Quality Control & Drug Regulation

27-MONTH TREND • JUN 2024 – Sept 2026

Drug Control Activities at a Glance

Field Activity Volume

39,118
Inspections
50,30
Seizures
27,292
Samples Taken

Non-Compliant Samples

Substandard / Unreg. / Adulterated / Misbranded 1,925
Spurious 538

Legal Case Pipeline

Cases Referred to PQCB 6,235
Prosecutions Launched 1,781
Cases Decided 1,101

Direct Enforcement Actions

433
Medicine Shops Sealed
245
FIRs Made

Reading the Trend

  • 70% 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

7,611
Narcotic (Form-11)
7,397
Retail (Form-9)
1,382
Wholesale (Form-10)
14
Pharmacy (Form-12)
16,404
Total Licenses
Province-Wide
PKR 71.1 M
Revenue Generated