NPPA Retail Prices for 23 New Drugs: 2026 Compliance Order
NPPA retail prices for 23 new drugs under DPCO 2013: check price caps, Form-IA rules and deadlines. Book a free consultation with us now for compliance support.
Schedule a Call Back
Businesses we've worked with on drug licence
Clients include Cure and Care Wellness, 1008 Digital Health, Nfilade Security Solutions, Evoq Technologies, Kantika Import Export and Trading, Rock Well Industries, Abhay Healthtech, Hind Svasthya Healthcare, Pridus Global Pharma, Arka Brenstech, Believe Cosmetics, Imedicndr Healthcare (12 of 40+ served since 2018).
A few more clients we've served in this industryHide the list
- Clients include
- Cure and Care Wellness · 1008 Digital Health · Nfilade Security Solutions · Evoq Technologies · Kantika Import Export and Trading · Rock Well Industries · Abhay Healthtech · Hind Svasthya Healthcare · Pridus Global Pharma · Arka Brenstech · Believe Cosmetics · Imedicndr Healthcare · Katre Enterprises · Soapsquare Healthcare · Xsourcee
National Pharmaceutical Pricing Authority (NPPA) has come up with retail prices of 23 new drug formulations under the newly released DPCO 2013 order of NPPA. The order was published on 31 July 2026 and involves medicines in various classes such as cardiovascular drugs, diabetes medicines, analgesics, antimicrobials, iron & nutritionals.
The NPPA retail prices for 23 new drugs are maximum per-unit prices, not a general price suggestion. They exclude Goods and Services Tax (GST). A manufacturer may add GST only where it has actually paid the tax or the tax is payable to the Government. Pack prices must be worked out from the notified unit price under paragraph 11 of DPCO 2013.
This order applies to the listed manufacturers/marketing firms. Other existing manufacturers can introduce the same new medicine within 12 months without a fresh price application, however, they have to abide by the ceiling price and submit Form-IA using IPDMS 2.0 within a month after the introduction of the product.
NPPA Retail Prices for 23 New Drugs at a Glance
NPPA has fixed the retail prices of 23 new drugs in its order dated 30 July 2026. The order sets out the prices applicable to the listed formulations and the companies covered by it.
| Particular | Verified details |
| Issuing authority | National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers |
| Document type | Gazette order fixing retail prices of new drugs |
| Order number | S.O. 4264(E) |
| Gazette details | Gazette of India Extraordinary, Part II, Section 3, Sub-section (ii), No. 4088 |
| Gazette identification | CG-DL-E-31072026-275036 |
| Proceeding and file reference | PN/281/149/2026/F, F. No. 8(149)/2026/D.P./NPPA-Div.-II |
| Authority decision | 281st overall and 149th DPCO meeting, 30 July 2026 |
| Order and publication date | 31 July 2026 |
| Separate future effective date | Not expressly specified, the order applies from its notification/publication |
| Governing law | Paragraphs 5, 11 and 15 of DPCO 2013, read with S.O. 1394(E), S.O. 5249(E) and S.O. 3516(E) |
| Products covered | 23 specified formulations, strengths and units |
| Main stakeholders | Named manufacturers and marketers, eligible follow-on existing manufacturers, dealers, retailers, State Drug Controllers |
| Nature of price | Maximum retail price per notified unit, exclusive of GST |
| Follow-on launch window | Same new drug may be launched by another existing manufacturer within 12 months of Gazette publication, subject to conditions |
| Follow-on filing deadline | Form-IA with supporting documents within one month of launch |
| Separate compliance fee | Not specified in the order |
The Regulatory Framework
NPPA acts under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. DPCO 2013 was issued under section 3 of the Essential Commodities Act, 1955. It supports price control, compliance monitoring and recovery of overcharged amounts. DPCO 2013 must be read with the 2026 Amendment Order.
What “new drug” means in this price order
The term does not necessarily mean a newly discovered active ingredient. Paragraph 2(1)(u) covers an existing manufacturer's formulation that combines an NLEM-listed dosage or strength with another drug, whether listed or not, or changes the strength, dosage, or both. An established medicine can therefore still be a “new drug” for DPCO pricing.
Role of paragraphs 5, 11 and 15
Paragraph 5 provides the pricing method, paragraph 15 governs the application route, and paragraph 11 converts a unit price into a pack price. The order does not publish a calculation sheet for each entry. Businesses cannot replace its figures with their own market calculation.
The 2026 amendment changes the follow-on route
S.O. 3516(E), issued on 1 July 2026, has changed what an existing manufacturer can do after NPPA fixes the price of a new drug. The first manufacturer still needs prior approval in Form-I. But if another manufacturer wants to launch the same drug, it can do so within 12 months without filing another price application, provided the product is an exact match. It must:
- keep its price at or below the latest notified retail price, plus applicable tax,
- intimate the launch in Form-IA within one month,
- file through IPDMS 2.0, and
- support the filing with the records specified by NPPA.
NPPA's 16 July clarification limits this route to prices notified on or after 1 July 2026 and requires the exact composition of the reference new drug. S.O. 4264(E) qualifies.
What Has Changed
The order does not give a separate reason for the price fixation. Under DPCO 2013, its purpose is to put approved prices into effect as maximum retail prices for NLEM-linked combinations and drugs with changed strengths.
| Compliance area | Earlier position | Position under this notification | Business meaning |
| Price for the 23 listed products | No price under this order | Specific maximum retail price per unit | Named companies must not exceed the stated amount |
| Pack pricing | Applicant proposed or existing commercial pack price | Pack price must be derived from the notified unit price under paragraph 11 | Packaging, billing and ERP masters need recalculation |
| GST | Commercial treatment could vary | GST may be added only if actually paid or payable | Tax cannot be used as an unsupported price addition |
| Follow-on launch | Before the 2026 amendment, notified prices generally applied to the applicant manufacturer and marketer | Another existing manufacturer may launch the exact same new drug within 12 months at no more than the notified price | Duplicate price applications are removed for this limited route |
| Follow-on filing | Separate approval route applied | Form-IA through IPDMS 2.0 within one month of launch | Filing is an intimation, but it remains mandatory |
| Retail display | General DPCO price-list duty | Retailers and dealers must display the price list and any supplement visibly | Distribution controls must extend to the point of sale |
Complete list of 23 notified formulations and prices
All prices below are exclusive of GST and apply to the unit shown. The Gazette contains no brand names for these entries, it identifies formulations and manufacturer-marketer combinations.
| No. | Formulation and notified strength | Manufacturer/marketing company | Unit | Retail price |
| 1 | Atorvastatin 10 mg + clopidogrel 75 mg + aspirin 75 mg capsule | Akums Drugs & Pharmaceuticals / Sun Pharma Laboratories, Akums Drugs & Pharmaceuticals / Sun Pharmaceutical Industries | 1 capsule | Rs. 6.37 |
| 2 | Atorvastatin 20 mg + clopidogrel 75 mg + aspirin 75 mg capsule | Akums Drugs & Pharmaceuticals / Sun Pharma Laboratories, Akums Drugs & Pharmaceuticals / Sun Pharmaceutical Industries | 1 capsule | Rs. 8.89 |
| 3 | Clonazepam 0.5 mg + paroxetine 12.5 mg controlled-release bilayered tablet | Akums Drugs & Pharmaceuticals / Mankind Pharma | 1 tablet | Rs. 17.52 |
| 4 | Clonazepam 0.5 mg + paroxetine 25 mg controlled-release bilayered tablet | Akums Drugs & Pharmaceuticals / Mankind Pharma | 1 tablet | Rs. 20.06 |
| 5 | Desvenlafaxine 50 mg extended release + clonazepam 0.5 mg bilayered tablet | Pure and Cure Healthcare / Mankind Pharma | 1 tablet | Rs. 17.47 |
| 6 | Desvenlafaxine 100 mg extended release + clonazepam 0.5 mg bilayered tablet | Pure and Cure Healthcare / Mankind Pharma | 1 tablet | Rs. 25.83 |
| 7 | Escitalopram 5 mg + clonazepam 0.5 mg tablet | Windlas Biotech / Ipca Laboratories | 1 tablet | Rs. 10.72 |
| 8 | Etoricoxib 60 mg + paracetamol 325 mg tablet | JK Print Pack (Pharma Division) / Torrent Pharmaceuticals | 1 tablet | Rs. 10.90 |
| 9 | Ferrous ascorbate equivalent to elemental iron 100 mg + folic acid 1.5 mg tablet | Crius Life Sciences / Eris Lifesciences | 1 tablet | Rs. 16.92 |
| 10 | Iron (III) hydroxide polymaltose complex equivalent to elemental iron 50 mg + folic acid 0.5 mg per 15 ml syrup | Skymap Pharmaceuticals / German Remedies Pharmaceuticals | 1 ml | Rs. 0.28 |
| 11 | Per 5 g sachet: vitamin D3 1000 IU + myo-inositol 2000 mg + D-chiro inositol 50 mg powder | Safetab Life Science / Anax Lifescience | 1 g | Rs. 9.29 |
| 12 | Per 5 ml: ofloxacin 100 mg + metronidazole 200 mg suspension | Hema Laboratories / Aristo Pharmaceuticals | 1 ml | Rs. 1.09 |
| 13 | Per 5 ml: ofloxacin 50 mg + metronidazole 100 mg suspension | Hema Laboratories / Aristo Pharmaceuticals | 1 ml | Rs. 0.86 |
| 14 | Paracetamol 500 mg per 5 ml oral suspension | Naxpar Pharma / GlaxoSmithKline Pharmaceuticals | 1 ml | Rs. 0.66 |
| 15 | Telmisartan 40 mg + metoprolol tartrate equivalent 25 mg extended-release tablet | Windlas Biotech / FDC | 1 tablet | Rs. 15.01 |
| 16 | Telmisartan 40 mg + metoprolol tartrate equivalent 50 mg extended-release tablet | Windlas Biotech / FDC | 1 tablet | Rs. 18.50 |
| 17 | Telmisartan 40 mg + chlorthalidone 6.25 mg + metoprolol tartrate equivalent 50 mg extended-release tablet | Mascot Health Series / Mankind Pharma | 1 tablet | Rs. 11.77 |
| 18 | Telmisartan 40 mg + chlorthalidone 6.25 mg + metoprolol tartrate equivalent 25 mg extended-release tablet | Mascot Health Series / Mankind Pharma | 1 tablet | Rs. 11.67 |
| 19 | Nebivolol 2.5 mg + telmisartan 40 mg bilayered tablet | Windlas Biotech / Torrent Pharmaceuticals | 1 tablet | Rs. 13.70 |
| 20 | Sitagliptin 100 mg + glimepiride 2 mg + metformin 1000 mg extended-release tablet | Exemed Pharmaceuticals / Alkem Laboratories, Exemed Pharmaceuticals / Sun Pharma Laboratories, Exemed Pharmaceuticals / Torrent Pharmaceuticals | 1 tablet | Rs. 19.46 |
| 21 | Sitagliptin 100 mg + glimepiride 1 mg + metformin 1000 mg extended-release tablet | Exemed Pharmaceuticals / Alkem Laboratories, Exemed Pharmaceuticals / Sun Pharma Laboratories, Exemed Pharmaceuticals / Torrent Pharmaceuticals | 1 tablet | Rs. 17.73 |
| 22 | Combikit strip: two clarithromycin 500 mg tablets, two pantoprazole 40 mg tablets and two amoxicillin 1000 mg tablets | Malik Lifesciences / Aristo Pharmaceuticals | 1 strip | Rs. 122.56 |
| 23 | Dapagliflozin 10 mg + pioglitazone 15 mg + metformin 1000 mg sustained-release bilayered tablet | Eris Lifesciences | 1 tablet | Rs. 18.77 |
Liquid and powder prices are per millilitre or gram even where composition is described for a larger quantity. The Gazette does not state a final bottle or sachet MRP.
Implementation Timeline/Norms
The revised DPCO framework changes how affected drug prices are notified, making timely compliance important for pharmaceutical manufacturers and marketers.
| Event or requirement | Date or period | Affected party | Required action |
| DPCO Amendment Order, 2026 took effect | Publication on 1 July 2026 | Pharmaceutical manufacturers and marketers | Apply the revised paragraph 15 and Form-IA framework to retail prices notified from this date |
| NPPA approved the 23 prices | 30 July 2026 | Applicant companies | Note the Authority decision |
| S.O. 4264(E) was issued and published | 31 July 2026 | Named manufacturers and marketers | Implement the notified maximum unit prices and related duties |
| Price list in Form-V | From the date of notification, no separate grace period is stated in S.O. 4264(E) | Named manufacturer/marketer | Issue through IPDMS and provide copies to the State Drug Controller and dealers |
| Follow-on launch of same new drug | Within 12 months of Gazette publication | Other existing manufacturers | Do not exceed the notified retail price, confirm exact composition and eligibility |
| Form-IA for follow-on launch | Within one month of launch | Follow-on manufacturer | File online through IPDMS 2.0 with supporting documents |
| Retail price-list display | Ongoing | Retailers and dealers | Display the manufacturer-supplied price list and supplement prominently |
No transition period or future effective date is stated. Gazette publication is the operative event. The Form-IA month runs from the follow-on launch date.
Why This Was Implemented
S.O. 4264(E) gives no separate statement of reasons. Under DPCO 2013, it converts NPPA's approval of price applications into enforceable maximum retail prices for NLEM-linked combinations or changed strengths.
The statutory scheme also supports three practical aims:
- price certainty for the named manufacturers, marketers, distributors and retailers,
- a consistent maximum for another existing manufacturer launching the same formulation during the 12-month window, and
- a traceable system of price lists, IPDMS filings and point-of-sale display.
The 2026 amendment reduces duplicate applications but keeps oversight through the price cap, Form-IA and supporting evidence.
Impact on Businesses
The new pricing order affects more than drug prices, with manufacturers, retailers, finance and compliance teams all facing practical changes.
- Named manufacturers and marketing companies
The companies in column 5 must align pricing, packaging, tax, invoices and product masters with the Gazette. Only GST actually paid or payable may sit above the unit figure.
Pack sizes create execution risk. The liquids are priced per ml and the powder per gram. Finance and packaging teams must derive pack value under paragraph 11 rather than price the larger composition reference quantity as one unit.
- Other existing manufacturers
The faster route applies only to an exact match. A different strength, release profile, dosage form or composition may require prior Form-I approval. A follow-on manufacturer cannot launch above the cap and regularise later. It should document its comparison with the Gazette row NPPA warns that false Form-IA claims may lead to proceedings.
- Dealers and retailers
Retailers and dealers must display the supplied price list and any supplement prominently and keep billing data from using a higher price.
- Compliance, finance and supply-chain teams
Regulatory Affairs must classify the row and filing process, finance will verify unit and pack pricing, taxation will confirm GST, Distribution will distribute the price list and the technology team will update IPDMS, ERP, and billing systems. Internal audit needs to test products and channels.
- Commercial cost and operational burden
There is no fee and no cost of implementation mentioned. The probable business cost will include calculation of pack price, label verification, system updates, dealer communication, Form IA and record keeping.
How Businesses Will Achieve Compliance
Affected companies should use this source-based control plan.
- Confirm Product Identity and Role: Match the name, strength, dosage form, release type, unit and manufacturer-marketer arrangement. Determine whether the business is named, launching a follow-on product or selling it.
- Check the Unit Price: Column 6 gives the maximum price before GST. Use that figure as it is and do not round it up.
- Work Out the Pack Price: The final pack price should be calculated from the notified unit price under paragraph 11. This needs extra care for liquids, powders and the combi kit strip.
- Check the GST Amount: GST can be added only if it is actually paid or payable. Keep the supporting tax records with the pricing file.
- Send the Form-V Price List: The price list needs to be filed through IPDMS and shared with the State Drug Controller and dealers. Keep proof that it was circulated.
- Update Your Systems: Check the MRP on labels, ERP, invoices and billing records. Retailers should also display the latest price list.
- Check Form-IA Eligibility: Use Form-IA only for an exact product match launched within the 12-month window and priced within the notified cap. File it through IPDMS 2.0 within one month of launch.
- Keep Your Records: Keep the product comparison, price calculation, GST proof, filing receipt and circulation records. The required records must be kept for at least seven financial years.
Form-IA information and supporting documents
Form-IA asks for the basic details of the drug and the company. This includes the approved composition, date of launch, dosage form, pack size, therapeutic category, launch price without GST, and the latest notified price and date.
For a follow-on filing, NPPA’s office memorandum dated 16 July 2026 also asks for some supporting documents:
| Supporting Record | Compliance Purpose |
| Approval for the new drug formulation granted by the Drugs Controller General (India) | Shows central regulatory approval |
| Currently valid manufacturing permission from the State Licensing Authority | Shows valid manufacturing authority |
| Declaration that the new drug formulation is not prohibited by DCGI or the Ministry of Health and Family Welfare | Confirms absence of a stated prohibition |
| Declaration on non-discontinuation or non-reduction of production of the NLEM 2022 scheduled formulation combined with the new drug, or whose strength is changed | Addresses continued availability of the scheduled component |
| CA or CMA-certified quarterly production and sales for the last six quarters for the scheduled component | Supports the production and sales position |
| New-drug category under the Kokate Committee report for fixed-dose combinations | Records the FDC category |
| Status of the new drug under the Drugs Technical Advisory Board | Records the DTAB position |
These records belong to the follow-on Form-IA route, not every drug-price application.
Compliance consequences
A manufacturer or marketer that charges more than the permitted price may have to deposit the excess amount with interest under DPCO 2013 and the Essential Commodities Act, 1955. The order does not specify a fixed fine or interest rate.
Benefits for Businesses
The order creates price certainty while preserving control.
- A Clear Launch Ceiling: Each covered product has a verified per-unit maximum, reducing uncertainty in pricing decisions.
- One Supply-chain Reference: Manufacturers, marketers, distributors and retailers can use the same Gazette figure.
- Lower Duplication: Eligible follow-on manufacturers can use Form-IA within the 12-month window.
- Faster Portfolio Review: Companies can check their proposed formulation against the notified rows before moving ahead.
- Better Audit Readiness: The order identifies the price, unit and parties.
- Transparent Retail Pricing: Display duties and a cap can reduce confusion.
- Recorded Controls: IPDMS, Form-V and Form-IA create an implementation trail.
These benefits depend on exact product matching and correct unit-to-pack conversion.
Is This a Right Decision or Additional Burden?
The order gives businesses and consumers a clear maximum price for the covered NLEM-linked formulations. For an eligible exact-match follow-on launch, it also means another price application is not needed.
The practical side is harder. The notified prices use different units for tablets, capsules, liquids, powders and combikits. Manufacturers also have to get the tax, packaging, billing and distribution details right. There is no separate transition period in the order. Smaller manufacturers may also need to spend more time checking whether their product qualifies and putting together the Form-IA documents.
So, the impact will depend largely on how well the manufacturer has its product and pricing records in place.
Business Opportunities Created
- S.O. 4264(E) creates practical business opportunities around compliant product launches, pricing implementation and regulatory support rather than creating a new market entitlement.
- Manufacturers can assess exact-match follow-on launches during the 12-month window.
- Contract manufacturers may support eligible products, subject to applicable approvals and pricing conditions.
- Regulatory advisers can provide regulatory compliance services, map products, assess Form-I or Form-IA requirements and support IPDMS filing.
- Finance and technology providers can configure pack pricing, GST rules, ERP systems and audit reports.
- Compliance and audit teams can test price-list circulation, invoices, retail display and supporting evidence.
- Training providers can brief sales, distribution and retail teams on the updated pricing requirements.
The commercial value lies in helping businesses make quicker launch decisions while reducing pricing, documentation and filing risks. It does not guarantee higher sales or market access.
How Corpseed Can Help?
Corpseed provides regulatory compliance services based on the product, formulation and specific role of the business. The support is designed to help manufacturers and marketers understand their obligations before they move ahead with pricing, filing, printing or distribution.
Regulatory Compliance Services for Manufacturers and Marketers
- Applicability assessment against the 23 notified formulations, strengths, units and company combinations.
- Product regulatory consulting to distinguish a named-product obligation from an eligible exact-match follow-on launch.
- Pack-price and GST compliance review against the notified per-unit ceiling.
- Form-I or Form-IA route analysis, IPDMS 2.0 filing support and document coordination.
- Form-V price-list review and circulation control for State Drug Controllers and dealers.
- Compliance gap assessment covering packaging, ERP, invoices, distribution and retail display.
- Manufacturer compliance services for evidence files, record retention and audit readiness.
- Ongoing compliance support for later NPPA clarifications, inspections or price-related queries.
Corpseed helps businesses interpret the order, organise supporting records and implement the appropriate workflow without guaranteeing approval or processing timelines.
Manufacturers and marketers can seek compliance consulting services before filing applications, printing packaging or distributing stock, particularly where product composition, eligibility or pack pricing requires closer review.
Final Takeaway
The new NPPA prices are not just reference figures. They are the maximum prices that apply to the 23 listed drugs from the Gazette notification dated 31 July 2026.
Manufacturers and marketers covered by the order need to check their pack prices, GST, Form-V filing and IPDMS records. The updated price information also has to reach dealers, while retailers and dealers need to display it properly.
About the Author
Parul Bohral
Legal Content WriterParul Bohral, a BALLB graduate and experienced legal researcher and content writer with expertise in various legal areas, including corporate law and intellectual property. I have gained valuable experience in esteemed legal environments, where I have strengthened my research skills, allowing me to approach legal writing with precision and depth.
As a legal content writer, I am committed to delivering work that not only informs but also engages readers. By staying informed about the latest trends in content marketing and regulatory developments, I ensure that my writing remains sophisticated and meets industry standards. My dedication to thorough research enables me to craft content that is both insightful and impactful.