Health activists have welcomed the withdrawal of approval the market of fixed dose combination (FDC) drugs that affect patient safety and undermine public health. These are FDCs that the Indian industry has developed to either circumvent price control and/or push their individual brands as better that their competitors, a statement issued by Leena Menghaney, a lawyer who has been working on access to medicines and public health since 2002.
“”Since the issuance of Gazette Notification, more than 20 pharmaceutical companies (including Pfizer, Abbott, Macleods) have approached the Delhi High Court to grant stay on the order. But the Indian judiciary should be cautious in its approach in granting interim injunctions. It could undo years of technical work that a number of expert committees did – despite the pressure from industry – to move the Central drugs Standard Control Organization (CDSCO) to a more scientific and evidence based approach to approving and regulating FDCs for the Indian market,”” she said in her Ã statement.
The legal resolution of the dispute over the Gazette notification that withdraws approval for a number of irrational FDCs should be based on technical evidence, which is now well highlighted in medical journal articles and expert committee reports and not on the objections of the pharmaceutical industry, she added.Ã
Fixed Dose Combinations (FDC) are particularly useful in the management of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), malaria and tuberculosis, which are considered to be the foremost infectious disease threats in the world today. They are part of WHO and national treatment guidelines playing a role in reducing pill burden, simplifying treatment in resource poor settings, improving adherence and reducing the cost of procurement. But this is not what the Indian Ministry of Health and FDA (Central Drugs Standard Control Organization (CDSCO) is seeking to remove from the Indian market through its gazette notification issued on 10th March 2016 Section 26A of the Drugs and Cosmetics Act, 1940. It is clear from the list of FDCs in the Gazette Notification that the CDSCO is taking action against those that compromise patient safety and public health, Ms Menghaney said.
Fixed Dose Medicines (pain and fever) that expose patients to increased risk of adverse reactions, for instance, formulations of nimesulide and paracetamol (increased hepatotoxic effects) which is basically combination of paracetamol with other analgesics.
Similarly, FDCs of quinolones and nitroimidazoles (Norfloxacin and metronidazole, ofloxacin and ornidazole) which have not been recommended in any standard treatment guidelines, but continue to be heavily prescribed drugs for many infections. This kind of indiscriminate use contributes to antimicrobial resistance or drug resistanceÃ – a global public health challenge. In fact, the antibiotic drug linezolid that is usually preserved for serious infections like MRSA and Drug Resistant TB by many countries is available as a FDC (Cefixime + Linezolid) in India. Linezolid has been called a “”reserve antibiotic”” – one that should be used sparingly so that it will remain effective as a drug of last resort.
The third category are FDCs containing the anti diabetic drug metformin. According to a prominent article in the LancetÃ (2015) given the constant monitoring and rapid adjustment of treatment regimens required to maintain adequate glycemic control, metformin FDCs are not recommended by international or national treatment guidelines for the management of type2Ã diabetes (T2DM). However, Ms Menghaney says patient and their families should not panic if they are using a particular FDC. The medicines are available as a single ingredient formulation (like metformin) and should approach their treatment provider on how to adjust their prescription.”