Drugs (Eleventh Amendment) Rules, 2026 revise product identification, labelling, shelf-life and GMP requirements for ASU drugs

The Ministry of Ayush has notified the Drugs (Eleventh Amendment) Rules, 2026 (“Amendment Rules”), further amending the Drugs Rules, 1945 (“Principal Rules”) in relation to Ayurveda, Siddha and Unani (“ASU”) drugs. The Amendment Rules, published in the Official Gazette on 5^th August 2026, revise the existing framework relating to licensing, product identification and labelling, shelf life, testing and inspection, and Good Manufacturing Practices (“GMP”).

Key Highlights:

1. Licensing and product identification framework revised: While the Principal Rules separately provided for grant and duration of manufacturing and loan licences, the Amendment Rules expressly provide for their perpetual validity, subject to continued compliance. A uniform Specific Product Code (“SPC”) has also been introduced for licensed products, with existing product codes required to be reissued in the prescribed format and reflected on product labels within two years.
2. Product naming and labelling requirements expanded: The existing restriction on using names of classical medicines for patent or proprietary medicines will extend to extract-based single-plant formulations after one year, with such products also requiring a licensee-specific prefix or suffix. The Amendment Rules further permit lengthy ingredient and other label information to be provided through QR codes, GTIN or barcodes, and prescribe additional labelling requirements for specified cosmetic preparations.
3. Shelf-life requirements revised to recognise accelerated stability studies: In addition to the existing requirement to scientifically substantiate shelf life, manufacturers may now rely on accelerated stability studies to support an initial one-year or two-year shelf life, subject to subsequent submission of real-time stability data. Changes in dosage form of classical medicines must also be supported by appropriate stability data.
4. Testing and regulatory oversight strengthened: Qualification requirements for personnel engaged in drug testing have been expanded, including a specific requirement for a qualified Microbiologist, while eligibility requirements for Inspectors have been revised to cover recognised Ayurveda, Siddha, Sowa-Rigpa and Unani qualifications. The earlier general inspection framework has also been replaced with risk-based inspections, and the range of laboratories authorised to test suspected drug samples has been expanded.
5. GMP requirements substantially expanded: Compared with the earlier minimum requirements under Schedule T, the revised framework introduces detailed controls relating to premises, workflow, cross-contamination, storage, sanitation, equipment, personal hygiene and annual medical examination of personnel. Additional safeguards apply to Rasaushadhis and herbo-mineral-metallic formulations, including segregated manufacturing, emission controls, adverse-event investigation, product recall, employee health surveillance and controlled product release.
6. Transition period provided for revised GMP requirements: While the Amendment Rules take effect from 5^th August, 2026, existing manufacturers have been given time up to 31^st July, 2029 to align their facilities and systems with the amended GMP requirements.

Source: E Gazette