To know all the details about the 2020 approved drugs in india, read this blog and check all the details that are mentioned below:-
| S.No | Name of drug | Indication | Date of issue |
| 1 | Cidofovir dihydrate bulk drug and Cidofovir injection 75 mg/ ml (5 ml single use vial) | Cidofovir is indicated for the treatment of CMV retinitis in adults with acquired immune deficiency syndrome (AIDS) and without renal dysfunction. It should be used only when other medicinal products are considered as unsuitable. | 03.01.2020 |
| 2 | Dacomitinib tablet 15mg, 30mg and 45mg | For the first line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations | 03.01.2020 |
| 3 | Alpelisib film coated tablets 50mg, 150mg, 200mg | Alpelisib is a kinase inhibitor indicated in combination with Fulvestrant for the treatment of postmenopausal women, and men, with Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. | 03.01.2020 |
| 4 | Isavuconazole Sulfate 100mg capsules | Indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis | 14.02.2020 |
| 5 | Azelnidipine tablets IP 8 mg | For the treatment of Stage I Hypertension | 04.03.2020 |
| 6 | Riboflavin Ophthalmic Solution 0.1% | It is intended to treat keratoconus and corneal ectasia following refractive surgery | 11.03.2020 |
| 7 | Pixantrone 29 mg powder for concentrate for solution for infusion | Indicated as 3rd line and 4th line therapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin’s B- Cell Lymphomas (NHL) | 11.03.2020 |
| 8 | FDC of Bilastine 20 mg and Montelukast 10mg tablets | Indicated for the treatment of allergic rhinitis in adults. | 11.03.2020 |
| 9 | Obeticholic acid bulk drug and Obeticholic acid 5mg/10mg tablets | For the treatment of primary biliary cholangitis (also known as primary biliary cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adult with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA | 11.03.2020 |
| 10 | Isavuconazole (as Isavuconazonium Sulfate) 200mg powder for concentrate for solution for infusion | Indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis | 11.03.2020 |
| 11 | Polymyxin B for injection 500000 IU | Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Ps. Aeruginosa. It may also be used as a subconjunctival infection in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa. It may be indicated in serious infections caused by susceptible strains of the following organisms, 1. H. influenzae, specifically meningeal infections 2. Escherichia coli, specifically urinary tract infections 3. Aerobacter aerogenes, specifically bacteremia 4. Klebsiella pneumoniae, specifically bacteremia | 30.03.2020 |
| 12 | Sucroferric oxyhydroxide bulk and Sucroferric oxyhydroxide chewable tablet 500mg | Phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis | 18.04.2020 |
| 13 | Hydrogen peroxide 0.5% w/w wipes | Cleans, disinfects and deodorizes hard nonporous inanimate environmental surfaces | 29.04.2020 |
| 14 | Centhaquin citrate bulk and Centhaquin citrate injection 1.0mg/vial | Add on resuscitative agent for hypovolemic shock | 14.05.2020 |
| 15 | Hydrogen peroxide 0.5% w/w spray | Cleans, disinfects and deodorizes hard nonporous inanimate environmental surfaces | 28.05.2020 |
| 16 | Remdesivir Injection 5 mg/mL and Remdesivir lyophilised powder for Injection 100 mg | For treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in adults and children hospitalized with severe disease, in light of Covid 19 outbreak, for restricted emergency use in the country. | 01.06.2020 |
| 17 | Lymphoseek 50mcg kit (each kit contains : Tilmanocept 50mcg, Glycine 0.1mg, Sodium ascorbate 0.1mg, Trehalose dihydrate 16mg, stannous chloride dihydrate 0.015mg, sodium hydroxide as, hydrochloric acid q.s, Nitrogen q.s, water for injection q.s) | Indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. This medicinal product is for diagnosis only. | 04.06.2020 |
| 18 | Favipiravir bulk and Favipiravir film coated tablet 200mg | For the treatment of patients with mild to moderate Covid-19 disease, in light of Covid 19 outbreak, for restricted emergency use in the country. | 19.06.2020 Ramdev Sivir bulk drug |
| 19 | Remdesivir bulk drug | 20.06.2020 | |
| 20 | Propylene glycol 0.6% lubricant eye drops | Dry eye therapy for the temporary relief of burning and irritation due to dryness of the eye | 30.06.2020 |
| 21 | Pretomanid bulk and Pretomanid tablets 200mg | Indicated as part of a combination regimen with Bedaquiline and Linezolid, in adults for the treatment of pulmonary extensively drug resistant (XDR), or treatment intolerant or nonresponsive multidrug resistant (MDR) tuberculosis (TB) | 15.07.2020 |
| 22 | Favipiravir film coated tablet 400mg | For the treatment of patients with mild to moderate Covid-19 disease, in light of Covid 19 outbreak for restricted emergency use in the country | 22.07.2020 |
| 23 | n-alkyl dimethyl benzyl ammonium chloride 0.105% w/w spray | Cleans, disinfects, deodorizes hard, nonporous inanimate environmental surfaces | 31.07.2020 |
| 24 | Dofetilide bulk and Dofetilide capsules 125 mcg, 250mcg, 500mcg | Maintenance of Normal Sinus Rhythm (Delay in AF/AFl Recurrence) Dofetilide is indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/ atrial flutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. Because Dofetilide can cause life threatening ventricular arrhythmias, it should be reserved for patients in whom atrial fibrillation/atrial flutter is highly symptomatic. In general, antiarrhythmic therapy for atrial fibrillation/atrial flutter aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients. Conversion of Atrial Fibrillation/Flutter Dofetilide is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm. Dofetilide has not been shown to be effective in patients with paroxysmal atrial fibrillation. | 31.07.2020 |
| 26 | Octyl decyl dimethyl ammonium chloride 6.670% spray | Cleans, disinfects, deodorizes hard, nonporous inanimate environmental surfaces | 07.08.2020 |
| 27 | Carbetocin bulk and Carbetocin injection 100 mcg/ml | Prevention of postpartum hemorrhage due to uterine atony | 21.09.2020 |
| 28 | Netarsudil mesylate bulk and Netarsudil ophthalmic solution 0.02%w/v | For the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension | 14.10.2020 |
| 29 | Risdiplam powder for oral solution 60mg | For treatment of Spinal Muscular Atrophy (SMA) in patients 2 months of age and older | 16.10.2020 |
| 30 | FDC of Azelnidipine 8 mg and Telmisartan 40mg tablet | For the treatment of Stage-II hypertension | 16.10.2020 |
Why are Approved Drugs in India Important?
Firstly, drugs should be approved, and it is very important in India. It represents that the Medication has checked all the boxes and is safe for use. Approved drugs in india give the guarantee that the medicines are risk-free and effective for use by the Indian population. This procedure of drug approval in India helps to protect everyone’s health by reducing the risk factors that are associated with unregulated medication.
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How are Drugs Approved in India?
Drugs Approved in India is an organized system, and it is done under the Central Drug Standard Control Organization; this process involves these major things. All the points are mentioned below:-
- Application Submission – Medication enterprises put forward a comprehensive application that has thorough information about pre-clinical data and information on manufacturing.
- Review & Analysis – The CDSCO process leads to a complete review of the submitted data to assess the medicine’s safety, efficacy, and quality.
- Determination of Approval – The medicine should fulfill all the legal requirements; the Central Drug Standard Control Organization grants approvals, which will allow the drug to be marketed and sold in india.
How Long Does it Take to Approve Drugs In India?
Basically, it can take up to twelve to eighteen months to get drug approval in India.
Who Approved Drugs in India?
The Central Drug Standard Control Organization approves drugs in India.