Delhi HC Sets Aside Centre's Ban On FDCs For Type-2 Diabetes, Takes Note Of Its Therapeutic Justification For Large Population Of Patients [Read Judgment]

The Delhi High Court has set aside the Centre's notifications banning manufacture and sale of fixed drug combinations (FDCs) used for the treatment of Type-2 diabetes mellitus in patients who do not show improvement or glycemic control with diet, exercise and the usage of dual therapy. Justice Vibhu Bakhru set aside the Centre's notifications issued last year whereby the manufacture and sale of FDCs of the formulations "Glimepiride 1 mg/ 2 mg/ 3 mg + Pioglitazone 15 mg/ 15 mg/ 15 mg + Metformin 1000 mg/ 1000 mg/ 1000 mg" had been proscribed for inclusion of the formulation Metformin, which it felt might involve risk to human lives. Another FDC of the formulation "Glimepiride 1 mg/ 2 mg + Pioglitazone 15 mg/ 15 mg + Metformin 850 mg/ 850 mg" had been proscribed on the ground that there were sufficient therapeutic options already available and since increments in dose of Metformin are made in steps of 500 mg as per treatment guidelines, availability of multiple strengths can lead to medication error. While setting aside the notifications, the court asked the Drug Technical Advisory Board (DTAB) to examine the issues regarding the FDCs and submit a report to the Centre clearly providing an explanation for its recommendations along with the material in support thereof. The order of the court came after pharma company Lupin Limited, which manufactures Gluconorm-PG 1 Forte and Glulconorm-PG2 Forte for the treatment of diabetes, challenged the said notifications. Intas Pharmaceuticals Ltd, Eris Lifesciences and M/s Micro Labs too had opposed the notification. The pharma companies challenged the notifications on the ground that the DTAB was not in existence when the sub-committee was constituted for examining the FDCs in question. Besides, the finding of the sub-committee that there were safety concerns regarding Metformin is incorrect, they claimed. They also claimed that the said FDCs have a sound therapeutic justification and pose no risk to human beings as the FDCs in question are used for the treatment of Type-2 diabetes mellitus when diet, exercise and the usage of dual therapy do not result in adequate glycemic control. At the outset, the court noted that the sub-committee has approved an FDC comprising Glimepiride ½ mg + Pioglitazone 15 mg + Metformin 500 mg by another notification dated 07.09.2018, which makes it apparent that the only objection in respect of the FDCs which form subject matter of instant petitions relate to the increased dosage of Metformin: 1000mg and 850mg. In 2016, the Centre had issued notifications banning 344 drugs. In December 2017, the Supreme Court in case titled Union of India v. Pfizer Limited and Ors remanded the matter back to the DTAB. The DTAB formed a sub-committee to review the matter pertaining to 344 + 5 FDCs, including the drugs in question in the instant petitions. The sub-committee then recommended a prohibition on the manufacture, sale and distribution of the FDC of Glimepiride 1 mg/2 mg/3 mg, Metformin 1000 mg and Pioglitazone 15 mg, saying they may involve risk to human lives. It also recommended prohibition of the FDC Glimepiride of 1 mg/2 mg, Metformin 850 mg and Pioglitazone 15 mg on the ground that there were sufficient therapeutic options already available and since increments in dose of Metformin were made in steps of 500 mg as per treatment guidelines, availability of multiple strengths can lead to medication error. While deciding the petitions, Justice Bakhru noted that the sub-committee had expressly noticed that the FDCs in question contain "recommended" and "approved" therapeutic dosage of each ingredient and therefore, there was no dispute that the FDC in question have a therapeutic justification and has the potential to address the need of patients with Type II diabetes, who are not responding to mono or dual therapy. He also noted that the reasoning of the sub-committee indicates that there is a sufficiently large population of patients that requires a triple drug combination for addressing the chronic disease. Lack of safety data and availability of alternatives not a good ground to ban "The only reason provided by the Sub-Committee for proscribing the said FDC is that it can lead to the risk of hypoglycemia and there is no safety data pertaining to this FDC. Once it is accepted that the formulations in the dosages, as included in the said FDC, is recommended and approved therapeutic dosages for treatment of Type II Diabetes in certain cases, it is difficult to understand the reason for proscribing the said FDCs on the ground of lack of safety data," said the court. The court also took note of Section 26A of the Act according to which a drug can be proscribed only if -- (i) it involves any risk to human being or animals; (ii) the drug does not have any therapeutic value purported to be claimed; and (iii) that the drug contains ingredients in such quantity for which there is no therapeutic...

Delhi HC Sets Aside Centre's Ban On FDCs For Type-2 Diabetes, Takes Note Of Its Therapeutic Justification For Large Population Of Patients [Read Judgment]

akanksha jain

Tags