The medicines that could be banned are antibiotics Orflaz, Nuforce 3 kit and Vaginobact, and hypertension drugs Telipril H and Ramtel H.
New Delhi: The government is planning to ban over 80 more fixed-dose combination (FDC) drugs in its ongoing crackdown against “irrational” medications, ThePrint has learnt.
A notification to enforce the ban is likely by next month.
If implemented, this will take the total number of banned FDCs to 405, with 325 others banned just this September. The latter, however, remain available on account of the legal challenge mounted by affected pharma firms.
A fixed-dose combination contains two or more drugs combined in a fixed ratio of doses, available as a single dose.
“We are ready with a new list of FDCs, which will prohibit the manufacture, sale, and distribution of those medicines,” said a senior official from the Ministry of Health and Family Welfare.
According to the draft ban notification, viewed by ThePrint, the 80 drugs include products by several multinationals such as Abbott, Mankind Pharma, Sun Pharma, Cipla, Torrent, and Aristo Pharmaceuticals.
The medicines likely to be banned include antibiotics Orflaz, Nuforce 3 kit and Vaginobact, and hypertension drugs Telipril H and Ramtel H.
‘Ready with new list’
The government order, based on the recommendation of the drugs technical advisory board (DTAB, an expert panel of the government), stems from a bid to end the manufacture of FDCs that have been found to offer no additional therapeutic advantage, and are feared to bolster resistance.
“The Supreme Court had asked us to prohibit the sales of these (FDCs) drugs after it accepted a report submitted by DTAB that proved these combinations are irrational,” the official added.
The 80 FDCs were among the 294 banned by the government in 2007. However, pharma firms had, at the time, secured a stay on the order from the Madras High Court. When the matter reached the Supreme Court, it was handed over to the DTAB for analysis.
The DTAB first took up the issue at a meeting on 16 January 2008. Over the nine years since, the board discussed the efficacy of the drugs, before submitting its recommendations to the court.
Last year, on 15 December, the apex court accepted the recommendations and directed the government to follow the panel’s suggestions on the 294 drug combinations.
A final decision on the list remains pending.
Ban & legal challenge
The September ban by the Health Ministry was on 328 FDCs, of which the Supreme Court excluded three, including Saridon.
At that time, activists had termed the move “a bold decision” aimed at prioritising public health and patient safety over the interests of the pharmaceutical industry.
Many manufacturers have challenged the ban on the remaining 325 FDCs, owing to which they remain on shelves.
“Every time the government announces a ban, manufacturers drag the decision to the court,” said S. Srinivasan, co-convener of the All-India Drug Action Network (AIDAN), a network of NGOs that has been at the forefront of efforts to ban FDCs.
“The government must involve the Ministry of Law and bring out an ordinance that only allows the court to check if the due procedure was followed while announcing the ban,” he said. “The court has no role to check the scientific basis [of the ban].”
Pharma companies have championed FDCs as cheaper and more convenient alternatives.
Their therapeutic value has long been questioned, and experts fear the combination of multiple drugs from the same therapeutic group may lead to resistance.
However, lax regulatory structures have allowed these drugs to be prescribed to patients.