GMP-Info

Gute Herstellungspraktik (GMP)

Hier der Originaltext der GMP-Bestimmungen Indiens für Produzenten Ayurvedischer Produkte. Entgegen anderslautender Behauptungen ist an keiner Stelle und für kein Produkt die Verwendung von Benzoe vorgeschrieben oder vorgeschlagen. Uns wurde auch von Prof. Dr. Sasidharan (Leiter der Klinik in Trivandrum, Kerala) und vom staatlichen Drug Inspektor von Trivandrum sowie einigen weiteren hochrangigen Ayurvedaexperten in Indien versichert, dass es keinerlei solche Bestimmungen gibt. (Benzoe ist im Übrigen lt. Aussage unseres Prüfinstitutes LEFO in Kleinstmengen in einigen Früchten (etwa Preiselbeeren) natürlich vorhanden).

DRUGS AND COSMETICS (AMENDMENT)

RULES, 2000

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Indian Systems of Medicine & Homeopathy)

(*Published in the Gazette of India Extraordinary Part n Section 3 subsection (i) vide G.S.R.560 (E) dated 23.6.2000.)

NOTIFICATION

New Delhi, the 23 rd June, 2000

*G.S.R. 560 (E).— Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published as required by section 33-N of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India Extraordinary Part-II Section 3, Sub-section (i ) dated the 24 th May, 1999, vide No'. G.S.R. 384(E) inviting objections and suggestions from persons likely to be affected thereby and notice was given that the said draft will be taken into consideration after the expiry of a period of forty five days from the date on which copies of the Official Gazette containing the notification were made available to the public;

And whereas the said Gazette was made available to the public on 14 th May, 1999;

And whereas objections and suggestions from the public on the said draft have been considered by the Central Government;

Now, therefore, in exercise of the powers conferred by section 33-N of the said Act, the Central Government, after consultation with the Ayurveda, Siddha and Unani Drugs Technical Advisory Board hereby makes the following further amendments in the Drugs and cosmetics Rules, 1945, namely:-

RULES

(1) These rules may be called the Drugs and Cosmetics (Amendment) Rules, 2000.

      They shall come into force on the date of their publication in the official Gazette:

      Provided that in the case of Ayurveda, Siddha and Unani units which have been   

      rules shall come into force after two years from the date of such commencement.

(2) In the Drugs & Cosmetics rule, 1940,

(a) after rule 155-A, the following rule shall be inserted, namely :--

" 155-B Certificate of award of G.M.P. of Avurveda. Siddha and Unani Drugs: The certificate of Good Manufacturing Practices to manufacturers of Ayurved-Siddha or Unani drugs shall be issued to licensee who comply with the requirements of Good Manufacturing Practice of Ayurveda, Siddha and Unani drugs as laid down in   Schedule T.

(b) in rule 157, after condition (1), the following shall be inserted, namely:—

"(1A) For getting a certificate of 'Good Manufacturing Practices of Ayurveda-Siddha-Unani drugs, the applicant shall make an application on a plain paper, providing the information on existing infrastructure of the manufacturing unit, and the licensing authority shall after verification of the requirements as per Schedule 'T', issue the certificate within a period of 3 months in Form 26 E-I";

(c) after Form E, the following form shall be inserted, namely :-

Form 26 E-I

(See rule 157-B)

(Certificate of Good Manufacturing Practices (GMP) to manufacturer of Ayurveda, Siddha or Unani drugs);

Certified that manufacturing unit licensee, namely ..........situated at ……… .........State.............License No.........comply with the requirements of Good Manufacturing Practices of Ayurveda-Siddha-Unani drugs as laid down in Schedule T of the Drugs and Cosmetics Rules, 1945.

This certificate is valid for a period of two years.

Dated:           Signature

Place                                                                                          Designation/

  •  
    •  
      •  
        •  
          •  
            •  
              •  
                • Licensing Authority (ISM&H).

(d) for Schedule T', the following shall be substituted, namely:-

SCHEDULE 'T'

(See rule 157)

GOOD MANUFACTURING PRACTICES FOR

AYURVEDIC. SIDDHA AND UNANI MEDICINES

The Good Manufacturing Practices are prescribed to ensure that:

  •  
    • Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination.
    • The manufacturing process is as has been prescribed to maintain the standards.

(iii)      Adequate quality control measures are adopted and

 

(iv)     The manufactured drug which is released for sale is of acceptable quality.

(v)      To achieve the objectives listed above, each licensee shall evolve methodology and procedures for following the prescribed process of manufacture of drugs which should be documented as a manual and kept for reference and inspection. However, teaching institutions and registered qualified Vaidyas, Siddhas and Hakeems who prepare medicines on their on to dispense to their patients and not selling such drugs in the market are exempted from the purview of G.M.P

PART-I

GOOD MANUFACTURING PRACTICES

Factory Premises;-

The manufacturing plant should have adequate space for :

  •  
    • Receiving and storing raw material,
    • Manufacturing process Areas
    • Quality control section.

(iv)       Finished goods store

(v)         Office

  •  
    • Rejected goods/drugs store

1.2 General Requirements;

(A) Location and surroundings ;

The factory buildings for manufacture of Ayurveda, Siddha and Unani medicines shall be so situated and shall have such construction as to avoid contamination from open sewerage, drain, public lavatory or any factory which produces disagreeable or obnoxious odour or fumes or excessive soot, dust or smoke.

1.1 (B) Buildings;

The building used for factory shall be such as to permit production of drugs under hygienic conditions and should be free from cobwebs and insects/rodents. It should have adequate provision of light and ventilation. The floor and the walls should not be damp or moist. The premises used for manufacturing, processing , packaging and labelling will be in conformity with the provisions of the Factory Act. It shall be located so as to be :

(I)       Compatible with other manufacturing operations that may be carried out in The same or adjacent premises.

(II)     Adequately provided with working space to allow orderly and logical placement of equipment and materials to avoid the risk of mix up between different drugs or components thereof and control the possibility of cross contamination by other drugs or substances and avoid the risk or omission of any manufacturing or control step:

 (III)    Designed, constructed and maintained to prevent entry of insects and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks and permit easy cleaning and disaffection. The walls of the room in which the manufacturing operations are carried out shall be impervious to and be capable of being kept clean.  The flooring shall be smooth and even and shall be such as not be permit retention or accumulation of dust or waste products.

(IV)   Provided with proper drainage system in the processing area. The sanitary Fitting and electrical fixtures in the manufacturing area shall be proper and safe.

(V)      Furnace/Bhatti   section  could   be   covered   with   tin   roof &   proper ventilation, but sufficient care should be taken to prevent files and dust.

(VI)    There should be fire safety measures and proper exits should be there.

1.1 (C)Water Supply :

The water used in manufacturer shall be pure and of potable quality. Adequate provision of water for washing the premises shall be made.

1.1 (D) Disposal of Waste;

From the manufacturing sections and laboratories the waste water & the residues which might be prejudicial to the workers or public health shall be disposed off after suitable treatment as per guidelines of pollution control authorities to render them harmless.

1.1 (E) Container's Cleaning ;

In factories where operations involving the use of containing such as bottles, vials and jars are conducted, there shall be adequate arrangements separated from the manufacturing operations for washing, cleaning and drying of such containers.

1.1 (F) Stores;

Storage should have proper ventilation and shall be free from dampness. It should Provide independent adequate space for storage of different types of materials, such as raw material & finished products.

1.1 (F) (A) Raw Materials ;

All raw materials procured for manufacturing will be stored in the raw materials store. The manufacture based on the experience and the characteristics of the particular raw material used in Ayurved, Siddha and Unani system shall decide the use of appropriate containers which would protect...

Quality of the raw material as well as prevent it from damage due to dampness, microbiological contamination or rodent and insect infestation etc. If certain raw materials require such controlled environmental conditions, the raw materials stores may be sub-divided with proper enclosures to provide such conditions by suitable cabinization. While designing such containers, cabins or areas in the raw materials store, care may be taken to handle the following different categories of raw material:—

(1) Raw material of metallic origin

(2) Raw material of mineral origin.

(3) Raw material from animal source.

(4) Fresh Herbs.

(5) Dry Herbs or plant parts.

(6) Excipients etc.

(7) Volatile Oils/perfumes & flavours.

(8) Plant extracts and exudates /resins.

Each container used for raw material storage shall be properly identified with the label which indicates name of the raw material, source of supply and will also clearly state the  status of raw material such as  'UNDER TEST'  or 'APPROVED'  or 'REJECTED'. The labels shall further indicate the identify of the particular supply in the form of batch No. or lot No. and the date of receipt of the consignment.

All the raw materials shall be sampled and got tested either by the in house Ayurvedic, Siddha and Unani experts (Quality control technical person) or by the laboratories approved by the Government and shall be used only on approval after verifying. The rejected raw material should be removed from other raw material store and should be kept in separate room. Procedure of 'First in first out" should be adopted for raw materials wherever necessary. Records of the receipt, testing and approval or rejection and use of raw material shall be maintained.

1.1 (F)(B) Packaging Materials ;

All packaging materials such as bottles, jars, capsules etc. shall be stored properly.    All containers and closure shall be adequately cleaned and dried before packing the products.

1.1 (F)(C) Finished goods Stores ;

The finished goods transferred from the production area after proper packaging shall be stored in the finished goods stores within an area marked "Quarantine". After the quality control laboratory and the experts have checked the correctness of finished goods with reference to its packing/labelling as well as the finished product quality as prescribed, then 'A will be moved to "Approved Finished Goods Stock" area. Only approved finished goods shall be dispatched as per marketing requirements. Distribution records shall be maintained as required.

If any Ayurvedic, Siddha and Unani drug needs special storage conditions, finished goods store shall provide necessary environmental requirements.

l.l(G) Working space:

The manufacturing area shall provide adequate space (manufacture and quality control) for orderly placement of equipment and material used in any of the operations for which these are employed so as to facilitate easy and safe working and to minimise or to eliminate any risk of mix-up between different drugs, raw materials and to prevent the possibility of cross contamination of one drug by another drug that is manufactured, stored or handled in the same premises.

l.l(H) Health Clothing, Sanitation and Hygiene of Workers :

All workers employed in the Factory shall be free from contagious diseases. The clothing of the workers shall consist of proper uniform suitable to the nature of work and the climate and shall be clean. The uniform shall also include cloth or synthetic covering for hands, feet and head wherever required. Adequate facilities for personal cleanliness such as clean towels, soap and scrubbing brushes shall be provided. Separate provision shall be made for lavatories to be used by men and women, and such lavatories shall be located at places separated from the processing rooms. Workers will also be provided facilities for changing their clothes and to keep their personal belongings.

1.1 (I) Medical Services :

The Manufacturer shall also provide :—

(c)  adequate facilities for first aid;

(d) medical examination of workers at the time of employment and periodical check up thereafter by a physician once a year, with particular attention being devoted to freedom from infections. Records thereof shall be maintained.

1.1 (J) Equipment;

For carrying out manufacturing depending on the size of operation and the nature of product manufactured, suitable equipment either manually operated or operated semi-automatically (Electrical or steam based) or folly automatic machinery shall be made available. These may include machines for use in the process of manufacture such as crushing , grinding, powdering, boiling, mashing, burning, roasting, filtering, drying, filling, labelling and packing etc. To ensure case in movement of workers and orderliness in operations a suitably adequate space will be ensured between two machines or rows of machines. These Equipment have to be properly installed and maintained with proper cleaning.

Proper standard operational procedure (SOPs) for cleaning, maintaining & performance of every machine should be laid down.

1.1(K) Batch Manufacturing Records :

The licensee shall maintain batch manufacturing records of each batch of Ayurvedic, Siddha and Unani drugs manufactured irrespective of the type of product manufactured (classical preparation or patent and proprietary medicines). Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store, tests conducted daring the various stages of manufacture like taste, colour, physical characteristics and chemical tests as may be necessary or indicated in the approved books of Ayurveda, siddha and Unani mentioned in the First Schedule of the Drugs and cosmetic Act, 1940 (23 of 1940). These tests may include any in-house or pharmacopoeia! test adopted by the manufacturer in the raw material or in the process material and in the finished product. These records shall be duly signed by Production and Quality control Personnel respectively. Details of transfer of manufactured drug to the finished products store including dates and quantity of drugs transferred along with record of testing of the finished product, if any, and packaging, records shall be maintained. Only after the manufactured drugs have been verified and accepted quality shall be allowed to be cleaned for sale.

It should be essential to maintain the record of date, manpower, machine and equipment used and to keep in process record of various shodhana, Bhavana, burning in fire and specific grindings in terms of internal use.

1.1 (L) Distribution Records ;

Records of sale and distribution of each batch of Ayurveda, Siddha and Unani Drugs shall be maintained in order to facilitate prompt and complete recall of the batch, if necessary.

1.1 (M) Record of Market Complaints :

Manufacturers shall maintain a register to record all reports of market complaints received regarding the products sold in the market. The manufacturer shall enter all data received on such market complaints, investigations carried out by the manufacturers regarding the complaint as well as any corrective action initiated to prevent recurrence of such market complaints shall also be recorded. Once in a period of six months the manufacturer shall submit the record of such complaints to the licensing authority. The Register shall also be available for inspection during any inspection of the premises.

Reports of any adverse reaction resulting from the use of Ayurvedic, Siddha and Unani drugs shall also be maintained in a separate register by each manufacturer. The manufacturer shall investigate any of the adverse reaction to find if the same is due to any defect in the product, and whether such reactions are already reported in the literature or it is a new observation.

1.1 (N) Quality Control:

Every licensee is required to provide facility for quality control section in his own premises or through Government approved testing laboratory. The test shall be as per the Ayurveda, Siddha and Unani pharmacopoeial standard. Where the tests are not available, the test should be performed according to the manufacturers specification or other information available. The quality control section shall verify all the raw materials, monitor in process, quality checks and control the quality of finished product being released to finished goods store/ware house. Preferably for such Quality control there will be a separate expert. The quality control section shall have the following facilities.

(1)      There should be 150 sq. feet area for quality control section.

(2)       For identification of raw drugs, reference books and reference samples should be maintained.

(3)       Manufacturing record should be maintained for the various processes.

(4)       To verify the finished products, controlled samples of finished products of each batch will be kept for 3 years.

(5)       To supervise and monitor adequacy of conditions under which raw materials, semi-finished products and finished products are stored.

(6)       Keep record in establishing shelf life and storage requirements for the Drugs.

(7)       Manufacturers, who are manufacturing patent proprietary /Ayurveda Siddha and Unani medicines shall provide their own specification and control references in respect of such formulated drugs.

(8)       The record of specific method and procedure of preparation, that is, "Bhavana", " Mardana" and "Puta" and the record of every process carried out by the manufacturer shall be maintained.

(9)      The standards for identity, purity and strength as given in respective

pharmacopoeias of Ayurveda, Siddha and Unani systems of medicines published by Government of India shall be complied with.

(10)    All raw materials will be monitored for fungal, bacterial contamination with a view to minimise such contamination.

(11)    Quality control section will have a minimum of

(a)      One person with Degree qualification in Ayurveda/Siddha/Unani (A.S.U) as per Schedule II of Indian Medicine Central Council Act, 1970 (84 of 1970) of a recognised university or Board.

(b)     Provided that Bachelor of Pharmacy, Pharmacognosy and Chemistry may be associated with the quality control section.

3.0 Requirement for Sterile Product;

A) Manufacturing Areas

For the manufacture of sterile Ayurvedic, Unani and Siddha drugs, separate enclosed areas specifically designed for the purpose shall be provided. These areas shall be provided with air locks for entry and shall be essentially dust free and ventilated with an air supply. For all areas where aseptic manufacture has to be carried out, air supply shall be filtered through bacteria retaining filters (HEPA Filters) and shall be at a pressure higher than in the adjacent areas. The filters shall be checked for performance on installation and periodically thereafter the record of checks shall be maintained. All the surfaces in sterile manufacturing areas shall be designed to facilitate cleaning and disinfection. For sterile manufacturing routine microbial counts o£all Ayurvedic, Siddha and Unani drug manufacturing areas shall be carried out during operations. Results of such count shall be checked against established in-house standards and record maintained.

Access to manufacturing areas shall be restricted to minimum number of authorised personnel. Special procedure to be followed for entering and leaving the manufacturing areas shall be written down and displayed.

For the manufacturing of Ayurvedic, Siddha and Unani drug that can be sterilised in their final containers, the design of the areas shall preclude the possibility of the products intended for sterilisation being mixed with or taken to be products, the design of the areas shall preclude the possibility of mix up between non-sterile and sterile products.

(B) Precautions against contamination and mix ;

(a) Carrying out manufacturing operations in a separate block of adequately isolated building or operating in an isolated enclosure within the building.

(b) Using appropriate pressure differential in the process area.

(c) Providing a suitable exhaust system.

(d) Designing laminar flow sterile air systems for sterile products.

(e) The germicidal efficiency of UV lamps shall be checked and record indicating the burning hours or checked using intensity.

(f) Individual containers of liquids, and ophthalmic solutions shall be examined against black-white background fitted with diffused light after filling to ensure freedom from contamination with foreign suspended matter.

(g) Expert technical staff approved by the Licensing Authority shall check and compare actual yield against theoretical yield before final distribution of the batch.

All process controls as required under master formula including room temperature relative humidity, volume filled, leakage and clarity shall be checked and recorded.

PART – II

A.     LIST OF MACHINERY, EQUIPMENT AND MINIMUM

MANUFACTURING PREMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS CATEGORIES OF AYURVEDIC SIDDHA SYSTEM OF MEDICINES.

 

si.no.   Category of   Minimum manufacturing   Machinery/ equipment

Medicine   space required     Recommended

(1)        (2)    (3)     (4)

1200 Square feet

covered area with

separate cabins

     partitions for each activity.

If Unani medicines are

Manufactured in same

Premises an additional

Area of 400 sq. feet Will

 be required.

1.       Anjana/Pisti           100 Sq. feet      Karel/mechanised

  •  
    • motorised, kharel, End runner/Ball-Mill Sieves/Shifter

2.  Churna/Nasya  200 Sq. feet      Grinder/ Disintegrator/

Manjan/Lepa Kwath       Pulverisar/ Powder mixer/

Churn         sieves/shifter

3. Pills/Vatti/Gutika  100 Sq. feet      Ball Mill, Mass

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    • Matirai      mixer powder Mixer
      • pill/vati Cutting machine,
      • stainless steel trays /Containers for storage Drivers/ Mechanised Chattee (for mixing guggul required)

4.    Tablets  100 Sq. feet     Ball Mill, Mass xer/powder-

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    • mixer Granulator drier,
      • Tablet compressing Machine and sugar-Coating. foliating pay in case of sugar coated tablets, mechanised chattee (for mixing of guggulu) where required.

5. Kupi pakva/   100 Sq. feet      Bhatti, Karahi/ Stainless Ksara/Parpati        Steel Vessels/Patila Flask, LavanaBhasma        Miltani Matti/Plaster of Satva/Sindura        Paris, Copper Rod Karpu/Uppu/Param        Earthen container, Gaj Put

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    • Bhatti, Muffle furnace
    • (Electrically oprated) End/
    • Edge Runner, Exhaust
      • Fan, Wooden/S.S. Spatula.

6. Kajal   150 Sq. feet     Earthen lamps for

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    • Collection of Kajal, Tipple
    • Roller Mill, End Runner,
    • Sieves, S.S.Patila, Filling/
    • packing and
    • manufacturing room
    • should be provided with
    • exhaust fan & ultra violet
    • lamps.

7. Capsules  250 Sq. feet      Air Conditioner, De humidifier, hygrometer,

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    • Thermometer Capsule
    • filling Machine and
    • Chemical balance

8. Ointment/Marham  100Sq. feet       Tube filling machine,

Pasai          Crimping Medicine/Oint

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    • ment Mixer, End
    • Runner/Mill (Where
    • required), S.S.Storage
    • Con--tainer S.S.Patila.

9.  Pak/Avaleh/Khand/   100 Sq. feet      Bhatti section fitted with Modak/Lakayam        Exhaust fan and should be

  •  
    • fly proof, Iron Kadahi/S.S.
    • Patila and S.S. Storage
    • container.

10. Panak Syrup/ Pravahi  150 Sq. feet     Tinctum press, haust

Kwath Manapaku        fan fit ted And fly proof,

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    • Bhatti section, Bottle
      • washing Machine, filter press/Gra filter Liquid filling Tan with tap/liq
    • -uid filling machine, P.P.
    • Copping Machine.

11. Asava/Aristha  200 Sq. feet    Same as men-

  •  
    • -tioned above.
    • Fermentation tanks
    • Containers and Distillation
    • Plant where necessary,
    • Filter Press.

12. Sura    100 Sq. feet    Same as mentioned above

  •  
    • plus Distillation plant and
    • plant Liquid filling tank with
    • tap/ Gravity filter/ Filter
    • press, Visual inspection
    • box.

14. Tail/Ghrit   100 Sq. feet    Bhatti, Kadahi/ S.S.Patila Ney         S.S. Storage Containers, Filtration

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    •  
      •  
        •  
          •  
            •  
              •  
                •  
                  • equipment, filling tank with
                  • tap/Liquid filling machine.

15. Aschyotan/    100 Sq. feet     Hot air oven electrically

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    • Netra Malham Panir     heated with thermostatic
      • control, certle gas or
      • electrically heated with
        • suitable mixing arrangements collation mill or ointment mill, tube filling equipment, mixing and storage tanks of stainless steel or of other suitable material sintered glass runnel, seitz filter or filter candle, liquid filling equip-ment.autoclavee

16.   Each manufacturing unit    200 Sq. feet

will have a separate area

for Bhatti, furnaces,

boilers, puta, etc.,

this will have proper ventilation,

removal of smoke, prevention of

files, insects,dust etc,

The furnace section could have tin roof.

B.      LIST OF MACHINERY, EQUIPMENT AND MINIMUM

MANUFACTURING PERMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS CATEGORIES OF UNANI SYSTEM OF MEDICINE 

  •  
    • 1200 square feet covered area
    • with separate cabins, Partitions
    • for each Activity. If Ayurveda/
    • Siddha, Medicines are also
    • manufactured in same premises
    • an additional areas of 400 square
    • feet will be required.

1. Itrifal Tiryao/    100 Sq. feet   Grinder/Pulve -riser,

  •  
    • majoon/Laooq/  Sieves, powder mixer Jawarishkhamiras (if
    • required), S.S.Patilas
    • Bhatti And Other acessoroes,

2. Arq.      100 Sq. feet   Distillation Plant

  •  
    • (garembic) S.S. Storage
    • Tank, Boiling Vessel,
    • Gravity filter, Bottle Filling
    • machine Bottle washing
    • Machine,Bottle drier.

3. Habb (Pills)    100 Sq. feet   Grinder/ Pulversier,

  •  
    • Sieves, Powder
    • Mixer,(Where required)
    • Trays

4. Sufoof (Powder)    100 Sq. feet   Grinder/ Pulversier,

  •  
    • Seives, Trays, Sccops,
    • Powder mixer, (Where re
    • quired).

5. Raughan (oils)    100 Sq. feet     Oil Expeller, S.S.Patilas Oil filter (Crushing & Boiling)     Bottle, filling Machine Bottle drier,         Bhatti.

6. Shiaf, Surma, Kajal   100 Sq. feet   End runner,] mixing S.S.

  •  
    • Vessel.

7. Marham, Zimad   100 Sq. Feet   Kharal, Bhatti, End runner,

  • (Ointment)         Grinder Pulveriser,
    • Tripple Roller Mill ( if

8. Qurs (Tab)    100 Sq. feet   Grinder/ Pulversier, lieves,

  •  
    • Powder mixer (Where
      • needed)Granu-lator), Drier,
    • Tablet Com-Pressing
      • Machine,Die punches Trays, O.T.Apparatus, Balance with weights, Scoops, Sugar Coating
      • Pan, Polishing pan, Heater.

9. Kushta     100 Sq. feet   Bhatti, Kharal, Sil Batta,

  •  
    • Eartern  pots.

10. Murabba    100 Sq. feet   Aluminimum Vessels50-

  •  
    • 100 kgs. Capacity Gendna
    • Bhatti

11. Capsule    100 Sq. feet   Pulveriser, Powder

  •  
    • mioxer( Where needed), cap sule filling machine, Air Conditioner, Dehumidifier Balance with
    • weights, storage-Containers, glass.

12. Sharbat&    100 Sq. feet   Tinctum Press, exhausted

 Jushanda        fan fitted, Bhatti section,

  •  
    • Bottle Washing  machine,Filter Press
    • Gravity Filter, Liquid Filling
    • tank with tap/liquid filling
    • machine, PP capping machine, air oven electrically heated with
    • Thermostatic control, cettle.

13. Qutoor Chasm   100 Sq.feet   Hot air oven electrically

 and Marham (Eye drops      heated with Thermostatic

 Eype ointment)       Control, Cettle

14. Each manufacture ing  200 Sq.Ft.

 will have a separate area

for Bhatti, furnaces, boilers,

  • putta, etc. This will have proper
  • ventilation, removal of smoke,
  • prevention of files, insects, dust etc.

Note :

The above requirements of machinery, equipment, space, qualifications are made subject to the modification at the discretion of the Licensing Authority; if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter then in the circumstances in a particular case.

L.PRASAD, Jt. Secy.

 

Foot-Note : The Principal rules were published in the official Gazette vide notification No.F.28-10/45H(l) dated 21-12-1945 and has last amended vide GSR 352(E) dated 26.04.2000. The Drugs and Cosmetics Rules, 1945 as amended up to 1-5-1979 is contained in the publication of the Ministry of Health and Family Welfare (Department of Health) containing the Drugs and cosmetics Act, 1940 (PDGHS-61).