FDA asks DCGI to initiate measures to make paracetamol syrup 125 mg available in Maharashtra

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The Maharashtra Food and Drug Administration (FDA) has asked the union health ministry to initiate immediate measures to make paracetamol syrup 125 mg available in the market across Maharashtra as the manufacturers have stopped manufacturing it as it has impacted their profitability due to it being regulated under the new DPCO.

According to sources, the Maharashtra FDA has asked both the Drug Controller General of India (DCGI) and the national drug price controller National Pharmaceutical Pricing Authority (NPPA) to immediately intervene in the matter as the state is facing severe shortage of Paracetamol syrup 125 mg.

As per the Maharashtra FDA’s findings, it has been given to understand that Paracetamol Oral Suspension 125 mg which falls under the non-controlled category in the current pricing regime is abundantly available in the market across the state. While, on the contrary, paracetamol syrup is not available as manufacturers have stopped manufacturing it as it has impacted their profitability due to it being regulated under the new pricing regime or DPCO.

Moreover, it has been found that manufacturers are selling paracetamol oral suspension 120 mg and paracetamol oral suspension 125 mg at different prices claiming that it does not fall under the new Drug Price Control Order (DPCO). Whereas paracetamol syrup 125 mg in 60 ml volume is sold at Rs.20.79 as per the DPCO, paracetamol oral suspension has been injudiciously priced between 127 per cent and 157.5 per cent more by some manufacturers.  It is learnt that the manufacturers have tried to offset the losses due to sales on medicines in controlled category by raking in profits on the non-controlled category through overpricing.

The FDA has urged the NPPA to bring a uniform pricing policy so that essential medicines which fall under the National List of Essential Medicines (NLEM) could be brought under the controlled category for making it affordable and accessible.

  Source: PharmaBiz

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