Gaining FDA approval for a new drug is a significant obligation for pharmaceutical companies, particularly Indian companies wishing to penetrate the very profitable U.S. market.
The U.S. Food and Drug Administration (FDA) ensures that drugs produced in the U.S. are not only safe and effective but also manufactured according to the highest standards. For Indian companies, these turn out to be complex processes involving more than one stage within documentation, and compliance with very stringent regulations.
This blog will discuss key steps that must be followed in terms of applying for US FDA certification in India.
Steps to Get FDA Approval for New Drug
Whenever a pharmaceutical company develops a new medicine, the drug passes through a series of steps involved in obtaining FDA approval, carefully following which every step tests safety and efficacy of the drugs.
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Conduct Preclinical Studies
Pharmaceutical companies will be involved in laboratory and animal testing before testing drugs on humans. The aim of preclinical studies is to ascertain the safety and effects that the drug will have. Data collected in this phase become very important in applying for the next phase. The process usually lasts between 1 and 2 years.
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Submit Investigational New Drug Application (IND)
The next step after completion of preclinical data is IND application to the FDA. The application has a series of mandatory forms such as Form FDA 1571 (cover sheet) and Form FDA 1572 (investigator details). The application is subject to review by the FDA to ensure safety and feasibility. The review period is approximately 30 days, and if the FDA does not object, the company may proceed with clinical trials.
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Carry out Clinical Trials (Phases 1-3)
These clinical trials have three phases.
- Phase 1 involves administering the drug to small groups of healthy volunteers with the aim of letting them experience the drug’s effectiveness, safety, and potential side effects.
- The drug is then tested on a larger group of individuals for about 100-300 patients in Phase 2.
- Phase 3 involves a substantially larger group (1,000 or more patients) to confirm safety and effectiveness in relation to the existing treatments.
This whole clinical trial process stretches across 3-5 years, where each phase must successfully pass completion before moving to the next phase.
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New Drug Application (NDA)
After the completion of all clinical trials, the applicant submits a New Drug Application (NDA) before the FDA. The NDA contains numerous reports and details from clinical studies and information about manufacturing and proposed labeling for the drug. This is deemed a submission to the FDA for review, which usually takes about six to ten months for approval. In case of any queries or requirement of unforeseen data from the FDA, this period usually gets extended.
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Obtain FDA Approval
When the FDA is fully satisfied with the safety and efficacy of the drug as well as its overall quality in reviewing the NDA, approval is given to the drug such that it may be marketed in the United States. It takes many months after submission of the NDA because the complexity of the review varies.
Conclusion
Getting FDA approval for a new drug is a time-consuming project that has several phases-several preclinical studies and clinical trials and, ultimately, NDA submission. On an average, the total duration of this chain is eight to ten years.
Ensuring that manufacturing facilities meet these necessary manufacturing standards for US FDA Certification in India is also a crucial facet of this pathway. To streamline this process and secure US FDA Certification efficiently, consider partnering with E-Startup India for expert guidance and support.
If you want any other guidance relating to the US FDA Certification, please feel free to talk to our business advisors at 8881-069-069.
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