics Act and those products that are cancelled or suspended.

Recalls are categorized into two types, i.e., voluntary and statutory. A voluntary recall is initiated from the manufacturer side due to non-adherence to standards found through post-marketing stability studies, market complaints highlighting product defects, adverse impacts detected on distributed products, etc. Statutory recall is introduced when drug regulatory authorities mandate the withdrawal of drugs in some specific situations. It could be due to failure in meeting legal standards, removal of drugs that are banned, in case of violation of guidelines, etc.

In addition, recalls are classified into three classes based on the repercussions or health hazards they can cause in the country. Class 1 is a situation when those products are recalled, which can cause serious health implications or death of the user. Class 2 includes those products that may give rise to temporary health issues or can cause serious harm but its risk remains low. Lastly, Class 3 is a situation in which exposure or use of a defective product is less likely to cause any adverse health consequences.

The level of recall depends on its distribution and classification. There are three levels of recalls, namely consumer level, retail level, and wholesale level. Consumer or retail-level recall involves withdrawing drugs or products from individual consumers, physicians, patients, and hospitals. Similarly, retail recall includes withdrawal from retail groceries, pharmacies, clinics, nursing homes, etc. The wholesale level encompasses everyone from manufacturer to retailer.

Recalls by CDSCO are done after making public announcements through print, and electronic media, including television, radio, newspapers, etc.

Conclusion

Launching any venture into the healthcare industry is a strenuous task, especially due to the daunting and complex regulatory provisions. However, CDSCO Medical Device Certification ensures operational safety and trustworthiness in the Indian healthcare market. This promotes brand recognition in overseas markets, enhances export and business opportunities, attracts users from all across the world and encourages its usage in medical practice.

Although the registration process for a CDSCO licence is paperless, the approval still requires ample time to manage the application and obtain approval for the usage of medical products and devices. Businesses have to fill out the relevant form, submit it on the portal, attest the requested documents, and track compliance on an ongoing basis. To streamline the entire process, Legal Raasta is here to offer expert consulting services and support. Connect with us to get all your queries solved and obtain your drug and import licence by following just a few simple steps.