Exemption from warning label need for marketing dried Ivy leaf extract cough syrup: CDSCO Panel

New Delhi: Analyzing the details of the concentration of saponin in the drug major USV’s Dried lvy Leaf Extract Cough Syrup, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the exemption from the “WARNING” label requirement for the marketing of approved drug ” Dried lvy Leaf Extract Cough Syrup” for treatment of cough and sore throat.

This came after the firm presented patient safety data, details of the concentration of saponin in the product, and the details of countries in which the product is marketed, package insert, and regulatory status before the committee.

Ivy leaf dry extract belongs to the class of herbal medications used to treat sore throats, coughs, and phlegm in adults and children over two years of age. Ivy leaf dry extract is an expectorant containing dry ivy leaf extract.It acts as a mucolytic agent that works by thinning and loosening phlegm or mucus in the lungs, windpipe, and nasal passage, thereby helping to cough out easily. It also soothes the airways. Since it is sugar-free cough syrup, it is suitable for people with diabetes.

Ivy leaf is the leaf of the common ivy plant, also known as English ivy or Hedera helix. Ivy leaf has been found to contain compounds including saponins which, through the nervous system, stimulate cells in the lungs to remove excess mucous. Ivy leaves have also been shown to liquefy thick, sticky mucous in the respiratory tract. Clinical studies have efficiently shown that after 7 to 10 days of using ivy leaf extract, symptoms like cough and expectoration are improved in a large majority of patients.

Earlier, at the 60th SEC meeting for pulmonary, drug-maker USV had submitted a proposal to switch Dried Ivy Leaf Extract Cough Syrup from a prescription to a non-prescription drug.

However, during the presentation, the committee noted that the product contains saponins and that the product is marketed in other countries.

At the earlier meeting, the expert panel had directed the firm to submit details of the concentration of saponins in the product and also the details of countries in which the product is marketed along with the package insert and regulatory status.

At the recent SEC meeting for pulmonary held on June 7, 2022, the expert panel reviewed the patient safety data, details of the concentration of saponin in the product, and the details of countries in which the product is marketed, package insert, and regulatory status presented by the drug major, USV .

After detailed deliberation, the committee recommended exemption from the “WARNING” label requirement for marketing of the approved drug “Dried Ivy Leaf Extract Cough Syrup.”

Further, the committee opined that opinions of phytopharmaceutical experts may be obtained.

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