Expert Panel Recommends Permission For Manufacturing And Marketing Of A Few More Anti-Diabetic FDCs


New Delhi : The over $2 billion Indian diabetes market may see entry of a few fixed dose combinations (FDCs) in various strengths to be launched by various drug manufacturers in the near future, as a panel has recommended the drug regulator for their approval in due course.

The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission for manufacturing and marketing of anti-diabetes drug combinations by various manufacturers including Cipla Ltd, Synokem Pharmaceuticals and others in a recent meeting. Some of these recommendations are subject to certain conditions related to submission of further data.

Cipla’s application for Sitagliptin 50mg/50mg/100 + Metformin HCI (sustained release) 500mg/1000/1000mg tablets was considered by the SEC in a meeting held on February 18, 2022. The firm presented its proposal along with the Bioequivalence (BE) study report and justification for clinical trial waiver before the Committee.

The committee noted that the proposed FDC is approved in US And also FDC Sitagliptin 100mg/100mg+ Metformin HCl (SR) 500mg/1000 tablets and FDC of Sitagliptin ( as phosphate) 50mg + Metformin HCl. 500mg/1000mg immediate release tablets was already approved in the country

“After detailed deliberation, the committee recommended grant of permission for manufacture and marketing of the proposed FDC,” it said.

Synokem Pharmaceuticals’ application for approval of Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg/20mg + Pioglitazone Hydrochloride eq. to Pioglitazone 15mg/30mg film coated tablets was also considered, as the firm presented the proposal along with Phase III clinical trial report. The Committee recommended grant of permission for manufacture and marketing of the proposed FDC.

MSN Lab has presented their proposal for Empagliflozin 5mg/10mg/12.5mg/25 mg + Metformin 1000mg/1000mg/ 1000mg/1000mg, along with BE study report and justification for clinical waiver. The committee noted that the proposed FDC is approved in US and also the FDC of Empagliflozin 5mg/5mg/5mg/12.5mg/ 12.5mg/12.5mg + Metformin HCl 500mg/850mg/1000mg/500mg/850mg /1000mg tablets in immediate release form was already approved in the country.

While it has recommended for manufacturing and marketing permission, the Committee placed a condition that the firm should conduct Phase IV clinical trial and should submit the trial protocol to the CDSCO within three months of approval for further review by the committee.

Akums Drugs’ proposal for Metformin Hydrochloride (as sustained release) IP + Sitagliptin Phosphate monohydrate eq. to Sitagliptin IP (500mg + 50mg, 1000mg + 50mg & 1000mg + 100mg) tablets was submitted along with BE study report and justification for clinical waiver.

Again, the Committee observed that the formulation is approved in the US and also some of the related FDCs are already approved in the country. Similar to the approval to MSN Lab, the Committee recommended granting of manufacturing and marketing permission, with a condition that the firm should submit in-vitro dissolution data of the test products as against innovator’s FDC.

An application by Glenmark Pharmaceuticals for Remogliflozinetabonate 100mg/100mg+ Vildagliptin 50mg/50mg+Metformin Hydrochloride 500mg/1000mg tablets received permission to conduct the proposed Phase IV clinical trial, as the company submitted the revised clinical trial protocol for the same.

Exemed Pharmaceuticals requested permission to present the Phase III clinical trial data after completion of 16 weeks of study duration for the FDC Vildagliptin (as sustained release) 100mg/100mg+Dapagliflozin Propanediol eq. to Dapagliflozin 5mg/10mg tablets, for seeking manufacturing and marketing permission.

The Committee noted that similar treatment duration has been recommended for FDC of Dapagliflozin + Sitagliptin and FDC of Dapagliflozin + Teneligliptin tablets.

After detailed deliberation, the committee agreed to the request for presenting the results of Phase III clinical trial on completion of 16 weeks for further review, it added.

It may be noted that the anti-diabetes market has been seeing increasing competition with the patent expiry of drugs like Vildagliptin and Dapagliflozin in recent years. The approvals show that the competition in the segment is expected to further increase even as the diabetes market in the country is also growing, said experts.


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