Quality Control & Drug Regulation

23-MONTH TREND • JUN 2024 – MAY 2026

Drug Control Activities at a Glance

Field Activity Volume

33,441

Inspections

4,277

Seizures

24,463

Samples Taken

Non-Compliant Samples

Substandard / Unreg. / Adulterated / Misbranded 1,721

Spurious 497

Legal Case Pipeline

Cases Referred to PQCB 5,146

Prosecutions Launched 1,439

Cases Decided 970

Direct Enforcement Actions

395

Medicine Shops Sealed

181

FIRs Made

Reading the Trend

73% of inspections led to a sample being taken
Referrals to PQCB far outpace finalized prosecutions
Non-compliant samples remain under 10%

Major Prohibitions — Section 23, Drugs Act 1976

COGNIZABLE OFFENCES

Spurious Drugs23 1(a)(i)
Unregistered Drugs23 1(a)(vii)
Manufacturing without License23 1(b)

Punishable under Section 27: 3–10 years imprisonment and fine up to PKR 1 lakh.

NON-COGNIZABLE OFFENCES

Substandard Drugs23 1(a)(v)
Misbranded Drugs23 1(a)(iii)
Adulterated Drugs23 1(a)(iv)
Counterfeit Drugs23 1(a)(ii)
Expired Drugs23 1(a)(vi)
Without Drug Sale License23 1(c)

Punishable with imprisonment up to 7 years and/or a fine up to PKR 1 lakh.

Regulatory Framework

Scope of Federal & Provincial Government — The Drugs Act, 1976 & DRAP Act, 2012

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Provincial Government

• Regulation of sales & distribution (Sec. 44)
• Inspection & compliance monitoring
• Licensing of pharmacies & retailers

Khyber Pakhtunkhwa Drug Rules

Established 1982 • Amended 2017, 2018, 2019
Revised Drugs Sale Rules 2025 submitted for Cabinet approval

DIGITAL TRANSFORMATION

e-Drug Sale Licensing

Visit Portal

Developed in collaboration with the KP IT Board — enabling fully online issuance of retail, wholesale, narcotic, and pharmacy licenses.

Licenses Issued by Category

7,073

Narcotic (Form-11)

6,859

Retail (Form-9)

1,316

Wholesale (Form-10)

Pharmacy (Form-12)

15,263

Total Licenses

Province-Wide

PKR 66 M

Revenue Generated