1) Salient features of DRAP:

 DRAP is the principal regulatory body to ensure the safety, efficacy, and quality of
pharmaceuticals, medical devices, and biological products in Pakistan.

 The regulatory functions performed by DRAP include registration and marketing

authorization, vigilance, market surveillance and control, licensing establishments,
regulatory inspection, laboratory testing, clinical trials oversight, pharmacovigilance,
and lot release of biologicals etc.

 DRAP is responsible for setting and enforcing quality standards for pharmaceuticals,
medical devices, and biological products. It conducts inspections and audits of
manufacturing facilities to ensure compliance with Good Manufacturing Practices
(GMP) and other relevant standards.

 DRAP regulates the prices of essential drugs to ensure affordability and accessibility
to the general population. It establishes pricing policies and mechanisms to control the
prices of pharmaceutical products in the market.

 Facilitating the earliest availability of new therapies to the public and Enlisting
alternative medicines and over-the-counter products.

2) Key points of Vitamin Policy as decided by DRB in its 291st Meeting:

 Vitamin/mineral products can fall under both pharmaceutical and Health OTC (Over-
the-Counter) regulations.

 Recommended Daily Allowance/Upper Tolerable Limits determine whether a product

is categorized as pharmaceutical or HOTC, following standards set by Reference/
Stringent Regulatory Authorities.

 Vitamins and minerals exceeding the Recommended Daily Allowance (RDA) will be
treated as drugs.

 If any ingredient in a combination exceeds the RDA, the entire product will be
considered a drug.

 Combinations with existing registration and 5-7 years of market availability with no
adverse reactions will be considered as reference for safety and efficacy of these
combinations.

 For new combinations, availability in already adopted reference regulatory authorities

will be considered as reference.
 3) Grey Area Molecules:

For molecules falling in the grey areas or overlapping between PE&R and H&OTC division:
 Formulations or molecules already approved as "drugs" by the Registration Board
will remain classified as drugs, regardless of their status in Reference Regulatory
Authorities, unless withdrawn due to safety, efficacy, or quality concerns.

 If any such formulation was also enlisted by H&OTC Division, it will be un-enlisted.
The applicants shall be advised to approach PE&R Division for processing of
application for registration.

 This decision shall not apply to those formulations / molecules covered under
Vitamin-Policy as approved by the Policy Board.

 Registered molecules or formulations not found in RRAs but with a history of

registration, prescription, and availability for the past 10 years will continue to be
registered as drugs unless withdrawn due to safety or efficacy issues.

 New formulations or molecules not previously registered will be evaluated based on

their classification in Reference Regulatory Authorities. If considered drugs in RRAs,
they will be handled by the PE&R Division; otherwise, they will be managed by the
Health & OTC Division.

4) Role of stability studies in PRVs:

 Real-time and accelerated stability studies are conducted for a duration of 6 months
on three trial batches under different temperature and humidity conditions. Real-time
conditions simulate typical storage conditions, while accelerated conditions simulate
exaggerated conditions to predict long-term stability.

 According to the (ICH) guidelines, the 6-month accelerated study can predict drug
stability over a period of 2 years. These studies aim to assess how temperature and
moisture affect the deterioration of the active ingredient in the drug product.

 The primary purposes of conducting these studies are to ensure that:

The potency of the drug remains consistent throughout its shelf life, meaning the quantity
of the active ingredient needed for efficacy remains intact.
The drug remains safe for consumption, without degradation into harmful impurities,
throughout its shelf life.
The appropriate storage conditions for the drug product are determined to maintain its
stability over time.
Compliance with quality parameters is maintained, especially in case of any changes to
the drug formulation.

 Temp 30⁰C + 5⁰C / RH 65% + 5% RH (real time)

Temp 40⁰C + 5⁰C / RH 75% + 5% RH (accelerated)