Drug & Cosmetic Act,1940.Rules 1945 . Relevant to Homeopathy
Weekly general seminar On The Drugs and cosmetics act,1940 and its rule 1945, relevant to homoeopathy By Dr. Javed aqutar bappa, Pgt, 15th batch, dept.of homoeopathic pharmacy Under the guidance of Prof. Dr. Dilip panakkada. Md(hom) Co-guide Dr. gitashree pal. Md(hom). Reader Venue: national institute of homoeopathy (govt. of India) auditorium hall, kol-106 date :22.08.2014
Drugs and cosmetics act, 1940
An act to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
- It extends to whole of India.
Arrangement of sections:–
- Chapter 1:- introductory
- Chapter 11:- the drugs technical advisory board, the central drug laboratory and the drug consultative committee.
- Chapter iii:- import of drugs and cosmetics.
- Chapter iv:- manufacture, sale and distribution of drugs and cosmetics.
- Chapter iva:- provisions relating to ayurvedic , siddha and unani drugs.
- Chapter v:- miscellaneous.
The first schedule
Ayurvedic and siddha systems
The second schedule
Standards to be complied with by imported drugs and by drugs manufactured for sale, stocked or exhibited for sale or distributed.(other than ayurveda & siddha system).
|Class of drugs||Standard complied with Homoeopathic medicine|
|a.Drugs included in HPI.||Standards specified in HPI|
|b. Drugs not included in HPI
But in HPUS or united king
Dom or GHP.
|standards specified in HPUS. GHP or united kingdom.|
|c. Drugs not included in this Homoeopathic pharmacopoeia.||standards approved by Central gov and displayed in prescribed mann er on the label of container.|
Homoeopathic medicines include any drug which is recorded in homoeopathic proving 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 technique of homoeopathic pharmacy and covers combination of ingredients of such homoeopathic medicines but does not include a medicine which is administered by parentaral route.
Registered homoeopathic medical practitioner:-
Person who is registered in the central register or state register of homoeopathy.
Central drugs laboratory:-
Central government stablished this laboratory under the control of Director. For homoeopathic medicine it is carried out by Homoeopathic Pharmacopoeia Laboratory, Ghaziabad.
Parts of the rule related to homoeopathy:-
- Part iv;- import of new homoeopathic medicine.
- Part via:- sale of homoeopathic medicine.
- Part viia:- manufacture for sale or distribution of homoeopathic medicine.
- Part ixa:- labelling and packing of homoeopathic medicine.
- Part xii:- standards for homoeopathic ophthalmic preparation.
Schedules related to homoeopathy:-
- Schedule a:- forms.
- Schedule b:- fees for test or analysis by the central drug laboratories or state drugs laboratories.
- Schedule ff:- standards for ophthalmic preparation.
- Schedule m 1:-good manufacturing practice(gmp), requirements of premises, plant and equipments.
- Schedule j:- disease and ailments (by whatever name described) which a drug may not purport to prevent or cure or make claims to prevent or cure.
- Schedule k:- extent and condition of exemption of drugs.
- Schedule u;- record maintain.
Part iv 30aa:- import of new homoeopathic medicine:-
- Without the permission in writing of Licensing Authority no new homoeopathic medicine shall be imported.
- The importer of new homoeopathic medicine when applying for permission shall be produce before the licensing authority such documentary and other evidence as may be required by the authority for assessing the therapeutic efficacy of the medicine including the minimum proving carried out with it.
- New homoeopathic medicine means—a homoeopathic medicine which not specified in HPI, HPUS or united kingdom or GHP. OR not recognized in authoritative homoeopathic literature. OR a combination containing one or more medicine which are not specified in any of the above pharmacopoeia or literature.
Part vi a:- sale of homoeopathic medicine:-
67A:- a. LICENSING AUTHORITY:- State govt. Shall appoint for this purpose.
APPLICATION FOR GRANT OR RENEWAL OF LICENCE;- shall be made in form 19B to the authority with fee of Rs 250.
* if applicant applies for renewal of licence after its expiry but within 6 months of expiry shall pay Rs 250 plus Rs 50(additional).
- ORIGINAL LICENCE DEFACED, DAMAGED OR LOST:- duplicate copy issued on payment of Rs 50.
67 B:- Other person in place of licensing authority :-
A licensing authority with the approval of state government by written order delegate the power to any other person under his control to sign licence and other powers.
67C:- FORMS OF LICENCE TO SALE DRUGS:-
For retail———- Form 20C
For wholesale. … Form 20D.
(Licence to sale, stock or exhibit or offer for sale or distribute) homoeopathic medicines by retail.
- ………………..is hereby(licensed to sale, stock or exhibit or offer for sale by wholesale or distribute) by retail homoeopathic medicines on the premises situated at …………… subject to the conditions specified below and to the provisions of the drugs and cosmetics act, 1940 and rules made there under.
- The licence shall be in force from ……… to…………
- Name and competent person in charge.
Dated……… licensing authority.
* Conditions of licence:-
- Licence shall be displayed in premises, open to public.
- Licence shall comply with Drugs and Cosmetics Act, 1940 and rules.
- Licensee shall report to the authority any change in stuff within one month of change.
- Licence authorises to sale homoeopathic medicine made from one earlier potency up to a quantity of 30 ml at a time.
- Where any change in constitution of firm, inform to authority in written.
(Licence for sale, stock or exhibit or offer for sale or distribute) homoeopathic medicines by wholesale.
- ………………. is hereby (licence to sale, stock or exhibit or offer for sale or distribute.) by wholesale homoeopathic medicines on the premises situated at……… subject to the conditions specified below and to the provisions of the Drugs and Cosmetics Act,1940 and rules made there under.
- The licence shall be in force from………….. to ……………….
Date…………… licensing authority.
* Conditions for licence:-
- &2. – same as form 20c.
3 . no sale of any drug to a person, not holding licence. Provided that this condition not apply to an authority purchasing on behalf of govt. Or a hospital, medical, educational or research institute or a homoeopathic medical practitioner for the purpose of supply to his patient.
4 . same as form 20c.
67D. Sale at more than one place:- a separate application and licence in respect of each place.
67E:- DURATION OF LICENCE:-
Original and renewal licence unless it is sooner suspended or cancelled , valid for 5 years from the date of grant or renew.
67EE. CERTIFICATE FOR RENEWAL:-
Issued in Form 20E.
- Number of licence and date of issue…………….. certified that licence no……….. in form 20c/ 20D granted on the………… to ………… for sale of homoeopathic medicines at the premises situated at …………….. has been renewed for a period from ……….. to ……………
- Name of competent person in charge…
Date………. licensing authority.
67F.:-CONDITION TO BE SATIESFIED BEFORE A LICENCE IN FORM 20C OR 20D IS GRANTED:- 1. Unless the authority empowered to grant the licence is restricted that the premises in respect of which the licence is to be granted are clean and in case of licence in form 20c the sale premises is in charge of a person who is dealing in homoeopathic medicines.
- Registered homoeopathic medical practitioner who is practising homoeopathy should not present in sold places.
2 . any person who is aggrieved by the order of licensing authority may apply to state govt. Within 30 days from the date of receipt. The state govt. After enquiry in to the matter as if consider necessary and giving the applicant an opportunity for representing his case and make such order as it think fit.
67G:- CONDITIONS OF LICENCE:-
- Premises are maintained in a clean condition.
- Sale conducted under the supervision of a person who is competent to deal in homoeopathic medicine.
- The licensee shall permit an inspector to inspect the premises and furnish such information as he may require as per act and rule.
- The licence in form 20D and 20C shall maintain record of purchase & sale of medicine containing alcohol. For form 20D together with name and address of the patient to whom sold. For form 20C no record of sale for potentised preparation up to 30ml and for mother tincture up to 60ml.
- The licensee shall maintain an inspection book in form 35, to enable an inspector to record his inspections defects noticed.
- The cover of inspection book shall contain the following particulars
- Name & address of licensee……………..
- Lic no & date up to which it is valid………..
- The pages of inspection book shall be numbered and stamped by lic .authority and having following particulars:-
Name and designation of inspector who inspect the premises of lic.
Date of inspection………………
Observation of the inspector……………
Signature of inspector
- first & last page of inspection book shall be enclosed by licensing authority with followings:-
inspection book maintain by M/S…………………. situated at ………. for licence no…………… in form ………… under the Drugs and Cosmetics Rules, 1945.
Seal & signature of licensing authority.
67GG:- ADDITIONAL INFORMATION FOR LICENCE:-
Documentary evidence in respect of ownership or occupation or rental or other basis of the premises.
67H:- CANCELLATION AND SUSPENSION OF LICENCE:-
- the licensing authority giving the licensee an opportunity to show cause for cancel or suspend for a period.
- If failure related with agent or employee, the licence shall not cancelled or suspended, if the licensee proves to the satisfaction of the authority.
- A licensee whose licence has been suspended or cancelled may within 3 months of the date or order, may appeal against the order to the state government.
Part vii a:- manufacture for sale of homoeopathic medicine:-
85A:- MORE THAN ONE PREMISES:-
separate application and separate licence.
85B:-APPLICATION FOR LICENCE TO MANUFACTURE:-
Application in form 24C
Application for grant or renewal of a homoeopathic medicines or a licence to manufacture potentised preparations from back potencies by licensees holding licence in form 20c.
- I/we ………….of……….. holder of licence no………… in form 20c hereby apply for the grant/renewal of licence to manufacture the under mentioned homoeopathic mother tincture/ potentised preparations on the premises situated at……………
Name of homoeopathic preparations………………………
(each item to be separately specified)
- Names , qualifications and experience of technical staff employed for manufacture and testing of homo medicine……
- A fee of rupees…………….has been credited to government under head of account……………………………..
FORM 24C ACCOMPANIED:-
- Manufacture of mother tincture & potentised preparation:-
First inspection:- fees Rs 200+ inspection fees Rs 100.
Renewal:- fees Rs 200 + inspection fees Rs 50
- For potentised preparation:-
First inspection: fees Rs 200 + inspection fees Rs 100
Renewal: fees Rs 200+ inspection fees Rs 50
- Potentised preparation from back potency by pharmacy licensed for sale:- first inspection:- fees RS 200+ inspection fees Rs 100
Renewal: fees Rs 200+ inspection fees Rs 50.
RENEWAL OF LICENCE AFTER EXPIRY BUT WITHIN 6 MONTHS:-
Rs 200+ Rs 100/month+ inspection fees Rs 50 for above three type of preparation.
DUPLICATE COPY OF LICENCE:-
Rs 50 shall be paid.
FOR ADDITIONAL ITEM:- Rs 50/ each additional item. + application.
85C: APPLICATION FOR MANUFACTURE NEW HOMOEOPATHIC MEDICINE:- 1. New homoeopathic medicine shall be manufacture after approval by licensing authority.
2 . manufacturer shall produce such documentary and other evidence to licensing authority including minimum proving on it.
3 . applicant shall produce along with his application evident that new homoeopathic medicine for the manufacture of which application is made has already been approved.
85D:- FORM FOR LICENCE:- shall be granted in form 25c.
85E:CONDITION FOR GRANT OR RENEWAL OF LICENCE IN FORM 25C:
- Manufacture conducted under the direction and supervision of competent technical staff with at least one who is whole time employee and who is—-
- Science graduate with chemistry is a subject+ 3 years experience in manufacture of homoeopathic medicine.
- Pharmacy graduate+ 18 months experience.
- Qualification as per CCH ACT 1973+ 18 months experience
Or 5 year experience+ already licensed in Form 25c.
- Factory premises should be as per schedule M1.
- For mother tincture preparation:- applicant shall provide and maintain adequate staff, premises, equipments for identifying the raw materials and for testing the mother or make arrange some institution approved by the authority.
- Premises should be distinct and separate from residual area.
- Homoeopathic medicine not be manufacture with other system drug simultaneously.
- Proper storage of medicine.
85EA:- INSPECTION BEFORE GRANT OR RENEWAL OF LICENCE:–
Inspector shall examine all portions of the premises, plant & appliances and also the process of manufacture, standardization, testing process and inquire into the professional qualification of staff with the requirements of maintenance of records as per schedule U.
85EB: REPORT BY INSPECTOR:–
Detailed descriptive report of finding along with recommendations shall forward to the licensing authority.
85EC: GRANT OR RENEWAL OF LICENCE:–
- If licensing authority satisfied:– the requirement of rules under the act have been complied, he may grant or renew a licence in form 25c or form 26c.
Certificate of renewal of licence to manufacture for sale of homoeopathic medicine
- Certified that licence no…………. granted on the………….. for the manufacture for sale of the homoeopathic mother tincture/ potentised preparation at the premises situated at………… has been renewed for a period from……… to ………….
- Name of the technical staff………………………..
- Name of drugs(each item separately)…………….
- If not satisfied:— reject the application with reasons.
85ED:FURTHER APPLICATION AFTER REJECTION:-
Within 6 months of rejection in form 25c or in form 26c.
85EE: APPLICATION TO STATE GOVERNMENT:–
If any person is aggrieved with the order of licensing authority for refuse to grant or renewal, then he may apply to state government within 90 days. State govt. Give the person an opportunity for presenting the case if think fit.
85F: DURATION OF LICENCE:–
Valid for 5 years from the date of grant or renewal(if not otherwise suspend or cancel). * renewal is made within 6 months with additional fees.
85G: CERTIFICATE OF RENEWAL:– Renewal of licence in form 25c shall be issued in 26c.
85H:-CONDITIONS OF LICENCE:-
- Maintain staff and premises as per rule 85E.
- Licensee shall allow an inspector to enter with or without prior notice in any premises and to take sample of manufactured homoeopathic medicine and inspects all registers and records.
- Licensee shall maintain an inspection book in form 35 to enable an inspector to record his impressions and defects noticed.
- Licensee shall maintain the following for mother preparation:-
- Crud drug should identified and records should kept for 5 years.
- Total solid in Q should determined and record kept for 5 years.
- Alcohol content is determined and record kept for 5 yrs.
- Container of Q should free from impurity and made of neutral glass as possible.
- Hygienic condition shall be observed. Storage and handling condition also observed according to homoeopathic principles.
- No colour shall be added in medicine.
- Caramel may be added to combination with syrup base.
- Records shall maintained of homoeopathic medicine containing alcohol and quantities sold together with names and address of patient to whom sold and record for 5 yrs.
85HH: ADDITIONAL INFORMATION:-
Documentary evidence in respect to ownership or occupation in rental or other basis of the premises, constitution of firm or any other relevant matter furnish to the licensing authority.
85I: CANCELLATION AND SUSPENSION OF LICENCE:–
- The licensing authority after giving the licensee an opportunity to show cause by an order in writing , stating the reason, cancel a licence or suspend for such period as he think fit.
- A licensee may within 3 months of date of cancel or suspend may appeal against that order, to the state govt. Which shall decide the same.
Part ixa: labelling and packing of homoeopathic medicine:
106A:- MANNER OF LABELLING:-
- Following particulars shall be either printed or written in indelible ink on the label of the inner most container of medicine and other covering by which container is packed—
- The word” homoeopathic medicine”.
- Name of medicine:-
- As specified in HPI, HPUS or united kingdom or GHP.
- For other drugs, name descriptive of the true nature of the drugs.
- Potency of medicine either decimal, centesimal or millisimal systems.
- 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.
- Name and address of manufacture, when sold in original container, also seller name and address.
- Medicine contains alcohol:- the % by volume in term of ethyl alcohol shall be stated in label.
- Label of mother tincture:-
- Above particulars
- A distinctive bath no or lot no preceded by words ‘batch no’ or ‘lot no’ or lot should be written.
- Manufacturing licence no or ‘Mfg lic no’ or ML should also written.
- Not apply to mother tincture prepared outside of India.
- Single ingredient medicine:- no proprietary name on label.
106B:PROHIBITION OF QUANTITY AND PERCENTAGE:–
*. Medicine containing above 12% alcohol:–shall be pack and sold in packing or bottles not more than 30ml.
*. Except it may be sold in hospital/ dispensaries in packing and bottles not more than 100ml.
Schedule b:- fees for test or analysis by the central drug laboratories or state drug laboratories.
- Identification test for raw materials of botanic origin—Rs 125.
- For raw material of chemical origin—- Rs 100.
- Limit test for drug of chemical origin—Rs 150.
- Assay of total alkaloid or chemical drugs—Rs 100.
- Identification test of animal or microbiological drugs—Rs 100.
- Test of Q, lower potency up to 3x or equivalent—Rs 100.
- V or I.R or H.P.L.C. defect determination—Rs 75.
- Determination of biochemic drug through atomic absorbance spectrophotometer————————————– Rs 75.
For tests not listed in the schedule, charges will be determined by the Director or the Govt. Analyst of the laboratory/ institute as the case may be.
Schedule j:- disease and ailments (by whatever name describe) which a drug may not purport to prevent or cure or make claims to prevent or cure:–
- 2. Angina pectoris. 3. Appendicitis. 4. Arteriosclerosis. 5.Baldness. 6. Blindness. 7. Bronchial asthma. 8. Cancer and benign tumour. 9. Cataract. 10. Change in colour of hair and growth of new hair. 11. Change of foetal sex by drug. 12. Congenital malformation. 13. Deafness. 14. Diabetes. 15. Uterine disease. 16. Epileptic fits and psychiatric disorder. 17. Encephalitis. 18. Fairness of skin , 19. Structure of breast. 20. Gangrene. 21. Genetic disorder. 22.Glaucoma. 23. Goitre. 24. Hernia. 25. High/low blood pressure. 26.hydrocele. 27. Insanity. 28. Increase brain capacity and memory improvement. 29. Improvement of height of children/adults. 30.improvement of size and shape of sexual organ and duration of sexual performance. 31. Improvement of strength of natural teeth. 32.improvement in vision. 33. Jaundice/hepatitis/ liver disorder. 34.leukaemia. 35. Leucoderma. 36.maintainance or improvement of the capacity of the human being for sexual pleasure. 37.mental retardation/ sub normality/ growth. 38.myocardial infarction. 39.obesity. 40.paralysis. 41.parkinsonism. 42.piles and fistula. 43.power to rejuvenate. 44. Premature ageing. 45.premature greying of hair. 46. Rheumatic heart disease. 47.impotency, premature ejaculation and spermatorrhoea. 48. Spondylitis. 49. Stammering. 50.stone in gall bladder, kidney, bladder. 51. Varicose vein.
Schedule k: extent and conditions of exemption:–
- Arnica Montana hair oil
- Homoeopathic ointment each in 15 gm tube as arnica, calendula, cantharis, rhus tox
- All 12 tissue remedy in tablet form, each in 20 gm pack only in 3x and 6x trituration.
- Arnica, aconite,ars, aloe, apis, allium cepa. Bryonia,borax, bell, cantharis, carbo veg, cina, colocynth, calendula, caulophyllum, cocculus, drosera, hypericum, heper, ipecac, ledum, milefolium, merc sol, nux vom, puls, podo, plantago, rhus tox, ruta, symphytum,veratrum..
Sale licence should be given in form 20c in the following conditions:—
*. These homoeopathic medicine sold in original sealed small quantity packing of manufacturer.
*. May be stocked and sold by retail dealers of medicine licensed under rule 61.
*. Stored separately from other allopathic drugs.
*. Purchased from manufacturer or a dealer licensed under this rules.
*. Parched and sale record shall be maintain by dealer for 3 yrs.
*.labelled in generic/ pharmacopoeial name only.
Schedule m i:
- Requirements of factory premises for manufacture of homoeopathic preparation:—-
- LOCATION AND SURROUNDINGS:– factory shall be situated in place which not adjacent to a open sewage drain, public lavatory or any factory which produce a disagreeable or obnoxious odour or fumes or large quantities of soot, dust or smoke. Factory shall be located in a sanitary place, remove from filthy surroundings.
- BUILDING:– shall not be used for a sleeping place. Wall of the room for manufacture , be smooth, water proof and capable of being kept clean ,up to 6 feet from floor. Floor shall be smooth, even and washable and not permit the accumulation of dust.
- Building shall be constructed according to the Factory Act, 1948.
- WATER SUPPLY:– pure and drinkable quality, free from pathogenic microorganisms.
- DISPOSAL OF WASTE:– adequate arrangement for disposal of waste water and other residues.
- Room should be airy and clean, temperature – moderately comfortable.ie, 76 to 80 deg F.
- HEALTH, CLOTHING AND SANITARY REQUIREMENT OF STAFF:– Workers shall be free from contagious and obnoxious disease. Clothing of a white or coloured uniform suitable to the nature of work and climate. Maintain personal cleanliness. Required to wash and change into clean foot ware before entering in manufacturing room. Wear a clean cap or headgear to avoid contamination.
- MEDICAL SERVICES:– Adequate facilities for First Aid. Medical inspection of workers at the time of employment and periodically at least once a year.
- WORKING BENCH:– fitted with smooth, impervious tops capable of being washed.
- CONTAINER MANAGEMENT:– containers shall be adequate arrangement separated from potentisation chamber for washing, cleaning, drying with suitable equipments for this purpose.
2.requirements of plant and equipment:–
- mother tincture:–
- disintegrator, 2. Sieved separator. 3. Balances &fluid measures. 4.chopping boards & knives. 5.macerators with lids. 6.parcolators with lids. 7.moisture balance. 8. Filtering arrangement. 9.mixing vessel & storage container. 10.portable stirrer. 11. Water still.
*. Metal contact may be avoided as possible , once the drug is processed.
*. 55 sq. Meters is recommended area.
*. Separate storage facility for raw material quarantine, storage and bonded room for alcohol.
*. Separate and suitable storage facility for fresh herbs and odorous materials.
*. Adequate laboratory facility for test.
- potentisation section:- a. Washing tank. B. Purified water tank. C . closure macerating or washing tanks. D. drying chambers. E. Working table with washable tops. F. separate store for back potency. G. Measuring device. H. Potentiser with counter.
* an area of 20 sq. Meters is recommended for basic installations.
*. Different dropper for different potency.
*. Proper cleaning and sterilization of utensils.
*. Method of potentisation will be adopted as specified in HPI vol. 1.
- triturating, tableting & pill/ globules section:–
- triturating machine. 2. Disintegrator. 3.mass mixture. 4. Granulator. 5.oven. 6.tablet punching machines. 7.kettle 8.dryers. 9.sieved separator. 10.tablet counter. 11. Balance.
* an area of 55 sq. Meters is recommended for basic installation.
- ointment & lotion section:–
- mixing tank. 2.kettle. 3.suitable powder mixture. 4.ointment mill. 5.filling equipment.
*. An area of 20 sq. Meters is recommended for basic installation.
- syrup & tonic section:-
- mixing & storage tank. 2.potable mixture. 3.filtering equipment. 4.water still/ deioniser.5. filling & sealing equipment.
*. An area of 20 sq. Meters is required for basic installation.
- ophthalmic preparation section:–
- hot air oven electrically heated with thermostatic control. 2.colloid mill or ointment mill. 3.kettle with suitable mixture arrangement. 4.tube filling equipment. 5.mixing and storage tank of stainless still or other suitable materials. 6. Sintered glass funnel, Seitz filter or filter candle. 7.liquid filling equipment. 8. Autoclave.
*. Adequate precaution should be taken to ensure that the finished product is sterile.
* an area of 20 sq. Meters is recommended for basic installation.
- adequate arrangements for space and equipment should be made for labelling and packing..
schedule- u:– manufacturing records:=
- The Drugs and Cosmetic act 1940 as amended by the Drugs(amendment) Act,1955.
- The Drugs (amendment) act, 1960.
- The Drugs (amendment) act, 1962.
- The Drugs and Cosmetics(amendment) act, 1964.
- The Drugs and cosmetics (amendment) act, 1972.
- The Drugs and cosmetics(amendment) act, 1982.
- The Drugs and cosmetics (amendment) act,1993.
- The Drugs and cosmetics (amendment) act, 1995.
- The Drugs and cosmetic Rules, 1945.( amendment up to 2006). Ministry of health and family welfare. Govt. Of India.
- The finance act, 1993.
- The factory act, 1948.
- Homoeopathic pharmacopoeia of India vol I-IX, printed by the manager. GOVT. OF INDIA. PRESS, COIMBATORE. And published by the controller of publication, NEW DELHI.
- Hahnemann, Samuel, Organon of medicine. B.JAIN PUBLISHERS(P) LTD. NEW DELHI.
- Banerjee, D.D; Text book of homoeopathic pharmacy; B.JAIN PUBLISHERS(P)Ltd. NEW DELHI.
- Goel,DR.Sumit; Art and science of homoeopathic pharmacy.
- Mandal&Mandal,Dr.Parthapratim&Dr.Biman, A text book of homoeopathic pharmacy, New central book agency(p) ltd.
- Sahani, Dr. M.K, Principles and practice of homoeopathic pharmacy, B.JAIN PUBLISHERS (P) Ltd. NEW DELHI.
- K. Preventive and social medicine. 21 edition.
- Rajswasthya.nic.in-the drugs and cosmetics act, 1940- medical health.
- Manupatra.com/manfeed/contents-6349625902580076.pdf- drugs and cosmetics(first amendment) rules,2013.
- Drugscontrol.org/amendments.asp?act=drugs%20 and %20 cosmetic-drug and cosmetic act 1940-drug control.org.