DOES A QUALIFIED Regd. VETERINARY /MEDICAL PRACTITIONER NEED A DRUG LICENSE TO DISPENSE MEDICINES TO THEIR PATIENTS?
Compiled & Edited by-DR RAJESH KUMAR SINGH ,JAMSHEDPUR,JHARKHAND, INDIA, 9431309542,rajeshsinghvet@gmail.com
Recently it has come to notice from the newspapers that the directorate of drugs control has slapped cases against doctors under the Drugs and Cosmetics act for selling drugs to patients without valid license. In this scenario it will become very difficult for the doctors to carry out regular practice properly. A qualified medical/Veterinary practitioner (MBBS/ BVSc &AH or higher qualification) is best qualified to dispense medicines to patients as he is fully educated on effects. side effects, and drug interactions and individual variations, and to deal with all of these – which a pharmacist is not!! So there is absolutely no justication for the regulatory authorities to prevent doctors from dispensing medicines to their patients, and authorising pharmacists to advise patients about drugs.
I give below relevant excerpts from THE DRUGS AND COSMETICS RULES, 1945 which clearly indicates that private practioners and hospitals are exempted from obtaining a license for dispensing drugs to their patients with certain conditions.
Chapter IV of THE DRUGS AND COSMETICS ACT, 1940 (as amended by the Drugs (Amendment) Act, 1955, the Drugs (Amendment) Act, 1960, the Drugs (Amendment) Act, 1962, the Drugs and Cosmetics (Amendments)
Act, 1964, the Drugs and Cosmetics (Amendments) Act, 1972, the Drugs and Cosmetics (Amendments) Act, 1982, the Drugs and Cosmetics (Amendments) Act, 1986 and the Drugs and Cosmetics (Amendments) Act, 1995) deals with MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
PART XI- of the THE DRUGS AND COSMETICS RULES, 1945 (as corrected up to the 30th November, 2004) deals with EXEMPTION to Chapter IV of THE DRUGS AND COSMETICS ACT, 1940.
Rule 123. The drugs specified in schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.
SCHEDULE K[ See Rule 123]
Class of Drugs
4[5. Drugs supplied by a registered medical practitioner to his own patient or any drug specified in
Schedule C supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient provided the
registered medical practitioner is not (a) keeping an open shop or (b) selling across the counter or (c) engaged in the importation, manufacture, distribution or sale of drugs in the provision of Chapter IV of the Act and the
rules thereunder.
Extent and Conditions of Exemption
All the provisions of Chapter IV of the Act and the Rules made thereunder, subject to the following conditions:
5[(1)The drugs shall be purchased only from a dealer or a manufacturer licenced under these rules and records of such purchases showing the names and quantities of such drugs together with their batch numbers and the names and addresses of the manufacturers shall be maintained. Such records shall be open to inspection by an Inspector appointed under the Act, who may, if necessary, make enquiries about purchases of the drugs and may also take samples for test.
FORM 20-B
[See Rule 61 (1)]
1[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale, drugs other than
specified in2[Schedules C, C(I) and X]
- …………………………… hereby 1[licensed to sell, stock or exhibit or offer for sale
or distribute] by wholesale drugs other than those specified in 2[Schedule C,C(1) and X] on the
premises situated at……………………subject to the conditions specified below and to the
provisions of the Drugs and Cosmetics Act, 1940, and the Rules thereunder. - The licence shall be in force from ……………….. to…………………..
3[3. The sale shall be made under the personal supervision of a competent person
(Name of the competent person.)]
Conditions of Licence - This licence shall be displayed in a prominent place in part of the premises open to the public
- The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder for the time being in force.
13.(i) No drug shall be sold unless such drug is purchased under a cash or credit memo from a duly licensed dealer or a duly licensed manufacturer.
(ii) No sale of any drug shall be made to a person not holding the requisite licence to
sell, stock or exhibit for sale or distribute the drug.
Provided that this condition shall not apply to the sale of any drug to–
(a) an officer or authority purchasing on behalf of Government or
(b) a hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients, or
(c) a manufacturer of beverages, confectional biscuits and other nonmedicinal products, where such drugs are required for processing these products;
Rule (5)(1) Subject to the other provisions of these rules the supply of a drug by wholesale shall be made against a cash or credit memo bearing the name and address of the licensee and his licence number under the Drugs and Cosmetics Act in which the following particulars shall be entered____
(a) the date of sale.
(b) the name, address of the licensee to whom sold and his sale licence number. In case of sale to an authority purchasing on behalf of Government, or to a hospital, medical, educational or research institution or to a Registered Medical Practitioner for the purpose of supply to his patients the name and address of the authority, institution or the Registered Medical Practitioner as the case may be,
(9) (a) Substances specified in Schedule H or Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner and in the case of substances specified in schedule X, the prescriptions shall be in duplicate,one copy of which shall be retained by the licensee for a period of two years.
(b)The supply of drugs specified in Schedule H or Schedule X to Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for a period of two years;] - Packing of drugs.— (1) The pack sizes of drugs meant for retail sale shall be as prescribed in Schedule P-1 to these rules.
(2) The pack sizes of drugs not covered by the Schedule P-1 shall be as given below:
Unless specified otherwise in Schedule P-1,
(i) The pack sizes for Tablets/Capsules shall be-
Where the number of Tablets (coated or uncoated)/Capsules (hard or soft gelatin) is less than 10, such packing shall be made by the integral number. For numbers above 10, the pack size of Tablets/Capsules shall contain multiples of 5.
(ii) The pack sizes for liquid Oral preparations shall be 30ml (paediatric only) 60 ml/100 ml/200 ml/450 ml.
(iii)The pack sizes for Paediatric Oral Drops shall be 5 ml/10 ml/15 ml.
(iv) The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5 ml/10 ml.
(v) The pack size for Eye Ointment shall be 3 gm/5 gm/ 10 gm.
Provided that the provisions of the pack sizes covered under this rule shall not apply to: - Pack sizes or dosage forms not covered by the foregoing provisions of
this rule. - The imported formulations in finished form.
- Preparations intended for Veterinary use.
- Preparations intended for Export.
- Vitamins/Tonics/Cough Preparations/Antacids/Laxatives in Liquid Oral
forms, Unit dose (including applicaps). - Pack sizes of dosage form meant for retail sale to Hospitals, Registered Medic al practitioners, Nursing Homes.
- Physician’s Samples.
- Pack sizes of large volume intravenous fluids.
105-A. Packings of drugs specified in Schedule X.- The drugs specified in Schedule X shall be marketed in packings not exceeding-
(i) 100 unit doses in the case of tablets/capsules.
(ii) 300ml in the case of oral liquid preparations.
(iii)And 5 ml in the case of injections.
Provided that nothing in this rule shall apply to packing meant for use of a hospital or a dispensary subject to the conditions that-
(i) such supplied are made by the manufacturers or distributors direct to the hospital/dispensaries; and
(ii) hospital packs shall not be supplied to a retain dealer or to a Registered Medical Practitioner.
FORM 20-B
[See Rule 61 (1)]
1[Licence to sell, stock or exhibit or offer for sale, or distribute] by wholesale, drugs other than
specified in2[Schedules C, C(I) and X] - …………………………… hereby 1[licensed to sell, stock or exhibit or offer for sale
or distribute] by wholesale drugs other than those specified in 2[Schedule C,C(1) and X] on the
premises situated at……………………subject to the conditions specified below and to the
provisions of the Drugs and Cosmetics Act, 1940, and the Rules thereunder. - The licence shall be in force from ……………….. to…………………..
3[3. The sale shall be made under the personal supervision of a competent person
(Name of the competent person.)]
Conditions of Licence - This licence shall be displayed in a prominent place in part of the premises open to
the public - The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder for the time being in force.
13.(i) No drug shall be sold unless such drug is purchased under a cash or credit memo from a duly licensed dealer or a duly licensed manufacturer.
(ii) No sale of any drug shall be made to a person not holding the requisite licence to sell, stock or exhibit for sale or distribute the drug.
Provided that this condition
shall not apply to the sale of any drug to–
(a) an officer or authority purchasing on behalf of Government or
(b) a hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients, or
(c) a manufacturer of beverages, confectional biscuits and other nonmedicinal products, where such drugs are required for processing these products;
564.Conditions to be satisfied before a licence in Form3[20, 20-B, 20-F,20-G 21 or 21-B] is granted .(1)A licence in Form 3[20, 20-B, 20-F,20-G, 21 or 21-B] 6[to sell, stock, exhibit or offer for sale or distribute]drugs shall not be 7[granted or renewed] to any person unless the authority empowered to grant the licence is satisfied that the premise in respect of which the licence is to be 7[granted or renewed] are adequate, equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies and are in charge of a person competent in the opinion of the licensing authority to supervise and control the sale, distribution and preservation of drugs : Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be 7[granted or renewed] unless the licensing authority is satisfied that the requirements prescribed for a pharmacy in Schedule N have been complied with. 3[Provided further that licence in Form 20-F shall be 7[granted or renewed] only to a pharmacy and in areas where a pharmacy is not operating, such licence may be 7[granted or renewed] to a chemist and druggist] Explanation. For the purpose of this rule the term ‘Pharmacy’ shall be held to mean to include every store or shop or other place : (1) where drugs are dispensed, that is, measured or weighed or mode up and supplied : or (2), where prescriptions are compounded; or (3) where drugs are prepared; or (4) which has upon it or displayed within it, or affixed to or used in connection with it, a sign bearing the word or words “Pharmacy”, “Pharmacist,” “Dispensing Chemist” or “Pharmaceutical Chemist”; or (5) which, by sign, symbol or indication within or. upon it gives the impression that the operations mentioned at (1), (2) and (3) are carried out in the premises; or (6) which is advertised in terms referred to in (4) above
That means, In short the distributors MUSt supply drugs to Private Practitioners and Hospitals who have the right to buy and stock, dispense or sell any drug without a license, provided the drugs are dispensed to their OWN patients within the premises and not sold to outsiders ubder the sign of “Pharmacy”, “Pharmacist,” “Dispensing Chemist” or “Pharmaceutical Chemist” or any other sign that indicates sale of medicines .
Reference-On Request
