INDIAN STATUTES ON DRUGS/POISONS
Several legal acts have been passed regulating and controlling the manufacture, sale, distribution, and possession of drugs and poisons. The principal acts include the following:
This Act was amended in 1958 and repealed in 1960. It deals with the import of poisonous substances into India, license issu-ance for possession of certain specified poisons, and restrictions
This Act was amended in 1964, and very recently in 2008, and is today referred to as the Drugs And Cosmetics AmendmentAct (2008). It deals with the import, manufacture, distribution,and sale of all kinds of drugs (allopathic, ayurvedic, unani, siddha, etc.) and cosmetics. As per the Act, every patented or proprietary medicinal preparation should display on the label of the container, either the exact formula or a list of the ingre-dients. The amended Act has enhanced the scale of punishment for various offences, including sale of spurious drugs, adultera-tion of drugs and cosmetics, toxic contamination, etc.
This is an offshoot of the Drugs and Cosmetics Act of 1940, and is concerned mainly with the standard and quality of drugs, apart from exercising control over the manufacture, sale, and distribution, of drugs and cosmetics.* It was amended in 1988, and is now referred to as Drugs And Cosmetics Rules (Eigth Amendment) 1988. All types of drugs used in therapeutics have been included: allopathic, homeopathic, ayurvedic, unani, and siddha. All drugs and cosmetics are required to be labelled and packed appropriately. To advise the Central and State Governments on technical matters relating Drugs Technical Advisory Board, the Ayurvedic and Unani Technical Advisory Boards, and the Drugs Consultative Committee.
In order to facilitate the analysis or testing of drug samples to assess their quality, the Central Drugs Laboratory was established in 1962. Individual states have set up DrugControl Laboratories. Stringent punishments have been laid down for manufacture, stocking, or sale of substandard or spurious drugs. Guidelines for conducting clinical trials for new drugs have been made more strict (Schedule Y).
The Drugs and Cosmetics Rules have classified drugs into various Schedules as follows:
· Schedule C and C1—Biological products, e.g. serums and vaccines.
· Schedule D—Substances not intended for medicinal use—condensed or powdered milk, oats, spices and condiments, etc.
· Schedule E1—List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine.
· Schedule G—Chemotherapeutic agents for cancer, antihis-taminics, and hypoglycaemic agents.
· Schedule H and L—Injectables, antibiotics, antibacterials and other prescription drugs.
· Schedule J—Diseases and ailments (by whatever name described) which a drug may not purport to prevent or cure or make claims to prevent or cure, e.g. AIDS, cancer, cataract, congenital malformations, deafness, blindness, hydrocoele, hernia, piles, leucoderma, stammering, paralysis, etc.
· Schedule O—Standards to be followed with regard to disinfectant fluids.
· Schedule S—Standards to be followed with regard to cosmetics and allied products.
· Schedule X drugs—Barbiturates and certain other seda-tives, amphetamines, etc.
· A list of drugs banned for sale in India as per The Drugsand Cosmetics Rules is listed in Appendix 2
The objective of this Act is to allow only registered pharmacists to compound, prepare, mix, or dispense any medicine on the prescription of a registered medical practitioner. Under this Act, the Pharmacy Council of India has been constituted which regulates the study of pharmacy throughout the country. Individual states have State Pharmacy Councils for registra-tion of pharmacists.
This Act regulates the supply and distribution of drugs, and also guides the manufacturer or dealer in fixing the maximum price for every drug.
The objective of this Act is to ensure that ethical standards are maintained when drugs are advertised by the manufac-turers. Advertisements which offend decency or morality can be banned under this Act. Also, those which claim magical powers for certain drugs, e.g. enhancement of potency, cure for incurable diseases, etc. Magical remedies include the use of talismans or charms such as “mantras”, “kavachas”, etc.
This Act deals with regulatory problems arising out of the use of alcohol in various medicinal and toilet preparations. It has helped greatly in curbing the large scale inter-state smuggling of alcoholic medicinal, and toilet preparations which existed previously due to different rates of excise duties in different states. This Act has made uniform rates of duty applicable throughout the country.
The Narcotic Drugs and Psychotropic Substances Act(NDPS Act) was enacted in India and subsequently amendedin 1988, to implement the provisions of the Convention onPsychotropic Substances (1971), and the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988), both held in Vienna. This Act renders obsolete three previous Acts—the Opium Act (1857), the Opium Act (1878), and the Dangerous Drugs Act (1930).
The term “narcotic” in the legal sense is quite different from that used in the medical context which denotes a sleep-inducing agent. Legally, a narcotic drug could be an opiate (a true narcotic), cannabis (a non -narcotic), or cocaine (the very antithesis of a narcotic, since it is a stimulant). The term “psychotropic substance” is with reference to mind-altering drugs such as LSD, phencyclidine, amphetamines, barbiturates, methaqualone, benzodiazepines, mescaline, psilocybine, and designer drugs (MDMA, DMT, etc.).
The NDPS Act imposes complete prohibition on the cultivation of coca, poppy, and cannabis plants, and the manu-facture, sale, purchase, use, or transport of any narcotic drug or psychotropic substance except for medical or scientific purposes.
The minimum punishment for any offence committed under the Act is 10 years rigorous imprisonment and fine of Rs.1 lakh, while the maximum punishment is 20 years rigorous imprisonment and fine of Rs.2 lakhs. There is also sufficient scope under the NDPS Act for enhanced punishment for repeat offences especially after previous convictions, which includes the imposition of even the death penalty. The minimum quan-tity of drug seized in the subsequent offence should be as per Table 4.1, if death penalty is to be imposed. To constitute anoffence the first time around, the minimum quantity seized should be equal to or over 250 mg for heroin, 5 gm for hashish or charas, 5 gm for opium, 125 mg for cocaine, and 500 gm for ganja.
In addition to persons directly involved in trafficking narcotic drugs and psychotropic substances, any person who finances trafficking, or harbours a person involved in traf-ficking, 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.
However, immunity from prosecution is given to addicts volunteering for detoxification. Section 64 -A of the NDPSAct states that any addict who is not charged with any offencepunishable under Sections 15 to 25,* or Section 27-A ,** and who voluntarily seeks to undergo medical treatment for detoxification or de-addiction from a hospital or an institu-tion maintained or recognised by the government or a local authority, and undergoes such treatment shall not be liable to prosecution under Section 27 of the Act (once in his lifetime). Such immunity granted may be withdrawn if the addict does not undergo the complete treatment, and in such circumstances the accused shall be prosecuted for the said offence.
Further, the Act 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:
The quantity of the drug involved in the offence should be a small quantity as specified by the Central Government.
The onus is on the accused to establish that the drug in question was meant for personal consumption and not for sale, distribution, etc.
The Central Government of India constituted a NarcoticsControl Bureau in 1986 with its headquarters at NewDelhi, and zonal offices at Mumbai, Kolkata, Chennai, and Varanasi. In 1988, the Central Government constituted the
Narcotic Drugs and Psychotropic Substances Consultative Committee, consisting of a chairman (the minister of finance/minister of state in the ministry of finance), and 18 members from diverse fields who would among other functions, conduct periodic review of the NDPS Act.
While the NDPS Act prohibits the cultivation of poppy, cannabis, and coca plants, it does not impose a total ban. Restricted cultivation of these plants is allowed under strict control for scientific or medical use. Prior sanction in the form of license is necessary from the Central Government for this purpose. For instance, poppy can be cultivated only in certain specified tracts in the states of Rajasthan, Uttar Pradesh, and Madhya Pradesh during a specified period, the opium yearcommencing on the first day of October every year, and ending on the 30th day of September the following year. These policy controls are backed by strict enforcement on the ground which include the measurement of fields, periodical crop surveys, and physical checks to prevent diversion. Failure to tender the entire yield to the Government is treated as a serious offence and any cultivator who embezzles the opium produced by him, is in terms of section 19 of the Act, punishable with rigorous imprisonment for a term of between 10 to 20 years, and a fine which shall not be less than Rs.100,000/- but which may extend to Rs.200,000/-.
The 1998 UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances to which India is a signa-tory, requires countries to impose controls over the manufac-ture, internal distribution, and import and export of chemicals which can be used in the illicit manufacture of substances of abuse. In order to implement India’s obligations under this Convention, the NDPS Act was amended in 1998 in order to empower the Central Government to declare any substance as a controlled substance and to regulate its manufacture, import and export, etc.. Violations relating to such substances were established as criminal offences punishable with imprisonment for upto 10 years. In 1993, the Government of India promulgated the NDPS (Regulation of Controlled Substances) Order, to regulate the manufacture, distribution, etc. of any substance declared to be a “Controlled Substance”.
In exercise of its powers under the Act, the Central Government has so far notified acetic anhydride, which is used in the processing of opium into heroin, N-acetylanthranilic acid which is used in the illicit manufacture of methaqualone, and ephedrine and pseudoephedrine which are used in the illicit manufacture of amphetamine type stimulants as “controlled substances”.
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