The approval of new drugs in the market plays a very crucial role in advanced healthcare. It ensures the availability of safe and effective healthcare treatment. So, keeping these benefits in mind the Drugs Controller General of India (DCGI) approved several drugs in 2018 for various medical health conditions.The list of the 2018 approved drugs includes infectious diseases, chronic ailments, and veterinary care drugs.
Below is a comprehensive list of the drugs approved in India in 2018, along with their indications and approval dates.
Comprehensive List of 2018 Approved Drugs
Here is the list of bulk 2018 approved drugs in India, read thoroughly to know the use of the pharmaceuticals and more.
| S.No | Name of drug | Indication | Date of issue |
| 1 | Tenofovir Alafenamide Hemifumarate Bulk Emtricitabine 200mg/200mg +Tenofovir Alafenamide 10/25 mg Tablets | Treatment of HIV-1 in adults and adolescents (12 years and older) | 10.01.2018 |
| 2 | Clofarabine Bulk & Injection 20 mg/20ml vial | Treatment of relapsed or refractory acute lymphoblastic leukemia in patients aged 1 to 21 years | 16.01.2018 |
| 3 | Drotaverine Hydrochloride Injection (Vet.) | Facilitates parturition in cattle; regulates labor contractions in dogs | 16.01.2018 |
| 4 | Netupitant 300 mg + Palonosetron 0.5 mg Capsule | Prevention of nausea and vomiting in cancer chemotherapy | 20.02.2018 |
| 5 | Fipronil 6.1 % m/v + Permethrin 54.5% m/V spot on solution for Dog (Vet.) | Treatment of flea and tick infestations in dogs | 20.02.2018 |
| 6 | Praziquantel 0.0065 g + Abamectin 0.00025 g tablets for cat (Vet) | Treatment of parasitic infestations in cats | 20.02.2018 |
| 7 | Cadexomer Iodine Bulk & Powder 100 % w/w (contain 0.9 % w/v Iodine) or cadexomer Iodine Ointment 500 mg (contains 0.9% w/v iodine) | Treatment of chronic wounds like ulcers and surgical wounds | 05.03.2018 |
| 8 | Dalfampridine Bulk & Film-coated extended release tablet 10 mg | For treatment to improve walking in patients with multiple Sclerosis (MS) | 12.03.2018 |
| 9 | Ulipristal Acetate 5 mg tablets | Treatment of uterine fibroids in adult women | 14.03.2018 |
| 11 | Riociguat bulk & 0.5mg/1.0mg/1.5mg/2.0mg/2.5 mg tablet | For the treatment of persistent/ recurrent chronic Thromboembolic pulmonary Hypertension (CTEPH) WHO Group 4) After surgical treatment for inoperable CTEPH to improve exercise capacity and WHO function | 16.04.2018 |
| 12 | Baricitinib 2mg/4mg film-coated Tablets | For the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modification anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate | 07.05.2018 |
| 13 | Vortioxetine Hydrobromide 5mg/10mg/15mg/20mg | for the treatment of major depressive disorder in adults | 14.05.2018 |
| 14 | Vardenafil Hydrochloride Trihydrate Bulk and 2.5mg/5mg/10 mg/20 mg tablets | Treatment of erectile dysfunction in adult men | 11.06.2018 |
| 15 | Trientine Hydrochloride Bulk and 250 mg capsule | 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. | 11.06.2018 |
| 16 | Gadoteridol injection | To visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients over 2 years of age, lesions in the head and neck in adults. | 25.06.2018 |
| 17 | Fipronil 50 mg/134 mg/268 mg/402mg spot on solution for cats and dogs | For treatment of flea and tick infestation in cats and dogs (for veterinary use only) | 25.06.2018 |
| 18 | FDC of Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg tablets | In combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with Human Immunodeficiency Virus type-1 (HIV-1) | 25.06.2018 |
| 19 | FDC of Azilsartan + chlorthalidone (40 mg + 12.5 mg) and Azilsartan + chlorthalidone (40 mg + 25 mg) tablet | For the treatment of mild to moderate hypertension in adults | 09.07.2018 |
| 20 | FDC of Ceftolozane (1.0 gm) and Tazobactam (0.5 gm) injection | Indicated for the treatment of patients 18 years or older with the following infections caused by designated susceptible microorganisms: • Complicated intra-abdominal infections (cIAI) caused by the following Gram Negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius in combination with metronidazole in ICU setting only. • Complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa in ICU setting only. | 06.08.2018 |
| 21 | Olaparib film coated tablets (100mg, 150 mg) | 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 deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Breast cancer: • In patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. | 13.08.2018 |
| 22 | Ceftazidime 2gm/Avibactam 0.5 gm powder for concentrate for solution for infusion | Complicated Intra-abdominal infections (cIAI) Complicated Urinary tract infections (cUTI), including pyelonephritis Hospital-acquired pneumonia (HAP) including ventilator associated pneumonia (VAP) with susceptible gram negative microorganisms | 01.10.2018 |
| 23 | Evogliptin Tartrate Bulk and Tablets 5 mg | For treatment of type-2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control, when used as a monotherapy or in combination with Metformin | 22.10.2018 |
| 24 | Lorcaserin Hydrochloride Bulk and 10 mg tablets | An adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at one weight related comorbid condition (e.g. Hypertension, dyslipidemia, type 2 diabetes) | 22.10.2018 |
| 25 | Fimasartan potassium trihydrate bulk drug and Fimasartan film coated tablets 30mg/60mg/120mg | For the treatment of mild hypertension | 22.11.2018 |
| 26 | Sacubitril/Valsartan (as sodium salt complex) and FDC of Sacubitril + Valsartan 50 (24+26)/100 (49+51)/200 (97+103) mg film coated tablets | To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction | 24.12.2018 |
What is the Significance of 2018 Approved Drug List in India?
The 2018 approved drugs list in India marks the approval and introduction of so many different medicinal products for distinct medical circumstances. These drugs endured detailed analysis and are safe and useful for their use.
What are the Types of Conditions These Drugs Treat?
The drugs mentioned in 2018 address a broad spectrum of conditions for example – HIV-1, Leukemia, Hypertension, Diabetes, Major Depressive Disorder, and different types of cancer, that also includes ovarian and breast cancer.
- Infectious Diseases: HIV-1 (Tenofovir Alafenamide Hemifumarate), bacterial infections (Ceftazidime/Avibactam)
- Chronic Ailments: Hypertension (Azilsartan + Chlorthalidone), Type 2 Diabetes (Evogliptin Tartrate), Rheumatoid Arthritis (Baricitinib)
- Cancer Treatments: Ovarian and Breast Cancer (Olaparib)
- Neurological Disorders: Multiple Sclerosis (Dalfampridine), Major Depressive Disorder (Vortioxetine)
- Veterinary Care: Treatment of flea, tick, and parasite infestations in cats and dogs (Fipronil, Praziquantel)
Can these Drugs Be Used for Veterinary Purposes?
It depends on the pharmaceuticals as some drugs listed in the 2018 approved drugs like, fipronil or praziquantel are used for veterinarian purposes, particularly for the infestation in pets and especially in dogs.
How Can I Stay Updated on Future Drug Approvals in India?
To stay informed about the latest drug approvals in India:
- Follow CDSCO (Central Drugs Standard Control Organization) updates.
- Subscribe to healthcare and pharmaceutical news portals.
- Regularly check DCGI notifications and official websites.
- Stay engaged with medical and scientific journals.
How were these Drugs Approved?
These drugs get approved by the Drugs Controller General of India in short DCGI, by following a rigorous administrative process, this also includes pharmaceutical trials to illustrate safety and efficiency.
How Can I Stay Updated on Future Drug Approvals in India?
By reading healthcare information and directly checking through the server you can stay updated on future drug approvals in India.
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