NPPA Guidelines: For change of Manufacturer in Notified Drug Formulations

These guidelines aim to reduce instances where companies make such changes without informing the regulatory authority.

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Guidelines
Guidelines

Last Updated on January 6, 2024 by The Health Master

Change of Manufacturer in Notified Drug Formulations

The National Pharmaceutical Pricing Authority (NPPA) has recently devised new guidelines to address the issue of manufacturers seeking to change the manufacturer for drug formulations that have already been launched in the market and have retail prices notified.

These guidelines aim to reduce instances where companies make such changes without informing the regulatory authority.

This article will delve into the details of these guidelines and their implications for the pharmaceutical industry.

Examining Change of Manufacturer on a Case-to-Case Basis:

To ensure a systematic evaluation process, the NPPA has established five parameters to assess future cases of manufacturer changes. Only if a specific case falls within these parameters will the change be allowed.

The parameters include:

  1. Cancellation or seizure of the manufacturing company’s license.
  2. Natural calamities or civil riots leading to the destruction of the manufacturing plant.
  3. Dissolution or winding up of the manufacturing company.
  4. Closure of the concerned business segment by the manufacturing company.
  5. Any other circumstances proven to be beyond the control of the manufacturer or marketer.

Onus on the Applicant Company:

The responsibility of proving the aforementioned conditions for requesting a change of manufacturer lies with the applicant company.

They must provide documentary evidence to support their case. The NPPA emphasizes that each request will be assessed individually, and decisions will not be influenced by previous cases, as they should not serve as precedents for future instances.

Instances of Manufacturer Changes and Regulatory Approval:

In the past, the NPPA has granted approval to marketing companies to switch manufacturers after the retail price has been approved.

Such approvals were granted based on the compelling circumstances presented by the companies in their submissions to the NPPA. This leniency has led to an increase in similar requests from various companies.

Case Study:

Novartis India Ltd: Novartis India Ltd approached the NPPA regarding its product Voveran 1ml AQ, whose retail price had been fixed with Nitin Life Sciences Ltd as the manufacturer.

Novartis informed the NPPA that they intended to support environmentally sustainable business practices by reducing the supplier footprint, in line with their commitment to the Environmental Social and Governance (ESG) Policy.

They proposed manufacturing the drug with Sovereign Pharma Ltd, Daman, while also making minor changes to some excipients.

The NPPA verified that these changes were not substantial and did not require a separate license. Based on this information, the NPPA approved the change of manufacturer for Novartis.

Growing Routine Requests for Manufacturer Changes:

The NPPA has observed a trend where companies are now routinely applying to change manufacturers and are merely intimating the regulatory authority about these changes.

Reasons cited for such changes include alterations in business strategy or plans to manufacture the formulation at their own plant.

The NPPA has also noted instances of unauthorized changes made by companies without seeking permission.

Approval for Torrent Pharmaceuticals Ltd:

Torrent Pharmaceuticals Ltd, based in Gujarat, was granted permission by the NPPA to change the manufacturer for its chlorthalidone 12.5mg + telmisartan 40 mg tablet.

The company referred to guidelines outlined in an office memorandum from November 2017.

The NPPA decided that if a marketing company intends to change the manufacturer for a formulation with an existing brand and an already notified retail price, they may continue marketing the formulation under the same brand, provided the new manufacturer does not exceed the current applicable retail price.

Torrent Pharma later sought approval to manufacture their brands Rosucor Gold 10 and Rosucor Gold 20, previously manufactured by Synokem Pharmaceuticals, under their own production.

The NPPA granted the change of manufacturer for these brands, subject to specific conditions.

Conclusion:

The NPPA has developed these guidelines in response to the increasing frequency of manufacturer changes by pharmaceutical companies without proper authorization.

The Authority aims to establish a fair and case-specific evaluation process. The guidelines require companies to provide evidence supporting their requests for manufacturer changes.

It is essential for companies to adhere to these guidelines and seek approval from the NPPA to maintain regulatory compliance and ensure transparency in the pharmaceutical industry.

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