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FDC Ban and Endless Rounds of Litigation

S Srinivasan (chinusrinivasan.x@gmail.com) is affiliated with AIDAN (All India Drug Action Network) and LOCOST (Low Cost Standard Therapeutics).

Despite the recommendation of two expert committees to ban fixed dose combinations, the issue remains unresolved. Manufacturers of banned FDCs have approached Delhi High Court and sought to question the rationale of the ban on tendentious grounds. This also raises questions over the extent of judicial involvement in deciding upon the content of scientific matters.

AIDAN is a party to the Special Leave Petition along with the Union of India, as well as party to the 2018 cases in Delhi High Court and Supreme Court, mentioned in the article. Acknowledgements are due to legal counsel Colin Gonsalves and Tanya Agarwal, and author’s colleagues in AIDAN.
 

 

 

 

During March 2016, the Government of India had banned 344 FDCs (fixed dose combinations) on the recommendation of the Kokate Committee of experts.1 Over 400 drug pharma companies affected by the ban approached the Delhi High Court and got a stay in March 2016—the stay got confirmed by a detailed order of the Delhi High Court in December 2016. The argument given by the Delhi High Court quashing the ban was that the Drugs Technical Advisory Board (DTAB) was not consulted.

SLP in Supreme Court

The matter went on appeal to the Supreme Court through an SLP (Special Leave Petition) filed by the Government of India and the All India Drug Action Network (AIDAN). After hearing various parties, Justices Rohinton Fali Nariman and Sanjay Kishan Kaul on 15 December 2017, ruled2 that there was no need for the government to consult the DTAB for exercise of powers to prohibit (ban), restrict or regulate under Section 26A of the Drugs and Cosmetics Act. There was no mention of such a mandatory consultation in law, whereas in a dozen places in the act, consultation of the DTAB is mentioned in specific matters. One cannot supply a missing clause in Section 26A or read into an act what is not there.

Under Section 26A of the act, the central government must be “satisfied” that a drug has inadequate safety, efficacy and/or therapeutic justification for the central government to regulate, restrict or prohibit a drug. The “satisfaction” of the central government needs to be obtained by use of relevant material. The relevant material could be obtained through an expert committee appointed by it or data from other countries where a drug has been banned.

Having dismissed the logic of the Delhi High Court in quashing the ban, the Supreme Court could have reaffirmed the Kokate Committee findings and let the ban take effect. But in a twist, termed by the Supreme Court order as the “peculiar circumstances of the case” —and to “obviate further litigation”—the Court referred the Kokate report to the DTAB or an expert committee appointed by it. The expert committee so appointed was mandated—within a period of six months—to elucidate/explicate the recommendations of the Kokate Committee on each of the 344 (plus five FDCs added later) as to whether they fail to satisfy safety/efficacy/therapeutic justification criteria and whether therefore the FDC needs to be banned, restricted or regulated.

The action of the Supreme Court in returning the Kokate report to the DTAB or an expert committee appointed by it is a bit of contradiction as the Court in the earlier part of its ruling has pronounced consultation with the DTAB is not mandatory in respect of ban, etc, of a drug. It could have referred to any other committee suitably appointed by the central government. The doubts cast on the Kokate report, termed perversities by drug companies, seem to have persuaded the Supreme Court for the need to have a second look at the report. These “perversities” were in reality exaggerated by pharma manufacturers but they seem to have cast sufficient doubt to convince the presiding bench of Justices Nariman and Kaul on the necessity of another round of scrutiny of the Kokate report and its recommendations.

DTAB Subcommittee Report

On the face of it, it looked unlikely that another expert committee would have vastly different recommendations than that of the Kokate Committee. The move for a relook at the recommendations of the Kokate Committee therefore looked like prolonging the inevitability of the ban orders.

One could not have been more wrong. The government through the DTAB did appoint—per Supreme Court directions—another expert committee in February 2018 to look into the Kokate Committee recommendations. The expert committee, hereafter the DTAB Subcommittee, was headed by Nilima Kshirsagar, National Chair of Clinical Pharmacology, Indian Council of Medical Research (ICMR), and other subject medical experts, persons with impeccable scientific credentials.

The DTAB Subcommittee went through, among other factors, whether the ingredients in the FDC were justified as per pharmacological principles, and/or, whether the FDC was safe or likely to pose risk, and/or, whether the proof of efficacy of the FDC for the claimed indications by the manufacturer, was acceptable. All manufacturers of the impugned FDCs, and the AIDAN, were invited to depose in writing and also make presentations before the subcommittee.

The report of the DTAB Subcommittee was available by August 2018.3 It mostly reaffirmed the earlier recommendations of the Kokate Committee and also gave its reasons. The DTAB Subcommittee recommended ban on 343 FDCs plus restriction/regulation on another six FDCs. The quality of evidence presented by the manufacturers seems to have been poor, illogical, and scientifically untenable, with some manufacturers even changing the indications in the oral presentation before the subcommittee (see page 19 onwards of the subcommittee report). Flimsy arguments for safety were advanced by pharma companies, like the FDC being in the market for many years and no harmful effect was seen. In reality, however, many of the ingredients of the FDC were irrelevant to the indications claimed, if at all. Nor could the manufacturers show that the FDCs were mentioned in any standard treatment guidelines of the particular disease condition.

It is well known, that there are some basic scientific criteria when FDCs are acceptable—these can be found in many World Health Organization (WHO) publications and peer-reviewed papers. Violation of any of these principles is good enough reason for a ban. If a drug is not of proven safety, efficacy or therapeutic justification, there cannot be any other action other than banning the drug because any other action would be contrary to public interest. You cannot “regulate or restrict’’ an unsafe FDC but ban it. Indeed a drug is not a drug as defined in the act if it has no effect in mitigating a disease or illness.

One would have thought that two committees of top experts reiterating the same decision to ban the FDCs would have settled the issue. But it was not to be. No sooner than the subcommittee report was out in August 2018, and the government took out the relevant gazette notifications for ban, manufacturers of the banned FDCs approached the Delhi High Court. At the Delhi High Court, a slew of manufacturers, represented by India’s eminent counsel, have questioned the logic of the ban, or said the explanation given in the subcommittee report is not clear or comprehensible. Some even claimed wrongly that they were not given a hearing by the subcommittee. In the opinion of this writer this is vexatious litigation. Further, the Delhi High Court in its wisdom started perusing through the recommendations of the DTAB Subcommittee and has seen it fit to take a call whether a particular explanation (read formulations and sentences) in the report recommending ban on a FDC was logical and whether the subcommittee has applied its mind as evidenced by formulations recommending the ban. For experts in medicine and pharmacology, a narration of 10 lines, or even less, is good enough to communicate the logic of the ban. The line is thin as to what constitutes clear explanation, indeed how long should it be, and to whom should it be clear even if due process was followed by the regulatory authorities.

How much could/should courts opine on the content of scientific matters? The nature of judicial review in such cases, in this writer’s respectful opinion, is severely restricted and has been laid down in several judicial decisions.4In E Merck (India) Ltd vs Union of India and Another 90 (2001) DLT 60 (DB), the Delhi High Court held that:

25. Once we come to the conclusion that the ingredients of Section 26A of the Act are fulfillled, that the satisfaction of the Central Government is based on material on record after considering all possible views in the matter and relevant material germane to the issue was considered and the action was not ultra vires the powers of the Central Government, no further scrutiny of the matter is required while exercising the power of judicial review over such a decision. After all this Court is not sitting in appeal against the decision of the respondents.

As we go to the press (December 2018), the legality and raison d’être of the ban on several class of FDCs are being questioned in the Delhi High Court. There is a distinct possibility the Union of India may seek a transfer of all related cases to the Supreme Court.

Pre-1988 Approved FDCs

In a parallel development, manufacturers have approached the Supreme Court saying some 15 of the 343 FDCs recommended for ban by the subcommittee in September 2018 are pre-1988, that is, were approved before September 1988.5 However, the claim of the manufacturers of many of these 15 FDCs to be pre-1988 is misleading. One of the 15 FDCs contains nimesulide. However, nimesulide per se was introduced in India around 1995. So how can it be pre-1988? Also, a brand with changed contents after 1988 cannot be considered pre-1988. The only way the Supreme Court could ascertain the pre-1988 status or otherwise of these 15 odd FDCs is to ask the manufacturers to produce the approval letters they should have received from the licensing authorities. But this has not been done, at least not yet.

Of public health concern, inter alia, is that many of these pre-1988 FDCs suggested for ban are seriously harmful. For instance the FDC of paracetamol + propyphenazone + caffeine (brand Saridon)—there have been case reports describing risk of acute inferior myocardial infarction with low atrial rhythm due to propyphenazone (Kounis syndrome) and is banned in several countries.

This begs the question whether the Court should have disallowed the stay on ban of these pre-1988 FDCs irrespective of the legal merit of the pre-1988 status. After all an unsafe drug cannot be allowed to be in the market even for a day. In fact there is a good reason for review of the safety, efficacy and therapeutic justification of all FDCs ever approved in India. In the interests of public health, government needs to list positive criteria of acceptable FDCs and ban all not complying with these criteria—after taking care of legal pitfalls.

Notes

1 For details, see Srinivasan et al 2016; Srinivasan 2018.

2 Civil Appeal No 22972 of 2017 arising out of SLP (C) No.7061 of 2017, Union of India and Anr v Pfizer Limited and Ors, With Ors.

3 Available at https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Committee/dtab_sub_report.pdf, viewed on 30 November 2018.

4 For example: Union of India v Cynamide (1987) Systopic Laboratories (Pvt) Ltd v Dr Prem Gupta (1993), E Merck (India) Ltd v Union of India and Another (2001), Macleods Pharmaceuticals Limited v Union of India & Ors Writ Petition Nos. 21933 and 25442 of 2011.

5 We will not, for reasons of space, go into the rationale of this pre-1988 demarcation but effectively they cannot be touched in this exercise. But the government is free to examine them independently. As a result, the ban is effectively on 328 FDCs with six others allowed for sale subject to certain restrictions.

References

Srinivasan, S, S Shiva and M Aisola (2016): “Cleaning Up the Pharma Industry: A Landmark Ban on Irrational Drugs,” Economic & Political Weekly, 51 (14), 21–23.

Srinivasan, S (2018): “Fixed Dose Combinations and Their Ban: Issues of Concern,” Journal of Public Affairs and Change, 2456–9240, Vol 1, No 2.

Updated On : 3rd Jan, 2019

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