Pharma Industry urges NPPA to invoke Para 19 of DPCO 2013

Drugs with unit dosage value of less than Rs 5.00 should be kept out of price control

NPPA National Pharmaceutical Pricing Authority

Last Updated on December 31, 2023 by The Health Master

The Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) has stressed on the need to invoke Para 19 of DPCO 2013 in order to ensure availability of essential medicines.

Para19: Fixation of ceiling price of a drug under certain circumstances.- Notwithstanding anything contained in this order, the Government may, in case of extra-ordinary circumstances, if it considers necessary so to do in public interest, fix the ceiling price or retail price of any Drug for such period, as it may deem fit and where the ceiling price or retail price of the drug is already fixed and notified, the Government may allow an increase or decrease in the ceiling price or the retail price, as the case may be, irrespective of annual wholesale price index for that year.

Post pandemic, there has been supply chain disruptions leading to shortage as well as huge increase in prices of APIs, packaging materials and excipients used to manufacture essential medicines.

In these extraordinary circumstances, if ceiling prices of these essential medicines are not revised upwards by resorting to Para 19 of DPCO 2013, there might be challenges in ensuring availability of these medicines even in government healthcare centres and Janaushadhi stores, said Harish K Jain, president, KDPMA.

Drugs with unit dosage value of less than Rs 5.00 should be kept out of price control and all efforts should be made to control prices of high value drugs used for cancer, acute cardiac care, nephrology, neurology and rare diseases. This move will greatly benefit the poor patients, he added.

Stating that Indian pharma with its manufacturing prowess ensured prices of antibiotics like ciprofloxin which was Rs 35 per tablet over five decades ago to be clamped down to Rs. 1.50 per tablet with its high quality, good manufacturing practices, Jain noted that there was a need to replicate this for most high priced antibiotics among other life style disorder medicines which are being commonly prescribed now.

Highlighting pharma manufacturers initiative to Make in India, Jain at an event organized by the PMRU Society of the Karnataka Drugs Control department as part of the Union government’s Azadi Ka Amrit Mahotsav said “From a 100% importer of medicines, today we export to around 200 countries.

Our market has seen shift from being MNC dominated to be led by domestic players making medicines accessible not just to patients across India, but also to the world.

Even for Africa’s dreaded diseases like malaria and AIDS, Indian pharma made available high quality, safe, efficacious and affordable drugs to its patients.

This was possible with the patent policies of the Central government in the 70s and 80s which enabled Indian pharma not just to grow in size but reduce prices of ciprofloxacin, ofloxacin, plavix among other life-saving drugs.

Even during the ongoing C-19 pandemic, since the last 18 months Indian pharma ensured easy availability of non-C-19 medicines.”

Therefore, currently prices of essential medicines to Indian patients are amongst the lowest globally and available easily. Indian pharma is focused to improve process efficiency & supply chain to decrease cost and facilitate large scale manufacture, he stated.

Indian pharma strictly adheres to DPCO 2013 for schedule and non schedule products even though there is no cap on input prices. Essential medicines prices have remained consistent for the last 5 years.

Competition keeps prices low. Companies regularly invest to upgrade production plants to seek global certified quality standards and still maintain the same prices.

“However maintaining prices especially for essential scheduled drugs is a challenge making its availability for state and central government medical supplies, Janaushadhi and trade unless prices are revised upwards invoking Para 19 of DPCO 2013.” said Jain.

National Pharmaceutical Pricing Authority (NPPA)

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