LEGISLATION OF HOMOEOPATHIC PHARMACY IN INDIA
- Sumit Goel.
THE DRUGS AND COSMETICS ACT, 1940 (23 OF 1940 - 10TH April, 1940] Homoeopathy is included in the Second Schedule of The Drugs and Cosmetics Act, 1940 under the "Standards to be complied with by imported drugs and by drugs manufactured for sale, stocked or exhibited for sale or distributed".
Class of drug
4A. Homoeopathic Medicines
(a) Drugs included in the Homoeopathic Pharmacopoeia of India.
(b) Drugs not included in the Homoeopathic Pharmacopoeia of India but which are included in the Homoeopathic Pharmacopoeia of the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia.
(c) Drugs not included in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom or the German Homoeopathic Pharmacopoeia.
Standard to be complied with:
(a) Standards of identity, purity and strength specified in the edition of the Homoeopathic Pharmacopoeia of India for the time being and such other standards as may be prescribed.
(b) Standards of identity, purity and strength prescribed for the drugs in the edition of such Pharmacopoeia for the time being in which they are given and such other standards as may be prescribed.
(c) The formula or list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed by the Central Government.
THE DRUGS AND COSMETIC RULES, 1945
According to The Drugs and Cosmetics Rules, 1945, the following definitions are applicable to homoeopathy:
(dd) "Homoeopathic medicines" include any drug which is recorded in Homoeopathic provings or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative Homoeopathic literature of India and abroad and which is prepared according to the techniques of Homoeopathic pharmacy and covers combination of ingredients of such Homoeopathic medicines but does not include a medicine which is administered by parenteral route.
(ea) "Registered Homoeopathic Medical Practitioner" means a person who is registered in the Central Register or a State Register of Homoeopathy.
According to Part II, 'The Central Drugs Laboratory', the functions of the laboratory in respect of Homoeopathic medicines shall be carried out at the Homoeopathic Pharmacopoeia Laboratory, Ghaziabad and the functions of the Director in respect of the Homoeopathic medicines shall be exercised by the Director of the laboratory.
PART IV
IMPORT
30-AA : Import of New Homoeopathic medicines
32-A : Packing and labelling of Homoeopathic medicine
PART VI A
SALE OF HOMOEOPATHIC MEDICINES
67-A :
67-B :
67-C : Forms of licenses to sell drugs
67-D : Sale at more than one place
67-E : Duration of licenses
67-EE : Certificate of renewal
67-F : Conditions to be satisfied before a license in Form 20-C or Form 20-D is granted
67-G : Conditions of license
67-GG : Additional information to be furnished by an applicant for license or a licensee to the licensing authority
67-H : Cancellation and suspension of licenses
PART VII A
MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF HOMOEOPATHIC MEDICINES
85-A : Manufacture on more than one set of premises
85-B : Application for license to manufacture Homoeopathic medicines
85-C : Application to manufacture 'New Homoeopathic medicines'
85-D : Form of license to manufacture Homoeopathic medicines
85-E : Conditions for the grant or renewal of a license in Form 25 - C
85-EA : Inspection before grant or renewal of license
85-EB : Report by Inspector
85-EC : Grant or refusal of license
85-ED : Further application after rejection
85-EE : Appeal to the State Government
85-F : Duration of license
85-G : Certificate of renewal
85-H : Conditions of license
85-HH : Additional information to be furnished by an applicant for license or a licensee to the licensing authority
85-I : Cancellation and suspension of licenses
PART IX A
LABELLING AND PACKING OF HOMOEOPATHIC MEDICINES
106-A : Manner of labelling of Homoeopathic medicines
106-B : Prohibition of quantity and percentage
PART XII
STANDARDS
126-A : Standards of ophthalmic preparations including Homoeopathic Ophthalmic preparations
PART IV
IMPORT
30-AA : Import of New Homoeopathic medicines
(1) No New Homoeopathic medicine shall be imported except under and in accordance with the permission in writing of the Licensing Authority.
(2) The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it.
Explanation - For the purpose of this rule, 'New Homoeopathic medicine' means, -
(i) a Homoeopathic medicine which is not specified in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom or the German Homoeopathic Pharmacopoeia; or
(ii) which is not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended; or
(iii) a combination of Homoeopathic medicines containing one or more medicines which are not specified in any of the Pharmacopoeias referred to in clause (i) as Homoeopathic medicines and also not recognized in authoritative Homoeopathic literature as efficacious, under the conditions recommended.
32-A : Packing and labelling of Homoeopathic medicine
No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IX-A.
PART VI - A
SALE OF HOMOEOPATHIC MEDICINES
67-A :
(1) The State government shall appoint Licensing authorities for the purpose of this Part for such areas as may be specified.
(2) Application for the grant or renewal of a license to sell, stock, exhibit or offer for sale or distribute Homoeopathic medicines shall be made in Form 19-B to the Licensing Authority and shall be accompanied by a fee of rupees ten.
Provided that if the applicant applied for renewal of license after its expiry but within six months of such expiry the fee payable foe renewal of such license shall be rupees ten plus an additional fee at the rate of rupees eight per month or thereof.
(3) If the original license is either defaced, damaged or lost, a duplicate copy thereof may be issued on payment of a fee of one rupee and twenty-five paise.
67-B :
A Licensing Authority may, with the approval of the State Government, by an order in writing, delegate the power to sign licenses and such other powers, as may be specified, to any other person under his control.
67-C : Forms of licenses to sell drugs
A license to sell, stock, exhibit or offer for sale or distribute Homoeopathic medicines by retail or by wholesale shall be issued in Form 20-C or Form 20-D as the case may be.
67-D : Sale at more than one place
If drugs are sold or stocked for sale at more than one place, a separate application shall be made and a separate license shall be obtained in respect of each place.
67-E : Duration of licenses
An original license or a renewed license unless it is sooner suspended or cancelled shall be valid up to the 31st December of the year following the year in which it is granted or renewed.
Provided that if the application for renewal of a license in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the license shall continue to be in force until orders are passed on the application and the license shall be deemed to have expired if application for its renewal is not made within six months after its expiry.
67-EE : Certificate of renewal
The certificate of renewal of a sale license in Forms 20-C and 20-D shall be issued in form 20-E.
67-F : Conditions to be satisfied before a license in Form 20-C or Form 20-D is granted
(1) A license in Form 20-C or Form 20-D to sell, stock, exhibit or offer for sale or distribute Homoeopathic medicines shall not be granted to any person unless the authority empowered to grant the license is satisfied that the premises in respect of which the license is to be granted are clean and in the case of a license in Form 20-C the sale premises is in charge of a person who is or has been dealing in Homoeopathic medicines or who is in the opinion of the Licensing Authority competent to deal in Homoeopathic medicines.
Provided that no registered Homoeopathic medical practitioner who is practising Homoeopathy in the premises where Homoeopathic medicines are sold shall deal in Homoeopathic medicines.
(2) Any person who is aggrieved by the order passed by the Licensing Authority under sub-rule (1) may within 30 days from the date of the receipt of such order appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his case, make such order in relation thereto as it thinks fit.
67-G : Conditions of license
License in Form 20-C or 20-D shall be subject to the conditions stated therein and to the following further conditions, namely -
(!) The premises where the Homoeopathic medicines are stocked for sale or sold are maintained in a clean condition.
(2) The sale of Homoeopathic medicines shall be conducted under the supervision of a person, competent to deal in Homoeopathic medicines.
(3) The licensee shall permit an Inspector to inspect the premises and furnish such information as he may require for ascertaining whether the provisions of the Act and the Rules made thereunder have been observed.
(4) The licensee in Form 20-D shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol together with names and addresses of parties to whom sold.
(5) The licensee in form 20-C shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol. No records of sale in respect of Homoeopathic potentised preparations in containers of 30 ml. or lower capacity and in respect of mother tinctures made up in quantities up to 60 ml. need be maintained.
(6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.
67-GG : Additional information to be furnished by an applicant for license or a licensee to the licensing authority
The applicant for the grant of a license or any person granted a license under this part shall, on demand furnish to the licensing authority, before the grant of the license or during the period the license is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises specified in the application for license or in the license granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements, made by the applicant or the licensee, while applying for or after obtaining the license, as the case may be.
67-H : Cancellation and suspension of licenses
(1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, cancel a license issued under this Part or suspend it for such period as he thinks fit, if in his opinion, the licensee has failed to comply with any of the conditions of the license or with any of the provisions of the Act or Rules made thereunder.
Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the license shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority - (a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or (b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission, the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or (c) if the act or omission was a continuing act or omission, that he had not or could not reasonably have had knowledge of that previous act or omission, or (d) that he had used due diligence to ensure that the conditions of the license or the provisions of the Act or the rules thereunder were observed.
(2) A licensee whose license has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.
PART VII - A
MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF HOMOEOPATHIC MEDICINES
85-A : Manufacture on more than one set of premises If Homoeopathic medicines are manufactured in more than one set of premises a separate application shall be made and a separate license shall be obtained in respect of each such set of premises.
85-B : Application for license to manufacture Homoeopathic medicines
(1) Application for grant or renewal of licenses to manufacture for sale or for distribution of Homoeopathic medicines shall be made to the Licensing Authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the Licensing Authority) and shall be made in the Form 24-C.
(2) The application in Form 24-C shall be accompanied -
(a) by a fee of rupees eighty for the manufacture of Homoeopathic mother tinctures and potentised preparations and an inspection fee of rupees twenty for the first inspection or rupees ten in case of inspection for renewal of license; (b) by a fee of rupees forty for the manufacture of Homoeopathic potentised preparations only, and an inspection fee of rupees ten for the first inspection or rupees five in case of inspection for renewal of license;
(c) by a fee of rupees forty for the manufacture of potentised preparations from back potencies by pharmacies which are already licensed to sell Homoeopathic medicines by retail and an inspection fee of rupees ten for the first inspection or rupees five in case of inspection for renewal of license.
(3) If a person applies for renewal of a license after its expiry but within six months of such expiry, the fee payable for the renewal of such a license shall be -
(a) rupees eighty plus an additional fee at the rate of rupees thirty per month or part thereof and an inspection fee of rupees ten for the manufacture of Homoeopathic mother tinctures and potentised preparations;
(b) rupees forty plus an additional fee at the rate of rupees thirty per month or part thereof and an inspection fee of rupees five for the manufacture of Homoeopathic potentised preparations only;
(c) rupees forty plus an additional fee at the rate of rupees fifteen per month or part thereof and an inspection fee of rupees five for the manufacture of potentised preparations from back potencies by pharmacies who are already licensed to sell Homoeopathic medicines by retail.
(4) A fee of rupees fifteen shall be paid for a duplicate copy of the license for the manufacture of Homoeopathic mother tincture and potentised preparations issued under sub-rule (1) if the original is defaced, damaged or lost; while the fee to be paid for such a duplicate copy of the license for the manufacture of Homoeopathic potentised preparations only shall be rupees ten.
(5) Applications by the licensee to manufacture additional items of Homoeopathic medicines shall be made to the Licensing Authority and such applications shall be accompanied by a fee of rupees five for each additional item.
85-C : Application to manufacture 'New Homoeopathic medicines' Subject to the other provisions of these Rules - (1) no 'New Homoeopathic medicine' shall be manufactured unless it is previously approved by the Licensing Authority mentioned in Rule 21;
(2) the manufacturer of 'New Homoeopathic medicine', when applying to the Licensing Authority mentioned in sub-rule (1) shall produce such documents and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it;
(3) while applying for a license to manufacture a 'New Homoeopathic medicine' an applicant shall produce alongwith his application evidence that the 'New Homoeopathic medicine' for the manufacture of which application is made has already been approved.
Explanation - The term 'New Homoeopathic medicine' in this rule shall have the same meaning as in Rule 30-AA.
85-D : Form of license to manufacture Homoeopathic medicines License for manufacturer of Homoeopathic medicines is a license to manufacture potentised preparations from back potencies by Pharmacies who are already licensed to sell Homoeopathic medicines by retail shall be granted in Form 25-C.
85-E : Conditions for the grant or renewal of a license in Form 25-C Before a license in Form 25-C is granted or renewed the following conditions shall be complied with by the applicant -
(1) The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting atleast of one person who is a whole time employee and who is -
(a) a graduate in Science with Chemistry as one of the subjects with three years' experience in manufacture of Homoeopathic medicines; or
(b) a graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or
(c) holds qualification as defined under sub-clause (g) of clause (1) of Section 2 of Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homoeopathic medicines;
Provided that the persons who are already in employment with five years' experience in the manufacture of Homoeopathic medicines and whose name was accordingly entered in any license granted in Form 25-C for manufacture of different classes of Homoeopathic medicines included in them shall be deemed to be qualified for the purpose of this rule.
(2) The factory premises shall comply with the requirements and conditions specified in Schedule
M-1:
Provided that where the Licensing Authority considers it necessary or expedient so to do, it may having regard to the nature and extent of manufacturing operations, relax or suitably alter the said requirements or conditions in any particular case for reasons to be recorded in writing.
(3) The applicant for manufacture of Homoeopathic mother tinctures shall either (i) provide and maintain adequate staff, premises and laboratory equipment for identifying the raw materials and for testing the mother tinctures wherever possible, or (ii) make arrangements with some institution approved by the Licensing Authority under Part XV (A) of these Rules for some tests, wherever possible, to be regularly carried out on his behalf by that institution.
(4) The premises where Homoeopathic medicines are manufactured shall be distinct and separate from the premises used for residential purposes.
(5) Homoeopathic medicines shall not be manufactured simultaneously with drugs pertaining to other systems of medicine.
(6) The applicant shall make arrangements for proper storage of Homoeopathic medicines manufactured by him.
Provided that in case potentised preparations are made in a Pharmacy holding license in Form 20-C, the conditions (2) and (3) shall not apply. The licensee shall ensure to the satisfaction of the Licensing Authority that the products manufactured by it, conform to the claims made on the label.
85-EA : Inspection before grant or renewal of license Before a license under this Part is granted or renewed in Form 25-C or Form 26-C, the Licensing Authority shall cause the establishment, in which the manufacture is proposed, to be conducted or being conducted, to be inspected by one or more Inspectors appointed under the Act. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed alongwith the means to be employed or being employed for standardising and testing the substances to be manufactured and inquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the requirements of plant and equipment as laid down in Schedule U.
85-EB : Report by Inspector
The Inspector or Inspectors shall forward a detailed descriptive report giving his or their findings on each aspect of inspection alongwith his or their recommendations after completion of his or their inspection to the Licensing Authority.
85-EC : Grant or refusal of license
(1) If the Licensing Authority after such further enquiry, if any, as he may consider necessary is satisfied that the requirements of the rules under the Act have been complied with and that conditions of the license and the rules under the Act shall be observed, he shall grant or renew a license in Form 25-C or Form 26-C.
(2) If the license authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a license can be granted or renewed and shall supply the applicant with a copy of the inspection report.
85-ED : Further application after rejection
If within a period of six months from the rejection of an application for a license, the applicant informs the Licensing Authority that the conditions laid down have been fulfilled and deposits an inspection fee of rupees fifty, the Licensing Authority may, if, after causing further inspection to be made, he is satisfied that the conditions for the grant of license have been complied with, issue a license in Form 25-C or Form 26-C.
85-EE : Appeal to the State Government
Any person who is aggrieved by the order passed by the Licensing Authority refusing to grant or renew a license under this Part may within ninety days from the date of receipt of such order, appeal to State Government and the State Government may, after such enquiry into the matter as is considered necessary and after giving the said person an opportunity for representing the case pass such order as it thinks fit.
85-F : Duration of license
An original license or a renewed license unless it is sooner suspended or cancelled shall be valid upto the 31st December of the year following the year in which it is granted or renewed.
Provided that if the application for renewal of a license in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the license shall continue to be in force until orders are passed on the application and the license shall be deemed to have expired if application for its renewal is not made within six months of its expiry.
85-G : Certificate of renewal
The certificate of renewal in Form 25-C shall be issued in Form 26-C.
85-H : Conditions of license
A license in Form 25-C shall be subject to the conditions stated therein and to the following further conditions, namely -
(a) the licensee shall provide and maintain staff and premises as specified in Rule 85-E;
(b) the licensee shall allow an Inspector appointed under the Act to enter, with or without prior notice, any premises where the manufacture of Homoeopathic medicine in respect of which the license is issued is carried on, to inspect the premises and to take samples of the manufactured Homoeopathic medicines; (c) the licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the Rules made thereunder have been observed;
(d) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and defects noticed;
(e) the licensee shall comply with the following conditions in respect of mother tinctures manufactured by him -
(i) the crude drug used in the manufacture of the mother tincture shall be identified and records of such identification shall be kept for a period of five years;
(ii) the total solids in the mother tincture shall be determined and records of such tests shall be kept for a period of five years;
(iii) the alcohol content in the mother tincture shall be determined and records of the same shall be maintained for a period of five years;
(iv) the containers of mother tinctures shall preferably be of glass and shall be clean and free from any sort of impurities of adhering matter. The glass shall be neutral as far as possible.
(v) in the process of manufacture of mother tinctures hygienic conditions shall be scrupulously observed by the licensee. Storage and handling conditions shall also be properly observed by the licensee according to Homoeopathic principles;
(ea) no colour shall be added any Homoeopathic medicines;
Provided that caramel may be added to combinations of Homoeopathic preparations with syrup base; (f) records shall be maintained of Homoeopathic medicines containing alcohol and the quantities sold together with names and addresses of parties to whom sold. Such records shall be maintained for a period of five years.
85-HH : Additional information to be furnished by an applicant for license or a licensee to the licensing authority The applicant for the grant of license or any other person granted a license under this Part shall, on demand, furnish to the Licensing Authority, before the grant of the license or during the period the license is in force, as the case may be, documentary evidence in respect of the ownership or occupation in rental or other basis of the premises, specified in the application for license or in the license granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the license as the case may be.
85-I : Cancellation and suspension of licenses (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, cancel a license issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates if, in his opinion, the licensee has failed to comply with any of the conditions of the license or with any provisions of the Act or Rules made thereunder.
(2) A licensee whose license has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.
PART IX - A
LABELLING AND PACKING OF HOMOEOPATHIC MEDICINES
106-A : Manner of labelling of Homoeopathic medicines
(A) The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Homoeopathic medicine and on every other covering in which the container is packed:-
(i) The words 'Homoeopathic medicine'.
(ii) The name of the medicine -
(a) For drugs included in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia, the name specified in that Pharmacopoeia.
(b) For other drugs, the name descriptive of the true nature of the drugs.
(iii) The potency of the Homoeopathic medicine - For this purpose the potency shall be expressed either in decimal, centesimal or millesimal systems.
(iiiA) In case of a Homoeopathic medicine containing two or more ingredients, the name of each ingredient together with its potency and proportion expressed in metric system shall be stated on the label.
(iv) Name and address of the manufacturer when sold in original containers of the manufacturer. In case a Homoeopathic medicine is sold in a container other than that of the manufacturer - the name and address of the seller. (v) In case the Homoeopathic medicine contains alcohol, the alcohol content in percentage by volume in terms of ethyl alcohol shall be stated on the label.
Provided that in case that the total quantity of the pharmacopoeial Homoeopathic medicine in the container is 30 milliliters or less, it will not be necessary to state the content of alcohol in the label.
(B) In addition to the above particulars the label of a Homoeopathic mother tincture shall display the following particulars -
(i) a distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken and recorded are available for inspection, the figures representing the batch number being preceded by the words "Batch No." or "Batch" or "Lot Number" or "Lot No." or "Lot" or any distinguishing prefix;
(ii) manufacturing license number, the number being preceded by the words "Manufacturing License Number" or "Mfg. Lic. No." or "M.L.".
Explanation - This clause shall not apply to a Homoeopathic mother tincture manufactured outside India.
(C) No Homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label.
106-B : Prohibition of quantity and percentage
No Homoeopathic medicine containing more than 12 Pecent alcohol v/v (Ethyl Alcohol) shall be packed and sold in packing or bottles of more than 30 milliliters, except that it may be sold to hospitals / dispensaries in packings or bottles of not more than 100 milliliters.
PART XII
STANDARDS
126-A : Standards for ophthalmic preparations including Homoeopathic ophthalmic preparations
The standards for ophthalmic preparations including Homoeopathic Ophthalmic preparations shall be those laid down in Schedule FF, and such preparations shall also comply with the standards set out in the Second Schedule to the Act.
SCHEDULES
SCHEDULE A : FORMS
SCHEDULE FF : STANDARDS FOR OPHTHALMIC PREPARATIONS
SCHEDULE M-I: GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT
SCHEDULE M-1
(See Rule 85-E (2)]
1. Requirements of factory premises for manufacture of Homoeopathic preparations -
(a) Location and surroundings - The factory shall be situated in a place which shall not be adjacent to an open sewage drain, public lavatory or any factory which produced a disagreeable or obnoxious odour or fumes or large quantities of soot, dust or smoke. The factory shall be located in a sanitary place, remote from filthy surroundings.
(b) Buildings - The part of the building used for manufacturing shall not be used as a sleeping place and no sleeping place adjoining to it shall communicate therewith except through open air or through an intervening open space. The walls of the room in which manufacturing operations are carried out shall, upto a height of six feet from the floor, be smooth, water proof and shall be capable of being kept clean. The flooring shall be smooth, even and washable and shall be capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as not to permit of retention or accumulation of dust. There shall be no chinks or crevices in the wall or floor.
(c) The building used for the factory shall be constructed so as to permit production under hygienic conditions laid down in the Factories Act, 1948 (63 of 1948)
(d) Water Supply - The water used in the manufacture shall be pure and of drinkable quality, free from pathogenic microorganisms.
(e) Disposal of Waste - There should be adequate arrangement for disposal of waste water and other residues from the laboratory.
(f) The rooms should be airy and clean and the temperature of the room should be moderately comfortable.
(g) Health, Clothing and Sanitary Requirement of the Staff - All workers shall be free from contagious or obnoxious disease. Their clothing shall consist of a white or coloured uniform suitable to the nature of work and the climate, and shall be clean. Adequate facilities for personal cleanliness, such as clean towels, soap and hand scrubbing brushes, shall be provided separately for each sex. The workers shall be required to wash and change into clean footwear before entering the rooms where the manufacturing operations are carried on. Workers shall be required to wear either a clean cap or a suitable headgear so as to avoid any possibility of contamination by hair or perspiration.
(h) Medical services - The manufacturer shall provide adequate facilities for First Aid, Medical inspection of workers at the time of employment and periodically check up thereafter at least once a year.
(i) Working benches - Working benches shall be provide for carrying out operations such as filling, labelling, packing, etc. Such benches shall be fitted with smooth, impervious tops capable of being washed.
(j) Container management - Where operations involving use of containers such as bottles, phials and jars are conducted, there shall be adequate arrangements separated from potentisation chamber for washing, cleaning and drying such containers, with suitable equipment for the purpose. Wherever these are attended manually adequate precaution of perfection in respect of cleanliness and avoidance of pollutants shall be taken.
2. Requirements of Plants and Equipments
(a) Mother tinctures, External tinctures and Mother solution section
The following plant and equipment shall be provided, namely:-
(i) Disintegrator.
(ii) Seived Separator.
(iii) Balances and fluid measures.
(iv) Chopping board and knives.
(v) Macerators with lids.
(vi) Percolators with lids and regulated discharge.
(vii) Moisture determination apparatus or other suitable arrangement.
(viii) Filtering arrangement.
(ix) Mixing vessels and suitable non-metallic storage containers.
(x) Portable stirrers.
(xi) Water still.
Notes:(1) As far as possible metal contacts may be avoided once the drug is processed.
(2) An area of 55 sq. meters is recommended for basic installations.
(3) Adequate separate storage facility should be provided for raw material quarantine, storage and bonded room for alcohol where applicable.
(4) Separate and suitable storage facility should be provided for fresh herbs and odorous raw materials.
(5) Adequate laboratory facility shall be provided for testing of raw materials and finished products.
(b) Potentisation section
(1) The following arrangements are recommended for container for closure preparation section, namely:
(i) Washing tanks with suitable brushing arrangement manual or mechanical.
(ii) Purified water rinsing tank.
(iii) Closure macerating or washing tanks.
(iv) Drying chambers.
An area of 20 sq. meters is recommended for basic installations.
(2) The following arrangements are recommended for potency preparation section, namely:
(i) Working tables with washable top.
(ii) Facilities for separate storage of different grades of back potencies.
(iii) Suitable measuring devices for discharge of drug and diluent in potentisation vial.
(iv) Potentiser with counter or suitable manual arrangement.
An area of 20 sq. meters is recommended for basic installation.
Note: (1) Different droppers shall be used for different drug potencies.
(2) All measuring devices shall be metric system and be made of glass and shall be free of metallic contents.
(3) It is desired that glass droppers, etc. intended for re-use after cleaning should be sterilised by autoclave or by heating in a hot air oven.
(4) Plastics, rubber tubes, bulks, etc. coming in contact with tinctures or back potencies should not be re-used for other tincture and potencies.
(5) Method of potentisation will be adopted as specified in Homoeopathic Pharmacopoeia of India, Volume I
(3) Triturating, Tableting and Pill / Globules section
The following arrangement are recommended:
(i) Triturating machine of suitable device.
(ii) Disintegrator.
(iii) Mass mixer.
(iv) Granulator.
(v) Oven.
(vi) Tableting machines.
(vii) Kettle (Steam / gas / electrically heated) for preparation solution.
(viii) Dryers.
(ix) Seived separator, tablet counters and balances.
Note: Tablet section shall be free from dust and floating particles. An area of 55 sq. meters is recommended for basic installations.
(4) Ointments and lotion section:
The following arrangements are recommended, namely:- (i) Mixing tank.
(ii) Kettle (Steam, gas or electrically heated).
(iii) Suitable powder mixer.
(iv) Ointment mill.
(v) Filling equipment or arrangement.
An area of 20 sq. meters is recommended for basic installation.
(5) Syrups and tonics:
The following arrangements are recommended, namely: -
(i) Mixing and storage tank.
(ii) Portable mixer.
(iii) Filtering equipment.
(iv) Water still / Deioniser.
(v) Filling and sealing equipment.
An area of 20 sq. meters is recommended for basic installations.
(6) Ophthalmic Preparations:
The following equipment is recommended for manufacture under aseptic conditions of Eye Ointments, Eye Drops, Eye Lotions and other preparations for external use only, namely: -
(i) Hot air oven electrically heated with thermostatic control.
(ii) Colloid mill or ointment mill.
(iii) Kettle (gas or electrically heated) with suitable mixing arrangement.
(iv) Tube filling equipment.
(v) Mixing and storage tanks of stainless steel or of other suitable material.
(vi) Sintered glass funnel, Seitz filter or filter candle.
(vii) Liquid filling equipment.
(viii) Autoclaves.
Adequate precaution should be taken to ensure that the finished product is sterile.
An area of 20 sq. meters is recommended for basic installations.
(7) Adequate arrangements for space and equipment should be made for labelling and packing.
SELF ASSESSMENT
* Discuss Drugs and Cosmetics Act, 1940.
* Discuss provisions related to Import of new homoeopathic medicines in India.
* Discuss provisions related to sale of homoeopathic medicines in India.
* Discuss provisions related to manufacture of homoeopathic medicines in India.
* Discuss provisions related to labeling and packing of homoeopathic medicines in India.
QUIZ 1. Application for license for procurement of alcohol shall be made to
(a) Drug inspector
(b) Licensing authority of Central Government
(c) Local Excise Authority of the relevant state
(d) State Health Minister
2. The license for sale of homoeopathic medicines shall be deemed to be expired if application for renewal is not made within
(a) One year after its expiry
(b) Six months after its expiry
(c) One month after its expiry
(d) One week after its expiry
3. Application for the grant or renewal of a license to sell, stock, exhibit or offer for sale or distribute Homoeopathic medicines shall be made in
(a) Form 19-B
(b) Form 20-C
(c) Form 20-D
(d) Form 24-C
4. The duration of license to sell homoeopathic medicines in India is valid upto (a) 1st March of the year in which it is granted or renewed (b) 31st December of the year following the year in which it is granted or renewed
(c) 5 years after license is issued
(d) 10 years after license is issued
5. Drug inspector is appointed, in India, by
(a) Local excise authority of the relevant state
(b) State Health Minister
(c) Central Government Health Minister
(d) Central or State Government, after notification in gazette
ANSWERS: 1 (c); 2 (b); 3 (a); 4 (b); 5 (d).
THE DRUGS AND COSMETICS ACT, 1940 (23 OF 1940 - 10TH April, 1940] Homoeopathy is included in the Second Schedule of The Drugs and Cosmetics Act, 1940 under the "Standards to be complied with by imported drugs and by drugs manufactured for sale, stocked or exhibited for sale or distributed".
Class of drug
4A. Homoeopathic Medicines
(a) Drugs included in the Homoeopathic Pharmacopoeia of India.
(b) Drugs not included in the Homoeopathic Pharmacopoeia of India but which are included in the Homoeopathic Pharmacopoeia of the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia.
(c) Drugs not included in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom or the German Homoeopathic Pharmacopoeia.
Standard to be complied with:
(a) Standards of identity, purity and strength specified in the edition of the Homoeopathic Pharmacopoeia of India for the time being and such other standards as may be prescribed.
(b) Standards of identity, purity and strength prescribed for the drugs in the edition of such Pharmacopoeia for the time being in which they are given and such other standards as may be prescribed.
(c) The formula or list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed by the Central Government.
THE DRUGS AND COSMETIC RULES, 1945
According to The Drugs and Cosmetics Rules, 1945, the following definitions are applicable to homoeopathy:
(dd) "Homoeopathic medicines" include any drug which is recorded in Homoeopathic provings or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative Homoeopathic literature of India and abroad and which is prepared according to the techniques of Homoeopathic pharmacy and covers combination of ingredients of such Homoeopathic medicines but does not include a medicine which is administered by parenteral route.
(ea) "Registered Homoeopathic Medical Practitioner" means a person who is registered in the Central Register or a State Register of Homoeopathy.
According to Part II, 'The Central Drugs Laboratory', the functions of the laboratory in respect of Homoeopathic medicines shall be carried out at the Homoeopathic Pharmacopoeia Laboratory, Ghaziabad and the functions of the Director in respect of the Homoeopathic medicines shall be exercised by the Director of the laboratory.
PART IV
IMPORT
30-AA : Import of New Homoeopathic medicines
32-A : Packing and labelling of Homoeopathic medicine
PART VI A
SALE OF HOMOEOPATHIC MEDICINES
67-A :
67-B :
67-C : Forms of licenses to sell drugs
67-D : Sale at more than one place
67-E : Duration of licenses
67-EE : Certificate of renewal
67-F : Conditions to be satisfied before a license in Form 20-C or Form 20-D is granted
67-G : Conditions of license
67-GG : Additional information to be furnished by an applicant for license or a licensee to the licensing authority
67-H : Cancellation and suspension of licenses
PART VII A
MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF HOMOEOPATHIC MEDICINES
85-A : Manufacture on more than one set of premises
85-B : Application for license to manufacture Homoeopathic medicines
85-C : Application to manufacture 'New Homoeopathic medicines'
85-D : Form of license to manufacture Homoeopathic medicines
85-E : Conditions for the grant or renewal of a license in Form 25 - C
85-EA : Inspection before grant or renewal of license
85-EB : Report by Inspector
85-EC : Grant or refusal of license
85-ED : Further application after rejection
85-EE : Appeal to the State Government
85-F : Duration of license
85-G : Certificate of renewal
85-H : Conditions of license
85-HH : Additional information to be furnished by an applicant for license or a licensee to the licensing authority
85-I : Cancellation and suspension of licenses
PART IX A
LABELLING AND PACKING OF HOMOEOPATHIC MEDICINES
106-A : Manner of labelling of Homoeopathic medicines
106-B : Prohibition of quantity and percentage
PART XII
STANDARDS
126-A : Standards of ophthalmic preparations including Homoeopathic Ophthalmic preparations
PART IV
IMPORT
30-AA : Import of New Homoeopathic medicines
(1) No New Homoeopathic medicine shall be imported except under and in accordance with the permission in writing of the Licensing Authority.
(2) The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it.
Explanation - For the purpose of this rule, 'New Homoeopathic medicine' means, -
(i) a Homoeopathic medicine which is not specified in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom or the German Homoeopathic Pharmacopoeia; or
(ii) which is not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended; or
(iii) a combination of Homoeopathic medicines containing one or more medicines which are not specified in any of the Pharmacopoeias referred to in clause (i) as Homoeopathic medicines and also not recognized in authoritative Homoeopathic literature as efficacious, under the conditions recommended.
32-A : Packing and labelling of Homoeopathic medicine
No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IX-A.
PART VI - A
SALE OF HOMOEOPATHIC MEDICINES
67-A :
(1) The State government shall appoint Licensing authorities for the purpose of this Part for such areas as may be specified.
(2) Application for the grant or renewal of a license to sell, stock, exhibit or offer for sale or distribute Homoeopathic medicines shall be made in Form 19-B to the Licensing Authority and shall be accompanied by a fee of rupees ten.
Provided that if the applicant applied for renewal of license after its expiry but within six months of such expiry the fee payable foe renewal of such license shall be rupees ten plus an additional fee at the rate of rupees eight per month or thereof.
(3) If the original license is either defaced, damaged or lost, a duplicate copy thereof may be issued on payment of a fee of one rupee and twenty-five paise.
67-B :
A Licensing Authority may, with the approval of the State Government, by an order in writing, delegate the power to sign licenses and such other powers, as may be specified, to any other person under his control.
67-C : Forms of licenses to sell drugs
A license to sell, stock, exhibit or offer for sale or distribute Homoeopathic medicines by retail or by wholesale shall be issued in Form 20-C or Form 20-D as the case may be.
67-D : Sale at more than one place
If drugs are sold or stocked for sale at more than one place, a separate application shall be made and a separate license shall be obtained in respect of each place.
67-E : Duration of licenses
An original license or a renewed license unless it is sooner suspended or cancelled shall be valid up to the 31st December of the year following the year in which it is granted or renewed.
Provided that if the application for renewal of a license in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the license shall continue to be in force until orders are passed on the application and the license shall be deemed to have expired if application for its renewal is not made within six months after its expiry.
67-EE : Certificate of renewal
The certificate of renewal of a sale license in Forms 20-C and 20-D shall be issued in form 20-E.
67-F : Conditions to be satisfied before a license in Form 20-C or Form 20-D is granted
(1) A license in Form 20-C or Form 20-D to sell, stock, exhibit or offer for sale or distribute Homoeopathic medicines shall not be granted to any person unless the authority empowered to grant the license is satisfied that the premises in respect of which the license is to be granted are clean and in the case of a license in Form 20-C the sale premises is in charge of a person who is or has been dealing in Homoeopathic medicines or who is in the opinion of the Licensing Authority competent to deal in Homoeopathic medicines.
Provided that no registered Homoeopathic medical practitioner who is practising Homoeopathy in the premises where Homoeopathic medicines are sold shall deal in Homoeopathic medicines.
(2) Any person who is aggrieved by the order passed by the Licensing Authority under sub-rule (1) may within 30 days from the date of the receipt of such order appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his case, make such order in relation thereto as it thinks fit.
67-G : Conditions of license
License in Form 20-C or 20-D shall be subject to the conditions stated therein and to the following further conditions, namely -
(!) The premises where the Homoeopathic medicines are stocked for sale or sold are maintained in a clean condition.
(2) The sale of Homoeopathic medicines shall be conducted under the supervision of a person, competent to deal in Homoeopathic medicines.
(3) The licensee shall permit an Inspector to inspect the premises and furnish such information as he may require for ascertaining whether the provisions of the Act and the Rules made thereunder have been observed.
(4) The licensee in Form 20-D shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol together with names and addresses of parties to whom sold.
(5) The licensee in form 20-C shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol. No records of sale in respect of Homoeopathic potentised preparations in containers of 30 ml. or lower capacity and in respect of mother tinctures made up in quantities up to 60 ml. need be maintained.
(6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.
67-GG : Additional information to be furnished by an applicant for license or a licensee to the licensing authority
The applicant for the grant of a license or any person granted a license under this part shall, on demand furnish to the licensing authority, before the grant of the license or during the period the license is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises specified in the application for license or in the license granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements, made by the applicant or the licensee, while applying for or after obtaining the license, as the case may be.
67-H : Cancellation and suspension of licenses
(1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, cancel a license issued under this Part or suspend it for such period as he thinks fit, if in his opinion, the licensee has failed to comply with any of the conditions of the license or with any of the provisions of the Act or Rules made thereunder.
Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the license shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority - (a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or (b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission, the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or (c) if the act or omission was a continuing act or omission, that he had not or could not reasonably have had knowledge of that previous act or omission, or (d) that he had used due diligence to ensure that the conditions of the license or the provisions of the Act or the rules thereunder were observed.
(2) A licensee whose license has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.
PART VII - A
MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF HOMOEOPATHIC MEDICINES
85-A : Manufacture on more than one set of premises If Homoeopathic medicines are manufactured in more than one set of premises a separate application shall be made and a separate license shall be obtained in respect of each such set of premises.
85-B : Application for license to manufacture Homoeopathic medicines
(1) Application for grant or renewal of licenses to manufacture for sale or for distribution of Homoeopathic medicines shall be made to the Licensing Authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the Licensing Authority) and shall be made in the Form 24-C.
(2) The application in Form 24-C shall be accompanied -
(a) by a fee of rupees eighty for the manufacture of Homoeopathic mother tinctures and potentised preparations and an inspection fee of rupees twenty for the first inspection or rupees ten in case of inspection for renewal of license; (b) by a fee of rupees forty for the manufacture of Homoeopathic potentised preparations only, and an inspection fee of rupees ten for the first inspection or rupees five in case of inspection for renewal of license;
(c) by a fee of rupees forty for the manufacture of potentised preparations from back potencies by pharmacies which are already licensed to sell Homoeopathic medicines by retail and an inspection fee of rupees ten for the first inspection or rupees five in case of inspection for renewal of license.
(3) If a person applies for renewal of a license after its expiry but within six months of such expiry, the fee payable for the renewal of such a license shall be -
(a) rupees eighty plus an additional fee at the rate of rupees thirty per month or part thereof and an inspection fee of rupees ten for the manufacture of Homoeopathic mother tinctures and potentised preparations;
(b) rupees forty plus an additional fee at the rate of rupees thirty per month or part thereof and an inspection fee of rupees five for the manufacture of Homoeopathic potentised preparations only;
(c) rupees forty plus an additional fee at the rate of rupees fifteen per month or part thereof and an inspection fee of rupees five for the manufacture of potentised preparations from back potencies by pharmacies who are already licensed to sell Homoeopathic medicines by retail.
(4) A fee of rupees fifteen shall be paid for a duplicate copy of the license for the manufacture of Homoeopathic mother tincture and potentised preparations issued under sub-rule (1) if the original is defaced, damaged or lost; while the fee to be paid for such a duplicate copy of the license for the manufacture of Homoeopathic potentised preparations only shall be rupees ten.
(5) Applications by the licensee to manufacture additional items of Homoeopathic medicines shall be made to the Licensing Authority and such applications shall be accompanied by a fee of rupees five for each additional item.
85-C : Application to manufacture 'New Homoeopathic medicines' Subject to the other provisions of these Rules - (1) no 'New Homoeopathic medicine' shall be manufactured unless it is previously approved by the Licensing Authority mentioned in Rule 21;
(2) the manufacturer of 'New Homoeopathic medicine', when applying to the Licensing Authority mentioned in sub-rule (1) shall produce such documents and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it;
(3) while applying for a license to manufacture a 'New Homoeopathic medicine' an applicant shall produce alongwith his application evidence that the 'New Homoeopathic medicine' for the manufacture of which application is made has already been approved.
Explanation - The term 'New Homoeopathic medicine' in this rule shall have the same meaning as in Rule 30-AA.
85-D : Form of license to manufacture Homoeopathic medicines License for manufacturer of Homoeopathic medicines is a license to manufacture potentised preparations from back potencies by Pharmacies who are already licensed to sell Homoeopathic medicines by retail shall be granted in Form 25-C.
85-E : Conditions for the grant or renewal of a license in Form 25-C Before a license in Form 25-C is granted or renewed the following conditions shall be complied with by the applicant -
(1) The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting atleast of one person who is a whole time employee and who is -
(a) a graduate in Science with Chemistry as one of the subjects with three years' experience in manufacture of Homoeopathic medicines; or
(b) a graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or
(c) holds qualification as defined under sub-clause (g) of clause (1) of Section 2 of Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homoeopathic medicines;
Provided that the persons who are already in employment with five years' experience in the manufacture of Homoeopathic medicines and whose name was accordingly entered in any license granted in Form 25-C for manufacture of different classes of Homoeopathic medicines included in them shall be deemed to be qualified for the purpose of this rule.
(2) The factory premises shall comply with the requirements and conditions specified in Schedule
M-1:
Provided that where the Licensing Authority considers it necessary or expedient so to do, it may having regard to the nature and extent of manufacturing operations, relax or suitably alter the said requirements or conditions in any particular case for reasons to be recorded in writing.
(3) The applicant for manufacture of Homoeopathic mother tinctures shall either (i) provide and maintain adequate staff, premises and laboratory equipment for identifying the raw materials and for testing the mother tinctures wherever possible, or (ii) make arrangements with some institution approved by the Licensing Authority under Part XV (A) of these Rules for some tests, wherever possible, to be regularly carried out on his behalf by that institution.
(4) The premises where Homoeopathic medicines are manufactured shall be distinct and separate from the premises used for residential purposes.
(5) Homoeopathic medicines shall not be manufactured simultaneously with drugs pertaining to other systems of medicine.
(6) The applicant shall make arrangements for proper storage of Homoeopathic medicines manufactured by him.
Provided that in case potentised preparations are made in a Pharmacy holding license in Form 20-C, the conditions (2) and (3) shall not apply. The licensee shall ensure to the satisfaction of the Licensing Authority that the products manufactured by it, conform to the claims made on the label.
85-EA : Inspection before grant or renewal of license Before a license under this Part is granted or renewed in Form 25-C or Form 26-C, the Licensing Authority shall cause the establishment, in which the manufacture is proposed, to be conducted or being conducted, to be inspected by one or more Inspectors appointed under the Act. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed alongwith the means to be employed or being employed for standardising and testing the substances to be manufactured and inquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the requirements of plant and equipment as laid down in Schedule U.
85-EB : Report by Inspector
The Inspector or Inspectors shall forward a detailed descriptive report giving his or their findings on each aspect of inspection alongwith his or their recommendations after completion of his or their inspection to the Licensing Authority.
85-EC : Grant or refusal of license
(1) If the Licensing Authority after such further enquiry, if any, as he may consider necessary is satisfied that the requirements of the rules under the Act have been complied with and that conditions of the license and the rules under the Act shall be observed, he shall grant or renew a license in Form 25-C or Form 26-C.
(2) If the license authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a license can be granted or renewed and shall supply the applicant with a copy of the inspection report.
85-ED : Further application after rejection
If within a period of six months from the rejection of an application for a license, the applicant informs the Licensing Authority that the conditions laid down have been fulfilled and deposits an inspection fee of rupees fifty, the Licensing Authority may, if, after causing further inspection to be made, he is satisfied that the conditions for the grant of license have been complied with, issue a license in Form 25-C or Form 26-C.
85-EE : Appeal to the State Government
Any person who is aggrieved by the order passed by the Licensing Authority refusing to grant or renew a license under this Part may within ninety days from the date of receipt of such order, appeal to State Government and the State Government may, after such enquiry into the matter as is considered necessary and after giving the said person an opportunity for representing the case pass such order as it thinks fit.
85-F : Duration of license
An original license or a renewed license unless it is sooner suspended or cancelled shall be valid upto the 31st December of the year following the year in which it is granted or renewed.
Provided that if the application for renewal of a license in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the license shall continue to be in force until orders are passed on the application and the license shall be deemed to have expired if application for its renewal is not made within six months of its expiry.
85-G : Certificate of renewal
The certificate of renewal in Form 25-C shall be issued in Form 26-C.
85-H : Conditions of license
A license in Form 25-C shall be subject to the conditions stated therein and to the following further conditions, namely -
(a) the licensee shall provide and maintain staff and premises as specified in Rule 85-E;
(b) the licensee shall allow an Inspector appointed under the Act to enter, with or without prior notice, any premises where the manufacture of Homoeopathic medicine in respect of which the license is issued is carried on, to inspect the premises and to take samples of the manufactured Homoeopathic medicines; (c) the licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the Rules made thereunder have been observed;
(d) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and defects noticed;
(e) the licensee shall comply with the following conditions in respect of mother tinctures manufactured by him -
(i) the crude drug used in the manufacture of the mother tincture shall be identified and records of such identification shall be kept for a period of five years;
(ii) the total solids in the mother tincture shall be determined and records of such tests shall be kept for a period of five years;
(iii) the alcohol content in the mother tincture shall be determined and records of the same shall be maintained for a period of five years;
(iv) the containers of mother tinctures shall preferably be of glass and shall be clean and free from any sort of impurities of adhering matter. The glass shall be neutral as far as possible.
(v) in the process of manufacture of mother tinctures hygienic conditions shall be scrupulously observed by the licensee. Storage and handling conditions shall also be properly observed by the licensee according to Homoeopathic principles;
(ea) no colour shall be added any Homoeopathic medicines;
Provided that caramel may be added to combinations of Homoeopathic preparations with syrup base; (f) records shall be maintained of Homoeopathic medicines containing alcohol and the quantities sold together with names and addresses of parties to whom sold. Such records shall be maintained for a period of five years.
85-HH : Additional information to be furnished by an applicant for license or a licensee to the licensing authority The applicant for the grant of license or any other person granted a license under this Part shall, on demand, furnish to the Licensing Authority, before the grant of the license or during the period the license is in force, as the case may be, documentary evidence in respect of the ownership or occupation in rental or other basis of the premises, specified in the application for license or in the license granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the license as the case may be.
85-I : Cancellation and suspension of licenses (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, cancel a license issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates if, in his opinion, the licensee has failed to comply with any of the conditions of the license or with any provisions of the Act or Rules made thereunder.
(2) A licensee whose license has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.
PART IX - A
LABELLING AND PACKING OF HOMOEOPATHIC MEDICINES
106-A : Manner of labelling of Homoeopathic medicines
(A) The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Homoeopathic medicine and on every other covering in which the container is packed:-
(i) The words 'Homoeopathic medicine'.
(ii) The name of the medicine -
(a) For drugs included in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia, the name specified in that Pharmacopoeia.
(b) For other drugs, the name descriptive of the true nature of the drugs.
(iii) The potency of the Homoeopathic medicine - For this purpose the potency shall be expressed either in decimal, centesimal or millesimal systems.
(iiiA) In case of a Homoeopathic medicine containing two or more ingredients, the name of each ingredient together with its potency and proportion expressed in metric system shall be stated on the label.
(iv) Name and address of the manufacturer when sold in original containers of the manufacturer. In case a Homoeopathic medicine is sold in a container other than that of the manufacturer - the name and address of the seller. (v) In case the Homoeopathic medicine contains alcohol, the alcohol content in percentage by volume in terms of ethyl alcohol shall be stated on the label.
Provided that in case that the total quantity of the pharmacopoeial Homoeopathic medicine in the container is 30 milliliters or less, it will not be necessary to state the content of alcohol in the label.
(B) In addition to the above particulars the label of a Homoeopathic mother tincture shall display the following particulars -
(i) a distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken and recorded are available for inspection, the figures representing the batch number being preceded by the words "Batch No." or "Batch" or "Lot Number" or "Lot No." or "Lot" or any distinguishing prefix;
(ii) manufacturing license number, the number being preceded by the words "Manufacturing License Number" or "Mfg. Lic. No." or "M.L.".
Explanation - This clause shall not apply to a Homoeopathic mother tincture manufactured outside India.
(C) No Homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label.
106-B : Prohibition of quantity and percentage
No Homoeopathic medicine containing more than 12 Pecent alcohol v/v (Ethyl Alcohol) shall be packed and sold in packing or bottles of more than 30 milliliters, except that it may be sold to hospitals / dispensaries in packings or bottles of not more than 100 milliliters.
PART XII
STANDARDS
126-A : Standards for ophthalmic preparations including Homoeopathic ophthalmic preparations
The standards for ophthalmic preparations including Homoeopathic Ophthalmic preparations shall be those laid down in Schedule FF, and such preparations shall also comply with the standards set out in the Second Schedule to the Act.
SCHEDULES
SCHEDULE A : FORMS
SCHEDULE FF : STANDARDS FOR OPHTHALMIC PREPARATIONS
SCHEDULE M-I: GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT
SCHEDULE M-1
(See Rule 85-E (2)]
1. Requirements of factory premises for manufacture of Homoeopathic preparations -
(a) Location and surroundings - The factory shall be situated in a place which shall not be adjacent to an open sewage drain, public lavatory or any factory which produced a disagreeable or obnoxious odour or fumes or large quantities of soot, dust or smoke. The factory shall be located in a sanitary place, remote from filthy surroundings.
(b) Buildings - The part of the building used for manufacturing shall not be used as a sleeping place and no sleeping place adjoining to it shall communicate therewith except through open air or through an intervening open space. The walls of the room in which manufacturing operations are carried out shall, upto a height of six feet from the floor, be smooth, water proof and shall be capable of being kept clean. The flooring shall be smooth, even and washable and shall be capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as not to permit of retention or accumulation of dust. There shall be no chinks or crevices in the wall or floor.
(c) The building used for the factory shall be constructed so as to permit production under hygienic conditions laid down in the Factories Act, 1948 (63 of 1948)
(d) Water Supply - The water used in the manufacture shall be pure and of drinkable quality, free from pathogenic microorganisms.
(e) Disposal of Waste - There should be adequate arrangement for disposal of waste water and other residues from the laboratory.
(f) The rooms should be airy and clean and the temperature of the room should be moderately comfortable.
(g) Health, Clothing and Sanitary Requirement of the Staff - All workers shall be free from contagious or obnoxious disease. Their clothing shall consist of a white or coloured uniform suitable to the nature of work and the climate, and shall be clean. Adequate facilities for personal cleanliness, such as clean towels, soap and hand scrubbing brushes, shall be provided separately for each sex. The workers shall be required to wash and change into clean footwear before entering the rooms where the manufacturing operations are carried on. Workers shall be required to wear either a clean cap or a suitable headgear so as to avoid any possibility of contamination by hair or perspiration.
(h) Medical services - The manufacturer shall provide adequate facilities for First Aid, Medical inspection of workers at the time of employment and periodically check up thereafter at least once a year.
(i) Working benches - Working benches shall be provide for carrying out operations such as filling, labelling, packing, etc. Such benches shall be fitted with smooth, impervious tops capable of being washed.
(j) Container management - Where operations involving use of containers such as bottles, phials and jars are conducted, there shall be adequate arrangements separated from potentisation chamber for washing, cleaning and drying such containers, with suitable equipment for the purpose. Wherever these are attended manually adequate precaution of perfection in respect of cleanliness and avoidance of pollutants shall be taken.
2. Requirements of Plants and Equipments
(a) Mother tinctures, External tinctures and Mother solution section
The following plant and equipment shall be provided, namely:-
(i) Disintegrator.
(ii) Seived Separator.
(iii) Balances and fluid measures.
(iv) Chopping board and knives.
(v) Macerators with lids.
(vi) Percolators with lids and regulated discharge.
(vii) Moisture determination apparatus or other suitable arrangement.
(viii) Filtering arrangement.
(ix) Mixing vessels and suitable non-metallic storage containers.
(x) Portable stirrers.
(xi) Water still.
Notes:(1) As far as possible metal contacts may be avoided once the drug is processed.
(2) An area of 55 sq. meters is recommended for basic installations.
(3) Adequate separate storage facility should be provided for raw material quarantine, storage and bonded room for alcohol where applicable.
(4) Separate and suitable storage facility should be provided for fresh herbs and odorous raw materials.
(5) Adequate laboratory facility shall be provided for testing of raw materials and finished products.
(b) Potentisation section
(1) The following arrangements are recommended for container for closure preparation section, namely:
(i) Washing tanks with suitable brushing arrangement manual or mechanical.
(ii) Purified water rinsing tank.
(iii) Closure macerating or washing tanks.
(iv) Drying chambers.
An area of 20 sq. meters is recommended for basic installations.
(2) The following arrangements are recommended for potency preparation section, namely:
(i) Working tables with washable top.
(ii) Facilities for separate storage of different grades of back potencies.
(iii) Suitable measuring devices for discharge of drug and diluent in potentisation vial.
(iv) Potentiser with counter or suitable manual arrangement.
An area of 20 sq. meters is recommended for basic installation.
Note: (1) Different droppers shall be used for different drug potencies.
(2) All measuring devices shall be metric system and be made of glass and shall be free of metallic contents.
(3) It is desired that glass droppers, etc. intended for re-use after cleaning should be sterilised by autoclave or by heating in a hot air oven.
(4) Plastics, rubber tubes, bulks, etc. coming in contact with tinctures or back potencies should not be re-used for other tincture and potencies.
(5) Method of potentisation will be adopted as specified in Homoeopathic Pharmacopoeia of India, Volume I
(3) Triturating, Tableting and Pill / Globules section
The following arrangement are recommended:
(i) Triturating machine of suitable device.
(ii) Disintegrator.
(iii) Mass mixer.
(iv) Granulator.
(v) Oven.
(vi) Tableting machines.
(vii) Kettle (Steam / gas / electrically heated) for preparation solution.
(viii) Dryers.
(ix) Seived separator, tablet counters and balances.
Note: Tablet section shall be free from dust and floating particles. An area of 55 sq. meters is recommended for basic installations.
(4) Ointments and lotion section:
The following arrangements are recommended, namely:- (i) Mixing tank.
(ii) Kettle (Steam, gas or electrically heated).
(iii) Suitable powder mixer.
(iv) Ointment mill.
(v) Filling equipment or arrangement.
An area of 20 sq. meters is recommended for basic installation.
(5) Syrups and tonics:
The following arrangements are recommended, namely: -
(i) Mixing and storage tank.
(ii) Portable mixer.
(iii) Filtering equipment.
(iv) Water still / Deioniser.
(v) Filling and sealing equipment.
An area of 20 sq. meters is recommended for basic installations.
(6) Ophthalmic Preparations:
The following equipment is recommended for manufacture under aseptic conditions of Eye Ointments, Eye Drops, Eye Lotions and other preparations for external use only, namely: -
(i) Hot air oven electrically heated with thermostatic control.
(ii) Colloid mill or ointment mill.
(iii) Kettle (gas or electrically heated) with suitable mixing arrangement.
(iv) Tube filling equipment.
(v) Mixing and storage tanks of stainless steel or of other suitable material.
(vi) Sintered glass funnel, Seitz filter or filter candle.
(vii) Liquid filling equipment.
(viii) Autoclaves.
Adequate precaution should be taken to ensure that the finished product is sterile.
An area of 20 sq. meters is recommended for basic installations.
(7) Adequate arrangements for space and equipment should be made for labelling and packing.
SELF ASSESSMENT
* Discuss Drugs and Cosmetics Act, 1940.
* Discuss provisions related to Import of new homoeopathic medicines in India.
* Discuss provisions related to sale of homoeopathic medicines in India.
* Discuss provisions related to manufacture of homoeopathic medicines in India.
* Discuss provisions related to labeling and packing of homoeopathic medicines in India.
QUIZ 1. Application for license for procurement of alcohol shall be made to
(a) Drug inspector
(b) Licensing authority of Central Government
(c) Local Excise Authority of the relevant state
(d) State Health Minister
2. The license for sale of homoeopathic medicines shall be deemed to be expired if application for renewal is not made within
(a) One year after its expiry
(b) Six months after its expiry
(c) One month after its expiry
(d) One week after its expiry
3. Application for the grant or renewal of a license to sell, stock, exhibit or offer for sale or distribute Homoeopathic medicines shall be made in
(a) Form 19-B
(b) Form 20-C
(c) Form 20-D
(d) Form 24-C
4. The duration of license to sell homoeopathic medicines in India is valid upto (a) 1st March of the year in which it is granted or renewed (b) 31st December of the year following the year in which it is granted or renewed
(c) 5 years after license is issued
(d) 10 years after license is issued
5. Drug inspector is appointed, in India, by
(a) Local excise authority of the relevant state
(b) State Health Minister
(c) Central Government Health Minister
(d) Central or State Government, after notification in gazette
ANSWERS: 1 (c); 2 (b); 3 (a); 4 (b); 5 (d).
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