Syrup furosemide shortage: Will the DCGI Intervene?

Few days back I visited Satya Sai Heart Hospital in Ahmedabad. The hospital is doing a wonderful job of providing free heart surgeries to children. During the visit I came across a genuine issue: shortage of Furoped (syrup furosemide) in the market.

For children with heart failure, Furoped is a life-saving diuretic.

In an order in November 2017, the price of Furoped was reduced by 92% with the MRP coming down from Rs 106 to Rs 10/-. Then in June 2018, the National Pharmaceutical Pricing Authority (NPPA) increased the per unit price of Furoped from 29 p per ml to Rs 2.60 p.

A 30 ml bottle now costs around Rs 78/-.

Before the November price revision which was undertaken by NPPA without access to market data, the monthly sales of the drug were to the tune of approximately Rs 30- 35 lakh. Supplies dwindled to about 40% in the aftermath of that decision.

About two years back, there was a shortage of two drugs in the market, d-penicillamine (DPEN) and penicillin G potassium (Pentid-Abbott).

D-penicillamine is used to treat patients with Wilson’s disease (copper overload) with liver, neurological and psychiatric manifestations. And, patients have to be on this drug lifelong. The Indian Medical Association (IMA) had raised this issue and both drugs were freely available again.

There can be several reasons for drugs running short in supply. These can include manufacturing and quality problems, delays and discontinuations.

In the United States, manufacturers provide the FDA with most drug shortage information. And, the agency works closely with them to prevent or reduce the impact of shortages.  All current and resolved drug shortages and discontinuations are reported to FDA at drugshortages@fda.hhs.gov, which are then compiled in a Drug Shortages Database.

But, unfortunately no such system exists in India to take care of drug shortages.

Furosemide is included in the National List of Essential Medicines (NLEM). All formulations of the drug (Tablet 40 mg, Oral liquid 10 mg/ml, Injection 10 mg/ ml) are to be available at all levels of healthcare – primary, secondary, tertiary, as per the NLEM. This means that it is under price control and profits are limited.

The continuing shortage of any life-saving or essential drug is a matter of concern.

All pediatric cardiologists, if they find that Furoped is still in shortage, should voice their concern.

All drug shortages can be reported on the platform of Medical Voice for Policy Change.

Read our earlier stories on this issue:

IMA is change maker: Medical voice is heard

http://blogs.kkaggarwal.com/2017/10/ima-is-change-maker-medical-voice-is-heard/

Artamine shortage

http://blogs.kkaggarwal.com/2016/09/artamine-shortage/

An Open letter to the DCGI

To

The Drugs Controller General of India (DCGI)

Central Drugs Standard Control Organization

Directorate General of Health Services

Ministry of Health & Family Welfare

Government of India

Dear Sir

This is to bring to your kind attention that there is a shortage of Furoped (syrup furosemide), a diuretic drug, in the market. Furoped is a life-saving drug for children with heart failure.

All formulations of furosemide (tablet, oral liquid and injection) are included in the National List of Essential Medicines (NLEM) and are to be available at all levels of health care – primary, secondary and tertiary.

The continuing shortage of any life-saving or essential drug is a matter of concern.

We request you to look into the matter and ensure that the shortage is taken care of and that no similar shortages or of any other drug included in the NLEM occur in the future.

Warm Regards

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