In what could be the Maggi moment for the pharma majors, the Delhi High Court will today hear cases filed by various pharmaceutical companies against a ban imposed by the central government on 344 drug combinations. Popular drugs D'Cold, Vicks Action 500 Extra, Benadryl are among 6,000-odd brands or 344 drug combination formulas which were impacted by the government move.
The Health Ministry notification of March 10 had banned these drugs, citing health reasons. The government decided to prohibit manufacturing, sale and distribution of fixed drug combinations, saying that these drugs have "no therapeutic justification" and are likely to "involve risk to human beings".
Last week, leading pharma companies including Glenmark, Pfizer, Abbott India, Macleods, Reckitt Benckiser, Piramal Enterprises, Alembic Pharma and Procter and Gamble (P&G) had moved the Delhi High Court against the government order. About 50 companies have moved the court so far.
The full impact of the ban would be Rs 3,800 crore a year on the Indian pharmaceutical industry. The government had constituted a panel under Professor Chandrakant Kokate to review the fixed combination drugs. The panel, which had examined 5,518 drug combinations, had recommended in January 2015 that 963 drug combinations are irrational.
The government's argument is that there is not much data available on drug-drug interaction and side-effects in fixed dose combination (FDC) drugs. And at the same time most of these drugs are sold without proper approvals and this may also lead to weakening of the immune system. The government says that most developed countries do not allow these drugs in their market. Though the ban on fixed combination drugs was welcomed by the doctors, the pharmaceutical companies have been up in arms.
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