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GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 1096
TOBE ANSWERED ON24THJULY,2026
PRESCRIPTION OFGENERIC MEDICINESBYGOVERNMENT DOCTORS
†1096.SHRIDINESH CHANDRAYADAV:
SHRIKAUSHALENDRAKUMAR:
SHRIRAMPRITMANDAL:
SHRIGIRIDHARI YADAV:
Will the Minister of HEALTHANDFAMILYWELFAREbe pleasedtostate:
(a) whether the Government has issued any instructions to all Government doctors to
prescribe generic medicines asfar aspossible, if so, the detailsthereof;
(b) whether it is also true that most of the medicines being distributed and used in Central
Government Health Scheme (CGHS) and in Government hospitals in various States are
generic medicines;
(c)if so, the detailsof the arrangementsmade bythe Government toensure the quality, safety
and testing of generic medicines as per the prescribed standards keeping in view their large
scale supply anduse across the country; and
(d) the details of the provisions made and steps taken by the Government regarding quality
testing, inspection, sample testing, laboratory set up quality control mechanisms and
complianceof standards of generic medicines?
ANSWER
THE MINISTER OFHEALTH AND FAMILYWELFARE
(SHRIJAGATPRAKASH NADDA)
(a) & (b): The Directorate General of Health Services has instructed vide order dated
12.05.2023 that all doctors in Central Government hospitals, CGHS Wellness Centres and
polyclinics prescribe generic medicines. Further, Clause 1.5 of the Indian Medical Council
(Professional Conduct, Etiquette and Ethics) Regulations, 2002 provides that every physician
should prescribe drugs with generic names legibly and preferably incapital letters and he/she
shall ensure thatthere isa rationalprescription anduse of drug.(c) & (d): Further, Central Drugs Standard Control Organization (CDSCO) and Ministry of
Health and Family Welfare have taken following regulatory measures to ensure the import
andmanufactureof safe, efficacious andqualitymedicines across the country:
(i) The Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E) dated
28.12.2023 to revise the schedule M to the said rules related to Good Manufacturing
Practicesandrequirementsofpremises,plantandequipmentforpharmaceuticalproducts.
Revised ScheduleMhasbecome effectivefor the drug manufacturerswithturnover>Rs.
250 crores from 29.06.2024 and for manufacturers having turnover of less than Rs. 250
Cr from 01.01.2026.
(ii) The Drugs Rules, 1945 have been amended in year 2023 to mandate that manufacturers
of the top 300 drug formulation brands listed in Schedule H2 shall print or affix a Bar
Code or QR Code on the primarypackaging label, or on the secondary labelwhere space
is insufficient, to store data readable through software applications for authentication.
Similarly, the Rules have also been amended to require that everyActivePharmaceutical
Ingredient (bulk drug), whether manufactured or imported, shall bear a QR Code oneach
level of packaging containing data readable through software applications to facilitate
trackingandtracing.
(iii) An online portal, SUGAM labs is inplace since September 2023 for integrating the drug
testing labs of the CDSCO. It automates the entire workflow for testing of Medical
Products (Drugs, Vaccine, Cosmetics & Medical devices) to meet the quality
specificationandtracing the testing status inthe laboratories.
(iv) In February 2024, CDSCO published regulatory guidelines for the sampling of drugs,
cosmetics, and medical devices by Central and State Drugs Inspectors. These guidelines
provide a structured approach to ensure the quality and efficacy of products available in
the marketthrough uniform drug sampling methodology.
(v) In order to assess the regulatory compliance of drug manufacturing premises in the
country, the CDSCO along with State Drugs Controllers (SDCs) have conducted Risk-
Based Inspections of more than 1040 premises since December, 2022 and based on
findings, more than 950 actions like issuance of show cause notices, stop production
order, suspension, cancellation of licenses /product licenses, warning letters have been
takenby the StateLicensingAuthorities.
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