After U-Turn on Rare Disease Policy, Health Ministry Assures New One in 9 Months

The ministry had in December told the Delhi high court that the policy had been erroneously framed and asked for permission to withdraw it.

New Delhi: The Delhi high court has accepted the submissions of the Union health ministry that it would need nine more months to come up with a new policy for rare diseases.

The government was first directed to come up with this policy nearly two and a half years ago – in November 2016.

The health ministry asked the court for this extension, even though the same ministry had, in fact, finalised and submitted a policy on rare diseases in May 2017, as The Wire had first reported.

In that policy, the government had promised an initial corpus fund of Rs 100 crore for the treatment of patients with rare genetic diseases, many of them children.

No money from that corpus was released, and petitioners had to approach the Delhi high court again on the matter.

Also read: India’s Ignoring Its Rare Disorders and Their Orphan Drugs Led to the Thalassaemia Crisis

The health ministry’s ‘somersault’

A year-and-half after finalising the policy, last December, the government did a ‘somersault.’

The health ministry told the court that the policy had been erroneously framed and asked for permission to withdraw it.

The Wire has reviewed the affidavits of the health ministry on this.

Justice Manmohan in Delhi high court was not pleased and noted that health ministry officials had done a flip-flop. The health secretary, Preeti Sudan has herself been attending hearings in court.

The health ministry told the court that the policy would need to be kept in “abeyance” until they could make a revised one.

Through 2017 and 2018, the government continued to promote the same rare disease policy that it later withdrew as erroneous. A 2018 press release from the ministry said that health minister J.P. Nadda had spoken about the policy and assured “full support from the government” to rare disease patients.

Also read: What Is Life Like When Lived With a Very Rare Disorder?

Getting nine more months for the policy

The Wire has reviewed the filings submitted by the health ministry in the Delhi high court this month. In it, the health ministry again stated that it would need an additional nine months to come up with a new policy altogether.

In the affidavit, they have listed the various efforts they are undertaking as well as their further plans.

Justice Manmohan, who is hearing the case in the Delhi high court, has issued an order recording the health secretary’s assurance on this.

Health secretary Preeti Sudan assured the court that in these nine months, her ministry would convene meetings with stakeholder bodies such as Lysosomal Storage Disorders Support Society, Employees’ State Insurance Corporation, All India Institute of Medical Sciences (AIIMS) and the pharmaceutical company Sanofi.

Sanofi has an important enzyme replacement therapy for the treatment of lysosomal storage disorders such as Gaucher disease, Fabry disease, MPS I and Pompe disease. They have been running a donation programme for therapy in India.

The government told the court they will be studying the Orphan Drug Act (1983) of the US, EU regulations from 1999 on rare diseases and also legislation and policies from Japan, Australia and Israel.

They will also keep in mind the already drafted policy of 2017 and will also study another important judgement of the Delhi high court from 2014 on rare diseases (Mohammed Ahmed vs Union of India).

They have already constituted an expert committee headed by director general of health services to draft this new policy.

As an interim measure, the government will give one-time assistance to patients under another scheme, the Rashtriya Arogya Nidhi, which provides health funding to people below the poverty line suffering from life-threatening illness, cancer and rare diseases.

The government also told the court that it would send SMS to the 1.2 million ASHA workers and auxiliary nurse midwives to create community awareness among people about rare diseases.