After the COVID-19 wave, many new drugs have been introduced in the market to cure all the symptoms of COVID-19. So, the year 2021 also brings a new list of 2021 approved drugs in India for COVID-19 patients. The approved drugs list is provided by CDSCO (Central Drug Standard Control Organization). It is a government of India’s Ministry that maintains health and family welfare. In this article you will get to know about the newly introduced drugs of 2021.
What Are Some of The Significant Drugs Approved By CDSCO in 2021?
Before going deep into the list of 2021-approved drugs in India. Most of the drugs are approved to cure COVID-19 patients due to the high number of patients coins. Some notable drugs approved by CDSCO in 2021 include:
- 2-Deoxy-D-Glucose (2-DG): Approved as an adjunct therapy for moderate to severe COVID-19 patients.
- Molnupiravir: Approved for the treatment of adult COVID-19 patients at high risk of progression.
- Capmatinib: Approved for the treatment of metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations.
- Rucaparib: Approved for the treatment and maintenance therapy of ovarian and prostate cancers.
List Of 2021 Approved Drugs in India By CDSCO
Below you will find a list of 2021 approved drugs in India By CDSCO. CDSCO approved 25 drugs in India in year 2021 and most of the drugs are related to curing COVID-19 patients. The list of the approved drugs is as follows:
| S.No | Name of the Drugs | Indication | Date of Issue |
|---|---|---|---|
| 1 | Avanafil bulk and Avanafil tablets 50mg/100mg/200mg | For the treatment of erectile dysfunction | 26.02.2021 |
| 2 | Omidenepag isopropyl ophthalmic solution 0.002% w/v | For the treatment of glaucoma and ocular hypertension | 12.03.2021 |
| 3 | Ozenoxacin bulk and Ozenoxacin cream 1% w/w | Indicated 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 |
| 4 | 2-Deoxy-D-Glucose bulk and 2-Deoxy-D-Glucose 2.34g & 5.85g sachet | As an adjunct therapy only in moderate to severe Covid-19 patients | 01.05.2021 |
| 5 | Capmatinib 150mg and 200mg film coated tablets | Capmatinib 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 |
| 6 | Rucaparib camsylate bulk and Rucaparib tablets 200mg/300mg | 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 (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 |
| 7 | Trientine 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 |
| 8 | Rucaparib 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 FDA-approved 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 taxane-based chemotherapy. | 18.06.2021 |
| 9 | Vigabatrin bulk and Vigabatrin powder for oral solution 500mg | For 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 |
| 10 | Cangrelor tetra sodium bulk and Cangrelor for injection 50mg/vial | Indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, 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 inhibitor | 21.06.2021 |
| 11 | Rifapentine 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 |
| 12 | Lemborexant tablets 5mg/10mg | Treatment for insomnia | 01.07.2021 |
| 13 | Cetilistat bulk and Cetilistat 120 mg tablets | For the treatment of Obesity (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 |
| 14 | Benzonatate bulk and Benzonatate capsules 100mg | For the treatment of refractory cough | 15.07.202 |
| 15 | Cariprazine 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 adults | 16.07.2021 |
| 16 | Gadoteridol 279.3 mg/ml for injection | For intravenous use in magnetic resonance 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 |
| 17 | Darolutamide 300mg film-coated tablets | For the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) | 13.08.2021 |
| 18 | Tetracosactide BP bulk and Tetracosactide injection BP 250 mcg/ml | Diagnostic test for the investigation of adrenocortical insufficiency | 13.08.2021 |
| 19 | Cabozantinib (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 |
| 20 | Tipiracil 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 |
| 21 | Selumetinib 10mg & 25mg capsule | Indicated 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 |
| 22 | Biapenem sterile bulk and Biapenem for injection 300mg | Complicated urinary tract infections | 17.09.2021 |
| 23 | Tafamidis soft gelatin capsules 61 mg | Indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTRCM) | 30.11.2021 |
| 24 | Molnupiravir bulk and Molnupiravir capsules 200mg | For treatment of adult patients with COVID-19, with SpO2 >93% and who have a high risk of progression of the disease including hospitalization or death, in light of the Covid-19 outbreak for restricted emergency use in the country | 28.12.2021 |
| 25 | Selexipag bulk and Selexipag tablets…200mcg/ 400mcg/ 600mcg/ 800mcg/ 1000mcg/ 1200mcg/ 1400mcg/ 1600mcg | For the treatment of Pulmonary Arterial Hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH | 31.12.2021 |
Newest Drugs Approved in India
Several new drugs were approved in India in 2021 to address a range of health conditions. Among the latest entries in the pharmaceutical market are:
- Iqirvo: A new drug designed for the treatment of specific cancers or other medical conditions. (Note: Provide more detailed information if available)
- Rytelo: Another recent approval, focusing on addressing a unique set of medical issues. (Note: Elaborate on its specific indications if more information is available)
- Imdelltra: A newly approved medication used for advanced-stage conditions. (Note: Add details on the therapeutic area and patient group)
- Xolremdi: This is one of the newest drugs in India, aimed at treating specific diseases or health conditions. (Note: Provide additional context if available)
These newly approved drugs represent advancements in medical treatment options, offering hope to patients with various conditions. For specific information on each drug, consult your healthcare provider or refer to the latest updates from CDSCO.
What Drugs Require FDA Approval?
FDA approval is mandatory for drug manufacturing, marketing and distribution in the United States. The approval process of the drug involves rigorous evaluation by the Food and Drug Administration (FDA). It ensures that the drugs are safe and effective for public use. The approval process typically involves:
- Preclinical Testing: Laboratory and animal testing to assess the safety and efficacy of a drug before human trials.
- Clinical Trials: Human testing in multiple phases (Phase I, II, III, and sometimes IV) to evaluate the drug’s safety, dosage, side effects, and efficacy.
- New Drug Application (NDA): A comprehensive submission to the FDA that includes all data from preclinical and clinical testing.
- FDA Review: Expert evaluation by FDA scientists and advisors, including assessments of the drug’s labelling and manufacturing processes.
- Post-Marketing Surveillance: Ongoing monitoring for any adverse effects or safety concerns after the drug is on the market.
Drugs approved by the FDA are considered safe and effective for their intended use, and the approval is a key requirement for bringing new medications to the U.S. market.
Conclusion
This guide provides an overview of the drugs approved in India in 2021 by the CDSCO, highlighting the indications, approval dates, and newest medications. It also explains the process for FDA approval in the United States and the significance of generic drug names. Staying informed about the latest drug approvals and regulatory processes helps patients and healthcare providers make educated decisions regarding treatment options.
FAQs
What Drugs Require FDA Approval?
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.