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Continued from last…….
International Business has and is still evolving in various forms. However, the pace at which our pharma industry has embraced regulatory changes happening worldwide is not in line with the pace of changes. Consequently, Pharma Industry’s capability to compete internationally has weakened over time. My analysis of situation is as under.
There are two kinds of regulatory barriers which have developed quite rapidly. One, which are aimed at truly upgrading the standard of Pharmaceutical manufacturing in general. These have invariably come from the developed countries. The other larger portion is ‘protectionist’ in nature and is aimed at either maintaining technological supremacy or discouraging imports so that indigenous industry flourishes.
While WTO endeavored to open the world to trade freely across the globe, at the same time, it gave rise to regional protective movements. The NAFTA (North America Free Trade Agreement), SAFTA (South Asia Free Trade Agreement), South & South IBSA (India, Brazil, South Africa), COMESA (Common Markets East and South Africa), ASEAN (Association of South East Asian Countries), CIS (Common Wealth of Independent States), SAARC (South Asian Association for Regional Cooperation). Some of these became very active while others just dragged. ASEAN for example is very active and keeps doing something.
On the regulatory front, USFDA, Health Canada, EMA (EU), MHRA (UK), PMDA (Japan), TGA (Australia) are leading. PIC/s is trailing and though the number of member countries is increasing but the acceptance is variable. Countries such as ours are in nobody’s league. They kept getting pushed from one corner to the other.
Our Pharma Industry has consistently stuck to old habits. And it reflects the mindset of our businessmen. It is ironic that our politicians want to live abroad but want to do politics in Pakistan; our businessmen want to earn here and invest abroad; and our public cries Islam but desires to live in non-Islamic countries.
It is a sad commentary that out of 700 Pharma manufacturing companies, none has international certification. Of course, the reason is lack of investment in facilities although the business has grown rapidly and the ‘Billion Club’ is now fairly crowded.
Our regulatory policies have definitely contributed to evolution of fragmented industry. If the MoH had allowed ‘Contract Manufacturing’ and ‘Contract Marketing’ it would help to develop upgraded manufacturing facilities which would provide contract manufacturing for number of marketing companies. DRAP still does not subscribe to this idea. The result is that anyone desirous of coming into Pharma business is forced to build a manufacturing unit, albeit a barely acceptable one.
These factors put together dictate a rather gloomy outlook for IM&S in Pakistan. Pakistan Pharma is falling short on regulatory parameters and finding itself unable to compete on prices. There has been virtually no investment on basic manufacturing. Pakistan Pharma is forced to import almost all Active Pharmaceutical Ingredients and Excipients. Even some packaging components have to be imported. China and India are the only source of APIs and Excipients. Both are forcing price increases frequently and it is squeezing the Pharma Industry. Locally, the government does not grant price increase and internationally the price competition is fierce. International business is going to be ever more difficult.
IM&S has another challenge also. Pakistan Pharma may decide to rush all resources back to domestic market if the going gets tough in international markets.
Yes. IM&S faces many challenges. Having said that, I do hope that the resilience of our people shall keep propelling it forward.