Government License & Certification

GMP

Good Manufacturing Practices (GMP) are quality and hygiene standards for manufacturing. In India, pharmaceutical GMP is mandatory under Schedule M of the Drugs Rules, 1945 (revised Schedule M notified on 28 December 2023), enforced by state drug controllers and CDSCO. Exporters usually also need a WHO-GMP certificate and product-wise COPP from CDSCO, applied for on the ONDLS portal and typically valid for three years. Food GMP and GHP are covered by Schedule 4 of the FSSAI licensing regulations, and cosmetics by Schedule M-II.

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Service Overview

What is GMP?

GMP stands for Good Manufacturing Practices, a system of requirements ensuring that products are consistently produced and controlled to quality standards. It covers premises, equipment, personnel, documentation, hygiene, validation and self-inspection. Revised Schedule M requires a Pharmaceutical Quality System, including Quality Risk Management, an annual product quality review, validation and computerised-system provisions, aligned with WHO-GMP and PIC/S.

The term ‘GMP certification’ can mean two things. One is compliance with Schedule M for the manufacturing licence, which is mandatory for pharmaceutical manufacturers. The other is a WHO-GMP certificate issued after inspection, which is voluntary except where importing countries or tenders require it, mainly for exports.

GMP

Who Needs This Service

Pharmaceutical manufacturers, nutraceutical and cosmetic producers, food manufacturers, and exporters needing WHO-GMP or COPP certificates all need this service. Firms bidding for government pharma tenders often need proof of GMP compliance.

MSME pharma units must plan for revised Schedule M requirements, which involve upgrades to systems and documentation. Contract manufacturers who serve multiple brands should maintain strong quality systems because their clients audit them.

Startups planning to launch pharmaceutical or cosmetic products should build GMP into their facility design from the start, since retrofitting is expensive.

If you only need a basic food safety licence, FSSAI GMP and GHP may be enough, but export customers may ask for more.

Key Benefits

Clear understanding of which GMP rules apply to your products
Gap assessment and upgrade plan for premises and quality systems
Site Master File and documentation prepared
Support for CDSCO WHO-GMP and COPP applications
Better readiness for audits and exports

Next Steps & Related Services

After GMP compliance, maintain the quality system and prepare for inspections.

Related services: CDSCO registrations, HACCP, ISO certification, FSSAI registration and AYUSH licence.

Common Mistakes

Relying on old Schedule M requirements.
Treating WHO-GMP as the same as a manufacturing licence.
Underestimating documentation and validation effort.
Not planning equipment and facility upgrades in time.
Ignoring client audits and self-inspections.

Timeline, Costs & Practical Tips

Timelines depend on the readiness of your facility and the inspection schedule. WHO-GMP certificates are typically valid for three years.

Practical tip: run a gap assessment early and prioritise changes that affect product quality and documentation.

Additional Information

Schedule M of the Drugs Rules, 1945 sets GMP requirements for pharmaceutical products. The 2023 revision aligns India's requirements with international standards to improve quality and support exports.

Practical Scenarios

Scenario 1:

A mid-size pharma plant performs a gap assessment to meet revised Schedule M.

Scenario 2:

An exporter applies for a WHO-GMP certificate and COPP to supply to overseas buyers.

Scenario 3:

A cosmetics manufacturer aligns its facility with Schedule M-II.

Written By

Raghav Sharma

Operations Executive

10+ Years Experience

As seen on

Raghav Sharma has 10+ years of experience covering Company Registration - Operation, MCA Services - Operation, Corporate Operation, Import Export Services - Operation, Goverment Licence Services - Operation, FSSAI - Operation, SEBI - Operation, Labour Compliance - Operation, Fund Raising - Operation, Licence & Certificate - Operations.

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Frequently asked questions

Need clarity?

Is GMP mandatory for pharma manufacturers?

Yes, compliance with Schedule M is mandatory for pharmaceutical manufacturing licences.

What is WHO-GMP?

A certificate issued after inspection, mainly for exports, typically valid for three years.

When did revised Schedule M come into force?

It was notified on 28 December 2023; transition timelines differ, so confirm with CDSCO.

Does GMP apply to food and cosmetics?

Yes, through FSSAI Schedule 4 for food and Schedule M-II for cosmetics.

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