NEW DELHI: As India witnesses an increased incidence of communicable and non-communicable diseases every year, the drug industry is also pooling in drugs but without getting necessary approval from the government.
A recent research survey carried out by William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Global Health, Policy and Innovation Unit, Queen Mary University of London along with Foundation for Research in Community Health, India published in PLOS ONE journal on Tuesday has revealed that many common drugs flood the Indian market without approval of the Central Drugs Standard Control Organisation (CDSCO).
Data were obtained from PharmaTrac, a commercial database comprising monthly audits of pharmaceutical product sales through multiple supply routes (5,000 pharmaceutical companies, 18,000 distributers and stockists besides 32,000 sub-stockists) to over 5,00,000 retailers, hospitals, and dispensing doctors in 23 regions of India.
The researchers investigated CDSCO approvals for and availability of oral Fixed Dose Combination (FDC) drugs in four therapeutic areas: analgesia (non-steroidal antiinflammatory drugs (NSAIDs), diabetes (metformin), depression/anxiety (anti-depressants/ benzodiazepines), and psychosis (antipsychotics).
“For NSAID FDCs, 124 formulations were marketed, of which 34 (27 per cent) were centrally approved and 90 (73 per cent)were unapproved; for metformin 25 formulations, 20 (80 per cent) approved, five (20 per cent) unapproved; antidepressants/ benzodiazepines: 16 formulations, three (19 per cent) approved, 13 (81 per cent) unapproved; anti-psychotics: 10 formulations, three (30 per cent) approved, seven (70 per cent) unapproved," Abhay Kadam from the Foundation for Research in Community Health said.
Patients who are prescribed different tablets to treat a single condition or multiple coexisting conditions find it hard to take drugs correctly. For some conditions, clinicians can improve medication compliance by prescribing a FDC product — a drug formulation containing two or more active drugs combined in a fixed ratio of doses that are usually available only in a single dosage form.
FDCs, sometimes called “polypills," are useful in situations where both the drug combination and the doses needed to treat patients are standardised and stable, such as in the management of HIV/AIDS. FDCs can also be cheaper to manufacture and easier to distribute, but they have some disadvantages. For example, the risks of adverse effects can be compounded by including multiple drugs from the same therapeutic group in a single FDC.
So, many countries regulate their development and marketing. “FDC formulations gave rise to multiple branded products, ranging from 211 anti-psychotic FDC creations from 10 formulations to 2,739 NSAID FDC outcomes from 124 formulations.
The proportions of FDC sales volumes arising from unapproved formulations were antidepressants/ benzodiazepines 69 per cent; anti-psychotics 43 per cent; NSAIDs 28 per cent; and metformin 0.4 per cent. Formulations, including drugs banned/restricted internationally, comprised over 12 per cent of NSAID FDC sales and 53 per cent of anti-psychotic FDC sales," Kadam said.
Reproduced From Mail Today. Copyright 2015. MTNPL. All rights reserved.