Indian Pharma industry urges NPPA for stable drug pricing policy

Last Updated on August 14, 2024 by The Health Master

NPPA

NPPA: The Indian pharmaceutical industry is calling for a significant overhaul of the regulatory process to streamline drug approvals and exit procedures for low-demand segments.

In a recent representation to the Department of Pharmaceuticals (DoP), industry associations outlined key changes aimed at easing the burden on pharmaceutical companies and fostering a more conducive business environment.

Simplifying New Drug Price Approval

One of the primary concerns raised by the industry is the complex process for obtaining price approval for new drugs under the Drug Price Control Order (DPCO) 2013.

The current interpretation of ‘new drug’ has led to numerous cases of overcharging and confusion among pharmaceutical companies.

To address this issue, industry associations have proposed the following:

• Streamlined Form I submission: If a new drug’s retail price has been notified by the National Pharmaceutical Pricing Authority (NPPA) within the past 180 days, other companies should not be required to submit a mandatory Form I application for the same drug. Instead, they can simply upload their price list on the Integrated Pharmaceutical Database Management System (IPDMS) along with the NPPA notification.
• Revised Para 15: The industry has suggested splitting Para 15(2) into two parts:
  • Para 15(2)(a): Companies seeking prior price approval for a new drug must submit Form I with required documents.
  • Para 15(2)(b): Companies can submit Form V price list and NPPA notification if the retail price has been fixed within the past 180 days. After 180 days, a fresh Form I application is mandatory.

Easing Exit Procedures for Low-Demand Segments

Currently, pharmaceutical companies with a market share of less than 1% for a particular drug must obtain permission from the NPPA to exit that segment, which involves a lengthy and burdensome process.

To simplify this, the industry has recommended:

• Simplified exit notification: Companies wishing to discontinue low-demand formulations should only need to inform the NPPA six months in advance.
• Elimination of additional requirements: The industry believes that the issuance of a public notice, submission of production and sales data, and other formalities should not be mandatory for low-demand segments.

“These proposed changes are crucial for the growth and competitiveness of the Indian pharmaceutical industry,” said an industry expert. “By reducing regulatory hurdles, we can create a more business-friendly environment and encourage innovation.”

If implemented, these recommendations are expected to significantly improve the ease of doing business for pharmaceutical companies, leading to increased efficiency, compliance, and overall industry growth.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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