Sale of Medicines by Registered Medical Practitioners (RMP) or Registered Veterinary Practitioners at their Clinics: Legal and Ethical issues
According to the World Health Organization, dispensing refers to the practice of preparing and giving medicine to a person based on a prescription from a registered medical practitioner (RMP) or Veterinarian. Dispensing of medicines by an RMP has been legalized for the convenience of the patients. It allows the availability of consultation, treatment-related supplies, prescription and drugs under one roof, i.e. the doctors clinic to the patients.
Many issues border the practice of dispensing of medicines by registered practitioners. It is not uncommon for RMPs to exercise the option of prescribing as well as dispensing medicines, especially in semi-urban and rural areas yet this dual practice of prescribing and dispensing medicines raises many ethical and legal concerns.
Can Medical or Veterinary Practitioners dispense medicines in India?
The question of whether clinical specialists should sell medicines at their clinic has been raised on several occasions but still remains unanswered.In India, the manufacturing, storing, transportation, conveyance, and administering of drugs and medicines are governed under various statutes, including:
- The Drugs and Cosmetic Act, 1940;
- Indian Medical Council Act, 1956;
- The Pharmacy Act, 1948; and
- The Narcotic Drugs and Psychotropic Substances Act, 1985.
S.42 of the Pharmacy Act requires mandatory registration of pharmacists selling medicines but exempts RMPs from this requirement. Recently, the Pharmacy Council of India had unanimously adopted a resolution requiring an amendment of S.42 of the Pharmacy Act permitting RMPs to sell medicines to their patients. Rajan B Rajan, former President of the Kerala State Pharmacy Council, also demanded following up on the implementation of this resolution. It is argued that since RMPs are unregistered drug specialists, they should not be allowed to sell drugs.
Rules governing dispensing of medicines by RMPs or Vets in India
Primary legislation dealing with the dispensation of drugs by medical practitioners is the Drugs and Cosmetics Act, 1940 (DCA). Form 20B of the DCA discharges the RMPs from procuring a license to dispense medicines. The rules framed under DCA, namely the Drugs and Cosmetic Rules, 1945 (hereinafter referred to as �Rules�), extensively lay down the requirements that allow an RMP to commence dispensing medicines. Schedule K of the Rules regulates the selling of medicines by medical practitioners.
RMPs can supply drugs to their own patients provided the following conditions are fulfilled:
- The RMP must not keep an open shop
- He must not sell across the counter
- He must not be engaged in the import, manufacture, distribution or sale of drugs in India to such an extent that makes him liable for the breach of provisions of Chapter IV, DCA or the Rules.
- The drugs must be purchased by a licensed manufacturer or dealer, and records of such purchase should be maintained and shall be open for examination at all times by the Inspector appointed under DCA.
- The drugs must be stored under proper conditions as prescribed on the label.
- No drug shall be sold beyond its expiry date mentioned on its label or wrapper.
These conditions also apply in case a drug mentioned in Schedule C of the Rules is provided by the RMP to another medical practitioner at their request.
In Schedule K of the Rules, additional conditions have been prescribed if the medicine to be dispensed is mentioned in Schedules G, H or X of the Rules. These are:
- The medicine must bear a label mentioning the name and address of the RMP to whom it is supplied.
- Route of administration is also to be labelled
- A register has to be maintained by the RMP, listing out the name of medicine or ingredients of preparation and quantities, the dose prescribed, the name of the patient, date and time of supply, and the person who prescribed the medicines.
- Each entry in the register shall be numbered, and such a number must be written on the label of the container.
- The register and the prescription upon which the medicines were issued shall be preserved for at least two years from the date of the last entry in the register or the date of the prescription.
Non-compliance with these conditions will render the RMP liable for penalty under Chapter IV of the DCA. According to S.27(d), any person acting in contravention of the Rules shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and with fine which shall not be less than twenty thousand rupees. Furthermore, the State Medical Council can proceed against the RMP.
Although RMPs are not required to obtain a license for dispensing medicines to their own patients, if the drug to be dispensed is a controlled drug declared under S.2 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act), the RMP needs to secure a license to procure, transport, stock and dispense these controlled drugs.
Furthermore, the Narcotic Psychotropic Substances Rules, 1985, govern the dispensation of controlled drugs by RMPs. Under Rules 52H and 52R, every RMP is required to maintain a separate record for each patient in Form no. 3E. Form no. 3D is to be filled detailing a day-to-day account of all transactions of essential narcotics. RMPs are also required to maintain a record of all receipts and disbursements of essential drugs in the manner prescribed in Form no. 3H.
Sabira M. v. State of Kerala and Ors. is a landmark judgement of the Kerala High Court wherein the Court held that �no person other than a registered pharmacist shall compound, prepare, mix or dispense any medicine on the prescription of a medical practitioner. However, the said provision shall not apply to dispense by a medical practitioner of medicine for his/her own patients, or with the general or special sanction of the state government for the patients of another medical practitioner.�
Ethical guidelines for Registered Medical /Vets Practitioner dispensing medicines
There has been a debate regarding the practice of RMPs to sell medicines in their own clinic. It is regarded as an ethical violation as doctors would benefit by prescribing expensive medicines to the patients. There is an inherent conflict of interest in this dual role as prescriber and seller of medicines of the RMP. In India, it is not unethical or illegal for an RMP to sell medicines to his patients, provided certain conditions are fulfilled.
The Medical Council of India, with the approval of the Central Government, has notified regulations regulating the professional conduct of RMPs in India under S.33(m) of the Indian Medical Council Act, 1956.This code is known as the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. According to these regulations, RMPs should not run an open shop to sell medicines prescribed by him. This restriction does not apply in the case of the sale of medical or surgical instruments.
The aim of this prohibition is to prevent the RMP from exploiting his patients. Subsequent to the amendment in 2016 to these regulations, the RMP is now required to legally prescribe drugs with their generic names, preferably in capital letters. Furthermore, it is now the responsibility of the RMP to ensure rational prescription and use of drugs.
Responsibility of RMPs
There is an inherent danger of the profit motive of the medical practitioners in dispensing medicines. The RMP selling medicines to people has a dual interest in making profits as well as treating his patients. One must maintain a balance of interests for an ethical and efficient medical practice.
Besides fulfilling the conditions prescribed by law, RMPs must disclose all relevant information to the patient. They should clearly reveal the name of the medicine, its efficacy, side-effects, economically friendly alternatives or substitutes of the prescribed medicines. The RMPs should refrain from taking any share in the profit from the sale of the medicines. The medical practitioner should not, under any circumstance, pressurize the patients into purchasing the medicines from him.
Can doctors legally dispense medicines to their patients?
Yes you can legally dispense though you have to follow certain conditions as cannot open shop or cannot import drugs you have to purchase it from registered DCR and then has to keep record of same.
RULES REGARDING KEEPING & DISPENSING OF DRUGS BY THE RMPS or VETS
- A license is required for sale, distribution etc. of drugs as per DCA and DCR. However, considering the nature, manner &
conduct of Medical Practice in India and also considering the emergencies and other related contingencies often encountered
by the RMPs, while treating the patients, the law has exempted the RMPs from having a license in the interest of public
health. This exemption is for the following categories of drugs :-
(a) All drugs supplied by RMPs to his patients only, or
(b) Any drug specified in Schedule C (Biological & Special Products) of DCR, supplied by a RMP on the request of another RMP
if it is specifically prepared with reference to the condition and for the use of the individual patient.
- Thus, though the RMPs enjoy the exemption, they are required to strictly follow the following conditions when they keep and dispense the drugs :-
- RMPs should not (a) keep an open shop or (b) sell across a counter or (c) engage in importation, manufacture,
distribution or sale of drugs in India to a degree which makes him liable to provisions of Chapter IV (It refers to manufacture, sale and distribution of drugs and cosmetics) of DCA and DCR.
- (a)The drugs shall be purchased only from a dealer or a manufacturer licensed under DCR and (b) Records of such purchases showing the names and quantities of such drugs, together with their batch numbers and names and addresses of manufacturers should be maintained. Such records shall be open to inspection by a drug inspector who may, if necessary, make enquiries about the purchases of drugs and may also take samples for test.
III. The drug should be stored under proper storage conditions as directed on the label of the drug.
- No drug should be supplied or dispensed after the date of expiration of potency recorded on its container, label or wrapper or in violation of any statement or direction recorded on such container, label or wrapper.
- Additional conditions in case of medicine containing substance specified in Schedule G, H or X of DCA and DCR :-
(a) The medicine shall be labeled with the name and address of the RMP by whom it is supplied.
(b) Medicine for external application should be labeled with the words ‘For External Use Only’. If it is for internal use, it should be labeled with dose.
(c) The name of the medicine or ingredients of the preparation and the quantities thereof, the dose prescribed the name of the patient and the date of supply and the name of the person who gave the prescription shall be entered at the time of supply in the register to be maintained for the purpose.
(d) The entry in the register shall be given a number and that number shall be entered on the label of the container.
(e) The register and the prescription, if any, on which the medicines are issued shall be preserved for not less than two years from the date of the last entry in the register or the date of the prescription, as the case maybe.
Note: – The law has contemplated the practices followed by RMPs in the past namely, to purchase the drugs in the bulk and dispense them in small quantities to the patients and at times, compound and dispense the drugs to the patients. Though this practice is presently on the wane, the conditions given above, at (a) to (e) are still required to be followed by the RMPs. RMPs may prepare a stamp containing full name, address & registration number and stamp it on (a) & (b) above, while dispensing. Information regarding (c), (d) & (e) may be kept in soft for inspection of drug inspector etc.
- This also applies to drugs received as Not for Sale Physician’s Samples.
- The intention of the law, as reflected in the above conditions, is to account and trace the drugs as per the batch number, in case of any instance of substandard drug & to take further action in accordance with law and also to trace the consumer/patient who could be a likely victim. Any violation of conditions given in I to VI above is punishable under the DCA.
The concerned State Medical Councils may also take disciplinary action against the RMPs, as they deem fit, if reported by the regulatory agencies.
Doctor Can’t Be Punished Under Drugs & Cosmetics Act For Storing Small Quantities Of Medicines : Supreme Court
Supreme Court: Doctors cannot be punished for storing small quantities of medicines under the Drugs and Cosmetics Act 1940.
The apex court quashed the criminal proceedings against a doctor under the Drugs and Cosmetics Act 1940, for storing small quantities of medicines in S. Athilakshmi vs. The State Rep. by the Drugs Inspector. It held that a doctor’s act of storing modest quantities of medications will not amount to a crime of unauthorised stocking of medications under Section 18(c) of the above act. It further noted that such quantities can be easily found in the consultation room of the doctor.
The two-judge bench comprising of Justice Krishan Murari and Justice Sudhanshu Dhulia was hearing a special leave petition filed by the Doctor against the criminal proceedings on her on account of the inspection carried out by the Drug inspector in her premises, where a certain quantity of medicines and lotions were found. The inspector filed a request for a sanction for prosecution with the office of the Director of Drugs Control, Tamil Nadu, alleging that she had drugs on hand for sale and sold them without a valid drug license, punishable under section 27(b)(ii) of the aforementioned Act. In response to receiving the sanction in January 2018, the Inspector filed a complaint at the Magistrate Egmore about pursuing the Appellant under Section 18(c) of the 1940 Medicines and Cosmetics Act. Upon challenging the proceedings before Madras High Court, the High Court dismissed the petition.
The apex court relied on the Schedule K of the Drugs and Cosmetics Rules, 1945, which exempted certain drugs from the provisions of the Chapter IV of the act. It held that this exemption is in the favour of the appellant and has exemptions from both section 18 and section 27, that are applied in this case. Entry 5 of the Schedule K of the above rules is as follows.
The court further held that since the quantity of the drugs found is extremely small, and it can easily be found in a doctor’s office or consultation premises, no offence can be made out in the present case. Rule 123 of the rules when read with schedule K provides adequate benefit for the practitioners.
The Court also found fault with the judgement of the Madras High Court and the sanctioning authority for not examining properly whether such a case could be made out considering the small number of medicines recovered given that the appellant is a registered medical practitioner. Accordingly, the proceedings against the registered medical practitioner are quashed.
The Supreme Court of India, on 15 March, held that doctors were not liable for prosecution under the Drugs and Cosmetics Act 1940 for storing small quantities of drugs.
Bench of Justices Krishna Murari and Sudhanshu Dhulia heard an appeal of a registered medical practitioner whose premises was inspected and several medicines/drugs in small quantities were recovered. The inspector proceeded with a complaint for prosecuting the Appellant under Section 18(c) of the Drugs and Cosmetics Act, 1940 punishable under Section 27(b)(ii) of the Act.
The appellant thereafter filed a petition under Section 482 of CrPC for quashing but it was dismissed.
The Supreme Court opined that the charge was that she had stocked the medicines for sale but it was not unimaginable that she had stored the medicines for her patients in cases of emergency use.
It was observed by the Court that, “The sanctioning authority had not examined at all whether a practising doctor could be prosecuted under the facts of the case, considering the small quantity of the drugs and the exception created in favour of medical practitioner under Rule 123, read with the Schedule “K”.”
The appeal was allowed and the case was quashed.
Supreme Court has held that a doctor’s act of storing small quantities of medicines will not amount to an offence of unauthorized stocking of medicines under Section 18(c) of Drugs and Cosmetics Act.
https://main.sci.gov.in/supremecourt/2022/29229/29229_2022_11_1501_42840_Judgement_15-Mar-2023.pdf
Schedule K:Exempted Drugs, Conditions and extent of exemption
Schedule K:
Schedule K describe the exempted drugs, conditions and extent of exemption from all the provisions of Chapter IV of the Act and the Rules there under subject to the conditions. 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.
Exemption is provided only against fulfillment of conditions specified in Schedule.
Few Exempted Drugs are as follow:
- Drugs Labelled as ‘Not for medicinal Use’
- Quinine and other antimalarial drugs as per conditioned mention in Schedule
- 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
- All the provisions of Chapter IV of the Act and the Rules made thereunder, subject to the conditions mention in schedule
- Drugs supplied by a hospital or dispensary maintained or supported by Government or local body as per conditions mentioned in schedule
- Whole Human Blood I.P. and/or its components stored for transfusion by a First Referral Unit Community Health Centre, Primary Health Centre and Hospital as per conditions mentioned in schedule
- Quinine Sulphate as per conditions mentioned in schedule
- Magnesium Sulphate as per conditions mentioned in schedule
- Some substances which are used both as articles of food as well as drugs as per conditions mentioned in schedule
- Substances intended to be used for destruction of vermin or insects as per conditions mentioned in schedule
- Mechanical and Chemical Contraceptives as per conditions mentioned in Schedule
- Some household Asprin Tablets, Paracetamol Tablets, Analgesic Balms, Antacid Preparations, Gripe Water for use of infants, Inhalers, containing drugs for treatment of cold and nasal congestion, Syrups, lozenges, pills and tablets for cough, Liniments for external use, Skin ointments and ointments for burns, Absorbent cotton wool, bandages, absorbent gauze and adhesive
- Plaster, Castor Oil, liquid Paraffin and Epsom Salt, Eucalyptus Oil, Tincture Iodine, Tincture Benzoin Co.and Mercurochrome solution in containers not exceeding 100 ml, Tablets of Quinine Sulphate I.P., Tablets of Iodochlorohydroxy quinoline – 250 mg as per conditions mentioned in schedule
- Cosmetics as per conditions mention in schedule
- Ophthalmic ointments of the Tetracycline group of drugs as per conditions mention in schedule
- Hair Fixers, namely mucilagenous preparations containing gums, used by men for fixing beard as per conditions mention in schedule
- Radio Pharmaceuticals as per conditions mentioned in schedule
- Tablets of Chloroquine Salts as per conditions mentioned in schedule
and Many more
AMENDMENT TO THE DRUGS & COSMETICS RULES
The Government of India has amended Drugs & Cosmetics Rules, 1945 for the purpose to bring about changes in Schedule K.
Schedule K to the Drugs and Cosmetics Rules, 1945 lists the classes of drugs and the extent and conditions of exemption granted to these drugs from the provisions of Chapter IV of the Drugs and Cosmetics Act, 1940. The Chapter IV of the Act pertains to manufacture, sale and distribution of drugs. It is now proposed to include the following classes of drugs under this Schedule with specified conditions of exception.
- Entry No 5A pertains to the drugs supplied by a hospital or dispensary maintained or supported by Government or local body is proposed to be amended so that the drugs purchased from the licenced manufacturer or dealers or have been received as transferred stocks from hospital stores. Records of such purchases shall be maintained. The condition is proposed to be stipulated to ensure that the quality drugs are purchased by hospitals and dispensary from authorised stores only for supply to the patients.
- Entry No.15, gives the list of Chemical Contraceptives, which can be sold without a sale licence. It is now proposed to further include the Contraceptives having the following composition also under this entry:
- i) Desogestrel 0.150 mg
Ethinyloestradiol 0.030 mg
- ii) Levonorgestrel 0.1 mcg
Ethinyloestradiol 0.02 mg
These are low concentration Contraceptive pills and are proposed to be included under the Schedule for the promotion of Family Planning Programmes.
- Supply of First Aid Kit along with motor vehicle by the manufacturer or its distributor at the time of first sale of vehicle has been made mandatory under the Motor Vehicle Rules, 1989. As this is a social legislation for providing medical aid to the occupants of motor vehicle in case of necessity, it has been proposed to exempt the manufacturer and dealers of motor vehicles from the provision of sale licence for storing or supplying First AIF Kits along with the motor vehicle provided these items are procured from a dealer licensed under the Drugs and Cosmetics Rules.
Objections and suggestions to the said rules are invited from the public within 45 days for consideration of the Government and these should be addressed to the Secretary, Health, Ministry of Health and Family Welfare, Nirman Bhavan, New Delhi.
NB- Doctors having clinics are also found to be getting supplies of some of the expensive drugs directly from some pharmaceutical companies for selling to patients. … As per the Schedule K (5) of Drugs & Cosmetics Act, doctors are allowed to stock and sell limited number of medicines to their own patients.
While the association is of the view that the clause exempts a private medical practitioner to obtain a license for dispensing drugs to patients, the state drugs control department stands to its interpretation that only a single-doctor clinic can keep medicines and dispense them to patients, but he cannot open a separate pharmacy in his premises or sell drugs across the counter, for which it would be mandatory for him to obtain a license under the rules.
While the clause (Clause–5 of Schedule-K of the Drugs and Cosmetics Rules) allows a single doctor to stock, prescribe or dispense medicines without having a license, it does mandate a clinic run by more than one doctor to obtain a license.”
If we interpret the law by the viewpoint of the drugs control department then over two lakh medical practitioners should be behind the bars. Then why only few doctors are targeted and punished? They are merely being harassed by the inspection teams. Moreover, nowhere the law states that a doctor and his wife cannot dispense medicines working in separate rooms of the same clinic.
Compiled & Shared by- Team, LITD (Livestock Institute of Training & Development)
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Reference-On Request.
