Jitendar Chauhan / 28th April, 2023

API Registrations of Drugs In India

Regulation/Guidelines

Drug,

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Summary:

Central Drugs Standard Control Organization (CDSCO) is the regulatory body of India regulating medical devices, drugs, and cosmetics in the Indian market. The CDSCO regulates the manufacturing and import of these products to ensure that the products are safe and effective to use and do not cause any harm to the intended population. Central Drugs Standard Control Organization (CDSCO) is headed by the Drugs Controller General of India (DCGI). CDSCO regulates the manufacturing and import of API drugs in India. So, if any manufacturer or importer plans to work with API drugs, they must understand the rules and regulations they must follow. Drug and Cosmetic Act 1940 and Rules 1945 and New Drugs and Clinical Trials Rule, 2019 are the primary foundation for API drug manufacturing and import in India.

Active pharmaceutical ingredient (API) is defined as the component of a drug that is active biologically and is present in the tablet, injection, capsule, or cream and produces the intended health effect. It is used to manufacture drugs and, when manufactured, becomes an active ingredient. Majorly API is used as an active ingredient in high-quality drug formulations to treat diseases under the categories such as oncology, cardiology, pulmonology, gastroenterology, nephrology, ophthalmology, and endocrinology. To manufacture or import an API in India, one must get a license from DGCI. In the case of a foreign manufacturer, one must have an Indian agent appointed through Power of attorney (POA) in India. The CDSCO keeps updating the list of APIs so that it becomes easy for manufacturers or importers to classify if their drugs fall under the category of API. For any new drug which is yet to be introduced in the country, the manufacturer or importer shall conduct the clinical trials, collect the sample data and get the approval as per the process given in New Drugs and Clinical Trials Rule, 2019. Given below are the following rules which are mandatory for the API manufacturer or importer given under the Drugs and Cosmetics Act 1940 and Rules 1945 and New Drugs and Clinical Trials Rule, 2019:

S. No.	Rule Number	Description
1	Rule 76 of NDCT 2019	Import permission for New Drugs
2	Rule 80 of NDCT 2019	Manufacturing Permission for New Drugs
3	Rule 2 (j) of NDCT 2019	Definition of Clinical Trials
4	Rule 2 (w) of NDCT 2019	Definition of Drugs

Any new drug must undergo clinical trial testing to ensure that drugs are safe and will not cause harm or adverse reaction to the intended population. The phases of a clinical trial are given below:

Pre-Clinical Study
Phase I – Human Pharmacological Trail
Phase II – Exploratory Trail
Phase III – Confirmatory Trail
Phase IV – Post-Marketing Trail

Forms required for API/Bulk drug manufacturing and import:

Forms	Application/Approval	Description
Form CT-10	Application	Application for permission to manufacture of new drug or investigational new drug for clinical trial or bioavailability and bioequivalence study or for examination, test and analysis
Form CT-11	Permission	Permission to manufacture new drugs or investigational new drugs for clinical trial or bioavailability or bioequivalence study, or for examination, test and analysis
Form CT-12	Application	Application for permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability and bioequivalence study
Form CT-13	Application	Application for permission to manufacture unapproved active pharmaceutical ingredient for development of pharmaceutical formulation for test or analysis or clinical trial or bioavailability and bioequivalence study
Form CT-14	Permission	Grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability and bioequivalence study
Form CT-15	Permission	Grant of permission to manufacture unapproved active pharmaceutical ingredient for development of pharmaceutical formulation for test or analysis or clinical trial or bioavailability and bioequivalence study
Form CT-16	Application	Application for import of new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis
Form CT-17	Permission	Grant of licence for import of new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis.
Form CT-18/CT-21:	Application	Application for permission to import/manufacturer new drug for sale or distribution
Form CT-19:	Permission	Grant of permission for import of new drugs for sale or distribution
Form CT-22:	Permission	Manufacturing raw material (new bulk drug substance)
Form 40	Application	Application for issue of Registration Certificate for import of drugs into India under the Drugs and Cosmetics Rules 1945
Form 41	Permission	Registration Certificate to be issued for import of drugs into India under Drugs and Cosmetics Rules, 1945
Form 8	Application	Application for license to import drugs
Form 10	Permission	License to import the drugs

Conclusion: A drug’s safety and efficacy depend on its API quality. An API manufactured poorly or unsafe can cause harmful consequences such as infection, death, or adverse reaction. That’s why it is essential to regulate the API, and one must adhere to the regulations if planning to manufacture or import the API.