The Government of India has officially mandated the disclosure of excipient quality on drug labels, effective March 1, 2026, through amendments to the Drugs and Cosmetics Rules, 1945.

The change is that the Drugs (Second Amendment) Rules, 2025 revise Rule 96 of the Drugs and Cosmetics Rules, 1945, introducing a new requirement , the “qualitative details of excipients” used in the formulation must be printed on the innermost container’s label, alongside the expiry date of potency where applicable .

This requirement initially applies to Schedule H2 medicines India’s top 300 pharmaceutical brands where QR/barcodes are already mandated. The excipient details should now be included as part of that labeling information .

It Matters because of the following reasons :
1)Patient Safety & Allergy Awareness: Many excipients like parabens can cause hypersensitivity. This change helps prescribers and patients identify and avoid such compounds .

2)Transparency & Regulatory Clarity: Previously, drug labels focused only on active ingredients. Including excipients aligns with global best practices and improves accountability

The timeline allows the pharmaceutical industry to adjust label design and manufacturing processes. Stakeholders had opportunities to provide feedback during the draft stage of rule-making .

So Starting March 1, 2026, drug manufacturers in India must clearly display the qualitative composition of excipients on medicine labels — specifically for Schedule H2 products. This marks a major step toward enhancing drug safety, transparency, and informed use. Over time, this initiative may expand to include more medications, fostering broader improvement in the pharmaceutical labeling landscape.
Regards,
JAKSTAR PHARMA