List of 2014 Approved Drugs in India

List of 2014 Approved Drugs In India

The drug ontroller genral of india (DCGI) provide 2014 approved drugs in india list with a wide range of pharmaceutical drugs. It ensure that th medication met the regulatory standards for sagfety, efficacy and quality for use in the country. Below you will find a comprehensive list that provide detailed information of these approved drugs of 2014, that helps in enabling infomed healthcare decisions.

How Drugs Are Approved in India?

When you explore the list of the 2014 approved drugs in india then you must be aware of how the drygs are approved as per the CDSCO government guidelines. The process follows a systematic procedure to ensure that pharmaceutical drugs meet the required safety and efficacy standards. The approval process typically involves:

  • Submission of Application: For the approval of manufacturing any drugs the pharmaceutical companies must submit a detailed application. The application must contains data on pre-clinical studies, clinical trials, manufacturing processes, and the drug’s intended use.
  • Review and Analysis: The CDSCO conducts a thorough review of the application to assess the safety, quality, and efficacy.  The analysis of the drug based on clinical trial results, pharmacological data, and manufacturing details.
  • Approval and Licensing: If the drug meets all legal requirements and passes the review process, CDSCO grants the approval. After this, the drug is licensed to be marketed and sold in India.
  • Post-Marketing Surveillance: Even after approval, the drugs undergo ongoing monitoring to ensure they continue to meet safety standards. This includes tracking adverse reactions and ensuring compliance with labeling and manufacturing guidelines.

Popular 2014 Drugs Approved in India – In Detail

Below you will find a comprehensive list of all the mentioned 2014 drugs approved in India. If you are drug manufacturer then explore the list before manufcaturing any of them:

  1. Tolterodine Tartrate Extended Release Tablets (2mg/4mg)
    • Indication: Treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency.
    • Approval Date: 31.01.14
  2. Bortezomib for Injection (3.5mg)
    • Indication: Used as an alternate to intravenous administration for the same indications (including multiple myeloma and mantle cell lymphoma).
    • Approval Date: 28.01.14
  3. Paclitaxel Injection (Nanodispersion 100mg/300mg)
    • Indication: Treatment of breast cancer after failure of combination therapy or relapse.
    • Approval Date: 22.01.14
  4. Heparin Sodium Topical Solution (1000 IU/ml)
    • Indication: For the management of post infusion superficial thrombophlebitis.
    • Approval Date: 16.01.14
  5. Simethicone Orally Disintegrating Strip (62.5mg)
    • Indication: Treatment for flatulence and as an adjuvant in hyperacidity.
    • Approval Date: 14.11.10 (Approval added in 2014)
  6. Eltrombopag Olamine (25/50mg Tablets)
    • Indication: Used for patients with chronic hepatitis C Virus (HCV) infection for the treatment of thrombocytopenia.
    • Approval Date: 07.04.14
  7. Decitabine Lyophilised Powder for Injection (50mg/20ml Vial)
    • Indication: For the treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukemia (AML).
    • Approval Date: 09.04.14
  8. Glycopyrronium Bromide Inhalation Powder (63mcg)
    • Indication: Maintenance bronchodilator treatment for Chronic Obstructive Pulmonary Disease (COPD).
    • Approval Date: 01.04.14
  9. Micafungin Sodium for Injection (100mg/vial)
    • Indication: Treatment of systemic fungal infections like candidemia, peritonitis, and aspergillosis.
    • Approval Date: 02.05.14
  10. Mometasone Furoate Nasal Spray (50mcg/actuation)
    • Indication: Treatment of nasal symptoms of seasonal allergic and perennial allergic rhinitis.
    • Approval Date: 21.05.14
  11. Apixaban Tablets (2.5mg/5mg)
    • Indication: Prevention of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF).
    • Approval Date: 16.05.14
  12. Micronised Purified Flavonoid (MPFF) 1000mg Tablets
    • Indication: For the treatment of acute hemorrhoid piles.
    • Approval Date: 28.11.13 (Approval added in 2014)
  13. Gemcitabine HCl Injection (Ready-to-Use Infusion Bags)
    • Indication: For ovarian cancer, breast cancer, and non-small cell lung cancer.
    • Approval Date: 17.06.14
  14. Tadalafil Orally Disintegrating Strip (10mg & 20mg)
    • Indication: For erectile dysfunction.
    • Approval Date: 30.07.14
  15. Hydroxychloroquine Sulphate (400mg Tablets)
    • Indication: As an adjunct to diet and exercise for type II diabetes.
    • Approval Date: 28.07.14
  16. Nevirapine Extended Release Tablets (400mg)
    • Indication: For the treatment of HIV-1 infection in adults.
    • Approval Date: 01.07.14
  17. Artesunate Injection (120mg)
    • Indication: Severe malaria, including cerebral malaria.
    • Approval Date: 13.11.14
  18. Cerebrolysin Solution for Injection (215.2mg)
    • Indication: For cranial injury, cerebrovascular diseases, and dementia.
    • Approval Date: 25.07.14
  19. Artesunate Powder for Injection (60mg/vial)
    • Indication: For severe falciparum malaria.
    • Approval Date: 02.07.14
  20. Montelukast Sodium Chewable Tablet (4mg/5mg)
    • Indication: For mild to moderate asthma and exercise-induced bronchoconstriction.
    • Approval Date: 26.02.02 (Approval added in 2014)
  21. Lactobacillus Brevis CD2 Lozenges (100mg)
    • Indication: Prevention of chemotherapy and radiotherapy-induced oral mucositis.
    • Approval Date: 09.08.14
  22. Rivaroxaban Tablets (15mg/20mg)
    • Indication: Treatment of deep vein thrombosis (DVT) and prevention of stroke.
    • Approval Date: 02.09.14
  23. Hydroxychloroquine Sulphate Tablets (300mg)
    • Indication: For rheumatoid arthritis, lupus, and polymorphic light eruption.
    • Approval Date: 09.08.14
  24. Ginkgo Biloba Extract Tablets (120mg)
    • Indication: For the treatment of dementia, vertigo, and tinnitus.
    • Approval Date: 09.12.14
  25. Bendamustine Hydrochloride Lyophilised Injection (25mg)
    • Indication: For chronic lymphocytic leukemia.
    • Approval Date: 19.09.14
  26. Metformin ER Tablet (750mg)
    • Indication: For the treatment of type II diabetes.
    • Approval Date: 25.09.14
  27. Sorafenib Tosylate Tablets (200mg)
    • Indication: For advanced or metastatic differentiated thyroid carcinoma.
    • Approval Date: 25.09.14
  28. Deferasirox Dispersible Tablets (100/400mg)
    • Indication: For chronic iron overload in thalassemia patients.
    • Approval Date: 26.09.14
  29. Imatinib Mesilate Tablets (100/400mg)
    • Indication: For pediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).
    • Approval Date: 09.09.14
  30. Tapentadol Extended Release Tablets (100/150/200mg)
    • Indication: For severe acute pain in hospital settings.
    • Approval Date: 09.12.14
  31. Olanzapine Pamoate Prolonged Release Powder for Suspension for IM Injection
    • Indication: For the treatment of schizophrenia.
    • Approval Date: 14.10.14
  32. Rivastigmine Transdermal Patch (15cm², 27mg)
    • Indication: For severe dementia in Alzheimer’s patients.
    • Approval Date: 28.10.14
  33. Dabigatran Etexilate Mesilate Hard Gelatin Capsules (75/110/150mg)
    • Indication: For treatment of acute DVT and pulmonary embolism, and prevention of recurrent DVT/PE.
    • Approval Date: 17.11.14
  34. Pegaspargase 3,750 IU/5mL
    • Indication: For the treatment of acute lymphoblastic leukemia in hypersensitive patients.
    • Approval Date: 07.03.14
  35. Tulobuterol Transdermal Patch (0.5mg/1.0mg/2.0mg)
    • Indication: For asthma and COPD treatment without co-morbidity.
    • Approval Date: 24.04.14
  36. Azacitidine (100mg/vial)
    • Indication: For the treatment of Myelodysplastic Syndrome.
    • Approval Date: 29.04.14
  37. Azacitidine
    • Indication: For the treatment of all subtypes of Myelodysplastic Syndrome.
    • Approval Date: 23.07.14
  38. Regorafenib Film Coated Tablets (40mg)
    • Indication: For metastatic colorectal cancer treatment.
    • Approval Date: 01.07.14
  39. Roflumilast Tablets (500mcg)
    • Indication: For severe COPD treatment.
    • Approval Date: 17.07.14
  40. Dimethyl Fumarate Delayed Release Capsules (120mg/240mg)
    • Indication: For relapsing-remitting multiple sclerosis.
    • Approval Date: 27.08.14
  41. Alogliptin Tablets (6.25mg/12.5mg/25mg)
    • Indication: For type 2 diabetes mellitus in combination with other antidiabetic agents.
    • Approval Date: 19.08.14
  42. Cilnidipine Tablets (5mg)
    • Indication: For hypertension.
    • Approval Date: 22.09.14
  43. Denosumab (60mg/ml)
    • Indication: For bone metastasis treatment in cancer patients.
    • Approval Date: 30.09.14
  44. Deferasirox (500mg/250mg)
    • Indication: Iron overload syndrome.
    • Approval Date: 25.08.14
  45. Darunavir (600mg/300mg)
    • Indication: HIV-1 infection treatment in combination with other anti-retroviral agents.
    • Approval Date: 22.08.14
  46. Bupropion Extended Release Tablets (150mg/300mg)
    • Indication: For depression and smoking cessation.
    • Approval Date: 29.10.14
  47. Bendamustine Hydrochloride (25mg/50mg)
    • Indication: For the treatment of non-Hodgkin lymphoma.
    • Approval Date: 30.09.14
  48. Levothyroxine Sodium Tablets (25mcg/50mcg/100mcg)
    • Indication: For hypothyroidism.
    • Approval Date: 10.10.14
  49. Olmesartan Medoxomil Tablets (5mg/20mg/40mg)
    • Indication: For hypertension treatment.
    • Approval Date: 15.09.14
  50. Sumatriptan Nasal Spray (20mg)
    • Indication: For the acute treatment of migraine headaches.
    • Approval Date: 13.10.14
  51. Ivabradine Tablets (5mg/7.5mg)
    • Indication: For heart failure and angina treatment.
    • Approval Date: 18.11.14

Why Is It Important to Know About Approved Drugs?

Understanding which drugs have been approved by the DCGI is essential for patients and healthcare professionals alike. Here’s why:

  • Safety and Effectiveness: Drugs approved by the DCGI have undergone rigorous testing and trials to ensure their safety and effectiveness. This assures patients that these medications are reliable and have passed various safety checks.
  • Awareness and Informed Choices: When patients are aware of the drugs available to them, they can make better decisions regarding their health. For example, knowledge of the latest treatments for conditions like cancer, diabetes, and heart disease can guide patients toward the most appropriate therapeutic options.
  • Availability of New Treatment Options: Drug approvals often introduce new treatment paradigms for diseases that previously had limited options. By knowing the approved drugs, patients can access the latest therapies.
  • Counteracting Fake or Substandard Drugs: By being aware of approved drugs and their indications, patients can also avoid the risks associated with fake or substandard medications that may be available in the market.

Conclusion

The process of 2014 drugs apprival in india ia a thorough and highly regulated procedure. This will ensure the patient safety and efficacy. The drugs approved in the year 2014 brings a significant adavancement in the treatment of several medical conditions, including cancer, heart disease, diabetes, and respiratory disorders. 

As the pharmaceutical industry continues to evolve, it is important for patients and healthcare professionals to stay informed about the latest drug approvals to make informed decisions about treatment options.

What Are The Different Categories Of Drugs Approved In India?

The types of drugs that approved in India are: Prescription Drugs, Over-the-Counter (OTC) Drugs, Controlled Drugs or Biologicals.

What Do The Indications Listed With Each Drug Mean?

The indication of a drug refers to the condition or disease it is intended to treat or manage. For example, a drug indicated for hypertension is used to treat high blood pressure.

What Is The Significance Of ‘approval Date’ In The List?

The apprved date in the list indicates that on which date the drugs is approved for the manufacturing/

Comments are closed

×