Bangladesh is one of the leading pharmaceutical products manufacturing countries for generic medicine. Almost 95-97% of medicine is manufactured locally and exported to more than 150 counties.
Bangladesh imports 97-98% of active pharmaceutical ingredients (API) from India and China mostly. Every year, Bangladesh imports around 700 million dollars of raw materials.
Foreign API manufacturers must have to register API with the local regulatory authority called the Director General of Drug Administration (DGDA) to export here. If they are not registered, local manufacturers can not import them.
Active Pharmaceutical Ingredient (API) registration and source validation are cornerstones of the pharmaceutical industry. They ensure the quality, safety, and efficacy of medicines, which are essential for public health. Without proper validation, substandard or fake drugs can harm lives and damage business trust.
In Bangladesh, where the pharmaceutical sector is a major growth driver, compliance with the most essential regulations is non-negotiable. This service also matters for international companies. Because it offers them a seamless way to enter the thriving Bangladeshi market by meeting local standards.
And this is where Ziva DRA plays an important role. Our team specializes in regulatory and compliance services tailored to this industry. And our expertise in API registration and source validation ensures smooth processes.
Understanding API Registration/Source Validation
What is API Registration/Source Validation?
API registration and source validation are crucial processes in the pharmaceutical industry. API registration involves documenting and approving the active ingredients used in medicines to ensure they meet regulatory standards.
Source validation, on the other hand, confirms that the supplier of these ingredients complies with quality and safety requirements. Together, they build a foundation of trust and reliability in pharmaceutical products.
In Bangladesh, the Directorate General of Drug Administration (DGDA) enforces strict regulations to maintain industry standards. These include detailed guidelines on API quality, manufacturing processes, and source certifications. Businesses must submit the necessary documents to receive approval.
Why is it Necessary?
It safeguards the quality, safety, and efficacy of medicines, protecting public health. Poorly validated APIs can result in ineffective or harmful drugs, which is a risk no company can afford. Moreover, compliance with both national and international standards is vital for businesses aiming to operate in Bangladesh or export to other countries.
By ensuring regulatory compliance, API registration and source validation help companies avoid legal issues, enhance credibility, and meet the growing demand for high-quality pharmaceutical products. This process is vital for sustainable business growth.
Who Needs API Registration/Source Validation?
Active Pharmaceutical Ingredient (API) registration and source validation are essential for several groups within the pharmaceutical industry. Each of them relies on this process to ensure compliance, build trust, and grow their business.
Local Pharmaceutical Companies
Bangladeshi pharmaceutical companies must validate their API sources to meet regulatory requirements. This ensures their products are safe, effective, and approved for the local market.
International Companies
Firms exporting APIs to Bangladesh or setting up local operations need this service to comply with the Directorate General of Drug Administration (DGDA) standards. Proper validation makes the journey for market entry smoother and secures long-term success.
Contract Manufacturers
Manufacturers producing medicines on behalf of other companies must verify that their APIs meet quality and safety standards. This is critical for maintaining their reputation and fulfilling client requirements.
Third-Party Suppliers
Suppliers providing APIs to pharmaceutical companies need validation to prove that their products comply with regulatory guidelines. Without it, they risk losing clients and facing legal challenges.
The Process of API Registration/Source Validation
Navigating the API registration and source validation process in Bangladesh involves several key steps:
Step 1: Identifying the Source of APIs
The process begins by selecting reputable manufacturers or suppliers for your Active Pharmaceutical Ingredients (APIs). Make sure they comply with Good Manufacturing Practices (GMP) and possess the necessary certifications.
Step 2: Preparing Documentation and Dossier Submission
Prepare the required documents and attested from Bangladesh embassy or notarized from your advocate.
Step 3: Compliance with DGDA Requirements
Submit the prepared dossier to the DGDA through a local representative or indenting firm. The DGDA will review the application to make sure all regulatory standards are met.
Step 4: Product Testing, Inspection, and Approval
The DGDA may conduct inspections or request samples for testing to verify the quality and safety of the APIs. Upon satisfactory evaluation, they will grant approval for the API source.
Step 5: Timeline and Costs Associated with the Process
The DGDA aims to complete source validation within three months after receiving a complete application. If any documents are missing, a deficiency letter will be issued within seven working days.
Note: Source validation for up to ten items can be accomplished in a single application, with no limit for previously validated organizations or suppliers. And the validity of the source validation certificate is three years.
Benefits of API Source Validation for Businesses
API source validation is more than a regulatory requirement. It is a strategic step for ensuring success and sustainability in the pharmaceutical industry. Here’s how it benefits your business:
Quality Assurance
Validated API sources guarantee high-quality raw materials. This ensures that the medicines you produce are safe, effective, and consistent. It reduces the risks of faulty batches, recalls, or negative customer experiences, ultimately protecting your brand reputation.
Risk Mitigation
By thoroughly validating API sources, businesses can avoid risks like contamination, inconsistent quality, or supply chain disruptions. A reliable API source minimizes these issues, it saves you from costly setbacks, and maintains operational continuity.
Enhanced Credibility
When your APIs come from validated and trusted sources, it reflects your company’s commitment to quality and compliance. This credibility helps you stand out in a competitive market and strengthens relationships with clients, regulators, and partners.
Compliance with Regulatory Bodies
Regulatory compliance is critical for staying in business. API validation ensures your operations meet the stringent guidelines of the DGDA and other global standards. Thus, it helps you avoid penalties or delays.
Smooth Market Entry
For international businesses, validated APIs simplify the process of entering Bangladesh’s market. It builds trust with local regulators, fast-tracks approvals, and makes launching your products smoother.
Sustainable Business Operations
A validated API source supports long-term growth by creating a solid foundation. It allows for efficient production processes, reduces risks, and ensures compliance, to make your operations more reliable and profitable.
Building Trust with Consumers and Stakeholders
Consumers and stakeholders value transparency and safety. Using validated APIs reassures them of your commitment to delivering safe and effective medicines. This way, your company earns loyalty and confidence in your brand.
Required Documents for API Source Validation in Bangladesh:
The registration process is not very complicated compared with other counties. To register or source validation of API in DGDA, below documents are required-
1. Letter of Authorization (Attested by Bangladesh embassy/Chamber of Commerce)
2. Principal company profile (Attested by Bangladesh embassy/Chamber of Commerce)
3. Principal company manufacturing license (Attested by Bangladesh embassy/Chamber of Commerce)
4. Registered office address of the Manufacturer & the factory address (Attested by Bangladesh embassy/Chamber of Commerce)
5. GMP Certificate (Attested by Bangladesh embassy/Chamber of Commerce)
6. List of Countries where the API is being exported (Attested by Bangladesh embassy/Chamber of Commerce)
7. Certificate of Analysis (COA) with Specification of the API/RM (Attested by Bangladesh embassy/Chamber of Commerce)
8. Product list of the manufacturer (Attested by Bangladesh embassy/Chamber of Commerce)
9. Form-9 (mentioning the product name) – Signed by the manufacturer
Validity of Source validation certificate: 3 years
After 3 years, the renewal process are same, and the required documents are the same.
How Ziva DRA Helps with API Registration/Source Validation
Our tailored services make the API registration and source validation process seamless and stress-free. It also makes sure your business complies with all necessary regulations in the following ways.
Regulatory and Compliance Support
We provide comprehensive regulatory guidance to ensure your APIs meet the stringent standards set by the Directorate General of Drug Administration (DGDA). Our team helps you stay updated with the latest compliance requirements, minimizing risks and delays.
Documentation Preparation and Submission
Preparing and submitting accurate documents is critical for successful API validation. Our Ziva DRA team assists with every detail, from compiling dossiers to verifying essential certificates like GMP, COA, and manufacturing licenses. We always ensure your submission is error-free and complete.
Coordinating with DGDA and Authorities
Of course, dealing with regulatory bodies can be challenging. However, our professional team acts as a bridge between your business and the DGDA. It helps with smooth communication and quick resolution of any queries or issues during the application process.
Assistance in Product Testing and Certification
We also guide you through product testing requirements to ensure compliance with safety and quality standards. From coordinating laboratory tests to obtaining the necessary certifications, we simplify each step for you.
Why Clients Choose Us
Here’s why businesses trust us for API registration and source validation:
- Client-Centric Focus: We prioritize your needs, offering tailored solutions that align with your business goals. Because your success is our priority.
- Experienced Professionals: Our team comprises skilled experts with years of experience in regulatory and compliance services. We bring unmatched knowledge and precision to every project.
- 24×7 Live Support: We are always available to assist you. With round-the-clock support, you can rely on us to address your concerns anytime.
- Right Time Delivery: Ziva DRA values your time. Our efficient workflows ensure the timely delivery of services. It also helps you meet deadlines and stay ahead in the competitive market.
- Cost-Effective Solutions: Quality does not have to be expensive. We provide affordable services without compromising on standards. It makes regulatory compliance accessible for businesses of all sizes.
Let Ziva DRA Simplify Your API Validation
API registration and source validation are critical for ensuring quality, safety, and compliance in the pharmaceutical industry. These are the foundations of trust and success.
That’s why, at Ziva DRA, we make this complex process smoother. With our experience, client-first approach, and reliable support, we’re the perfect partner for businesses navigating regulatory requirements in Bangladesh.
Get in touch with Ziva DRA today! And let us take care of the complexities for you!
Frequently Asked Questions
Q. How long does the API/Source Validation process take?
Ans: The process typically takes about three months once all required documents are submitted. If any documents are missing, the DGDA issues a deficiency letter within seven working days to address the gaps promptly.
Q. What is the validity of API certification?
Ans: The API source validation certificate remains valid for three years, starting from the issued date. After that, it needs to be renewed to ensure compliance with current regulations.
Q. Can I be involved in the registration process?
Ans: Absolutely! While we handle the technical and regulatory aspects, we keep you informed at every step. Your input and collaboration are valuable, and we ensure transparency throughout the process.
Q. What if I am not satisfied with the result or the request gets rejected?
Ans: In the rare event of dissatisfaction or rejection, we work with you to identify and address the issues. Our team can resubmit applications, correct deficiencies, and take proactive steps to achieve the desired outcome.
If you have any queries about registering your API, feel free to contact us at polash_saiful@yahoo.com