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.
Additional Chief Secretary, Health and Family Welfare B.K. Agarwal said the decision has been made based on the 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 human being.
He said that the Government of India has also restricted manufacturing, sale or distribution of the drug fixed dose combinations from 7 September, 2018.
Product permissions granted to manufacturers and its loan licensees to manufacture fixed dose combinations of 328 also stands prohibited, Agrawal further stated.
He said that manufacture for sale, sale or distribution of fixed dose combinations hence forth would attract section 28B of Drugs and Cosmetics Act. He said that these formulations must be withdrawn from the market immediately.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.
Agarwal said that the notification has been circulated to the Himachal Pradesh Drug Manufacturing Associations, HP Society of Chemists and Druggists and all the Drugs Controllers and the Drugs Inspectors in the state.