Bioequivalence and Bioavailability Forum

Dear all,

I am having questions regarding bio-equivalence study requirements to get Marketing Authorization in India itself.

1. In India after introduction of new drug (D&C Act Rule 122E(a), definition of New drug) by innovator company within four years after this introduction, other companies have to conduct stability studies and carryout bio-equivalence study of these products, get approval from M/s Drug Control India and subsequently get manufacturing license by local state FDA before starting production and marketing.

After four years, this bio-equivalence study is not required. Is it true?

2. If it is true, how can therapeutic equivalence be assured without bio study?

3. What is bio study requirement for anti-cancer drugs which are four years older?

4. In India, There are so many small and medium sized pharmaceuticals manufacturing units across the country. Do they perform bio study for drugs (Four years older) which they manufacture? If no, what are others requirements/criteria to get approval for manufacturing and marketing?