The central government passed the order citing “extraordinary circumstances” and “public interest”.
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On October 14, India’s National Pharmaceutical Pricing Authority (NPPA) increased the maximum price of eight drugs, including those for common diseases such as asthma, tuberculosis, bipolar disorder and glaucoma. Prices have increased by 50%.
What are the reasons given by the government?:
The central government passed the order citing “extraordinary circumstances” and “public interest”. NPPA is part of the pharmaceutical sector under the federal Ministry of Chemicals and Fertilizers, and a government statement said the price hike was in the larger public interest.
“The mission of the NPPA is to make essential medicines affordable and to ensure affordability without jeopardizing access.Essential medicines must remain available, and through price regulation, There should never be a situation where these medicines are no longer available.”
The NPPA added that it has received applications from manufacturers for upward price revisions due to the rising cost of active pharmaceutical ingredients. Increased production costs. Fluctuations in exchange rates make it impossible to produce and sell pharmaceutical products. Companies have also applied for suspension of some formulations due to their unviability.
How are drug prices controlled in India?
The NPPA, established in 1997, regulates price ceilings for medicines and has the power to fix costs under the so-called “Drug Price Control Order” (DPCO) issued by the government under the Essential Commodities Act.
The central government said the decision to increase drug prices was taken following deliberations at a meeting on October 8. This invoked special powers under Section 19 of the DPCO 2013. The NPPA has approved the planned price increase for 11 formulations of eight drugs. In the greater public interest, 50% of the current price ceiling will be reduced.
“Most of these drugs are low-cost and are commonly used as first-line treatments important to national public health programs,” the report said.
Preparations with revised ceiling prices include Atropine Injection 06.mg/ml. Streptomycin powder for injection 750mg and 1000mg. Salbutamol tablets 2mg and 4mg and ventilator solution 5mg/ml. Pilocarpine decreased by 2%. Cefadroxil tablets 500mg, desferrioxamine for injection 500mg. Lithium tablets 300mg.
These special powers were invoked by the NPPA in 2019 and 2021 to increase the prices of 21 and 9 drug products by 50%, respectively, to ensure continued availability of essential medicines. Ta.
Article 19 of the DPCO allows the government to revise the cost ceiling. This may occur under unusual circumstances.
Article 19 states: “Notwithstanding anything in this Order, the Government may, in special circumstances, fix the maximum price or retail price of pharmaceutical products for that period if it deems it necessary in the public interest.” ” If the ceiling price or retail price for a drug has already been determined and notified, the government may allow an increase or decrease in the ceiling price or retail price, as the case may be, irrespective of the annual wholesale price index for the drug. You can. That year. ”
Are drug prices revised every year?
For each fiscal year beginning April 1, the NPPA increases the maximum price for pharmaceutical products based on the previous year’s Wholesale Price Index (WPI).
Pharmaceutical pricing in India is strictly controlled by the central government and the NPPA monitors the prices of scheduled and unscheduled drugs under the 2013 DPCO. Action is being taken against companies selling formulations at prices above the permissible price or being overcharged. The amount will be recovered. In 2023-24, Rs 7,273 crore was recovered from defaulting companies.
Additionally, according to the Drugs and Cosmetics Act and Regulations 1945, manufacturers of pharmaceutical products must comply with the conditions of manufacturing licenses and Good Manufacturing Practice (GMP) requirements. According to the Drugs Regulations, 1945, manufacturing, testing, labeling, packaging, storage and distribution shall be carried out in accordance with license conditions including Good Manufacturing Practice (GMP) as set out in Schedule M of the Drugs Regulations, 1945 There is a need. In the event of a breach, the licensing authority will be empowered to act.
issued – October 25, 2024 6:00 AM IST
