SC asks govt to expedite regulating prices of life saving drugs: A practical reader guide

SC asks govt to expedite regulating prices of life saving drugs: A practical reader guide

The Supreme Court on Monday told the Centre to show urgency in the matter of regulating prices of life saving drugs and devices even as the government said that anti-cancer drugs will now be significantly reduced by up to 70% with the recent decision to cap the trade margin of these drugs at 30% of the maximum retail price (MRP).

“How does the manufacturer fix a price and sell it at a price to retailer (PTR) which is one-tenth or one-fifth of the MRP…Can there be anything more important than this in the entire country,” the bench of justices Vikram Nath and Sandeep Mehta said.

Once finalised, the TMR of non-scheduled anti-cancer drugs will be notified along with a set of instructions and procedures to be followed by the manufacturers, so as to ensure that the benefits are passed on to the patients. We are not averse to what the court is saying but we need to await the report. The affidavit said that the government on October 8 has decided to cap the trade margin of anti-cancer drugs at 30% of the MRP of these drugs which are priced as high as ₹ 27,000. The Centre said that with the proposed trade margin rationalisation (TMR), there will be significant reductions in the MRP of anti-cancer drugs, estimated to be in the range of 20% to 70%. Additional solicitor general (ASG) Aishwarya Bhati who also appeared for Centre said that the TMR on anti-cancer drugs will result in an expected annual savings of approximately ₹ 2,500 crore for the patients and will greatly reduce the out-of-pocket expenditure for patients undergoing cancer treatment.

The government said that upon receipt of the Expert Committee’s report, the National Pharmaceutical Pricing Authority (NPPA) will place the matter for deliberation and suitable directions before the ministry. Solicitor general Tushar Mehta appearing for the Centre said, “I request the court to go through the affidavit. Mehta said that he has discussed the matter with the bureaucrats who have said that the issue involves consultation with stakeholders. The decision taken by the government is aimed at “greater affordability and accessibility of anti-cancer medicines” and will reduce excessive trade mark-ups without directly reducing the manufacturer’s selling price.

To choose the list of anti-cancer drugs whose prices will be rationalised, the ministry of health and family welfare (MHFW) has constituted an Expert Committee on October 9 under the chairmanship of the Director General of Health Services (DGHS) that is expected to submit a report within 10 to 15 days.

“The said list is to include all drugs approved for the treatment of cancer, except those which are inexpensive,” the affidavit said. The decision of the Centre was disclosed to the court in an affidavit filed by the department of pharmaceuticals, ministry of chemicals and fertilizers on Monday during the hearing on two petitions filed by advocate Kishan Chand Jain and a medical practitioner Sanjay Kulshrestha seeking regulation of prices of non-scheduled medicines.