At a time when the Supreme Court is scrutinising the Centre’s notification banning 344 Fixed Dose Combination (FDC) drugs issued last year, the Government is moving ahead to prohibit the sale and manufacture of five more such FDCs, citing them as ‘irrational’ and ‘unsafe’ for consumption.
The Union Health Ministry is analysing more FDC drugs and may ban 100 more combination drugs in near future as their manufacturers have failed to submit details of clinical trials of such medicines.
FDC drugs are the combination of two salts into a single dose.
The five FDC drugs that are on the Government’s immediate ban list are Nimesulide+ levocetirizine (sold by the popular brand name Combipunch and Openos); Etodolac plus Paracetamol sold as Etogesic-P, Etornext-P, Alembic, Orthokind-P; Ofloxacin plus Ornidazole injection sold by the brand name Zenflox-Oz, Ornof, Normet; Ibuprofen plus Glucosamine and Gemifloxacin plus Ambroxol.
“All the combination drugs that have been banned are no more sold in developed countries because of various reasons, health safety being the major one. These have side effects too. We are hopeful of convincing the Supreme Court of our case. We have acted in public interest based on an expert committee which has found these combination drugs unsafe and have been banned in several other countries,” a senior official from the Ministry said.
The Ministry in January had moved the apex court challenging a Delhi High Court order that had revoked its notification banning over 344 FDC drugs in December last year.
The affected pharma manufacturers had challenged the notification claiming that marketing approvals for these combo drugs were granted after following all the procedures. The ban had estimated to effect around 6,000 medicine brands including the popular Corex, Phensedyl, Saridon, D’Cold Total and Vicks Action 500 Extra.
The Ministry has argued that its move aims to ensure elimination of unwanted and “unsafe” drugs. In its judgment, however, the court noted that the Government had failed to consult statutory authorities like the Drug Testing Advisory Board and the Drugs Consultative Committee for the ban.
The case is to come up for final hearing in SC in July.
