The Central Government, has recently, in exercise of its powers under Section 26-A of the Drugs and Cosmetics Act, 1940 ("the Drugs Act"), vide various notifications ("Notifications"), prohibited the manufacture of 14 Fixed Dose Combinations (FDCs) drugs for sale, sale or distribution for human use. These were approved for use prior to 21.09.1988 ("Pre-1988 FDCs")1. Pertinently, the Notifications are justified by the Centre on the basis of an Expert Committee recommendation that "there is no therapeutic justification for these the ingredients contained in these FDCs and the same could involve risk to human beings".
2. The date-21.09.1988, becomes relevant because Rules 122A, 122B, 122D, 122E and Schedule Y prescribing the guidelines for import and manufacture of new drugs including FDCs were first introduced in the Drugs and Cosmetics Rules, 1945 vide GSR No. 944E dated 21.09.1988.
3. The Notifications come as a new twist in a saga which dates back over a decade but is still marred with the same innate flaws as before. In May 2012, the 59th Report of the Parliamentary Standing Committee on Health and Family Welfare, examined the issue regarding the prevalence of FDCs not being tested for efficacy and observed that some of the State Licensing Authorities had been issuing manufacturing licenses for a large number of FDCs without prior clearance from Central Drugs Standard Control Organization ("CDSCO"). Pursuant to the Standing Committee's report, Drug Controller General of India ("DCG(I)") requested all States / Union Territories' Drug Controllers to direct the concerned manufacturers in their respective jurisdictions to prove the safety and efficacy of such FDC licenses issued prior to 01.10.2012, within a period of 18 months, failing which their manufacturing and marketing would be prohibited.
4. Due to a large number of such applications, the Ministry of Health and Family Welfare ("Ministry") constituted a dedicated committee ("Kokate Committee") under the Chairmanship of Professor C.K. Kokate for examining the safety and efficacy of such FDCs. In the terms of reference made to the Kokate Committee, Pre-1988 FDCs were not expressly included.
5. The first assessment report of the Kokate Committee was submitted to the Ministry on 19.01.2015. In the said report, Pre-1988 FDCs were conspicuously not discussed. The first assessment report considered multiple FDCs as irrational, and subsequent to this a detailed report dated 16.04.2015 was submitted by the Kokate Committee to the Ministry. The said report along with subsequent final recommendations dated 10.02.2016, considered 344 FDCs as irrational. Within the 344 FDCs considered as irrational, 15 Pre-1988 FDCs were also included.
6. Therefore, vide notifications dated 10.03.2016 issued under Section 26-A of the Drugs Act, the Centre banned the 344 FDCs. After protracted litigation, the challenge to the above ban on FDCs landed before the Hon'ble Supreme Court in the case of Union of India & Anr. v. Pfizer Limited & Ors2 ("Pfizer"). The central issue in the said case was whether for exercising the power under Section 26-A3 of the Drugs Act, the Centre was to mandatorily consult the Drugs Technical Advisory Board ("DTAB") set up under Section 5.
7. Answering against the proposition, the Hon'ble Supreme Court inter alia held that:
- Section 26-A is an additional power governed by its own terms.
- Section 26-A when read with other provisions of the Drugs Act, makes it clear that there is no explicit requirement to indulge in prior consultation with the DTAB.
- Section 26-A does not mandate any previous consultation with the DTAB. So long as the Centre's satisfaction can be said to be based on relevant material, non-consultation with DTAB cannot be said to make exercise of power under Section 26-A non-est.
8. However, in holding the above, in the facts and circumstances of the case, the Hon'ble Supreme Court directed as follows:
- An analysis be made in greater depth by the DTAB and/or the sub-committee formed by the DTAB for having a relook into the banned FDCs by hearing the aggrieved manufacturers. The Centre must give due regard to the report of the DTAB and any other relevant information and ultimately apply its mind to the parameters contained in Section 26-A of the Drugs Act to either maintain the notifications already issued or modify them.
- For the 15 Pre-1988 FDCs, the notifications banning them be set aside as the said cases were never meant to be referred to the Kokate Committee. However, the Centre would be at liberty to carry out a fresh inquiry as to whether such FDCs should be subject matter of a notification under Section 26-A of the Drugs Act or not.
9. In terms of the decision in Pfizer, on 19.02.2018, the Centre constituted a sub-committee ("Kshirsagar Committee") under the chairpersonship of Dr. Nilima Kshirsagar to relook into the banning of 344 FDCs which yet again included the 15 Pre-1988 FDCs. In the 79th DTAB meeting held on 16.05.2018, the DTAB deliberated upon a request from Abbott Health Care Pvt. Ltd. to exclude the 15 Pre-1988 FDCs from Kshirsagar Committee's inquiry. However, the DTAB dismissed this request and decided that the Kshirsagar Committee shall submit the report on the Pre-1988 FDCs as well.
10. Since the Pre-1988 FDCs report by Kshirsagar Committee was only a relook and in fact, not a fresh inquiry as directed by the Hon'ble Supreme Court in Pfizer, the issue again reached the Hon'ble Supreme Court. Through its judgement dated 07.09.2018,4 the Hon'ble Supreme Court directed the the Centre to act upon Kshirsagar Committee's Report save the 15 Pre-1988 FDCs.
11. Meanwhile, the Centre banned a few other Pre-1988 FDCs which were outside the ambit of the Kshirsagar Committee's Report, by its notifications dated 07.09.2018 issued under Section 26-A of the Drugs Act. Through an interim order dated 09.20185, the Hon'ble Supreme Court stayed the said fresh ban on Pre-1988 FDCs. By a final order in the said matter dated 14.02.20196, the Hon'ble Supreme Court also clarified that FDCs pertaining to Paracetamol + Propyphenazone + Caffeine/Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol/ Salbutamol+ Hydroxyethyltheophylline (Etofylline) + Bromhexine/ Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate, would be at par with the list of 15 Pre-1988 FDCs covered in Pfizer and therefore the Centre can initiate a fresh inquiry against the said FDCs also.
12. In this view thereof, on 02.02.2021, the Ministry constituted another expert committee ("Expert Committee") under the chairmanship of Dr. M. S. Bhatia for examining Pre-1988 FDCs de novo. Through public notices dated 26.07.2021 and 19.08.2021, the Expert Committee called for the concerned stakeholders to submit all relevant information for its consideration. Subsequently, a hearing was also afforded to the concerned stakeholders. Ultimately, the Expert Committee recommended to prohibit the manufacture, sale or distribution of 14 Pre-1988 FDCs.
13. In the 88th meeting held on 26.09.2022, the DTAB examined and agreed to the Expert Committee Report, in furtherance of which, the Notifications came to be issued. It appears that the Expert Committee's report or its analysis / findings have not been published in the public domain.
14. Following the recent ban, certain manufacturers have already challenged the Notifications before the Hon'ble Delhi High Court. By an order dated 14.06.20237, the Hon'ble Delhi High Court, by way of interim relief, has directed that no action shall be taken against the Petitioner therein, on the basis of the FDCs already in circulation.
15. The Hon'ble Supreme Court in Pfizer delineated the principles underlying Section 26-A of the Drugs Act – public interest in regulating, restricting, or prohibiting manufacture, sale or distribution of drugs/cosmetics involving risk to human beings. The Court also held that where the FDC (i) would involve risk to human beings or animals; (ii) does not have the therapeutic value claimed or; (iii) does not contain ingredients and in such quantity for which there is no therapeutic justification, the Centre can exercise its power under Section 26-A if it is satisfied of the existence of any or all of these factors.
16. From the express wordings of the Notifications, it presently appears that the Expert Committee has tested the 14 FDCs on the above touchstones and thereafter recommended a prohibition on their manufacture, sale and distribution. The Notifications also state that the Centre is satisfied of such findings of the Expert Committee and has exercised its power under Section 26-A of the Drugs Act in larger public interest. Therefore, at first blush, the Notifications do appear to be in line with the findings in Pfizer.
17. Having said that, in Pfizer, the Hon'ble Supreme Court has also held that when the power under Section 26-A of the Drugs Act is exercised on the basis of irrelevant or no material, the satisfaction contemplated under Section 26-A would not be there. We believe that the above finding in Pfizer would be a key determinant of the Notifications' fate. Aggrieved manufacturers would surely be keen on challenging the Notifications in writ petitions on the ground that in reaching its findings, the Expert Committee has relied upon irrelevant or no material.
18. While the provisions of the Drugs Act give wide powers to the Centre for regulating drugs including FDCs, whether a FDC has therapeutic justification or not is essentially recommended by an Expert Committee. Since it appears that the Expert Committee' report is not available in public domain, until these Notifications are challenged and the Expert Committee's report or findings are submitted in Court or provided to pharmaceutical companies for either refuting the said report or presenting contrary opinions based on scientific research, it can only be assumed that the Expert Committee has followed Pfizer in its letter and spirit.
19. Currently there is a case to be made out that the Expert Committee may have over-looked the representations made by the concerned pharmaceutical companies qua the safety, efficacy and therapeutic justification for 14 banned Pre-1988 FDCs. However, the real question would be whether a High Court or the Supreme Court has the expertise to decide if the Expert Committee's recommendations are scientifically well-founded. The Courts, as they did in the past, would then appoint another Committee to look into the efficacy of a particular FDC and may allow the affected pharmaceutical companies to make representations again.
20. The aggrieved manufacturers may also resort to contend how a blanket ban on manufacture, sale and distribution on Pre-1988 FDCs is excessive and arbitrary when they can very well be regulated. With grounds of challenge being apparent, it appears that the concerned manufacturers would surely impugn the Notifications through various writ petitions. Suffice it to say, that this whale of a tale of Pre-1988 FDCs is far from being over just yet.
1. See notifications S.O. 2394(E) to 2407(E) dated 02.06.2023
2. (2018) 2 SCC 39
3. Power of Central Government to regulate, restrict of prohibit manufacture etc. of drug or cosmetic in public interest.
4. Miscellaneous Application Nos. 2200-2201/2018 in Civil Appeal Nos. 22982-23404/2018
5. Miscellaneous Application Nos.600/2018 in Civil Appeal Nos. 23405-23472/2017
6. Miscellaneous Application Nos.600/2018 in Civil Appeal Nos. 23405-23472/2017
7. W.P.(C) 8460/2023
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