How Pakistan does approve /reject a particular medicine to be sold in market,

what is the Mechanism and which actors are involved?

The Drug Regulatory Authority of Pakistan (DRAP) has been established under the DRAP Act
2012 to provide effective coordination and enforcement of the Drugs Act, 1976 and to bring
harmony in inter-provincial trade and commerce of therapeutic goods.

Registration of newly launched drugs and application for pricing:

New drugs launched by a Pharmaceutical company cannot be marketed until they are registered
under the Drugs Act and their prices are determined by DRAP.
Regulatory Affairs function ensures that the new products are timely registered and most
favorable pricing is obtained from DRAP based on underlying market and cost data.

Post registration variations and approvals of Pharmaceutical products

After the launch of products, Pharmaceutical companies are required to renew their licenses
every five years. In some cases, where there is any change in the particulars, such as brand name,
company name, source of import etc. the company can apply to DRAP for the change in the
registration documents.

Pricing and inflationary indexation

In Pakistan, prices of all Pharmaceutical products are fixed by DRAP and cannot be changed
unilaterally by the Pharmaceutical companies. Any new price or increase requires approval from
the DRAP.

The global smart pills market is segmented on the basis of applications and regions. The market
by applications is categorized into capsule endoscopy, drug delivery, and patient monitoring. On
the basis of regions, the market is divided into North America, Europe, Asia, and Rest of the
World (RoW: Pacific countries, Africa, and Latin America).

Factors such as favorable reimbursement scenario, patient preference for minimally invasive
procedures, technological advancements in endoscopy procedures, and rising prevalence of colon
cancer are driving the growth of this market. Moreover, benefits provided by the smart pill’s
technology such as technological advancements in endoscopy procedures, targeted drug delivery,
and easy remote patient monitoring are propelling the adoption of this technology.

On the other hand, in spite of numerous benefits offered by the smart pills technology, certain
barriers such as technological incompetence of capsule endoscopes, high costs, and fear among
patients regarding swallowing a microchip are hindering the growth of this market. North
America is the largest market. The high growth of this region can be attributed to the favorable
reimbursement scenario, FDA approvals for smart pills, and rising investments by government
and other agencies. The prominent players in the global smart pills market include Capso Vision,
Inc. (U.S.), Given Imaging, Inc. (Israel), Med metrics S.A. de C.V. (Mexico), Olympus
Corporation (Japan), and Bio-Images Research Limited (U.K.).

Smart Pills Market, by Application

 Capsule Endoscopy
 Drug Delivery
 Patient Monitoring

Smart Pills Market, by Region

 North America
 Europe
 Asia
 RoW
 Pacific Countries
 Africa
 Latin America