If you run a PCD franchise or buy from a third-party manufacturer, your brand carries your manufacturer’s quality. Under the revised Schedule M, that quality is now checked far more closely. Here is what changed and how to verify a manufacturer before you partner with one.
Schedule M is the part of India's Drugs and Cosmetics Rules that sets Good Manufacturing Practices (GMP). The revised version brings Indian requirements closer to WHO standards. It adds a pharmaceutical quality system, quality risk management, product quality review, equipment qualification and validation, and computerised storage for drug products.
Small and medium manufacturers have had extra time to comply, and the deadline has been pushed back more than once because many units struggled with structural changes to their plant layouts. This means manufacturers are not all at the same stage of compliance. A weak manufacturer can mean supply delays, failed batches or regulatory trouble that lands on your brand.
Verify that the licence is valid and covers the required dosage forms, such as tablets, capsules, and syrups.
Check the issue date, validity, issuing authority, and the manufacturing facility covered by the certificate.
Ask whether the facility meets the applicable revised Schedule M requirements and request supporting evidence.
Confirm testing arrangements and request recent batch Certificates of Analysis (CoAs).
Ensure every batch can be traced through manufacturing records to its raw materials and suppliers.
Check how suppliers are approved and how incoming raw materials are tested and controlled.
Choose a manufacturer willing to support a facility visit, document review, or virtual walkthrough.
Reluctance to share licences or certificates
Certificates with no dates, or covering a different address
Prices far below the market with no explanation
No clear answer about testing or batch records
Yes. Small and medium units have had more time to comply, but the requirements apply to them too.
Not exactly. A GMP certificate is one piece of evidence. Ask what the plant has done specifically for the revised requirements.
You should be able to. Be cautious if a manufacturer refuses.
Looking for a quality-focused pharma partner in Panchkula? Share your product requirements and we’ll respond with our licence and quality documents.
