Clinical trials in India

India. Country Overview
India is emerging as a favorable destination to conduct clinical trials. 
India has a significant history of conducting clinical trials, and the country has been an active participant in the global clinical research landscape. The foundation of clinical trials in India can be traced back to the 1960s and 1970s when multinational pharmaceutical companies started conducting trials to evaluate the safety and efficacy of their products in the Indian population.
In the initial years, clinical trials in India were primarily focused on testing drugs for communicable diseases such as malaria, tuberculosis, and leprosy, which were prevalent in the country.
The Guidelines for Good Clinical Practice (GCP) were introduced in 2001 by the Central Drugs Standard Control Organization (CDSCO) to align Indian regulations with international standards.
In 2005, the Indian Council of Medical Research (ICMR) released guidelines for the ethical conduct of biomedical research involving human participants, which further strengthened the ethical framework for clinical trials.
Over the years, India has witnessed a significant increase in the number of clinical trials conducted. The country's large and diverse patient population, availability of qualified healthcare professionals, and lower trial costs compared to Western countries have contributed to its attractiveness as a clinical trial destination. 
There are many reasons to do clinical trials in India.
India has a huge population. In September 2021, the population of India was estimated to be approximately 1.366 billion people. India is the second most populous country in the world, following China. The population of India has been steadily increasing over the years, and it is known for its diverse demographics, cultural richness, and multiple languages spoken across different regions.
India is a country known for its ethnic and cultural diversity. The population of India comprises various ethnic groups and races. 
India has a long history of migration, invasions, and cultural interactions, which has further contributed to the diversity of its population. Over the centuries, people from various regions, including Central Asia, Persia, Arab countries, and Europe, have migrated to and settled in different parts of India. As a result, India's population has been influenced by a mix of genetic, linguistic, and cultural elements. This makes India a great place for clinical trials thanks to its diverse and huge population. 
Huge population also means a big number of patients. India faces a significant burden of various diseases due to factors such as huge population size, socio-economic conditions, lifestyle changes, and healthcare infrastructure.
India has a multi-payer universal health care model that is paid for by a combination of public and private health insurance funds along with the element of almost entirely tax-funded public hospitals. India had allocated only 1.8% of its GDP to health in 2020–2021. India is ranked 155th on the health spending index. Low spending on healthcare results in lack of diagnostics, lack of treatment, high out-of-pocket expenses for medical treatment and abundant patient population.
Here are some of the most common diseases in India:
  • Cardiovascular Diseases: Cardiovascular diseases, including heart attacks, strokes, and hypertension, are a leading cause of mortality and morbidity in India. 
  • Respiratory Diseases: Respiratory diseases such as chronic obstructive pulmonary disease (COPD), asthma, and respiratory infections are common in India. 
  • Diabetes: India has a high prevalence of diabetes, both type 1 and type 2. Diabetes-related complications, such as cardiovascular diseases and kidney diseases, are also common.
  • Infectious Diseases: India faces a significant burden of infectious diseases, including tuberculosis (TB), malaria, dengue fever, hepatitis, and HIV/AIDS. 
  • Cancer: Cancer is a growing health concern in India. Common types of cancer include breast cancer, cervical cancer, lung cancer, and oral cancer. 
  • Mental Health Disorders: Mental health disorders, including depression, anxiety disorders, and substance abuse, are increasingly recognized as a significant public health issue in India.
  • Maternal and Child Health Issues: Maternal and child health issues, including malnutrition, neonatal disorders, infant mortality, and maternal mortality, remain significant challenges in India. 
Sponsors have plenty of opportunity to recruit subjects in India. In India, a large section of the population being unable to afford their own medical treatments, opt for such clinical trials as they are assured of treatment and healthcare, which would have not been available otherwise.
Clinical trial infrastructure in India is well developed due to a big number of hospitals and doctors.
According to the data available in 2021 there were over 25,000 registered hospitals in India. This number includes various types of hospitals, such as government-run hospitals, private hospitals, specialty hospitals, district hospitals, and primary health centers. These hospitals vary in size, capacity, and the range of services they provide.
According to available data, India had approximately 1.3 million hospital beds in the country. These beds are distributed across various types of healthcare facilities, including government-run hospitals, private hospitals, specialty hospitals, district hospitals, and primary health centers.
In 2014 India had approximately 1.1 million registered doctors in the country. The number of registered nurses and midwives is also very high. The figures above show that there is a big selection of hospitals and doctors for clinical trials. 
Patient-to-physician ratio is quite high in India. In America, for every 384 patients there is one doctor, whereas in India there are 1242 patients for one doctor.
In addition to a well-developed infrastructure of clinical trials sites there is a good infrastructure of clinical trial support vendors such as CRO, laboratories, data management and biostatistics companies. Most global CRO companies are present in India. 
Big cities have a big concentration of patients which is very convenient for clinical trials enrollment. 
India is home to several megacities and metropolitan areas, including Mumbai, Delhi, Kolkata, Chennai, Bengaluru, and Hyderabad. These cities serve as economic and cultural centers, attracting people from rural areas in search of better employment opportunities and improved living conditions. The urban population in India is approximately 423 460 000. The big cities in India have a great selection of clinical research sites and KOLs. Most doctors speak English. 
English, despite not being a state language, is extensively used for official and administrative purposes at the central government level, as well as in various state governments and institutions. It plays a significant role in communication, education, business, and judiciary throughout the country. English is also commonly used as a medium of instruction in many educational institutions. English can be easily used for clinical trials conduct in India.
India can provide big economic advantages for clinical trials Sponsors. For example, salaries in the medical and healthcare sector vary depending on the specialization, experience, and type of employment. Mean salaries for doctors can range from INR 6 lakh to INR 20 lakh per annum, with specialists and doctors in private practice typically earning higher salaries. In the USA the salaries of doctors are 8-10 higher in comparison with doctors in India which makes it a place to conduct lower cost clinical trials due to the lower labor cost. It is possible to get lower CRO budgets and lower site/investigators fees. 
The pharmaceutical industry in India is one of the largest and fastest-growing sectors in the country. It plays a significant role in both domestic healthcare and the global pharmaceutical market.
In 2021, the market size was around USD 40-45 billion. The market has been growing steadily over the years and is projected to continue its growth trajectory.
India is a major exporter of generic drugs, active pharmaceutical ingredients (APIs), and formulations to various countries around the world. India is known for its cost-effective production capabilities, which enable it to supply affordable medicines globally.
The country has a robust generic drug manufacturing industry, producing a wide range of medicines at competitive prices for countries all over the world.
The Indian pharmaceutical industry is increasingly investing in research and development (R&D) activities to develop new drugs, improve existing formulations, and enhance manufacturing processes. The sector has been actively involved in developing novel drug delivery systems and conducting clinical trials.
Clinical trials landscape in India
The Clinical Trials Registry - India (CTRI) was established in 2007 as a publicly accessible database for registration and tracking of clinical trials conducted in India.
The CTRI contain information on thousands of clinical trials across various therapeutic areas. These trials included both interventional studies (testing new drugs, treatments, or devices) and observational studies (collecting data on patients without intervening). The number of clinical trials registered in India has been increasing over the years, indicating ongoing research activity in the country.
In 2021, India approved over 100 global clinical trials, the highest number since 2013. In 2021, India approved 184 domestic trials. Covid-hit 2020 also saw 87 global clinical trials in India. These were 95 in 2019, 76 in 2018 and 71 in 2017.
The Indian clinical trials market size was valued at USD 1.93 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 8.2% from 2022 to 2030.
Regulatory landscape for clinical trials in India
From 2009 to 2014 there were 1442 US sponsored trials were placed in India. It became an extremely popular place for outsourcing of clinical trials. 
In 2014 there were instances where the regulatory authorities have imposed temporary suspensions or restrictions on specific trials or certain aspects of the clinical trial process. These measures were taken to address concerns related to participant safety, ethical practices, and regulatory compliance. The authorities took these measures to ensure that trials are conducted ethically, adhere to good clinical practices, and prioritize participant safety.
On the whole, the Indian Government has made а great effort to improve the patient safety on streamlining and revising the clinical trial regulations Ьу instituting а structured accreditation process accrediting investigators, trial sites and ethics committees, making ethics committees function effectively, and ensuring diligent adherence to guidelines concerning informed consent fГom trial subjects.
India has implemented stringent regulations and guidelines for clinical trials to ensure the protection of participants and the integrity of the trial process. The Drug Controller General of India (DCGI) and the Indian Council of Medical Research (ICMR) play key roles in overseeing and regulating clinical trials in the country today. 
Under the Ministry of Health and Family Welfare, Govt. of India, the Central Drugs Standard Control Organization (CDSCO), headquartered in New Delhi, is the National Regulatory Authority in India. The Drugs Controller General of India (DCGI), an official of the CDSCO, is the final regulatory authority for the approval of clinical trials in the country. 
The approval process for conducting clinical trials in India involves several regulatory steps to ensure the ethical conduct of research and participant safety. Here is an overview of the clinical trial approval process in India:
Submission of Trial Application: The sponsor or investigator submits an application to the Drug Controller General of India (DCGI) or the relevant State Licensing Authority (SLA) for approval to conduct the clinical trial. The documents are submitted online. The regulatory authority evaluates the scientific validity, safety measures, trial protocol, investigator qualifications, and compliance with regulatory requirements. 
The application may get referred to a scientific expert committee which is termed as the “Subject Expert Committee (SEC)” by the CDSCO based in the category of the CT application for e.g. New Drug, Biological, Vaccine etc. 
This expert committee comprises of domain experts from medical fraternity (academic research and teaching institutions, public medical colleges) and the DCGI office. The CDSCO has developed several such expert committees based on the specific indications for e.g. Oncology and Hematology, Cardiology and Renal, Pulmonary, Ophthalmology, Metabolism and Endocrinology, Reproductive and Urology, Antimicrobial, Antiparasitic, Antifungal and Antiviral, Analgesics, Anesthetics & Rheumatology, Neurology and Psychiatry, Dermatology and Allergy, Dermatology and Allergy, Vaccine Section, and even Dentistry. 
These committees have been established under the direct supervision of DCGI (regulatory authority) and are developed to smoothen & fast track the regulatory review and approval process while keeping all the scientific & technical review guards & transparency in place to rule out specific biases. 
In case the CT application is referred to one of the above SECs, the committee based on the review submits its comments to the regulatory authority. 
Based on the review, the regulatory authority may grant approval for the clinical trial, request revisions to the protocol, or reject the application. The sponsor or investigator may need to address any concerns or submit additional information requested by the regulatory authority.
The trial protocol is reviewed by an independent Institutional Ethics Committee (IEC) or Independent Ethics Committee (IEC) for ethical considerations.
If the trial involves importing investigational products or manufacturing investigational drugs within India, separate licenses are required from the Central Drugs Standard Control Organization (CDSCO).
The Indian regulatory framework allows concurrent submission of applications for regulatory and institutional ethics committee (IEC) approval.
Study approval process takes from 3 to 4 months. Most documents can be submitted in the English language. ICF and patients documentation shall be translated into all state languages. 
Summary. Clinical trials in India
Because of its huge population, low medical costs, and ability to conduct trials at а low cost, India has become a good destination for international companies to conduct clinical trials.
India has а huge population, of which а significant portion are "drug-naive," and has the diseases that many potential new drugs aim to target. With the low cost of health care and clear regulatory environment, it is one of the most favorable destinations for outsourcing а clinical study.
India is emerging as a natural choice and ultimate destination for contract clinical research services because: 
  • Lower infrastructure costs and the rapidity of subject recruitment for clinical trials,
  • Decreased clinical trial timelines due to speedy enrollment, 
  • A huge population with a diversity of diseases, 
  • Competitive costs, 
  • High enrolment rates, 
  • Good patient compliance and retention rate, 
  • Sound infrastructure facilities
  • Favorable regulatory environment
  • Higher percentage of treatment-naive patients
  • GCP compliance
  • No need to translate documents into local languages (except ICF and patients documentation)
  • CTRI registration of clinical trials facilitating transparency of the clinical trial process
Smooth Drug Development — a CRO in India
Smooth Drug Development is a full service CRO in EAEU, CIS, EC, Middle East and India. Smooth Drug Development has a registered office in India and an experienced local team to effectively manage clinical trials. 
Smooth Drug Development has capabilities to provide full spectrum of clinical trials services for phase I-IV trials in India:
  • Project management
  • Regulatory support
  • Medical writing
  • Biomedical statistics
  • Study feasibility
  • Data management / IWRS
  • ePRO
  • eTMF/eISF service
  • Logistics and storage
  • Clinical monitoring
  • Centralized monitoring
  • Medical monitoring
  • Pharmacovigilance
  • Central laboratory
  • Patient logistics
  • Clinical study report