Ministry of health and family welfare has officially included the biopharmaceutical classification system (BCS) in the Drugs & Cosmetics Rules. The final notification was issued on April 4, 2017. The new guidance mandates that the bioequivalence (BE) study will be needed for approval of oral dosage forms of BCS Class II and IV drugs. There will no need for BE study needed for BCS class I and III drugs.
According to the MoHFW communication, these rules may be called Drugs and Cosmetics (Ninth Amendment) Rules, 2017. It is included in Rule 2, after clause inserted as (a). It will read as “BCS which means a system used to classify drugs on the basis of solubility and permeability, classified as category I- high solubility and high permeability, category II- low solubility and high permeability, category III- high solubility and low permeability, and category IV- low solubility and low permeability.”
Under Rule 74, after clause (p), the there will also be an addition as “(q). This will mention that the applicant will need to submit the result of bioequivalence study referred to in Schedule Y, 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.”
In the Rule 74B, after clause (7), will have an insertion as “(8) the applicant would need to submit the result of bioequivalence study referred to in Schedule Y, 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.”
Under Rule 76, after clause (9), will have an addition as “(10) asking the applicant to submit the result of bioequivalence study referred to in Schedule Y, 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.”
Further under Rule 78, after clause (q), it mentions “(r) the applicant shall submit the result of bioequivalence study referred to in Schedule Y, 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.”
Similarly in Rule 78A, after clause (8), the insertion will be “(9) the applicant shall submit the result of bioequivalence study referred to in Schedule Y, 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.
The industry observers view the new guidance as much wanted as these standards will facilitate rapid development of dissolution methodology and related specifications for these classes during drug development and application review.