India holds off on combination drug ban

Pharmaceutical lawyers in India have secured a momentary respite from a pending ban on combination drug products, though the proposal will come before a judge again early next week.

Somsak Sudthangtum

Lawyers and executives from both national and international drugmakers packed the Delhi High Court earlier this week when the court restrained the Indian government from enforcing a planned block on the manufacture and sale of around 344 fixed-dose combination medications. Combination drugs are developed and sold worldwide to assist patient compliance by making it easier to take multiple medicines regularly in a single dosage. However, Indian health regulators have moved to ban combination drugs, arguing that there is no medical justification for administering them. Inconsistent enforcement of pharmaceutical regulations and India has led to the market being flooded by medicines approved by state authorities but not the national centralised government.

The local arms of global pharma giants Abbott Laboratories and Pfizer have come out swinging together with local makers like Cipla and Macleods Pharmaceuticals in an attempt to have the ban thrown out. According to Prabhudas Lilladhar research analyst Surajit Pal, a ban on combination medicines is likely to deliver a heavy blow to the local revenue of drugmakers operating in India. 'Most Indian companies are dependent on combination drugs because they drive sales,' he commented, adding however that 'around 60-70 per cent of combination drugs in the industry do not hold any logic' medically and are produced for 'purely commercial purposes.'

'Commercial interests are not larger than public health,' said government lawyer Sanjay Jain in support of the ban. With a temporary block on the new regulation now in place, the ban is set to come before the court again on 28 March.  

Sources: Asian Legal Business; Quartz India

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