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  • a review on drug approval process for us, europe and india …

    This article focuses on drug approval process in different countries like USA, Europe and India. Keywords: MAA, USFDA, Drug approval, Clinical trial.

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    The new drug approval is of two phase process – the first phase for clinical trials and second phase for marketing authorization of drug. Firstly, non-clinical …

    The regulatory scenario in India is changing very fast and DCGI is coming up with precise guideline on each topic. The documentation for product registration in India has become at par with US FDA and seems to objective of DCGI so that data generated in India is acceptable globally. Ever-changing laws and regulations are driving demand for regulatory affairs professionals to cater the current needs of industries for the global competition and who can help pharmaceutical companies to effectively bring their medical products to the Indian market. In today’s competitive scenario, the reduction of the time taken to launch the product is imperative and hence vital for company’s success.  This post will be helpful to all pharma manufacturer/importer, regulatory, preclinical, formulation scientists, and clinical trial professional who are involved directly or indirectly in new drug registration process. The post covers new drug including fixed-dose combination in India and import & registration by foreign manufacturer. Need integrated knowledge and broad perspectives which you need to effectively manage the regulatory process for approval of new drugs in India.

    key points

    1. Regulatory Overview in India
    2. Regulatory Dossier
    3. Chemical, Pharmaceutical Information and Animal Studies data
    4. Clinical Trial Requirement and Documentation
    5. New Drug Application: IND developed in India
    6. New Drug Application: Marketed in other countries, not approved in India
    7. New Drug Application: New Indication, Dosage form or route of administration
    8. New Drug Application: Fixed dose combination of two or more drugs
    9. New Drug Application: Approved in India within four year and PSUR
    10. Import and Registration

Approval of New Drug in India (7-10): When a company in India wants to manufacture/import a new drug it has to apply to seek permission from the licensing authority (DCGI) by filing in Form 44 also submitting the data as given in Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945. In order to prove its efficacy and safety in Indian population it has to conduct clinical trials in accordance with the guidelines specified in Schedule Y and submit the report of such clinical trials in specified format.

But a provision is there in Rule – 122A of Drugs and Cosmetics Act 1940 and Rules 1945 that the licensing authority may waive certain trails if he considers that in the interest of public health he may grant permission for import of new drugs basing on the data of the trials done in other countries. Similarly there is another provision in Rule – 122A which says Section 2.4 (a) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 says for those drug substances which are discovered in India all phases of clinical trials are required. Section 2.4 (b) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 says that for those drug substances which are discovered in countries other than India; the applicant should submit the data available from other countries and the licensing authority may require him to repeat all the studies or permit him to proceed from Phase III clinical trials. Section 2.8 of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 says that the licensing authority may require pharmacokinetic studies (Bioequivalence studies) first to show that the data generated in Indian population is equal to data generated that the clinical trials may be waived in the case of new drugs which are approved and being used for several years in other countries. abroad and then require him to proceed with Phase III trials.

In summary, the exact requirements of Clinical trials may change from case to case and depend on the extent to which licensing authority is satisfied about its safety and efficacy.

The process of approval of new drug in India is a very complicated process, which should meet necessary requirements along with NDA to FDA. The need of the present work is to study and document the requirements for the process of approval of new drug in India with emphasis on clinical trials as per Drugs Control department, Government of India.

New Drug Application NDA is an application submitted to the FDA for permission to market a new drug. To obtain this permission a sponsor submits preclinical and clinical test data to NDA for analyzing the drug information, description of manufacturing procedures. After NDA received by the agency, it undergoes a technical screening. This evaluation ensures that sufficient data and information have been submitted in each area to justify “filing” the application that is FDA formal review. At the conclusion of FDA review of an NDA, there are 3 possible actions that can send to sponsor:

Not approvable- In this letter list of deficiencies and explain the reason. Approvable – It means that the drug can be approved but minor deficiencies that can be corrected like-labeling changes and possible request commitment to do post-approval studies. Approval- It state that the drug is approved. If the action taken is either an approvable or a not approvable, then FDA provides applicant with an opportunity to meet with agency and discuss the deficiencies.







The Drug approvals in the US, Europe & India are the most demanding in the world. The primary purpose of the rules governing medicinal products in US, Europe & India is to safeguard public health. It is the role of public regulatory authorities to ensure that pharmaceutical companies comply with regulations. There are legislations that require drugs to be developed, tested, trailed, and manufactured in accordance to the guidelines so that they are safe and patient’s well – being is protected.






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