The Central Drugs Standard Control Organisation (CDSCO) has approved a proposal to impose a fine equal to the price of the entire batch on the manufacturer even if one drug in the batch is found to be substandard.
The proposal was approved by the Drug Technical Advisory Body and is awaiting clearance by the health ministry.
There are usually 10,000 to one lakh units in a batch but the number of drugs – tablets or liquid – in a batch varies as per the size of the shipment.
According to the new provision, the manufacturer will be liable to pay an amount equal to the MRP of the entire shipment as penalty if any unit is found substandard or damaged.
The provision, in addition in the existing Drugs and Cosmetics Act, will apply even if the packaging is faulty, the official said.