The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority, tasked with ensuring that all drugs and medical devices meet safety, quality, and efficacy standards. Before any drug can be sold or marketed in India, it must receive approval from CDSCO. This process ensures that medications are safe for public use and are effective for their intended purpose.
The CDSCO-approved drug list includes drugs that have passed rigorous testing and evaluation. This list covers a wide range of medications used for treating various health conditions such as epilepsy, bacterial infections, cardiovascular diseases, and more. Below is a table that highlights the first 20 drugs approved by CDSCO:
| Sr.No | Drug Name | Strength & Formulation | Indication | Date of Approval |
|---|---|---|---|---|
| 1 | Eslicarbazepine Acetate Tablets | 200mg/400mg/600mg/800mg | Adjunctive therapy in adults with partial-onset seizures with or without secondary generalization | 07.03.11 |
| 2 | 2-Sulphanilamide-5-methyl pyrimidine | 0.5 g tablets | Sulpha drug | 1970-January |
| 3 | 2-thymyloxy methyl Glyoxalidine Hcl | 100 ml contains; 2-thymyl-oxy-methyl glyoxalidine hydrochloride-0.05 | 1971-January | |
| 4 | Acetylcystein | Antimycolytic enzyme. | 1966-March | |
| 5 | Amylobarbitone & Trifluoperazine dihydrochloride | Psychoneurotics, tranquilizer & sedative. | 1967-February | |
| 6 | Atenolol bulk | 1986-January | ||
| 7 | Azacitidine for injection | 100 mg/vial | Treatment of adult patients with all subtypes of Myelodysplastic Syndrome. | 29.04.14 |
| 8 | Bromonaphthol | 250 mg tabs | Anthelmintic – for hookworm infection. | 1963-February |
| 9 | Cefprozil Powder for oral suspension | 125mg/5ml | Antibiotic. | 06.01.2006 |
| 10 | Centbucridine (0.5%) + Feracrylem (3%) | For hemorrhoid & anal fissure. | 11.01.2005 | |
| 11 | Cephradine | 250mg, 500mg & 1gm (capsules/vials); 250mg/5ml (suspension) | Antibiotic – treatment of G.I., genito-urinary, respiratory tract, and soft tissue infections. | 1976-March |
| 12 | Cinnarizine + Domperidone tablets | Cinnarizine-20mg, Domperidone-15mg | Prevention of symptoms from vestibular disorders, vertigo, motion sickness, nausea, dizziness, headache, vomiting, fullness due to delayed gastric emptying | 1992-February |
| 13 | Ciprofloxacin eye drops/ointment | Ciprofloxacin-0.3% w/v | Treatment of external ocular infection. | 1991-February |
| 14 | Cyanocobalamine + Zinc Tannic acid | 500 mcg every 2 weeks | Same as Vit. B12, but has rapid onset and provides prolonged effect for a month or more. | 1961-January |
| 15 | Cyproheptadine | Cyproheptadine Hcl-4mg | 1973-January | |
| 16 | Degarelix for Injection | 80mg / 120mg per vial | Treatment of adult patients with advanced hormone-dependent prostate cancer. | 19.01.12 |
| 17 | Deoxyribonuclease | 250,000 & 100,000 units (vials) | Enzyme preparation from bovine pancreas indicated for treatment of localized abscess in mammary infection. | 1968-January |
| 18 | Dimethindene maleate | Anti-histaminic. | 1965-January | |
| 19 | Disprospan injection | Betamethasone dipropionate-6.43mg, Betamethasone sodium phosphate-2.63mg | 1984-July | |
| 20 | Dobutamine hcl in 5% dextrose inj. | 250mg, 500mg, 1000mg | Short-term treatment of adults with cardiac decompensation due to depressed contractility from organic heart disease or cardiac surgery. | 05.01.2001 |
How to Access the CDSCO Approved Drug List
The complete list of drugs approved by CDSCO can be accessed through the official CDSCO online portal. This online database is frequently updated to reflect the latest drug approvals, ensuring healthcare professionals, pharmacists, and the general public have access to accurate and up-to-date information.
In addition to drug approvals, CDSCO is responsible for a variety of other regulatory functions, including medical device approvals and clinical trial oversight. For more details on drug safety and regulatory functions, visit CDSCO’s official website.