REGULATORY AFFAIRS AND HEALTHCARE ETHICS

HEALTH AND OTC RULES 2014

GROUP MEMBERS

ABEER AJAZ 02-300192-004

HIRA JAMIL 02-300192-001

SHAN E ZEHRA 02-300192-016

SUBMITTED TO
MA’AM MAHNOOR
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HEALTH AND OTC RULES 2014

EXECUTIVE SUMMARY:
This report provides a brief review of DRAP Alternate medicines and OTCs rules that were established in
2014 enacted under DRAP ACT, 2012; for the purpose of deep understanding and subjective analysis of
the document and give recommendations in the regulation, manufacturing, import, storage, distribution
and sale of Alternate medicines and health products used exclusively in homeopathic, unani, ayrvedic,
biochemic, Chinese or any other system of treatment and health products including probiotics,
disinfectants, nutritional products, food supplements, baby milk and food, medicated soaps and
medicated shampoos. DRAP formulated these rules for the evaluation, registration and monitoring of
Alternate medicines. This report will be is highly beneficial for manufacturers, contract givers, and
stakeholders keeping in view the proposed recommendations.

The DRAP Alternate medicines and OTCS’s rules contains nine sections altogether that included short
title and commencement, definitions, procedure for enlistment, application evaluation, evaluation
criteria, contract manufacturing, evaluation committee, responsibilities of enlistment holder, certificate
of free sale, manufacturing and distribution and prohibition. All these sections are critically analyzed for
any lacking and grey area that is existed in the rules proposed by DRAP and make recommendations
where necessary.

After analyzing the definitions, applications, protocols and procedures present in Alternate medicine and
OTC’s rules, numerous recommendations are made: recommendations must be reviewed and revised
annually keeping in view health care dynamics. It must introduce regulations new methods for of
promotion and marketing that are Webinar, self e-detailing and live e-detailing. Complementary food
for infants and young children, older age cut off age is not given, this is so the caloric requirement of
body changes progressively. Liabilities and sanctions must be defined in-case of selling counterfeit drugs,
sub-standard drugs, spurious drugs and drugs with prohibited ingredients. Disinfectants contain alcohol
as precursor molecule; it should be tightly regulated, its advertisement and promotion should also be
checked, all this must be highlighted in this document. Drug extract ratio DER calculations must be
clearly explained with the use of formulae and it should be mentioned that the achieved levels must be
checked in blood and the minimal acceptable percentage of total preparation should be mentioned.
Expiry date should be properly explained and should not only indicate the year and month but also the
proper date to avoid any ambiguity and eliminate grey areas. In the document, enlistment is done on
temporarily basis and it is a provisional allocation, but the renewal of enlistment is not mentioned.
Dextrodes use must be tightly regulated since interfering with the homeostasis. Exclusion criteria for
Analytical markers must be mentioned. Checks on the advertisement of medicated cosmetics must be
defined as registration holders are misusing this opportunity. Stocking of raw material is defined but the
procurement information of raw material is not defined nor seemed regulated. Structure-Function Claim
definition has ambiguity; first of all: it is interacting with the structural and physiological functions of the
body and DRAP is asking for evidence of safety and efficacy so it is controversial. Secondly, if it is
supporting the anatomy of the body so why not it is included in medical devices class. Clear and precise
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definition and criteria should be given. Traditional medicines are defined as having prolonged history of
usage, efficacy and safety; DRAP should also ask for evidence. Recommendations for procedure od
enlistment includes: Annual rise on application fee should be mentioned. Method for the renewal of
enlistment should be given. Experts from quality, homeopathic and Unani are included in the evaluation
committee, in addition, nutritionists, cosmetologists must also make part of the committee.
Punishments for the false use of certificate of free sale shall be the part of document. For application of
enlistment of importers, detailing of the taxations must also be the part of document. For application for
the enlistment of the locally manufactured products, a column indicating “the total caloric benefit
patient is receiving” should be the part of the table in Form 4 in case of baby milk and complementary
foods. For application of enlistment of new formulations and imported products, certificate of origin and
document of insurance policies shall be attached with the application. For provisional certificate for
enlistment as manufacturer/importer, this certificate should be revised and give rise to two certificates
for manufacturing and for import respectively (to make import difficult). And finally for provisional
certificate of enlistment of products, criteria for the renewal of “provisional/temporary” certificate
should be given

INTRODUCTION:
Alternate medicines and health OTC’s rules are promulgated by Drug Regulatory Authority of Pakistan in
2014, through DRAP Act 2012, for the regulation, manufacturing, import, storage, distribution and sale
of Alternate medicines and health products used exclusively in homeopathic, unani, ayrvedic, biochemic,
Chinese or any other system of treatment and health products including probiotics, disinfectants,
nutritional products, food supplements, baby milk and food, medicated soaps and medicated shampoos.
DRAP formulated these rules for development of globally harmonized standards for the evaluation,
registration and monitoring of Alternate medicines and health and OTCs. This will contribute a step
forward in enhancing the product quality and efficacy and will ultimately promote the public health. The
document is highly valuable for manufacturers and contract givers of alternate medicines. This
document also provides necessary information for importers authorized by overseas principal
manufacturer and manufactures holding manufacturing license for therapeutic goods under the Act.

ALTERNATIVE MEDICINES AND HEALTH PRODUCTS (ENLISTMENT) RULES, 2014.

Health products means health & OTC products includes all those products defined in the DRAP Act; like
probiotics, probiotics, baby milk and foods, medicated cosmetics, medicated soaps, medicated
shampoos, medicated plasters and derma-care products to name a few

 Act” means the Drugs Act, 1976

 Adulterated alternative medicine means it consists of impurities, toxic substances or prepared
under insanitary conditions
 Allersode are those homeopathic preparations that contain antigens
 Allopathic medicines are those which contain active chemical ingredients whereas alternative
medicines are other than allopathic medicines like unani/herbal/homeopathic and active
ingredients are derived from natural sources
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 Baby milk and food are usually the infant formula which acts as breast milk substitutes, it also
includes follow up formulae and formulae for medical purposes
 Complementary foods for infants and young children” means foods that are intended for infants
six months of age and older and these do not contain follow up formula and formulas for special
medical purposes
 Counterfeit are those products which imitate or resembles the original product so as to deceive
the consumers. It may also means selling with a false brand name
 Dietetic foods are used for special dietary purposes and used under medical supervision and is
used to manage the diets of people with certain diseases, disorders or medical conditions. These
special foods are intended for people whose nutritional requirements cannot be met by normal
foods.
 Drug extraction ratio is the criteria to approve therapeutic equivalence of different preparations.
It specifies the initial amount of drug used for the preparation of a certain amount of extract.
 Enlistment is allocating number to either manufacturer or the product regarding manufacturing
license or product registration. Enlistment Application is simply the application to get registered;
enlistment certificate is the number issued to the manufacturing firm or the product whereas
enlistment holder is the owner of the firm
 Follow up formulae is usually the liquid part of the weaning diet (protein based or milk based
vitamins and minerals) for infants of at least 6 months of age or young children of 1-3 years of
age
 Food supplements or nutraceuticals are those dietary supplements presented in pharmaceutical
dosage forms; they are made from food and provides medical or health benefits
 Herbal medicines are those which contains herbal substance or herbal preparation as active
ingredients. Herbal substances includes plants, algae, fungi or lichens in unprocessed form while
herbal preparation are the herbal substances gone through some process or treatment like
extraction, distillation or fermentation to name a few
 Herbal teas are those herbal substances which are prepared by decoction, infusion or
maceration.
 Infant formulae are human milk substitutes for infants to provide nutrition in first few months
up to the introduction of complementary foods. This formula is also protein based of milk based
minerals or vitamins
 Isode or Dextodes are those homeopathic preparations which when ingested cause disease.
They may be drugs, excipients or binders.
 Homeopathic medicines include all those substances containing therapeutic efficacy and they
are mentioned in approved pharmacopoeias and they should be prepared in accordance with
the methods outlined in pharmacopoeias (HPUS, PhF, BHF, IHP, Ph.Eur, EHO)
 Homeopathic raw materials are the original raw materials obtained from natural sources and
are used for the production of homeopathic medicines
 Indigenous or Unani medicine contains those ingredients as medicinal substance which are
mentioned in authorized books of Tibb-e-Unani
 Medicated Cosmetics are those products which contain active ingredients from natural source
and use for cosmetic purpose like beautifying, improving or cleansing skin, hair or nails.
 Medicated oils and balms are topical medicated products used for soothing purposes made up
of essential oils, fixed oils, methyl salicylate and camphor.
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 Misbranded alternative medicines are those which are wither improperly labelled, made in a
way to conceal the damage or making false claim of the product.
 Mother tincture is concentrated form of finished homeopathic medicines.
 Nosodes are specific category for homeopathic treatments prepared by infectious disease
product like bacteria or viruses
 Nutritional supplements are used as a supplement to normal diet to maintain normal body
functions
 pre-biotic means the non -digestible nutritional ingredient that stimulates the growth or activity
of bacteria in the digestive system and produce health benefits
 pro-biotic means an ingredient or product containing microorganisms that confers health
benefits on the host
 prohibited substances for alternative medicines includes allopathic ingredients, colors/additives,
steroids, hormones or any toxic plant/animal ingredient
 proprietary medicines are those medicines which are not mentioned in pharmacopoeia and
their information is obtained from the owner like its manufacturing and testing
 phyto medicines are those herbal medicines which contain plant materials prepared in a dosage
form for medical purposes
 substandard alternative medicines are those which do not conform to specifications of
pharmacopoeias
 spurious alternative medicines are those which conceals the true identity of the product and
made to resemble another drug
 Stocks are used as starting materials of homeopathic preparations.
 synthetic duplicate means a substance that shares an identical chemical structure and
pharmacological properties with its natural counterpart. “Natural” means a product that is
isolated or comes from a natural source (e.g., plant or mineral). “Synthetic” means a product
that is chemically produced. For example, most of the vitamin C in products marketed in
Pakistan is a synthetic duplicate of the ascorbic acid that occurs naturally in plants and animals
 Traditional medicine includes all the medicines before the era of modern medicine. It comprises
medical aspects of traditional knowledge that developed over generations based on belief
systems of different cultures used for health benefits e.g.; Chinese medicine, Ayurvedic
medicine & Japanese traditional herbal medicine (Kampo)

APPLICATION EVALUATION:
(1) Applications shall be scrutinized by the Division of Health and OTC Products (non-drugs) for
conformance to the evaluation criteria.
(2) Authority may verify contents or information provided in the application dossier through panel
of Inspectors or any authorized Inspector of Authority or Provincial Inspector

EVALUATION CRITERIA:
Applications shall meet the following criteria, namely:

(1) applications shall be complete and possess manufacturing and quality control facilities;
(2) applicants shall submit necessary evidence to support applications for manufacturing unit
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(3) applicants shall conform to the principles of quality assurance for contract manufacturing or
contract testing and analysis
(4) application containing false, incorrect or misleading information shall be liable to rejection;
(5) the formulation of the applied product shall not contain prohibited substance or ingredient or
ingredients that have been declared dangerous or injurious to health by any international body
or as may be prescribed;
(6) the formulations as a whole or containing any of its ingredients that have been withdrawn due
to safety concerns shall be liable to 20 rejection
(7) the applicants of new formulation or new ingredients shall submit safety, efficacy and quality
data as per recognized evidence and standards;
(8) applicant shall support applications through necessary proof or evidence, to prove quality,
safety and efficacy of the products
(9) import documents shall be attested by the regulatory authority of the country of origin and
verified by the embassy or consulate

CONTRACT MANUFACTURING:
(1) The application for enlistment of product for manufacturing on contract basis submitted to the
Authority shall be reviewed and decided in the light of fulfillment of criteria prescribed.
(2) Contract acceptor shall have pre-determined surplus capacity in terms of manufacturing
facilities, sections, equipment, testing procedures, qualified technical personnel and quality
control operations.
(3) Contract acceptor shall be possessing established systems of quality assurance and validation of
manufacturing process and testing methods and no major deficiencies or non-conformities has
been identified during the inspection of manufacturing unit of the contract acceptor.
(4) Every operation of cleaning and sanitization, validation, calibration, manufacturing, in-process
controls, quality control, stability protocol, packaging and release shall be clearly defined and
documented through standard operating procedures.
(5) Quality control laboratory shall be equipped with Chemistry, Pharmacognosy and Microbiology
facilities and equipment, as applicable.

EVALUATION COMMITTEE:
The Enlistment Evaluation Committee shall comprise of the following members, namely:

(1) Director Health and OTC Products ex-officio Chairperson/member;

(2) Deputy DG Health and OTC Products Vice Chairperson/member;
(3) Chief Drug control and Traditional Medicine Division NIH Member;
(4) Chief Nutrition Division NIH Member;
(5) One Expert of homeopathy to be nominated by the Authority Member;
(6) One expert of quality control to be nominated by the Authority. Member;
(7) One expert of unani to be nominated by the authority Member;
(8) Deputy Drugs Controller Health and OTC Products

CERTIFICATE OF FREE SALE AND COMPLIANCE TO G.M.P.-

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(1) Application for award of free sale and Good Manufacturing Practices compliance certificate shall be
submitted to the Division of Health and OTC Products of the Authority on Form 9
(2) The certificate for compliance to Good Manufacturing Practices to the manufacturer of alternative
medicine and health products shall be issued to enlistment holder on Form 10

MANUFACTURING AND DISTRIBUTION:

(1) The baby milks and foods, nutritional products and probiotics shall be manufactured and tested in
accordance with the internationally recognized standards, codes of practice, guidelines and other
recommendations of Codex Alimentarius of Food and Agriculture Organization and World Health
Organization.
(2) The enlistment holder or his authorized agent shall issue warranty on Form 11
(3) Manufacturer shall use only permitted excipients as prescribed in Schedule B complying to the
conditions and specifications
(4) Enlistment holder shall authorize distributors as authorized agents for supply and sale on Form 12

PROHIBITIONS:
(1) No person himself or any other person on his behalf shall issue or cause to be issued any
advertisement by any means what so ever, except obtaining permission after review of contents of
advertisement material by the Authority.23
(2) No person himself or any person on his behalf shall manufacture, import or sell any adulterated,
misbranded, spurious, counterfeit or substandard medicine or health products.
(3) Violation of this rule shall be offence under Schedule II and is punishable under Schedule III of DRAP
Act.

SCHEDULE A:
FORM 1:

Application for enlistment of manufacturer or contract giver

FORM 2:

Application for enlistment of importer

FORM 3:

Application for enlistment of locally manufactured indigenous unani medicine, herbal medicinal
products (phytomedicine) homeopathic, medicine or health products for traditional use nutritional or
structure- function claims

FORM-4:
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Application for enlistment of locally manufactured indigenous unani, herbal medicinal products or
phytomedicine homeopathic, medicine or health products for therapeutic or disease reduction claims

FORM-5:

Application for enlistment of new medicine (new formulations) or imported products

FORM 6:

Provisional certificate for enlistment as manufacturer/ importer

FORM 7:

Provisional certificate for enlistment of products

FORM 8:

Certificate for carrying out contract manufacturing of alternative medicines or health products on behalf
of enlistment holder or licensees

FORM 9:

Good manufacturing practices /free sale certificate(s)

FORM 10:

Invoice/warranty

FORM 11:

Authority letter to the authorized agent

SCHEDULE B
PERMITTED EXCIPIENTS:
Permitted Excipients, i.e. additives, preservatives, anti-oxidants, coloring agents, flavoring agents,
alternate sweeteners

RECOMMENDATIONS FOR DEFINITIONS:

1. Must be reviewed and revised annually keeping in view health care dynamics
2. Must introduce regulations new methods for of promotion and marketing that are Webinar, self
e-detailing and live e-detailing.
3. Complementary food for infants and young children, older age cut off age is not given, this is so
the caloric requirement of body changes progressively and must be defined against each age
group.
4. Liabilities and sanctions must be defined in-case of selling counterfeit drugs, sub-standard drugs,
spurious drugs and drugs with any prohibited ingredient
 9

5. Disinfectants contain alcohol as precursor molecule; it should be tightly regulated, its

advertisement and promotion should also be checked, all this must be highlighted in this
document
6. Drug extract ratio DER calculations must be clearly explained with the use of formulae and it
should be mentioned that the levels must be checked from blood and the minimal acceptable
percentage of total preparation should be mentioned
7. Expiry date should be properly explained and should not only indicates the year and month but
also the proper date to avoid any ambiguity and eliminate grey areas
8. In the document, enlistment is done on temporarily basis and it is a provisional allocation, but
the renewal of enlistment is not mentioned
9. Dextrodes must be tightly regulated since interfering with the homeostasis
10. Exclusion criteria for Analytical markers must be mentioned
11. Checks on the advertisement of medicated cosmetics must be defined as registration holders
are misusing the opportunity
12. Stocking of raw material is defined but the procurement information of raw material is nor
defined and seemed regulated.
13. Structure-Function Claim definition has ambiguity; first of all it is interacting with the structural
and physiological functions of the body and DRAP is asking for evidence of safety and efficacy so
it is controversial. Secondly, if it is supporting the anatomy of the body so why not it is included
in medical devices class. Clear and precise definition and criteria should be given
14. Traditional medicines are defined as having prolonged history of usage, efficacy and safety.
DRAP should also ask for evidence

RECOMMENDATION FOR PROCEDURE OF ENLISTMENT:

15. annual rise on application fee should be mentioned
16. method for the renewal of enlistment should be given
17. experts from quality, homeopathic and Unani are included in the evaluation committee, in
addition, nutritionists, cosmetologists are also made part of the committee
18. punishments for the false use of certificate of free sale shall be the part of document

RECOMMENDATIONS FOR THE APPLICATION OF ENLISTMENT OF IMPORTERS:

19. detailing of the taxations must also be the part of document

RECOMMENDATIONS FOR THE APPLICATION OF ENLISTMENT OF LOCALLY MANUFACTURED

PRODUCTS:
20. a column indicating “the total caloric benefit patient is receiving” should be the part of the table
in Form 4 in case of baby milk and complementary foods

RECOMMENDATIONS FOR THE APPLICATION OF ENLISTMENT OF NEWFORMULATIONS AND

IMPORTED PRODUCTS
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21. certificate of origin and document of insurance policies shall be attached with the application.

RECOMMENDATIONS FOR THE PROVISIONAL CERTIFICATE OF ENLISTMNET AS

MANUFACTURER/ IMPORTER
22. this certificate should be revised and give rise to two certificates for manufacturing and for
import respectively (to make import difficult)

RECOMMMENDATION FOR THE PROVISIONAL CERTIFICATE OF ENLISTMENT OF PRODUCTS:

23. criteria for the renewal of “provisional/temporary” certificate should be given