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Government Notifies New Drug Prices: NPPA Clarifies GST Applicability on 11 Formulations - CAclubindia

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The National Pharmaceutical Pricing Authority (NPPA) has notified the retail prices of 11 new drug formulations, acting under the powers granted by the Drugs (Prices Control) Order, 2013. The detailed order, published in the Gazette of India, specifies the retail prices (excluding GST) along with the drug strengths, units, and the names of manufacturers and marketing companies.

The notification, issued as S.O. 5476(E), applies to formulations submitted through Form-I for price fixation or revision under the DPCO framework.

Key Highlights of the NPPA Price Fixation Order

1. Retail Prices Fixed for 11 Formulations

The NPPA has approved retail prices for a range of cardiovascular, antibiotic, anti-allergic, anti-diabetic, and combination drugs. Some key price approvals include:

  • Bisoprolol Fumarate & Telmisartan Tablets (2.5 mg/40 mg) - Rs 10.49 per tablet, manufactured by Windlas Biotech, marketed by Intas Pharmaceuticals.
  • Ceftriaxone & Sulbactam Injection (250 mg/125 mg) - Rs 65.30 per vial, manufactured by Innova Captab, marketed by Dr. Reddy's Laboratories.
  • Levocetirizine & Montelukast Syrup - Rs 1.48 per ml, manufactured by East African (I) Overseas, marketed by SRK Puremed LLP.
  • Teneligliptin + Dapagliflozin + Metformin SR Tablet - Rs 12.15 per tablet, manufactured by Synokem Lifesciences, marketed by Glenmark Pharmaceuticals.

The highest priced formulation in the notification is Ceftriaxone + EDTA + Sulbactam (2000 mg/74 mg/1000 mg), fixed at Rs 1,140.26 per vial.

2. GST May Be Added Only If Paid

Manufacturers may levy GST only if it is actually payable to the government on the notified retail price. This prevents unjustified price inflation at the retail level.

3. Mandatory Requirement to Issue Price Lists

Manufacturers of these drugs must:

  • Issue a Form-V price list for all approved formulations from the date of notification
  • Submit it to NPPA via the IPDMS portal
  • Provide copies to State Drug Controllers and all dealers

Retailers and dealers must display these price lists prominently on their premises as required under Paragraph 24(4) of DPCO 2013.

4. Non-Compliance Will Trigger Recovery of Overcharged Amount

If a manufacturer or marketer sells above the notified retail price:

  • They will be required to deposit the overcharged amount with interest
  • Action will be taken under DPCO 2013 read with the Essential Commodities Act, 1955

This ensures strict enforcement of ceiling and retail price controls.

5. Earlier Price Orders Stand Superseded

Any previous price orders for these formulations-issued for the same strength and the same manufacturer/marketer-are deemed superseded with immediate effect.

Implications for the Pharma Industry

This notification is significant for the pharmaceutical sector as it:

  • Brings price clarity for new drug formulations that recently entered the market
  • Ensures affordability for critical therapeutic categories, especially antibiotics and chronic-care medicines
  • Reinforces compliance requirements under India's price-control regime
  • Requires manufacturers and marketers to immediately realign MRPs, packaging, and supply chain documentation

With increasing scrutiny under DPCO 2013, companies must ensure that all retail sales strictly follow NPPA's notified rates.

Conclusion

The 28 November NPPA order provides updated, legally binding retail prices for 11 important formulations across multiple therapeutic classes. Manufacturers and retailers are now obligated to comply with the new rates, issue mandatory price lists, and ensure transparent price display to consumers.

This move continues NPPA's push toward improving affordability and strengthening price regulation across India's pharmaceutical ecosystem.

Official copy of the notification has been attached