Pharma firms may soon be required to mention excipients on medicine strips

Central Drugs Standard Control Organization (CDSCO) is mulling mandating the mention of excipients on the strip of medicine for its safe use, reported Economic Times (ET) citing sources.

According to the report, CDSCO sources said that people popping medicines should be able to make informed decisions and hence it's important to make them aware of what they are consuming.

The report further added that as of now the labels on medicines only declare active substances, which are added to the formulation.

According to Freyer.com, a regulatory solutions and service provider in the life sciences industries, 'excipients' are defined as substances other than the Active Pharmaceutical Ingredients (APIs) used in the formulation of a drug product for long-term stabilization. 

The excipients play an important role in the formulation of a stable medicinal drug and its administration. While an excipient does not demonstrate any medicinal properties, it, however, facilitates the absorption of the drug.

While most of these excipients are considered inactive, some can have a known action or effect in some circumstances, the report said.

A technical body of experts' from the Drugs Consultative Committee (DCC) discussed the issue in its recent meeting last week and is yet to take a final decision, the report added.

ET citing a source said, "The DCC has been considering the proposal to incorporate provision for inclusion of details of excipient on every strip of medicines."

The report suggested that if the proposal is approved and comes into place, all marketing holders will need to identify excipients included in any and all human medicines that are authorised in the country as part of its product information.