DRAP to issue licenses to pharma companies through CTD system

Jan 19, 2020: The Drug Regulatory Authority of Pakistan (DRAP) has decided to introduce Common Technical Documentation (CTD) system for registration of pharmaceutical companies, issuance of licences to them and carrying out communication with them in the country.

Under the CTD formate, which was already in place in Europe and the USA, all types of communications including applying for registration of products and issuance of licences would be held online through paperless e-mail system.

Sources related to manufacturing of medicines said the net worth of Pakistan's

allopathy medicine market was over US $ 8 billion, besides US $ 4 billion herbal medicines, and the market was expanding day by day.

As many as 910 pharmaceutical companies have been issued licences, out of which 620 are functional in the country including 22 multinational companies.

It has been learnt that not even a single multinational company had acquired the Food and Drugs Association (FDA) certification from the USA and Europe's Good Manufacturing Practices (GMP).

On the other hand, three national companies including Getz Pharma had got the

World Health Organisation (WHO) certification and it was exporting medicines to 66 countries.

The CCL Pharma has also got approval of the WHO pre-qualification certification and was exporting medicines to 35 countries, while Pacific Pharma had already got European GMP and exporting medicines to 18 countries including Germany and England.

Currently, Pakistan's pharmaceutical market is included in top 20 markets of the world, while in 2025, it would be among top 10 markets of the world.

Therefore, in the current scenario, the step of introducing the CTD

formate by DRAP was a good step. However, some experts of the sector have expressed their reservations regarding the training and capacity building of the pharma industry employees before launch of the formate.

They have also expressed reservations over provision of online data of prices of medicines by the local pharmaceutical companies, which till date had not been provided to DRAP.

Moreover, there is no check on prices of medicines due to absence of online data of pharmaceutical companies.

APP