CDSCO Approved Drugs: A Detailed Overview of New Therapeutic Options

Overview

The CDSCO Approved Drugs list is a critical tool for healthcare professionals and patients in India to have access to the latest therapeutic options certified by the Central Drugs Standard Control Organisation. It avails access to all available approved medications across the CDSCO online portal with ease and perfect compliance with the standards of safety and efficacy.

Understanding CDSCO and Its Functions

The Central Drugs Standard Control Organisation is the most prominent regulatory body in the country and is responsible for the regulation of pharmaceuticals, medical devices, and cosmetic products. CDSCO also works under the Ministry of Health and Family Welfare to ensure drugs are safe to use, effective, and of high quality. Key responsibilities of CDSCO also include the approval of new drugs, management of clinical trials, and ensuring compliance with the Drugs and Cosmetics Act for securing public health.

• New Drug Approvals: CDSCO tests and approves new drugs before they enter the market so that they are safe for public consumption.
• Clinical Trials Regulation: The institution governs the carrying out of clinical trials to ensure that they are implemented safely and ethically.
• Quality Control: CDSCO formulates standards and enforces compliance with the quality of drugs for health protection.

The Role of the CDSCO SUGAM Portal

CDSCO SUGAM Portal is an online portal developed by the Central Drugs Standard Control Organisation (CDSCO) to make drug registration, licensing, and compliance processes easy. It offers the following facilities:

• CDSCO online services. The portal would help applicants apply for licenses and certificates online.
• Application Tracking: Users can monitor the status of their applications in real-time, thus increasing transparency and allowing for better planning.
• Document Uploads: Candidates can upload all the relevant documents about their submission directly and thus save considerable time throughout the procedure.
• Query Management: It has a system of query management through which all applicants will receive a response within time.

CDSCO Approved Drugs

These vary in the range of CDSCO-approved drugs, offering an array of drugs for numerous therapeutic needs related to several health conditions. The evaluation and testing of new drugs are very stringent and directed to determine their safety and effectiveness. Some of the notable points are as follows:

• New Therapeutic Options: New treatments for chronic diseases, rare conditions, and advanced therapies such as biologics and biosimilars have recently been approved.
• Regulatory Framework: The drug approval process is governed by the Drugs and Cosmetics Act of 1940. The Act lays stress on sufficient documentation and clinical evidence.

List of CDSCO-Approved Drugs

S. NO	Name of drug	Date of issue
1.	Tirzepatide 2.5mg /0.5ml, 5mg/0.5ml, 7.5mg/0.5 ml,10mg/0.5 ml,12.5mg/0.5 ml,15mg/0.5 ml solution for injection in a prefilled pen	19-01 2024
2.	Plazomicin injection 500mg/10ml (50mg/ml)	2-02-2024
3.	Etifoxine Hydrochloride Bulk drug & Etifoxine Hydrochloride capsules 50 mg	21-03-2024
4.	Vonoprazan fumarate Bulk drug& Vonoprazan tablets 10mg/20 mg	8-05-2024
5.	rdESAT-6 and rCFP-10 (Cy-Tb) injection (Additional indication)	16-05-2024
6.	Selpercatinib Capsules 40 mg & 80mg	16-05-2024
7.	Nelarabine bulk drug & Nelarabine Injection 250mg/50ml(5mg/ml)	31.05.2024
8.	Enmetazobactam bulk drug & Cefipime 2gm and Enmetazobactam 500mg Dry powder for injection	31.05.2024
9.	Methenamine Hippurate bulk drug &Methenamine Hippurate Tablets USP 1gm	09.07.2024
10.	Sodium Phenylbutyrate USP bulk drug& Sodium Phenylbutyrate Oral Powder USP	09.07.2024
11.	Elobixibat Hydrate Bulk Drug and Elobixibat Tablets 5 mg	15.07.2024
12.	Tedizolid Phosphate Bulk & Tedizolid Phosphate Tablets 200mg	19.07.2024
13.	Remifentanil Hydrochloride EP Bulk	31.07.2024
14.	Pimavanserin Tartrate Bulk & Pimavanserin Capsules 34 mg	02.08.2024
15.	Elagolix Sodium Bulk & Elagolix tablets 150mg and Elagolix tablets 200 mg	09.08.2024
16.	Brigatinib Tablets,30mg,90mg, and 180mg	18.09.2024
17.	Mavacamten capsules 2.5mg,5 mg,10mg,15 mg	08.10.2024
18.	Ferumoxytol Bulk Drug &Ferumoxytol Injection 510 mg Elemental Iron/17mL(30mg/mL)	08.10.2024

Future Prospects for CDSCO-Approved Drugs

1. Growing Approvals: Over the years ahead, CDSCO is to clear more and more innovative drugs to bring better treatment for the rising number of medical and health-related disorders.
2. Innovation in Therapeutics Approvals: Biologics, personalized medicine, etc. will significantly surge ahead for clearance and approvals by unmet medical needs.
3. Easy Regulatory Process: This portal of SUGAM would make the process of registration and compliance with drug and other requirements very simple. This will motivate more companies to bring new products to the market.
4. State Regulators Co-operation: This collaboration between the state regulators would lead to uniformity in the practices of the regulators and save public health from undue menace.
5. Demand in the Market: Greater awareness regarding health issues will give more demand for new treatment drugs and efficient drugs available in the market, thereby encouraging CDSCO-approved drugs.
6. Focus on Quality Control: Strict quality control measures by CDSCO would result in ensuring that the safest and most effective drugs will reach the consumers only.

Conclusion

The CDSCO is the main hub of safety, efficacy, and quality of drugs in India. With the approval process being stringent, new therapeutic options are made accessible to healthcare professionals and patients. With the improvement of CDSCO’s regulatory framework and processes by platforms such as the SUGAM portal, drug approvals in the future seem promising, with innovation and public health at the forefront.