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List Of DCGI-Approved Products In India

List Of DCGI-Approved Products In India - India's pharmaceutical industry is the largest industry globally, serves primarily the health needs of Indians, but now exports to almost 200 countries worldwide. As the sector grows it becomes even more important for credible and trusted regulation of drugs. The Drugs Controller General of India (DCGI) is the authority that regulates the vast and different sectors of the pharmacy profession through the Central Drugs Standard Control Organisation (CDSCO). If anyone is taking a medicine, vaccine, or medical device intended for use within India, it must first meet the safety, efficacy and quality assessments of the DCGI. The DCGI approval assures doctors, pharmacists, and patients that the respective product meets the structural scientific standards and is therefore safe to therapeutically use.

DCGI approved products has great respect. The meaning of such an approval is that it separates legitimate, researched products from unsafe or unverified products. The DCGI has approved thousands of products across varied health categories. Given the complexities and lengths in the drug treatment processes, healthcare professionals and businesses, as well as patients, should know what is meant by DCGI-approved products, so safe treatment can be promoted and to help protect against counterfeit or drug combinations. Below is more information on the list of DCGI-Approved Products in India that are avaliable for the use and treatment.

Understanding the “DCGI Approved”

DCGI stand for Drug Control Controller General of India. Under the Ministry of Health and Family wellfare the DCGI heads the Central Drugs Standards Control Organisation. The setting of standards and Granting of approvals for the various categories of drugs, vaccines, or pharmaceutical product are done by these regulatory body. The DCGI are responsible for the quality, safety and efficacy of the products that are yet to be introduced in the market 

The CDSCO operates in India through specialized division such as New Drugs, FDC (Fixed Dose Combinations), Biologics, Medical Devices & Diagnostics, Import & Registration, among others.

Scope of DCGI Approvals

The  DCGI approves the drug in three different categories these are based on the nature, uses and manufacturing of the drug , below is more information on it. 

New Drugs

The New Drugs Division of CDSCO provides an official list of newly approved drugs that is updated once a year. This list gives you the most up to date look at the new therapies medicine that are approved by DCGI and are available in the market.

Fixed Dose Combinations (FDCs)

The FDC/New Drug Marketing Division approves the various FDCs. these medicinal combination are very commonly found in the Indian market, but require additional jumping through hoops and hurdles because of the potential risks with indiscriminate combinations.

Other Categories: Biologics, Vaccines, Medical Devices

DCGI approval applies to biologics, special biological products, vaccines and blood components/products and medical devices each of these products usually have their own specific approval tracks which appears to be avoided in descriptions and are through CDSCO lists, portals, communications and notifications.

Best DCGI Approved products | Biophar Life Sciences 

Biophar life Sciences is one of the most trusted and reputed company that delivers DCGI approved products in the market. Biophar has a very large product portfolio and is preferred by most of the doctors and healthcare facilities. Biophar Life Sciences operates under ISO 9001:2015 certification and adheres to GMP–WHO standards to ensure the highest level of quality assurance.

Following are the list of exclusive products that are manufactured by Biophar are are DCGI approved : 

SNO

BRAND

FORM

COMPOSITION

PACKING

1

Feboxit-40

TABLET

Febuxostat 40 mg

10*10 Alu Alu

2

Dapawalk-GM 10/1/500

TABLET

Dapagliflozin 10 mg + Glimpride 1 mg + Metformin 500 mg ER

10*10 Alu Alu

3

Dapawalk-GM 10/2/500

TABLET

Dapagliflozin 10 mg + Glimpride 2 mg + Metformin 500 mg ER

10*10 Alu Alu

4

Dydrolist 10

TABLET

Dydrogesterone 10 mg

10110 Blister

5

Dydrolist 20 SR

TABLET

Dydrogesterone 20 mg SR

10*10 Alu Alu

6

Duoraft Plus

TABLET

Sodium Alginate 250 mg, Sodium Bicarbonate 106.5 mg & Calcium Carbonate 187.5 mg (Chewable Tablet)

10*9 Blister

7

Ranolist

TABLET

Ranolazine Sr 500 mg

10*10 Alu Alu

8

Bilguard M

TABLET

Bilastine 20 mg + Montelukast 10 mg

10*10 Alu Alu

9

Vildalist DP 100/10

TABLET

Vildagliptin 100 mg SR + Dapagliflozin 10 mg

10*10 Alu Alu

10

Ivabase-5

TABLET

Ivabradine 5 mg

10*10 Blister

11

Sitawalk-D 100/10

TABLET

Dapagliflozin 10 mg + Sitagliptin 100 mg

10*10 Alu Alu

12

Apixaref 5

TABLET

Apixaban 5 mg

10*10 Alu Alu

13

Proninto

TABLET

Ticagrelor 90 mg

10114 Blister

14

Dapawalk M 1000

TABLET

Dapagliflozin 10 mg + Metformin 1000 mg

10*10 Alu Alu

15

Subaitra SB 130

TABLET

Itraconazole SB 130 mg

10*10 Alu Alu

16

Toflist

OINTMENT

Tofacitinib 2% w/w

15 gm

17

Dexfar BL

SYRUP

Bilastine 3.3 mg + Dextromethorphan Hydrobromide 10 mg + Phenylephrine 5 mg

100 ml

18

Youphar

TABLET

Iron 30 mg + Zinc 10 mg + Folic Acid 1.5 mg + Vitamin B12 15 mcg

10*15 Alu Alu

19

Dapawalk-10

TABLET

Dapagliflozin 10 mg

10*10 Alu Alu

20

Vildalist-DM-1000

TABLET

Vildagliptin 100 mg + Dapagliflozin 10 mg + Metformin 1000 mg

10*10 Alu Alu

21

Vildalist-DM-500

TABLET

Vildagliptin 100 mg + Dapagliflozin 10 mg + Metformin 500 mg

10*10 Alu Alu

22

Vildalist-DP-100/10

TABLET

Vildagliptin 100 mg SR + Dapagliflozin 10 mg

10*10 Alu Alu

23

Sitawalk-50/1000

TABLET

Sitagliptin 50 mg + Metformin 1000 mg

10115 Blister

24

Sitawalk-50/500

TABLET

Sitagliptin 50 mg + Metformin 500 mg

10115 Blister

25

Sitawalk-M 100/500 PR

TABLET

Sitagliptin 100 mg + Metformin 500 mg

10*10 Alu Alu

26

Sitawalk-D 100/10

TABLET

Dapagliflozin 10 mg + Sitagliptin 100 mg

10*10 Alu Alu

27

Sitawalk-DM-1000

TABLET

Dapagliflozin 10 mg + Metformin 1000 mg + Sitagliptin 100 mg

10*10 Alu Alu

28

Sitawalk-DM-500

TABLET

Dapagliflozin 10 mg + Metformin 500 mg + Sitagliptin 100 mg

10*10 Alu Alu

29

Sitawalk-100

TABLET

Sitagliptin 100 mg

1017 Blister

30

Sitawalk-50

TABLET

Sitagliptin 50 mg

1017 Blister

31

Rawheal

GEL

50 gm

32

Vildalist-P

TABLET

Vildagliptin 50 mg + Pioglitazone 15 mg

10*10 Alu Alu

33

Mepride-PG1

TABLET

Glimepiride 1 mg + Metformin HCl 500 mg SR + Pioglitazone 15 mg

10*10 Alu Alu

34

Mepride-PG2

TABLET

Glimepiride 2 mg + Metformin HCl 500 mg SR + Pioglitazone 15 mg

10*10 Alu Alu

35

Mypride-M1

TABLET

Glimepiride 1 mg + Metformin HCl 500 mg SR

10*10 Blister

36

Mypride-M2

TABLET

Glimepiride 2 mg + Metformin HCl 500 mg SR

10*10 Blister

37

Mypride-M1-1000

TABLET

Glimepiride 1 mg + Metformin HCl 1000 mg

10*10 Blister

38

Mypride-M2-1000

TABLET

Glimepiride 2 mg + Metformin HCl 1000 mg

10*10 Blister

39

Emprace-10

TABLET

Empagliflozin 10 mg

10*10 Blister

40

Emprace-25

TABLET

Empagliflozin 25 mg

10*10 Blister

Conclusion

THe DCGI Approval is a very regulating way of approving the products thye classification of the drugs in to various categories helps the public to understand the nature of the medicine and protect the health of the patient. This blog of List Of DCGI-Approved Products In India contains all the information and the list of DCGI approved product manufatcured by Biophar Life Science that are available in the market.. DCGI is a very important and crucial if your business is related to healthcare products. It ensure that the product is safe for use and help in gaining trust of market and customers.