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GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
RAJYASABHA
UNSTARREDQUESTION NO. 2028
TOBE ANSWERED ON10TH MARCH, 2026
TESTING AND SURVEILLANCEOFDRUGS BYCDSCO
2028. SHRIASHOKRAO SHANKARRAO CHAVAN:
DR. MEDHAVISHRAM KULKARNI:
SHRIBRIJ LAL:
SHRINARAYANAKORAGAPPA:
SMT.KIRAN CHOUDHRY:
SHRIUJJWALDEORAO NIKAM:
SHRIBABURAM NISHAD:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the details of testing carried out by the Central Drugs Standard Control Organisation
(CDSCO) during the last five years, State/UT-wise;
(b) the numberof samples declared sub-standard, misbranded or adulterated,and;
(c)the enforcementaction initiatedagainst the respective manufacturersor distributors;
(d) whether any special enforcement or monitoring drives have beenundertaken todetect and
curbthe circulation of counterfeithealthandnutritionalproducts;
(e)if so, the detailsthereof andif not,the reasons therefor; and
(f) the steps taken or proposed to be taken by the Ministry to augment drug testing
infrastructure andenhance laboratorycapacityacross the country, State/UT-wise?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)to(c): The manufacture, sale and distribution of drugs are regulated in the country
under the provisions of Drugs & Cosmetics Act, 1940 and Rulesthereunder through a system
of licensing andinspection.As perinformation received from variousStates/Union Territories Drugs Controllers (SDCs),
number of drug samples reported Not of Standard Quality/spurious/adulterated by the
States/UTs Drugs Controller during the last five yearsisasfollows:
FinancialYear No.ofdrugssamples No.ofdrugs No.ofdrugssamples
tested samplesdeclared declaredSpurious/
NotofStandard Adulterated
Quality
2020-21 84,874 2,652 263
2021-22 88,844 2,545 379
2022-23 96,713 3,053 424
2023-24 1,06,150 2,988 282
2024-25 1,16,323 3,104 245
(d) & (e): As a part of quality monitoring and in order to assess the regulatory
compliance of drug manufacturing premises in the country, the Central Drugs Standard
Control Organization (CDSCO), in collaboration with state regulators, initiated risk-based
inspections of drug manufacturing and testing firms in December 2022. Firms have been
identified based on risk criteria like number of drugs declared as not of standard quality,
complaints, criticality of the products etc. As of now, CDSCO along with SDCs have
conducted risk-based inspections of more than960 premises since December, 2022andbased
onfindings, more than860 actionslike issuance of show cause notices, stop productionorder,
suspension, cancellation of licenses /product licenses, warning letters have been taken by the
States/UTs asperthe provisions of the Drugs Rules1945.
Also, more than 1100 cough syrup manufacturers and 380 blood centres have been
subjected to intense audit in coordination with State authorities. Increased market
surveillance sampling of syrup formulations by Central and State drugs regulators has also
beendone.
Further, Food Safety Standard Authority of India (FSSAI) and its regional offices
through the State/UT Food Safety Departments, carry out regular surveillance, monitoring,
inspections, and random sampling of food to ensure compliance with the quality & safety
standards established under the Food Safety and Standards Act (FSS), 2006, and the Rules
andRegulationsmade thereunder.
(f): To strengthen the drug testing infrastructure and enhance laboratory capacity across
the country, Ministry of Health and Family Welfare has implemented a Centrally Sponsored
Scheme 'Strengthening of States’ Drug Regulatory System (SSDRS). The scheme envisagesupgrading existing State laboratories, setting up of new drug testing laboratories and
upgradation of existing State drug control offices in the country. Under the SSDRS Scheme,
funds totallingRs. 756 Crore has beenreleased toStates/UTs aspart of the Central Share and
19 New Drug Testing Labs have been constructed and 28 existing labs have been up-graded
invariousStates/UTs.
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