Drug Regulation Patent

SpicyIP Tidbit: Top selling medicine brands may soon become cheaper



The National Pharmaceutical Pricing Authority (NPPA) is all set to slash the prices of popular medicines for stress, hypertension, HIV, pain and pneumonia. The move seeks to cover as many as 100 new drugs and would apply to drugs of varying strengths; for example, NPPA regulates the price of only one strength of Paracetamol currently, but the NPPA intends to control the pricing of all strengths of Paracetamol available in the market.

This is the second time that NPPA has proposed regulating the price of drugs outside the National List of Essential Medicines (NLEM), 2011.

The first time that NPPA had attempted this was in May this year when it sought to control the prices of 108 medicines on the ground of ‘public interest’. This it did rather unsuccessfully because in September, the Government withdrew the guidelines which gave NPPA the power to fix the prices of drugs which were not on the NLEM. (We had blogged about it here). As Swaraj noted in a later post, the NPPA’s power to fix prices of drugs falling outside NLEM were not being clipped but merely clarified, because in the Government’s opinion the ‘public interest’ clause was to be invoked only in exceptional circumstances. Subsequently, All India Drug Action Network (AIDAN) had filed a PIL in Delhi HC, challenging the withdrawal of NPPA’s guidelines by the Government (The PIL was dismissed by the Court).

In a dramatic volte-face, the Government is backing NPPA’s decision to bring down the prices of common drugs and one guesses that this is because of the upcoming assembly elections in some states.

At present, only 348 medicine formulations or 652 packs listed in the NLEM are being regulated by the Government; these include only specific dosages, strengths and combinations of medicine formulation. NPPA aims to regulate prices of all life-saving and essential drugs of mass consumption.

The announcement by NPPA comes in light of its findings that certain “anomalies or discrepancies” exist in the description/specification of drugs in NLEM.

Miffed by the NPPA’s proposal, D G Shah, Secretary General of Indian Pharmaceutical Alliance said, “Mass consumption is not a criterion for NLEM. It would be desirable that the selection of drugs is left to the core committee of experts as per the established criteria. The role of the NPPA is to implement the policy in letter and spirit and not create confusion leading to instability,

For now, the list of proposed changes to NLEM has been forwarded to the Health Ministry which is the final authority on the matter. On its website, NPPA seeks comments from various stakeholders such as patient groups and drug-makers on the correction of anomalies/discrepancies of specification/description of drug formulations in NLEM 2011.

Devika Agarwal

Devika Agarwal

Devika is a Policy Analyst at Nasscom. She first started writing on Spicy IP in 2013 when she was awarded the Spicy IP Fellowship, which sparked her passion for writing on IP. Devika is interested in copyright and technology law.

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