Pharmacy education / Medical Store

PCI to implement Pharmacy Practice Regulations, 2015

Based on this communication, the PCI urged all state governments to immediately implement the Pharmacy Practice Regulations, 2015.

The Health Master

October 20, 2022

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Last Updated on December 31, 2023 by The Health Master

The Pharmacy Council of India (PCI) has directed all the state and Union territory (UT) governments and state pharmacy councils to take steps to immediately implement the Pharmacy Practice Regulations (PPR), 2015, notified by the Council in January 2015.

Download Pharmacy Practice Regulations, 2015

The Council also shared a letter from the ministry of health and family welfare (MoHFW) clarifying the procedures for implementation of the regulation in the states, considering education is on the concurrent list.

The MoHFW clarified that the state government may declare that the education regulations shall take effect in the state at any time after the constitution of the state pharmacy councils.

“Section 11 of the Pharmacy Act, 1948, states that at any time after the constituent of the state council under Chapter III and after consultation with the state council, the state government may, by notification in the official gazette, declare that the education regulations shall take effect in the state,” it said.

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However, it provided that where no such declaration has been made, the education regulations shall take effect in the state on the expiry of three years from the date of the constitution of the state council, it added.

It further pointed out that, as per Article 254 of the Constitution of India, “If any legislation enacted by the state legislature is repugnant to the legislation enacted by the Parliament, then the state legislation will be declared void, and the legislation enacted by the Parliament will prevail over the former.”

Download Pharmacy Act 1948

“Since the PCI’s regulations come under the concurrent list, hence, based on the above facts, it is binding on the state governments to implement the same with immediate effect, and the same is not required to be notified again by the state governments,” added the MoHFW.

Based on this communication, the PCI urged all state governments to immediately implement the Pharmacy Practice Regulations, 2015.

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The said regulation lays out norms, including:

The code of pharmacy ethics,
Duties and responsibilities of the registered pharmacists,
Maintaining good pharmacy practices,
Maintenance of patient records,

The duties of registered pharmacists to their patients,
Promotion of rational drug use,
The definition of unethical acts,
Punishment and disciplinary action in case of violation of the conduct.

The regulation also details how the pharmacist can provide patient counseling. Under the Regulation, a registered pharmacist is required to dispense medicines on the prescription of a registered medical practitioner and can counsel the patient or caregiver on medicine to enhance or optimize drug therapy.

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The elements of patient counseling include:

Providing information on the name and description of the drugs;
The dosage form,
Dose,
Route of administration,
Duration of drug therapy;

Intended use of the drug and expected action;
Special directions and precautions for the drug;
Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;