The Drugs Technical Advisory Board (DTAB) has reportedly appointed an expert committee under Ms Nilima Shirsagar, retired dean of Mumbai’s KEM Hospital to review the safety, efficacy and therapeutic justification of several fixed dose combinations (FDCs). Presently, it is unclear as to what would be the constitution of the said committee, and as to what would be the modus-operandi adopted by the said committee in reviewing these FDCs.
On 10 March 2016, the Central Government has issued 344 identically worded notifications (Notifications) prohibiting the manufacture, sale, and distribution of 344 fixed dose combinations. The Notifications purported to ban the FDCs in question, because they posed substantial risks to human life, and on ground that safer alternatives were available. The Notifications were purported to be based on the findings and recommendations of an expert committee (the Kokate Committee) appointed by the Central Government, which stated that the FDCs in question were found to have no 'therapeutic justification'. The Notifications were issued by the Central Government in exercise of its powers under Section 26A of the Drugs and Cosmetics Act, 1940 (Drugs Act). Five similar notifications were issued on 8 June 2017, whereby five FDCs were banned.
Judgement of the Delhi High Court
The Delhi High Court judgment set aside the Notifications issued by the Central Government. Although several issues were raised, the Delhi High Court set aside the notifications on only one moot point, i.e., the Notifications have been issued by the Central Government without consulting the DTAB and Drugs Consultative Committee (DCC), which were statutory bodies created under the Drugs Act, despite the Drugs Act mandated consultation. It is relevant to note that during the pendency of the petitions challenging the Notifications, vide its interim orders, the Delhi High Court has stayed the operation of the Notifications.
Challenge before the Supreme Court
On 15 December 2017, the Hon’ble Supreme Court pronounced its judgment in the FDC ban matters pursuant to an appeal filed by the Central Government against the judgment of the Hon’ble Delhi High Court dated 01 December 2016. The Hon’ble Supreme Court held that, Section 26A of the Drugs Act does not necessarily mandate any previous consultation with the DTAB. Thus, ‘so long as the Central Government’s satisfaction can be said to be based on relevant material, it is not possible to say that not having consulted the DTAB, the power exercised under the said Section would be non est.’ Further, the civil appeal filed by the Central Government was disposed off in the following terms:
1. FDCs manufactured pre 21 September 1988
For certain FDCs that were manufactured pre 21 September 1988, the respective Notifications (1st March 2016) were set aside, as those cases were never meant to be referred to the Kokate Committee.
2. FDCs which were post 21 September 1988, but were approved by DCG(I)
The Supreme Court directed that all the FDCs that would fall under this category should be sent for re-examination to the DTAB.
3. FDCs manufactured post 1988 and not approved by DCG(I)
The Hon’ble Court proceeded to refer these FDCs to DTAB, so that it can examine each of these cases afresh, and ultimately send a report to the Central Government.
Mandate of the Committee appointed by DTAB
The Hon’ble Supreme Court proceeded to lay down the parameters that are required to be met by DTAB, and/or a Sub-Committee formed by the DTAB, when it re-examines the FDCs and sends its report to the Central Government. Firstly, as per the directions of the Supreme Court, the DTAB/Sub-Committee appointed is to hear not only the pharmaceutical companies before the Supreme Court, but also the All India Drugs Action Network (an association which strongly supported the judgement of the Delhi High Court and alleged severe irregularities in grant of licenses for manufacture/distribution/sale of these FDCs). The Supreme Court further directed that the DTAB/Sub-Committee would first satisfy itself that the FDC in question was likely to involve any one of the ingredients specified in Section 26A, i.e., (a) that the FDC was likely to involve any risk to human beings or animals; or (b) that the said FDC did not have the therapeutic value claimed or purported to be claimed for them; or (c) that such FDC contains ingredients in such quantity for which there is no therapeutic justification. Additionally, the Supreme Court directed that the DTAB/Sub-Committee would also apply its mind as to whether it is necessary or expedient, in the larger public interest, to regulate, restrict, or prohibit the manufacture, sale, or distribution of such FDCs. In doing so, the DTAB/Sub-Committee was mandated to clearly indicate in its report as to (i) why, according to it, any one of the three factors indicated above is attracted; (ii) post such satisfaction, that in the larger public interest, it is necessary or expedient to (a) regulate, (b) restrict, or (c) prohibit the manufacture, sale or distribution of such FDCs. The DTAB/Sub-Committee was also directed to indicate in its report as to why, in case it prohibits a particular FDC, restriction or regulation is not sufficient to control the manufacture and use of the FDC. Lastly, the Supreme Court directed DTAB to afford a hearing to all concerned, and complete the entire exercise of sending a consolidated report within a period of six months from the date on which the judgment was received by the DTAB.
The constitution of the Sub-Committee by DTAB has been a much-awaited development since the pronouncement of the judgement of the Supreme Court. Needless to say, in so far as merits of the FDCs is concerned, courts are unlikely to interfere with the findings of the DTAB/Sub-Committee (as may be adopted by the Central Government), particularly in exercise of their writ jurisdiction. However, with such detailed and exhaustive parameters being set out by the Supreme Court on the mandate, procedure and functioning of the DTAB/Sub-Committee, the slightest omission or variance from the directions of the Supreme Court could result in litigation with pharmaceutical companies challenging the decision taken by the DTAB/Sub-Committee citing non-compliance of the decision of the Supreme Court.