List of 2021 Approved Drugs in India

List of 2021 Approved Drugs in India

If you are curious to know the year 2021 approved drugs in India, here is the list of approved drugs list by the Central Drug Standard Control Organization, widely known as CDSCO. CDSCO is the Government of India’s Ministry that maintains Health and Family Welfare. Check out the table given below:-

S.NoName of the DrugsIndicationDate of Issue
1Avanafil bulk and Avanafil tablets 50mg/100mg/200mg For the treatment of erectile dysfunction26.02.2021
2Omidenepag isopropyl ophthalmic solution 0.002% w/v For the treatment of glaucoma and ocular hypertension12.03.2021
3Ozenoxacin bulk and Ozenoxacin cream 1% w/wIndicated for the topical treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes in adult and pediatric patients 2 months of age and older 15.04.2021
42-Deoxy-D-Glucose bulk and 2-Deoxy-D-Glucose 2.34g & 5.85g sachetAs an adjunct therapy only in moderate to severe Covid-19 patients 01.05.2021
5Capmatinib 150mg and 200mg film coated tabletsCapmatinib is a kinase inhibitor indicated for the treatment of adult patient with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal epithelial transition (MET) exon 14 skipping.12.05.2021
6Rucaparib camsylate bulk and Rucaparib tablets 200mg/300mgOvarian cancer 
• For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. 
• For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDAapproved companion diagnostic for RUBRACA. 
Prostate cancer 
• For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic) associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
12.05.2021
7Trientine Tetrahydrochloride bulk and Trientine Tetrahydrochloride capsules 333 mg (Each capsule contains Trientine tetrahydrochloride 333mg equivalent to Trientine 167mg base) For the treatment of Wilson’s disease (hepatolenticular degeneration) in patients intolerant to Penicillamine. It should be used when continued treatment with Penicillamine is no longer possible because of intolerable or life endangering side effects. 08.06.2021
8Rucaparib tablets 250mg Ovarian cancer • For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. • For the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)- associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDAapproved companion diagnostic for RUBRACA. Prostate cancer • For the treatment of adult patients with a deleterious BRCA mutation (germlin and/or somatic) associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. 18.06.2021
9Vigabatrin bulk and Vigabatrin powder for oral solution 500mgFor the treatment of 
1) Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin for Oral Solution, USP, 500 mg is not indicated as a first line agent.
2) Infantile Spasms – monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss. 
18.06.2021
10Cangrelor tetra sodium bulk and Cangrelor for injection 50mg/vialIndicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revarscularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor21.06.2021
11Rifapentine bulk and FDC of Isoniazid and Rifapntine (300mg/300mg)Indicated for treatment of latent tuberculosis, caused by Mycobacterium tuberculosis (For use in NTEP only)28.06.2021
12Lemborexant tablets 5mg/10mg Treatment for insomnia 01.07.2021
13Cetilistat bulk and Cetilistat 120 mg tabletsFor the treatment of Obseity (limited to patients with both type 2 diabetes mellitus and dyslipidaemia, and with a BMI ≥ 25 kg/m2 inspite of dietary treatment and /or excersise therapy)09.07.2021
14Benzonatate bulk and Benzonatate capsules 100mgFor the treatment of refractory cough15.07.202
15Cariprazine hydrochloride bulk and Cariprazine capsules 1.5mg/3mg/4.5mg and 6mg For the treatment of Schizophrenia in adults. Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults16.07.2021
16Gadoteridol 279.3 mg/ml for injection For intravenous use in magnetic reasonance imaging (MRI) in adults and pediatric patients over 2 years of age for whole body MRI including the head, neck, liver, breast, musculoskeletal system and soft tissue pathologies 29.07.2021
17Darolutamide 300mg film coated tabletsFor the treatment of patients with nonmetastatic castration resistant prostate cancer (nmCRPC)13.08.2021
18Tetracosactide BP bulk and Tetracosactide injection BP 250 mcg/mlDiagnostic test for the investigation of adrenocortical insufficiency13.08.2021
19Cabozantinib (S) – Malate bulk and Cabozantinib tablets 20mg, 40mg and 60mg(1) For the treatment of patients with advanced renal cell carcinoma (RCC). 
(2) For the treatment of patients with Hepatocellular Carcinoma (HCC) who have been previously treated with sorafenib.
10.09.2021
20Tipiracil hydrochloride bulk and FDC of 1) Trifluridine 15mg + Tipiracil 6.14mg and 2) Trifluridine 20mg + Tipiracil 8.19mg Indicated for the treatment of 
i) adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, an antiVEGF biological therapy, and if RAS wildtype, an anti-EGFR therapy 
ii) Adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/ neu-targeted therapy.
16.09.2021
21Selumetinib 10mg & 25mg capsuleIndicated for the treatment of Pediatric patients 3 years of age and older with neurofibromatosis type 1 (NF1) and who have symptomatic, inoperable plexiform neurofibromas (PN)17.09.2021
22Biapenem sterile bulk and Biapenem for injection 300mgComplicated urinary tract infections17.09.2021
23Tafamidis soft gelatin capsules 61 mgIndicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTRCM)30.11.2021
24Molnupiravir bulk and Molnupiravir capsules 200mgFor treatment of adult patients with COVID-19, with SpO2 >93% and who have high risk of progression of the disease including hospitalization or death, in light of Covid 19 outbreak for restricted emergency use in the country 28.12.2021
25Selexipag bulk and Selexipag tablets…200mcg/ 400mcg/ 600mcg/ 800mcg/ 1000mcg/ 1200mcg/ 1400mcg/ 1600mcgFor the treatment of Pulmonary Arterial Hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH31.12.2021

What are the Newest Drugs?

Here is the list of newly approved drugs in India; look below.

  • Iqirvo
  • Rytelo
  • Imdelltra
  • Xolremdi

What Drugs Require FDA Approval?

Basically, FDA approval is needed by US law, as all the drugs that are manufactured need to get FDA approval to show it is safe and effective and can be used by the public.

What is a Generic Name?

The chemical name of the drug is known as a Generic name. 

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