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NPPA allows Torrent Pharma to make combination drug in its own site at same retail price
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GireeshBabu, New Delhi
June 06 , 2025
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The National Pharmaceutical Pricing Authority (NPPA) has allowed Torrent Pharmaceuticals to shift manufacturing facility for its combination drug for nutritional deficiencies from a contract manufacturer to its own site, at the retail price approved by the Authority earlier.
The move is in tune with the guidelines issued by the Authority almost two years back, allowing the marketing companies to continue marketing the already launched formulation with a new manufacturer, for which one of the conditions is "shifting of manufacturing to its own plant by the existing marketing entity".
The decision was taken in an Authority meeting held in the end of May, 2025, following request from the company regarding its formulation of film coated tablets containing calcium carbonate IP 1250 mg equivalent to elemental calcium 500 mg, vitamin D3 IP 2000IU, mecobalamin IP (methylcobalamin) 1500 mcg, l-methylfolate calcium 1 mg, pyridoxal-5-Phosphate 20 mg.
The company, in December, 2024, requested NPPA to permit marketing of the formulation at prices notified by the NPPA in November, 2019, while shifting the manufacturing of the formulation to its own site at Sikkim from Akums Drugs and Pharmaceuticals Ltd.
"The Authority deliberated upon the matter in detail and noted that in the instant case since Torrent Pharmaceuticals Ltd has applied for manufacturing the captioned formulation at its own site, the company may be permitted to market the said formulation at approved retail price, not exceeding the present applicable retail price," said the Authority. Following this, the decision was notified by the NPPA in the Official Gazette.
As reported earlier, 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, it noted.
The drugs price regulator modified the parameters in the 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, came as 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 another 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.
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