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The Government of India continues its keen study on the merits of the use of fixed dose combinations (“FDCs”) in India. This is evident from certain recent developments that arise in this space and the analytical rigour that is being directed to the intended FDC ban and its scope.
As per the meeting minutes of the Drugs Technical Advisory Board (“DTAB”) held on April 2, 2019, the DTAB has constituted a sub-committee to evaluate the findings of the Kokate Committee Report (the genesis of all FDC ban attempts).
This sub-committee, based on the minutes, has been given the mandate to prepare a second assessment report which would then have to take decisions on the ban of an additional list of over 300 identified FDCs.
In the fulfilment of abovementioned role, the Drugs Controller General of India has issued a notice to manufacturers of FDCs dated May 29, 2019, calling on such manufacturers to provide details of the FDCs being manufactured by such manufacturers, as per a prescribed format. The deadline for this submission, as of now, is June 30, 2019.
While the level of rigour involved in this analysis is notable and there is a conspicuous attempt being made to better examine the medical benefits of FDCs, there are a few considerations that still abound, as a consequence of the manner in which this subcommittee has been constituted.
The obvious challenge that this delegation by the DTAB to the sub-committee creates is that the terms of reference for this subcommittee remain considerably limited, based on the specific wording as recorded in the DTAB minutes; this is especially telling when examined in light of the comprehensive litigation that the FDC ban has undergone in the Indian context. The terms of reference appear confined to an examination of the existing analysis available in the Kokate Committee report, without fully accounting for the history of litigation and concerns that have been raised by industry representatives from time to time. By virtue of the May 29 notice, there is an attempt to at least take on record further material and data, based on manufacturer inputs. However, what is crucial in this case is to consider how much new material can or ought to be included in the assessment by the sub-committee, as a consequence of this limited term of reference granted by the DTAB. Hence, the next question that arises here is the extent to which such new material may be used in the case of the study by the DTAB.
The crucial question that then comes up in this analysis is whether the information set out in any submissions provided by manufacturers would have any persuasive or useful value in the hands of the DTAB subcommittee, when the terms of reference of the sub-committee at best remain silent on the consideration of new material in this matter. The eventual point to then consider is whether any purpose would be served in even providing the required information based on the May 29 notice by the relevant manufacturers.
Furthermore, while framing these terms of reference, what seems to be somewhat absent is the considerations that have been raised by industry during the various proceedings in courts. Industry members have highlighted a range of concerns, including distribution, availability, and public confusion related issues in attempting to ban FDCs, as well as challenges in creating alternative mechanisms to ensure continued supply of medication to the public. The very process in which the original ban itself was sought to be implemented itself was fraught with questions, but this point isn’t germane to the specific issue at hand.
Linked to the above issue on non-consideration of industry concerns and in respect of the May 29 notice, the third consideration that arises here is whether the major legal challenges to the earlier attempted bans have would even been taken into account by the current subcommittee, in view of the queries that have been raised in the May 29 notice.
To illustrate this point further, the May 29 notice takes the same line of probing that has been assumed by the Kokate committee in the past, by simply considering marketing approvals of the said FDCs in other jurisdictions and therapeutic justifications. Not a question is raised in the May 29 notice on sales data of the FDCs, alternative formulations (in respect of identified indications) and relevant marketing material (which could be useful in understanding sales practices of the current FDCs and hence possibly minimizing supply disruption). In addition to the fundamental question on whether, and if so to what extent new material could be considered, whether there really is an appreciation of industry’s concerns in this matter remains at best, unanswered.
All of these considerations point to a fundamental question as to whether the eventual findings of the sub-committee, are likely to differ in stance from earlier assumed positions by the DTAB, and other government agencies; the ultimate question then that arises is whether this exercise of analyzing these newly identified FDCs is even going to offer a complete and realistic assessment of the future use of the listed FDCs in the Indian context.
The constitution of the committee, with the notable absence of industry representatives and going by the past record of its current members in their previous reviews of the FDC ban, create a looming question on whether the necessary “fresh pair of eyes” could be expected in the deliberations of this sub-committee.
Any ban that would emanate from any decision taken on the basis of such deliberations by this sub-committee already runs the risk of opening up further litigation by industry. This would only serve to create more uncertainty for the industry as a whole on the sale of FDCs in India.
Looking at global trends in the pharmaceutical industry and given the greater regulatory oversight, it is likely that greater scrutiny on the workings of the pharmaceutical industry and its practices are only going to continue.
Whatever the merits of such scrutiny may be, the question here remains as to whether the FDC ban that the government has envisioned and remains steadfast in seeing through, is likely to fully fructify.
Considering at the way in which this issue continues to be perceived and the seemingly set course in which our regulators remain keen on responding to this matter, the only likely outcome that seems on hand is greater uncertainty that the industry is likely to face on this issue, as a whole.
Krishna Venkat is a Corporate/M&A lawyer with 15 years of experience in handling cross border M&As for leading Indian conglomerates and foreign MNCs. He currently heads the FMCG, Pharmaceutical and healthcare vertical at Anoma Legal. He advises pharmaceutical and healthcare companies on a range of legal/regulatory issues that affect companies in these industries.
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