publication of notification no t 11011 3 2023 dcc ayush dated 10 01 2025 in the gazette of india

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-14012025-260208 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 24] NEW DELHI, MONDAY, JANUARY 13, 2025/ PAUSHA 23, 1946 MINISTRY OF AYUSH NOTIFICATION New Delhi, the 10th January, 2025 G.S.R. 28(E).—Whereas the draft of certain rules further to amend the Drugs Rules, 1945 was published as required by sub-section (1) of section 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940) in the Gazette of India, Extraordinary, Part-II, section 3, sub-section (i), vide notification of the Government of India, in the Ministry of Ayush, number G.S.R. 891(E), dated the 12th December, 2023, for inviting objections and suggestions from all persons likely to be affected thereby before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And Whereas, the copies of said Gazette was made available to the public on 14th December, 2023; And Whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by section 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Ayurveda, Siddha and Unani Drugs Technical Advisory Board constituted under section 33 C of the said Act, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:- 1. Short title and commencement:- (1) These Rules may be called the Drugs (First Amendment) Rules, 2025. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs Rules, 1945,- in rule 158 B, after sub-rule (V) the following sub-rule shall be inserted, namely:- “VI. For issue of licence to the medicine with respect to Ayurveda, Siddha and Unani drugs with nasal spray as dosage form, the Licensing Authorities shall follow the guidelines as per Schedule TB." 3. After Schedule TA, following Schedule TB shall be inserted – "SCHEDULE TB (Refer sub-rule VI of Rule 158 B) Guidelines for development of nasal spray as dosage form for Ayurveda, Siddha and Unani drugs I. Introduction. Any medicine administered through the nose (Nasika) is considered Nasya (Nasal administration) in Ayurveda. Usually, all the clinical conditions related to head and neck (Urdhwajatrugatavikara) are treated by following Nasya as the main line of treatment. In conditions like Apasmara, Unamada etc. procedures like Pradhamana nasya provide instant relief by reflex or systemic action. There are several varieties like Snehana Nasya (medicated oil or ghee used as nasal drops), Shamana Nasya (fresh herbal juices or decoctions used for nasal administration), Avapeedana Nasya (fresh herbs squeezed and the juice used as nasal drops), Pradhama Nasya (powdered herbs forcedly sprayed into the nose) and Dhuma Nasya (medicated fumes inhaled). For example, Anutaila nasya is indicated for daily usage; Dadimapushpa svarasa or durva svarasa is used in Nasagata Raktapitta (~epistaxis); Avapeedana Nasya is used in Ardhavabhedaka; Trikatu churna or Pippali churna is used as Nasya in Apasmara. The Nasya procedures like Snehana, Avapeedana Nasya etc. are used in the gravitational direction as the other methods like Dhumanasya and Pradhamana nasya are used against gravitational force. Acharya Charaka contraindicated herbs like Kushtha (Saussurealappa D C Clarke) and Tagara (Valeriana wallachii DC) from using in Shiro-virechana. This shows the safety consciousness of Ayurveda practice. In Siddha system, Nasiyam (Nasal drops) and Nasika aparanam (Medicated snuff) are the types of external medication applied through nostrils. Nasiyam (Nasal instillation) is a process of instillation of drugs in liquid form through the nostrils while Nasika aparanam (medicated snuff) is inhalation of medicated substances in powder form. In the Unani system, various nasal dosage forms are used and most are nervine tonics and stimulants, especially helpful in neurological diseases. Dosage form of Nasal drop or fine powder used in the Unani system of Medicine comes under Drug and Cosmetic Act. • Saoot (Nasal drop) or Qutoor: A liquid preparation which is used as nasal drop. • Shamoom: Smelling of the drugs which may be in dry or liquid form so that volatile substances reach the nasal cavity and respiratory tubes. • Nashuq or Naswar (Insufflation): A liquid preparation or powder that is used for insufflations. • Bakhoor or Dhuni (Fumigation): Smoking an affected organ by burning the drugs. II. Definition. A nasal spray is a liquid or powder formulation dispensed as a fine spray from a container or device into the nostril. In this combination of formulation and device, the end user sprays the nasal spray formulation into the nostril while breathing in through his or her nose. Nasal sprays are used to deliver medications locally in the nasal cavity. III. Differentiation from Nasya. Though the route of administration for Nasya and Nasal Spray is the same (nose), the main differentiating aspect between traditional Nasya and the new dosage form of Ayush nasal spray is that “in the traditional method medicated juices or oils are administered through the nasal route without the support of any specialized instrument or device. Whereas the nasal spray is administered by using a specific device”. The present definition or introduction of Nasal Spray shall not interfere with the existing Nasal drops used in the form of oils or decoctions etc. The respective existing nasya methods shall continue. The medication standards for those items remain to be the same as indicated in the Ayurvedic Pharmacopoeia of India (API), Part-II (example for Anutaila and Shadbindutaila). The Standard Operating Procedures (SOPs) for the performance of Nasya shall also be the same as those developed by Central Council for Research in Ayurvedic Sciences (C.C.R.A.S.) at National Institute for Panchakarma, Cherthurthy, Kerala. The standards for the new dosage form "Nasal Spray" and the guidelines for the usage of the new device are defined in this document. IV. Guidelines for active ingredient selection. Active Ingredients should be selected as per the definition of Ayurvedic, Siddha or Unani drugs in Section 3(h) under the Drugs and Cosmetics Act, 1940. V. Guidelines for excipient selection. Selection of excipients should be as per the provisions and terms and conditions provided under Rule 169 of the Drugs Rules, 1945 and amendments therein. VI. Specifications for the device (as per the details provided by the manufacturer). The following quality parameters provide guidance for the selection of packaging material. The data for these parameters can be obtained from the packaging material supplier and consistency across the manufacturing lots can be confirmed, based on the certificate of analysis. +-------+---------------------------------------+-----------------------------------------------------------------+----------------------+ | S.No. | Parameter. | Description. | Specifications or Limit. | +=======+=======================================+=================================================================+======================+ | | Details for Bottle or other components | | | +-------+---------------------------------------+-----------------------------------------------------------------+----------------------+ | 1. | Material of construction | Glass, High Density Poly Ethylene | Specify | | | of Bottle | (HDPE) or Suitable and compatible | | | | | material | | +-------+---------------------------------------+-----------------------------------------------------------------+----------------------+ | 2. | Bottle dimensions | Refer Annexure - 1 for details | Specify | +-------+---------------------------------------+-----------------------------------------------------------------+----------------------+ | | Details for Pump and Actuator (with du | st cap) or other components | | +-------+---------------------------------------+-----------------------------------------------------------------+----------------------+ | 3. | Name and Material of | Suitable and compatible material | Specify | | | construction of Pump | | | +-------+---------------------------------------+-----------------------------------------------------------------+----------------------+ | 4. | Pump dimensions | Refer Annexure - 1 for details | Specify | +-------+---------------------------------------+-----------------------------------------------------------------+----------------------+ | 5. | Material of construction | Suitable and compatible material | Specify | | | of Actuator and Dust | | | | | cap | | | +-------+---------------------------------------+-----------------------------------------------------------------+----------------------+ | 6. | Dimensions of Actuator | Refer Annexure - 1 for details | Specify | | | and Dust cap | | | +-------+---------------------------------------+-----------------------------------------------------------------+----------------------+ VII. Specifications for the finished product (mandatory). +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | S.No. | Parameter. | Description. | Specifications or Limit. | +=======+=======================================+=================================================================================================================================================================================================+=================================================================================================================================================================================================+ | 1. | Description | A qualitative description of the dosage form should be provided | | | | | (e.g., appearance and color). | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 2. | Assay of Active ingredients | Basis vendor Certificate of Analysis (CoA) of Raw material | | | | | Specification or Extract Specification or Pharmacopoeial | | | | | reference or Using Pharmacopoeial method. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 3. | Assay of Preservatives and | Content limits of 90-110 percentage. | | | | Stabilizing excipients | | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 4. | Pump Delivery (Liquid | Weight delivery acceptance criteria should control the weight of | | | | dosage form) | the individual sprays to within "15 percent of the target weight | | | | | and their mean weight to within "10 percent of the target weight. | | | | | However, for small dosage pumps (e.g. 20ml) other acceptance | | | | | criteria maybe justified. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 5. | Net Content | Basis number of dose requirement. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 6. | pH value (Liquid dosage | The pH or apparent pH, as appropriate, of the formulation | | | | form) | should be tested and an appropriate acceptance criterion to be | | | | | established. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 7. | Osmolality (Liquid dosage | The osmolality of the formulation should be tested and | | | | form) | controlled during release of product with an appropriate | | | | | procedure and acceptance Criterion, as applicable based on the | | | | | ingredients used. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 8. | Microbial | or Pharmacopeia of concern system, Coliforms- Absent. The | | | | Microbiological limits | dosage form should be free from the pathogens like Salmonella, | | | | | Escherichia coli, Pseudomonas aeruginosa and Staphylococcus | | | | | aureus. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 9. | Number of actuations per | The number of actuations per container should be demonstrated | | | | container | to be not less than the labelled number of actuations. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 10. | Heavy Metals | Pharmacopoeia of concerned system. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 11. | Pesticide Residues | Pharmacopoeia of concerned system. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 12. | Aflatoxins | Pharmacopoeia of concerned system. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 13. | Moisture Content (Powder | The limit for moisture content should be established based on | | | | dosage form) | results seen in stability studies. If the results are stable | | | | | throughout the shelf life of the product, or if any changes in | | | | | moisture content do not result in changes to any other | | | | | parameters, it may be acceptable to omit this test from the | | | | | specification; this should be fully explained in the Justification | | | | | of Specification(s) section. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 14. | Leak test | As per in-house procedure. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ VIII. Specifications for the finished product (optional). +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | S.No. | Parameter. | Description. | Specifications or Limit. | +=======+=======================================+=================================================================================================================================================================================================+=================================================================================================================================================================================================+ | 1. | Droplet Size | If a laser diffraction method is used, droplet size or particle | | | | Distribution | distribution can be controlled in terms of ranges for the D10, D50, | | | | or Particle Size | D90, span [(D90 -D10)/D50], and percentage of droplets less than | | | | Distribution | 10 µm. For nasal sprays, mean D10, D50, D90 values for a given | | | | | bottle or canister can be computed from the mean of up to three | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ consecutive sprays from that unit at each life stage. However, to assess precision, the data of each spray would also be reported. Single spray droplet size distribution and span would be reported based on volume (mass) rather than count (number of droplets). The data be provided for nasal sprays at: Fully developed phase only, Two distances from the actuator orifice. For the increased ability to detect potential differences between products, it is recommended that the studies be performed within a range of 2 to 7 cm from the orifice, with the two distances separated by 3 cm or more. Other Methods that can be used: Microscopy, Cascade impactor, and Laser Diffraction. 2. Aerodynamic Particle Size measurement (Powder dosage form) The Particle or droplet size distribution in the plume discharged from inhalation aerosols and sprays and the particle size distribution in the cloud discharged from inhalation powders are the important characteristics used in judging product performance. Although particle size measurement by microscopy can be used to evaluate the number of large particles, agglomerates, and foreign particles in the emissions of inhaled aerosols and sprays, whenever possible, this test should be replaced with a method to determine the aerodynamic size distribution of the drug aerosol leaving the product. 3. Spray Pattern The acceptance criteria for the spray pattern should include the shape (example, ellipsoid of relative uniform density)as well as the size of the pattern (example, no axis is greater than 10 millimeters) and the ratio of the longest to the shortest axes should lie in a specified range, (for example, 1.00 - 1.30). Data should be provided to demonstrate that the collection distance selected for the spray pattern test will provide the optimal discriminatory capability. For nasal sprays, these distances are recommended to be at least 3cm apart within the range of 3 to 7 cm. 4. Plume Geometry Plume geometry describes a side view of the aerosol cloud parallel to the axis of the plume, and we recommend it be based on high- speed photography, a laser light sheet and high-speed digital camera, or other suitable methods. Plume geometry can be evaluated by a variety of procedures (example, the time sequence sound-triggered high speed flash photography method, video tape recording and taking pictures of different frames). Photographs should be of high quality. The approaches used should allow monitoring the plume development to define the shape (example, two side views, at 90° to each other and relative to the axis of the plume) of the individual spray plume over time. Plume geometry would be performed at: Beginning life stage only, One side view only, A single delay time. We recommend plume geometry measurements be summarized as mean, geometric mean, and % CV (coefficient of variation). 5. Effect of Dosing Determine the comparative performance of the devices in terms of Orientation Spray Content Uniformity and particle or droplet size distribution at various dosing orientations. 6. Profiling of Sprays Determine the profiles of Spray Content Uniformity and droplet distribution of each individual spray after the point at which the labeled number of sprays have been dispensed until no more sprays are possible (i.e., the container is empty). 7. Effect of Storage on Particle size distribution to be evaluated. the Particle Size Distribution 8. Effect of Resting Determine the effect of increasing resting time on the first spray Time of unprimed units, followed immediately by the second and the third sprays. Uniformity of the formulation delivered in the first, second and third spray (no priming) should be determined. IX. One-time studies as part of product development (to be submitted along with the license applied) (mandatory) - For the most part, these should be one-time studies, preferably performed on multiple batches (e.g. three or more) of the product, representative of the product intended for distribution. +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | S.No. | Parameter. | Description. | | +=======+=======================================+=================================================================================================================================================================================================+================================================================================================================================================================---------------------------------+ | 1. | Priming and Repriming in | Determine number of Sprays recommended to prime or | | | | various orientations (Liquid | reprime the unit and approximate interval that can pass before | | | | dosage form) | the drug product should be reprimed. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 2. | Temperature Cycling | Determine effect of variation in temperature on finished goods | | | | | parameters, as applicable. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 3. | Preservative Effectiveness | If preservatives are used in the formulation, the minimum | | | | test | content limit should be demonstrated as microbiologically | | | | | effective by performing a microbial challenge assay. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 4. | Stability Studies | Standard Stability Studies, including compatibility with the | | | | | containers and closure system, shall be conducted. | | | | | Optional: Photostability studies should be performed using | | | | | appropriate test conditions, if warranted by the immediate | | | | | container, i.e., the formulation in the primary container can | | | | | receive light exposure. These studies should be conducted in | | | | | the absence of any additional packaging(example, foil | | | | | overwrap) | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 5. | Cleaning Instructions | Through in-use studies determine the frequency and | | | | | instructions for cleaning. | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 6. | Drug deposition | on The purpose of these studies is to determine the amount of drug | | | | Mouthpiece | and/or deposited within the device constituent part during use, which | | | | Accessories | (Powder can relate to cleaning requirements. Study Design: Measure the | | | | dosage form) | mean amount of drug deposited per actuation on the | | | | | mouthpiece or other device constituent part components | | | | | (example, spacers or valved holding chambers). | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ | 7. | Specific Rotation (Powder | As applicable, based on the pure form of active used. | | | | dosage form) | | | +-------+---------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+ 8. Robustness (Powder dosage Vibrational stability of powder mixtures should be form) demonstrated, in order to simulate vibrations during transport and use. Significant variations in the delivered dose and/or fine particle mass should be fully discussed in terms of the safety and efficacy of the product. 9. Weight Loss Nasal spray products should include acceptance criteria for weight loss during stability. 10. Leachable(Liquid dosage form) The Ayush product should be evaluated for compounds that leach from elastomeric or plastic components of the container closure system or justified otherwise. 11. Spray content uniformity(SCU) The spray discharged from then as actuator should be thoroughly analysed for the Ayush active content. This should be performed using individual container, between containers and multiple batches. Suitable in house analytical methods may be deployed and communicated to the Ayurveda, Siddha and Unani Licensing Authority. X. Stability guidelines. As per the guidelines provided in concerned Pharmacopoeia. XI. Safety and efficacy studies. Broadly safety and efficacy studies need to be conducted as per the guidelines provided in Rule158 B of the Drugs Rules, 1945 and Amendments as well as those provided in General Guidelines for Safety or Toxicity Evaluation of Ayush formulations, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of India. As per the requirement, safety or toxicity of the intended therapeutic formulation in its final form must be justified through appropriate means as relevant, such as ingredient literature as per text, indication (example, textbook rationale), classical medicine or proprietary medicine, hydro-alcoholic extract or other, mucosal irritation test on experimental animals and/or clinical studies on safety, efficacy and tolerability as per Good Clinical Practice guidelines for clinical trials in Ayurveda, Siddha and Unani medicine (GCP- ASU), 2013 and Indian Council of Medical Research (ICMR) - National Ethical Guidelines For Biomedical and Health Research involving Human Participants- 2017 and other guidelines as appropriate. +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | Additional detailed specifications for device. | | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | S.No. | Parameter. | Description. | Specifications or Limit. | +=========================================+=================================================+=================================================+============================+ | | Details for Bottle (Note: Attach Bottle drawing | for reference) | | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | 1. | Bottle dimensions | Base color of Bottle | Specify bottle color | | | | Weight of Bottle, gm | Specify bottle weighty | | | | Overfill capacity of Bottle, ml | Specify | | | | Bottle Height, mm | Specify dimension | | | | Bottle Body diameter, mm | Specify dimension | | | | Bottle Neck type | Screw-on or Crimp-on or Pre | ss-fit | | | | Bottle Neck Bore(ID), mm | Specify dimension | | | | Bottle Neck Outer Dia (OD), mm | Specify dimension | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | Details for Pump and Actuator (with dust cap) | | | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | 2. | Pump dimensions | Neck of Pump | Specify Neck size and type | | | | Material of construction of Pump | Specify details of each co | mponent | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | Pump closure OD, mm | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | Dip tube length, mm | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | Pump output, mcl or stroke | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | 3. | Pump dimensions | Gasket thickness, mm | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | Pump and bottle fitment | As per approved sample | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | Strokes to prime | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | 4. | Dimensions of | Actuator OD (at base), mm | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | Actuator & | Actuator shoulder height, mm | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | Dustcap | Total actuator + over cap height, | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | mm | | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | Total actuator (without over | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | cap)height, mm | | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | Weight of actuator, gm | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | Weigh to fovercap, gm | Specify | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ | | | Pump and Actuator Fitment | As per approved sample" | +-----------------------------------------+-------------------------------------------------+-------------------------------------------------+----------------------------+ [F. No. T.11011/3/2023-DCC] Dr. KOUSTHUBHA UPADHYAYA, Adviser (Ayurveda) Note: The principal rules were published in the Gazette of India, vide, notification No. F. 28-10/45-H(1), dated the 21st December, 1945 and last amended, vide, notification number G.S.R. -669 (E), dated the 28.10.2024.