Pharma firms hail decision to lift ban on FDC drugs

Ambika Sharma

Tribune News Service

Solan,December 2

The pharmaceutical manufacturers have welcomed the Delhi High Court’s decision to lift the ban imposed on the manufacturing of 344 fixed dose combination (FDCs) drugs.

Sanjay Guleria, chief advisor, Himachal Drug Manufacturers Association, said the decision brings respite to the small scale manufacturers who produced such drugs after permission from the regulatory authorities. Manufacturers have large stocks of such drugs. They wanted the stock to be utilised lest they incur losses worth Rs 1.5 crore to Rs one crore. There are about 650 pharmaceutical manufacturers in the state. A majority of them are small entrepreneurs.

The Ministry of Health and Family Welfare had imposed a ban on the plea they posed a risk to human health by causing antibiotic resistance.

The FDCs are produced by adding two or more active drugs in a fixed ratio. The state drug control administration had stopped giving approvals for such products after the Central Drug Standard Control Organisation directed the authorities not to approve such FDCs till their efficacy was scientifically proved. About 80 per cent of such products were approved by the state drug control administrations of Uttarakhand, Puducherry and Sikkim and barely 10 to 15 per cent of such products were manufactured in the state.

The banned FDCs include commonly used cough syrups like phensedyl and corex and others, which are not available in the market. Pharmaceutical firms such as Macleods, Mankind Pharma, USV, Proctor and Gamble, Abbott, were among the major firms in the state whose products — phensedyl, corex, panderm, vicks action 500, glimperide pyoglytazone and metphormim, — had been banned. Various cough syrups had been banned due to the presence of chlopheniramine maleate plus codiene as they were misused by drug addicts.