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 justification.
"The fact that there are other alternatives available cannot be a ground for proscribing the FDC in question," said the court.
The court also held to be "unsustainable" the subcommittee's reason that increments in the dosage of Metformin is in steps of 500 mg and, therefore, the FDC which contain the formulation in the strength of 850 mg ought to be proscribed.
"This is so because it is conceded before this Court that Metformin 850 mg is an also approved drug. The petitioner has also produced material to indicate that Metformin in the dosage of 850mg is prescribed in certain patients. Plainly, if Metformin 850mg is an approved dosage, the question of prescribing the FDC on the ground that the strength of Metformin is not a multiple of 500 mg is not sustainable," said Justice Bakhru.
The court also took note of another notification issued by the Centre proscribing FDCs comprising Metformin 1000 mg + Pioglitazone 7.5 mg + Glimepiride 1 mg; and Metformin 1000 mg + Pioglitazone 7.5 mg + Glimepiride 2 mg. The said notification was the subject matter of challenge in case titled Unison Pharmaceuticals Pvt. Ltd. and other connected matters v. Union of India & Anr, wherein the Centre had proscribed the said FDCs on the ground that Pioglitazone 7.5 mg was not an approved dose while there was no issue with regard to the inclusion of Metformin 1000 mg.
Availability of multiple strengths can lead to medication error
The court rejected this argument too for being "cryptic in the sense that drugs comprising of the FDC are available in multiple strengths".
"It was contended on behalf of the respondents that if the FDC in question is overprescribed or under prescribed, it would entail a serious risk to the patient. In this regard, it is relevant to observe that the rationale for making a FDC is for the convenience of a patient, who is prescribed several drugs (comprising the FDC). There is a compelling argument that an FDC is expedient in cases where a patient is required to take multiple medicines. The risk of over prescription or under prescription is common in all FDCs. The reasons indicated by the Sub-Committee do provide any clarity as to why this reason is relevant for the FDCs in question," said the court.
Read the Judgment Here