Based on the recommendations made by the industry and Union commerce ministry, Union health ministry may soon exempt bioavailability (BA)/bioequivalence (BE) studies for drugs manufactured solely for export purpose.
BA/BE studies are needed by regulations to guarantee remedial proportionality between a pharmaceutically comparable test item and a reference item.
The recommendations come close on the heels of representations made by the union commerce ministry and pharma industry which suggested exemption of BA/BE studies data for the drugs manufactured for export purpose as the manufacturers comply with the regulations of the importing countries.
Some countries may not require BA/BE study, while some others may require BA/BE study of specific design as per their BA/BE guidelines. Therefore, it would be appropriate to provide exemption of the BA/BE study for manufacture of drugs solely meant for export, it was recommended.
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Based on the recommendations, Drugs Technical Advisory Board (DTAB) deliberated the proposal and further recommended for amendment of Rule 74, 74B, 76, 78, 78A and 84 of the Drugs and Cosmetics (D&C) Rules, 1945 to provide exemption of BA/BE studies for the drugs manufactured solely for export purpose.
The D&C Rules, 1945 were amended vide G.S.R 327(E) dated April 3, 2017, providing that the applicant shall submit the result of BE study, along with the application for grant of a licence of oral dosage form of drugs specified under Category II and Category IV of the biopharmaceutical classification system.
To download the notification G.S.R 327(E) dated April 3, 2017, click here
As per Rule 84 of the D&C Rules, the provisions shall apply to the manufacture of drugs for sale notwithstanding that such drugs are manufactured for sale outside India. However, for export of any drug to any country, the manufacturer is required to meet the requirements of the importing country.