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List Of DCGI Approved Products In India

Jul 17, 2024

Central-Drugs-Standard-Control-Organization

What is DCGI approved?

India, being the largest democracy, has a vast list of ministries and departments that are controlled by the government. The Ministry of Health and Family Welfare, which is supposedly to look after the healthcare sector of the country, operates the Central Drugs Standard Control Organization (CDSCO). 

The head of CDSCO is DCGI, i.e., the Drugs Controller General of India, who is responsible for approving licenses for drugs, cosmetics, and other medicinal products in India. DCGI-approved products ensure high quality, total safety, and complete efficacy. The medicinal product gets approval from DCGI after thorough testing and vigorous quality checks. Once all the regulatory and quality standard requirements are met, the product is said to be safe for consumption and effective for treatment, and it even enjoys DCGI approval.

This DCGI-approved medical product confirms the safety and security of public health. Various pharmaceutical manufacturers in India have approval from the DCGI for the production of high-quality goods by all the latest regulatory standards in WHO GMP-approved manufacturing plants.

List of DCGI-Approved Products in India

The DCGI-approved products are present on the Central Drugs Standard Control Organization page. Some of the products are as follows: Aceclofenac – Usually for the treatment of adult patients. 

Paracetamol – Used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Diclofenac Sodium – For the symptomatic treatment of acute pain and inflammation in patients

Paracetamol + Tramadol Hydrochloride Tablets 

Diclofenac Sodium IP (as sustained release Pellets) + Thiocolchicoside (as sustained release pellets) Capsule. (New Dosage Form)

Thiocolchicoside + Ketoprofen tablets – A muscle relaxant drug 

Aceclofenac + Thiocolchicoside tablets – For the treatment of acute inflammation conditions associated with spasms in adults only.

Fluconazole + Secnidazole + Azithromycin – Used to treat different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases.

Ofloxacin + Ornidazole Infusion – For the treatment of Diarrhea of mixed infections.

Metoprolol succinate ER +Telmisartan – used in the management of hypertension

Metoprolol ER + Amlodipine tablets – Amlodipine is also used to treat high blood pressure (hypertension).

Rosuvastatin Calcium tablets 5/10/20/40 mg – As an adjunct to diet to reduce elevated total cholesterol (TC), LDL-C, non–HDL-C, apolipoprotein B (Apo B), and triglyceride (TG) levels

Pantoprazole Sodium (With Sodium bicarbonate as a buffer) 20mg/40mg tabletsGlimepiride – Pantoprazole is an Anti-ulcerative (Proton pump inhibitor).

Tranexamic Acid + Mefenamic acid tablet – For primary dysmenorrhoea and pain associated with menorrhagia in women.

Ferrous Ascorbate eq. to elemental iron + Folic acid IP + Methylcobalamin + Zinc Sulphate monohydrate IP eq to elemental Zinc Tablets – Usually for the treatment of iron deficiency anemia

Dried ferrous Sulphate + Ascorbic acid + Sodium Bicarbonate + Talcum – Ascorbic acid tablets occur naturally in foods such as citrus fruit, tomatoes, potatoes, and leafy vegetables.

Paracetamol + Phenylephrine Hydrochloride – For the treatment of fever associated with cold and nasal congestion in adults.

Fexofenadine + Montelukast – Montelukast is an antihistamine that is used to treat allergic rhinitis.

Torsemide + Amiloride tablets – Torsemide is a pyridine-sulfonyl urea type loop diuretic mainly used in the management of edema associated with congestive heart failure

Pirfenidone film-coated tablet – For the treatment of idiopathic pulmonary fibrosis (IPF).

Sildenafil Citrate Orally Disintegrating Strips 

Clopidogrel Tablet – Used to reduce the risk of heart disease and stroke in those at high risk.

Carvedilol Phosphate ER tablet 10/20/40/80mg – A beta blocker used for treating mild to severe congestive heart failure(CHF), left ventricular dysfunction (LVD) following heart attack in people

Itraconazole capsules – Antifungal

Artemether + Lumifantrine – Anti-malaria 

Spironolactone tablets – Diuretic

Naproxen CR tablets – NSAID

Metoprolol succinate ER tablets – Used Cardio selective beta-blocker

Etodolac caps/tabs – A muscle relaxant with anti-inflammatory and analgesic effects.

Ferrous Ascorbate eq. to elemental iron + Folic acid IP + Methylcobalamin + Zinc Sulphate monohydrate IP eq to elemental Zinc Tablets – Usually for the treatment of iron deficiency anemia.
Many more drug products are approved by DCGI as these contain ingredients that are termed completely safe by CDSCO. Numerous products are used for treating various other conditions and are produced in WHO GMP-approved manufacturing plants.

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How do you check if a drug is approved?

It is very important to check whether the drug is approved to ensure complete safety and reliability of the product you’re using.

  • Visit the CDSCO official website:

The CDSCO website is an official government website where Indians can easily find out the drugs that are approved for usage. The DCGI-approved products are available on this website. Go to this website and check for the name for which you want to see the approval status. The website maintains all the updated databases.

  • Access the Drug Database:

The website not only provides you with the latest approved drug products but also gives a detailed study of every drug’s therapeutic usage. You must access this database to find all the required regulatory information.

  • Check public notices:

The CDSCO website also publishes official notices and circulars regarding the new DCGI-approved products or the existing product updates. Reviewing these notices and circulars will assist you in checking whether any particular drug is approved or not.