Key Regulations and Ethical Standards in Pharmacy

Posted on Mar 21, 2025 in Other university degrees and diplomas

Pharmacist’s Oath

  • At this time, I vow to devote my professional life to the service of all humankind through the profession of pharmacy.
  • I will consider the welfare of humanity and relief of human suffering my primary concerns.
  • I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy outcomes for the patients I serve.
  • I will keep abreast of developments and maintain professional competency in my profession of pharmacy.
  • I will maintain the highest principles of moral, ethical, and legal conduct.
  • I will embrace and advocate change in the profession of pharmacy that improves patient care.
  • I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.

Medical Termination of Pregnancy (MTP) Act

The Medical Termination of Pregnancy Act (MTP Act) is linked with abortion practices. It has been in effect since 1971 and was recently amended in 2020. The amendment increased the period within which abortion can be performed.

Objectives of the Medical Termination of Pregnancy Act

  1. Legalization of Abortion: The MTP Act legalized abortion in India, subject to certain conditions.
  2. Conditions for Abortion: The MTP Act allows for abortion if the pregnancy poses a risk to the physical or mental health of the mother, if there is a risk of the child being born with physical or mental abnormalities, or if the pregnancy is a result of rape or failure of contraception.
  3. Time Limit for Abortion: The Act permits abortion up to 20 weeks of pregnancy. However, in certain cases, such as when the woman’s life is in danger or in case of fetal abnormalities, abortion can be carried out beyond the 20-week limit.

Provisions Under the MTP Act

  1. Consent: The woman’s consent is mandatory for the termination of pregnancy.
  2. Reason: The termination of pregnancy must be carried out for reasons such as the woman’s health, her life, contraceptive failure, or rape.
  3. Medical Practitioner: The termination must be performed by a registered medical practitioner.
  4. Place: The termination must be carried out in a registered medical facility.
  5. Time: The termination can only be performed within the first 20 weeks of pregnancy; beyond that, it requires the approval of a medical board.

Power to Suspend or Revoke Registration: If a committee finds that an establishment, breeder, or Institutional Animal Ethics Committee is not following its rules, the committee may, after providing a reasonable opportunity for a hearing, revoke the registration for a specified period or indefinitely. The committee may also impose special conditions.

Offenses:

a) Exhibiting or training any performing animal without being registered under this Chapter.

b) Exhibiting or training any performing animal for which one is not registered, if registered under this Act.

c) Exhibiting or training any animal as a performing animal that is not to be used for that purpose, as per a notification issued under clause (ii) of section 22.

Penalties: Contravention of any order made by, or committing a breach of any condition imposed by, the committee is punishable with a fine of up to 200 rupees. If the contravention or breach of condition occurs in an institution, the person in charge of the institution is guilty of the offense and will be punished accordingly.

Drug Pricing Calculation

The retail price of a drug is calculated using the formula:

R.P. = (M.C. + C.C. + P.M. + P.C.) x (1 + MAPE / 100) + E.D.

Where:
R.P. = Retail Price
M.C. = Material Cost
C.C. = Conversion Cost
P.M. = Packing Material Cost
P.C. = Packing Charges
MAPE = Maximum Allowable Post-Manufacturing Expenses
E.D. = Excise Duty

Examples Under the Poison Act in India

Under the Poison Act in India, examples of substances considered “poisons” include arsenic, cyanide, strychnine, mercury compounds, concentrated acids like sulfuric acid, certain pesticides, some potent pharmaceutical drugs like morphine, and certain highly concentrated chemicals like sodium hydroxide. These are substances that can be harmful or lethal if ingested or absorbed in significant quantities and require strict control in their sale and distribution due to potential misuse.

The State Government may, by rule, regulate the possession of any specified poison in any local area where the use of such poison for committing murder or mischief by poisoning cattle is frequent enough to warrant restrictions on its possession.

FSSAI Licenses and Functions

There are three types of FSSAI licenses: Basic Registration, State License, and Central License.

Functions of FSSAI

  • Set standards: FSSAI sets standards for food safety and quality.
  • Issue licenses: FSSAI issues licenses to food businesses.
  • Ensure compliance: FSSAI ensures that food businesses comply with food safety regulations.
  • Spread awareness: FSSAI educates citizens about the importance of safe food consumption.
  • Maintain records: FSSAI keeps records and data on registered food businesses.
  • Take legal action: FSSAI can take legal action against businesses that don’t comply with food safety regulations.

Pharmacist’s Code of Ethics

Pharmacists in Relation to His Trade

  1. Price Structure: Prices charged to customers should be fair, reflecting the quality and quantity of the goods supplied, as well as the labor and skill required. This ensures adequate remuneration for the pharmacist, considering their knowledge, skill, time, and responsibility, without unduly burdening the purchaser.
  2. Fair Trade Practices:
    • No pharmacist should attempt to capture the business of a fellow pharmacist through unfair competition, such as offering prizes, gifts, or knowingly charging lower prices.
    • If a prescription intended for one dispensary is mistakenly brought to another, the latter should refuse it and direct the customer to the correct place.
    • Labels, trademarks, and other signs and symbols of competitors should not be imitated or copied.

Pharmacists in Relation to His Profession

  1. Extend help to fellow pharmacists in emergency situations.
  2. Maintain the standards of the profession.
  3. Work to eliminate corruption in the profession and society.

Pharmacists in Relation to the Medical Profession

  1. Limitation of Professional Activities: Pharmacists should not engage in medical practice, such as diagnosing diseases or prescribing medicines. In emergencies, they can provide first aid. They should not recommend a specific medical practitioner.
  2. Clandestine Arrangement: Pharmacists should not enter into secret arrangements or contracts with physicians to offer them commissions or any other advantages.

The Code of Pharmaceutical Ethics is a set of guidelines and principles governing the behavior of pharmaceutical professionals in their interactions with patients, healthcare providers, and other stakeholders.

Handling of Prescriptions

  • A pharmacist should receive a prescription without any comment that might cause anxiety to the patient.
  • No part of the prescription should be changed without the consent of the prescriber. If changes are necessary, the prescription should be referred back to the prescriber.

Role of a Registered Medical Practitioner (RMP)

A Registered Medical Practitioner (RMP) has many duties, including diagnosing and treating patients, upholding professional standards, and respecting patient rights.

Medical Duties:

  • Diagnose and treat medical conditions
  • Assess symptoms
  • Order and interpret diagnostic tests
  • Develop treatment plans
  • Prescribe or supply drugs, remedies, or appliances
  • Provide anticipatory guidance
  • Respect patient confidentiality and autonomy
  • Pay attention to patient concerns
  • Respect patient privileges to be involved in healthcare decisions

Professional Duties:

  • Uphold the code of conduct
  • Preserve high standards of professional conduct and care
  • Keep professional competence up to date
  • Continuously improve medical knowledge and skills
  • Use medical knowledge to benefit both patients and other colleagues
  • Practice methods of healing founded on a scientific basis

Other Duties:

  • Shall not willfully commit an act of negligence that may deprive his patient or patients from necessary medical care.
  • Shall be permissible to consult through telemedicine following the Telemedicine Practice Guidelines.

MTP Act: Offenses and Penalties

Offenses:

  • Terminating a pregnancy by someone who is not a registered medical practitioner (RMP)
  • Terminating a pregnancy in a place that is not approved under the Act
  • Owning a place that is not approved under the Act

Penalties:

  • Rigorous imprisonment for a minimum of two years and a maximum of seven years.
  • A police officer can arrest a doctor for violations without a warrant.

RMP Experience to Terminate Pregnancy

Training and Qualification:

  • Must be registered with the State Medical Register and possess a recognized medical degree (like MBBS) with additional training in gynecology and obstetrics, often including a postgraduate diploma or degree.

Who Can Sell Poison According to the Poison Act

License Required:

  • A specific license is needed to sell any poison, typically issued to pharmacists or other qualified medical professionals.

Personal Sale:

  • The sale must be conducted by the licensed individual themselves or under their direct supervision if selling through a company.

Record Keeping:

  • Detailed records of all poison sales must be maintained.

Restrictions on Sale:

  • The Act specifies which poisons can be sold and may have restrictions on who can purchase them.