The Ministry of Ayush has published the draft Drugs (Amendment) Rules, 2025 (“Draft Amendment”), proposing amendments to the Drugs Rules, 1945 for Ayurvedic, Siddha or Unani (“ASU”) drugs.
Comments and suggestions are invited from stakeholders, which may be addressed to: Secretary, Ministry of Ayush, AYUSH Bhawan, ‘B’ Block, GPO Complex, INA, New Delhi – 110023, or via email at dcc-ayush@nic.in by 21st March, 2025.
Key Highlights:
- The requirement to submit an annual self-declaration for licenses to manufacture ASU drugs (Form 25D) and loan licenses (Form 25E) is proposed to be dispensed with, while the perpetual validity of these licenses remains unaffected;
- Exemption on using ASU drug names for single-ingredient formulations licensed as patent or proprietary medicines is proposed to be removed;
- The updated manufacturing license number of a product must be displayed in all advertisements, including electronic, social media, and print media;
- The qualification requirements for conducting ASU drug testing on behalf of licensees are proposed to be broadened. Earlier, experts with qualifications under Schedule II of the IMCC Act, 1970 were considered. The amendment now proposes to expand recognition to degrees under the National Commission for Indian System of Medicine Act, 2020 and graduates in Pharmacy (ASU) from a recognized university. It also proposes to include Microbiologists holding a Bachelor’s degree with six months of quality control experience or a Postgraduate degree in Microbiology from a recognized university;
- It is further proposed that labels must have a minimum font size of nine points for readability, and ingredient details are proposed to be displayed through QR codes as an alternative to textual labelling;
- For drugs approved based on accelerated stability studies, manufacturers must submit a self-declaration to the Licensing Authority confirming that they will provide real-time stability data. The shelf-life of such medicines shall be determined for one or two years based on three or six months of accelerated stability study data, respectively, with due intimation to the Licensing Authority. Any determination of shelf-life beyond two years must be supported by real-time stability studies and reported accordingly;
- Proposes to introduce a new provision in the event classical medicines (e.g., Avaleha tablets, Bhasma tablets) undergo a change in dosage form, their expiry date must be supported by stability study data;
- NABL-accredited drug testing laboratories under the Ministry of Ayush will act as Central Drug Laboratories for ASU drugs . The amendments also propose new qualification requirements for microbiologists and experts in ASU drug manufacturing;
- Besides requiring the mention of preservatives and colouring agents for consumer information, the proposed amendment in labelling of ASU drugs now also proposes that the quantity of Base material shall be mentioned on the label;
- The proposed amendment in Schedule M-I, which outlines Good Manufacturing Practices (“GMP”) for homeopathic drugs, updates facility requirements, mandating exclusive use of premises for drug production with separate areas for key processes. It proposes implementation of five-micron air filtration, validated water treatment and enhanced fire and safety measures. The use of stainless-steel workbenches is mandated, while jewellery, nail polish, and exposed hair in production areas are prohibited under updated hygiene protocols;
- The proposed amendment further updates quality control and compliance requirements by mandating an independent quality control division responsible for stability studies, raw material testing, and adherence to pharmacopeial standards. It updates record-keeping requirements and requires laboratories to include advanced testing such as HPTLC and microbial analysis. Standard Operating Procedures (“SOP”) are mandated for all processes, with regular staff training to ensure GMP compliance.
- The proposed amendment in Schedule T, which outlines GMP for ASU medicines, updates requirements for raw material storage, facility standards, and safety protocols. It mandates that raw materials be stored on HDPE or equivalent raised platforms, prohibits wooden storage, and requires separate designated areas for flammable and hazardous chemicals. Manufacturing premises must now have clearly defined sections for processing, quality control, and rejected goods;
- The proposed amendment also updates quality control, personnel qualifications, and record-keeping requirements. Stability testing of products is now mandatory per government guidelines, with sterility tests required where applicable. The eligibility for quality control personnel is expanded to include degrees under the National Commission for Indian System of Medicine Act, 2020, and microbiologists with relevant experience. Record-keeping requirements have been updated to ensure detailed documentation of production, raw material testing
- Labels may additionally be required to specify the quantity of base material used in drug formulations.
Source: Ministry of Ayush
