Drug Laws & Regulations

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Linette Waters
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Drug Laws & Regulations Acts covered in this module: 1. The Pharmacy Act, 1948 2. The Drugs And Cosmetics Act, 1940, And Rules, 1945 3.

1 Drug Laws & Regulations Acts covered in this module: 1. The Pharmacy Act, The Drugs And Cosmetics Act, 1940, And Rules, Narcotic Drugs and Psychotropic Substances Act and Rules, Drugs (Prices Control) Order, The Consumer Protection Act, 1986 Introduction: 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. These Acts have been devised because purchasing, stocking and dispensing the right medicines directly affects 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. The Pharmacy Act, 1948 Pharmacy Act came into existence for regulating profession and practice of pharmacy.to achieve this purpose there is provision of central council that is pharmacy council of India (PCI) and State Pharmacy councils in individual states. In older days there was no restriction to practice the profession of pharmacy and thousands of such cases were brought to the notice of the then Government and it was decided to have an Act for same.this act came into existence in 1948 and is amended six times till date.presently the Act has five chapters. Chapter II enumerates the provisions of PCI and chapter III enumerates the provisions of State Pharmacy Councils. PCI is the Education Regulatory body. PCI decides minimum education standards required to be fulfilled by an institute running the pharmacy course. The inspectors appointed by PCI visit the institute, check various parameters and submit report to the Executive committee of PCI.Then after due consideration committee decides on granting approval to the concerned institute.it is learnt that PCI has recently drafted amendments in present Pharmacy Act which includes defining certain important terms like practice and professing of pharmacy and also making MSPC s Drug Information Centre Any Content is not for public circulation or reproduction, whether in whole or in part. Page 1

2 pharmacy practice regulation, incorporating other important provisions taking into consideration current Indian as well as global scenario of pharmacy profession. In each state, there is provision of State pharmacy council whose main function is to grant registration as per provisions of the Act. In Maharashtra, registration is granted as per provisions of section 32(2) accordingly a candidate who has attained age of 18 years and passes approved examination (as per section 12) and who resides or carries on business or profession of pharmacy in this state is eligible for registration. Discretionary powers are vested in Registrar and considering the case Registrar may accept or reject an application. A person who is aggrieved on Registrar s decision can appeal to the council. Council also does process of change of name, new copy of registration certificate, duplicate certificate, additional qualification, etc.council also issues letter of good standing to students who wish to appear for foreign equivalent examination and enroll himself as registered pharmacist in that country. Section 42 of the Act deals with dispensing of drugs by unregistered person. No person other than registered pharmacist can dispense medicines on prescription of registered medical practitioner and doctor himself can dispense medicines to his own patients. Council has appointed pharmacy inspectors to implement section 42 in the State of Maharashtra. Section 36 of the Act deals with penal removal of the name of registered Pharmacists from the register of pharmacists maintained by state council. A pharmacist or a person appointed by him who is convicted to be guilty of doing any act which amounts to professional Misconduct is penalized by council. Council acts as quasi judicial body. Upon receiving a complaint about pharmacist, he is asked to give explanation in writing about same. If the explanation is not satisfactory, he is asked to appear before executive committee (EC) and is given an opportunity of being heard and explain his say. Then after going through all details of the case, EC decides on the case. Decision of EC is put before full council for consideration. He is either relived or depending on offence, he is issued warning for same. In certain cases, his name is removed from register for temporary or permanent period for which he cannot work as registered pharmacist. Name of pharmacist can also be removed if the name is entered by error or misrepresentation of facts. In last few year council has received many cases wherein the act of pharmacists has amounted to professional misconduct. Absence of pharmacist at workplace, undergoing higher education and given Registration Certificate elsewhere, working at one place as pharmacist (for instance industry, etc) and giving away Registration Certificate at some retail shop, signing in advance on bills to pretend presence of pharmacists are few examples of same. MSPC s Drug Information Centre Any Content is not for public circulation or reproduction, whether in whole or in part. Page 2

3 Dispensing wrong medicines, thereby committing medication errors amounts to negligence in executing your duties as a pharmacist. Submitting false affidavits, false information and cheating competent authority like council, FDA, etc amounts to professional misconduct.some cases under section 36 include the instances of pretending to be other Registered pharmacist and misusing property of council such as logo, seal,etc. The procedure to be followed in such cases is enumerated in Maharashtra State Pharmacy Council Rules-1969.Also if a pharmacists is aggrieved by the decision of state council, he may appeal to the State Government within 30 days from the date of receipt of the order. 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. Standards of quality: For the purposes of this Chapter, the expression "standard quality" means (a) In relation to a drug, that the drug complies with the standard set out in [the Second Schedule], and (b) In relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.] Misbranded drugs For the purposes of this Chapter, a drug shall be deemed to be misbranded, (a) If it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is ; or (b) If it is not labeled in the prescribed manner ; or (c) If its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular. Adulterated drugs For the purposes of this Chapter, a drug shall be deemed to be adulterated, (a) If it consists in whole or in part, of any filthy, putrid or decomposed substance; or MSPC s Drug Information Centre Any Content is not for public circulation or reproduction, whether in whole or in part. Page 3

4 (b) If it has been prepared, packed or stored under unsanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health ; or (c) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (d) If it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or (e) If it contains any harmful or toxic substance which may render it injurious to health ; or (f) If any substance has been mixed therewith so as to reduce its quality or strength. Spurious drugs For the purposes of this Chapter, a drug shall be deemed to be spurious, (a) If it is manufactured under a name which belongs to another drug; or (b) If it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or (c) If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist ; or (d) If it has been substituted wholly or in part by another drug or substance; or (e) If it purports to be the product of a manufacturer of whom it is not truly a product. Misbranded cosmetics For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded, (a) If it contains a colour which is not prescribed; or (b) If it is not labeled in the prescribed manner; or (c) If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular. Adulterated cosmetics - For the purposes of this Chapter, a cosmetic shall be deemed to be adulterated, (As per Drugs and Cosmetics (Amendment) Act, 2008) (a) If it consists in whole or in part, of any filthy, putrid or decomposed substance; or (b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or (c) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (d) If it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or (e) If it contains any harmful or toxic substance which may render it injurious to health; or (f) If any substance has been mixed therewith so as to reduce its quality or strength. MSPC s Drug Information Centre Any Content is not for public circulation or reproduction, whether in whole or in part. Page 4

5 Spurious cosmetics For the purposes of this Chapter, a cosmetic shall be deemed to be spurious, (a) If it is manufactured under a name which belongs to another cosmetic; or (b) If it is an imitation of, or a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic ; or (c) If the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist ; or (d) If it purports to be the product of a manufacturer of whom it is not truly a product. Narcotic Drugs and Psychotropic Substances Act and Rules, 1985 The NDPS Act 1985 sets out the statutory framework for drug law enforcement in India. The main elements of the control regime mandated by the Act are as follows: 1. To consolidate and amend the law relating to narcotic drugs and psychotropic substances, 2. To make stringent provisions for the control and regulation of operations relating to narcotic drugs and psychotropic substances, 3. To provide for the forfeiture of property derived from, or used in, illicit traffic in narcotic drugs and psychotropic substances, 4. To implement the provisions of the International Convention on narcotic drugs and psychotropic substances and for matters connected therewith. "Narcotic drug" means coca leaf, cannabis (hemp), opium, poppy straw and includes all manufactured goods. "Psychotropic substance" means any substance, natural or synthetic, or any natural material or any salt or preparation of such substance or material included in the list of psychotropic substances specified in the Schedule. Offences and Penalties Chapter IV, (Sections 15 to 40) sets out the penalties for offences under the Act. These offences are essentially related to violations of the various prohibitions imposed under the Act on the cultivation, production, manufacture, distribution, sale, import and export etc. of narcotic drugs and psychotropic substances. All these offences are triable by Special Courts and the punishments prescribed range from imprisonment from 10 to 20 years for first offences to 15 to 30 years for any subsequent offences together with monetory fines. In addition to persons directly involved in trafficking narcotic drugs and psychotropic substances, any person who finances trafficking or harbours a person involved in trafficking, or abets, or is a party to a criminal conspiracy, including a criminal conspiracy to commit an offence outside India, is also liable to the same scale of punishments. The Act was amended in May 1989 to mandate the death MSPC s Drug Information Centre Any Content is not for public circulation or reproduction, whether in whole or in part. Page 5

6 penalty for second offences relating to contraventions involving more than certain quantities of specified narcotic drugs and psychotropic substances. The Act, however, makes a distinction between possession for personal consumption and trafficking, the punishment for the former being limited to between six months and one year only. The application of this provision is subject to the following two qualifications: 1. The quantity of drug involved in the offence should be a small quantity as specified by the central Government 2. The onus is on the accused to establish that the drug in question was meant for personal consumption & not for sale, distribution etc. The punishments for many offences under the NDPS Act depend on the quantity of drug involved- with three levels of punishment for small, more than small but less than commercial and commercial quantities. Few examples of the same are given below: Sr. no Drug / Psychotropic Substance Small Quantity Commercial Quantity 1 Codeine 10 grams 1 kg 2 Diazepam 20 grams 500 grams 3 Morphine 5 grams 250 grams 4 Amphetamine 2 grams 50 grams 5 Buprenorphine 1gram 20 grams 6 Methaqualone 20 grams 500grams Guidelines for dealing with NDPS Drugs : Purchase Check invoice for correct Name and Address of Supplier, Drug License No, Sales Tax No, quantity, batch number and expiry Purchase minimum quantity possible Do not accept these drugs from unauthorized persons or medical representatives or on challan, Purchse from authorized wholesaler only Do not accept these drugs as replacement for settlement of expiry or claims Sale Sell against a valid prescription with all the details of the Doctor along with the signature On the bill write the complete name and address of the doctor and the patient with exact quantity, batch number, expiry date, etc. After dispensing the prescription, put a 'DISPENSED' stamp. DO NOT dispense more than the prescribed quantity Storage and records 1. Store all NDPS medicines safely and place them under the supervision of a qualified person or a responsible person. 2. In case of theft or loss, immediately inform the Drug Authorities. MSPC s Drug Information Centre Any Content is not for public circulation or reproduction, whether in whole or in part. Page 6

7 3. Maintain proper records of all sales and purchases for a period of three years. Avoid home delivery of these medicines. 4. Do not accept any telephonic orders. 5. Never SUBSTITUTE such medicines. Contact the doctor in case of unavailability or any other problem. 6. In case of any doubts, like huge quantity prescribed or a suspicious character with a bogus prescription immediately contact and confirm with the doctor/ prescriber, OR POLITELY REFUSE to dispense the prescription. 7. All expired/ damaged stock should be returned by filling in all the relevant details and obtaining stamps/ signatures on the goods returned proforma. If sent by transport/ courier, maintain a copy of the LR/RR or POD 8. Do not fall prey to evil designs of unscrupulous persons who would like to purchase huge quantities without bills and are ready to pay a premium. 9. Educate pharmacy personnel to be cautious while purchasing, storing & selling such products& comply with the rules and counsel the patient whilst dispensing the products Drugs (Prices Control) Order, 1995 The Drugs Price Control Order (DPCO), 1995 is an order issued by the Government of India under Section 3 of the Essential Commodities Act, 1955 to regulate the prices of bulk drugs and formulations. The DPCO controls the prices of medicines, trying to make them available at fair prices. 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 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. 1. 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. 2. The Act enshrines certain rights of the consumers and provides for the setting up of Consumer 3. 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. MSPC s Drug Information Centre Any Content is not for public circulation or reproduction, whether in whole or in part. Page 7

8 The salient features of the Act are summed up as under: 1. The Act applies to all goods and services unless specifically exempted by the Central Government. 2. Since a pharmacy provides goods and services, it is also covered under this Act. 3. It covers all the sectors whether private, public or cooperative. 4. It enshrines the following rights of the consumers: The right to be protected against the marketing of goods, which are hazardous to life and property. 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. The right to be assured, wherever possible, access to a variety of goods at competitive prices The right to be heard and to be assured that the consumer s interests will receive due consideration at appropriate forums. The right to seek redress against unfair trade practices or unscrupulous exploitation of consumers, and The right to consumer education. MSPC s Drug Information Centre Any Content is not for public circulation or reproduction, whether in whole or in part. Page 8

COUNTERFEIT AND FAKE DRUGS AND UNWHOLESOME PROCESSED FOODS (MISCELLANEOUS PROVISIONS) ACT

COUNTERFEIT AND FAKE DRUGS AND UNWHOLESOME PROCESSED FOODS (MISCELLANEOUS PROVISIONS) ACT ARRANGEMENT OF SECTIONS SECTION 1. Prohibition of sale, etc., of counterfeit and fake drugs and unwholesome processed