GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
DEPARTMENT OF HEALTH AND FAMILY WELFARE
RAJYA SABHA
UNSTARRED QUESTION NO.266
TO BE ANSWERED ON 04TH FEBRUARY, 2025
BLUE STRIP FOR ANTIMICROBIAL DRUGS
266: SHRI S NIRANJAN REDDY:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether it is fact that the Drug Consultative Committee of the Central Drugs Standard
Control Organization (CDSCO) recommended changing the color of antimicrobial drug strips to blue to warn consumers;
(b) Government position on the proposal to change the color of antimicrobial drug strips to blue under the Drugs and Cosmetics Act and Rules, 1945, as part of efforts to combat antimicrobial resistance (AMR); and
(c) the additional measures being taken by the Ministry to monitor and regulate antibiotic prescriptions, especially for over-the-counter sales, to prevent misuse and address AMR?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE
(SMT. ANUPRIYAPATEL)

(a) to (c): The Drugs Consultative Committee (DCC) under Section 7 of the Drugs and Cosmetics Act, 1940 is the advisory committee to advise the Central Government, the State Government and the Drugs Technical Advisory Board (DTAB) on any matter tending to secure uniformity throughout India in the administration of the said Act. The DTAB, a statutory body under the Drugs and Cosmetics Act, 1940, has deliberated the addition of Blue strip/ Box for providing Antimicrobial Resistance (AMR) warning on the label of the antimicrobial drugs. Central Drugs Standard Control Organization (CDSCO) and Ministry have taken various regulatory measures to monitor and regulate antibiotic prescriptions, especially for over-the-counter sales, to prevent misuse and address AMR issues:

(i) Antibiotics are included in Schedule H and H1 of the Drugs Rules, 1945. These drugs have specific caution labeling requirements and are sold only under the prescription of a Registered Medical Practitioner. The supply of a drug specified in Schedule H1 is recorded in a separate register at the time of the supply and such records are maintained for three years and are open for inspection.

(ii) Various Notices/ Advisories/ Letters have been issued to the State Drugs Regulators,
and other stakeholders for strict compliance of the requirements and raising awareness in the public regarding adverse effects of misuse of antibiotics.

(iii) Government has issued National Treatment guidelines for judicious use of antibiotics. The Guidelines on Infection Prevention and Control aims at prevention and control of healthcare associated infections to reduce the use of antibiotics inhealthcare settings.

(iv) The Food Safety and Standards Authority of India (FSSAI) has issued a Notification prohibiting the use of 19 antibiotics and veterinary drugs at any stage of processing of meat, meat products, poultry and eggs, sea food or any variety of fish and fishery products and has specified tolerance limits for 103 antibiotics and veterinary drugs for various animal tissues and milk.
(v) Rule 97 of Drugs and Cosmetics Rules, 1945 have been amended making it
mandatory that the container of a medicine for treatment of food producing animals shall be labelled with the withdrawal period of the drug for the species on which it is intended to be used.
(vi) Colistin and its formulations have been prohibited w.e.f. 19.07.2019 to manufacture, sell and distribution for food producing animals, poultry, aqua farming and animalfeed supplements.
(vii) MoHFW launched Red Line awareness campaign on Antimicrobials Resistance, urging people not to use medicines marked with a red vertical line, including antibiotics, without a doctor’s prescription.
(viii) Indian Council of Medical Research (ICMR) has released treatment guidelines for antimicrobial use in common syndromes which contain guidelines for use of antibiotics for viral bronchitis and low-grade fever.