Regulatory affairs

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Regulatory affairs

Text of Regulatory affairs

  • I. Regulatory Affairs


    Various laws and ethics govern pharmacy operations. While the laws are the legal framework within which a pharmacy and its personnel can operate, ethics are professional regulations, which govern a pharmacist in operating a pharmacy.

    This module highlights the various legal compulsions that are binding upon pharmacists with regard to the various categories of medicines, handling of prescriptions, dispensing, keeping records, and operating in this framework by implementing Good Pharmacy Practice.


    To discuss the various legal aspects/ regulatory affairs related to dispensing in community pharmacy practice.

    To illustrate the need to adhere to the laws.

    OBJECTIVES: By the end of this module, pharmacists will be able to describe

    The laws related to pharmacy practice in India. The importance of adhering to these laws. Different categories of medicines How to tackle emergency supplies. Other legal aspects of dispensing

    This module has been grouped into the following sections to allow the free and easy flow of information.

    1. Laws related to Community Pharmacy1.1 The Drugs and Cosmetics Act, 1940 and Rules, 1945 1.2 The Narcotic Drugs and Psychotropic Substances Act and Rules, 1985.1.3 Drugs Price Control Order, 1995 1.4 Consumer Protection Act, 19861.5 Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 19921.6 Drugs and Magic Remedies Act and Rules, 1954.1.7 Prevention of Food and Adulteration Act, 1954.

    2. Code of ethics

    3. Legal aspects in the dispensing process3.1 Legality and authenticity of the prescription a) Doctor's details

    - 1 -Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE

  • b) Patients details c) Medicine details d) Other details i) Date ii) Refill information iii) Doctor's signature3.2 Details of medicines and their legal requirementsA. Schedules or categories of drugs

    a) Schedule H b) Narcotic Drugs and Psychotropic Substancesc) Schedule X d) Schedule C and C (I)e) Schedule Gf) Schedule Kg) Schedule Jh) Schedule P and P (I)i) Schedule Y

    B. OTC MedicinesC. New DrugD. Veterinary medicinesE. Brand substitution and bio-equivalenceF. Indian systems of medicine and homoeopathy (ISM and H)G. Physician samples and ESIC medicines3.3 Emergency supply of prescription medicines3.4 Record keeping (i) Prescription Register(ii) Cash Memos(iii) Purchase Bills and Register(iv) Display of Licenses(v) Display of Registration Certificate

    4. Presence of a pharmacist

    5. Other aspects


    The legal aspects related to the retail purchasing, stocking and selling or dispensing products/ medicines in a pharmacy are prescribed and governed by various laws: The Drugs and Cosmetics Act, 1940 and Rules, 1945.

    - 2 -Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE

    I. Regulatory Affairs

  • The Narcotic Drugs and Psychotropic Substances Act and Rules, 1985. Drugs Price Control Order, 1995. Consumer Protection Act, 1986. Infant Milk Substitutes, Feeding Bottles and Infant Foods Act, 1992. Drugs and Magic Remedies Act and Rules, 1954. Prevention of Food and Adulteration Act, 1954.

    These Acts have been devised because purchasing, stocking and dispensing the right medicines directly affect a patient's treatment or health. A slight error could become a matter of life and death for the patient. All pharmacists and other staff must thus ensure that the entire pharmacy operates within the legal framework of these laws.

    Need to adhere to laws

    Adhering to laws is essential for providing optimum health care by minimizing errors. Thus, carrying out duties according to the laws highlights professionalism, and wins the respect and confidence of the public/ or of clients.Laws regulate and lay down standards of conduct for the pharmacy trade/ profession. Legislation ensures that the patients receive drugs of required quality, tested and evaluated for safety as well as efficacy for the intended use.

    1.1 The Drugs And Cosmetics Act, 1940, And Rules, 1945

    The Drugs and Cosmetic Act, 1940, was enacted to regulate the import, manufacture, sale and distribution of drugs and cosmetics. The Act includes laws governing the setting up and operation of a pharmacy.The emphasis of the Act is on self-regulation, but it can also be an effective tool in the hands of the regulatory agencies for quality management through licensing, periodic inspections to assess the extent of compliance, and initiating steps to continuously enhance the degree of compliance.

    The Act intends to:

    1. Prevent manufacture and distribution of substandard drugs. 2. Control the manufacture, sale and distribution of drugs and ensure standard and quality drugs.3. Monitor the licenses of premises from which medicines are sold/ distributed.4. Bring cosmetics in its purview, to regulate their import, manufacture, distribution and sale.

    1.2 Narcotic Drugs And Psychotropic Substances Act And Rules, 1985

    This Act, has been enacted:

    - 3 -Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE

    I. Regulatory Affairs

  • To consolidate and amend the law relating to narcotic drugs and psychotropic substances, To make stringent provisions for the control and regulation of operations relating to narcotic drugs

    and psychotropic substances, To provide for the forfeiture of property derived from, or used in, illicit traffic in narcotic drugs and

    psychotropic substances, To implement the provisions of the International Convention on narcotic drugs and psychotropic

    substances, and for matters connected therewith.

    1.3 Drugs (Prices Control) Order, 1995

    The Drugs Prices Control Order, 1995, is an order that lays down rules with respect to the fixation of prices of bulk drugs and formulations.

    The Order covers details like

    Fixation of maximum sales prices of bulk drugs Calculation of retail price of formulations Fixation of retail price and ceiling price of scheduled formulations Maintenance of records Penalties for contravention of provision of the Order Other details

    The Drugs Price Control Order controls the prices of medicines, trying to make them available at fair prices.

    1.4 The Consumer Protection Act, 1986

    The Consumer Protection Act, 1986, is a milestone in the history of the socio-economic legislation in the country. It is one of the most progressive and comprehensive pieces of legislation enacted for the protection of consumers.

    The main objective of the Act is to provide better protection of the consumers. The Act intends to provide simple, speedy and extensive redress of the consumer's grievances. The Act enshrines certain rights of the consumers and provides for the setting up of Consumer

    Protection Councils in the Centre and the states. The objective of these Consumer Protection Councils will be to promote and protect the rights of the consumers.

    The salient features of the Act are summed up as under:

    The Act applies to all goods and services unless specifically exempted by the Central Government. Since a pharmacy provides goods and services, it is also covered under this Act.

    It covers all the sectors whether private, public or cooperative.

    - 4 -Good Pharmacy Practice - I.P.A. - C.D.S.C.O. - W.H.O. INDIA COUNTRY OFFICE

    I. Regulatory Affairs

  • The provisions of the Act are compensatory in nature. It enshrines the following rights of the consumers:

    i. The right to be protected against the marketing of goods, which are hazardous to life and property.ii. The right to be informed about the quality, quantity, potency, purity, standard and price of goods

    so as to protect the consumer against unfair trade practices.iii. The right to be assured, wherever possible, access to a variety of goods at competitive pricesiv. The right to be heard and to be assured that the consumers interests will receive due

    consideration at appropriate forums.v. The right to seek redress against unfair trade practices or unscrupulous exploitation of

    consumers, andvi. The right to consumer education.

    1.5 The Infant Milk Substitutes, Feeding Bottles And Infant Foods (Regulation Of Production, Supply And Distribution) Act, 1992

    This Act provides for the regulation of production, supply and distribution of infant milk substitutes, feeding bottles and infant foods with a view to protect and promote breastfeeding and ensure the proper use of infant foods. Under this Act, Health care system means an institution or organization engaged, either directly or indirectly, in health care for mothers, infants or pregnant women, and includes health workers in private practice, in a pharmacy, in a drug store and any association of health workers

    According to this Act, no pharmacy should :-

    1. Advertise, or take part in the publication of any advertisement, for the distribution, sale or supply of infant milk substitutes, infant foods or feeding bottles.

    2. Give an impression or create a belief in any manner that feeding of infant milk substitutes and infant foods are equivalent to, or better than, mother's milk.

    3. Take part in the promotion of infant milk substitutes, infant foods or feeding bottles. 4. Supply or distribute samples of infant milk substitutes or feeding bottles or infant food gifts of utensils

    or other articles.5. Offer inducement of any other kind.6. Use any health care system for displaying placards or posters relating to, or for the distribution of,

    materials for the purpose of promoting the use or sale of infant mil