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<h2 id="a-simple-guide-to-understanding-clinical-trials-in-india">A Simple Guide to Understanding Clinical Trials in India</h2>Clinical trials are a key part of medical research. They help doctors and scientists find out whether a new medicine, treatment, or medical device is safe and effective for humans. In India, clinical trials follow specific methods to ensure the health and rights of participants are protected while producing accurate, reliable results.&nbsp;<h2 id="what-are-clinical-trials-and-why-are-they-important">What Are Clinical Trials and Why Are They Important?</h2>Before any new medicine can be made available to the public, it must go through a series of steps to validate safety and efficacy – the fundamentals of a clinical trial. These steps are carefully planned in what’s known as a ‘study design’. The goal is to prove that a treatment works better than placebo or existing treatments, and is safe to use across different populations.<h2 id="study-design-of-a-trial">Study Design of a Trial</h2>The study design is the heart of a clinical trial. It outlines exactly how the research will be conducted – what is being tested, where are the tests being conducted, who will participate, how they will be divided into groups, and how the results will be measured. A well-thought-out design ensures that the data collected is meaningful and that the study is fair, unbiased, and safe for all participants.<h2 id="common-clinical-trial-study-designs">Common Clinical Trial Study Designs</h2><ul class="list-disc mx-5"><li>Randomised Controlled Trial (RCT): Participants are randomly assigned to groups - one gets the treatment, the other a placebo or existing ‘standard-of-care’ medicine. Ensures fairness and reliable results.</li><li>Double-Blind Trial: Neither participants nor doctors know who’s getting the treatment or placebo. Removes bias.</li><li>Open-Label Trial: Both doctor and participant know the treatment. Used when blinding isn’t feasible.</li><li>Parallel-Arm Study: Two or more groups receive different treatments at the same time. Helps compare effectiveness directly.</li><li>Crossover Study: Each participant receives multiple treatments in sequence. Useful when treatment effects are temporary.</li></ul><ul class="list-disc mx-5"><li>Multicentric Trial: Conducted at multiple hospitals or centres. Increases diversity and generalisability of results.</li><li>Placebo-Controlled Study: One group gets the active treatment under study, the other gets an inactive placebo. Helps identify the real effects of the drug.</li><li>Adaptive Trial Design: Allows modifications mid-study based on early data (e.g., expanding sample size). Increases efficiency and responsiveness.</li><li>Single-Arm Study: All participants receive the same treatment. Often used in rare or life-threatening conditions where a control group isn&apos;t ethical.</li><li>Interventional Study: Researchers actively assign treatment or interventions to participants across different groups.</li><li>Observational Study: No treatment groups are assigned. Researchers observe and record treatment outcomes over time, without cross-group comparisons.</li></ul>Each of these <a target="_blank" rel="noopener" href="https://pmc.ncbi.nlm.nih.gov/articles/PMC7331444/">study designs</a> is chosen based on the goals of the trial, the nature of the disease, the treatment being studied, and the need to ensure safety, fairness, and scientific accuracy.<h2 id="who-can-participate">Who Can Participate?</h2>In India, <a target="_blank" rel="noopener" href="https://pmc.ncbi.nlm.nih.gov/articles/PMC1609186/">selecting participants for clinical trials</a> is done very carefully. Each trial has inclusion and exclusion criteria, rules that determine who can or cannot join the study, based on age, health status, medical history, and other factors.Before joining, every participant must go through an informed consent process. This means they are fully informed about the trial’s purpose, procedures, possible side effects, and their rights. Participation is completely voluntary, and people can choose to leave the trial at any point without affecting their medical care.<h2 id="phases-of-clinical-trials">Phases of Clinical Trials</h2>Clinical trials are conducted in four main phases, each with a specific purpose:<ul class="list-disc mx-5"><li>Phase 1: Small group of healthy volunteers; checks basic safety and correct dosage.</li><li>Phase 2: A Larger group of patients; tests how well the treatment works and looks for side effects.</li><li>Phase 3: Large-scale testing on hundreds or thousands of patients; comparison with standard treatments.</li><li>Phase 4: Post-approval monitoring; tracks long-term effectiveness and rare side effects in the general population.<img height="400" width="1200" class="" src="https://media.savikalpa.com/storage/v1/object/public/media/phases-of-a-clinical-trial-blog-infographic.jpg" alt="cme2snc7f01nakzigwlmw7e14"></li></ul><h2 id="data-collection-and-monitoring">Data Collection and Monitoring</h2>Throughout the trial, doctors and researchers carefully monitor each participant. They collect medical data, track side effects, and measure the treatment’s effects through tests and observations.Data is stored securely using digital systems. Independent review boards and monitoring committees check that the trial is progressing safely and ethically. If any serious issues arise, they can stop the trial immediately to protect participants.<h2 id="regulatory-oversight-in-india">Regulatory Oversight in India</h2>India’s clinical trials follow a strong regulatory framework to ensure ethical conduct, transparency, and participant safety.<ul class="list-disc mx-5"><li>The Central Drugs Standard Control Organisation (CDSCO) regulates trials under the Drugs and Cosmetics Act, 1940 and Rules, 1945.</li><li>The <a target="_blank" rel="noopener" href="https://pmc.ncbi.nlm.nih.gov/articles/PMC7034142/">New Drugs and Clinical Trials Rules (2019)</a> introduced streamlined approvals, participant protections, and mandatory compensation for trial-related harm.</li><li>Trials need clearance from both CDSCO and a registered Ethics Committee, ensuring scientific and ethical soundness.</li><li>All trials must be registered with the Clinical Trials Registry – India (CTRI), maintained by ICMR, for public transparency.</li></ul><h2 id="reforms-and-safeguards">Reforms and Safeguards</h2>India’s clinical research regulations have become stronger over time. The New Drugs and Clinical Trials Rules, 2019, introduced faster approval timelines, mandatory ethics approvals, and clear guidelines for compensating participants in case of injury or death during a trial.These reforms have made India a more trusted and globally respected location for ethical clinical research. By understanding how clinical trials work, we can all play a role in supporting medical progress and improving healthcare for everyone.<div class="note">Medically Reviewed by - <a target="_blank" rel="noopener" href="https://savikalpa.com/about">Dr. Bhanu, Ayurvedic Physician</a></div>

A Simple Guide to Understanding Clinical Trials in India

Clinical trials are a key part of medical research. They help doctors and scientists find out whether a new medicine, treatment, or medical device is safe and effective for humans. In India, clinical trials follow specific methods to ensure the health and rights of participants are protected while producing accurate, reliable results. 

What Are Clinical Trials and Why Are They Important?

Before any new medicine can be made available to the public, it must go through a series of steps to validate safety and efficacy – the fundamentals of a clinical trial. These steps are carefully planned in what’s known as a ‘study design’. The goal is to prove that a treatment works better than placebo or existing treatments, and is safe to use across different populations.

The study design is the heart of a clinical trial. It outlines exactly how the research will be conducted – what is being tested, where are the tests being conducted, who will participate, how they will be divided into groups, and how the results will be measured. A well-thought-out design ensures that the data collected is meaningful and that the study is fair, unbiased, and safe for all participants.

 is chosen based on the goals of the trial, the nature of the disease, the treatment being studied, and the need to ensure safety, fairness, and scientific accuracy.

selecting participants for clinical trials

 is done very carefully. Each trial has inclusion and exclusion criteria, rules that determine who can or cannot join the study, based on age, health status, medical history, and other factors.

Before joining, every participant must go through an informed consent process. This means they are fully informed about the trial’s purpose, procedures, possible side effects, and their rights. Participation is completely voluntary, and people can choose to leave the trial at any point without affecting their medical care.

Clinical trials are conducted in four main phases, each with a specific purpose:

Throughout the trial, doctors and researchers carefully monitor each participant. They collect medical data, track side effects, and measure the treatment’s effects through tests and observations.

Data is stored securely using digital systems. Independent review boards and monitoring committees check that the trial is progressing safely and ethically. If any serious issues arise, they can stop the trial immediately to protect participants.

India’s clinical trials follow a strong regulatory framework to ensure ethical conduct, transparency, and participant safety.

India’s clinical research regulations have become stronger over time. The New Drugs and Clinical Trials Rules, 2019, introduced faster approval timelines, mandatory ethics approvals, and clear guidelines for compensating participants in case of injury or death during a trial.

These reforms have made India a more trusted and globally respected location for ethical clinical research. By understanding how clinical trials work, we can all play a role in supporting medical progress and improving healthcare for everyone.

How Clinical Trials Work in India?

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is cannabis legal in india blog featured image

<h2 style="text-align: left" id="contextualising-cannabis-regulations">Contextualising Cannabis Regulations</h2>“Is this even legal? What are the rules and regulations governing cannabis?” These are often the first questions that arise whenever someone comes across cannabis medicine in India. In this brief explainer, we break-down what the current laws governing cannabis are, and their likely evolution in years to come.In India, cannabis is a restricted substance, governed by the draconian Narcotics Drugs and Psychotropic Substances (NDPS) Act. It is pertinent to note that prior to the enactment of the NDPS Act in 1985, cannabis was legal in India. But as a founding member of the United Nations, and as signatory to the United Nation’s Single Convention on Narcotics Drugs which it signed in 1961, India was obliged to ratify into its local laws its international obligations under this UN Convention, which outlawed cannabis. It is thus that the NDPS Act was born.However, due credit must be given to the mandarins in New Delhi who, when drafting the NDPS Act, recognised that cannabis was widely cultivated across the country, and had been for millennia. Furthermore, India’s classical medicine systems, primarily Ayurveda and Unani, classified cannabis as a therapeutic herb, and cannabis was widely used as an ingredient in many classical medical formulations. Furthermore, large parts of the Indian population, especially persons residing in rural areas, often relied on these traditional medicine systems for primary care. Keeping all this in mind, while ensuring India did not fall foul of its international commitments, the government of the day enacted the NDPS Act, but carved out exceptions, which remain in force today, and which make India a uniquely interesting and uniquely positioned country with respective to cannabis medicine regulations.<h2 style="text-align: left" id="legality-under-ndps">Legality Under NDPS</h2>The first thing to note is that cannabis cultivation is banned in India. However, the NDPS Act allows State governments to enact Rules for the cultivation of cannabis for scientific, medical and industrial purposes. In other words, cultivation for recreational use is expressly forbidden, but enabling provisions in the Act exist to allow for cultivation for scientific/industrial uses. It is under these provisions that various State governments, such as Uttarakhand, Uttar Pradesh, Orissa, Madhya Pradesh, Jammu &amp; Kashmir, Himachal Pradesh and others have enacted, or are contemplating enacting cannabis cultivation regulations.The other interesting facet to note is that while the NDPS Act disallowed cannabis cultivation, it defined only the flower/bud of the cannabis plant as ganja. Thus, only the fruiting top of the cannabis plant and resin extracted from this fruiting top (charas) are expressly prohibited. All other parts of the plant, that is the seed, leaf, stem, stalk and roots are allowed to be used for various purposes, including medical/horticultural/industrial uses. Now it is anyone’s guess how one part of a plant can be legal and another part illegal, but it is this unique legal definition that actually sets India apart from many other countries that have explored deregulating or legalising cannabis for industrial/medical/recreational use.<h2 style="text-align: left" id="cannabis-medicine">Cannabis Medicine</h2>Cannabis is listed as a therapeutic herb in the Ayurvedic Pharmacopoeia of India (API). The API is a book of standards listing all therapeutic herbs, minerals, metals (single drugs) that can be manufactured, sold and marketed across India. Thus, classical formulations, listed in reference texts of Ayurveda and Unani systems of medicine, and even novel, proprietary formulations, made using single drugs listed in the API, can be manufactured and sold as medicine across the country.&nbsp;Given that Ayurveda is the science of “whole-plant” medicine, cannabis formulations approved under India’s Ayurveda regulations must necessarily be made using “whole-plant” extracts. Another common reference to “whole-plant” extract is “full-spectrum” extract, which refers to an extract of the cannabis plant (‘cannabis leaf’ in India) that retains all the cannabinoids, terpenes and flavonoids found in the cannabis plant, that is over 500 unique compounds. It is pertinent to note that even in countries around the world conducting “modern” pharmacological research, “full-spectrum” extracts are proving more efficacious than any single cannabis compound in isolation.Which brings us to the fact that isolated cannabis compounds, in other words, single compounds such as THC or CBD, or even their combination in any ratio, are illegal in India. This is because modern drug rules require that any compound which is used in a medical preparation must first undergo a series of tests to establish the safety and efficacy of that compound – which is a long and expensive exercise wherein India’s allopathic drug regulator needs to sanction each stage of this clinical testing process. Only once a compound has successfully undergone these tests/trials does it get listed in the Indian Pharmacopoeia (IP) – which is like the API, but lists all single molecules/compounds used in modern allopathic formulations. No cannabinoid, whether THC or CBD or any other, is listed in the IP – thus anyone selling any product marketed just as CBD or THC or any ratio thereof is technically operating in a regulatory grey-zone. Furthermore, isolated THC is specifically illegal in India, as the Central Bureau of Narcotics has listed THC as a narcotic substance; whereas CBD is neither legal nor illegal.For this reason, any patient accessing cannabis-based medicines in India should be cautious only to purchase medicines approved by India’s traditional medicine regulator, that is the AYUSH Department of the Govt. of India; and these medicines should be “whole-plant” extracts and not simple THC or CBD.<h2 style="text-align: left" id="oral-vs-topical-medicine">Oral vs. Topical Medicine</h2>One further distinction to be understood is the difference in regulations governing oral versus topical cannabis medicines. As cannabis-based medicines fall under “Schedule E(1)” of the Drugs &amp; Cosmetics Rules, any formulation containing substances listed under Schedule E(1), and meant for oral consumption, should be “taken under medical supervision”. Given the vagueness of this official guidance, it is better to interpret the same strictly and equate “should be taken under medical supervision” as “prescription medicine”. Technically, only drugs listed under “Schedule H” of the Drugs &amp; Cosmetics Rules require a doctor’s prescription – but given the potential for abuse of drugs containing cannabis, it is prudent to equate Schedule E(1) with Schedule H and allow access to oral cannabis medicines only post a prescription from a Registered Medical Practitioner.No such restriction is applicable to topical medicines. These can be sold over the counter, thus any formulations in form factors such as oils, creams, gels, balms, and patches can be bought and used by persons as per need. Such topical formulations typically target localised pain relief, inflammations and dermatological use cases.Explore from our wide range of plant based medicine <a target="_blank" rel="noopener" href="https://shop.savikalpa.com/collections/shunyata">here</a>.

“Is this even legal? What are the rules and regulations governing cannabis?” These are often the first questions that arise whenever someone comes across cannabis medicine in India. In this brief explainer, we break-down what the current laws governing cannabis are, and their likely evolution in years to come.

In India, cannabis is a restricted substance, governed by the draconian Narcotics Drugs and Psychotropic Substances (NDPS) Act. It is pertinent to note that prior to the enactment of the NDPS Act in 1985, cannabis was legal in India. But as a founding member of the United Nations, and as signatory to the United Nation’s Single Convention on Narcotics Drugs which it signed in 1961, India was obliged to ratify into its local laws its international obligations under this UN Convention, which outlawed cannabis. It is thus that the NDPS Act was born.

However, due credit must be given to the mandarins in New Delhi who, when drafting the NDPS Act, recognised that cannabis was widely cultivated across the country, and had been for millennia. Furthermore, India’s classical medicine systems, primarily Ayurveda and Unani, classified cannabis as a therapeutic herb, and cannabis was widely used as an ingredient in many classical medical formulations. Furthermore, large parts of the Indian population, especially persons residing in rural areas, often relied on these traditional medicine systems for primary care. Keeping all this in mind, while ensuring India did not fall foul of its international commitments, the government of the day enacted the NDPS Act, but carved out exceptions, which remain in force today, and which make India a uniquely interesting and uniquely positioned country with respective to cannabis medicine regulations.

The first thing to note is that cannabis cultivation is banned in India. However, the NDPS Act allows State governments to enact Rules for the cultivation of cannabis for scientific, medical and industrial purposes. In other words, cultivation for recreational use is expressly forbidden, but enabling provisions in the Act exist to allow for cultivation for scientific/industrial uses. It is under these provisions that various State governments, such as Uttarakhand, Uttar Pradesh, Orissa, Madhya Pradesh, Jammu & Kashmir, Himachal Pradesh and others have enacted, or are contemplating enacting cannabis cultivation regulations.

The other interesting facet to note is that while the NDPS Act disallowed cannabis cultivation, it defined only the flower/bud of the cannabis plant as 

. Thus, only the fruiting top of the cannabis plant and resin extracted from this fruiting top (

) are expressly prohibited. All other parts of the plant, that is the seed, leaf, stem, stalk and roots are allowed to be used for various purposes, including medical/horticultural/industrial uses. Now it is anyone’s guess how one part of a plant can be legal and another part illegal, but it is this unique legal definition that actually sets India apart from many other countries that have explored deregulating or legalising cannabis for industrial/medical/recreational use.

Cannabis is listed as a therapeutic herb in the Ayurvedic Pharmacopoeia of India (API). The API is a book of standards listing all therapeutic herbs, minerals, metals (single drugs) that can be manufactured, sold and marketed across India. Thus, classical formulations, listed in reference texts of Ayurveda and Unani systems of medicine, and even novel, proprietary formulations, made using single drugs listed in the API, can be manufactured and sold as medicine across the country. 

Given that Ayurveda is the science of “whole-plant” medicine, cannabis formulations approved under India’s Ayurveda regulations must necessarily be made using “whole-plant” extracts. Another common reference to “whole-plant” extract is “full-spectrum” extract, which refers to an extract of the cannabis plant (‘cannabis leaf’ in India) that retains 

 the cannabinoids, terpenes and flavonoids found in the cannabis plant, that is over 500 unique compounds. It is pertinent to note that even in countries around the world conducting “modern” pharmacological research, “full-spectrum” extracts are proving more efficacious than any single cannabis compound in isolation.

Which brings us to the fact that isolated cannabis compounds, in other words, single compounds such as THC or CBD, or even their combination in any ratio, are illegal in India. This is because modern drug rules require that any compound which is used in a medical preparation must first undergo a series of tests to establish the safety and efficacy of that compound – which is a long and expensive exercise wherein India’s allopathic drug regulator needs to sanction each stage of this clinical testing process. Only once a compound has successfully undergone these tests/trials does it get listed in the Indian Pharmacopoeia (IP) – which is like the API, but lists all single molecules/compounds used in modern allopathic formulations. No cannabinoid, whether THC or CBD or any other, is listed in the IP – thus anyone selling any product marketed just as CBD or THC or any ratio thereof is technically operating in a regulatory grey-zone. Furthermore, isolated THC is specifically illegal in India, as the Central Bureau of Narcotics has listed THC as a narcotic substance; whereas CBD is neither legal nor illegal.

For this reason, any patient accessing cannabis-based medicines in India should be cautious only to purchase medicines approved by India’s traditional medicine regulator, that is the AYUSH Department of the Govt. of India; and these medicines should be “whole-plant” extracts and not simple THC or CBD.

One further distinction to be understood is the difference in regulations governing oral versus topical cannabis medicines. As cannabis-based medicines fall under “Schedule E(1)” of the Drugs & Cosmetics Rules, any formulation containing substances listed under Schedule E(1), and meant for oral consumption, should be “taken under medical supervision”. Given the vagueness of this official guidance, it is better to interpret the same strictly and equate “should be taken under medical supervision” as “prescription medicine”. Technically, only drugs listed under “Schedule H” of the Drugs & Cosmetics Rules require a doctor’s prescription – but given the potential for abuse of drugs containing cannabis, it is prudent to equate Schedule E(1) with Schedule H and allow access to oral cannabis medicines only post a prescription from a Registered Medical Practitioner.

No such restriction is applicable to topical medicines. These can be sold over the counter, thus any formulations in form factors such as oils, creams, gels, balms, and patches can be bought and used by persons as per need. Such topical formulations typically target localised pain relief, inflammations and dermatological use cases.

Explore from our wide range of plant based medicine 

The Savikalpa Journal

How Clinical Trials Work in India?

Is Cannabis Legal in India? Here's Everything You Need to Know