Metformin Hydrochloride

New Delhi: The Fixed Dose Combination (FDC) of popular anti-diabetes medicine Metformin Hydrochloride and Voglibose is set to be excluded from the list of unapproved FDCs notified by the CDSCO in April this year. In a statement before the Delhi High Court over a petition challenging the classification of the combination as an unapproved drug, the Drugs Controller General of India ( DCGI ) has formally stated to exclude the above combination from the notified list. In April this year, the apex drug regulator issued a list of 35 unapproved fixed dose combinations (FDCs) and directed state regulatory authorities to prohibit their manufacture, sale, and distribution, citing concerns over “ patient safety .” However, Mumbai-based Macleods Pharmaceuticals challenged the directive and sought the exclusion of ‘Metformin Hydrochloride IP (As Prolonged-Release) 500mg & Voglibose IP 0.2mg Tablet’ from the notified list. During the earlier proceedings the counsel for the petitioner (Macleods) stated that it is “completely erroneous and appears to be a result of oversight / clerical error.” Macleods Pharma markets one such drug under the brand name Voglimac MF’ and during the proceedings the drugmaker highlighted that “it has been manufacturing and marketing the said formulation since 2016 under valid licences.” Giving its response on the arguments at the most recent hearing, the regulator informed the single judge bench presided over by Justice Sachin Datta, that the concerned FDC shall stand “excluded from the list of unapproved FDCs.” “It is stated by learned counsel for the respondents (DCGI) on instructions that the concerned FDC of Metformin Hydrochloride IP (As Prolonged-Release) 500mg & Voglibose IP 0.2mg Tablet, shall stand excluded from the list of unapproved FDCs,” the court order stated. In its order Justice Datta pronounced that the grievance of the petitioner stands “redressed and taking on record the aforesaid statement, the court has disposed of the petition. Metformin Hydrochloride and Voglibose is a widely prescribed oral FDC formulation indicated for the treatment of Type-2 diabetes. The drug helps to reduce glucose production in the liver, improve insulin sensitivity (metformin function) and slow down the digestion and absorption of carbohydrates in the intestines to prevent post-meal sugar spikes (voglibose function). Metformin is also widely used in fixed-dose combinations with other notable antidiabetic agents such as empagliflozin, dapagliflozin, and several others, to enhance glycemic control through complementary mechanisms. Notably, besides the above-mentioned FDC, the list issued by the regulator also includes three other anti-diabetes combinations that have metformin as an active ingredient. According to PharmaTrack data, of India’s total ₹21,000 crore anti-diabetic (OAD) therapy market, OAD combos account for nearly 60 per cent of the total market. The monthly sales tracker suggests that in June this year, OAD combos recorded total sales of ₹1079 crore, where metformin combos accounted for over 21 per cent of the total share with a MTH value of ₹230 crore. By Online Bureau ,