NPPA changes to Guidelines allowing Manufacturers shift for Approved Formulations

Last Updated on December 31, 2023 by The Health Master

NPPA Guidelines for approved formulations

The National Pharmaceutical Pricing Authority (NPPA) has recently made amendments to its guidelines concerning the change of manufacturers following the approval of retail prices for pharmaceutical approved formulations.

This adjustment permits the marketing entity currently associated with a product to take up manufacturing in their own facility.

This decision, which was finalized in May 2023, provides welcome flexibility for marketing firms to initiate in-house production when necessary.

However, the NPPA has declined an industry proposal to notify the change of manufacturer solely through filing Form V, rather than seeking explicit approval.

Enhanced Flexibility for Marketing Firms

The modification, sanctioned during a recent NPPA meeting, signifies a significant development for marketing firms by allowing them to shift manufacturing operations to their own plants.

The inclusion of “Shifting of manufacturing to its own plant by the existing marketing entity” among the permissible conditions for changing manufacturers underscores the NPPA’s evolving approach to such scenarios.

Refusal of Industry Suggestion

The NPPA’s decision to maintain the existing process of seeking approval, rather than opt for the proposed simplified method of filing Form V, showcases the authority’s dedication to thorough scrutiny of manufacturing changes.

This stance underscores the NPPA’s focus on upholding stringent standards to ensure the integrity of pharmaceutical manufacturing practices.

Modified Parameters for Change of Manufacturer

During the NPPA’s meeting held on July 31, 2023, the inclusion of the provision for changing the manufacturing entity to the marketing company’s own plant was discussed and approved.

This modification encompasses a range of circumstances under which a manufacturer may seek a change, including license cancellation, natural disasters, civil unrest, the dissolution of manufacturing companies, and other factors beyond a company’s control.

Each application will be evaluated on a case-by-case basis, and past instances will not necessarily set precedents for future cases.

Industry Feedback and Authority’s Stance

Industry stakeholders and associations responded to the NPPA’s decision with suggestions for streamlining the process.

They advocated for notifying changes via Form V and allowing marketers to manufacture within their own facilities.

The NPPA’s subsequent meeting acknowledged that the retail price determined by the authority pertains specifically to the manufacturer and marketer who have sought approval through Form-I, adhering to the Drug (Prices Control) Order (DPCO) of 2013.

These approvals encompass compliance with all statutory requirements, including manufacturing licenses.

The Authority recognized that merely submitting Form-V would not suffice, emphasizing the marketer’s responsibility for drug availability and supporting the move to allow manufacturing within their own facilities.

Guidelines for Streamlined Change Process

The issued guidelines address the growing trend of manufacturers seeking changes without proper authorization.

The NPPA’s past leniency in granting manufacturer changes has prompted companies to increasingly request such modifications.

For instance, Novartis India Ltd.’s application to change manufacturers for Voveran 1 ml AQ highlights a shift towards environmentally sustainable practices.

Similarly, Torrent Pharmaceuticals Ltd. sought to change manufacturers for specific formulations under certain conditions, in line with guidelines set by the NPPA in November 2017.

The NPPA has allowed such changes with an emphasis on adherence to DPCO provisions and specific circumstances.

Conclusion

The NPPA’s recent amendments to its guidelines regarding manufacturer changes demonstrate the authority’s commitment to upholding stringent standards while acknowledging the evolving needs of the pharmaceutical industry.

This move aims to strike a balance between streamlining processes and ensuring the highest quality standards are maintained throughout the manufacturing chain.

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

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