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The Union health ministry is all set to make submission of bioequivalence data mandatory prior to grant of licence for manufacturing of all drugs including those in the market. For this a Biopharmaceutics Classification System (BCS) is going to be worked out and adopted for all drugs soon.
BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
To begin with, conduct of bioequivalence study will be made mandatory only for drugs in category II and IV of the BCS system. For the drugs already being marketed in the country, three years’ time may be given for submission of BE study data. An amendment has been already made to the D&C Rules after the recommendations made by the Drug Technical Advisory Board in this regard a few weeks ago.
The DTAB had recommended constitution of an expert Group to lay down the modalities for identification of the reference drug for the conduct of BE studies. A draft notification related to this topic was already issued by the ministry a couple of months back for inputs from all the stakeholders. Industry sources, however, said that the final notification was subsequently issued without even considering the points raised by the industry bodies.
The DTAB also noted that for manufacture of drugs which are no more new drugs, that is, after completion of four years from the date of first approval, licenses to manufacture such drugs are currently issued by the concerned State Licensing Authorities. Drugs & Cosmetics Act and Rules thereunder do not require an applicant to submit BE data for drug formulations, to the State Licensing Authorities for grant of manufacturing Licence which are no longer considered as new drugs.
Now, this arrangement is going to change and it will be necessary for the pharma companies to submit data from BE study for grant of licence for manufacture of drugs which are no more new drugs in addition to other requirements.
Industry sources said that although the notification has been amended to include the condition for BE studies to be performed in accordance with Schedule Y of the D&C Act, the requirement of identifying the Reference Drug has not been included in the notification. The Schedule Y makes a reference to the BA/BE Guideline for the purpose of carrying out studies. This Guideline requires a Designated Reference Product to be notified for the purpose of establishing bioequivalence of the generic version of the product.
DTAB also requires the modalities to be laid down for identifying the Reference Drug. It is necessary to define the term ‘Bioequivalence’ in the notification by clearly stating the need to perform the study against a Reference Drug. Both these requirements seem to have been overlooked while issuing the notification. In the absence of these clarifications in the notification, the provisions of the revised Rules related to the performance of BE study would be difficult to implement, industry sources point out.
At present country does not have adequate number of reliable CROs and there is a need to improve quality of CROs and BA/BE centres to support the clinical studies related to new products. Bringing any additional regulation of BE studies at this stage for the existing products can thus delay the process of drug approval, delay launch of new products, increase cost of medicines and halt the growth of the domestic industry. Besides, many of the State Licensing Authorities are not technically geared to analyse and review the BE data when submitted for grant of manufacturing license. This calls for adequate capacity building of the SLAs has to be undertaken first before this notification is implemented, the sources said.
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