Last week the Supreme Court gave its verdict on a case involving fixed dose combination medicines paving the way for greater transparency in the approvals of these medicines.
A key part of the Supreme Court’s order was that it clears the air on whether the government can order a drug off the market shelf if it is found to be unsafe, without having the issue first examined by the Drugs Technical Advisory Board (DTAB).
The government can indeed take a product off the market if there are reports that it has been banned in other countries or there are reports within the country that the product was unsafe, the Supreme Court said putting a lid on much heart-burn in the pharmaceutical industry that had stressed on the need for DTAB’s evaluation before an FDC was banned.
A fixed dose combination (FDC) medicine involves more than one ingredient bundled into a product, and the market place has seen sometimes five to seven drugs being combined into a single product. And concerns over whether FDCs were a product of scientific rationale or commercial greed have been festering in the country for over a decade.
In an attempt to address the issue, the Centre had the Kokate committee look into it and finally banned 344 FDCs last year. This, however, went through several legal twists and turns finally landing up at the Supreme Court.
But last week’s order in a sense looks to put a lid on industry complaints once and for all as the Supreme Court sent the 344-plus drugs banned by the government back to the DTAB or a technical sub-committee to clear inconsistencies that may be there. Some drug companies had complained that their products had been banned despite getting approvals from the central authority, the Drug Controller General of India (DCGI).
The Court further indicated that the technical committee re-evaluating the issue needed to listen to all stakeholders including the All India Drug Action Network. While some health advocacy representatives felt that the order to relook at the banned list of drugs would give drug companies a foot in the door to keep unscientific FDCs, others felt the order gave the government a large broom to sweep the market clean of irrational FDCs.
S Srinivasan, AIDAN co-convenor, told BusinessLine that the approval process on FDCs is clear with approval required from the DCGI on a new product and this is received only after safety and efficacy tests are done.
Only after this is cleared can a company get a manufacturing licence from State authorities, he said, adding that in the past this process had been bypassed.
While focussed on the 344-odd FDCs, the Supreme Court’s 54-page order in fact powers the way to clear out the domestic market of irrational FDCs, says Srinivasan.
The 344 drugs account for about 2 per cent of the FDC market, he said adding that about half the domestic pharmaceutical market or ₹50,000 crore worth of FDCs exist in the market place. And at least half the FDC segment are irrational, he said indicating that it was still a long road ahead before these too are taken out of local chemist stores.