FORENSIC PHARMACY OBJECTIVES FORENSIC PHARMACY OR PHARMACEUTICAL JURISPRUDENCE

FORENSIC PHARMACY & OBJECTIVES

FORENSIC PHARMACY OR PHARMACEUTICAL JURISPRUDENCE is the study of fundamental legal principles which, in general sense, deals with the knowledge of law and related aspects. The study of legal principles related to DRUGS is called PHARMACEUTICAL JURISPRUDENCE The purpose of introducing this subject in the curriculum of pharmacy students is two folds Ø To aid practicing pharmacists to understand their legal and ethical responsibilities and thereby to avoid the pitfalls that lead to litigation. Ø To serve as a text providing the students with some insight into the legal aspects of the practice of his profession

PHARMACEUTICAL LEGISLATION IN INDIA

WHAT IS THE PURPOSE OF PHARMACEUTICAL LEGISLATION ? �To ensure that the patients receive drugs of required quality, tested and evaluated for safety and efficacy for their intended result.

DRUG LEGISLATION IN INDIA � Manufacture of modern drugs in India started by the end of 19 th century. Initially, Bengal Chemical and Pharmaceutical works at Calcutta, was established by Acharya P. C. Ray in the year 1901 & Alembic Chemical works was established at Baroda by prof. T. K. Gajjar. � During 1920 -1930 a number of reports of harmful substitutes and adulterants were identified to be marketed in place of genuine drugs. � According to Indian Medical gazette there was no control over the manufacturing sale and distribution of drugs in India. As there were no restrictions on quality of drugs that are being imported, unscrupulous manufacturers abroad took advantage and flooded the Indian markets with adulterated & spurious drugs.

WRITE A NOTE ON ORIGIN OF PHARMACEUTICAL LEGISLATION IN INDIA. � History of Pharmaceutical units Year Name of Founder Name of shop/ Industry Year of commencemen t of manufacturing 1811 Mr. Bathgate (East India Company) Chemist Shop in Calcutta 1910 1821 Mr. Smith Stainstreet and Co. Apothecary Shop 1918 1901 Acharya Praffula Chandra Ray (Calcutta) Bengal Chemicals and Pharmaceutical Works 1928 1903 Prof. T. K Gajjar Factory at Parel Alembic Chemical works, Baroda

DRUG LEGISLATION IN INDIA � As a result of such frauds, the British Government was forced to initiate action for drug legislation. . Sir Haroon Zaffer moved a resolution on March 9, 1927 in the council of states recommending to the Governer General "to take immediate steps to control the craze of medicinal drugs by legislation for standardization of preparation and sale of such drugs. “ In every civilized country the sale of foods and drugs is control by law, but in India there were no such restrictions. � To avoid this Lt. Col. H. A. J Gidney in the legislative council demanded for the control of adultarated drugs. On september 4, 1928 he moved for leave to adjourned the house for the consideration of the "Gigantic Quinine fraud". The local press and even the pharmacuetical journal of England supported the agitation. � In response to such agitations, Drugs enquiry committee constituted under the chairman ship of Col. R. N. Chopra as Chairman , Shri C. Govindan nair as secretary and Dr. B. Mukharjee as assistant secretary.

� Reasons 1. 2. 3. 4. formation of Chopra Committee Units were not sufficient to fulfil the requirements of Indian Public. Drugs were imported form UK, Germany and France. During first world war cheaper drugs were imported into India, which increased the demand for indigenous drugs. Unhealthy competition grew up and Indian market was flooded with inferior quality drugs.

5. 6. 7. Public pressurized government to introduce effective legislation to control import, manufacture, distribution and sale of drugs. There was no legal and effective control on pharmacy profession. Hence to have a comprehensive legislation, the Indian government appointed a ‘ Drug Enquiry Committee’ under the chairmanship of Col. R. N. Chopra in 1931. this was formally known as Chopra Committee.

THE MAIN OBJECTIVES OF THIS COMMITTE WERE � * To enquire & check the quality of drugs, that are being imported, manufactured and sold. � * To suggest remedial measures in preventing adulteration. � The committee submitted its report in 1931. Until 1937 British rulers do not act on this report. In 1937 import of drugs bill was introduced with limited reference to import and later it was withdrawn due to public criticism. � Finally in the year 1940 The Drugs Bill was introduced in the Parliament, based on the recommendation of D. E. C and after in-depth deliberation The Drugs Act, 1940 was enacted which was latter amended to the Drugs and Cosmetics Act, 1945. � Later on, Drugs Enquiry Committee & Health Survey and Development Committee lead foundation for The Pharmacy Act, 1948.

WHAT WERE THE RECOMMENDATIONS OF DRUG ENQUIRY COMMITTEE? (V. I. P) � RECOMMENDATIONS 1. 2. 3. OF CHOPRA COMMITTIE Formation of Central P harmacy Council and State P harmacy Council. (PCI) Creation of Drug Control Machinery. (DCM) Establishment of well equipped Central Drug Laboratory, and State Drug Laboratory. (CDL)

� Implementations: - Due to Second World War in 1939, there was delay in introduction of the legislation. q Government was reluctant to implement the recommendations of DEC, and the public was pressurizing the government. q Finally an Import of Drug Bill was introduced in 1937. q This bill dealt with only import of drugs and manufacturing and sale of drugs was not included. q

SCOPE AND OBJECTIVE � � � Drug bill was introduced in 1940 in legislative assembly, and Drug Bill 1940 was passed, which came to force in 1947. since then drug act was amended many times and at present it covers the provisions related to Drugs, Cosmetics, Ayurvedic, including Unani and Homeopathic medicines. The present Drug and Cosmetic Act is an improved version of the Drug Act, 1940. the main objective of this act was to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. The Central Government made several rules entitled the Drug and Cosmetic Rules 1945. These act and rules were amended from time to time

The Pharmacy act 1948 was passed with the main objective to regulate the profession of Pharmacy in India. � In 1954 the Drug and Magic Remedies Act was passed with the main aim to control certain types of advertisements related to drug and to prohibit certain types of advertisements related to magic remedies. � Medicinal and Toilet Preparations (Excise duty) Act, 1955 was passed providing for the levy and collection of duties of excise on medicinal and toilet preparations containing alcohol, opium Indian hemp or other narcotic drugs. �

� Central government implemented Drug Price Control order 1987. � In 1985 the Narcotic and Psychotropic Substance Act, was passed. The main objective of this act was to consolidate and amend the laws relating to narcotic drugs and Psychotropic substance.

OTHER IMPORTANT MILESTONES IN DRUG LEGISLATION OF INDIAThe some of the Acts we have to discuss for the better understanding of legal aspects Ø Pharmacy Act – 1948 Ø Drugs and Cosmetics Act - 1940 Ø Indian Patent Act – 1970 Ø Drugs & magic remedies act - 1954 Ø Narcotic & Psychotropic Substances Act – 1985 Ø Drugs (price control) order – 1995 Ø Medicinal & Toilet Preparation Act – 1955 Ø Code of Pharmaceutical Ethics Ø Poisons Act – 1919 Ø Prevention of Cruelty to Animal Act – 1960

OTHER IMPORTANT MILESTONES IN DRUG LEGISLATION OF INDIA� � � � � Prevention of food Adulteration act, 1954 and rules. The Industries (Development and Regulations) Act, 1951. The Industrial Employment (Standing order) Act 1946 and rules. Industrial Dispute Act, 1947. Factory Act, 1948. The Indian Patent and Design Act 1970. The Trade and Merchandise Mark, 1958. The Epidemic Disease Act, 1897. Shops and Establishment acts of respective states.

OTHER IMPORTANT MILESTONES IN DRUG LEGISLATION OF INDIA 1946 - Indian Pharmaceutical Codex (I. P. C) published. 1954 -- The first B. Pharmacy Course approved by Pharmacy Council of India at Birla College, Pilani. 1955 -- First Indian Pharmacopoeia published. 1956 -- Essential Commodities Act enacted. 1962 -- Beginning of National Pharmacy week celebrations in third week of November every year. 1963 -- The Indian Hospitals Phrmacists assosciation (IHPA) was launched at Pilani, Rajasthan. 1970 -- First DPCO (Drugs Price Control Ordrer) 1986 -- Consumer Protection Act enacted.

PHARMACY ACT – 1948 India has been a late starter specifically with reference to the profession of pharmacy. Up to almost fifth decade of the 20 th century the land has no laws to exercise any control over preparation related to drugs. In the earlier part of this century anyone could prepare any drug in anyway and give it to anyone and anything could happen to him without anybody being held responsible for it. Closely on the heels of Drugs Act legislated in 1940, an Act upgrade and uplift the non- existent profession of pharmacy was promulgated in 1948 entitled the PHARMACY ACT 1948 Objective of this Act is Ø To frame a programme of education and practical training for persons desirous of entering and practicing the profession of pharmacy to ensure that such persons have a fund of knowledge and skills suitable for the practice of the profession in the modern age. Ø To restrict the practice of profession to such qualified and trained professionals only and to monitor their professional work.

DRUGS & COSMETICS ACT – 1940 The Drugs & cosmetics Act 1940 and rules 1945 was passed by central legislative Assembly and it received the acceptance of the Governor General on 10 th April 1940. The act was passed with the objective of regulating the import, manufacturing, distribution and sale of drugs and cosmetics. Though cosmetics are used externally, constant use of substandard cosmetics may prove to be harmful and need to be controlled. Objective of this act is Ø Regulate import of drugs and cosmetics into the country in order to prevent entry of substandard or harmful drugs and cosmetics. Ø Exercise control over the manufacture of drugs and cosmetics in the country so that no substandard or spurious drugs or cosmetics are produced. Ø Provide for the regulation of sale and distribution of drugs and cosmetics whereby only qualified and trained person can undertake their handling, compounding and distribution. Ø Regulate the manufacture and sale of Ayurvedic, Siddha and Unani, wherever applicable.

INDIAN PATENT ACT – 1970 The patent act can be discussed with reference to the intellectual property rights (IPR) Patent can be said to be the most common and impartant one amongst the intellectual property system because of the strongest and widest legal protection one can secure under this. Patent are legal rights granted by the Government for the new inventions employing scientific and technical knowledge which can conferred on its holder the exclusive right for a limited specified period The patent gives, to the holder/inventor, the exclusive right to sell, manufacture and use the invention disclosed in the patent. The right can be exercised for a limited period after which the invention becomes a public property. Accordingly Indian patents and drugs act 1911 was passed by the British rules which was replaced later by the patent act 1970 which is a consolidated one and more comprehensive. The act extends to whole of india

DRUGS & MAGIC REMEDIES ACT - 1954 Advertisement is a must and has become the life for the sale of any product espeally in the present electronic era and even drugs and doctors are not exempted from the same. It is only through advertisement of product the consumers are attracted and convinced to buy the products, may be consumer goods, drugs or services by banks, doctors or lawyers. But drugs are chemicals whose irrational use may harm the health of the people and hence direct advertisement of drugs to public is not advisable. Hence drugs are advertised only to health related professionals like doctors, pharmacist, nurses etc. To have a control over Drugs & Magic remedies the act was passed in 1954. This act extends to the whole of india except the state of jammu and Kashmir. OBJECTIVES The Drugs & Magic remedies (Objectionable Advertisement) Act waspassed on 1 st April, 1955 with these objectives Ø To control certain types of advertisements relating to drugs. Ø To prohibit certain kind ofadvertisements relating to magic remedies which make false claims and are likely to misleadthe public

NARCOTIC & PSYCHOTROPIC SUSTANCES ACT – 1985 There a number of drugs of natural origin and their derivatives which are very much useful as medicines. At the same time their irrational use may lead to habit forming. Excess use of these drugs also leads to physical and mental injuries leading to moral weakness and lack of self respect. In view of these ill effects of those drugs the Government of different countries passed different acts time to time namely the opium act 1857, opium act 1978, and the Dangerous drugs act 1930. OBJECTIVES Ø To consolidate and amend the existing laws relating to narcotic drugs. Ø To make stringent provisions for the control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances. Ø To considerably enhance the penalties particularly for trafficking offences. Ø To make provisions for the implementations of International conventions relating to Narcotic Drugs and Psychotropic substances to which India is a party.

DRUGS (PRICE CONTROL) ORDER – 1995 Drugs (Price Control) Order – 1995 was passed by the central Govt. in the year 1995 under Essential commodities act 1995 with an object to control the price of drugs. It came into force on 6 th January 1995 repealing the drugs(price control) order 1985. OBJECTIVES Ø To regulate the equitable distribution of essential bulk drugs. Ø To fix the maximum retail price of essential bulk drugs.

POISONS ACT – 1919 The poisons act 1919 was passed with a view to control the import, possession, and sale of poison. Under the act, the central govt. has been authorized to regulate the import of poisons across any of the defined frontiers, while the various state govt. have been authorized to make rules regarding the possession and sale of poisons within their respective territories This act was first passed in 1904 to control same operations over poisonous substances. The U. P Govt. in 1910 as well as in 1914 praposed some radical amendments in the act to make it more effective. This view of the U. P Govt. was supported by many other local governments. As such the 1904 act was replaced by a new act that is the POISONS ACT – 1919

MEDICINAL & TOILET PREPARATIONS ACT – 1955 Alcohol is a very good medicine if used properly and at the same time Alohol has been a fascinating friend of mankind sinceages for its euphonic effect. Alcohol can also be used in the beverages and in toilet preparations like perfumes. Use of alcohol as medicine is essential where as its use for drinking is abuse and its use in the toilet preparation is considered to be luxury. Alcohol supplied for medicinal use attracts lower rate of excise duty whereas higher rate of excise duty is charged on alcohol used for other purposes. More over the excise duty charged use to be different in different states which lead to inter state smuggling of preparations containg alcohol. OBJECTIVES Medicinal & Toilet Preparations(Excise Duties) Act – 1955 was passed with these objectives Ø To provide for the collection levy and duties of excise on medicinal and toilet preparations containing alcohol, narcotic drugs. Ø To provide for uniformity in the rules rate of Excise duties leviable of such preparations throughout the country.

CODE OF ETHICS The code of Ethics, formulated by the pharmacy council of India for the guidance of Indian pharmacist as to how he should conduct him self in relation to himself, his patrons and the general public, his co-professionals, and members of the medical and other health professions. Ethics may be defined as the code of moral principles or as the science of morals. Pharmacist should have the moral values in various duties for better society and uphold the professional conduct v PHARMACIST IN RELATION TO HIS JOB v PHARMACIST IN RELATION TO HIS TRADE v PHARMACIST IN RELATION TO MEDICAL PROFESSION v PHARMACIST IN RELATION TO HIS PROFESSION By sincerely obey the pharmacist oath

PREVENTION OF CRUELTY TO ANIMAL ACT – 1960 In the living world, animals are most akin to the man and that is why perhaps the feelings and sensations of animals have been better appreciated by him. In all most all the progressive countries there are laws to save the animals from infliction of unnecessary pain and suffering or in other words to prevent the man from behaving cruelly towards them in india too, there were a variety of such rules in different parts of the country most of them being ineffective in practice. To assess the effectiveness of the existing legislation on the subject and with a view to consolidating various laws in to one single Act, that is known as PREVENTION OF CRUELTY TO ANIMAL ACT In the act animals have been defined to include all species of animals (except man) as well as all speciesof birds. The term cruelty has not been precisely defined but roughly it means infliction of unnecessary pain or suffering.

REFRENCES; 1. Forensic pharmacy by B. M. MITHAL 2. Forensic pharmacy by N. K. Jain 3. Text book of Forensic Pharmacy, C. K. Kokate 4. Pharmaceutical Jurisprudence and ethics by S. P. Agarwal

FREQUENTLY ASKED QUESTIONS. What is the objective of Pharmaceutical Legislation in India? � Write a note on origin/ history of Pharmaceutical Legislation in India. � What were the recommendations of Drug Enquiry Committee? � Write a short note on scope and objectives of Pharmaceutical Legislation in India. �