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An overview on Drugs Law
Merriam Webster dictionary defines drugs as “something and often an illegal substance that causes addiction, habituation or a marked change in consciousness”. According to Food, Drugs and Cosmetic Act, drugs means:
- A substance recognized in an official pharmacopoeia
- A substance intended for use in diagnosis, cure, mitigation, prevention or treatment of disease.
- A substance other than food intended to affect the structure or function of the body and
- A substance intended for use as a component of medicine but not a device or a component, part, or accessory of a device.
- A drug is any substance which when administered into the body alters the body’s function either physically or physcologically. Drugs maybe legal such as caffeine, alcohol, tobacco or illegal like cocaine, heroin, cannabis, etc.
Countries both developed and developing needs to focus their attention and fit their approach to drug regulation to their resources. All countries share the responsibility of assuring the quality, safety and efficacy of the drugs. In order to ensure the quality of the product, the manufacture and the subsequent handling and distribution within the domestic territory as well as movements about the country must be regulated under defined conditions and prescribed norms.
Provision to the countries with limited resources has been one of the prime concerns o WHO. In wake of the 1985 conference on the Rational Use of Drugs , WHO had embarked upon the development of two key components, foremost being the Guidelines for developing national drug policies, in which legislation and regulation are identified and described as the first component of drug policy and secondly, the Guiding principles for small national regulating authorities which was published in 1990 and was endorsed by the World Health Assembly in 1994. Since then many countries have started to develop and adopt policies regulating drugs in their countries.
Drugs Regulation:-
- Drug registration: Also known as market authorization or product licensing is an essential element of drugs regulation. All the drugs that are marketed, distributed and used in the country must be registered with the national controlling authority of the country. Only the inspection of manufacturing plants and laboratory quality control analysis certainly does not guarantee product quality and safety. Drug regulation should therefore include the scientific evaluation of products before registration, to ensure that all marketed pharmaceutical products meet the criteria of safety, efficacy and quality.
- Drug Prohibition law:- it is a prohibition based law by which the government prohibits, except by a way of license, the manufacture, import , production, sale or possession of many substances recognized as drugs and which corresponds to the international treaty commitments. The law is based on the view that certain drugs and substances are so addictive or independence inducing that it poses harmful effects on the human body both physically and mentally. Such drugs are called as controlled substances such as opium poppy, coca, etc. The use of such prohibited drugs is permitted for medicinal, scientific or research purposes by way of licensing. There is an extensive illegal industry supplying such prohibited substances for recreational use. Thus while the drug prohibition alw remains in force, there is a perpetual law enforcement action directed against such illegal industries.
- Drug Policy Reform: also known as Drug Law reform is any proposed changes to the way government responds to the socio- cultural influence on the perception of psychotropic substances. Other proposed alternative is the Harm Reduction which provides for development of a range of public health policies which would reduce the harmful consequences that it has on the bodies of individuals by way of recreational drug consumption and other high risk activities.
- Drug Decriminalization: this calls for reduced governmental controls and penalties as compared to the existing laws. It purports the use of fines or other punishments to replace the prison terms. It proposes to introduce a system whereby the person caught hold of using illegal substances shall only be fined instead of criminal records appearing against their names.
- Drug Legalization: this calls for a complete end on the government controls and policies towards the usage, cultivation, possession, sale and consumption of illegal substances. Proposed ideas range from complete legalization to various forms of legalized controls which would allow for drugs being legally available.
- Inverse Benefit Law: the law states the ratio of benefits to harms amongst the patients consuming the new drugs to vary inversely with how extensively the drug must be marketed. This is the reason why the organizations like “ Worst Pill, Best Pill” recommends not to use drugs or medications which have not been in the market for at least 10 years exceptions being important new drugs which solves the previously unsolved problems.
Legal framework in India
- Drugs and Cosmetic Act, 1940: the Act has been formulated to regulate, distribute, import, and sale of drugs and cosmetics in the country. It contains provisions with respect to the import of drugs and cosmetics of standard quality, prohibition on the import, distribution, sale of certain drugs and cosmetic , spurious drugs, misbranded cosmetics, etc.
- Drugs and Magic Remedies (Objectionable Advertisements Act, 1954): it is an Act which controls the advertisements of drugs in India. It prohibits the advertisements of drugs and remedies claiming magical properties which constitute a cognizable offence. It prohibits the advertisements of drugs and medicines which –
- Induces miscarriages and prevention of contraception in women
- Improvement or maintenance of capacity of sexual pleasure
- Correction of menstrual disorders
- Curing, diagnosing or preventing any of the diseases provided in the Schedule to the Act.
- Narcotics Drugs and Psychotropic Act, 1985: under the act it is illegal for a person to buy, possess, store, trade, consume any narcotic drug or psychotropic substance. It has been designed to fulfill India’s treaty obligation under the Single Convention on Narcotic Drugs, Convention on Psychotropic Substances, and the United Nations Convention against illicit Traffic in Narcotic Drugs and Psychotropic Substances. The NDPS rules and regulations are applicable to all states and Union Territories as announced by the Government of India.
- Prevention of Illicit Trafficking and in Narcotic drugs and Psychotropic Substances Act is a drug control law which had been passed in 1966 by the Parliament of India to enable the full implementation of the narcotics Drugs and Psychotropic Substances Act.
National Regulatory Organisations-
- The Central Drugs Standard Control Organization is the national regulatory body for the Indian pharmaceuticals and medical devices. The government has announced its plan to bring all the medical devices, including plants and contraceptives under the control of CDSCO. With the CDSCO, the Drugs Controller General of India works under the gamut of Ministry of Health and Family welfare.
- Narcotics Control Bureau is the chief law enforcement and intelligence agency of India responsible for fighting drugs trafficking and abuse of illegal substances.
Judicial Review
Recently , the judiciary has passed verdicts pertaining the NDPS Act which further aids in streamlining the related law.
- In the case of Arif Khan v. State of Uttarkhand , the Supreme Court reitered the settled position of law that Section 50 of NDPS Act is a mandatory provision. Section 50 enumerated the conditions under which the search of the person shall be conducted.
- Similarly in the case of State of Punjab v. Baldev Singh it had been held be a 2 bench judge of the Supreme Court that Section 50 of NDPS Act is a mandatory provision and it has to be strictly complied with.
Many drugs have been made “illegal” in an attempt to reduce their availability and so their harms. This control occurs at both national and international levels—in the latter case, in the United Nations conventions that made a whole range of drugs from cannabis to heroin “illegal.” Many people are aware of the challenges to this system of control in terms of human rights abuses by those who seek to implement a prohibitionist approach to drug control, as well as the failure of, and massive collateral damage from, the “War on Drugs” that is currently being waged to stop drug use.
