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February 2022 marks my completing 47 years of working in Pharma Industry. Allah be praised. I am still working. The first half of my working career was spent in Multinational companies, and the latter half in the Local Pharma, making me well-versed with both innovators and generics markets. I also had the opportunity to work in business as well as operations.
My journey of near half century is also the journey of Pharma Industry in Pakistan. Great changes have occurred in this time and a lot could be written about it. In my blogs, which were started about four and a half years ago, I have covered several topics related to Pakistan Pharma Industry. This multi-part series shall do and review the SWOT – Strengths, Weaknesses, Opportunities, Threats – of the Pharma Industry.
SWOT – WEAKNESSES
As mentioned in the introduction of SWOT, Strengths and Weaknesses are internal while Opportunities and Threats are external.
Another point to mention is that my focus is mostly on Local Pharma which is dominating the Pharma Industry since many years.
- Research & Development – Local Pharma has not developed R&D – research and development facilities and activities. Pharmaceutical development internationally starts from identification of new, prospective drug molecules. The process itself is elaborate and tedious where multiple compounds are screened to get few promising ones. Then, in the Pre-clinical Stage, toxicology studies are performed on animals. Clearance from this stage will take the process to efficacy assessment in animal models. Clinical Stage would be next where Phase II and III studies will determine the safety and efficacy in humans. If all goes well, the data is submitted to relevant regulatory authority for grant of registration for marketing. It is a long, arduous, expensive process, and it is now estimated that a new drug candidate may take 7-10 years and one billion US$ from identification to get to market. For this reason, NCEs – New Chemical Entities, or entirely new drugs development is restricted to the US and Europe. It is not being done elsewhere.
R&D in other countries is limited to formulation development of generic versions, their testing and rarely some clinical work. Pakistan Local Pharma has burgeoned in size, volume, and market share, but has constantly refused to invest in R&D. The formulations are developed by copying information available in the public domain, and even those are adjusted to reduce costs. The formulated drugs thus developed carry a hypothetical efficacy profile. In the developed countries, generic formulations are required to get BE – Bio-Equivalence studies in healthy, human volunteers to show that the pharmacokinetic profile (absorption, metabolism, distribution, excretion) of innovator and generic version matches. It would be an indicator that both versions may provide matching efficacy. There is no center for conducting BE study in Pakistan. Couple of very basic facilities were developed in the private sector some twenty years ago, whose data was not reliable. Those centers have also closed for many years. The nearest country to get BE done is India. Next step is to do clinical studies of generic version in patients to establish the efficacy. International CROs – Clinical Research Organizations are located in India, Jordan, China, South Korea, whose data is acceptable everywhere in the world. These are expensive, and a BE study may cost 60,000 – 100,000 US$. Large companies in Pakistan can afford this money, while the smaller ones simply cannot. Nobody does it because our regulatory agency, DRAP, does not require it for registration of the product. These are the reasons that Local Pharma has never been pushed to invest in R&D.
The flip side of this omission is that Local Pharma cannot export its generic products to any of the SRA – Stringent Regulatory Authority Countries and is therefore limited to exporting to countries like ours and even below us. Our neighbor India exports over 20 billion US$ worth of generics annually to the US and other SRA countries – Canada, UK, EU, Australia, Japan, Malaysia, Brazil etc. One estimate says that almost 40% generics sold on the US market are of Indian origin.
Lack of interest in investing in R &D is a serious handicap in improving overall quality of Local Pharma.
- International Certifications – this is another area of self-inflicted weakness. International Certification is a process in which a Pharma company applies for registration of product in an SRA country, or to WHO – World Health Organization. The first step is to develop and submit the drug dossier for registration. After the dossier has been accepted, the regulatory body of that country sends a team of inspectors to visit the manufacturing site and see if it complies with the international GMP standards. If the manufacturing site is cleared, the product will be registered, and the plant would be certified as compliant to that country’s regulatory body standards. Some of these are US FDA, UK MHRA, EU EMA, Australia TGA, and Japan PMDA. Pakistan has only one manufacturing site whose one section has been certified by UK MHRA. India has over 40 sites approved by USFDA which is the most stringent. In fact, USFDA has a camp office in India for inspections and re-inspections.
WHO is also a global buyer of medicines for its programs running in poor countries. For this purpose, they approve manufacturing sites in various countries, and these are known as GDF – Global Drug Facilities. The process for getting approved as GDF is the same as outlined above. WHO runs the process itself, however. GDF status does not mean that the same drugs can be exported to SRA countries. In Pakistan, two manufacturing sites have recently been approved by WHO for one product each. Probably four more are planning to start the process.
Two certifications are available which make the manufacturing site eligible to export to relevant countries. EU GMP certification is good for exporting to EU countries. The process follows the same pattern as above.
PIC/S – Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme was founded in 1970 by the European Free Trade Association – EFTA. It was established as an instrument to improve cooperation is the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.
PIC/s certification is first awarded to the regulatory agency of a country who then becomes eligible to certify the manufacturing sites in their own country. PIC/S carries following benefits.
- Recognition that inspection carried out by officials of one member country will be considered valid by other members.
- Inspection methodology which makes inspectors in each member country follow the same best practices thereby standardizing the process.
- Training of inspectors
- Harmonization of written standards of Good Manufacturing Practices.
- Communication between member country inspectors and regulatory agencies.
Iran, Indonesia, Malaysia, Thailand, and Turkey are PIC/S members since many years. Pakistan regulatory agency DRAP had probably been pursuing membership of PIC/S, but the progress in unquantified. Recent statement of the new CEO DRAP promises to pursue WHO certification, but not PIC/S.
Lack of International Certifications puts Local Pharma in Pakistan at great disadvantage to expand business outside Pakistan. Many companies are exporting to several countries in Africa, Central Asia, South Asia but our total export volume is very small, and it will stay small unless our manufacturers make real effort to get international certifications.
To be Continued……
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