India tightens regulation of generic drugs

Pushing to improve the quality of generic drugs available on the Indian market, the Central Drugs Standard Control Organisation (CDSCO) plans to require manufacturers to submit to tests proving their products are biologically equivalent to the corresponding patented drug.

An implementation date for the new requirements has not been set, but officials say they are moving forward with the plan to mandate that generic manufacturers prove their product is similar to their branded competitor before their product can be offered for sale.

The initiative follows previous moves to improve the accessibility of affordable drugs to consumers in India. Generic drugs are widely produced in India, but have been scarcely regulated.