Why India Leads Global BA/BE Studies in 2025: Strategic Advantages for International Submissions
BA/BE studies 2025 are essential for global generic drug submissions. As the number of submissions continues to increase, countries are actively enhancing their capabilities to keep pace. India has positioned itself as a preferred destination, supported by its technical expertise, growing infrastructure, and regulatory alignment.
BA/BE studies are cornerstones in developing and approving generic medicines, making them requisites for global drug approvals. As regulatory agencies worldwide have strengthened standards, sponsors are also on the hunt for efficient, compliant, and cost-effective settings to conduct the studies. This article explores why India remains the preferred choice for global submissions, beginning with the key criteria for evaluating countries for BA/BE studies.
Criteria for evaluating countries for BA/BE studies
Before commencing bioequivalence studies, sponsors must understand the guidelines of the country where they intend to market their generics. When choosing a country, it is important to consider factors such as cost optimisation, volunteer recruitment, ethical standards, and so on. Below is an overview of the main criteria for selecting countries for BA/BE studies.
1. Regulatory factors: Assess whether major regulatory authorities (like the US FDA, EMA, and Health Canada) accept the country’s data. Equally important are the timelines, transparency, and requirements of approval processes, including ethics committee review.
2. Infrastructure: Availability of experienced CROs with certified bioanalytical lab facilities, validated methods, and a proven track record in BA/ BE studies is essential. The clinic facility should also be well-equipped with adequate beds and provisions for volunteers.
3. Cost- effectiveness and workflow efficiency: While considering the overall cost of BA/BE studies, never compromise on quality.
4. Volunteer recruitment and diversity of subjects: Consider the availability of healthy human volunteers. Also, account for special populations required for certain studies.
5. Ethical considerations and data quality: The review processes of Ethics Committees and Institutional Review Boards (IRBs). It must be evaluated for compliance with regulations. Confirm systems for data integrity and an independent Quality Assurance unit
6. Logistics and accessibility: The provision of reliable cold chains and logistics for biological samples is important. Geographical accessibility and the availability of sufficient staff are also key factors.
To analyze the key regulatory requirements of selected countries for BA/ BE studies, click here to read our article.
Having discussed the criteria for evaluating prospective countries for BA/BE studies. Now, turn to the global acceptance of Indian BA/BE studies and why choosing India could be the right move.
Global acceptance of Indian BA/BE studies in 2025
India has become a major hub for BA/BE studies. Its high-quality data is accepted by strict global regulators. Below is a list of key regulatory authorities that recognize BA/BE studies from India
Regulatory Authorities Accepting BA/BE Studies from India
- The US FDA accepts BA/BE studies from India. India has several accredited CROs and study centers recognized for meeting regulatory and quality standards
- The EMA generally accepts BA/BE studies from India if they follow required standards and GCP. The studies must comply with relevant guidelines as well as local regulations.
- Both the FDA and EMA give high priority to data integrity and quality. Both regulatory bodies may conduct inspections of the study sites and bioanalytical laboratories at any time.
- ANVISA, Brazil, recognizes BA/BE studies performed in India as well. Also requires the clinical sites and bioanalytical laboratories involved to be certified by the agency.
- To date, India’s BA/BE studies have been accepted by Health Canada and the Australian Therapeutic Goods Administration (TGA). Also, by regulatory authorities in emerging markets such as Latin America, the Middle East, and Africa.
- Similarly, BA/BE studies that meet the requirements as per the ASEAN Guideline for the Conduct of Bioequivalence Studies are acceptable in all ASEAN Member States
A summary of the details is presented in the table below for easy reference:
| Regulatory Authority | Acceptance | Requirements / Remarks |
|---|---|---|
| US FDA (United States) | Accepted | -Must meet US FDA regulatory and quality standards -Use of accredited CROs and centers. -GCP compliance required -Subject to FDA inspection |
| EMA (European Medicines Agency) | Accepted | -Must follow EMA guidelines and local Indian regulations -GCP compliance required -Focus on data quality and integrity -May inspect study sites and labs. |
| ANVISA (Brazil) | Accepted | -Clinical sites and labs must be certified by ANVISA |
| Health Canada | Accepted | -Must comply with Health Canada’s clinical trial standards and GCP |
| TGA (Australia) | Accepted | -Must meet Australian regulatory standards -GCP compliance required |
| ASEAN Member States | Accepted | -Must comply with ASEAN Guideline for the Conduct of Bioequivalence Studies |
| Emerging Markets (Latin America, Middle East, Africa) | Accepted | -Must follow EMA guidelines and local Indian regulations -GCP compliance required -Focus on data quality and integrity -May inspect study sites and labs |
India: A smart choice for BA/BE studies
In the last decade or so, India has been the fastest-growing economy in the world. This creates the perfect environment for holistic development across all sectors, including the development of the healthcare system. This, coupled with India’s large population, makes India conducive for high quality, cost-effective BA/BE studies with global acceptance standards. We will explore the key reasons that make India an ideal option for BA/BE studies.
- Expert clinical research organizations: India’s strong academic base and hardworking culture create a skilled workforce with deep expertise and hands-on experience. Many of these experts have extensive experience working with global regulatory frameworks, ensuring studies meet international requirements. Additionally, India’s expanding network of accredited laboratories equipped with advanced instrumentation such as LC-MS/MS and HPLC provides a significant advantage for conducting BA/BE studies.
- Substantial, diverse pool of subjects: India has a large population with a significant demographic spread. At a relatively lower average age. This gives the sponsors an opportunity to choose from a diverse pool of healthy or even special population subjects required for BA/BE studies.
- Cost effectiveness: The availability of efficient and cost-effective labour, logistics and other infrastructure, undoubtedly, makes India a good choice for cost-effective BA/BE studies.
- Robust healthcare system: The large and well-developed medical network supports advanced clinical research through a wide network of hospitals, research centers and skilled professionals in line with the regulatory framework in India.
- Robust regulatory authority: India’s regulatory authority, CDSCO, follows international standards like the US FDA and EMA for BA/BE studies and enforces strict GCP and GLP compliance. With approvals from major global regulators, India remains a top choice for BA/BE research. Next, let’s review the key criteria for regulatory acceptance.
Indian BA/BE studies: Critical criteria for regulatory acceptance
The national regulatory authority that handles the approval of BA/ BE studies in India is the Central Drugs Standard Control Organization (CDSCO). CDSCO mandates strict adherence to its guidelines, aligned with US FDA, EMA, and ICH standards. Compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP) is also mandatory.
Stakeholders must submit BA/BE study applications online via SUGAM. This platform manages approvals, licenses, and registrations. Additional criteria for acceptance include:
Sound Study design: The study must be designed considering the critical quality factors. Like randomization, adequate sample size, clear inclusion/ exclusion criteria, and relevant pharmacokinetic endpoints. The protocol should incorporate standardized procedures for drug administration, sampling time points, and bioanalytical method validation. To guarantee the reproducibility and validity of results.
Ethical Conduct of Study and Subject Safety: BA/ BE studies in India require Ethics Committee approval before initiation. Submit the Informed Consent Form (ICF) and Patient Information Sheet in regional languages and get approval before recruiting subjects. Conduct studies only at CDSCO-approved centers equipped with emergency facilities, controlled environments, and SOPs for crisis management. Document, manage, and report all AEs/SAEs to the Ethics Committee and CDSCO within stipulated timelines.
For more insights on the overview of BA/ BE studies in India, we invite you to explore another informative article on ‘Bioavailability (BA) & Bioequivalence (BE) Studies In India’
Conclusion
Today, India stands out in the domain of BA/ BE research for consistently delivering high-quality, cost-effective and internationally accredited studies. These studies are backed by a strong regulatory framework, advanced infrastructure, and a competent workforce. This makes the country a leading choice for research. India’s vast and diverse population further strengthens the studies by generating comprehensive and representative data.
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