1. DRUG REGISTRATION AUTHORITY IN PAKISTAN

Registration board is the competent authority for the registration of a drug, which is appointed by the Ministry of Health. "Drug" means any biological or chemical preparation of natural or synthetic origin ready for use for prophylactic, therapeutic or diagnostic purposes in human being.

2. COMPOSITION OF REGISTRATION BOARD

Director General Health is the head of the registration board - other members are as follows:

One Deputy Director General Health
One person from Drug Administration who is also the secretary of Registration Board.
One professor of pharmacology
One medical specialist from Army

3. FUNCTIONING OF REGISTRATION BOARD

Registration Board meets once in three months, usually 60 - 70 applications are discussed. Each application for registration of drug is reviewed in detail, decision to register the drug Is based on:

Efficacy of the drug
Registration status in USA, UK and other western European countries
Availability of locally manufactured substitutes
Price of the drug "Most Important factor"

4. VARIOUS FACTORS DETERMINING OUTCOME. OF APPLICATION FOR REGISTRATION

Availability of similar products,with reference to safety, efficacy, quality and economic value.
Drug is allowed to be imported in finished form only if locally manufactured
substitute are not available and manufacture of drugs involves advance technology.

5. REFERAL OF APPLICATION TO COMMITTEE OF EXPERTS

Registration board may refer any application for registration to clinical specialist for clinical trail.The decision of Registration board is based on report submitted by the
Clinician.

6. FACTORS DETERMINING PRICE FIXATION

The following formula is used for fixation of maximum retail price.

The price demanded by Efroze Chemical Industries is compared with existing prices

1) Price in country of origin and
2) In neighbouring countries such as Afghanistan, Bangladesh, India, Philippines, Sri Lanka, Thailand, Indonesia

7. DOCUMENTS TO BE SUBMTTED ALONGWITH APPLICATION FOR REGISTRATION OF A DRUG

Package leaflet of the product
List of production equipment
Composition and method of manufacture
List of quality control lab equipment
Analytical method and specification of each ingredient
Analytical method and specification of finished goods
Bioavailability studies
Stability studies
Labelling
Costing sheet
Certificate of good manufacturing practice
Certificate of free sales and registration
Additional information
Clinical trial
Toxicity data

8. VALIDITY OF REGISTRATION

Validity of Registration is = 5 years. (Unless, earlier suspended or cancelled)

9. UPDATE FILES OF REGISTRATION

Any change regarding a product after its registration for instance, new indication contra indications, side effects, information for the patients or method of manufacture, change of Excipients etc, are to be approved before implementation