Parliament Question: Storage and Distribution Standards for Drugs

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 4776 TOBE ANSWERED ON20TH MARCH, 2026 STORAGE AND DISTRIBUTIONSTANDARDS FORDRUGS 4776.SHRIAZAD KIRTI JHA: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) the existing legal and regulatory provisions to ensure the quality and integrity of drugs aftermanufacture,including during transit andstorage at wholesale andretail premises; (b) whether the Government hasassessed gapsinthe current regulatoryframework relatingto mandatory cold-chain facilities, humidity control and other storage conditions for different categories of drugs, particularly in view of India’s climatic and humidity variations and if so, the detailsthereofalong with the reasons for not updatingthe regulationsso far; (c) whether the Government proposes to undertake reforms in line with the standards of the World Health Organization and if so, the details of the existing provisions governing such storage conditions along with the prescribed qualifications for persons operating wholesale andretailpharmacies; (d) whether the existing qualifications and regulatory provisions are considered adequate as per modern practices and if so, the details thereof and if not, the reasons therefor along with the measures takenor proposed tobe taken bythe Government tostrengthen them; (e) whether the Central Drugs Standard Control Organisation (CDSCO) has issued any guidelines on distribution practices for drugs and if so, the current legal and implementation status thereof; and (f) whether the Government proposes to provide statutory backing to such guidelines and if so, the detailsthereofalong with the reasons for anydelayindoingso? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT. ANUPRIYAPATEL) (a)to(f): The legal andregulatory provisions relatedto sale of drugs are provided under the Drugs Rules, 1945.The premises inrespect of which the sale licenceistobe grantedshallbe adequate, equipped with proper storage accommodation for preserving the properties of the drugs asperthe requirements. As per Rule 64 and Rule 65 of Drug Rules, 1945 and conditions of license issued for wholesale/retail sale of drugs states that no drug shall be sold unless purchased under cash or creditmemofrom a duly licenseddealeror dulylicensedmanufacturer, enablingtraceability. Further, guidelines have been issued by Ministry of Health and Family welfare regarding storage, temperature monitoring and handling of vaccines during transit across all the rural aswell asurbanareas. CDSCO has issued guidelines on “Recall and Rapid Alert System for Drugs” (including Biologicals & Vaccines). Further, draft Guidelines on Good Distribution Practices for Pharmaceutical Products is also published for ensuring quality of Drugs in the supply chain.These guidelinesare availableonwebsite of CDSCO (www.cdsco.gov.in). Further, a proposal for affixing bar code or quick response code on other drug formulation products was deliberated in the 90th Drugs Technical Advisory Board (DTAB) meeting held on 25.01.2024. The Board has agreed to the proposal to extend the provision of QR code toall vaccineproducts andtoall antimicrobials, narcotic & psychotropic substances ina phase wise manner. *******