New proposal says even if one drug is a substandard drug, manufacturer will have to pay for the entire batch
After having rolled out a landmark health insurance/assurance programme Ayushman Bharat, the government is readying to tighten drug regulation norms to crack down on substandard drugs.
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 10,00 to one lakh units in a batch, but the number of medicines in a batch varies depending on the size of the shipment. This stands both for tablets and syrups. 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, say highly placed health ministry officials.
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.
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, officials said.
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,” an 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.
