A Drugs Technical Advisory Board (DTAB) sub-committee reviewing the ban on 349 fixed dose combination (FDC) drugs has completed hearings of petitioners and appellants and is expected to submit its final report within a week. The panel had given stakeholders time till June 22 to make submissions on these cocktail medications that were termed ‘irrational’ by an expert committee.
All India Drug Action Network (Aidan), which had made its presentation to the sub-committee, voiced optimism about the outcome of its petition. “The panel members have given us a patient hearing and listened to our concerns. We are optimistic that the ban on these FDCs will stay. The committee would make that decision for the greater common good,” S Srinivasan, co-convener of Aidan, told Pharmabiz.
The health ministry banned these FDCs – drugs containing two or more active pharmaceutical ingredients in a fixed dosage ratio – after a committee headed by Prof CK Kokate declared them unsafe. Drug makers challenged the ban in high courts across the country. In January this year, the ministry moved the apex court challenging a Delhi high court order that quashed the ban. The DTAB panel was constituted in accordance with the top court’s order to re-examine the issue. Aidan, a consortium of non-profits in the health sector, had also filed a petition in the top court against the Delhi high court order.
The DTAB panel is headed by Dr Nilima Kshirsagar, the chair in clinical pharmacology at ICMR Mumbai. The committee was given three months to finalise the report, but the deadline was later extended.
“The FDCs in question account for only about 5 per cent of the value of total combination drugs in India. We expect the government to make the right decision in the interest of patient safety,” Srinivasan, who attended the panel hearing, added.
Abbott Health Care, in its representation, requested the panel to exclude 15 FDCs approved prior to 1988 and 17 products that were approved by the Drug Controller General of India from the list of drugs under the purview of the panel. “However, the DTAB members deliberated the issue and were of the view that the sub-committee shall submit the report of all 344 plus 5 FDCs again as per the directions from the Supreme Court,” the minutes of the May 16 meeting showed.
According to an industry source, drug manufacturers know that the review panel would most likely uphold the ban on most of the 349 FDCs and have already started changing drug combinations. “The ban on irrational drug combinations and the subsequent legal wrangle helped put the whole issue in perspective and prompted drug companies to change tack. Numerous studies have shown that these companies blend drugs recklessly and place public health in jeopardy,” the source pointed out.
A recent study report in the British Journal of Clinical Pharmacology has revealed some alarming facts about the FDCs available in the Indian market. Of the 118 FDC antibiotic formulations sold between 2007 and 2012, around 64 per cent were not approved by the Central Drugs Standard Control Organisation. Only 4 per cent of these FDCs were cleared in the US or Britain.