Annex-I
CHECK LIST FOR ALLOCATION OF QUOTA OF
CONTROLLED SUBSTANCES
S#
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Document
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Yes/No
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Page#
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Remarks
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1
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Whether application is
for routine allocation or for enhancement.
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Routine/ First time /
Export /
Enhancement
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2
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Undertaking by the firm
on stamp paper that they have fulfilled conditions of previous allocation
letter.
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3
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Sales reported in the
IMS alongwith IMS data, if applicable.
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4
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(a)
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Quota allocation letter
for the year , 2015
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……. KG
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||
(b)
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Quota allocation letter
for the year , 2014
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……. KG
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(c)
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Quota allocation letter
for the year , 2013
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……. KG
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(d)
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Copies of ADC attested
invoices
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5
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(a)
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Manufacturing record for the year , 2015 as per Annex-A.
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……. KG
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(b)
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Manufacturing record for the year , 2014 as per Annex-A
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……. KG
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(c)
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Manufacturing record for the year , 2013 as per Annex-A
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……. KG
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6
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(a)
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Consumption for the year 2015 supported by
documents of sales record as per
Annex-B.
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……. KG
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||
(b)
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Consumption for the year
2014 supported by documents of sales record as per Annex-B.
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……. KG
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|||
(c)
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Consumption for the year
2013 supported by documents of sales record as per Annex-B.
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……. KG
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|||
(d)
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Average consumption for
the three years
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……. KG
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|||
(e)
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Percentage (%) of Consumption of pervious allocation
(Manufacturing and Sales)
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7
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Consumption certificate
from concerned ADC or DDG for the Morphine, Pethidine, Codeine Phosphate,
Buprenorphine, Phenobarbitone, Alprazolam, Diazepam, Pentazocine.
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8
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The firm will have to submit the Undertaking that the
quota granted in the last years has been used in the licit manufacturing of
registered products and new quota will also be used for licit manufacturing
and maximum precaution will be taken to avoid any possible diversion.
All documents attached with the application are true
copies of the original and the same have been notarized from notary public as
“Certified True Copy”
All other submitted information is true.
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||||
9
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Proportion of the quota
indicated by firms required for exports.
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||||
10
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Copy of the valid
Registration letter of the drug (with status of renewal)
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11
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Copy of valid Drug
Manufacturing Licence (with status of renewal)
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Name, Seal
& Signature
MANAGING
DIRECTOR/
CHIEF
EXECUTIVE OFFICER
|
Annex-II
No.F.8-29/2014-DDC (I&E)
GOVERNMENT OF PAKISTAN
Ministry of National Health Regulation,
Services & Coordination
Drug Regulatory Authority Of Pakistan
*****
Islamabad, the
Subject:- GUIDELINES /STANDARD OPERATINMG PROCEDURE FOR QUOTA ALLOCATION OF
CONTROLLED SUBSTANCES.
1.
a) Applications of controlled substances shall be submitted for each year by
the firm/applicants by 7th January, with data consumed till 31st
December of previous year.
b)
Checklist submitted with application shall be duly signed by MD / CEO /
authorized senior representative and should also clearly indicate percentage of
consumption (manufacturing and sale).
c)
Applications complete in all respects with 75% consumption in manufacturing and
65% sales will be considered by COACD in 1st meeting. Meeting of
COACD will be held preferably every month.
d)
A Committee comprising of officers of Ministry of Narcotics Control, ANF and
DRAP would scrutinize the application and shortcomings of incomplete
applications will be conveyed to the applicants within one week after meeting
giving 15 days time period.
2. Only those firms will be granted
quota of Controlled Substances who have fulfilled the conditions/procedures as
laid down in the quota allocation letters including information which is to be
submitted to the field offices after procurement and sale etc.
3. The firms having sales reported in
the IMS should submit the relevant IMS data along with their application
dossier. The IMS data will be considered for framing ALR.
4. All firms to submit detailed
consumption record of last import authorization along with import invoices. ADC
consumption certificate (where applicable) and consumption record of material
should be made basis for the allocation of new quota.
5. The detail of the last three year
quota allocation and its consumption will also be submitted by the firms along
with related documents (quota allocation letter, ADC attested invoices etc.)
6. The firms will have to provide
supporting documents to justify their existing quota by submission of
manufacturing for last three years on Annex-A and sales record reflected in the
IMS, exports (if any) as on Annex-B for last three years. No signature shall be
accepted on behalf of any authorized person. However, MD / CEO shall authorize
senior representative on stamp paper who would sign on his behalf / absence on
the relevant documents. His specimen signature in triplicate shall be attested
by MD/CEO himself and oath commissioner for record purpose.
7. The quota for the firms who have
applied for the first time will not exceed the maximum slab fixed for the
molecule as at Annex. C.
8. The submission of the consumption
certificate from concerned ADC or DDG would be mandatory for following
controlled substances namely Morphine, Pethidine, Codeine Phosphate,
Buprenorphine, Phenobarbitone, Alprazolam, Diazepam, Pentazocine.
9. The firm will have to submit the
Undertaking that the quota granted in the last years has been used in the licit
manufacturing of registered products and new quota will also be used for licit
manufacturing and maximum precaution will be taken to avoid any possible
diversion.
10. All documents attached with the
application are true copies of the original and the same have been notarized
from notary public as “Certified True Copy”
11. The committee may decide enhancement
cases applied by the firms from July onward at any time every year, provided
that the enhancement will be granted once in a year after consumption of 75%
manufacturing & 65% sales and providing consumption of the last allocation.
12. Firms to indicate proportion of their
quota required for export. The enhancement of quota will be considered on the
basis of export orders provided by the firms.
13. Enhancements and allocations
applications will also be considered in case of natural calamities or other
emergency need.
14. While providing source for import, in
cases where manufacturer and exporter are different, the firms/importer should
provide name and address of both in writing for mentioning in import permit.
* * * * * * * * *
*
ANNEX-A
`
MANUFACTURING RECORD FOR THE PREVIOUS YEAR’S ALLOCATION
TO BE SUBMITTED ALONGWITH THE APPLICATION FOR CURRENT YEAR’ ALLOCATION.
1. NAME
OF THE CONTROLLED SUBSTANCE …………………… 2.
QUANTITY ALLOCATED
(Year)……………………
3. BALANCE
quantity FROM PERVIOUS YEAR ………….. …….
4. TOTAL QUANTITY ………………………………Kgs
S#
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Name (Brand) of the Drug
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Registration #
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Batch Number
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Date of Manufacture
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Quantity/ Units
Manufactured
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Composition for
the controlled substance
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Quantity of R.M consumed
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Remarks
|
1
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Pack Size of the
Finished Drug
|
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2
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Total Unit Packs
Manufactured
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3
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Yield Loss during
Manufacturing
|
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4
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Total Quantity of
Controlled Substance Consumed in Samples
|
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5
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Total Quantity of
Controlled Substance Consumed
|
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6
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Quantity of raw material
in balance (Kgs)
|
Name, Seal & Signature
PRODUCTION MANAGER
|
Name, Seal & Signature
QUALITY CONTROL MANAGER
|
Name, Seal & Signature
MANAGING DIRECTOR/
CHIEF EXECUTIVE OFFICER
|
ANNEX-B
SALES RECORD FOR THE PREVIOUS YEAR’S
ALLOCATION TO BE SUBMITTED ALONGWITH THE APPLICATION FOR CURRENT YEAR’S
ALLOCATION.
NAME OF THE CONTR OLLED
SUBSTANCE ………… CARRY OVER FINISHED STOCKS FROM
PERVIOUS YEAR …………Kgs
S#
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Name (Brand) of the Drug
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Registration #
|
Batch Number
|
Date of Manufacture
|
Quantity/ Units
Manufactured
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Name of the Distributor (s) with Address
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Quantity Sold
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Warranty Number/ Sale Invoice with date
|
Remarks
|
1
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Total Unit Packs
sold
|
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2
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Total Quantity of raw material consumed (Kg)
|
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3
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Total Unit Packs unsold (lying in warehouse)
|
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4.
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Quantity of raw material for Unit Packs unsold (Kg)
|
Name, Seal & Signature
DIRECTOR/ MANAGER SALES
|
Name, Seal & Signature
AUTHORIZED WARRANTOR
|
Name, Seal & Signature
MANAGING DIRECTOR/
CHIEF EXECUTIVE OFFICER
|
Annex-C
S.No
|
Name of Molecules
|
Maximum Slab for New Registration
|
1.
|
Pholcodine
|
25Kg
|
2.
|
Diphenoxylate
|
23Kg
|
3.
|
Codeine Phospate
|
180Kg
|
4.
|
Oxycodone HCL
|
75 Gram
|
5.
|
Phenobarbitone
|
72Kg
|
6.
|
Diazepam
|
106Kg
|
7.
|
Bupernorphine
|
440 Gram
|
8.
|
Alprazolam
|
2.2Kg
|
9.
|
Bromazepam
|
10Kg
|
10.
|
Chlordiazepoxide
|
90Kg
|
11.
|
Clobazam
|
--
|
12.
|
Clonazepam
|
10Kg
|
13.
|
Clorazepate
|
100Kg
|
14.
|
Estazolam
|
05Kg
|
15.
|
Fludiazepam
|
600Gram
|
16.
|
Lorazepam
|
05Kg
|
17.
|
Lormetazepam
|
10Kg
|
18.
|
Meprobamate
|
150Kg
|
19.
|
Medazepam
|
05kg
|
20.
|
Methylphenidate
|
05Kg
|
21.
|
Midazolam
|
05Kg
|
22.
|
Nimetazepam
|
3.6Kg
|
23.
|
Oxazepam
|
15Kg
|
24.
|
Nitrazepam
|
10Kg
|
25.
|
Pinazepam
|
05Kg
|
26.
|
Prazepam
|
15Kg
|
27.
|
Temazepam
|
100Kg
|
28.
|
Triazolam
|
100 Gram
|
29.
|
Pentazocine
|
14Kg
|
30.
|
Zolpidem
|
10Kg
|
31.
|
Ephedrine
|
100Kg
|
32.
|
Pseudoephedrine
|
100Kg
|
33.
|
Ergotamine Tartrate
|
--
|
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