Even if a single drug in a batch is found substandard the manufacturer may have to pay a penalty equal to the MRP of the entire batch shipped, according to a new government proposal. There are usually 1,000 to one lakh units in a batch, but the number of drugs - which can be in the form of tablets or liquid - in a batch vary depending on the size of the shipment, a Health Ministry official said.
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, he said.
The new provision, proposed by the Central Drugs Standard Control Organisation (CDSCO) for addition in the existing Drug and Cosmetics Act, will apply even if the packaging is faulty, the official added.
The proposal has been approved by India's highest drug advisory body the Drugs Technical Advisory Board (DTAB) and is pending for approval by the Union health minister.
"Even if one tablet in a batch fails in any of the 45 tests identified under the Drug and Cosmetic Rules Act and is thus declared substandard, then instead of initiating legal action and taking him to the court, the proposal is to penalise the accused financially and make the manufacturer pay an amount equal to the MRP of the particular batch," the official said.
The provision will apply if the drug is found substandard or broken or if the bottle containing the drug in liquid form is damaged or leaking. Once approved, the provision will be a part of the Drug and Cosmetics Act. Under the existing system, if a drug is found substandard, the drug inspector can initiate legal action against the manufacturer.