NPPA Approves Change Of Manufacturer For Brands From Torrent Pharma And Sun Pharma

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has approved applications from Torrent Pharma and Sun Pharma Laboratories to shift manufacturing to their own facilities at the existing retail price.

The decision comes after the Authority in its earlier meetings framed guidelines for examining such cases and allowing the change of manufacturer for formulations for which retail prices has been fixed already.

In a latest meeting, the Authority noted the changes proposed by the marketers to manufacture the brands on their own. This include Torrent Pharmaceuticals’ applications for manufacturing of diabetes formulations of Azulix 3MF and 4 MF, cardiology drugs Unistar Gold 20 and Rozuplatt capsules. It also deliberated on the applications filed by Sun Pharma Laboratories for its diabetes brands Istamet D-XR 500 mg tablet, Oxramet-S XR 500 mg tablet and Sitared-MD XR 500 mg tablet.

“The Authority deliberated upon the matter in detail noted that the marketing companies who intend to shift the manufacturing activity to their own plant have already launched the formulations and have approved the notified retail price from NPPA,” it said.

“Hence the Authority approved that such marketers may be permitted to manufacture and market the formulations under their existing (same) brand at the NPPA approved retail price not exceeding the present applicable retail price for already launched formulations,” added the Authority.

It may be noted that the Authority, in its meetings held on May 26, 2023 and July 31, 2023 had framed the guidelines for examining the cases of continuation of same retail price by the marketers, in case of change of manufacturer by them for formulations for which retail price has been already notified by the NPPA. The formulations were launched in the market under a specified brand and the guidelines were framed to ensure consistency and predictability in examination of such cases.

Modified the parameters in its guidelines for allowing change of manufacturers after retail price of formulations are approved, allowing the existing marketing entity to produce the medicine in its own plant.

The decision modifying the guidelines finalised in May, 2023, will be a relief to the marketing firms as they will have the flexibility to start manufacturing the products on their own, if required.

However, the Authority in its recent meeting which approved the modification, refused to accept the industry’s suggestion that the change of manufacturer may be notified by way of filing Form V only, instead of seeking approval.

The NPPA, in its meeting held on July 31, 2023, added the point allowing “Shifting of manufacturing to its own plant by the existing marketing entity,” to the parameters under which the change in manufacturer may be allowed by the Authority in future cases.

The parameters fixed in an earlier meeting of the Authority on May 26, 2023, to allow change in manufacturer on conditions including cancellation or seizure of license of the manufacturing company; natural calamity or civil riots leading to destruction of plant of manufacturing company; dissolution or winding up of the manufacturing company; closure of the concerned business segment by the manufacturing company, etc; or any other circumstance(s) proved to be beyond the control of manufacturer or marketer.

The onus to prove these conditions will be on the applicant company with documentary evidence and the request will be examined on a case to case basis and the earlier cases may not be treated as a precedent for future cases.

With the decision coming out on June 8, the industry and industry associations submitted suggestions that the change may be notified by way of filing Form V only instead of seeking approval and change in manufacturer to produce in marketer’s own plant may be allowed.

Following the guideline and the modification, Torrent Pharma and Sun Pharma submitted their applications proposing to manufacture the formulations at their own manufacturing plant rather than with their present manufacturers and market under the same brand name at current maximum retail price. They requested the NPPA to allow continuation of retail price already approved on change of manufacturer.

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