NPPA Approves Discontinuation of 20 Scheduled Formulations Including Grisovin FP, Doncept in FY26

For Johnson & Johnson Pvt. Ltd, the list records Motilium M, a brand-specific domperidone 10 mg tablet. The company applied on February 26, 2024, citing a market share below 1% and challenges sourcing API from the registered manufacturing site. NPPA issued its final direction on June 6, 2025. The continuation date was January 2, 2026, and the public notice was issued on July 2, 2025.

Eight entries belong to Emcure Pharmaceuticals Limited, all with applications dated June 7, 2024, final directions dated September 4, 2025, and public notices issued on June 4, 2024. In every case, the recorded reason is “No demand and insignificant market share.” The formulations are Biaclpro Tablet (bicalutamide 50 mg), Dolospan Injection (tramadol 50 mg/ml), Ramipro capsules in 2.5 mg and 5 mg strengths, Nutin (nitrofurantoin 100 mg tablet), Materna CC (clomifene 50 mg tablet), and Carmuta carboplatin injections in 150 mg/15 ml and 450 mg/45 ml presentations, both at 10 mg/ml. The continuation date is December 12, 2024, for the two Ramipro strengths and December 7, 2024, for the other six entries.

MSD Pharmaceuticals Pvt. Ltd has two entries. Its application for the brand-specific Isentress raltegravir 400 mg tablets was dated January 20, 2025. The list states that importing Isentress after January 1, 2022, violated the applicable requirement because the Indian Pharmacopoeia mandates a heavy-metal test unlike the US Pharmacopeia. NPPA’s final direction was dated September 1, 2025; the continuation date was June 9, 2025, and the public-notice date was April 12, 2023. MSD’s second entry, Temodal temozolomide 100 mg capsules, followed an application dated August 20, 2025. Its recorded reason refers to the availability of 23 alternative generic brands as adequate substitutes. The final direction was dated February 27, 2026, the continuation date February 20, 2026, and the public-notice date August 13, 2025.

Jenburkt Pharmaceuticals Ltd applied on February 24, 2025, for Itriben itraconazole 100 mg capsules, describing the product as non-moving. NPPA’s final direction was dated April 3, 2025; the continuation date was August 24, 2025, and the public notice was issued on February 24, 2025. Novartis India Limited’s entry covers Zometa zoledronic acid 4 mg injection. Its March 21, 2025, application cited the Novartis Group’s portfolio-optimisation strategy. The final direction was dated September 19, 2025, the continuation date March 31, 2026, and the public-notice date March 21, 2025. FDC Limited cited very poor sales offtake for Fungotek terbinafine 1% cream. Its application was dated May 2, 2025, its final direction May 23, 2025, its continuation date July 1, 2025, and its public notice April 29, 2025.

The remaining four entries concern Cipla Ltd’s Doncept donepezil tablets in 5 mg and 10 mg strengths and Migarid flunarizine tablets in 5 mg and 10 mg strengths. Each cites low demand for the company’s brand and insignificant market share. Cipla’s application for Doncept 5 mg was dated November 7, 2025; the other three applications were dated November 9, 2025. NPPA’s final directions for all four were dated December 31, 2025, and their public notices were issued on November 4, 2025. The listed continuation date is May 7, 2026, for Doncept 5 mg and May 9, 2026, for Doncept 10 mg and both Migarid strengths.