The Drugs Controller General of India (DCGI) has directed all state drug regulators to enforce World Health Organization (WHO)-compliant Good Manufacturing Practices (GMP) across pharmaceutical manufacturing units by January 2026, marking a major step toward ensuring global-standard drug quality.
The DCGI has also instructed states to initiate inspections immediately, beginning with large-scale companies, to assess compliance levels and identify facilities that need upgradation.
Pharma Companies Divided by Scale
As per the directive, pharma companies with an annual turnover above ₹250 crore must implement the stricter global GMP norms within six months — by January 2026.
Meanwhile, smaller pharmaceutical firms have been granted up to one year, or until July 2026, to fully comply with the new manufacturing standards.
“We have given industry players sufficient time to upgrade facilities. The aim is not to penalize but to ensure safety, quality, and export credibility,” a senior DCGI official said.
This phased approach is expected to balance regulatory enforcement with industry preparedness, given India’s vast network of over 10,000 drug manufacturing units.
Global Reputation at Stake
The move comes in response to international scrutiny following multiple reports of substandard exports from Indian firms to Africa and Southeast Asia.
By aligning Indian manufacturing norms with WHO-GMP, the government aims to reinforce India’s position as the “pharmacy of the world” while restoring trust among global buyers.
The Ministry of Health and Family Welfare has instructed the Central Drugs Standard Control Organisation (CDSCO) to coordinate with state authorities for training, documentation, and digital record tracking under the new framework.
Stricter Norms: What They Include
Under the revised Schedule M of the Drugs and Cosmetics Rules, pharma companies will now need to:
Maintain data integrity and digital batch records
Implement validated quality assurance (QA) systems
Ensure real-time equipment calibration and contamination control
Conduct risk-based audits and self-inspections every quarter
Inspections will be conducted jointly by state FDAs and CDSCO zonal offices, and non-compliance could lead to suspension or cancellation of manufacturing licenses.
How States Are Preparing
Several state drug controllers — including Maharashtra, Gujarat, and Himachal Pradesh — have begun mapping facilities and training inspectors in WHO-GMP verification techniques.
Industry associations, meanwhile, have requested financial and technical support for smaller units to meet the new compliance costs.
“Small manufacturers will need both financial aid and technical hand-holding to upgrade their infrastructure to international levels,” said a senior official from the Indian Drug Manufacturers’ Association (IDMA).
Impact on Exports and Industry
Analysts say the initiative could initially strain smaller drug producers, but it will ultimately boost export competitiveness and global trust in Indian pharmaceuticals.
India currently exports medicines to over 150 countries, and compliance with WHO-GMP norms will be a key differentiator in international tenders and approvals.
“By enforcing these standards, India is not only protecting domestic consumers but also strengthening its export credibility in regulated markets,” said a healthcare policy analyst.
Frequently Asked Questions (FAQ)
Q1: What has DCGI directed states to do?
To launch inspections and enforce WHO-GMP manufacturing standards across all pharmaceutical plants starting January 2026.
Q2: What’s the deadline for compliance?
Large companies (turnover > ₹250 crore): January 2026.
Smaller units: July 2026.
Q3: Why are these reforms needed?
To ensure drug safety, improve quality control, and align with international pharmaceutical manufacturing standards.
Q4: What happens to non-compliant firms?
They risk license suspension or cancellation following DCGI audits.
Q5: How will this affect India’s pharma exports?
Positively — it enhances India’s image as a globally trusted drug manufacturer.
Published on : 11th November
Published by : SMITA
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Source Credit : Written by Anonna Dutt — NDTV Profit / Health & Policy Desk