BE NOC for Export (Bioequivalence NOC for Drugs)

BE NOC for Export (Bioequivalence NOC for Drugs)

BE NOC for Export (Bioequivalence NOC for Drugs)

Bioequivalence is a term in pharmacokinetics which is used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.

Bioequivalence studies are conducted to compare two medicinal products containing the same active substance. The studies should provide an objective means of critically assessing the possibility of alternative use of them. Two products marketed by different licensees, containing same active ingredient(s), must be shown to be therapeutically equivalent to one another in order to be considered interchangeable. Several test methods are available to assess equivalence, including:

• Comparative bioavailability (bioequivalence) studies, in which the active drug substance or one or more metabolites is measured in an accessible biological fluid such as plasma, blood or urine
• Comparative pharmacodynamic studies in humans
• Comparative clinical trials
• In-vitro dissolution tests

In India the office of Drugs Controller General (India) at CDSCO (HQ) FDA Bhavan, New Delhi has been reviewing applications on behalf of Pharmaceutical companies, both Manufacturers and Importers as well as CRO’s, requesting for the approval to carry out BE studies with various pharmaceutical dosage formulations on Indian subjects. The office of DCG(I) would like to ensure the demonstration of the safety and efficacy of generics against corresponding innovator drugs; to ensure they are comparable and safe for consumption by human subjects.

In view of the above, the office of DCGI would like to ensure the uniformity of documents to be submitted to the Directorate for review and approval of BE-NOC’s to meet tenets of Drugs and Cosmetics Act 1940 & Rules made thereunder and also Indian Good Clinical Practices (GCP).

All BE-NOC applications should be submitted to DCGI as per following Categories:

1. A new molecule not approved in India but approved by other countries
2. New drugs approved in India within period of one year
3. New Drugs approved within period of more than 1 year & less than 4 years.
4. BE NOC for all the drug products in modified release form irrespective of their approval status
5. For old drugs application to be submitted at Zonal FDA