Understanding Schedule M and Why It Matters to Distributors

Schedule M of the Drugs and Cosmetics Rules lays down Good Manufacturing Practices and the requirements for premises, plant and equipment used to manufacture pharmaceutical products in India.

What it covers

• Facility design, air handling and cleanliness classification
• Equipment qualification and preventive maintenance
• Documentation — batch records, SOPs, change control
• Quality control laboratory requirements and stability testing
• Personnel qualification, training and hygiene

Why a distributor should care

The distributor's name appears on the supply chain even though they do not manufacture. If a batch is questioned, the paperwork trail runs through everyone who handled it. Sourcing from units with current Schedule M compliance reduces the chance of being caught in a recall, a market complaint, or a licensing query.

What to ask for

A copy of the manufacturing licence and GMP/WHO-GMP certificate for the units your products come from, and confirmation that certificates of analysis are available batch-wise when needed.

Storage is your responsibility

Compliance does not stop at the factory gate. Maintaining storage conditions, stock rotation and temperature records at your own premises is part of keeping the product within specification.