ABSTRACT
Drugs regulation play a critical role shaping public health, social norms, and economic landscapes. This paper examines the evolution of drug regulation in India and their multifaceted impact on society. India’s regulatory framework governed by the Drugs and Cosmetics Act,1940, and subsequent amendments, aims to ensure the quality safety and efficiency of pharmaceuticals while controlling the misuse of narcotics and psychotropic substances. The study explores the effectiveness of these regulations in addressing critical issues such drug affordability, counterfeit medicine and the opioid crisis. It also implicates the socio-economic implication including access to essential medicine, public health outcomes and the burden of regulatory compliances on pharmaceutical industries. Additionally, the paper highlights challenges such as corruption, lack of enforcement, and the rise of unregulated online drug markets. Through a combination of policy analysis and case studies, the research underscores the need for robust, transparent and adoptive regulatory mechanism to balance public health priorities with industry growth and innovation. The finding aims to inform policymakers and stakeholders on fostering a more equitable and effective drug regulatory environment in India.
Keywords–
Narcotic substances- a substance used to treat moderate severe painPsychotropic
substance- a substance that alters cognition and perception by acting on the brain
Menace – a thing or situation that is considered a threat or a danger
Counterfeit – a fake or imitation of something, with a goal of financial gain or other benefits.
INTODUCTION –
India’s drug regulatory framework plays a vital role in protecting public health by ensuring the availability of quality drugs and controlling the abuse of narcotic drugs and psychotropics substances. The drugs and cosmetics act, 1940, forms the cornerstone of pharmaceutical regulation, with subsequent amendments catering to emerging challenges. Despite theseeffort challenges like counterfeit drugs, uneven enforcement, and substance abuse continue to impact Indian society.The Bollywood drugs cases has been in the news since 2020, with industries bigwigs like Deepika Padukone, Sara Ali khan, shraddha Kapoor summoned by the Narcotic Control Bureau. Crimes are generally of two types, first is traditional crime that affect only individual and second, white collar crimes that affect the general public. Smuggling, accumulation, trafficking and sale of narcotic drugs and psychotropic substances are those kind of crimes. The main purpose of these crimes is to obtain money property or personal gain. The menace of drug abuse cannot be ignored as it is growing in India, causing several problems in the society like increasing mortality and increasing psychiatric problems. This writing explores the complex relation between Indian drug regulation and their social impact. It looks at the regulatory framework and its historical revolution, effectiveness, and implications for public health and the pharmaceutical industry.
DRUGS REGULATION IN INDIA
–HISTORICAL EVOLUTION
The genesis and development of drug trafficking is closely connected to the geographical location of India, which experiences a massive flow heroin and hashish from the IndoPakistan originating from the ‘golden Crescent’ composed of Iran, Pakistan and Afghanistan, the main source regions for illegal drugs in the world. In the north-east of the country is the so-called “Golden Triangle”, consisting of Burma, Laos and Thailand, which is also one of the largest sources of illegal opium in the world. Nepal is a traditional source of cannabis. Before the enactment of the Act, legal control over narcotics was exercised through a series of central and state laws in India. India’s drugs regulation starts with the drugs and cosmetics act,1940, introduced to ensure the safety and efficacy of medicines. Over time, amendments were made to address emerging challenges, including counterfeit drugs, clinical trial ethics, and online pharmacies.The Narcotics and Psychotropic Substances act,1985 was enacted to combat drug abuse and illicit trafficking.
FEATURES OF THE ACT–
The law prohibits the use, production, cultivation, possession or trafficking of all types of narcotic and psychotropic drugs. This law covers a wide scope and applies to all citizens, whether living in India or abroad, or persons working on aircraft and ships registered in India. A list of about 237 substances in included in law.Narcotics substances include herbal products such as opium, heroin and codeine. Synthetic narcotics such as cannabis, cocaine and coke.Psychotropic substance includes any substance that has effect on the brain and cause changes in mood and or consciousness. This act gives power to central government to remove or include any other substance in the list of NDPS Act. The second chapter includes the competent authorities and officers who have been introduced through this act. It also lays down the guidelines of the central government for appointment of Narcotics commissioner commission of the advisory commission on Narcotics and psychotropic substances and funding for the National Drug Control Fund. The third chapter covers the prohibition, regulation and control of the abovementioned substances. It prohibits the cultivation and production of coca, opium, poppy and cannabis by any citizen. Any form of inter-state or international smuggling of these substance is also prohibited. Chapter 4 deals with criminal offences and provide for the different sanctions. It describes the different possible violation and outlines the period of punishment associated with them, for example the punishment for possession of such substance, cultivation or preparation, smuggling of these substances. The fifth chapter discusses the procedure to be followed in handling cases and establish guidelines for officials.
Objectives
The NDPS Act was enacted to amend the laws relating to narcotic and lay down strict provision regarding the control and regulation of operations relating to narcotic drugs and psychotropic substances, to ensure against loss of property due to illegal trafficking in drugs and substances, To enforce the provisions of international conventions and for matters connected herewith.
Amendments
The NDPS Act has been amended thrice till date. The 1st amendment was made in 1988. Followed by amendments in 2001 and finally the amendment in 2014 introduced new provision and regulation on the use narcotic drugs and psychotropic substances. The NDPS Act, 2014, transferred the power to regulate the possession, purchase, sale, transportation, import, export or consumption of narcotic drugs and poppy straw from the state government to central government. Essential narcotics include codeine, fentanyl, morphine, methadone and codeine.
Punishment
If a person is found in possession of banned drugs, the law provides for rigorous imprisonment and fine or both. The amendment to NDPS Act has removed the mandatory death penalty for repeat convictions for possession of large quantity of drugs, giving the court discretion to use the alternative sentence of 30 years imprisonment. Also, the punishment for possession of small quantities has been increased from 6 months to 1 year in prison due to the change. Since drug addiction is a recurring problem, the law imposes severe penalties on repeat offenders. The penalty for the second offence can be put to one and a half times higher than that for the first offence. The penalty then range from one year to 30 year in prison depending upon the severity of the crime. Similarly, the fine would be one and a half times higher for a second offence.
Major flaws in the lawThe law is considered to be failure by many due delays in judgement. parole laws, which grant parole to the rich while keeping the poor in prison. Failure to file prosecution cases according to the procedure determined by the investigative bodies. The law presumes the guilt of the accused, reversing the burden of proof of innocence. Section 35 assumes that the accused has the intention, motive and knowledge of his action. Section 54 of the Act goes further and state that, unless the contrary is proven, it is presumed the accused was in possession of illegal drugs seized from him. Bail restrictions under the law constitute denial and ensures years of imprisonment. Section 37(1) of the act sates that the accused shall not be released on bail unless the court has reasonable ground to believe that such accused is not guilty. Furthermore, section 31 A of the act provided for mandatory death penalty for the convicted offender. However, the supreme court of India ruled that mandatory death penalty was unconstitutional.
IMPACT OF DRUG REGULATION ON SOCIETY–
Positive impacts
1. Ensuring drugs safety and efficacy Regulations have improved the quality of medicines, reducing public health risk associated with substandard product.
2. Curbing drug abuse Strict control under NDPS Act have helped curb the misuse of narcotics and psychotropic substances.Global reputation Robust regulations have enhanced India’s reputation as a reliable supplier of affordable and quality generic medicine worldwide.
Challenges and negative impact
1. Accessibility and affordability regulatory delays and high compliances cost can increase the price of essential drugs, limiting access for low income populations.
2. Counterfeit medicines Despite regulations, India faces a significant challenge with counterfeit drugs, impacting public trust and health outcomes.
3. Inefficiency and corruption lack of enforcement and bureaucratic inefficiencies undermine the effectiveness of drug regulations.
4. Rising substance abuse Weak implementation of the NDPS Act has led to the proliferation of certain illicit substance in urban and rural areas.
CASE STUDIES
1. Punjab’s drug problem-
Punjab, located near the golden crescent, has been significantly affected by the threat of illegal drugs. The most distinctive features of the demand for illegal drugs in Punjab is that it is met entirely from outside the state through a supply network controlled by local, interstate and international criminal gangs. Multimillion dollar synthetic drug rings were busted in June 2012 and march 2013. A study found that an overwhelming number (75.8%) of the sample of drug addicts (1527) from the border district of Punjab belonged to the age group of 15 to 35 years. similarly the PODS conducted in 2015 by the SPYM and the NDDTC, AIIMS, New Delhi, found that 76 % of drug addicts in Punjab were aged between 18 to 35.
2. Counterfeit drug epidemic-
Reports of fake medicines, especially in rural areas, underscore the need of stricter monitoring mechanism. According to the Pharmaceutical Security Institute, 2177 reported cases of incidents involving counterfeit drugs in 2014, 875 cases (around 40%) were from Asia of which India is one of the key players in the manufacture, distribution and sale of counterfeit drugs.
3. Covid-19 vaccine rollout –
the expedited approval of vaccines during the pandemic showcased the regulatory system’s ability to adapt but also highlighted the importance of transparency and public trust.
RESEARCH METHODOLOGY–
This section outlines the research design, methods and tools employed to analyse drug regulation in India and their societal effect. The study adapts a mixed method approach, integrating qualitative and quantitative method to ensure a comprehensive understanding of the subject.
• Research design The research follows a descriptive and analytical design focusing on documenting the evolution of drug regulation in India and its key elements and assessing the effectiveness and social impacts of these regulations, including positive outcomes and challenges.
• Data collection methods
o Analyse of official documents such as the Drugs and Cosmetics act, NDPS Act and amendments.
o Literature review of academic articles on drug regulation and public health.
o Examination of specific instances e.g., the opioid crisis, counterfeit drug cases to contextualise findings.o Analyse of public health metrics, pharmaceutical market data, and drug abuse trend from organizations such as the WHO, NCRB and Ministry of health.
• Tools and techniques
o Thematic analysis of interview transcripts to identify recurring challenges and trends in drug regulation and enforcement.
o Policy analysis to evaluate the coherence and effectiveness of regulatory frame works.o Statistical tools to analyse survey data and assess the correlation between regulatory measures and public health outcomes.
o Trends analysis of drug related crime rates, availability of essential medicines, and pricing data.
o In depth analysis of specific cases such the opioid cases in Punjab, the impact of counterfeit drugs and regulatory challenges during covid 19 vaccine rollout.
REVIEW OF LITERATURE
1. Historical context of drug regulation
o The Drugs and Cosmetics Act, 1940, was introduced to ensure drug safety and efficacy, with subsequent amendment addressing the challenges of clinical trials, counterfeit drugs, and pricing. (Kumar et al., 2019)
o The NDPS Act, 1955, aimed to regulate the production, sale, and use of narcotics, but gaps in enforcement have allowed drug abuse to persist. (Sharma, 2021)
2. Impact of Regulation on Pubic health
o Studies highlight the role of regulations in reducing substandard and counterfeit drugs but emphasize the need for stricter enforcement and public awareness. (Gupta & Patel, 2018)
o Regulations during the covid 19 pandemic showcased India’s ability to adapt rapidly, but issues of transparency and equity emerged. (Reddy et al., 2022)
3. Economic and social impact
o The pharmaceutical sector, a major contributor to India’s economy, faces high compliances costs due to regulatory inefficiencies. (Bose, 2020)
o The social impact of drug abuse, especially in states like Punjab, underscores the need for better enforcement of the NDPS Act. (Mehta & Singh, 2017)
o Comparison with regulatory frameworks in developed countries reveals areas where India lags, such as digital tracking systems and public transparency. (WHO, 2020)
SUGGESTIONS
• Strengthening enforcement mechanisms – increase funding and resources for regulatory agencies such CDSCO to enhance their capacity for inspection and enforcement and establish dedicated task forces to combat counterfeit and substandard drugs, ensuring stricter penalties for violation.
• Promoting accessibility and affordability – simplify regulatory process to reduce the time to approve the drugs without compromising safety and quality and expand the scope of price control under the NPPA for essential drugs to make them affordable to all section of the society.
• Implementation of advance technology – introducing digital tracking systems such as barcodes and blockchain technology to monitor the production, distribution and sale of drugs and create a centralized database of drugs approved, withdrawn, or reported for quality issues, accessible to regulators and the public.
• Encourage innovation in pharmaceutical sector – Introducing accelerated approval mechanism for drugs targeting rare disease or public health emergencies. And providing tax incentives and subsidies for research and development of innovative drug formulations.
• Improve drug control – to improve coordination among law enforcement agencies to combat drug trafficking and abuse under NDPS Act. Develop community based drug abusive prevention, rehabilitation and counselling programmes, particularly in vulnerable regions such as Punjab and northeast India.
• Learn from global best practices – adopt successful model from countries with advanced regulatory frameworks, such as the US FDA and the EMA (European Medicines Agencies). Collaborate with international agencies such as WHO to build capacity and adopt universal standards.
Improve public awareness – launch nationwide awareness campaigns about the dangers of counterfeit drugs and the importance of using prescription drugs. Encourage patient education on regulatory labels, such as Drug Application Validation and Verification (DAVA)
CONCLUSION – –
India’s drug regulatory framework has made significant progress in ensuring drugs safety and supporting the pharmaceutical industry. However, challenges such as counterfeit drugs, substance abuse, and regulatory inefficiencies highlight the need for reform. Strengthening enforcement mechanisms, leveraging technology, and fostering transparency can address these gaps. By adapting a balanced approach that prioritise public health and industry innovation, India can build a more effective and equitable regulatory environment, befitting both its citizens and the global community.
References
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/actsrules/2016drugsandCosmeticsAct1940Rules1945.pdf – Drugs and Cosmetics Act,1940
https://www.cdsco.gov.in/opencms/opencms/en/Acts-and-rules/New-drugs
https://www.dsir.gov.in/sitees/default/files/2019-11/7_5.pdf
https://www.cdsco.gov.in/opencms/opencms/en/Acts-and-rules/New-Drugs
https://blog.finology.in/criminal-law/ndps-act-1985-analysis — objectives, punishments and amendments in NDPS Act
Research paper by- Awani payasi
BALLB 2nd year
Government New Law college Indore
Madhya Pradesh
Plagiarism report
