Drug Licence Renewal in India 2026: Validity, Fees, Retention & Process

If you own a medical store or pharmacy in India, understanding the drug licence renewal process, validity period, retention fees and deadlines is essential to keeping your business legally operational.

One important change that many pharmacy owners are still unaware of is that most retail and wholesale drug licences no longer require traditional renewal every five years. Instead, they remain valid subject to payment of a drug licence retention fee every five years and continued compliance with licensing conditions.

This guide explains the rules applicable in 2026, including Form 20 and Form 21 validity, drug licence renewal fees, retention deadlines, late charges, required documents and the online process.

Last updated: October 30, 2026

Drug Licence Renewal 2026: Quick Answer

Drug licences covered by Rule 63 of the Drugs and Cosmetics Rules, 1945, remain valid without a fixed expiry date, provided the licensee pays the required retention fee every five years and the licence is not suspended or cancelled.

Under the amendment introduced through G.S.R. 1337(E) on 27 October 2017, periodic renewal was replaced by a licence retention system.

The main requirements are:

1. What Is the Validity Period of a Drug Licence in India?

The drug licence validity period in India is perpetual for licences covered by Rule 63, subject to payment of the prescribed retention fees and continued compliance with the law.

Earlier, drug licences were issued for a fixed period of five years and required renewal.

This changed on 27 October 2017 when the government introduced the Drugs and Cosmetics (Tenth Amendment) Rules, 2017.

Under the amended Rule 63:

• A covered drug licence remains valid unless suspended or cancelled.
• The licensee must pay a retention fee every five years.
• The licensing authority can conduct inspections to verify compliance.
• Failure to pay retention fees within the permitted period can result in cancellation.

This means that drug licence validity and the five-year retention period are not the same thing.

A licence does not normally expire automatically after five years simply because its fifth anniversary has arrived. However, the retention fee becomes due, and failing to pay it within the prescribed period has serious consequences.

Form 20 and Form 21 Drug Licence Validity Period

Forms 20 and 21, the two licences most retail pharmacies hold, both fall under Rule 63, along with the wholesale and Schedule X sale licences:

Rule 63 also covers Forms 20A, 20BB, 21A and 21BB.

Therefore, if your pharmacy holds Form 20 and Form 21, both licences remain valid subject to payment of their respective retention fees and compliance with licensing conditions.

For more information about licence categories, read our guide to the types of drug licences in India.

2. Drug Licence Renewal vs Retention: What Is the Difference?

The law no longer uses the word renewal for these licences. Since 2017, the retail and wholesale licences covered by Rule 63 are retained, not renewed, and the difference is important.

What Does Drug Licence Retention Mean?

Drug licence retention means maintaining the validity of an existing drug licence by paying the required fee within the prescribed period.

For example, suppose a medical store received its drug licence in November 2021.

Its first five-year period ends on the fifth anniversary of the issue date in November 2026, and the owner must pay the retention fee before that date.

The pharmacy does not ordinarily need to apply for a completely new licence merely because five years have passed.

However, changes in ownership, constitution, premises or technical personnel may require separate applications or approvals.

What Does Licence Retention Mean in Hindi?

Licence retention ka matlab hai apne existing drug licence ko valid banaye rakhne ke liye har 5 saal mein prescribed fee jama karna.

Retail aur wholesale drug licences ke liye har 5 saal mein naya licence banwana generally zaroori nahi hota, lekin retention fee time par jama karna zaroori hai.

3. Drug Licence Renewal Fees in India 2026

The drug licence retention fee is equivalent to the respective fee required for the grant of the licence, as stated in Rule 63(2), so the amount depends on the type of drug licence held.

The grant fees for common sale licences are set by Rule 59(2) of the Drugs and Cosmetics Rules, 1945, as listed in the Delhi Drugs Control Department's published sale-licence fee schedule:

Source: Delhi Drugs Control Department — Sale Licence Forms, Fees and Retention Guidelines. Check the applicable government portal for the final payable amount, any additional charges and current requirements.

Example: Drug Licence Retention Fee for Form 20 and Form 21

Suppose a retail pharmacy holds both licences and the applicable fee is ₹1,500 per form.

• Form 20 retention fee: ₹1,500
• Form 21 retention fee: ₹1,500
• Total retention fee: ₹3,000

This example excludes applicable portal charges and late-payment penalties.

Drug Licence Renewal Fees in UP (Uttar Pradesh)

In Uttar Pradesh, the Food Safety and Drug Administration (FSDA) provides online services for drug licensing and payment of renewal or retention fees.

For common Form 20 and Form 21 categories, the published ₹1,500-per-form fee provides a reference, but the amount displayed for the specific licence on the UP licensing portal should be checked before payment.

To verify the amount:

• Visit the Uttar Pradesh FSDA online licensing portal.
• Log in using your registered firm account.
• Open the service for retention of an existing drug licence.
• Select the applicable licence or licence forms.
• Check the calculated fee and any applicable late charges before making payment.

Do not assume every UP medical store will pay the same total. The payable amount depends on its licence categories and other applicable charges.

4. Drug Licence Renewal Time Limit and Due Date in 2026

The drug licence retention fee must be paid before the expiry of each succeeding five-year period from the date of issue of the licence, as required under Rule 63.

There is no universal deadline such as 31 December 2026 for every medical store.

How to Calculate Your Drug Licence Retention Due Date

Consider a pharmacy licence issued on 15 November 2021.

The owner should arrange payment before the applicable five-year deadline shown in the licensing record rather than waiting until the last day.

If the licence is older and has already completed one or more retention cycles, review the original issue date, previous retention records and current portal status together.

What If the Drug Licence Has an Expiry Date Printed on It?

Older drug licences may show an expiry date under the previous renewal system.

A printed historical expiry date does not necessarily establish that the licence is currently invalid.

To check your position:

• Confirm the licence form and issue date.
• Review previous renewal or retention records.
• Check whether the prescribed retention fee has been paid.
• Verify whether the licence has been suspended or cancelled.
• Confirm the current status with the State Drug Licensing Authority.

A licence's original issue date, historical printed expiry date and current legal status should not be treated as interchangeable.

5. What Happens If You Miss the Drug Licence Retention Deadline?

Missing a drug licence retention deadline can result in late fees and, eventually, cancellation of the licence.

Under Rule 63(3), late payment is permitted for up to six months, subject to an additional fee.

Drug Licence Late Fee Calculation

The late fee is calculated at 2% of the licence fee for every month or part of a month of delay, up to six months.

For illustration, consider a pharmacy with a total applicable retention fee of ₹3,000.

These figures are illustrative and assume an applicable licence fee of ₹3,000, without additional processing charges.

Is There a Grace Period for Drug Licence Renewal?

Rule 63 provides a maximum six-month late-payment window, with the prescribed late fee.

It should not be treated as an extension of the normal payment deadline.

If the retention fee and applicable late fee remain unpaid beyond the permitted six-month period, the rule provides that the licence shall be deemed to have been cancelled.

What Happens After Six Months?

If the licence has been deemed cancelled because the retention fee was not paid within the prescribed window:

• The pharmacy cannot treat the old licence as valid.
• Continuing regulated drug sale without the required valid licence can lead to legal action.
• Simply paying the overdue amount afterwards should not be assumed to restore the cancelled licence.
• The owner must contact the State Drug Licensing Authority to determine the procedure for obtaining valid authorisation before resuming operations.

For further information about enforcement, read What Happens If a Pharmacy Fails a Drug Inspection?

6. How to Renew a Drug Licence Online in 2026

On most state portals the service is listed as licence retention rather than renewal, and the steps vary by state and licensing system.

Step 1: Open Your State Drug Licensing Portal

Visit the drug licensing portal used by the authority that issued your licence.

Some states use the Online National Drugs Licensing System (ONDLS), while others have state-specific systems.

Useful portals include:

• ONDLS — Online National Drugs Licensing System
• Uttar Pradesh FSDA Online Licensing
• Madhya Pradesh FDA (MPOnline)

Use the system applicable to your state and licence type.

Step 2: Log In With Your Existing Licence Details

Sign in to your registered firm account and locate the existing licence.

Depending on the portal, you may need your firm registration, licence number or registered login credentials.

Step 3: Select Licence Retention

The wording differs across government platforms; look for a service named:

• Retention of Drug Sale Licence
• Drug Licence Retention
• Renewal/Retention Fee
• Existing Licence Services

Step 4: Verify Existing Licence Information

Check the details already recorded against your licence:

• Licence number and form
• Pharmacy or firm name
• Registered premises address
• Licence issue date
• Proprietor or business constitution
• Pharmacist or competent person details

If any information has changed, you may need to complete a separate amendment process.

Step 5: Upload Applicable Documents

Upload the documents specifically requested by your state portal.

Not every retention application requires the complete documentation used for a new licence.

Step 6: Pay the Retention Fee

Check the fee calculation and pay through the available government payment method.

If the payment is overdue, verify the applicable late fee before proceeding.

Save the payment receipt, transaction reference and acknowledgement.

Step 7: Track Your Drug Licence Renewal Status

After submitting, open your application dashboard to check its status.

Depending on the portal, you may see a submitted application, payment confirmation, departmental query or completed retention record.

Respond to any query raised by the licensing authority.

Step 8: Download the Retention Record or Letter

Where the portal issues a digitally signed retention letter, certificate or acknowledgement, download it after processing.

Maintain copies with your original drug licence and fee receipts.

7. Documents Required for Drug Licence Renewal or Retention

The documents required for drug licence retention depend on the State Drug Licensing Authority and whether there have been changes to the licence details.

Commonly relevant documents include:

For example, the Delhi Drugs Control Department's retention checklist specifically includes fee receipts, system-generated declarations and certain premises-related compliance documents. Its fresh-licence checklist is considerably longer.

Therefore, a pharmacy owner should not assume that every document needed for a new drug licence is automatically required again for retention.

A separate application may be required for changes involving the pharmacist, premises, business constitution or other licence particulars.

Also remember that a pharmacist's professional registration and a pharmacy's drug sale licence are different regulatory records.

Read Pharmacist Registration vs Drug Licence: Key Differences to understand how they relate.

8. Drug Licence Retention Letter: Meaning, Status and Download

A drug licence retention letter is a document or electronic record issued by a licensing authority to acknowledge or confirm the retention of an existing drug licence.

The exact name and format depend on the state: some portals provide a retention letter or certificate, while others display the payment and retention history in the licence record.

How to Download a Drug Licence Retention Letter

• Visit your state's official drug licensing portal.
• Sign in to your registered firm account.
• Find the existing drug licence.
• Open the retention history, approved applications or documents section.
• Download the available retention letter or certificate, if issued.
• Save the fee payment receipt separately.

Is a Retention Letter Different From the Original Drug Licence?

Yes. The original drug licence authorises the specified regulated activities, subject to its conditions; a retention letter or record only documents that the licence has been retained.

It is not a substitute for a fresh drug licence when one is legally required.

If you have paid the fee but cannot download a retention letter, do not automatically assume that your licence is cancelled. Check the portal status and contact the issuing authority for clarification.

Licence Retention Letter Meaning in Hindi

Drug licence retention letter ek document ya acknowledgement hota hai jo licence retention process ya fee payment ke record ko confirm karta hai, state ke process ke according.

Isse original drug licence aur fee receipt ke saath sambhal kar rakhna chahiye.

9. Drug Licence Renewal Rules in 2026: What Changed?

There are two important legal developments to understand.

The 2017 Amendment Introduced Perpetual Licensing

G.S.R. 1337(E), notified on 27 October 2017, introduced the five-year retention system for specified drug licences.

It also changed the regulatory approach from repeated periodic renewal towards continuing validity subject to retention fees, licence conditions and inspections.

Under Rule 65B, licensed premises must be inspected for compliance at least once every three years or as needed under a risk-based approach.

Jan Vishwas Acts of 2023 and 2026

The Jan Vishwas (Amendment of Provisions) Act, 2023 changed certain penalties and enforcement provisions under the Drugs and Cosmetics Act. Its Drugs and Cosmetics Act amendments took effect on 31 December 2024, the date appointed by S.O. 1577(E) of 28 March 2024.

The Jan Vishwas (Amendment of Provisions) Act, 2026 introduced further changes to specified provisions of the Act. Its Drugs and Cosmetics Act amendments are scheduled to commence on 30 June 2027, under government notification S.O. 3286(E) dated 22 June 2026.

Two things are worth reading carefully. First, neither reform touches genuinely dangerous violations — adulterated or spurious drugs causing serious harm remain subject to the Act's harshest provisions, including lengthy imprisonment. Second, imprisonment risk fell for technical lapses, but the financial exposure rose sharply in exchange, in some cases by a factor of twenty. Both Acts also build in an automatic revision: fines and penalties rise by 10% of the minimum amount prescribed, after the expiry of every three years from commencement. The 2023 Act's Drugs and Cosmetics Act amendments commenced on 31 December 2024, which puts that first revision at 31 December 2027.

These reforms should not be confused with the existing five-year retention requirements.

For retail and wholesale pharmacies in 2026, the central practical obligations remain:

• Pay the retention fee within the applicable five-year period.
• Maintain required licence conditions and records.
• Respond to inspection and compliance requirements.
• Avoid the six-month non-payment threshold that leads to deemed cancellation.

10. Common Drug Licence Retention Mistakes Pharmacy Owners Should Avoid

Understanding the rules is useful, but maintaining accurate records is equally important.

Confusing Perpetual Validity With No Retention Deadline

A drug licence may have perpetual validity, but the retention fee still becomes due every five years.

Do not assume that a licence without a fixed expiry date has no payment obligation.

Forgetting the Original Licence Issue Date

Your five-year retention cycle is linked to the original issue date.

Keep the original licence and previous payment records accessible.

Paying the Fee Without Saving Proof

Always save the government fee receipt, acknowledgement and any retention certificate issued.

These records can be important when resolving discrepancies or responding to an inspection.

Ignoring Changes in Pharmacy Details

Changes in premises, business constitution or pharmacist details may require separate reporting or approval.

Do not leave outdated information in your licensing records.

Confusing Pharmacist Registration With Drug Licence Retention

A pharmacist's registration is governed by a different process from the pharmacy's drug sale licence.

Both records need to be maintained according to their applicable requirements.

Keeping Incomplete Pharmacy Compliance Records

Licence retention is only one part of regulatory compliance.

Pharmacy owners also need to maintain appropriate purchase and sale records, prescription-related information, Schedule H1 registers where applicable, and other required documentation.

For a practical overview, refer to our Pharmacy Compliance Checklist.

11. Frequently Asked Questions About Drug Licence Renewal in India

12. How BitMed Helps Pharmacies Maintain Organised Compliance Records

Drug licence retention must be completed through the relevant government licensing authority. However, maintaining accurate day-to-day pharmacy records is also important for regulatory readiness.

BitMed is pharmacy management and billing software designed for Indian medical stores.

It helps pharmacy owners manage:

• GST billing and sales records
• Medicine inventory and batch-wise expiry tracking
• Purchase and supplier records
• Schedule H1 register entries
• Sales, stock and business reports
• Historical transactions and audit records

By keeping pharmacy operations organised in one system, owners can more easily access important business records when needed.

BitMed does not issue, renew or retain government drug licences. Those procedures remain the responsibility of the licence holder and the appropriate licensing authority.

Conclusion

Drug licence renewal in India has changed from a traditional five-year renewal system to a five-year retention-fee system for the licences covered by Rule 63.

For pharmacy owners in 2026, the most important things to remember are:

• Drug licences covered by Rule 63 remain valid subject to retention and compliance.
• Retention fees must be paid every five years.
• The applicable deadline is based on the original licence issue date.
• Late payment attracts a 2% monthly fee for up to six months.
• Non-payment beyond the permitted period results in deemed cancellation.
• Online procedures and supporting documents vary by state.

Whether you operate a single medical store or a growing pharmacy business, keeping track of your licence records and statutory obligations can help avoid unnecessary interruptions.

For additional guidance, explore our Complete Pharmacy Drug Licensing and Compliance Guide.

Official Sources and References

• Drugs and Cosmetics Rules, 1945 — CDSCO
• G.S.R. 1337(E), Drugs and Cosmetics (Tenth Amendment) Rules, 2017
• Delhi Drugs Control Department — Grant and Retention Guidelines
• Online National Drugs Licensing System (ONDLS)
• Uttar Pradesh FSDA Online Licensing
• Jan Vishwas (Amendment of Provisions) Act, 2023 — Gazette of India
• Jan Vishwas Act, 2023 — Drugs and Cosmetics Act Commencement Notification S.O. 1577(E)
• Jan Vishwas Act, 2026 — Commencement Notification S.O. 3286(E)

Disclaimer: This article provides general information based on the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945 and the official materials referenced above. Requirements and portal procedures may change. Confirm your specific licence status, fees and documentation with the relevant State Drug Licensing Authority.