As many as 328 fixed-dose combinations prohibited in Himachal Pradesh for human use

Shimla, September 17: As many as 328 fixed-dose combinations (FDCs) were banned in Himachal Pradesh for human use under section 26A of Drugs and Cosmetics Act, 1940.

 

The decision was taken by Chief Minister Jai Ram Thakur-led government on recommendations of Drugs Technical Advisory Board (DTAB) as there was no therapeutic justification for the ingredients contained in these 328 FDCs or and these FDCs could involve risk to a human being.

The notification has been circulated to the Himachal Pradesh Drug Manufacturing Associations, Himachal Pradesh Society of Chemists and Druggists and all the Drugs Controllers and the Drugs Inspectors in the state.

Additional Chief Secretary, Health and Family Welfare B.K. Agarwal on Sunday said that Himachal Government has prohibited 328 fixed-dose combinations (FDCs) for manufacture for sale, sale or distribution for human use with immediate effect in Himachal Pradesh under section 26A of Drugs and Cosmetics Act, 1940.

He further added that the Government of India has also restricted manufacturing, sale or distribution of the drug fixed-dose combinations from 7 September 2018. B.K. Agarwal said that product permissions granted to manufacturers and its loan licensees to manufacture fixed dose combinations of 328 also stands prohibited.

He said that manufacture for sale, sale or distribution of fixed-dose combinations henceforth would attract section 28B of Drugs and Cosmetics Act. He further noted that these formulations must be withdrawn from the market immediately. The action would be taken as per the provisions of the Act against the persons not adhering to these orders.