The continued presence of metoclopramide fixed dose combination in Indian market even after the office of the Drugs Controller General of India (DCGI) issued a ban on the drug two years ago, has been attributed to a stay order issued by Calcutta High Court.
Sources at the office of DCGI informed that though the fixed dose combination of metoclopramide and simethicone was banned vide gazette notification no GSR 603 (E) dated August 24, 2001, the company had managed to secure a stay on the ban, which enabled them to continue to market the product in the country, they said. The presence of the fixed dose combination namely Nausaifar-MPS from Organon India Ltd had been a subject of criticism very recently.
According to the latest issue of Monthly Index of Medical Specialties (MIMS), the drug regulatory system in the country has been put at fault for not banning the combination. The MIMS has pointed out that metoclopramide is not permitted to be combined with any other agent in any advanced country. However, the office of the DCGI has refuted this claim and said that the UK edition of MIMS itself carries list of metoclopramide combinations that has been approved for marketing in Britain. They feel that the combination is neither deadly nor new to be brought under strict ADR monitoring. The Nausaifar-MPS enjoys Rs 4 crore market in the country.
The MIMS is not confining itself on the combination. The report talks more about the need to have a check on the indiscriminate use of Metoclopramide, especially in children.
The drug, prescribed for nausea and vomiting in India, is a severely restricted category drug in many of the developed countries like USA, Britain and Australia, they say.
Pharmabiz has earlier reported the reported adverse effects of the drug in young children.
According to C M Gulhati, editor MIMS, the advanced countries have restricted the use of the drug as an anti-emetic in patients below 20 years that too during cancer therapy.
In India Indoco Remedies Ltd is the market leader in metocontin formulations. The company’s Perinorm enjoys 50% of the total market share of the drug. Metocontin from Modi Mundi Pharma Ltd and Reglan from CFL Pharmaceuticals Ltd are the other brands available in the market. Among these drugs, Reglan is sold without any prescribing information, says Dr Gulhati.