Executive Summary:
The Ministry of Health and Family Welfare addressed concerns raised in a WHO study regarding substandard and falsified drugs. While the study included data from India, the reported failure rate was an average across multiple countries, not specific to India. The Ministry and CDSCO have implemented various regulatory measures to ensure the quality of medicines, including inspections, updated guidelines, and stricter penalties.
Key Points / Main Content:
Regulatory Measures and Guidelines:
* Risk-Based Inspections: CDSCO, with 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, license suspensions/cancellations, and warning letters.
* Sampling Guidelines: CDSCO published regulatory guidelines in February 2024 for drug inspectors to ensure product quality through uniform drug sampling, covering sampling plans, selection, locations, and timelines.
* Vigilance: CDSCO and State Licensing Authorities (SLA) maintain vigilance and regularly draw drug samples to identify spurious, adulterated, or misbranded drugs.
Amendments to Drug Rules, 1945:
* Revised Schedule M: Amended via G.S.R. 922 (E) on 28.12.2023, effective from 29.06.2024 for manufacturers with turnover above Rs. 250 crores; conditional extension until 31.12.2025 for others with an upgradation plan.
* Barcodes/QR Codes: Amended via G.S.R. 823(E) on 17.11.2022, effective from 01.08.2023, requiring top 300 drug brands to affix Barcodes/QR Codes on packaging for authentication.
* QR Codes for APIs: Amended via G.S.R. 20(E) on 18.01.2022, mandating QR codes on Active Pharmaceutical Ingredient (API) labels at each packaging level for tracking and tracing.
* Marketer Responsibility: Amended via G.S.R. 101 (E) on 11.02.2020, effective from 01.03.2021, holding marketers responsible for drug quality and regulatory compliance.
Penalties and Infrastructure:
* Stringent Penalties: The Drugs and Cosmetics Amendment Act, 2008, amended the Drugs and Cosmetics Act, 1940, providing stringent penalties for manufacturing spurious and adulterated drugs, with certain offenses being cognizable and non-bailable.
* Special Courts: States/UTs have set up special courts for speedy trial of offenses under the Drugs and Cosmetics Act.
* Bioequivalence Studies: Mandatory submission of bioequivalence study results for manufacturing licenses of oral dosage drugs.
* Evidence of Stability: Mandatory submission of evidence of stability and safety of excipients for manufacturing licenses.
* Increased CDSCO Posts: Significant increase in sanctioned posts within CDSCO over the last 10 years.
* Coordination and Training: Central regulator coordinates with State Drug Control Organizations and provides training to CDSCO and State Drug Regulatory Authorities (22854 trained in FY 2023-24 and 20551 in FY 2024-25).
Centrally Sponsored Scheme (SSDRS):
* Scheme Implementation: Ministry of Health and Family Welfare is implementing the 'Strengthening of States Drug Regulatory System' (SSDRS) with an approved outlay of Rs. 850 Crore.
* Laboratory Upgrades: Funds totaling Rs. 756.00 Crore released to States/UTs; 17 new drug testing labs constructed, and 24 existing labs upgraded.
Impact Analysis:
Drug Manufacturers:
* Impact: Compliance with revised manufacturing standards (Schedule M), barcode/QR code requirements, and stricter penalties for non-compliance.
* Action Required: Upgrade manufacturing facilities, implement barcode/QR code systems, and ensure adherence to quality standards.
Drug Marketers/Distributors:
* Impact: Increased responsibility for drug quality and regulatory compliance.
* Action Required: Ensure the quality of drugs they sell or distribute and comply with all regulatory requirements.
Drug Inspectors (Central and State):
* Impact: Implementation of structured sampling guidelines and increased vigilance.
* Action Required: Follow the new sampling guidelines, conduct regular inspections, and identify spurious/adulterated drugs.
State Drug Control Organizations:
* Impact: Coordination with the central regulator and participation in training programs.
* Action Required: Coordinate with CDSCO, participate in DCC meetings, and attend training workshops.
General Public:
* Impact: Increased assurance of drug quality and safety.
* Action Required: No direct action required; benefit from improved drug quality control measures.
Key Entities Referenced
World Health Organization WHO: An international organization that conducted a study identifying countries manufacturing substandard and falsified drugs, and launched key documents concerning substandard and falsified medical products.
Central Drugs Standard Control Organization CDSCO: A central drug regulatory body in India responsible for regulatory compliance of drug manufacturing, distribution, and sale of quality medicines.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health and family welfare policies and programs, including drug regulation.
Drugs Rules 1945: A set of rules in India governing the regulation of drugs, which has been amended several times to improve drug safety and quality.
Drugs and Cosmetics Act, 1940: The primary legislation in India regulating the import, manufacture, distribution, and sale of drugs and cosmetics.
Good Manufacturing Practices: A set of guidelines and requirements for premises, plant, and equipment in the pharmaceutical industry, aimed at ensuring the quality of pharmaceutical products.
Strengthening of States Drug Regulatory System SSDRS: A centrally sponsored scheme by the Ministry of Health and Family Welfare to strengthen the drug regulatory system in States and Union Territories by upgrading labs and drug control offices.
Geneva: City in Switzerland, location of the headquarters of the World Health Organization.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 3373
TO BE ANSWERED ON 08THAUGUST, 2025
SUB-STANDARDAND FALSIFIED DRUGS
3373.SHRIESWARASAMYK:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the World Health Organization (WHO) in a study has identified India as one of
the countrieswhich manufactures andsupplies sub-standard andfalsified drugs;
(b) if so, the detailsthereof;
(c) whether the Government has any plan to take a serious call on the outcome of the study;
and
(d) if so, the detailsthereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)& (b): The Director General of the World Health Organization (WHO), Geneva,
launched two key documents in 2018 concerning the issue of substandard and falsified
medical products, namely: (i) A study on the public health and socioeconomic impact of
substandard and falsified medical products, and (ii) WHO Global Surveillance and
Monitoring Systemfor substandard andfalsified medicalproducts.
These documents are the outcome of collaborative efforts and data reported by various
Member States overa periodof time. The study includesdata from qualitysurveys conducted
between2007and2016,coveringover48,000samples from 88countries, includingIndia.
As per the aggregated data reported in these surveys, the observed failure rate of
sampled medicines in low- and middle-income countries was estimated at approximately
10.5%. These figures represent a consolidated average across participating countries and are
not specific toanyindividual country.
(c)& (d): Further, Central Drugs Standard Control Organization (CDSCO) and Ministry
of Health and Family Welfare have taken following regulatory measures to ensure the
manufacture,distribution andsale of qualitymedicinesacross the country:
(i). In order to assess the regulatory compliance of drug manufacturing premises in the
country, the CDSCO, in collaboration with state 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 innoticeable improvementsinthe regulatoryframework.
(ii). In February, 2024 CDSCO published regulatory guidelines for the sampling of
drugs, cosmetics, and medical devices by drugs inspectors of Central and State
Drug Authorities in the Country. The guidelines provide a structured approach to
ensure the quality and efficacy of products available inthe marketthrough uniform
drug sampling methodology for drugs inspectors under state and central drug
regulatory authorities in India. It covers various aspects of sampling, including
sampling plans, selection, locations, number and quantity of samples, timelines,
and role of testing laboratories. It stresses the importance of a structured sampling
plan, risk-based sample selection, and covering diverse locations, including rural
areas.
(iii). Apart from complaints from various sources, the inspectorate staff of CDSCO and
SLA keeps strong vigil and draw drug samples regularly for identification of
spurious /adulterated/misbranded drugsin the distribution chain.
(iv). Central Government has amended the Drugs Rules 1945 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.
(v). 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.
(vi). 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.
(vii). 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.(viii). The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics
(Amendment) Act, 2008 to provide stringent penalties for manufacture of spurious
and adulterated drugs. Certain offences have also been made cognizable and non-
bailable.
(ix). States/ UTs have set up special Courts for trial of offences under the Drugs and
Cosmetics Act for speedy disposal.
(x). 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.
(xi). 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.
(xii). The number of sanctioned posts in CDSCO has been significantly increased in last
10years.
(xiii). 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.
(xiv). 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.
(xv). 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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