Daily Times

Despite all claims by the Special Assistant to Prime Minister on Health Services Dr Zafar Mirza, the people don’t see the results of the ‘government’s revolutionary steps to provide quality drugs on affordable prices’. Rather prices of the essential medicines are increasing day by day without any improvement in their quality. Often the essential and the life-saving drugs disappear from the pharmacy stores. They come back to the shelves only after the inflated prices.

The general perception is that the Drug Regulatory Authority of Pakistan (DRAP) despite having all powers and mandate to check the substandard medicines deliberately behaves toothless. Many have reservations on its performance. The responsible elements in the pharma industry of Pakistan have also pointed out structural flaws in DRAP several times. Inactive and inefficient processes at DRAP have been bone of contention between government and pharma industry.

On the hand, Dr Zafar Mirza has confused many of his fanfare saying that DRAP (Drug Regulatory Authority of Pakistan) would be ‘turned to an Authority’. Perhaps, we need to contextualize and appreciate his statement if it is all about improving the functional authority of DRAP and injecting the new vision and vigour to the sluggish and nonperforming watchdog. If so, only then, the government could ‘ensure quality, efficacy and prices of medicines at country level’.

Dr Mirza has rightly expressed that the pharmaceutical industry has tremendous potential to grow and play more effective role in the economic development of the state. The first step he is going to take the initiative to reviewing the Drug Act order to redress the apprehensions of pharma industry in the ‘larger interest of the [Pakistan’s] economy’. It would certainly help in revamping the drug regulatory authority to an efficient and proactive organization that is of vital importance for the development of our pharmaceutical industry.

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 format by DRAP was a good step

DRAP would be taking up the Common Technical Documentation (CTD) system for the registration of pharmaceutical companies, issuance of licenses to them and carrying out all sort of communication with them. This paperless and time-efficient system is already in place in Europe and the USA for the sake of transparency and openness.

Sources related to manufacturing of medicines said the net worth of Pakistan’s allopathic medicine market was over US$ 8 billion, besides US$ 4 billion herbal medicines, and the market was expanding day by day. The new system may expedite the process of international marketing itself.

As many as 910 pharmaceutical companies have been issued licenses, out of which 620 are functional in the country including 22 multinational companies. Unfortunately, not even a single Pakistani company had acquired the Food and Drugs Association (FDA) certification from the USA and Europe’s Good Manufacturing Practices (GMP).

Only 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 format 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 format. They have reservations over provision of online data of prices of medicines. However, the CTD system is expected to improve government’s check on prices of medicines if the data is available online and to eliminate profiteering.

Besides provision of quality affordable medicines in country, the Pakistan’s pharma industry should focus on exports as a top priority. Government that is continuously emphasizing on building the export potential of various sectors shall provide pharma export enabling environment. We are one of the few counties that possess a strong pharma footprint in terms of an industrial base and support services. Keeping in view the promising potential of pharma industry, we need to help the industry to improve the industrial base according to internationally acceptable standards and certifications to have more share in the global branded generics market of about US$ 600 billion.

None of the companies have any major international regulatory body certifications such as Medicines and Healthcare products Regulatory Agency (MHRA) UK, United States Food and Drug Administration (USFDA) etc., whereas in our neighbourhood India, Bangladesh are way ahead of our industry in this regard, and effectively competing for share in the global USD 600 billion market. A mere one per cent share of this global market would amount to USD 6 billion in exports to developed or even developing markets. Unfortunately, even our current exports are on the decline.

In order to realize the tremendous potential, Pakistan’s pharma industry needs to consolidate and invest in upgrading itself in a big way to meet international standards. This way they will be able to command better prices in international markets. Investment for this is required and for that to materialize the government needs to provide a policy framework and enabling environment for genuine businesses to thrive in the domestic market as a first step.

With consolidation and upgradation, the industry will in any case meet the domestic market requirements. In fact, the upgraded and compliant companies will and should get preference not only in the domestic private market but in institutional and government supplies. The companies will thus not only become strong players in the domestic market but effectively compete in the highly lucrative global market.

There may be far fewer companies as a result but these will be able to not only cater to the domestic market through supply of quality medicines at affordable prices but create exponential growth for their own firms too while earning valuable and much needed foreign exchange for the country.

The writer is the Director Devcom-Pakistan, an Islamabad-based policy advocacy, strategic communication and outreach consulting