1
Government of Pakistan
Drug Regulatory Authority of Pakistan
Ministry of National Health Services Regulations & Coordination
********
Islamabad, the 22 November 2013
NOTIFICATION
S.R.O.
(I)/2013.In exercise of the powers conferred by section 23 of the
Drugs Regulatory Authority Pakistan Act, 2012 (XXI of 2012), the Drug Regulatory Authority
of Pakistan, with prior approval of the Federal Government, is pleased to make the following
rules,namely:1
Short title and commencement.- (1). These rules may be called the Medicines and Health
Products (Enlistment) Rules, 2013.
(2)
2.
They shall come into force at once.
Definitions.- (1) In these rules, unless there is any thing repugnant in the subject or the
context ;
(a) “Act”
means the Drugs Regulatory Authority of Pakistan Act, 2012 (XXI of 2012);
(b) “advertisement” means the publication, dissemination, conveyance of information for the
purpose of promoting ,whether directly or indirectly, the sale or use of any product by any means
or in any form including the following:(i)
publication in a news paper, magazine, journal or periodical;
(ii)
display of poster or notices.
(iii)
letters addressed to individuals, bodies corporate or uni-corporate;
(iv)
photographs or documentary or cinematographs films;
(v)
sound broad-casting through television or any other media;
(vi)
public demonstration for use of the product offer of trial of the product to
the member of the public;
(c) “allopathic ingredients” means ingredients used in allopathic or western system which are
chemically defined ingredients, excluding naturally occurring ingredients obtained from natural
sources;
(d)
“disinfectant” means a health product or ingredient used for destroying or inhibiting
micro-organisms that may be harmful to humans or animals. Disinfectants also include
ingredients or products having additional antiseptic activity or use ;
(e)
“enlistment” means provisional allocation or entry of proper number to the firm or the
product in the enlistment register for the purpose of gathering information but this shall not be
substitute of manufacturing license and registration of any product;
(f)
“enlistment application” means application in the relevant Form as specified in the
Schedule, accompanied with proper fee submitted by the manufacturer or importer to the
Division of Health and OTC Products(non drugs);
(g)
“enlistment number” means number allocated to the firm or product in the enlistment
register;
(h)
“enlistment holder” means proprietor or owner of the company or firm to whom
enlistment of company or product has been granted.
(i)
“food supplements” or “dietary supplement” or “health supplement” means products
containing vitamins,provitamins, multivitamins, minerals including a mineral salt, and a
naturally occurring mineral , metals and their salts, a lipid, including an essential fatty acid or
phospholipids liproteins,amino-acids, proteins, fatty acids, carbohydrates, a mucopolysaccharide,
plant or herbal material (or a synthetically produced substitute for material of that kind),
including plant fibers, enzymes, algae, fungi, cellulose and derivatives of cellulose and
chlorophyll, herbal preparation, resins,balsams,volatile oils, non-human animal material (or a
synthetically produced substitute for material of that kind) including dried material, bone and
cartilage, fats and oils and other extracts or concentrates, a microorganism, whole or extracted,
except a vaccine expressed juices, exudates etc. alone or their combinations and are presented in
pharmaceutical dosage forms intended for health related purpose;
(j)
“health products” means Health and OTC Products (non-drugs ) as defined in the Act and
include pro-biotics, pre-biotics, disinfectants, food supplements, nutritional products, baby milk
and foods, medicated cosmetics, medicated soaps, medicated shampoos, medicated plasters and
derma-care products or any other which may be notified in official gazette by Drug Regulatory
Authority of Pakistan(DRAP) as Health and OTC Products ;
(k)
“health related purpose” means a therapeutic, curative, preventive, palliative, or cosmetic
purpose or for promotion and well being of humans and animal health;
(l)
“herbal preparations” means preparation obtained by subjecting herbal substances to
treatment such as extraction, distillation, extraction, fractionation, purification, concentration or
fermentation, including comminuted or powdered herbal substances, tinctures, extracts, essential
oil, expressed juices and processed exudates;
(m) “homeopathic medicine”, means a medicine that meets with all of the below-mentioned
conditions:
(i)
it is intended for oral or external use only;
(ii)
no specific therapeutic indications appear on the labelling or in any information
relating thereto; and
(iii) there is a sufficient degree of dilution to guarantee the safety of homeopathic
medicine and shall not contain more than 1/10 000 part of the mother tincture or
more than 1/100th of the smallest dose used in allopathic drug to be dispensed on
a doctor's prescription.
(n)
“intended purpose” means use for which medicine or health product is intended according
to the claim of manufacturer or importer as stated on any or all of the following:
(i) label of the product.
ii) instruction for use of the product. and
iii) promotional material in relation to the product;
(o)
“label” means any written, printed or graphic presentation that appears on or is attached to
the container of the product or active ingredient or herbal preparation or any part of the
packaging and includes informational sheet or leaflets that accompanies when finished product
or active ingredient or preparation is being supplied;
(p)
“label claim” means any representation made on a product in relation to its indication,
benefits or actions. Claims could be stated directly or inferred in-directly but not limited to the
following:(i)
graphic or logos on the product packaging;
(ii)
product or branding;
(iii)
media advertisement (print, sound , light and sound);
(iv)
point of sales materials;
(v)
product broachers or information sheets distributed with or separately
from the product;
(q)
“medicated cosmetics” means health product used for cleansing, fragrencing, deodorizing,
beautifying, preserving, improving, altering or restoring complexion of skin, hair, nail or teeth of
human containing ingredients of natural origin;
(r)
“medicated oil and balm” means any external medicated embrocation, medicated cream,
ointment, lotion or inhalant used for soothing purposes containing following ingredients:-
(i)
essential oils;
(ii)
fixed oils derived from natural source;
(iii)
methyl salicylate;
(iv) menthol camphor and peppermint;
(s) “nutritional supplements” means a product that is used to supplement a diet beyond that of
normal nutrients to support or maintain the healthy body functions in humans and animals;
(t) “pre-biotics” means the non -digestible nutritional ingredient that stimulates the growth or
activity of bacteria in the digestive system and produce health benefits;
(u) “pro-biotic” means an ingredient or product containing micro organisms that confers health
benefits on the host;
(v)
“prohibited substance” means a substance that is not permitted to be contained in any
medicine or health product and include the following:(i)
allopathic ingredients(except homeopathic medicine);
(ii)
colours and additives, except the prescribed one;
(iii)
toxic ingredients containing plants or animals or their parts;
(iv)
restricted ingredients above the prescribed limits;
(v)
steroids and anabolic hormones ;
(vi)
any other substance which has been declared injurious to health by the
Authority, through notification in the official gazette;.
(w) “product” means a finished medicine or health product;
(x)
“recall” means any action taken by the manufacturer, importer, supplier or registrant or
enlistment holder of a product to remove it from the market or to retrieve from any person to
whom it has been supplied because of the reason that the product:
(i)
may be hazardous to health.
(ii)
may fail to conform to any claim made by its manufacturer, importer,
registrant or enlistment holder relating to the quality, safety, efficacy or its
usefulness; or
(iii)
(y)
may not meet to the requirement of the Act;
“review of application dossiers” means screening, assessment and evaluation of
information & contents included in the application dossiers submitted for the grant enlistment
certificates; and
(z)
“specified publication” means any of the following publications containing material
information regarding medicines and health products and include;
(i)
European Pharmacopoeia;
(ii)
British Pharmacopoeia and British National formulary;
(iii)
United States Pharmacopoeia and United States National formulary;
(iv)
British pharmaceutical codex;
(v)
German Pharmacopoeia;
(vi)
International Pharmacopoeia;
(vii)
Chinese Pharmacopoeia;
(viii) Indian Pharmacopoeia;
(ix)
Japanese Pharmacopoeia ; and
(x)
any other publication notified by the Authority as specified publication.
.
(2)
The terms and expressions used in these rules but not defined shall have same meanings
as assigned in the Act, Drug Act 1976 or WHO or ICH guidelines for Herbal medicines, Food
Supplements and Probiotics etc.
3. An application for enlistment shall be made to the Authority, addressed to the Director of
Division of Health and OTC Products (non-drugs) as under.:(a)
an application for the enlistment of manufacturer shall be made on form 1.
(b)
an application for the enlistment of importer shall be made on form 2.
(c)
an application for the enlistment of product(s) shall be made on form 3.
(d)
each application shall be accompanied with a fee of ten thousand rupees for
enlistment of manufacturer or importer and two hundred and fifty rupees for
enlistment of each product.
4. Fee shall be deposited in the head of account of Authority at the designated banks and duly
certified original receipt shall be attached with the application.
5. Manufacturers having manufacturing and quality control facilities ,those who were
manufacturing medicines or health products or importers who were importing these products
before the promulgation of the Act shall be eligible to submit enlistment applications.
6. Manufacturers holding manufacturing license under the Drug Act 1976(XXXI of 1976), and
obtained approval of dedicated sections for medicines or health products including probiotics or
food supplements and had submitted application dossiers before the promulgation of the Act
shall also be eligible for enlistment.
7. Applications shall be scrutinized by the Division of Health and OTC Products (non-drugs) for
conforming to the specified criteria.
8. Applicants shall be required to submit convincing evidence or documentary proof indicating
that manufacturing or import for sale was being conducted before the enactment of the Act.
9. Authority may verify contents or information provided in the application(s) through panel of
Inspectors or any authorized Inspector of Authority or Provincial Inspector.
10. Applicants shall be required to submit a declaration that the contents of the application are
correct.
11. Applications not meeting the criteria shall be rejected stating the reasons thereof, namely;(a)
incomplete applications;
(b)
applicants not having manufacturing and quality control facilities;
(c)
applicants not having necessary import documents as evidence of imports;
(d)
it is proved that the contents of the application are false, incorrect or
misleading;
(e)
the formulation of the applied product contains prohibited substance or
ingredients or ingredients that have been declared dangerous or injurious to health by
any
international body.
(f)
the formulations as a whole or any of its ingredients have been withdrawn due to
safety concerns.
(g)
The formulation or ingredients are new one whose safety and efficacy have not
been established or they are not available locally or internationally in the market;
(h)
failure of applicant to prove that he was conducting his business of medicines or
health products in manufacturing or importing before the enactment of the Act.
12.
Enlistment Certificate(s) for manufacturer or importer shall be issued on Form 4 to these
rules.
13.
Enlistment Certificate(s) for products shall be issued on Form 5 to these rules.
14.
Enlistment holder shall be responsible and liable for quality, safety and efficacy of the
enlisted product.
15.
The enlistment is an interim arrangement for a specified period and it does not confer any
right for unlimited continuation of manufacture, import and export, or grant of manufacturing
license or product registration.
16. Relevant provisions of the Act regarding quality, safety, and efficacy shall be applicable
upon enlisted companies or firms or products.
17.
Enlistment holder shall be responsible for compliance to the conditions of enlistment as
per enlistment certificate.
18.
No one person himself or any person on his behalf shall issue or cause to be issued any
medical advertisement except obtaining permit for approval of contents of advertisement from
the Authority.
SCHEDULE
Form 1
(See rule-3(a))
APPLICATION FOR ENLISTMENT OF MANUFACTURER
(Attach readable soft copy with application)
I/WE ………………………………..
(1)……………………….. (2)………………………….(attach list of partners)
Holder (s) of CNIC No. ……………………………………
Owner of M/S……………………………………………………………………hereby apply
for enlistment of my firm/company established under company/partnership Act........
Having NTN ………………………………. located at the premises as
under………………………………………………………………………………..
A)
That I am manufacturing following classes of therapeutic goods
1.
Alternate Medicines.
(Attach detail information as Annex-A)
(i) Herbal Medicines
(ii) Unani Medicines.
(iii) Ayurvedic Medicines
(iv) Siddah Medicines.
(v) Chinese Medicines.
(vi) Homeopathic Medicines.
(vii) Bio-chemic Medicines.
(viii) Herbal oils / Balms
(ix) Any other alternate/ complementary medicines.
2.
Health and OTC Products. (Attach the information as Annex-B)
(i)
Food supplements (Neutraceuticals or dietary or health supplements).
(ii)
Nutritional supplements.
(iii)
(iv)
(v)
(vi)
Baby Milks and Foods.
Disinfectants.
Medicated shampoos containing natural ingredients.
Medicated Soaps natural ingredients
(vii) Tooth
pastes/mouthwashes/throat
ingredients.
(viii) Medicated
cosmetics/Derma-care
medicated oils natural ingredients
(ix) Any other.
3.
lozenges/gargles
natural
products/Balms/
plasters/
That my manufacturing unit has following facilities:
(Attach the site master file as Annex-C)
4. Total size of the plot/ building is ………………………………………..sq/feet
5. No. of sections are as under:- (Attach list of equipment and instruments
available with copy of invoice)
(i)
Tablets.
(ii)
Capsules.
(iii)
Dry Syrup.
(iv)
Dry powder (s).
(v)
Liquid Solution, Syrup, emulsion, suspensions, drinking ampoules and
Drops.
(vi)
Ointment and Creams.
(vii)
Sachet/herbal teas/joshanda.
(viii)
Eye/ Ear/ Nasal Drops.
(ix)
Packaging and Labeling.
(x)
Quality Control Lab (The copy of contract with the Q.C. laboratory shall be
attached in case of contract testing).
(xi)
Warehouses.
(xii)
Water purification plant.
(xiii)
Any other section.
6..
Our facility has following staff:
(Attach the information as Annex-D)
(i)
Qualified staff name, qualification, experience and training .State
responsibility and attach their CV’s.
(ii)
Supportive and non technical staff.
7.
List of Manufactured and marketed products & product wise as well as total
turnover:
(Attach the information as Annex-E)
8.
I undertake and certify that the contents stated above are correct and true to the
best of my knowledge (please attach undertaking on the notarized stamp paper.
Name of the owner
Signature
Seal of the Firm/ Company
Form 2
(See rule-3(b)
APPLICATION FOR ENLISTMENT OF IMPORT
(Attach readable soft copy with application)
I/WE ………………………………..
(1)……………………….. (2)………………………….(attach list of partners)
Holder (s) of CNIC No. ……………………………………
Owner of M/S……………………………………………………………………hereby apply
for enlistment of my firm/company having NTN ………………………………. located at the
premises as under………………………………………………………………………………..
A.
That I am importing following classes of therapeutic goods
1.
Alternate Medicines.
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
(ix)
2.
(Attach detail information as Annex-A)
Herbal Medicines
Unani Medicines.
Ayurvedic Medicines
Siddah Medicines.
Chinese Medicines.
Homeopathic Medicines.
Bio-chemic Medicines.
Herbal oils / Balms
Any other alternate/ complementary medicines.
Health and OTC Products. (Attach the information as Annex-B)
(i)
Food supplements (Neutraceuticals or health supplements).
(ii)
Nutritional supplements.
(iii)
Baby Milks and Foods.
(v)
Disinfectants.
(vi)
Medicated shampoos containing natural ingredients .
(vii)
Medicated Soaps natural ingredients
(viii)
Tooth pastes/mouthwashes/throat lozenges/gargles natural ingredients.
(ix)
Medicated cosmetics/Derma-care products/Balms/plasters/medicated oils
natural ingredients
(x)
Any other.
B.
That overseas manufacturing unit has following facilities:
(Attach the site master file as Annex-C)
3. Total size of the plot/ building is ………………………………………..sq/feet
4. No. of sections are as under:- (Attach list of equipment and instruments
available)
(i)
Tablets.
(ii)
Capsules.
(iii)
Dry Syrup.
(iv)
Dry powder.
(v)
Liquid Solution, Syrup, emulsion, suspensions, drinking ampoules and
Drops.
(vi)
Ointment & Creams.
(vii)
Sachet/herbal teas/joshanda.
(viii)
Eye/ Ear/ Nasal Drops.
(ix)
Packaging and Labeling.
(x)
Quality Control Lab (The copy of contract with the Q.C. laboratory shall be
attached in case of contract testing).
(xi)
Warehouses.
(xii)
Water purification plant.
(xiii)
Any other section.
5.
The overseas manufacturer has following staff.(Attach the information as Annex-D)
(i)
Qualified staff name, qualification, experience and training .State
responsibility and attach their CV’s.
(ii)
Supportive and non technical staff.
6.
List of imported and marketed products and product wise as well as total annual
turnover. (Attach the information as Annex-E)
7. Manufacturing license and other Import documents for each product.
(Attach information as Annex-F)
8.
I undertake and certify that the contents stated above are correct and true to the
best of my knowledge (please attach undertaking on the notarized stamp paper).
Name of the owner
Signature
Seal of the Firm/ Company
FORM-3
(See rule-3(b)
APPLICATION FOR ENLISTMENT OF PRODUCTS
(Attach readable soft copy with application)
I/We……………………………………
Owner
(s)of
M/s……………………………………………………………………hereby
apply
for
enlistment of following products manufactured by my firm/company ( has already applied
as manufacturer or importer ) located at the premises as under
1.
Product profile.
Name
Product
2.
3.
of List
of Intended used
ingredients
Pack size
Maximum
Retail price.
Master Formula.
Manufacturing process.
3.
Testing specifications.
4.
Shelf life and storage.
5.
Recommended usage with evidence.
6.
Packaging and labeling.
7.
Maximum Retail price.
8.
Attach import documents for each applied drug.
9.
I undertake and certify that the contents stated above are correct and true to the
best of my knowledge(please attach undertaking on the notarized stamp paper ).
Name of the owner
Signature
Seal of the Firm/ Company
FORM-4
(See rule-12)
PROVISIONAL CERTIFICATE FOR ENLISTMENT AS MANUFACTURER/
IMPORTER
No. …………………..
Dated: ……………..
M/s…………………..………………………………………………………located
at
the
address
……...……………………………………………………………………………is
hereby enlisted in the enlistment register as manufacturer/ importer by the Authority
subject to the following conditions namely:-
(i)
The manufacturer or importer shall be responsible for the quality, efficacy and
safety of all the therapeutic goods manufactured and sold by him.
(ii)
He shall abide by all the provisions of the Drug Regulatory Authority of
Pakistan Act, (XXI) of 2012 except those exempted under the said Act.
(iii) He shall immediately recall the defected therapeutic goods within 15 days after
intimation to him and report the compliance to the Authority.
(iv)
(v)
(vi)
He shall be responsible to withdraw the unsafe therapeutic goods from the
market if so declared by the Authority. He shall also report adverse affect reports,
(if any), to the Authority within 15 days period and notify focal person for such
reporting.
Any other relevant condition imposed by the Authority in future.
This certificate shall not be valid after the date notified by the Authority through
official gazette.
(vii)Certificate of enlistment shall be surrendered to the Authority within 7 days if it
is suspended, revoked, becomes invalid or its holder winds up his business.
Designated Officer …………….
Division of Health and OTC Products
Drug Regulatory Authority of Pakistan
FORM-5
(See Rule 13)
PROVISIONAL CERTIFICATE FOR ENLISTMENT OF PRODUCTS
Following products of M/s………………………………………………………located at the
address ……...……………………………………………………………………is / are hereby
enlisted in the enlistment register by the Authority.
S.No.
Name of Product List of ingredients Pack size
and
their
strengths
Shelf Life
Conditions for Enlistment:
(i)
The product(s) shall test for microbial contamination and it is verified that these
products does not contain any type of pathogenic microbial contamination.
(ii)
The content the heavy metals in the finished product shall be within the limits as
prescribed in the .
(iii)
The product shall not contain any toxic or dangerous materials which are
injurious to health.
(iv)
The products shall be tested and released by the Quality Control of the unit or
contract laboratory approved by the Authority.
(v)
The products shall remain safe, effective and retain quality during the whole
shelf life.
(vi)
The product conforms to all the relevant provisions of the Drug Regulatory
Authority of Pakistan Act, 2012 (XXI) of 2012.
(vii)
The product is not contaminated with any type of ingredient not enlisted in the
formula approved by the Authority.
(viii)
The product does not contain any prohibited substance or Allopathic or any
western ingredient which is not part of approved formulation.
(ix)
The manufacturer/ importer shall be responsible for all the liabilities occurred
after damage due to usage of enlisted products.
(x)
The label claim for the treatment of diseases shall be made through valid
evidence based on standard reference books or published literature or proven
through clinical trial.
Label claim of prohibited diseases shall not be made in any case as required
under the labeling claim guidelines.
(xi)
(xii)
Maximum Retail Price (MRP) shall be as per policy finalized by the Authority.
(xiii)
This certificate shall not be valid after the date notified by the Authority through
official gazette.
(xiv)
Certificate of enlistment shall be surrendered to the Authority within 7 days if it
is suspended, revoked, becomes invalid or its holder winds up his business.
Designated Officer …………….
Division of Health and OTC Products
Drug Regulatory Authority of Pakistan
______________________________________________________________________________
(No. F. 3-5/2013 – DDC (Alt-Med)
Muhammad Arshad Khan
Director, (Legal Affairs)
Drug Regulatory Authority of Pakistan