The decision follows a proposal by the CDSCO, top internal advisory body-the Drugs Consultative Committee (DCC), which at its 67th meeting last month had also recommended to delete the provided exemptions for the category.
New Delhi: With rising safety concerns over syrup formulations, the Union Health Ministry is looking to revoke exemptions for the category and ‘remove’ it from the OTC drug list.
In a notification dated December 29, the ministry stated “Syrup” will be omitted from the “Class of Drugs” under the Schedule K, of the Drugs Rules, 1945.
The decision comes months after the deaths of at least 24 children in Madhya Pradesh, who consumed an DEG adulterated brand: Corlif cough syrup, and the death of a child in Rajasthan who was officially stated to have consumed an ‘unprescribed’ Dextromethorphan Hydrobromide syrup formulation.
Speaking to ETPharma a senior drug regulator said that, Syrups have been a matter of scrutiny and the recent cases (Madhya Pradesh and Rajasthan) are the “possible trigger for this decision.”
Moreover, the decision follows a proposal by the Central Drugs Standard Control Organisation (CDSCO) the top internal advisory body-the Drugs Consultative Committee (DCC), which at its 67th meeting last month had also recommended to delete the provided exemptions for the category.
According to the committee minutes of meet, “DCC was apprised about the recent incidences due to contaminated cough syrup” and it proposed that the exemption provided under Entry no.13 of Schedule K of Drugs Rules, 1945 in respect of syrups for cough may be deleted.”
The decision is currently in draft form and open for stakeholder comments for 30 days from the date of its publication.
Schedule K drugs are medicines which are exempted from the Chapter IV of the Drugs and Cosmetics Acts,—regulations for manufacturing and distribution-and are allowed to be sold over-the-counter (OTC).
The list includes common household medicines like antiseptics, anatacids, contraceptives, which can be dispensed by non-pharmacist as well.
However, with respect to cough syrups experts often caution against their unmonitored OTC warning that s it may pose health risks to children as several formulations in the category is not intended for pediatric population.
“Moving syrups from the OTC list will help to curtail the potential misuse or abuse of syrups as there will not be any syrup dispensed in the absence of valid prescription,” the regulator quoted above said.
Safety and quality of cough syrups has been a long concern in India, and past incidents of child deaths in countries like Uzbekistan and Cameroon, linked to Indian-made products, have also triggered international scrutiny.
Source : Economictimes
