New drug price cap exemptions pitch DoP against health ministry
The DoP decision came despite the ministry asking it to bring the life-saving drugs under price control
New Delhi: The ministry of health and family welfare and the department of pharmaceuticals (DoP) seem to be heading for a face off following the DoP’s decision to remove price caps on orphan drugs for the first five years, despite the ministry asking it to the bring such life-saving drugs under price control.
Exchange of letters between the DoP and health ministry show that even the DoP had initially asked the ministry to identify rare diseases so that the drug prices could be capped.
However, the sudden U-turn by the DoP is likely to set off a round of recriminations between the two.
On 29 November, health secretary Preeti Sudan had written to DoP secretary Jai Priye Prakash raising concerns over the “exorbitant cost” of life-saving drugs for rare diseases. “May I request (you) to kindly explore the feasibility of capping the prices of drugs used for treatment of rare diseases so that their prices become responsible and affordable to the patients.”
Mint has reviewed a copy of the letter. “Support for such patients from government is a subject matter of litigation in many cases. As you may be aware ministry has been receiving many representations regarding exorbitant cost of life saving drugs for rare diseases. The cost of treatment is unaffordable even for patients who are not poor,” the letter added.
On the same day, Sudan also wrote to the department of industrial policy and promotion (DIPP) asking it to explore the possibility of bringing such drugs under “compulsory licencing”.
The health ministry had also constituted an expert committee to revise the national policy on rare diseases. In fact, the day DoP came out with the notification to drop patented and orphan diseases from the price control list, the committee held its first meeting to discuss the future direction related to rare diseases. It is slated to meet again on 10 January with the mandate to make treatment of listed diseases affordable, including mechanisms such as price capping and/or compulsory licencing, in consultation with stakeholders.
On 24 April 2017, the DoP had written to the health ministry suggesting that the ministry may identify “rare diseases and bring their medicines under the national list of essential medicines (NLEM) so that they may be included in the drug price control order (DPCO) and, subsequently, the prices could be capped to make them affordable.
The sudden U-turn by DoP has, therefore, left everyone perplexed.
While senior DoP officials said the move was aimed at giving Indian patients access to drugs that are only available abroad, civil rights activists called it a “pro-pharma” step, with “no element of public interest”.
“The DoP’s decision was consciously done in contradiction with its own previous stand. While the government is actively deliberating measures such as price caps and compulsory licencing to make orphan drugs more affordable, the DoP’s actions seek to topple the efforts of the ministry and committee set up to review the rare drug policy. The ministry’s appeal to the DoP for price capping and to DIPP for compulsory licences was submitted in its affidavit to the Delhi high court,” said Malini Aisola, co-convenor, All India Drugs Action Network, adding that DoP’s action “appear to be mala fide”.
The government had on Thursday exempted innovative medicines developed by foreign companies from price control for five years.
In amendments to the DPCO, the ministry of chemicals and fertilizers exempted producers of new drugs patented under the Indian Patent Act, 1970, (39 of 1970) from price regulation for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.
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