Concerns Raised On The Validity Of Supreme Court’s Judgment On Combination Drugs

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Concerns Raised On The Validity Of Supreme Court’s Judgment On Combination Drugs
Concerns Raised On The Validity Of Supreme Court’s Judgment On Combination Drugs

Early this December the Supreme Court of India ruled in a case involving the government’s ban on marketing of 344 fixed dose combinations or FDCs.  

FDCs are medicines made up of two or more drugs sold as a way to bypass the government’s price control orders. Although most of these have been approved by the State Licensing Authorities in violation of the existing Drugs and Cosmetics Act, many lack scientific or therapeutic rationale for their use.

The government’s ban was based on the Drugs and Cosmetics Act’s Section 26A using the recommendations of an expert committee that was led by Professor CK Kokate. The pharmaceutical industry challenged the ban on the grounds that  the Government had failed to consult the advisory body Drugs Technical Advisory Board  .

Government Not Required To Consult  DTAB

Although the Delhi High Court ruled in favour of the pharmaceutical companies, the Supreme Court overruled the lower court, noting that the grounds used for setting aside the ban were not sound. The Delhi HC had set aside the ban on the grounds that the government had not consulted the DTAB.

The Supreme Court noted that Section 26A does not mandate that the Central Government consult the DTAB, stating that as long as “the government’s satisfaction can be said to be based on relevant material”, it wasn’t necessary to consult the DTAB.

However despite making such a strong case that Section 26A does not need the DTAB to be consulted , the Supreme Court has ordered that the DTAB to be consulted apparently on the advice of the government counsel.

The judgment has directed that the DTAB be consulted on the 344 FDCs  so that “it can examine each of these cases” and submit a report to the Central Government.

Although  the judgement clarifies that it is a one-off event given the case, experts have expressed surprise at the government counsel making such a recommendation to the Supreme Court which ignores Parliamentary law.  They have also expressed concern at the Supreme Court accepting this recommendation which is in contradiction of its own judgment.

Allowing Pharma Companies A Hearing Is Unnecessary

Another issue is the Supreme Court’s direction to the DTAB asking it to provide a hearing to all the pharmaceutical companies currently marketing such irrational drugs and submit a detailed report along with recommendations to the Central Government.

Such judgement contradicts the Court’s decision to not examine whether Section 26A is legislative or quasi-judicial in nature. However a closer examination would show that Section 26A is legislative in nature, which means it is not necessary for government to hear the parties affected before taking a decision.

Only in cases where authorities are exercising “quasi-judicial functions” is there a need to “follow the principles of natural justice”, according to experts.

By requiring the DTAB to conduct hearings, the pharmaceutical industry may take up hours seeking to make arguments on the need for these irrational drugs and possibly take DTAB to the courts for alleged procedural failures.

Kokate committee’s Findings Misunderstood 

A big concern noted with respect to the Supreme Court’s judgment is the virtual nullification of the Kokate Committee’s expert report.

The judgement notes that the committee had failed to specify the reasons for recommending the “extreme step of prohibiting”  the drugs instead of “restricting or regulating” them.

This conclusion is erroneous in law as the Kokate Committee had not been required to make a policy determination under Section 26A.  The committee was asked to examine the drugs and offer scientific opinion on their therapeutic benefit. The Kokate Committee did so in its reports, making a “scientific determination” that the several hundred FDCs studied are “irrational”.

This findings were then followed up with policy determination by the central government through the Ministry of Health and Family Welfare, based on which a statutory order was issued for every one of the 344 FDCs. This order stated that the government was convinced that the use of the FDCs is “likely to involve risk to human beings” when safer alternatives are available.

Supreme Court Judgement Fails To Consider Government Power 

The Supreme Court’s judgement appears to ignore a fundamental fact that under Section 26A the health ministry alone has the power to issue directions and not the unelected bureaucrats of the DTAB.

According to experts, given these reasons, the Supreme Court judgement in Pfizer & Ors. v. Union of India, is gravely flawed and must be recalled by the Supreme Court . It may signal to High Courts judges that they can sidestep any legislative procedure related to complex regulatory issues if it happens to be inconvenient.

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