You are here: Home » Economy & Policy » News
Business Standard

Govt's new proposal: Pay fine for full batch if one drug found substandard

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

Press Trust of India  |  New Delhi 

Govt's new proposal: Manufacturer to pay penalty for entire batch if single drug found substandard

Even if a single drug in a is found substandard the manufacturer may have to pay a penalty equal to the MRP of the entire shipped, according to a new government proposal.

There are usually 10,00 to 100,000 units in a batch, but the number of - which can be in the form of tablets or liquid - in a vary depending on the size of the shipment, a 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 Standard Control Organisation (CDSCO) for addition in the existing Drug and Cosmetics Act, will apply even if the packaging is faulty, the added.

The proposal has been approved by India's highest drug advisory body the Technical Advisory Board (DTAB) and is pending for approval by the

"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 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 can initiate legal action against the manufacturer.

First Published: Sun, January 27 2019. 11:40 IST
RECOMMENDED FOR YOU