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GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2292
TOBE ANSWERED ON 31ST JULY,2026
PRESCRIPTIONFOR MEDICINALSYRUPS
2292.SHRISUDAMAPRASAD:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the Government has assessed the impact of the prescription only requirement for
medicinal syrups on patient residing of rural, tribal and remote areas where access to
registered medical practitionersislimited,if so, the detailsthereof; and
(b) whether any monitoring mechanism has been established by the Government to prevent
the illegal sale of syrup-based medicines without a prescription in the country and if so, the
detailsthereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT. ANUPRIYAPATEL)
(a)& (b): As per the Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945, all drugs
including cough syrups covered under Schedule X, H and/or H1 are required to be sold by
retail on the prescription of a Registered Medical Practitioner (RMP) only. Further, Schedule
K to the said Rules provided an exemption for sale of cough syrups in villages with a
population not exceeding 1,000 persons and where no dealerwas licensedunder the said Act.
However, the Government vide notification G.S.R 477 (E) dated 09.06.2026, has amended
the Drugs Rules, 1945, withdrawing the said exemption to enhance regulatory control and
promote safe use of coughsyrup inthe interest of patientsafety.
However, drugs supplied by Multipurpose workers attached to Primary Health
Centres/Sub-Centres, Community Health Volunteers under the Rural Health Scheme, Nurses
Auxiliary Nurses, Midwives and Lady Health Visitors attached to Urban Family Welfare
Centres/Primary Health Centres/Sub-Centres, Anganwadi Workers and Community Health
Officers at Ayushman Bharat Healthand WellnessCentres are permitted under ScheduleK to
dispense prescribed drugs without a sale license.State Licensing Authorities carryout periodic inspections or as per risk-based
approach from time to time of the licensed premises for verification of compliance with the
provisions of the Act and rules thereunder. Actions such as suspension and cancellation of
licences, prosecutions in the court of law are taken against the erring firms by the State
LicensingAuthorities.
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