This slide show give you basic conclusion for online ePharmacy and Pharmacy act 1940 and 1945. Here is points for what is favorable to ePharmacy and what to not? After doing discovery of act I found some conclusion for online ePharmacy in India.

1. Pharmacy Act
BY TANMAY PATEL

2. Pharmacy Practice Definitions
▪ Section b-II, Interpretation, evaluation and implementation of medical orders;
dispensing of prescriptions, drug orders .
▪ Section b-II, Participation in drug and device selection, drug administration, drug
regimen reviews and drug or drug related research.
The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, have guidelines on the sale
of Schedule H and Schedule X drugs. These can be sold only on prescription and there are specific rules, including
for labelling and bar coding. It appears that electronic prescriptions should be valid especially in the light of the
Pharmacy Practice Regulations of 2015 declared by Pharmacy Council of India in January 2015. In these
regulations, “Prescription” is defined by regulation ‘means a written or electronic direction from a Registered
Medical Practitioner. On basis of existing regulations it appears that a scanned copy of prescription will be perfectly
considered as a valid prescription.
Definition of Online Pharmacy in India:

3. Key points for Online selling of drugs
▪ Laws for Pharmacies in India are derived from Drug and Cosmetics Act 1940, Drugs
and Cosmetic Rules 1945, Pharmacy Act 1948 and Indian Medical Act 1956. Apart
from this, there are few high court judgments that have provided further insights and
interpretation of the laws.
▪ Indian Laws related to pharmacies were written prior to arrival computers, let alone
internet.
▪ India doesn’t have any concrete laws defined for Ecommerce Companies. The only
laws related to internet in India are defined under Information Technology Act, 2000.
As per several media a report, Indian Government is currently drafting new set of laws
for Ecommerce companies.
▪ After analyzing the various laws, our we have come up with the following ‘zones’ for
online pharmacies in India. GREEN ZONE refers to activities that are legal under
Indian Laws, GREY ZONE refers to activities that are uncertain under current legal
system and RED ZONE refers to activities that are illegal. An online pharmacy must
operate under GREEN ZONE.

4. Green Zone
▪ Medicines can be sold only by a registered pharmacy that has retail license. The
pharmacy should have a registered pharmacist on payroll.
▪ It is mandatory for the customer to have a prescription for the medicines he/she is
ordering. Over the Counter products can be sold without prescription.
▪ Orders can be taken from the customer either over the phone or internet only from the
areas where the pharmacy retail license applies. For example, if the pharmacy has
license is issued by Gujarat State Government, orders can be taken over phone or
internet only in Gujarat State.
▪ All the medicines that go out for delivery has to be verified and certified by the
registered pharmacist.

5. Grey Zone
▪ Rules related to shipping medicines from one state of India to another aren’t clear.
Every state has a Drug Department that grants license for certain medicines to be
sold within a state. There is a possibility that, certain medicines valid in one state
might not have license in another. Hence, there is ambiguity regarding shipping of
medicines from one state to another.
▪ There is ambiguity in the Indian law whether a pharmacy is allowed to take money
prior to delivery of medicines. Certain provisions of the law mandate, money to be
collected from the customer only after medicines are physically handed over to the
customer.

6. Red Zone
▪ Exporting medicines outside of India directly to the customers (patients) is highly
regulated. There is no provision in the Indian law to recognize the prescription written
by the foreign doctor. (Note: India is one of the largest exporter of medicines but
these exports happen to authorized agencies with the approval from the Drug
departments of respective countries)
▪ Selling Schedule H and Schedule X medicines to customer without prescription is a
crime. Proper customer record including name of the patient, doctor and address
needs to be maintained for every Schedule H and Schedule X medicines sold by the
pharmacy.
▪ Selling medicines to minors (under age 18).
▪ Selling banned drugs/medicines i.e. selling any medicine that is not approved by the
State’s Drug Department.
▪ Selling medicines at cost higher than MRP unless customer is upfront told about
delivery or service charges.

7. Definitions from Pharmacy Practice Regulations, 2015
▪ Section 2,(d) “Dispensing” means the interpretation, evaluation, supply and
implementation of a prescription, drug order, including the preparation and delivery of
a drug or device to a patient or patient’s agent in a suitable container appropriately
labeled for subsequent administration to, or use by, a patient.
▪ Section 2,(e) “Distribute” means the delivery of a drug or device other than by
administering or dispensing.
▪ Section 2,(f) “Patient counseling” means the oral communication by the pharmacist
of information to the patient or caregiver, in order to ensure proper use of drugs and
devices.
▪ Section 2,(j) “Prescription” means a written or electronic direction from a Registered
Medical Practitioner or other properly licensed practitioners such as Dentist,
Veterinarian, etc. to a Pharmacist to compound and dispense a specific type and
quantity of preparation or prefabricated drug to a patient.

8. Definitions from Pharmacy Practice Regulations, 2015
▪ Contents of the Prescription :
(i) Prescribers office information – [Name, qualification, address & Regn. No.]
(ii) Patient information – [Name & address, Age, Sex, Ref.No.]
(iii) Date
(iv) Rx Symbol or superscription
(v) Medication prescribed or inscription
(vi) Dispensing directions to Pharmacist (or) subscription
(vii) Directions for patient [to be placed on label]
(viii) Refill, special labeling and /or other instructions
(ix) Prescriber’s signature and license (or) Drug Enforcement Agency (DEA) number as
required.

9. Definitions from Pharmacy Practice Regulations, 2015
▪ Section 4.3, Dispensing against prescription of Registered Medical Practitioner
only : Every registered pharmacist shall dispense only those medicines as prescribed
by the Registered Medical Practitioner and shall not substitute the prescription.
▪ Section 6.2, Maintenance of patient records:(a) Every registered pharmacist shall
maintain the medical / prescription records pertaining to his / her patients for aperiod
of 5 years from the date of commencement of the treatment as laid down by the
Pharmacy council of India in Appendix II.
▪ Section 6.5, Payment of Professional Services: The registered pharmacist,
engaged in the practice of pharmacy profession shall give priority to the interests of
patients. The personal financial interests of a registered pharmacist shall not conflict
with the medical interests of patients. A registered pharmacist shall announce his fees
before rendering service and not after. Remuneration received for such services shall
be in the form and amount specifically announced to the patient at the time the
service is rendered. It is unethical to enter into a contract of "no cure no payment".
Registered pharmacist rendering service on behalf of the state shall refrain from
anticipating or accepting any consideration.

10. Definitions from Pharmacy Practice Regulations, 2015
▪ Dispensing/Supply of Drugs:
(a) The various activities of dispensing (prescription assembly) like removal of drugs
from the packing, filling the prescription etc. may be performed under the super-vision
of a registered pharmacist by any person who has been trained to perform these
activities. However, the actual dispensing of drugs to patients shall only be performed
by the Registered pharmacist after due verification of the prescription filled by others.
(b) A Registered pharmacist shall undertake a pharmaceutical assessment of every
prescription presented for dispensing. For the purpose of the act, pharmaceutical
assessment is defined as the point at which Registered pharmacist applies his
knowledge to establish the safety, quality, efficacy and rational use of drugs treatments
specified by a prescriber.
(c) Patient confidentiality shall be maintained at all times.

11. Definitions from Pharmacy Practice Regulations, 2015
(d) Appropriate information shall be provided to the patient or the care giver and, where
possible, understanding of this information should be checked.
▪ For all prescriptions handled by the pharmacy:
(i) Patient details shall be checked and confirmed.
(ii) Pharmaceutical assessment shall be made.
(iii) Proper documentation shall be maintained.

12. Definitions from Pharmacy Practice Regulations, 2015
▪ Section 9.1, (f) Assessment of the prescription should include but not be limited
to assessment of whether :
(i) The prescription is legally valid.
(ii) The prescription includes an appropriate dosage form and appropriate route of
administration.
(iii) Prescription is appropriate to the patient’s condition.
(iv) Duration of treatment is correct.
(v) Prescription is appropriate according to patient’s para-meters (age, weight etc.) and
previous medication.
(vi) Prescription is compatible with other medications.
(vii) Prescription is consistent with formulary and guidelines, if any.

13. Definitions from Pharmacy Practice Regulations, 2015
(viii)Possibility of side effects and ad-verse drug reactions exist.
(ix) Contra-indicated.
(x) Potential for misuse and inappropriate use of the medicines in prescription by
patient exists.
(xi) Prescription is complying with labeling requirements.

14. Definitions from Pharmacy Practice Regulations, 2015
▪ Section 9.1 (g), Compounding, dispensing and labeling of required drug
products should ensure that
(i) The drug product matches the prescription.
(ii) The drug product has not expired.
(iii) The drug product is appropriately compounded (if necessary), packed and labeled
appropriately.
(iv) The accuracy of dispensing is checked by Registered Pharmacist.
(v) Proper documentation is made.

15. Definitions from Pharmacy Practice Regulations, 2015
▪ Delivery of the drug product to the patient/carer is done in such a way as to ensure
that:
(i) The Registered pharmacist hands over the drug to the patient/carer.
(ii) Appropriate information on drugs is provided to the patient/ carer.
▪ 9.3 Patient counselling :
(a) Upon receipt of a prescription (prescription drug order) and following a review of the
patient’s record, a Registered Pharmacist shall personally initiate discussion of matters
that will enhance or optimize drug therapy with each patient orcare given of such
patient. Such discussion shall be in person, whenever practicable or by telephone and
shall include appropriate elements of patient counseling. Such elements may include
the following.

16. Definitions from Pharmacy Practice Regulations, 2015
(i) Name and description of the drugs
(ii) The dosage form, dose, route of administration, and duration of drug therapy
(iii) Intended use of the drug and expected action
(iv) Special directions and precautions for the drug
(v) Common severe side effects or adverse effects or interactions and therapeutic contra
indications that may be encountered, including their avoidance, and the action required if
they occur.
(vi) Techniques for self monitoring drug therapy
(vii) Proper storage of the drugs
(viii) Prescription refill information

17. Definitions from Pharmacy Practice Regulations, 2015
(ix) Action to be taken in the event of a missed dose
(x) To ensure rational use of drugs
Note : The pharmacist shall not be required to counsel a patient or caregiver when the
patient or
caregiver refuses such consultations.
(b) The pharmacist shall maintain the records pertaining to drugs administered to the
patients (drugcard) that may be utilized for the evaluation of the drug therapy
(c) The pharmacist is authorized (as a Health care professional) to undertake process and
outcome research, health promotion and education and provide health information.

18. Subject to Change
▪ All provided information are subject to government of India. It may be changed or add
new section in original Act or in amendment. MEDBOX is not responsible for any
authenticity of information. Information has been referred from Drug and Cosmetic Act
1940 and 1945, Pharmacy Practice Regulation, 2005.
▪ This content to created only MEBOX information collection. We can not take any legal
actions based on this information. It is subject to Government of Indian.

19. Reference Documents and Source
▪ Drug and Cosmetic Act 1940 and Drug and Cosmetic Act 1945.
▪ Pharmacy Practice Regulations, 2005.
▪ http://www.cdsco.nic.in
▪ http://www.pci.nic.in

20. Thank you
TANMAY PATEL