New Delhi: At least 60.3 percent fixed-dose combination (FDC) drugs consumed for mental health disorders in India are unapproved and potentially putting the public at risk because their safety and efficacy have not been evaluated, revealed a latest study published in Journal of Pharmaceutical Policy and Practice.
The revelation comes at a time when India’s drug regulator, CDSCO, has recently prohibited 156 FDCs vide Gazette Notification no 3285 (E) to 3440 (E). Major FDC drugs in the prohibited list include a combination of Mefenamic Acid and Paracetamol Injection, which is used to reduce pain and swelling in various conditions, and a combination dose of Omeprazole Magnesium and Dicyclomine HCl, which is used to treat abdominal pain.
Prominent brands with Omeprazole Magnesium and Dicyclomine HCl combination include Mankind Pharma’s Ranispas and Xenspas from Zoic Life Sciences. The Journal of Pharmaceutical Policy and Practice’s analysis has said that FDCs contain two or more drugs in a single pharmaceutical form, such as a capsule. “Many FDCs available in India lack approval from the central regulator, the Central Drug Standards Control Organisation (CDSCO), meaning that their safety and efficacy have never been evaluated.
A detailed analysis of India’s drugs regulations found that central approval has been required for new drugs since 1961. While CDSCO has overall responsibility for assessing the safety and efficacy of drugs, state regulators have significant responsibilities, including issuing manufacturing licences to pharmaceutical companies.
“In some cases, these licences have been issued for FDCs that lack central approval. There have been concerns about the sale of such unapproved FDCs since the 1970s,” the journal said. It said that there are no explicit recommendations regarding use of FDCs in publicly available Indian clinical guidelines for treating psychiatric disorders and no such FDCs in the national list of essential medicines.
The study has revealed that there was a proliferation in the market for psychotropic FDCs in India, between 2008 and 2020. It said that the numbers of FDCs and formulations were 17.9 percent and 41.6 percent higher in 2020 than in 2008, respectively. Sales of psychotropic FDCs accounted for an increasing proportion of overall psychotropic drug sales (20.1 percent in 2020 vs 18.4 percent in 2008). This was driven mainly by growth in the market for antidepressant and benzodiazepine/sedative FDCs.
“Unapproved FDCs continued to account for over half of psychotropic FDC sales in 2020,” the study revealed. The use of unapproved or banned psychotropic FDCs could potentially cause significant harm to patients, from both adverse effects and lack of efficacy. When this correspondent contacted CDSCO over the issue, nobody was available for comments.
“Many FDCs contain combinations of psychotropic drugs. Psychotropic polypharmacy may lead to significant adverse effects such as liver injury and falls. Most of the FDCs contained benzodiazepines or related sedatives, which are associated with misuse and addiction. Some FDCs contained thioridazine, which was withdrawn worldwide in 2005 due to the risk of severe cardiac arrhythmias,” the study said.
It further said that some of the FDCs contained combinations of antipsychotics that are not evidence-based. “These risks are compounded by an under-resourced pharmacovigilance system, meaning that there is minimal opportunity to identify harms arising from the use of such FDCs,” it said.
