See Full Document Text
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 4641
TOBE ANSWERED ON20TH MARCH, 2026
ILLEGALSALE AND DISPOSALOFEXPIREDMEDICINES
4641.SHRIJAI PRAKASH:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the Government has taken or proposes to take strict action to curb the illegal and
dangerouspracticeof reselling expiredmedicines,which involvesalteringexpirydates andre
- entering them into the supply chain after such illegal practice was brought to the fore, if so,
the detailsthereof;
(b) whether the Central Drugs Standard Control Organization (CDSCO) has issued new
guidelines on the safe disposal of expired/unused drugs to ensure that they are not diverted
backintothe market, if so, the detailsthereof; and
(c) whether the Government has launched "Drug Take-Bank" programmes, where consumers
can drop off expired medicine at designated locations and if so, the response of consumers in
thisregard?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT. ANUPRIYAPATEL)
(a): The manufacture, sale and distribution of drugs in the country is regulated under the
provisions of Drugs and Cosmetics Act, 1940 and Rules, 1945 thereunder through a system
of licensing and inspection. Licenses for manufacture, sale and distribution of drugs are
granted by the State Licensing Authorities (SLAs) appointed by respective State
Governments.
Licensee is required to comply with all the conditions of license. One of the
conditions of license states that no drug shall be sold or stocked by the licensee after the date
of expiration of potency recorded on its container, label or wrapper, or in violation of any
statement or direction recordedon such container,label or wrapper.
SLAs are legallyempowered andtake stringent actions against violation of provisions
of the Act andRulesincludingthe instancesof reselling the expiredmedicines.(b) & (c): Central Drugs Standard Control Organization (CDSCO) with the approval of
Drugs Technical Advisory Board (DTAB) has issued a guidance document on disposal of
expired/unused drugs, available on website of CDSCO (www.cdsco.gov.in).
The guidance providesinformationregarding variousmethodsfor disposal of expired/
unused medicines, procedure tobe followed for disposal of the expired/unused medicines by
Retailers, Wholesalers, Manufactures, Government/ PrivateHospitals, Government Agencies,
etc.anddisposal of expiredmedicine/unused medicineby generalpublic.
Further, CDSCO vide letter dated 26.05.2025 has also requested all the States/ UT
Drugs Controllers to encourage the concernedstakeholders in theirStates/ UTs toadopt these
guidelinesfor safe disposal of expired/ unused drugs.
*******