If you are confused and want to check the list of approved drugs in India, then here is
The proper list of the approved drugs. This article consists of details like how to register medicines in India, what the requirements for drug registration are in India, and how long it takes to get drug approval. So, read this article and know every bit related to it.
Here is the List of New Drugs approved in the year 2024 to date in India:-
| S.No | Name of the Drugs | Indication | 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 | Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus | 19-01 2024 |
| 2. | Plazomicin injection 500mg/10ml (50mg/ml) | Indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible microorganism(s) Escherichia coliKlebsiella pneumoniaeProteus mirabilisEnterobacter cloacae | 02-02-2024 |
| 3. | Etifoxine Hydrochloride Bulkdrug & Etifoxin Hydrochloridecapsules 50 mg | Indicated for psychosomatic manifestations of anxiety | 21-03-2024 |
| 4. | Vonoprazan fumarate Bulk drug& Vonoprazan tablets 10mg/20 mg | Treatment of reflux esophagitis(RE) Treatment of gastric ulcer (GU) Treatment of duodenal ulcer(DU) Prevention of recurrence of gastric ulcer or duodenal ulcer during low-dose aspirin administration. Prevention of recurrence of gastric ulcer or duodenal ulcer during NSAIDs administration. Adjunct to Helicobacter pylori eradication associated with: Gastric ulcer, Duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early-stage cancer, or Helicobacter pylori gastritis. | 08-05-2024 |
| 5. | rdESAT-6 and rCFP-10 (Cy-Tb) injection (Additional indication) | For Detection of Latent-TB for population of age group 1 year and above. For detection of Latent-TB for population below 1 year in implementation research mode under National program only | 16-05-2024 |
| 6. | Selpercatinib Capsules 40 mg & 80mg | Adult patients with metastatic RET fusion-positive non-small cell lung cancer(NSCLC) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET mutant medullary thyroid cancer (MTC) who require systemic therapy. Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory(if radioative iodine is appropriate) | 16-05-2024 |
| 7. | Nelarabine bulk drug & Nelarabine Injection 250mg/50ml(5mg/ml) | For the treatment of patients with Tcell Lymphoblastic leukemia and Tcell Lymphoblastic lymphoma in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens | 31.05.2024 |
| 8. | Enmetazobactam bulk drug & Cefipime 2gm and Enmetazobactam 500mg Dry powder for injection | Indicated for the treatment of patients 18 years of age and older for: Complicated urinary tract infection(CUTI) including acute pyelonephritis Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) Bacteremia with complicated urinary tract infection or hospital-acquired pneumonia | 31.05.2024 |
How to Get FDA Approval In India?
To get FDA Approval in India, follow these steps to get an FDA-approved license.
- Fill in all the details in the form and upload all the required documents.
- Inspection will be held on your site
- Form Issuance of 360
- EIR Report Issuance
- Letter of Warning
- Approval or Cancellation of the FDA License.
Follow these steps if you need help with other methods.
How To Register For Drugs In India?
Here are the steps to register for drugs in India; read the points mentioned below:-
- Firstly, you have to fill out the application for a clinical trial.
- After this, the individual needs to apply to the clinical trials.
- Provide application to market authorization.
- Additionally, one has to apply to the manufacturing site.
These are the points you have to read and follow if you want to register for drugs in India; for more help or any other related query, you can click on medicaldeviceregistration.com or call the no. Mentioned on the top of the page.
How Are Drugs Approved In India?
In India, new drugs undergo thorough testing. First, researchers test them in labs and then on animals to assess safety. Then, human testing in clinical preliminaries occurs. If the drug proves safe and viable, it’s checked by the Central Drugs Standard Control Organization. Once approved, it can be sold and utilized, with ongoing monitoring to guarantee security.
How Long Before A Drug Is Approved?
Drug approval takes a maximum amount of time to get approved, so it’s better to talk with the experts and get yourself all the details about the doubts you have.
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ELT Corporate has been in the market for so long, and after all its successful services, ELT has already made its name in the market, which makes it reliable. It’s better to choose a company that is happy to help at an affordable price. Still confused? Talk to the experts and decide.
What is the complete FDA form?
FDA stands for the Food and Drug Administration.
What is the Full Form of the DCGI?
The Full form of the DCGI is Drug Controller General of India.
What is the Full form of the CDSCO?
The CDSCO stands for the Central Drug Standard Control Organization.
Who Certifies Drugs In India?
CDSCO certifies the drugs in India.
How Many Approved Drugs Are There?
There are 19,000 approved prescription drugs present in the market.