High Court of Delhi

Lupin Limited and Ors. Vs. Union of India and Ors.

MANU/DE/0730/2019

22.02.2019

Law of Medicine

A decision founded on an unclear report without any deliberation is manifestly arbitrary.

The Petitioners have filed the present petitions impugning Notification no. S.O. 4479(E) issued by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940 whereby the manufacture, sale and distribution of the Fixed Dose Combination (FDC) of "Pioglitazone 30 mg + Metformin 500 mg" has been proscribed by the Central Government. The Petitioner manufactures and markets the FDC comprising of "Pioglitazone 30 mg + Metformin 500 mg" under the brand name of "Gluconorm P 30".

The limited questions that fall for consideration of this Court are whether the Central Government's decision to ban the manufacture, sale and distribution of the FDC in question is based on relevant material and whether the directions of the Supreme Court in Pfizer have been duly complied with.

The notifications issued in exercise of powers under Section 26A of the Act are of general application and the power exercised by the Central Government under Section 26A of the Act is legislative in nature. However, such powers can be exercised only if the Central Government is satisfied that it is necessary in larger public interest and further the specified conditions for exercise of such power - the use is likely to involve risk to human beings or animals or the drugs do not have any therapeutic value - are established. Plainly, the Central Government's satisfaction would be required to be based on the relevant material.

The risk of overdose of one of the drugs constituting a FDC would always exist. If the matter is viewed in the context of titration of drugs constituting an FDC; any variation in the dosage of any drug included in an FDC would result in overdose of the other components. Titration of any component drug in an FDC is not feasible. FDCs by their very definition, include formulations in fixed doses. Since, it is not disputed that Pioglitazone 30 mg and Metformin 500 mg can be prescribed as a second line therapy in Type - II Diabetes, the observation that the FDC in question has no therapeutic justification, cannot be sustained.

If the Sub-committee was of the view that, Pioglitazone in the strength of 30 mg would provide a significant risk of overdose in an FDC, it would have been apposite for all FDCs including Pioglitazone 30 mg as a component to be proscribed. However, since all FDCs, which include Pioglitazone 30 mg have not be proscribed, the reason as provided by Sub-Committee lacks clarity.

The Supreme Court had given a specific direction that in cases where the DTAB/Sub-committee prohibits a particular FDC, it would also give its reasons as to why restricting or recalling the said FDC, would not be sufficient to control the manufacture and use of that FDC. In the present case, the Subcommittee had highlighted a risk of overdose, however, it did not indicate in its report as to why restricting or regulating its manufacture or use, would not suffice. Thus, the report submitted by Subcommittee also is not in conformity with the directions issued by the Supreme Court in Pfizer Limited. Concededly, the Central Government has based its decision solely on the report of the Subcommittee. A decision founded on an unclear report without any deliberation is manifestly arbitrary.

The impugned notification cannot be sustained. The same is set aside. The matter is remanded to DTAB/Subcommittee constituted by it to examine the issue regarding the FDC in question in accordance with the directions issued by the Supreme Court in Pfizer Ltd. The DTAB/Sub-committee shall submit a report to the Central Government. The Central Government may take an informed decision whether to proscribe, restrict, or approve the said FDC.

Relevant

Union of India (UOI) and Ors. vs. Pfizer Limited and Ors. MANU/SC/1611/2017

Tags : Notification Manufacture Ban

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