Pharmacy Law & Ethics is a key subject in D. Pharmacy, and understanding concepts of different laws, offenses and penalties in pharmacy are clearly important than just memorizing. In this post, Pharmacy Law & Ethics Important questions are explained in simple language, which is useful for MSBTE, AKTU, BTEUP, RUHS and other state boards.
1) Pharmacy Council of India (PCI): Constitution and Functions
The Pharmacy Council of India (PCI) is a statutory body constituted under Section 3 of the Pharmacy Act, 1948. It was first established in 1949 by the Central Government and is reconstituted every five years. The PCI functions as the apex regulatory authority for pharmacy education and the pharmacy profession in India.
Constitution of Pharmacy Council of India: The PCI consists of elected, nominated, and ex-officio members. Elected members include six representatives elected by the University Grants Commission (UGC) from among teachers of pharmacy subjects such as pharmaceutics, pharmaceutical chemistry, pharmacognosy, and pharmacology. One member is elected by the Medical Council of India, and each State Pharmacy Council elects one registered pharmacist.
Nominated members include six persons nominated by the Central Government, of whom at least four must possess a degree or diploma in pharmacy or be actively engaged in the profession. Each State Government nominates one registered pharmacist, and one nominee each is appointed from the UGC and AICTE.
The ex-officio members of PCI are the Director General of Health Services, the Drugs Controller General of India, and the Director of the Central Drugs Laboratory.
Functions of Pharmacy Council of India: The PCI prescribes minimum standards of pharmacy education and frames regulations regarding pharmacy courses. It approves pharmacy institutions and conducts inspections to ensure compliance with educational norms. The council maintains the Central Register of Pharmacists, prepares education regulations, and defines the powers and duties of its office bearers. It also determines allowances and remuneration of members and performs any additional functions assigned by the Central Government.
2) Drug Inspector: Powers and Duties
A Drug Inspector is appointed under the Drugs and Cosmetics Act, 1940 to ensure compliance with provisions related to the manufacture, sale, and distribution of drugs and cosmetics. Inspectors for Ayurvedic, Siddha, and Unani drugs are appointed under Section 33G, while inspectors for other drugs and cosmetics are appointed under Section 21.
Qualifications of Drug Inspector: A Drug Inspector must be a graduate in Pharmacy, Pharmaceutical Sciences, or Medicine, preferably with specialization in clinical pharmacology or microbiology. For inspection of Schedule C drugs, additional experience such as manufacturing, testing, or inspection of licensed premises is required.
Powers of Drug Inspector: A Drug Inspector has the authority to inspect licensed premises for manufacture or sale of drugs and cosmetics. They may take samples for analysis, search persons or premises involved in suspected offences, and examine vehicles transporting illegal drugs or cosmetics. The inspector can order a person in possession of suspected stock not to dispose of it for up to 20 days and may examine records, registers, and documents relevant to the investigation.
Duties of Drug Inspector: In the sale of drugs, the inspector conducts inspections at least twice a year, collects samples, investigates complaints, examines records, initiates prosecution where necessary, and submits inspection reports. In manufacturing units, the inspector examines manufacturing, testing, and storage conditions, collects samples, investigates complaints, verifies documentation, and ensures compliance with the Act.
3) State Pharmacy Council: Constitution and Functions
The State Pharmacy Council is constituted under Section 19 of the Pharmacy Act, 1948, while joint councils for multiple states are constituted under Section 20. It functions as the regulatory authority at the state level for registration and professional conduct of pharmacists.
Constitution of State Pharmacy Council
The council consists of six members elected by registered pharmacists of the state. Five members are nominated by the State Government, of whom at least three must possess a pharmacy qualification or be registered pharmacists. One member is elected by the State Medical Council. Ex-officio members include the Chief Administrative Medical Officer, the Officer-in-Charge of State Drugs Control, and the Government Analyst.
Functions of State Pharmacy Council: The State Pharmacy Council is responsible for registering qualified pharmacists and maintaining the State Register of Pharmacists. It appoints inspectors for inspection of pharmacy premises, defines the powers and duties of its office bearers, and submits five copies of the state register annually to the Central Council after 1st April.
4) Drug and Magic Remedies Act 1954: Objectives and Prohibition of Advertisements
Under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, a magic remedy includes talismans, mantras, kavachas, charms, or any other objects claiming miraculous powers for diagnosis, cure, prevention, or treatment of diseases or for altering human or animal bodily functions.
Objectives of the Act: The Act aims to control and prohibit misleading advertisements of drugs and magic remedies that make false claims. It protects the public from unethical advertisements promoting self-medication and unscientific treatments.
Prohibited Advertisements: Advertisements are prohibited for drugs claiming use in abortion, prevention of conception, correction of menstrual disorders, or improvement of sexual capacity. Advertisements for the treatment of diseases listed under Schedule J, such as cancer, diabetes, epilepsy, leprosy, paralysis, tuberculosis, venereal diseases, and others, are strictly banned. Any advertisement that gives a false or deceptive impression of a drug or promotes magic remedies claiming miraculous cures is prohibited.
5) Offences and Penalties under the Drugs and Cosmetics Act, 1940 and Pharmacy Act, 1948
Under the Drugs and Cosmetics Act, 1940, using a government analyst’s report for advertising purposes attracts a fine of up to ₹500 on first conviction and imprisonment up to 10 years with fine on subsequent conviction. Failure to disclose the manufacturer’s name may result in imprisonment up to one year or a fine up to ₹1,000 or both. Manufacture or sale of spurious cosmetics is punishable with imprisonment up to three years and fine. Other contraventions may lead to imprisonment up to one year or fine on first conviction, and higher penalties on subsequent convictions.
Under the Pharmacy Act, 1948, falsely claiming to be a registered pharmacist is punishable with a fine of ₹500 on first conviction, and ₹1,000 or imprisonment up to six months or both on subsequent conviction. Dispensing medicines by an unregistered person is punishable with fine or imprisonment up to six months or both. Obstructing State Pharmacy Council inspectors attracts similar penalties, while failure to surrender a registration certificate after removal from the register is punishable with a fine of ₹50.
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