Executive Summary:
The Ministry of Health and Family Welfare addressed concerns regarding counterfeit and substandard drugs in India. While "counterfeit medicines" are not explicitly defined, the Drugs and Cosmetics Act addresses spurious, adulterated, and misbranded drugs. The CDSCO, in collaboration with state regulators, has initiated risk-based inspections and is strengthening the drug regulatory system through various amendments, training programs, and centrally sponsored schemes. Compliance deadlines exist, particularly for manufacturers upgrading to revised Schedule M standards.
Key Points / Main Content:
Regulatory Definitions and Actions:
* Counterfeit medicines are not defined under the Drugs and Cosmetics Act, but the Act addresses spurious, adulterated, and misbranded drugs.
* The CDSCO and state regulators initiated risk-based inspections of drug manufacturing and testing firms in December 2022, inspecting 905 units and taking 694 actions including Stop Production Orders (SPO) and license suspensions.
* As of the inspection of 6 firms in Karnataka, 29 drug samples were collected for test and analysis; reports of 22 samples have been received and no samples were declared as spurious, substandard, or misbranded.
* CDSCO has not received information on interstate or international networks involved in counterfeit drugs.
Strengthening Regulatory Mechanisms:
* Drugs Rules 1945 were amended (G.S.R. 922E, 28.12.2023) to revise Schedule M regarding Good Manufacturing Practices (GMP).
* Effective 29.06.2024 for manufacturers with turnover greater than Rs. 250 crores.
* Conditional extension until 31.12.2025 for manufacturers with turnover less than Rs. 250 Cr who submitted an upgrade plan.
* Manufacturers of top 300 drug brands must affix Bar Code or Quick Response (QR) Code on packaging labels (G.S.R. 823E, 17.11.2022, effective 01.08.2023).
* All Active Pharmaceutical Ingredients (API) must bear a QR code on their labels (G.S.R. 20E, 18.01.2022).
* Marketers are responsible for drug quality and regulatory compliance (G.S.R. 101 E, 11.02.2020, effective 01.03.2021).
* The Drugs and Cosmetics Amendment Act, 2008 provides stringent penalties for spurious and adulterated drugs.
Quality and Infrastructure Improvements:
* Special courts have been set up for the trial of offences under the Drugs and Cosmetics Act.
* Bioequivalence studies are required for manufacturing licenses of oral dosage forms.
* Evidence of stability and safety of excipients is mandatory for manufacturing licenses.
* The number of sanctioned posts in CDSCO has significantly increased.
* The Central government coordinates with State Drug Control Organizations through Drugs Consultative Committee (DCC) meetings.
* Regular training and workshops are provided to CDSCO and State Drug Regulatory Authority officials.
* 22854 persons trained in FY 2023-24
* 20551 persons trained in FY 2024-25
* The "Strengthening of States Drug Regulatory System (SSDRS)" scheme, with an outlay of Rs. 850 Crore, upgrades state laboratories and drug control offices.
* Rs. 756.00 Crore released to States/UTs.
* 17 New Drug Testing Labs have been constructed and 24 existing labs have been upgraded.
Impact Analysis:
Drug Manufacturers:
* Impact: Compliance with revised Schedule M GMP, QR code requirements, bioequivalence study submissions, and excipient safety evidence. Stricter penalties for non-compliance.
* Action Required: Upgrade manufacturing processes to meet revised Schedule M standards, implement QR code labeling, conduct bioequivalence studies, provide excipient safety evidence, and ensure drug quality.
Drug Marketers/Distributors:
* Impact: Responsibility for drug quality and regulatory compliance.
* Action Required: Ensure drug quality and compliance with regulations.
Central Drugs Standard Control Organization (CDSCO):
* Impact: Increased responsibilities in inspections, coordination, training, and infrastructure upgrades.
* Action Required: Conduct inspections, coordinate with state organizations, provide training, and oversee infrastructure upgrades.
State Drug Regulatory Authorities:
* Impact: Collaboration with CDSCO, participation in training, and upgrades to laboratories and offices.
* Action Required: Collaborate with CDSCO, participate in training programs, and implement upgrades to laboratories and offices.
Key Entities Referenced
Drugs Consultative Committee DCC: A committee that facilitates coordination between the Central Drugs Standard Control Organization (CDSCO) and State Drug Controllers to ensure uniformity in the administration of the Drugs and Cosmetics Act.
Strengthening of States Drug Regulatory System SSDRS: A centrally sponsored scheme implemented by the Ministry of Health and Family Welfare to strengthen the drug regulatory system in states by upgrading laboratories and drug control offices.
Drugs and Cosmetics Act, 1940: The primary legislation in India governing the quality, safety, and efficacy of drugs and cosmetics. It defines spurious, adulterated, and misbranded drugs.
Central Drugs Standard Control Organization CDSCO: The national regulatory body in India responsible for drug regulation, including approving new drugs, conducting inspections, and coordinating with state drug control organizations.
Drugs Rules 1945: Rules framed under the Drugs and Cosmetics Act, 1940, which provide detailed procedures and requirements for the manufacture, sale, distribution, and testing of drugs.
Schedule M: A schedule within the Drugs Rules, 1945, outlining the Good Manufacturing Practices (GMP) requirements for pharmaceutical products. It specifies the standards for premises, plant, and equipment.
Karnataka: A state in India where drug manufacturing firms were inspected, and drug samples were collected for testing.
Drugs Cosmetics Amendment Act, 2008: An amendment to the Drugs and Cosmetics Act, 1940, which introduced more stringent penalties for the manufacture of spurious and adulterated drugs, making certain offenses cognizable and non-bailable.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2226
TOBE ANSWERED ON01ST AUGUST,2025
COUNTERFEITDRUGS AND ILLEGALPHARMACEUTICALNETWORKS
2226.SHRIPC MOHAN:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the Government is aware of the growing menace of counterfeit and substandard
drugs being sold across the country, including in urban and peri-urban markets, if so, the
detailsthereof;
(b) the estimated numberof drug samples found to be spurious, substandard or misbranded in
inspectionsduring the last three years, year-wisewith respect toKarnataka andBengaluru;
(c) whether the Government has identified any inter-state or international networks involved
inthe manufactureand distribution of counterfeitdrugs, if so, the detailsthereof;
(d) the steps taken by the Union Government to strengthen regulatory mechanisms, inter-
agency coordination and digital tracking of pharmaceutical supply chains to prevent
counterfeiting;and
(e) whether the Government is planning to implement or expand Track and Trace systems
and modernise drug testing laboratories under the Central Drugs Standard Control
Organisation (CDSCO), if so, the detailsthereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a): The terminology “Counterfeit Medicines” is not defined under the Drugs and
Cosmetics Act, 1940 and Rules made thereunder. However, the Drugs and Cosmetics Act
definesspurious, adulterated,misbranded drugs which includescounterfeitdrugs.
Isolated complaints regarding sale of not of standard quality and spurious drugs have
been received. As and when such complaints are received, action is initiated as per the
provisions of Drugs & Cosmetics Act, 1940andRules, 1945.
(b): In order to assess the regulatory compliance of drug manufacturing premises in the
country, the Central Drugs Standard Control Organization (CDSCO), in collaboration withstate regulators, initiated risk-based inspections of drug manufacturing and testing firms in
December 2022. As of now, 905 units have been inspected, resulting in 694 actions being
taken. These actions include Stop Production Orders (SPO), Stop Testing Orders (STO),
license suspensions/cancellations, warning letters, and showcause notices, depending on the
severity of non-compliance. This initiative has provided valuable insights into the ground
reality of manufacturing practices and has led to relevant corrective actions, resulting in
noticeableimprovements inthe regulatoryframework.
Out of aforementioned units, 06 firms are situated in Karnataka state and during
inspection, 29 numbers of drug sample were collected for test and analysis. Out of these 29
drugs samples, analysis reports of 22 samples have been received and no samples are
declaredasspurious, substandard or misbranded.
(c): Informationof such networks hasnot beenreceived by CDSCO.
(d) & (e): Central Drugs Standard Control Organization (CDSCO) and Ministry of
Health and Family Welfare have taken several measures to strengthen the drug regulatory
system inthe country.
(i). Central Government hasamended the Drugs Rules1945 vide G.S.R.922(E) dated
28.12.2023 to revise the schedule M to the said rules related to Good
Manufacturing Practices and requirements of premises, plant and equipment for
pharmaceutical products. Revised Schedule M has become effective for the drug
manufacturers with turnover > Rs. 250 crores from 29.06.2024. However, for
manufacturers having turnover of less than Rs. 250 Cr, conditional extension up to
31.12.2025 is currently operational for those who submitted their upgradation plan
for the extendedcompliance period.
(ii). On 17.11.2022, the Drugs Rules, 1945 were amended vide G.S.R. 823(E) which
has come into force from 1st of August, 2023 providing that the manufacturers of
top 300 brands of drug formulation products, as specified in Schedule H2, shall
print or affix Bar Code or Quick Response Code on its primary packaging label or,
in case of inadequate space in primary package label, on the secondary package
label that store data or information legible with software application to facilitate
authentication.
(iii). On 18.01.2022, the Drugs Rules, 1945 were amended vide G.S.R. 20(E) providing
that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported
inIndia shall bearQuick Response Code on itslabelat eachlevel of packagingthat
store data or information readable with software application to facilitate tracking
and tracing. The stored data or information shall include the minimum particulars
including unique product identification code, Batch Number, Manufacturing date,
ExpiryDate etc.
(iv). On 11.02.2020, the Drugs Rules, 1945 were amended vide G.S.R. 101 (E),
providing that with effect from 01.03.2021, any marketer who sells or distributes
any drug shall be responsible for quality of that drug as well as other regulatory
compliancesalongwith the manufacturerunderthese Rules.
(v). The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics
(Amendment) Act, 2008 to provide stringent penalties for manufacture of spuriousand adulterated drugs. Certain offences have also been made cognizable and non-
bailable.
(vi). States/ UTs have set up special Courts for trial of offences under the Drugs and
Cosmetics Act for speedy disposal.
(vii). To ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been
amended providing that applicant shall submit the result of bioequivalence study
along with the application for grant of manufacturing license of oral dosage form
of some drugs.
(viii). The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory
that the applicants shall submit evidence of stability, safety of excipients etc. to the
StateLicensingAuthority before grant of manufacturinglicense bythe Authority.
(ix). The number of sanctioned posts in Central Drugs Standard Control Organization
(CDSCO) hasbeensignificantlyincreased inlast 10 years.
(x). Central regulator coordinates activities of State Drug Control Organisations and
providesexpertadvice through the Drugs Consultative Committee (DCC) meetings
heldwith State Drugs Controllersfor uniformity inadministrationof the Drugs and
Cosmetics Act.
(xi). Central government is providing regular residential, regional training and
workshops to officials of CDSCO and State Drug Regulatory Authorities on Good
Manufacturing Practices. In the Financial Year 2023-24 CDSCO has trained 22854
persons while inFinancialYear 2024-25, 20551persons have beentrained.
(xii). Further, for strengthening the drug regulatory system in the country, Ministry of
Health and Family Welfare is implementing a Centrally Sponsored Scheme
'Strengthening of States’ Drug Regulatory System (SSDRS) with an approved
outlay of Rs. 850 Crore. The scheme envisages upgrading existing State
laboratories, setting up of newdrug testing laboratories andupgradationof existing
State drug control offices in the country. So far under the SSDRS Scheme, funds
totalling Rs. 756.00 Crore has been released to States/UT’s as part of the Central
Share and 17 New Drug Testing Labs have been constructed and 24 existing labs
have beenup-gradedinvariousStates/U.T’s.
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