National Formulary of India lists drugs not approved by CDSCO, DCGI seeks

Benchmarks Nifty22,622.70-99.25FEATURED FUNDS★★★★★UTI Aggressive Hybrid Fund Regular Plan-Growth5Y Return8.71 % Invest NowFEATURED FUNDS★★★★★Motilal Oswal Midcap Fund Direct-Growth5Y Return19.29 % Invest NowEnter search text:

The Economic Times daily newspaper is available online now. Read Today's Paper National Formulary of India lists drugs not approved by CDSCO, DCGI seeks explanation from IPCBy Vikas Dandekar, ET BureauLast Updated: Oct 09, 2026, 11:48:00 PM ISTSynopsis

The National Formulary of India released its latest edition amidst concerns regarding unapproved drugs included in it. The Drug Controller General of India has communicated with the Indian Pharmacopoeia Commission regarding this discrepancy. Several drugs listed in NFI 2026 have not received approval from the Central Drugs Standard Control Organisation. Stakeholders have also raised complaints about the unavailability of the online version of NFI 2026.

Listen to this article in summarized format

Loading...×Mumbai: The latest edition of the National Formulary of India (NFI), a reference manual for medical and pharmaceutical professionals and students, includes several drugs that are yet to be cleared by the central drug regulator.

The Drug Controller General of India (DCGI) has flagged the discrepancy in a communication to the Indian Pharmacopoeia Commission, a body under the union health ministry that publishes the reference document. It has sought the rationale for the inclusion of drugs that are not approved by the Central Drugs Standard Control Organisation (CDSCO), a senior government official told ET.

Also read: Health ministry proposes curbs on prescription drug ads by retailers, wholesalers and distributors

The 7th Edition of the NFI was released on September 21. The CDSCO, which was represented on the NFI core committee, had raised the issue while discussions were happening on the preparation of the document, but unapproved drugs still found their way into it, said another person aware of the matter. "The issue was raised based on the CDSCO's position in the committee and as a final check the note was sent to IPC as it started its launch plans," the person said.

In the note sent in August, the DCGI said the Indian Pharmacopoeia Commission (IPC), NFI and all other activities of the IPC formed an integral part of the regulatory ecosystem of the country and that "the discrepancy may have international implications and therefore requires an urgent response", according to the person.

Live Events

When contacted by ET, an official from the Indian Pharmacopoeia Commission said the best possible efforts were made not to include drugs that are not approved by the CDSCO in NFI 2026.

ET's email seeking comment to the DCGI, who heads the CDSCO, went unanswered.

The National Formulary of India is an authoritative guide to prescribing, dispensing and administering medicines.

ET found that at least five drugs or their variants in NFI 2026 were not approved. These were methylene blue 10 mg/ml injection; flumazenil injection 0.1 mg/ml; folinic acid injection 3mg/ml and 15 mg tablet; pyridostigmine 30, 60 and 180 mg tablets; and alteplase 20 and 50 mg injection vials. There are many more, according to people aware of the matter.

In a letter sent after the publication of the reference manual, the DCGI said various stakeholders had complained about the non-availability of the online version of NFI 2026. It termed the non-availability as a "serious concern".
Add as a Reliable and Trusted News Source Add Now!
(You can now subscribe to our Economic Times WhatsApp channel)
Read More News onNational Formulary of IndiaCDSCOIndian Pharmacopoeia Commissionmethylene blue injectionflumazenil injection

(Catch all the Business News, Breaking News and Latest News Updates on The Economic Times.)

...moreless
(You can now subscribe to our Economic Times WhatsApp channel)
Read More News onNational Formulary of IndiaCDSCOIndian Pharmacopoeia Commissionmethylene blue injectionflumazenil injection

(Catch all the Business News, Breaking News and Latest News Updates on The Economic Times.)

...morelessContinue reading with one of these options:Limited AccessFreeLogin to get access to some exclusive stories
& personalised newslettersLogin NowUnlimited AccessStarting @ Rs120/monthGet access to exclusive stories, expert opinions &
in-depth stock reportsSubscribe NowET

Unlock Access to All Exclusives with ETPrime FREE TRIAL

15 Days Free: Unlock All ETPrime Exclusives, Market Tools & ePapers

Trial offer expiring in00 : 05 : 00

I'd rather pay ₹2599 now

Uh-oh! This is an exclusive story available for selected readers only.

Worry not. You’re just a step away.

Prime Account Detected!

It seems like you're already an ETPrime member with

Login using your ET Prime credentials to enjoy all member benefits

Log out of your current logged-in account and log in again using your ET Prime credentials to enjoy all member benefits.

Unlock ETPrime's Exclusive Stories Today!

Big Price Drop! Flat 40% Off

Student Only OfferAlready a Member? Sign In nowAlready a Member? Sign In nowAlready a Member? Sign In now

Offer Exclusively For You

Save up to Rs. 700/-

ON ET PRIME MEMBERSHIP

Avail Offer

Offer Exclusively For You

Get 1 Year Free

With 1 and 2-Year ET prime membership

Avail Offer

Offer Exclusively For You

Get 1 Year Free

With 1 and 2-Year ET prime membership

Avail Offer

Offer Exclusively For You

Get Flat 40% Off

Then ₹ 1749 for 1 year

Avail Offer

Offer Exclusively For You

ET Prime at ₹ 49 for 1 month

Then ₹ 1749 for 1 year

Avail Offer

Special Offer

Get flat 40% off on ETPrime

Avail OfferAvail OfferClaim NowAlready a Member? Sign In now

Need Assistance?

Connect with an ETPrime expert for personalized support and guidance

+91 9484700004'; }); } if(listing) { var h3 = "You tried reading " + listArr.length + " locked stories in the past " + threshold + " days.", h4 = "Become an ET Prime member and don't miss out on these exclusive stories."; var html = '

' + h3 + '

' + h4 + '

' + listing + '

'; $('#paidSCWidget').html(html); var callback = $('#paidSCWidget').attr('data-callback'); if(callback && window[callback]) { window[callback](); } customDimension.dimension72 += ' | Shown SYFT no Trial_With Missed Paywalled Articles Collection'; } else { _processNormal() } } }); } else { _processNormal(); } } catch (e) { _processNormal(); } }, function () { _processNormal(); }); //console.log('storyCollectionLoad', $); }

What’s Included with

ETPrime Membership

1Exclusive Insights That Matter

Uncover the truth with our investigative stories

Make strategic moves using the real-world case studies

Read industry-specific stories to identify emerging trends

Spot opportunities with
in-depth insights that matter

• Trump temper on H-1B visas is forcing Indians to do these things to stay put in US

  What Adani’s US indictment means for India Inc’s overseas fundraising

• Why veterans like Reliance, L&T are on acquisition spree? Aswath Damodaran has an answer.

  Will China’s dollar bond sale in Saudi Arabia trump the US in financial world?

• Huawei launches its own OS to compete with Google and Apple. But can it win beyond China?

  The problem with lab grown diamonds

• Why a falling rupee is a better option for the economy

  A list of top 20 momentum stocks that have delivered massive returns in one year

2Invest Wisely With Smart Market Tools & Investment Ideas

Alpha Trade

Get daily trade ideas from SEBI-registered research analysts.

Investment Ideas

Grow your wealth with stock ideas & sectoral trends.

Stock Reports Plus

All-in-one stock research with Stock Score, peer comparison & key signals.

BigBull Portfolio

Get to know where the market bulls are investing to identify the right stocks.

Stock Analyzer

Check the score based on the company's fundamentals, solvency, growth, risk & ownership to decide the right stocks.

Market Mood

Analyze the market sentiments & identify the trend reversal for strategic decisions.

Stock Talk Live at 9 AM Daily

Ask your stock queries & get assured replies by ET appointed, SEBI registered experts.

3Stay informed anytime, anywhere with ET ePaper

ePaper - Print View

Read the PDF version of ET newspaper. Download & access it offline anytime.

ePaper - Digital View

Read your daily newspaper in Digital View & get it delivered to your inbox everyday.

Wealth Edition

Manage your money efficiently with this weekly money management guide.

TOI ePaper

Read the PDF version of TOI newspaper. Download & access it offline anytime.

Deep Explainers

Explore the In-depth explanation of complex topics for everyday life decisions.

Health+ Stories

Get fitter with daily health insights committed to your well-being.

Personal Finance+ Stories

Manage your wealth better with in-depth insights & updates on finance.

5Enjoy Complimentary Subscriptions From Top Brands

Stream new documentaries from all across the world every day.

Stories you might be interested in