The Centre’s ongoing efforts to remove ‘irrational’ combination drugs from the market has reignited the discussion on science versus commerce.
While some companies are seeking time to recall existing inventory, others like Emcure have taken a legal recourse to get a stay on one of their FDCs, an industry-insider confirmed.
Earlier this month, the Health Ministry had banned the sale of 156 fixed-dose combination (FDC) drugs, saying they were harmful for human consumption. FDCs are a combination of two more medicines in a single pill / product.
Medicines across segments including multi-vitamins, antibiotics, fever and painkillers, to mention a few, feature on the list and industry representatives said, the impact is dispersed and across companies including Sun Pharma, Cipla, Zydus, Torrent Pharma, Emcure and so on. As the pharma industry is mapping the impact of the move, businessline reached out to these companies for their response, which is awaited. Meanwhile, an industry source said, the size of the impact may be small for companies like Torrent and Sun Pharma.
FDCs elicit varied responses from the industry, with some arguing in favour of the convenience of a single pill combining multiple drugs, while others point to its ‘unstable’ nature and the inability for a doctor to change dosages.
Time sought
Harish K Jain, President with the Federation of Pharma Entrepreneurs said they have asked the Centre for time to allow doctors to put their patients on alternatives, and the inventory be recalled. Further, he said, they have asked members to restrict themselves to FDCs approved by the Central authority, as required by the law.
The latest move comes as part of the Centre’s efforts to remove FDCs, including sweeping measures in 2016 when 300-plus drugs were banned, and another 14-odd medicines removed in 2023, after reviews by multiple expert committees.
Unsafe formulations
Dr Sanjit Singh Lamba, former head of Eisai, India explained, FDCs sometimes contain unapproved drugs, with studies showing a high percentage of unsafe formulations, in therapeutic areas like analgesics and psychotropics. “The lack of rigorous regulatory oversight and sub-optimal enforcement have led to the marketing of combinations without adequate clinical data on safety and efficacy,” he added.
“On face of it, however, the FDCs look irrational. But the expert committee has to give a clear reason why the said FDC has no therapeutic justification,” observed S Srinivasan of Locost, that produces inexpensive medicine, and the All India Drug Action Network.