India Enforces Revised Schedule M: Strengthening Drug Manufacturing Standards
In News
The Drugs Controller General of India (DCGI), has directed all States and Union Territories to ensure strict compliance with the revised Schedule M norms under the Drugs and Cosmetics Act, 1940.
The move follows multiple incidents of cough syrup–related deaths, including those of children in Madhya Pradesh and Rajasthan, caused by diethylene glycol (DEG) contamination.
Background
1. What is Schedule M?
Schedule M of the Drugs and Cosmetics Rules, 1945 prescribes Good Manufacturing Practices (GMP) and requirements of premises, plant, and equipment for pharmaceutical manufacturing units.
It ensures that drugs are consistently produced and controlled according to quality standards appropriate to their intended use.
Objective: To guarantee that every medicine made in India is safe, effective, and of standard quality.
2. Why the Revision?
The original Schedule M norms had become outdated compared to global benchmarks such as the WHO-GMP standards.
The Union Ministry of Health and Family Welfare revised Schedule M in December 2023 to:
Bring uniformity with international standards.
Enhance quality assurance mechanisms.
Prevent incidents of substandard or contaminated drug production.
Key Highlights of the DCGI Directive
Directive | Details |
Immediate Inspections | State and UT drug controllers to inspect all pharmaceutical manufacturing units that have not applied for extension under revised Schedule M. |
Strict Action | Non-compliance to attract penalties under the Drugs and Cosmetics Act, 1940. |
Monthly Reports | States must submit reports to DCGI on inspection outcomes, observations, and corrective actions taken. |
Extension Applicants | Units that applied for extension must be inspected for compliance before the revised norms become fully enforceable (January 1, 2026). |
Top Priority | DCGI has directed States to treat enforcement as a “top priority” public health issue. |
Rationale Behind the Move
1. Public Health Concerns
India has faced international scrutiny due to incidents of toxic and substandard cough syrups:
Gambia (2022): Over 60 child deaths linked to contaminated syrups by an Indian manufacturer.
Uzbekistan and Cameroon (2023): Similar reports of deaths traced to DEG and ethylene glycol contamination.
India (2024–25): Deaths in Madhya Pradesh and Rajasthan due to DEG in locally produced syrups.
These events have damaged India’s pharmaceutical reputation and raised questions about domestic quality control.
2. Ensuring Compliance and Accountability
Over 8,500 small and medium-sized drug units operate in India.
Many lack infrastructure and resources to meet modern GMP standards.
The revised Schedule M ensures traceability, documentation, and stricter hygiene standards.
Revised Schedule M: Major Provisions
Component | Revised Requirement |
Quality Management System (QMS) | Mandatory documentation of production, testing, and distribution processes. |
Plant Layout & Premises | Must ensure prevention of cross-contamination and proper air-handling systems. |
Personnel & Training | Qualified technical staff; periodic GMP training mandatory. |
Self-Inspection & Audits | Internal audit mechanisms to ensure compliance and continuous improvement. |
Product Recall Mechanism | Companies must maintain systems for recalling defective batches. |
Environmental Controls | Enhanced waste management and safety measures in line with WHO-GMP. |
Quality Risk Management (QRM) | Structured evaluation of risks affecting product quality. |
Timeline for Implementation
Category of Manufacturers | Deadline for Compliance |
Large Manufacturers | Within 6 months of notification (June 2024) |
Micro, Small & Medium Enterprises (MSMEs) | By January 1, 2026 (extended timeline for capacity upgradation) |
Legal and Institutional Framework
Act / Rule | Purpose |
Drugs and Cosmetics Act, 1940 | Regulates manufacture, sale, and distribution of drugs and cosmetics. |
Drugs and Cosmetics Rules, 1945 | Provides detailed rules under the Act, including Schedule M. |
Central Drugs Standard Control Organisation (CDSCO) | National regulatory authority for pharmaceuticals and medical devices. |
DCGI | Head of CDSCO, responsible for ensuring drug safety, efficacy, and quality. |
Significance
1. Public Health and Consumer Safety
Prevents tragedies linked to toxic contamination.
Enhances patient safety and trust in Indian drugs.
2. Global Trade and Reputation
Aligns Indian standards with WHO and USFDA norms.
Protects India’s position as the “Pharmacy of the World.”
3. Governance and Federal Coordination
Strengthens Centre–State cooperation in regulatory enforcement.
Encourages data-driven inspection systems through monthly compliance reporting.
Challenges Ahead
Compliance Cost: Small manufacturers may find GMP upgrades financially burdensome.
Manpower Constraints: State drug controllers are understaffed, limiting inspection capacity.
Infrastructure Gaps: Laboratories and testing facilities unevenly distributed.
Enforcement Consistency: Varying state-level implementation of Schedule M norms.
Way Forward
Financial Support to MSMEs: Government can provide soft loans and tax incentives for GMP upgrades.
Capacity Building: Regular training programs for inspectors and industry personnel.
Third-Party Auditing: Authorise certified auditors to assist in ensuring compliance.
Transparency: Public disclosure of compliant and non-compliant units to ensure accountability.
Technology Integration: Use of AI-based traceability systems for drug batches to detect contamination sources.
Prelims Practice MCQs
Q. Schedule M of the Drugs and Cosmetics Rules, 1945, recently in news, deals with:
A. Licensing of new pharmaceutical ingredients.
B. Standards for clinical trials.
C. Good Manufacturing Practices (GMP) for drug manufacturing units.
D. Packaging and labelling of pharmaceuticals.
✅ Answer: C.
Q. With reference to the Drugs Controller General of India (DCGI), consider the following statements:
DCGI functions under the Ministry of Health and Family Welfare.
It is the statutory authority responsible for approval of new drugs and clinical trials.
It enforces standards under the Drugs and Cosmetics Act, 1940.
Which of the above statements are correct?
A. 1 and 2 only
B. 2 and 3 only
C. 1 and 3 only
D. 1, 2 and 3
✅ Answer: D.