The National Pharmaceutical Pricing Authority (NPPA) has granted Torrent Pharmaceuticals permission to shift production of its nutritional deficiency drug from a third-party manufacturer to its own Sikkim facility, while retaining the previously approved retail price. The decision aligns with NPPA’s updated policy on manufacturer transitions.

Key highlights

Approval for own-site manufacturing

• Torrent Pharma can now manufacture its combination drug at its own plant in Sikkim, previously made by Akums Drugs and Pharmaceuticals.

• Retail price will remain unchanged, as per NPPA’s 2019 notification.

Drug details

• The approved formulation includes:

  • Calcium carbonate IP 1250 mg

  • Vitamin D3 IP 2000 IU

  • Mecobalamin IP 1500 mcg

  • L-methylfolate calcium 1 mg

  • Pyridoxal-5-Phosphate 20 mg

Background on policy shift

• In May and July 2023, NPPA amended its guidelines to allow companies to shift to in-house production while retaining pricing, under specific conditions.

• Torrent’s case met the criteria of "shifting to own plant by existing marketer".

No blanket exemptions

• While marketers can now manufacture approved drugs at their own sites, the NPPA rejected industry demands to allow such changes via Form V filings alone.

• All such requests must still undergo case-by-case approval with supporting documentation.

This move by NPPA not only provides operational flexibility to pharmaceutical companies like Torrent but also reinforces policy clarity for price continuity. It supports self-reliance in manufacturing while safeguarding affordability for patients.