Professional Documents
Culture Documents
Amendments in The NWFP, Drugs Rules, 1982.
Amendments in The NWFP, Drugs Rules, 1982.
- To
The Secretary,
Government of Khyber Pakhtunkhwa,
1-Iealth Department.
2
SUBJECT: / AMENDMENTS IN THE NWFP, DRUGS
RULES, 1982.
Dear Sir,
(FASEH ULLAH)
ASSISTANT LEGAL DRAFTER-Ill
(LEGISLATION WING)
Endst:No. & date even:-
Copy is forwarded for information to the:
NOTIFICATION
AMENDMENTS
1. In rule 2, after clause (k), the following new clauses shall be added,
namely:
2. In rule 4,-
in sub-rule (2),-
3. In rule 6, after sub-rule (3), the following new sub-rule shall be added,
namely:
"(4) Drugs for which testing facilities are not available in the
laboratory, an Analyst shall conduct test analysis of samples of
drugs in any other laboratory, after its declaration and
authorization by the Board, for the purpose of the Act.".
(2) A fee of one thousand rupees shall be paid for any change
of proprietor of qualified persons or a duplicate copy of the
licence, if the original is defected, damaged or lost, and such
copy of the licence shall bear the words "duplicate copy and shall
only be valid for remaining period.".
5. In rule 16, the full stop appearing at the end shall be replaced by a colon
and thereafter the following proviso shall be added, namely:
8. In rule 19,-
serial number;
date of purchase/sale;
invoice number;
name of the drug;
name of the manufacturer;
batch number;
quantity purchased;
name and age of the patient;
name of the prescriber;
name of the hospital/clinic;
quantity sold;
quantity remained; and
signature of the qualified person;".
(iii) after sub-rule (9), the following sub-rules shall be added, namely:
9. In rule 20, in sub-rule (2), for the words "sixty days", the words "thirty
days" shall be substituted.
10. In Schedule A, for the existing Form 8, the following shall be
substituted, namely:
FORM NO.8(A)
(See rule 14 (1)}
Application for the license to sell, store and exhibit for sale drugs by way of
pharmacy.
The sale of drugs shall be under the personal supervision of; (name,
registration No, NIC No & address with qualification).
2.
(A) testimonials of the person (s), registered under section 24(1)(a) of the
Pharmacy Act 1967, who has agreed to personally supervise the sale
of drugs for license in Form 9 (pharmacy), and the proprietor (s),-
Name, address and Permanent Home Address of the person (s) who shall
' \ personally supervise the sale of drugs.
Signature: ------------------
Application for the license to sell, store, exhibit for sale drugs excluding the
drugs specified in Schedule "G" by way of Medical Store
2.
(A) testimonials of the person (s), registered under section 24(1)(a) or (b)
of the Pharmacy Act 1967, who shall supervise the sale of drugs for
license in Form 10 (medical store)and the proprietor (s); and
Testimonials of the person (s), registered under section 24(1) of the
Pharmacy Act, 1967, who shall personally supervise the sale of drugs
for license in Form 10 (medical store)and the proprietor (s).
(iv) affidavit of the person who shall supervise the sale of drugs
and the proprietor, duly verified, to the effect that they:
- (a) shall comply with the provision of the Drugs Act, 1976
and rules framed there under;
Dated: Signature:
Name, address and Permanent Home Address of the person (s) who
shall personally supervise the sale of drugs; and
Name, address and Permanent Home Address of the person (s) who
shall supervise the sale of drugs (if different from (i) above.
Signature: ------------------
The sale of drugs shall be under the personal supervision of; (name,
registration No, NIC No & address with qualification).
2.
Dated: Signature:---------
Name, address and Permanent Home Address of the person (s) who shall
personally supervise the sale of drugs.
Signature: ------------------
The sale of drugs shall be under the personal supervision of, (Name,
registration No, NIC No & address with qualification).
(A) testimonials of the person (s), registered under section 24(1)(a) or (b)
of the Pharmacy Act 1967, who shall supervise the sale of drugs for
license in Form 10 (medical store)and the proprietor (s); and
Testimonials of the person (s), registered under section 24(1) of the
\ Pharmacy Act, 1967, who shall personally supervise the sale of drugs
for license in Form 10 (medical store)and the proprietor (s)
affidavit of the person who shall supervise the sale of drugs and the
proprietor, duly verified, to the effect that they,-
Dated: Signature:-----------
Name, address and Permanent Home Address of the person (s) who
shall supervise the sale of drugs (if different from (i) above.
Signature:----
11. For the existing Schedule C, the following shall be substituted, namely:
SCHEDULE 'C'
[See Rule 11]
Unknown sample
Inorganic 170
Organic 225
(i) Element each 150
(i) group each 130
6. Leakage test Injectable 140
2. Fee for the other tests not given above is to be calculated by the incharge
of the Laboratory.
12. For the existing Schedule F, the following shall be substituted, namely:
SCHEDULE 'F'
[See Rule 18(1) (c)1
Premises: The premises shall be separated from room for private use.
The premises shall be built dry, well lit and ventilated and shall of
sufficient dimensions to allow the goods in stock, especially drugs
and poison to be kept in a clearly visible and appropriate manner. The
area of the section to be used at dispensing department shall not be
less than 6 sq Meters for one person working therein with additional 2
sq Meters for each additional person. The height of the premises shall
at least be 2.5 sq Meters. The floor shall be smooth and washable. The
walls shall be plastered or tiled or oil painted so as to maintain smooth
durable and washable surface devoid of holes cracks. A facility shall
be provided with good quality of water. The dispensing department
shall be separated by a barrier to prevent the entry of public.
13. After Schedule F, the following new Schedules shall be added, namely:
Schedule G
[See rule 19(1)(d)]
1. Antileprosy
i. Propofol Mitazolam
ii, Enfluran Naloxone HCl
iii . Isofluran xv. Vancuroniurn
iv. Halothane xi. Pancuronium
V. Bupivacain xii. Tubocuraine
vi. Thiopentone xiii. Suxarnethonium
vii. Benzodiazepine xiv. Neostigmine
Antibiotics
Inotropics
Injection Prostaglandins
Alpha Blocker
Biotechnological Products
11. Antiviral
Acyclovir vii. Idoxuridine
Amantadjne HC! viii. Ribavirin
Famciclovir ix. Vidarabin
Inosine Pranolsex X. Trifluridine
V. Zidovudine xi Methisozone etc
;i vi. Ganciclovir
15. Hormones
Vasopressin Finasteriode
Desmopressin Finasteriode
Stanozolol Somatropin
Nandrolone Testosterone
V. Mestero lone X. Progesterone's
Schedule H
[See Rule 18(1)(t)]
The person (s) registered under section 24(1)(a) of the Pharmacy Act
1967 (XI of 1967) shall personally supervise the sale of drugs;
A sign board having minimum length 5 feet and width of 2.5 feet in
black writing on a yellow colored shall be displayed on the front side;
The licensee shall maintain area sufficient for the storage of the drugs
intended to be sold/distributed but shall in no case be less than 144 Sq
Ft with minimum breath of 12 feet;
For the safe delivery of drugs to the sale outlets, the delivery van must
be air conditioned for preserving the properties of the content
throughout the period during which it remained in possession of the
supplier.
The licensee shall comply with the provisions of the Drugs Act, 1976
and the rules framed there under for the time being in force.
The supply of a drug shall be recorded suitably and the records, the
bills or the counterfoils shall be preserved for a period of at least three
years from the date of the sale;
SECRETARY TO
GOVT. OF KHYBER PAKHTUKHWA
HEALTH DEPARTMENT