14th February 2025, G.S.R. 140(E)

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14th February 2025, G.S.R. 140(E)

Here’s a simplified, pointwise breakdown of the draft amendment to the Drugs Rules, 1945, as published in the Gazette by the Ministry of AYUSH on February 14, 2025:

1. Short Title and Commencement:
– The rules will be called the Drugs (Amendment) Rules, 2025.
– They will come into effect on the date of final publication in the Official Gazette.

Omission of Provisos:
The following provisos will be removed from the existing rules:
2. Rule 156
3. Rule 156A
4. Rule 157 (1C)

5. New License Number Format:
A new uniform license number format will be implemented:
– Format: State code / D/E (License/Loan license) / serial number / system (classical or PP) / product serial number / licensing year.
– The manufacturing license number must be included in all advertisements (print, electronic, social media).
– Existing license numbers must be re-issued in this new format within one year.

6. Qualifications for Experts:
Rule 160B – Modification in qualifications:
– Replace “sub-clause (b)” with: Experts should be graduates in Ayurveda, Siddha, or Unani recognized under relevant acts, or graduates in pharmacy (Ayurveda/Siddha/Unani).
– Add new qualification: Microbiologists must have at least a Bachelor’s in Microbiology plus six months of quality control experience, or a postgraduate degree in Microbiology.

7. Label Information Requirements:
Rule 161 :
– Add a requirement for readable label information in a font size of at least ‘nine point’.
– Allow ingredient details to be displayed via QR code as an alternative.

8. Drug Approval Procedures:
Rule 161B – If drugs are approved based on accelerated stability studies:
– A self-declaration for real-time stability study submission is required.
– Licensees determine shelf-life based on accelerated study reports.
– Shelf-life beyond two years requires a real-time stability study.
– For changes in dosage forms of classical medicines, stability study data must support expiry dates.

9. Inspection Requirements:
Rule 162: Inspectors must check all premises for compliance based on a risk-based approach.

10. Laboratory Regulations:
Rule 163-B(B):
– Remove redundant terminology related to subsection references.
– NABL accredited drug testing laboratories will act as the Central Drug Laboratory.

11. Inspector Qualifications:
Rule 167: Inspectors must have degrees in Ayurveda, Siddha, Unani, or Ayurveda Pharmacy from recognized institutions.

12. Labeling for Base Material:
Rule 169: Base material quantity must also be mentioned on the product label.

13. Amendment to Schedule M-I

i) General Requirements (Paragraph 1):

(A) Cleaning and Sanitation:

  • Change the term “cleared periodically” to “cleaned and sanitized periodically.”
  • Ensure drainage systems prevent back siphonage and back flow.

(1.2) Building Requirements:

  • Premises must only be used for manufacturing homoeopathic drugs.
  • No part of the manufacturing area can serve another purpose.
  • Any additional facilities must be in separate buildings with valid licenses.
  • Dedicated storage for raw materials and finished products must be maintained, and these materials cannot enter production areas without Quality Control (QC) approval.
  • Heating, washing, drying, packing, and labeling of products must be done in designated areas.
  • Manufacturing areas need smooth, washable walls and floors, designed to minimize dust accumulation.

(a) Room Requirements:

  • Manufacturing areas should ensure a controlled, clean environment.
  • Incoming air should be filtered through a minimum 5-micron filter.
  • Cleaning and sanitation of production areas must occur after each batch, and QC clearance is required before starting a new batch.
  • Maintain suitable temperature and humidity for personnel comfort and product integrity.
  • Ensure well-lit production areas and install flame-proof electrical fittings where necessary.
  • Implement measures to prevent mix-ups and cross-contamination.

(b) Water Specifications:

  • A validated system for water treatment must meet the Bureau of Indian Standards.
  • Purified water must be used for production; potable water may only be used for cleaning.
  • Water storage tanks should prevent microbiological growth and be cleaned regularly.

(c) Waste Disposal:

  • Sewage and effluent disposal must align with Environment Pollution Control Board requirements.
  • Biomedical waste must be managed according to the Bio-Medical Waste (Management and Handling) Rules, 1996.

(d) Compliance with Factories Act:

  • Adhere to the provisions of the Factories Act, 1948.

(e) Medical Services:

  • All staff involved in drug manufacturing must undergo medical examinations and be free from communicable diseases.
  • Regular health checks are required at least annually.

(f) Safety Measures:

  • Provide easy access to first-aid facilities and train staff on first-aid procedures.
  • Install appropriate fire control equipment and ensure compliance with local fire safety regulations.
  • Conduct regular fire safety training for staff.

(g) Workbenches:

  • Workbenches must be created from stainless steel, easy to wash, and not made of wood or plastic.

(h) Container Management:

  • Establish procedures for receiving, washing, and drying containers.
  • Ensure cleaning agents are completely removed from containers before use.
  • Use neutral glass containers and inert materials for closures.
  • Maintain protective packaging for products sensitive to moisture or odor.

(ii). Plant and Equipment (Paragraph 2):

2.1 General Design:

  • The plant must allow unidirectional workflows, with machinery spaced to avoid mix-ups and contamination.
  • Separate entrances for personnel and materials; controlled access to manufacturing areas.
  • Provide personal hygiene facilities, separate lockers, and change areas for staff.
  • Issue uniforms that can be easily washed and do not shed fibers.
  • No food or dining in manufacturing areas; designate eating areas away from production.

2.2 Labeling and Documentation:

  • Clearly label all containers and batches used in manufacturing.
  • Maintain records for equipment maintenance, training, and monitoring.

Pest Control:

Implement measures to prevent pests, and maintain a fly-proof environment.

Material Handling:

Materials should be stored off the ground, on raised platforms, and adequately labeled.

Clearly separate the storage and handling of materials with strong odors.

Quality Control:

A dedicated laboratory for quality control must operate independently from production.

Separate responsibilities must be maintained between production staff and quality assurance personnel.

(iii) Equipment and Facilities Requirements (Paragraph 3):

(A) Potentisation Section Requirements:

  • Stainless steel workbenches with smooth, washable surfaces are required.
  • Store various potencies in filtered air areas.
  • Use devices for measuring potencies under horizontal laminar airflow for safety.
  • Provide a space of at least 20 square meters for this section.

Notes:

  • Using a potentiser is optional; manual procedures are also acceptable.
  • Maintain records of back-potencies from licensed manufacturers.
  • Ensure proper labeling of containers to prevent mix-ups.

(B) Containers and Closures Section (3.3)

  • Facilities Required:
    • Preparation Area: A dedicated area adjacent to the potentisation section for containers and closures.
    • Washing/Preparation Equipment:
      • Washing tanks with brushes (mechanical or hand-operated).
      • Bottle washing machines (rotary/linear).
      • Air-jet machines for cleaning.
      • Rinsing tanks using purified water.
      • Tanks specifically for washing or macerating closures.
      • Dryers for drying washed containers and closures.
  • Notes on Containers:
    • Use different droppers for each medicine and potency.
    • All measuring instruments must be in the metric system and made from neutral glass or stainless steel.
    • Metal or plastic droppers are prohibited.
    • Glass droppers can only be reused after proper cleaning, sterilization, and clearance from the Quality Control (QC) and Quality Assurance (QA) section.
    • Potentisation must follow methods specified in the Homoeopathic Pharmacopoeia of India.

(C) Trituration, Tableting, Pills and Globules Making Sections (3.4)

  • 3.4 Basic Equipment Required:
    • Triturating machine made from corrosion-resistant materials.
    • Disintegrator.
    • Mass mixer.
    • Granulator.
    • Electrical oven.
    • Tablets punching machine (must include effective dust control to prevent cross-contamination).
    • Kettle for preparing solutions (can be steam or electrically heated).
    • Dryers for granules and tablets.
    • Sieved separator (stainless steel).
    • Tablet counter.
    • Balances (scales).
    • Coating pan with spray-gun.
    • Multi-sifter.
    • Mill with perforations.
  • Area Requirements:
    • Minimum space of 55 square meters, organized into cubicles to minimize cross-contamination and mix-up.
    • Manufacturing of medicated tablets in 1X potency must be done in hygienic conditions.
    • Obtain the necessary licenses for the production of globules.
  • Notes: The working area must be free from insects, rodents, dust, and moisture.

(D). Syrups and Other Oral Liquids Section (3.5)

  • New Requirements:
    • A separate area for the preparation of syrups and for washing bottles using machines or air-jet cleaning methods.
    • Designated areas for primary packing, labeling, secondary packing, and tertiary packing.

(E). Ophthalmic Preparations Section (3.7)

  • 3.7 Required Equipment:
    • Hot air oven (electrically heated) with thermostatic control.
    • Horizontal laminar air flow bench.
    • Air handling unit with HEPA filters for filtered air and positive pressure.
    • Maintain temperature (27±2°C) and humidity (55%±5).
    • Ointment mill/colloidal mill.
    • Mixing and storage tanks (304-grade stainless steel).
    • Pressure vessels as needed.
    • Sintered glass funnels, Seitz filters, or filter candles.
    • Vacuum pump.
    • Filling machines for liquids and ointments.
    • Autoclaves with pressure and temperature gauges.
    • Necessary workbenches and a visual inspection bench.
  • Area Requirements: Minimum area of 20 square meters for basic installations.
  • Notes:
    1. Clean room facility must meet ISO Class 5 standards (ISO 14644-1).
    2. Air-conditioning and humidity control are required.
    3. Entry to sections must be regulated with air-locks.
    4. Materials should be passed through hatches.
    5. Personnel must wear sterile clothing that does not shed fibers.
    6. Phial washing must be done in separate areas with appropriate equipment.
    7. Designated areas for packing and labeling are necessary.

(iv). Quality Control Division (Paragraph 4)

4.1 Functions:
– A separate quality control division is mandated, supervised by an approved technical officer, independent from the manufacturing division.
Responsible for:
1. Sampling, testing, documentation, and ensuring compliance with legal/pharmacopeial standards.
2. Conducting or outsourcing stability studies and maintaining relevant records.
3. Dividing the QC laboratory into areas for chemical, instrumental, and microbiological testing.
4. Performing in-process quality checks.

Overall Duties:
1. Testing and approving raw materials and finished products.
2. Preparing and validating analysis methods, monitoring equipment use.
3. Prescribing SOPs related to quality.
4. Investigating quality complaints and recommending actions.

4.2 Personnel Requirements:
– Full-time quality control staff with appropriate qualifications (degree in Homoeopathy/Pharmacy or relevant sciences with practical experience).
– Specialty in microbiology requires a Bachelor’s or postgraduate degree with relevant experience.

4.3 Equipment Requirements:
– Necessary laboratory equipment tailored to approved dosage forms includes microscopes, balances, ovens, distillation apparatus, and other analytical instruments.

(v) Raw Materials

(A) New Requirements:

  1. Quarantine and Storage:
    • Quarantine: All incoming materials must be quarantined immediately upon receipt or processing.
    • Storage Conditions: Materials should be stored in an orderly manner, allowing for segregation and stock rotation based on the ‘first in/first out’ principle, paying attention to batch expiry.
  2. Purchase from Approved Sources:
    • All incoming materials must come from approved suppliers and should be accompanied by valid purchase vouchers.
  3. Receipt and Examination:
    • Authorized personnel (including Quality Control staff) must check each consignment upon receipt for:
      • Package integrity and seal integrity.
      • Identification of damaged containers, which should be recorded and segregated.
  4. Batch Handling:
    • If a delivery consists of multiple batches, treat each batch as a separate unit for sampling, testing, and release.
  5. Labeling of Storage:
    • All raw materials in storage must be clearly labeled with:
      • Designated product name and internal code.
      • Manufacturer’s name, address, and batch number.
      • Status of contents (e.g., quarantine, under test, released, approved, rejected).
      • Manufacturing, expiry, and re-test dates.
  6. Designated Areas:
    • Have separate designated areas for:
      • Materials “under test”
      • Approved materials
      • Rejected materials
    • These areas must be equipped for clean, dry, orderly storage, maintaining controlled temperature and humidity.
  7. Identification of Sampled Containers:
    • Containers from which samples have been taken should be clearly identified.
  8. Usage of Raw Materials:
    • Only use raw materials that have been released by the Quality Control Department and are within their shelf life. Ensure the formulation’s shelf life does not exceed the shelf life of the raw materials.
  9. Storage Practices:
    • All raw material containers must be placed on raised platforms or racks made of High Density Polyethylene (HDPE) or equivalent—not directly on the floor. Use of wooden structures for storage is prohibited.

(B) Omissions: Sub-paragraphs 5.1(a)(ii) and 5.1(b)(ii), (iii) will no longer apply.

(C) 5.2 Storage of Flammable and Hazardous Chemicals:

  • After existing provisions in sub-paragraph 5.2, add:
    • Dedicated Areas: Store flammable and hazardous materials in separate areas.
    • Staff Training: Ensure staff are trained in handling these chemicals and that handling is done under proper laboratory safety or fume hoods.

(D) 5.4 Sarcodes:

  • Substitute the current sub-paragraph with:
    • Sarcodes must be collected from healthy animals, meeting pharmacopoeial specifications.
    • Materials must be packed and transported under hygienic conditions and stored at controlled temperatures to avoid contamination.
    • Ensure testing for pathogenic organisms (e.g., E.Coli, Salmonella) is part of the process.

(vi) Laboratory Controls (paragraph 7):

  • Substitute the current paragraph with:
    • Perform tests per pharmacopoeial requirements on materials and products.
    • Establish product stability according to approved guidelines from the Government of India.
    • Conduct sterility tests where applicable.
    • Preserve control samples for a minimum of three years after the last sale.

(vii) Packing and Labelling (paragraph 8):

  • Substitute the current paragraph with:
    • Provide a minimum area of 50 square meters for the packing and labeling section.
    • All labels must receive Quality Control approval prior to use.
    • Ensure labels comply with all relevant laws and are stored in temperature-controlled environments to prevent degradation.

(viii) Standard Operating Practices (paragraph 10):

  • Substitute the current paragraph with:
    • Develop Standard Operating Practices (SOPs) for all activities including receipt, identification, cleaning, drying, warehousing, issuing, handling, and sampling of materials.
    • Write SOPs in both English and a local language.
    • Inspect and document labels and packing materials for compliance.
    • Maintain records of printing and usage of labels and packing materials.
    • Conduct regular training for staff on SOPs and maintain records of training.

(ix) Records and Registers (paragraph 11):

  • Substitute the current paragraph with:
    • Maintain comprehensive records for all operational activities including:
      • Production records.
      • Raw material records.
      • Testing records.
      • Sales and supply records.
      • Records of rejections, complaints, actions taken, SOP compliance.
      • Logbooks for equipment.
      • Master formula records.
      • Medical examination records for personnel.
    • Keep all records for one year beyond the expiry of a batch or for three years, whichever is longer.
    • Maintain files of staff-related records and training documentation.

14. Amendments to Schedule T

(i) In Paragraph 1

(A) Update to Item (iv):

  • After the phrase “acceptable quality”, insert the word “and”.

(B) Substitute Item (v):

  • New item (v):
    • Manufacturing Procedures: Each licensee must develop and document methodologies and procedures for the manufacturing, packaging, and quality control processes of drugs. This documentation should be kept as a manual available for reference and inspection.
    • Exemption Clause: Registered Vaidyas under the IMCC Act, 1970 or the National Commission for Indian System of Medicine (NCISM) Act, 2020 (14 of 2020) are exempt from the requirements of Good Manufacturing Practices (GMP) as long as they are not selling such drugs in the market.

(ii) In Part-I Relating to ‘Good Manufacturing Premises’

(A) Factory Premises:

  • Factory premises must include designated areas for:
    1. Receiving and storing raw and packaging materials.
    2. Manufacturing process areas.
    3. Quality control section.
    4. Finished goods storage.
    5. Office space.
    6. Storage for rejected goods/drugs.
    7. Ancillary areas.

(B) General Requirements:

  • 1.1(A) Location and Surroundings:
    1. Minimize Errors: Layout and design must prevent errors and allow effective cleaning and maintenance.
    2. Dust Control: Areas where dust is generated must address the risk of cross-contamination.
    3. Environmental Risk Management: Ensure the premises are designed to minimize contamination risk to materials/products.
    4. Sanitation: Ensure that premises facilitate good sanitation practices.
    5. Maintenance: Ensure that maintenance does not compromise product quality.
    6. Cleaning Protocols: Establish written procedures for cleaning and pest control.
    7. Environmental Controls: Proper electrical supply, lighting, temperature, humidity, and ventilation must be maintained.
  • 1.1(B) Buildings:
    1. Design Requirements: Windows, fittings, and similar installations should prevent the accumulation of dust and contaminants.
    2. Hygienic Production: Buildings must facilitate drug production under hygienic conditions and be free from pests.
    3. Adequate Lighting and Ventilation: Ensure there is proper light and ventilation throughout the facility.
    4. Moisture Control: Walls and floors must not be damp or moist.
    5. Compliance with Factory Act: Manufacturing facilities must comply with the Factory Act, 1948.
    6. Location Compatibility: Choose a location compatible with other operations to avoid contamination and facilitate workflow.
    7. Insect Control: Implement measures to prevent the entry of insects, birds, and rodents.
    8. Smooth Finishes: Ensure surfaces are smooth and easy to clean.
    9. Proper Drainage: Install drainage systems to manage waste and prevent contamination.
    10. Fire Safety: Ensure adequate fire safety measures and regular training on fire control equipment usage.
  • 1.1(C) Water Supply:
    1. Adequate Provision: Ensure sufficient supply of potable water.
    2. Quality Compliance: Water used in manufacturing must meet pharmacopoeial specifications.
    3. Cleaning Uses: Potable water may be used for washing and cleaning.
    4. Water Treatment Validation: Document and validate the water treatment system where applicable.
    5. Microbial Monitoring: Monitor storage tanks for microbial growth.
    6. Record Maintenance: Keep records of validation and testing of water systems.
    7. Water System Documentation: Maintain schematic drawings and sanitation descriptions of water systems.
  • 1.1(D) Waste and Effluent Disposal:
    1. Compliance with Regulations: Dispose of sewage and effluents per Environmental Pollution Control Board requirements.
    2. Biomedical Waste Management: Ensure biomedical waste is disposed of as per Bio Medical Waste (Management and Handling) Rules, 1996.
    3. Rejected Drug Storage: Special precautions for storage and disposal of rejected drugs, especially those with E1 ingredients.
    4. Record Keeping: Maintain records of all waste disposal activities.
    5. Storage for Disposal: Provide safe storage for waste materials awaiting disposal.
    6. Hazardous Materials: Store hazardous and flammable materials in designed, enclosed areas.
  • 1.1(E) Container Cleaning:
    • For operations involving containers (bottles, vials, jars), designate separate arrangements for washing, cleaning, and drying or air jet cleaning.
  • 1.1(F) Storage Requirements:
    1. Ventilation and Conditions: Ensure proper ventilation and acceptable temperatures to inhibit dampness and insect breeding.
    2. Sufficient Capacity: Storage should allow for orderly separation of materials (raw, intermediate, bulk, finished, quarantined, rejected).
    3. Clean and Controlled Environment: Storage areas must be clean, dry, well-lit, and maintained within acceptable temperature limits.
    4. Receiving and Dispatch Protection: Ensure protection from weather at receiving and dispatch areas.
    5. Quarantine Marking: Clearly mark quarantine storage areas and restrict access to authorized personnel.
    6. Segregation for Rejected Materials: Maintain segregation for storage of rejected, recalled, or returned materials.
    7. Warehouse Auditing: Conduct periodic audits of warehouses and maintain records.
    8. Flammable Storage: Segregate and store flammable substances in restricted, secure areas.

1.1(F) Storage and Handling of Materials

(F)(A) Raw Materials

  1. Storage Requirements:
    • All raw materials must be stored in a dedicated raw materials store.
  2. Quality Assurance:
    • Intermediate and semi-processed raw materials must only be procured from GMP-certified facilities, and purchase vouchers must include manufacturing license details.
  3. Verification of Consignment:
    • Incoming materials must be checked to confirm they match the order specifications and should be purchased from approved sources under valid purchase vouchers.
  4. Quarantine Procedures:
    • All incoming materials should be quarantined immediately upon receipt.
  5. Storage Conditions:
    • Containers must be placed on raised platforms/racks made of High Density Polyethylene (HDPE) or equivalent—wood is not permitted.
  6. Batch Handling:
    • For deliveries comprising multiple batches, treat each batch separately for sampling, testing, and release.
  7. Container Specifications:
    • Appropriate containers should be selected based on the characteristics of the raw material to prevent damage from dampness, microbiological contamination, or pests. Stainless Steel (SS) grade 304 is preferred.
  8. Environmental Controls:
    • If specific raw materials require controlled environmental conditions, raw material stores may be subdivided with suitable enclosures.
  9. Categorization of Raw Materials:
    • Special handling for various categories, including but not limited to:
      • Metallic and mineral origin
      • Animal sources
      • Fresh or dry herbs
      • Excipients
      • Volatile oils and plant extracts
    • Inflammable substances must be stored in secure areas.
  10. Labeling:
    • Each storage container must be labeled to indicate raw material name, source, status (color-coded: Yellow for “Under Test”, Green for “Approved”, Red for “Rejected”), and include batch/lot number, receipt date, expiry date, and retest date.
  11. Sampling for Quality Control:
    • Dedicated areas for sampling of raw materials and excipients to prevent contamination; all sampling must adhere to written SOPs.
  12. Testing and Approval:
    • Sampled raw materials must be tested by qualified personnel or approved laboratories and can only be used after approval.
  13. Handling Rejected Materials:
    • Rejected raw materials should be removed from the store and kept in a separate area until disposal, following written SOPs.
  14. Inventory Management:
    • Implement procedures for ‘First In First Out (FIFO)’ and ‘First Expired First Out (FEFO)’ for managing raw materials.
  15. Restricted Access:
    • Access to quarantine and recalled/returned goods must be limited to authorized personnel.
  16. Record Keeping:
    • Maintain comprehensive records for the receipt, testing, approval/rejection, and usage of raw materials.

(F)(B) Packaging Materials

  1. Storage Requirements:
    • All packaging materials (bottles, labels, cartons) must be segregated and securely stored.
  2. Status Labeling:
    • Use color-coded status labels (Yellow for “Under Test”, Green for “Approved”, Red for “Rejected”) on packaging materials.
  3. Pre-Packing Procedures:
    • Ensure all containers and closures are adequately cleaned and dried before use in packing.

(F)(C) Finished Goods Stores

  1. Quarantine Procedures:
    • Finished goods should be transferred to a designated area marked “Quarantine” after packaging.
  2. Quality Control Check:
    • Only after the approved quality control personnel confirm the compliance of finished goods with labeling and quality requirements shall they be moved to the “Approved Finished Goods Stock” area.
  3. Processed Goods:
    • Only approved finished goods can be dispatched as per marketing requirements.
  4. Distribution Records:
    • Maintain records of all distribution activities.
  5. Special Storage Conditions:
    • Stores must provide necessary environmental controls for finished goods requiring special conditions.

1.1(G) Working Space

  1. Adequate Space:
    • Manufacturing areas must allow smooth passage and logical placement of equipment and materials to prevent mix-ups or cross-contamination.
  2. Flow Maintenance:
    • Aim for unidirectional flow in operations wherever possible.
  3. Entry Control:
    • Separate entry points for personnel and materials should be established, ideally with an airlock facility.
  4. Crossover Benches:
    • Personnel should enter through crossover benches to minimize contamination risks.
  5. Usage Restrictions:
    • Manufacturing areas must not be used for dining or other non-manufacturing-related activities.
  6. Sanitation Procedures:
    • Regular sanitation of manufacturing areas must utilize disinfectants based on complex silver ions and hydrogen peroxide.
  7. Sanitation Records:
    • Maintain records of all sanitation activities performed.

1.1(H) Health, Clothing, Sanitation, and Hygiene of Workers

  1. Health Monitoring:
    • Ensure all workers are free from contagious diseases.
  2. Prohibited Activities:
    • Smoking, eating, storing food, and using tobacco in working areas are prohibited.
  3. Uniform Regulations:
    • Employees must wear clean uniforms suited for their work, with provisions for proper hygiene.
  4. Jewelry and Nail Polish:
    • Discourage wearing jewelry and prohibit nail polish in manufacturing areas.
  5. Personal Cleanliness:
    • Provide facilities for personal hygiene, including soap, hand sanitizers, and towels.
  6. Separate Lavatory Facilities:
    • Maintain separate lavatories for men and women, away from processing areas.
  7. Changing Facilities:
    • Provide facilities for workers to change clothes and store personal belongings safely.

1.1(I) Medical Services

  1. First Aid Facilities:
    • Provide adequate first aid facilities, including Ayush drugs.
  2. Medical Examinations:
    • Conduct medical exams for employees at hiring and annually thereafter to ensure freedom from infections.
  3. Health Records:
    • Maintain records of medical examinations, particularly for those involved in drug manufacturing and handling.

1.1(J) Machinery and Equipment

  1. Equipment Suitability:
    • Provide suitable equipment (manual, semi-automatic, or automatic) based on operational needs.
  2. Logical Layout:
    • Machinery should be arranged in a uniflow for operational efficiency.
  3. Adequate Space Between Machinery:
    • Ensure sufficient spacing for ease of movement and maintenance.
  4. Installation and Maintenance:
    • Ensure all machinery is properly installed and maintained, with SOPs established for cleaning and operations.
  5. Record Keeping:
    • Maintain records for equipment cleaning and maintenance activities.

1.1(K) Batch Manufacturing Records (BMR)

  1. Detailed Documentation:
    • BMRs must reflect all details concerning raw material usage, analytical numbers, manufacturing processes, and related tests.
  2. Procedure Records:
    • Record how traditional methods like “Bhavana,” “Mardana,” and “Puta” were executed.
  3. Machine Cleanliness:
    • Document the cleanliness status of all machines before use.
  4. Calibration Records:
    • Maintain calibration records for machinery separately.
  5. Personnel Documentation:
    • Include names and signatures of personnel involved in manufacturing in the BMR.
  6. Line Clearance Approval:
    • Ensure authorized personnel conduct line clearance before starting manufacturing, filling, and packing.
  7. Packaging Records:
    • Document the quantities of packaging materials ordered, used, rejected, and returned.
  8. Yield Records:
    • Specify both theoretical and actual yield of the finished product.
  9. Quality Control Release:
    • Ensure quality control release is documented post-testing as per specifications.

1.1(L) Distribution Records

  • Record-Keeping:
    • Maintain detailed records for the transfer, sale, and distribution of each batch of Ayurvedic, Siddha, and Unani drugs to facilitate recalls if necessary.

1.1 (M) Record of Market Complaints

  1. Complaint Register:
    • Manufacturers must maintain a register to record all market complaints regarding products sold.
  2. Data Recording:
    • Document all received complaints, investigation details, and corrective actions initiated to prevent recurrence.
  3. Reporting to Licensing Authority:
    • Manufacturers must submit records of complaints to the licensing authority every six months.
  4. Inspection Availability:
    • The complaint register must be available for inspection during any regulatory inspection.
  5. Adverse Drug Reactions (ADR):
    • Licensees must establish a pharmacovigilance system to collect, process, and communicate ADR reports to the licensing authorities.

1.1 (N) Quality Control

  1. Quality Control Facility Requirements:
    • Every licensee must establish a quality control section on their premises or utilize a State/UT Government-approved testing laboratory.
    • Tests must comply with the Ayurveda, Siddha, and Unani pharmacopoeial standards; if unavailable, manufacturers’ specifications should be followed.
  2. Responsibilities of Quality Control Personnel:
    • Quality control personnel are responsible for testing raw materials, monitoring in-process quality checks, and verifying finished products before release.
  3. Quality Control Section Facilities:
    • A minimum area of 150 square feet for the quality control section.
    • Reference books and samples must be maintained for raw drug identification.
    • Analytical records for various processes must be kept.
    • Controlled samples of finished products must be retained for three years.
    • Monitor storage conditions for raw materials and finished products.
    • Establish records for shelf life and storage requirements for drugs.
  4. Specifications for Proprietary Medicines:
    • Manufacturers of proprietary Ayurveda, Siddha, and Unani medicines should define their specifications and control references per formulated drugs.
  5. Compliance with Standards:
    • Follow identity, purity, and strength standards as per relevant pharmacopoeias.
    • Monitor raw materials for fungal and bacterial contamination.
  6. Quality Control Section Personnel:
    • Include a team comprising:
      • An expert in Ayurveda/Siddha/Unani medicine (with recognized qualifications).
      • A chemist with a Bachelor’s degree in science or pharmacy.
      • A pharmacognosist (botanist) with a Bachelor’s degree in relevant fields.
      • A microbiologist with appropriate qualifications and experience.
  7. Internal Audit Mechanism:
    • Manufacturers must develop an internal audit mechanism.
    • Quality control can also be achieved by outsourcing tests to recognized laboratories under Drug and Cosmetics Act rules.
  8. Process Validation:
    • Validation must be conducted for all processes, equipment, and testing methods according to written SOPs, particularly when changes occur.

1.1 (O) Training

  1. Training Provisions:
    • All personnel must receive adequate training relevant to their duties in Ayurvedic, Siddha, and Unani systems, as well as related areas (e.g., microbiology, hygiene, complaint handling).
  2. Record Keeping:
    • Maintain records of training and evaluate the effectiveness of training programs periodically.

1.1 (P) Qualification and Validation

  1. Qualification Section:
    • Establish a section for the qualification and validation of equipment, processes, testing procedures, and cleaning and maintenance SOPs.
  2. Calibration Requirements:
    • Regular calibration of measuring and analytical instruments should be performed at an appropriate frequency.
  3. Change Control System:
    • Implement a formal change control system to assess the potential impact of changes on product quality, guided by scientific judgment.

1.1 (Q) Internal Audits (Self-Inspection)

  1. Internal Audit Compliance:
    • Conduct regular internal audits to ensure compliance with GMP principles as per an approved schedule.
  2. Documentation of Findings:
    • Document audit findings, corrective actions, and communicate these to responsible management for timely resolution.

1.1 (R) Regulatory Amendments in Part-II

(A) Recommended Machinery and Equipment Amendments

  1. Substitution in Equipment Description:
    • The description for equipment serial no. 4 is amended from “Kupi pakava/Ksara/Parpati/LavanaBhasma/Satva/Sindura/Karpu/Uppu/Param” to “Ksara/Lavana/Satva (plant origin)/Uppu”.
  2. New Equipment Categories Inserted:
    • Additional Categories:
      • Saundaryaprasadhak: 100 sq. ft.
        • Equipment: Mixing and heating tank, filling machine,
      • Swarasa: 100 sq. ft.
        • Equipment: Juicer grinder, filter, mixing tank, packaging equipment.
      • AushadhaGhana/Extracts: 200 sq. ft.
        • Equipment: Boiler, extractor, condenser, receiver, distillation, tray dryer, vacuum dryer, grinder, blender, shifter.
      • Nasal Spray: 300 sq. ft.
        • Requires reverse laminar airflow, weighing balances, manufacturing vessel, bulk holding vessel, diaphragm pump, and specific sterilizing equipment.
    • Equipment Standards:
      • Use Stainless Steel (SS) grade 304 and above. The list of machines is indicative, and manufacturers can use technologies that meet their requirements.

(B) Supplementary Guidelines for Rasaushadhis

  1. Supplementary Guidelines Overview:
    • Guidelines complement the primary manufacturing requirements and outline minimum standards for quality assurance in Rasaushadhis or Rasamarunthukal and Kushtajat formulations.
  2. Quality Assurance Focus:
    • Emphasize authenticity of raw materials, in-process validation, and quality control measures aligned with classical texts for safe processing.
  3. Environmentally Conscious Practices:
    • Adhere to guidelines for the safe handling of hazardous substances, especially for materials like Mercury, Lead, and Arsenic, following environmental management protocols issued by the Central Pollution Control Board.

(C) 2. Manufacturing Process Areas

  1. Separation of Manufacturing Areas:
    • Separate areas must be provided for the manufacture of Bhasma, Kupipakwa, and Rasaushadhi preparations derived from metals and minerals, distinctly separate from plant and animal ingredient-based formulation areas to prevent cross-contamination.
  2. Specific Area Requirements:
    • 2.2(a) Bhatti or Heating Device Section:
      • Size: 100 sq. feet.
      • Must include ventilation and exhaust systems compliant with National Ambient Air Quality Standards (NAAQS).
      • Designed to accommodate batch sizes in compliance with the Drug and Cosmetics Act, 1940.
    • 2.2(b) Grinding, Drying, and Processing Section:
      • Size: 100 sq. feet.
      • Can be manual or mechanical; should allow sunlight or have suitable temperature-controlled drying.
      • Use appropriate materials and designs for drying to prevent quality degradation.
    • 2.2(c) Rasaushadi Related Store:
      • Size: 100 sq. feet.
      • Appropriate heating methods should be used to achieve required temperatures.
      • Ensure safe handling of materials that generate toxic fumes with adequate ventilation and smoke scrubbing systems.
      • Develop SOPs for cleaning and managing hazardous spills to protect the environment.
  3. Temperature Records:
    • Maintain records of temperatures during the entire Bhasmikaran and Kupipakwarasayana processes. Use appropriate temperature measurement devices; document data on Batch Manufacturing Records (BMR).
  4. Technology Utilization:
    • Appropriate technology (e.g., hand-operated extruders for creating chakrikas) may be utilized, ensuring equipment is not made of aluminum or its alloys.
  5. Restricted Access:
    • Access to the manufacturing areas should be limited to authorized personnel only.

(D) B. Product Quality Control

  1. Focus on Specifications:
    • Quality control must prioritize ensuring consistency in the use of starting materials that meet pharmacopoeial standards.
  2. Quality Testing:
    • Testing will conform to official pharmacopoeias for various characteristics including color, taste, and other physical properties.
    • Records of all tests conducted must be maintained.
  3. Master Formula and Characterization:
    • Develop and adhere to a master formula for each product.
    • Test particle size and carry out necessary physio-chemical characterization.
  4. Standard Manufacturing Procedures:
    • Establish standardized manufacturing processes, including monitoring the disintegration time of medicines.

(E) 4. Product Recalls

  1. Adverse Drug Reaction Reporting:
    • Product packages must include contact information for reporting adverse drug reactions.
  2. Recall Procedures:
    • Upon receiving reports of adverse drug reactions, manufacturers are responsible for investigating and, if necessary, recalling affected products.
  3. Storage Procedures for Recalled Products:
    • Establish SOPs for securely segregating recalled products in a compliant storage area until final disposal.

(F) 5. Medical Examination of Employees

  1. Regular Medical Examinations:
    • Employees working with Rasaushadhi must undergo annual medical check-ups to monitor for occupational hazards affecting vital organs.
  2. Record Maintenance:
    • Maintain medical examination records for review during GMP inspections, and ensure personnel are rotated to reduce exposure.

(G) 6. Self-Inspection

  1. Personnel Qualifications:
    • Rasaushadhi release control must be overseen by trained individuals in processing and quality assurance, holding appropriate academic qualifications in Ayurveda/Siddha/Unani fields.

(H) Dosage Forms of Rasaushadhi

  • The relevant terminology is updated to reference “Rule 169 of the Drugs Rules, 1945” in place of previous references.

(I) Entries in Machinery and Equipment Table

  • Update entry for S.No 4 in column 2 to include “Kupi Pakva/Parpati/Dhatu Satva/Sindura Karpu/Param.”

Disclosure

Important Notice: Simplified Version of Regulation Updates

This simplified version of the recent regulation updates is provided solely for general understanding and informational purposes. It may not contain all the specific details or true information as presented in the original e-gazette.

For comprehensive and accurate information, we strongly recommend visiting the original gazette document. Additionally, before implementing any changes or actions based on these updates, please consult with qualified experts to ensure compliance and proper understanding of the regulations.

The information contained herein is not a substitute for professional advice.

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