Law Updates

Subject

Summary: The Ministry of AYUSH notified the Drugs (Eleventh Amendment) Rules, 2026 in the Gazette notification on 24 July 2026. The amendment makes changes to the Drugs Rules, 1945 pursuant to the power conferred under Section 33N of the Drugs and Cosmetics Act, 1940. The amendment is based on the draft notification which was initially published for comments in February 2025, dated 14 February 2025). The amendment applies specifically to manufacturers operating under the Ayurvedic, Siddha, Unani, Sowa-Rigpa, and Homoeopathy systems of medicine. It touches licensing, product coding, labelling, inspection procedures, stability studies, inspector qualifications, and the Good Manufacturing Practice (GMP) schedules that govern factory premises and quality systems for these manufacturers (Schedule M-I for Homoeopathy, and Schedule T for Ayurveda, Siddha, Sowa-Rigpa, and Unani). This guide summarises the changes rule by rule, sets out the compliance timelines specified in the notification, and offers a practical checklist for manufacturers assessing what needs to change in their operations. All statements below are based directly on the text of the notification where a point is not explicitly addressed in the gazette, that is noted rather than assumed. Regulatory Background The parent law that governs drug manufacturing, selling, and distribution in India is the Drugs and Cosmetics Act of 1940, which covers AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy) drugs. The Drugs Rules of 1945, which are formulated under the aforementioned Act, provide all technical details. The Ministry of AYUSH periodically amends these rules to reflect changes in manufacturing practice, quality expectations, and administrative processes. The Eleventh Amendment was made after consultation with the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board, as required under the Act. It amends several individual rules (154 through 169) as well as two full GMP schedules: Schedule M-I (Homoeopathy) and Schedule T (Ayurveda, Siddha, Sowa-Rigpa, and Unani). Key Changes at a Glance Manufacturing licences issued under Rules 154 and 154A will remain perpetually valid the periodic renewal requirement is removed. Rules 156 and 156A, which dealt with licence renewal procedures, are omitted from the Drugs Rules, 1945. A one-year exemption window is introduced for single-plant-ingredient, extract-based patent or proprietary formulations under Rule 157, along with a new naming requirement. A uniform, standardised specific product code format is introduced under Rule 158B, replacing the earlier system existing codes must be reissued in the new format within two years. Qualification criteria for technical experts under Rule 160B are revised, and a microbiologist qualification route is added. Labelling requirements under Rule 161 are relaxed to allow display of full ingredient lists and other label information via QR code, GTIN, or barcode where space is limited. New provisions under Rule 161B govern shelf-life determination based on accelerated versus real-time stability studies. Inspections under Rule 162 move to a risk-based approach rather than a blanket inspection model. Central Drugs Laboratory testing provisions (Rules 163BB and 163C) are updated to include AYUSH Ministry-approved autonomous testing laboratories. Inspector qualification requirements under Rule 167 are revised. A new labelling disclosure requirement for cosmetic categories (Husn-e-Afza/Azhagh-sadhan) is added under Rule 169, with compliance required by 31 July 2028. Schedule M-I (Homoeopathy GMP) and Schedule T (Ayurveda, Siddha, Sowa-Rigpa, Unani GMP) are substantially rewritten, covering premises, personnel, equipment, quality control, raw materials, and records, with compliance required by 31 July 2029. A new supplementary GMP guideline (Schedule T, Paragraph D) is added specifically for Rasaushadhi, Rasamarunthukal, and Kushtajat herbo-mineral-metallic formulations addressing handling of mercury, lead, and arsenic. Rule-by-Rule Changes 1. Licensing: Rules 154, 154A, 156, 156A Under the amendment, any manufacturing licence issued under Rule 154(1) or Rule 154A (1) "shall remain valid perpetually." This removes the need for periodic renewal of these licences. Correspondingly, Rules 156 and 156A, which set out renewal-related provisions, are omitted from the Drugs Rules, 1945 altogether. The notification does not specify transitional treatment for licences that were already up for renewal at the time of commencement manufacturers with licences nearing their previous renewal date should confirm treatment with their state licensing authority. 2. Rule 157: Patent and Proprietary Medicines Rule 157(1C) is amended with a new proviso. Extract-based, single-plant-ingredient Ayurvedic, Siddha, Sowa-Rigpa, or Unani formulations that are licensed, or are to be licensed, as patent or proprietary medicines (as defined under Section 3(h)(i) of the Act) are exempted from the relevant sub-rule for one year from the commencement of the Eleventh Amendment Rules. A further proviso requires that such single-ingredient extract-based formulations be named with a prefix or suffix specific to the licensee intended to distinguish licensee-specific branding from generic ingredient names. 3. Rule 158B: Uniform Product Coding A new sub-rule (VII) sets out a standard pattern for the "specific product code" assigned to AYUSH drugs. The pattern combines: The State or Union Territory code, a designation of licence type (D or E, denoting licence or loan licence), the serial number of the licence, the system of medicine (classical or patent/proprietary referred to as "PP"), the product's serial number and the year of product approval. The Central Government will specify the details of the State/UT code component separately. Existing product codes must be reissued in this new pattern within two years of the amendment's commencement. Notably, the rule also states that the State/UT code, licence-type designator, and licence serial number embedded within the product code will itself be treated as the manufacturing licence number. 4. Rule 160B: Technical Personnel Qualifications The qualification criteria for experts under Rule 160B(2)(ii)(b) are revised. The updated item (i) recognises a degree qualification under Schedule II of the Indian Medicine Central Council Act, 1970, or a qualification recognised under Section 35 of the National Commission for Indian System of Medicine Act, 2020, or a graduate degree in pharmacy (in Ayurveda, Siddha, Sowa-Rigpa, or Unani) from a recognised university. A new item (iv) is inserted, recognising a microbiologist holding a bachelor's degree in microbiology with six months' experience in quality control, or a postgraduate degree in microbiology from a recognised university. 5. Rule 161: Labelling The second proviso to Rule 161(1) is substituted. Where the list of ingredients in a medicine is too long to fit on the label, the list may now be printed separately and enclosed with the packaging, with a reference to this on the label or displayed through a QR code, Global Trade Item Number (GTIN), or barcode. Rule 161(3)(iv) is also substituted to require that the specific product code, preceded by the words "specific product code" or "S.P.C.", be printed or written on the label within two years of the amendment's commencement. A new sub-rule 161(3A) permits all label information to additionally be displayed through QR code, GTIN, or barcode. 6. Rule 161B: Stability Studies and Shelf Life A new sub-rule (2A) sets out how shelf life is to be determined when a drug's approval was based on accelerated stability studies rather than real-time studies. Depending on whether the accelerated study covered three or six months, the licensee sets a shelf life of one or two years, respectively, and submits the accelerated study report to the licensing authority referred to in Rule 151. The licensee must then submit a real-time stability study report within one year of the expiry of the shelf life that was granted based on the accelerated data. An explanation clarifies that any shelf life determination beyond two years must be based on real-time stability study data, not accelerated data alone. A further new sub-rule (9) states that where the dosage form of an Ayurvedic, Siddha, or Unani drug (as defined under Section 3(a) of the Act) is changed, the expiry date for that drug category must be supported by accelerated or real-time stability study data, as applicable. 7. Rule 162: Risk-Based Inspection Clause (i) of Rule 162 is substituted to require inspectors to inspect all premises licensed for manufacture of Ayurveda, Siddha, Sowa-Rigpa, or Unani drugs within their allotted area "as needed as per risk-based approach," rather than on a fixed periodic basis, to verify compliance with licence conditions and the Act and Rules. 8. Rules 163BB and 163C: Testing Laboratories Rule 163BB (1) removes a cross-reference to Section 11(2) of the Act. A new sub-rule (4) designates the authorised drugs testing laboratory of an autonomous organisation of the Ministry of AYUSH, where approved under Part XVIA, to act as the Central Drugs Laboratory for testing suspected Ayurveda, Siddha, Unani, Sowa-Rigpa, or Homoeopathy drug samples referred to under Section 11(2) of the Act. Rule 163C is amended in two places to add a reference to "Central Drugs Laboratory, as the case may be" alongside the existing reference to the Ghaziabad (Uttar Pradesh) facility. 9. Rule 167: Inspector Qualifications Rule 167 is substituted in full. A person appointed as an Inspector under Section 33G of the Act must hold a degree in Ayurveda, Siddha, Sowa-Rigpa, or Unani systems of medicine, or a degree in pharmacy of these systems, conferred by a university recognised for this purpose by the Central Government or a State Government. 10. Rule 169: Cosmetic Labelling A new clause (3A) requires that, for the category of Saundarya Prasadak (Husn-e-Afza) / Azhagh-sadhan (cosmetic preparations), the quantity of base material be printed or written on the label in addition to the information already required under clause 3. This requirement must be complied with by 31 July 2028. Compliance Timeline The notification specifies several distinct deadlines, tied to the commencement date of the Eleventh Amendment Rules (24 July 2026, the date of publication) or to fixed calendar dates: Requirement Timeline Applicable Rule Reissue of existing product codes in the new uniform format Within 2 years of commencement Rule 158B(VII)(c) Printing of specific product code (S.P.C.) on labels Within 2 years of commencement Rule 161(3)(iv) Exemption window for single-ingredient extract-based patent/proprietary formulations 1 year from commencement Rule 157(1C) Real-time stability study report following accelerated-data shelf life Within 1 year of expiry of granted shelf life Rule 161B(2A)(b) Base material quantity disclosure for cosmetic categories (Husn-e-Afza/Azhagh-sadhan) By 31 July 2028 Rule 169(3A) Compliance with amended Schedule M-I (Homoeopathy GMP) By 31 July 2029 Schedule M-I, Para 12 Compliance with amended Schedule T (Ayurveda/Siddha/Sowa-Rigpa/Unani GMP) By 31 July 2029 Schedule T, Para 9 Timelines above are as stated in the notification. Where a provision does not specify a deadline (for example, risk-based inspection or revised inspector/technical staff qualifications), it is understood to apply from the date of commencement 24 July 2026 unless a licensing or state authority issues separate transitional guidance. Old Rule vs New Rule: Selected Comparisons Licence Validity Aspect Position Before Amendment Position After Amendment Licence validity Subject to periodic renewal under Rules 156/156A Perpetually valid once issued (Rules 154(4), 154A(5)) Renewal rules Rules 156 and 156A in force Rules 156 and 156A omitted Product Coding Aspect Position Before Amendment Position After Amendment Product code format No single uniform national pattern specified in this rule Standard pattern: State/UT code + licence type + licence serial + system of medicine + product serial + approval year Transition N/A Existing codes to be reissued in new format within 2 years Ingredient and Label Information Display Aspect Position Before Amendment Position After Amendment Long ingredient lists Printed on label or separately enclosed, referenced on label May additionally be displayed via QR code, GTIN, or barcode General label information Physical label only May also be displayed via QR code, GTIN, or barcode (Rule 161(3A)) Shelf-Life Determination Aspect Position Before Amendment Position After Amendment Basis for shelf life beyond 2 years Not specifically addressed in this manner Must be based on real-time stability study data Accelerated-study-based approval No defined follow-up mechanism in this rule Real-time study report due within 1 year of expiry of the granted shelf life Inspections Aspect Position Before Amendment Position After Amendment Inspection approach Inspector to inspect all licensed premises in allotted area Inspection frequency/scope guided by risk-based approach Changes to the GMP Schedules Both GMP schedules governing factory premises and quality systems are substantially revised. These changes are extensive, and manufacturers should review the full schedule text directly the summary below highlights the areas of change. Schedule M-I Homoeopathic Drugs Premises: Increased emphasis on cleaning and sanitization with additional requirements to avoid back siphonage or backflow in the drainage system. Building usage limits specified: premises shall not be put to any use other than the preparation of homoeopathic drugs, with specific requirements for separate storage and production premises if other premises are required within the same campus. Specific requirements for air filtering in production premises (at least five-micron filters), clearance of production lines between batches, and temperature-humidity requirements are detailed. Water treatment, waste disposal (bio-medical waste disposal under the Bio-Medical Waste (Management and Handling) Rules, 2016), medical check-up and fire safety requirements are detailed. Plant and equipment section revised, including minimum spacing between machinery, personal hygiene and clothing requirements for workers, and segregation of raw material storage by category. Potentisation section, container/closure section, trituration/tableting section, and ophthalmic preparation section specifications are substituted with more detailed facility and equipment requirements, including specific area minimums (for example, 20 square metres for potentisation and ophthalmic sections, 55 square metres for the trituration/tableting section). Quality Control Division requirements are fully substituted, specifying minimum personnel qualifications, equipment lists, and the division's functions regarding raw material and finished product testing, stability studies, and market complaint handling. Raw material handling, packaging materials, and finished goods store requirements are elaborated, along with standard operating procedures, records, and register requirements. Compliance with these Schedule M-I amendments is required by 31 July 2029. Schedule T Ayurveda, Siddha, Sowa-Rigpa, and Unani Drugs General requirements for location, surroundings, and building design are substituted, addressing contamination risk, pest control, drainage, and fire safety. Water supply, waste and effluent disposal, and container-cleaning provisions are elaborated, with specific attention to Schedule E1 ingredient disposal. Storage requirements (stores) are detailed for raw materials, packaging materials, and finished goods, including labelling, colour-coded status labels (yellow/green/red for under test/approved/rejected), and category-based segregation of raw materials (metallic/mineral origin, animal sources, fresh and dry herbs, excipients, volatile oils, plant concentrates, Schedule E1 ingredients, and inflammable substances). Working space, machinery and equipment, and Batch Manufacturing Record (BMR) requirements are substituted with more detailed documentation expectations. Worker health, clothing, sanitation, and medical examination requirements are elaborated. The requirement for the Quality Control Section is replaced with the minimum area (150 sq. ft.), personnel composition (one expert from the respective system of medicine, chemist, botanist/pharmacognosist, and microbiologist where applicable), and equipment list. Requirement for Training and Internal Audit (Self-Inspection) is included. A separate Supplementary Guidance (Paragraph D) is provided for preparation of Rasaushadhi, Rasamarunthukal and Kushtajat herbo-mineral-metallic preparations. This includes manufacture process areas (heating/Bhatti section, grinding/drying section, related stores), temperature monitoring during processes such as Bhasmikaran and Kupi-pakwa rasayana, handling of mercury, lead and arsenic, quality control of products (which includes classical parameters like Varitaratwa, Rekhapurnatwa and others), product recall procedure and personnel medical examination/ rotation for minimizing occupational exposure. Adherence to the above changes to Schedule T is mandatory by 31 July 2029. Why the Changes Were Introduced? While the notification itself does not include an explanatory statement of legislative intent beyond the standard preamble, the substance of the changes reflects several recognisable regulatory objectives: Reducing administrative burden on manufacturers by removing periodic licence renewal, replacing it with perpetual validity. Improving product traceability and standardisation through a uniform, nationally consistent product coding system. Enabling modern labelling technology (QR codes, GTIN, barcodes) to address space constraints on physical labels while preserving access to full ingredient and product information. Strengthening scientific rigour around shelf-life claims by distinguishing accelerated stability data from real-time data and requiring follow-up verification. Shifting inspection resources toward a risk-based model, which is consistent with broader regulatory trends toward proportionate oversight. Raising and clarifying technical personnel and inspector qualification standards, including recognition of microbiology expertise. Modernising and detailing GMP requirements for Homoeopathy and Ayurveda/Siddha/Sowa-Rigpa/Unani manufacturing, including specific, previously less-detailed provisions for herbo-mineral-metallic (Rasaushadhi) formulations given their handling of substances such as mercury, lead, and arsenic. Practical Compliance Checklist for Manufacturers The following checklist reflects the areas manufacturers are likely to need to review, based on the amendments described above. It is a general guide, not an exhaustive substitute for a formal compliance review. Confirm current manufacturing licence status and understand how perpetual validity interacts with any renewal that was pending at the time of commencement. Review existing product codes and prepare for reissuance in the new uniform format within the two-year window. Assess label design and printing processes to accommodate the specific product code requirement and, if desired, QR code/GTIN/barcode integration for ingredient and label information. Review stability study protocols to distinguish which products rely on accelerated versus real-time data, and build in the follow-up real-time study submission timeline. Compare the qualifications of technical staff and quality control staff members against the modified criteria provided under Rules 160B and GMP schedule. In respect of cosmetic products that fall in the Husn-e-Afza /Azhaaghsadhan category, plan to disclose the base material quantity on the label before the expiry of 31 July 2028. Assess the gaps at the facility level with reference to the modified criteria of Schedule M-I or Schedule T for premises layout, water purification, waste management, dedicated manufacturing area, list of equipment, and record-keeping system before 31 July 2029. In case of the manufacture of Rasaushadhi, Rasamarunthukal, and Kushtajat, check the supplementary GMP guidelines on dedicated manufacturing area and safe handling of mercury, lead and arsenic. Modify SOPs, Batch Manufacturing Record and internal audit schedule in accordance with the substituted GMP schedule requirements. Review the internal training program to ensure that staff are aware of the modified guidelines and respective timelines. Conclusion The Drugs (Eleventh Amendment) Rules, 2026, bring together several distinct types of change: administrative simplification (perpetual licence validity), a modernised approach to product identification and labelling (uniform coding, QR/GTIN/barcode display), tightened scientific standards for shelf-life claims, a shift toward risk-based inspection, updated qualification standards for technical and inspection personnel, and a substantial overhaul of the GMP schedules for Homoeopathy and for Ayurveda, Siddha, Sowa-Rigpa, and Unani manufacturing including new, more detailed guidance for herbo-mineral-metallic (Rasaushadhi) formulations. Manufacturers across these AYUSH systems have a phased set of deadlines to work against: one year, two years, and 31 July 2028 and 2029, respectively, for different provisions. Given the operational scope of the GMP schedule changes in particular, an early internal review against the specific rule and schedule text is likely to be more manageable than a compressed effort closer to the 2029 deadline. This summary is based on the text of the Gazette notification dated 24 July 2026, as published by the Ministry of AYUSH. Manufacturers should consult the full text of the notification and, where necessary, seek independent legal or regulatory advice specific to their products and operations.