No therapeutic justification: Central Government bans 14 FDCs for human use

This came in line with the inquiry carried out by the Central Government to confirm whether the fixed-dose combinations licensed prior to 1988 should be the subject matter of a notification under Section 26A of the Drugs and Cosmetics Act, of 1940.

Following the directions set forth by the Hon. Supreme Court of India in its judgment, the matter was examined by an Expert Committee established by the Government of India, which submitted its report to the Central Government on April 1, 2022, regarding the specified FDCs, and the Drugs Technical Advisory Board, established under Section 5 of the Drugs and Cosmetics Act, 1940 (23 of 1940), approved the Expert Committee's report.

The Expert Committee advised the following in relation to the specified FDCs:

"There is no therapeutic justification for this FDC, and the FDC may involve a risk to human beings. Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale, or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act, 1940. "In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under Section 26A is recommended";

Consequently, the Central Government, in the exercise of the powers conferred by Section 26 A of the Drugs and Cosmetics Act, 1940 (23 of 1940), prohibited the manufacture for sale, sale, and distribution for human use of 14 specific fixed-dose combinations (FDCs).

In continuation, on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in the public interest to regulate by way of prohibition the manufacture for sale, sale, and distribution for human use of the said drug in the country.

Therefore, in supersession of the notification of the Government of India, the Ministry of Health and Family Welfare (Department of Health and Family Welfare) published in the Gazette of India; on the basis of the recommendations of the said Expert Committee and the Drugs Technical Advisory Board; and in the exercise of powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government prohibits the manufacture for sale, sale, or distribution for human use of 14 specific fixed-dose combinations (FDCs) with immediate effect.

The prohibited FDCs include the following:

i. Fixed-dose combination of Nimesulide plus Paracetamol dispersible tablets,

ii. Fixed-dose combination of Amoxicillin plus Bromhexine,

iii. Fixed-dose combination of Pholcodine plus Promethazine,

iv. Fixed-dose combination of Chlorpheniramine maleate plus Dextromethorphan plus Guaiphenesin plus Ammonium Chloride plus Menthol,

v. Fixed dose combination of Chlorpheniramine Maleate plus Codeine Syrup,

vi. Fixed dose combination of Ammomium Chloride plus Bromhexine plus Dextromethorphan,

vii. Fixed dose combination of Bromhexine plus Dextromethorphan plus Ammonium Chloride plus Menthol,

viii. Fixed dose combination of Dextromethorphan plus Chlorpheniramine plus Guaiphenesin plus Ammonium Chloride,

ix. Fixed dose combination of Paracetamol plus Bromhexine plus Phenylephrine plus Chlorpheniramine plus Guaiphenesin,

x. Fixed dose combination of Salbutamol plus Bromhexine,

xi. Fixed dose combination of Chlorpheniramine plus Codeine Phosphate plus Menthol Syrup,

xii. Fixed dose combination of Phenytoin plus Phenobarbitone sodium,

xiii. Fixed dose combination of Ammonium Chloride plus Sodium Citrate plus Chlorpheniramine Maleate plus Menthol (100mg + 40mg + 2.5mg + 0.9mg) , (125mg + 55mg + 4mg + 1mg) , (110mg + 46mg + 3mg + 0.9mg) & (130mg + 55mg + 3mg + 0.5mg) per 5ml syrup,

xiv. Fixed dose combination of Salbutamol plus Hydroxyethyltheophylline (Etofylline) plus Bromhexine.